{"title":"Febbre e Dolore nei Bambini","description":null,"products":[{"product_id":"tachipirina-sciroppo-bambini-paracetamolo-120-mg-5-ml","title":"Tachipirina Syrup Children Paracetamol 120 mg\/5 ml","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eAs an antipyretic: symptomatic treatment of febrile diseases such as influenza, exanthematous diseases, acute respiratory tract diseases, etc. As an analgesic: headaches, neuralgia, myalgia and other medium-level painful manifestations of various origins.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003ci\u003e \u003cu\u003eTACHIPIRINA 120mg\/5 ml syrup\u003c\/u\u003e \u003c\/i\u003e 5 ml of syrup contain \u003cu\u003eactive ingredient: paracetamol 120 mg\u003c\/u\u003e excipients with known effects: sucrose, methyl parahydroxybenzoate, sodium. \u003ci\u003e \u003cu\u003eTACHIPIRINA 100mg\/ ml oral drops, solution\u003c\/u\u003e \u003c\/i\u003e 1 ml of solution contains \u003cu\u003eactive ingredient: paracetamol 100 mg\u003c\/u\u003e excipients with known effects: sorbitol, propylene glycol For the complete list of excipients, see par. 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• \u003cu\u003eSyrup\u003c\/u\u003e: sucrose, sodium citrate, sodium saccharin, methyl parahydroxybenzoate, potassium sorbate, Macrogol 6000, citric acid monohydrate, strawberry flavour, mandarin flavour, purified water. • \u003cu\u003eOral drops\u003c\/u\u003e: propylene glycol, Macrogol 6000, sorbitol, sodium saccharin, citrus vanilla flavouring, propyl gallate, caramel (E150a), sodium edetate, purified water.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. • Patients suffering from severe hemolytic anemia (this contraindication does not refer to the 500mg oral formulations). • Severe hepatocellular insufficiency (this contraindication does not refer to the 500mg oral formulations).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eIn children up to 10 years of age it is essential to respect the dosage defined on the basis of body weight and not on the basis of age, which is approximate and indicated for information purposes only. If the child's age does not correspond to the weight shown in the table, always refer to body weight when choosing the dosage. In children weighing up to 7.2 kg it is recommended to use the formulation in drops, between 7.2 and 11 kg it is possible to use the drops or the syrup as the dosage per weight range is identical, between 12 and 32 kg it is recommended to use the syrup. The dosage scheme of Tachipirina drops is as follows.\u003c\/p\u003e\n\u003cp\u003eTACHIPIRINA DROPS.\u003c\/p\u003e\n\u003cp\u003eWeight: from 3.2 kg - Age (approximate): 0-30 days. Single dose: 8 drops. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 4.3 kg - Age (approximate): 1 month. Single dose: 10 drops. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 5.3 kg - Age (approximate): 2 months. Single dose: 13 drops. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 6.1 kg - Age (approximate): 3 months. Single dose: 22 drops. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 6.7 kg - Age (approximate): 4 months. Single dose: 25 drops. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 7.2 kg - Age (approximate): 5-6 months. Single dose: 27 drops. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 8 kg - Age (approximate): 7-10 months. Single dose: 30 drops. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 9 kg - Age (approximate): 11-14 months. Single dose: 33 drops. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 10 kg - Age (approximate): 15-19 months. Single dose: 36 drops. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 11 kg - Age (approximate): 20-23 months. Single dose: 39 drops. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eThe dosage scheme of Tachipirina syrup is as follows.\u003c\/p\u003e\n\u003cp\u003eTACHIPIRINA SYRUP.\u003c\/p\u003e\n\u003cp\u003eWeight: from 7.2 kg - Age (approximate): 5-6 months. Single dose: 4.5 ml. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 8 kg - Age (approximate): 7-10 months. Single dose: 5 ml. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 9 kg - Age (approximate): 11-14 months. Single dose: 5.5 ml. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 10 kg - Age (approximate): 15-19 months. Single dose: 6 ml. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 11 kg - Age (approximate): 20-23 months. Single dose: 6.5 ml. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 12 kg - Age (approximate): 2 years. Single dose: 7.5 ml. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 14 kg - Age (approximate): 3 years. Single dose: 8.5 ml. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 16 kg - Age (approximate): 4 years. Single dose: 10 ml. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 18 kg - Age (approximate): 5 years. Single dose: 11ml. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 20 kg - Age (approximate): 6 years. Single dose: 12.5 ml. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 22 kg - Age (approximate): 7 years. Single dose: 13.5 ml. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 25 kg - Age (approximate): 8 years. Single dose: 15.5 ml. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 28 kg - Age (approximate): 9 years. Single dose: 17.5 ml. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eWeight: from 31 kg up to 32 kg - Age (approximate): 10 years. Single dose: 19 ml. Daily dose: Up to 4 times (every 6 hours).\u003c\/p\u003e\n\u003cp\u003eIn case of jaundice in children under three months, it is advisable to reduce the single dose. In children over 10 years of age, the relationship between weight and age becomes no longer homogeneous due to pubertal development which, at the same age, has a different impact on body weight depending on the sex and individual characteristics of the child. Therefore, above 10 years of age, the dosage of the syrup is indicated in terms of weight and age ranges, as reported below. Children weighing between 33 and 40 kg (over 10 years of age and under 12 years of age): 20 ml of syrup at a time (corresponding to 480 mg), to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. Adolescents weighing more than 40 kg (aged 12 years or more) and adults: 20 ml of syrup at a time (corresponding to 480 mg), to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. The doctor must evaluate the need for treatments for more than 3 consecutive days. \u003cu\u003eMethod of administration\u003c\/u\u003e The package includes a measuring syringe with indicated level marks corresponding to 1 ml, 2 ml, 3 ml, 4 ml, 4.5 ml and 5 ml and a measuring cup with indicated level marks corresponding to 5.5 ml, 6 ml, 6.5 ml, 7.5 ml, 8.5 ml, 10 ml, 11 ml, 12.5 ml, 13.5 ml, 15.5ml, 17.5ml, 19ml \u003cu\u003eSyrup\u003c\/u\u003e The syrup contains 24 mg of paracetamol per ml of product. To open the bottle, push the cap downwards and at the same time turn to the left. To use the syringe, insert the tip of the syringe fully into the hole in the undercap: For doses greater than 5 ml, withdraw the necessary quantity with the syringe and pour the contents into the glass. Repeat the process until the mark corresponding to the indicated dosage is reached, and administer to the child, inviting him to drink. For doses in children over 10 years of age and in adults, equal to 20 ml, use the glass by filling it 2 times up to the 10 ml mark. The product must be used immediately after removal from the bottle. Any residual product in the syringe or glass must be eliminated. After use, close the bottle by screwing the cap tightly and wash the syringe and the glass with hot water. Leave them to dry, keeping them out of the reach and sight of children. \u003cu\u003eDrops\u003c\/u\u003e Each drop contains 4 mg of paracetamol. Turn the bottle upside down and pour the number of drops corresponding to the dosage to be used into 25-50 ml of water, and let the child drink. \u003ci\u003e \u003cu\u003eRenal failure\u003c\/u\u003e \u003c\/i\u003e In case of severe renal insufficiency (creatinine clearance less than 10 ml\/min), the interval between administrations must be at least 8 hours.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThis medicinal product does not require any special storage conditions.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eIn rare cases of allergic reactions, administration must be suspended and appropriate treatment instituted. Use with caution in cases of chronic alcoholism, excessive alcohol intake (3 or more alcoholic drinks per day), anorexia, bulimia or cachexia, chronic malnutrition (low hepatic glutathione reserves), dehydration, hypovolemia. Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh\u003e9), acute hepatitis, in concomitant treatment with drugs that alter liver function, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia. High or prolonged doses of the product can cause even serious alterations to the kidney and blood, therefore administration to subjects with renal insufficiency must be carried out only if actually necessary and under direct medical supervision. In case of prolonged use it is advisable to monitor liver and kidney function and blood count. During treatment with paracetamol, before taking any other medicine, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur. Invite the patient to contact the doctor before combining any other drug (see section 4.5). \u003cb\u003e \u003cu\u003eImportant information about some excipients\u003c\/u\u003e \u003c\/b\u003e \u003cu\u003eTachipirina drops, solution contains\u003c\/u\u003e: - sorbitol: patients suffering from rare hereditary problems of fructose intolerance should not take this medicine. - propylene glycol: can cause symptoms similar to those caused by alcohol. - The container of \u003cu\u003eTachipirina drops, solution\u003c\/u\u003e It is made of latex rubber. May cause serious allergic reactions. \u003cu\u003eTachipirina syrup contains\u003c\/u\u003e: - sucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. For the 15 ml dose this medicine contains 5.25 g of sucrose, for the 16.5 ml dose it contains 5.78 g of sucrose, for the 18.5 ml dose it contains 6.48 g of sucrose and for the 20 ml dose it contains 7 g of sucrose. To be taken into consideration in people suffering from diabetes mellitus. - methyl parahydroxybenzoate: may cause allergic reactions (even delayed). - sodium: this medicine contains 1.2 mmol (or 27.6 mg) sodium per 20 ml equivalent to 1.38% of the WHO recommended maximum daily intake of 2 g sodium for an adult. To be taken into consideration by people following a low sodium diet.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eOral absorption of paracetamol depends on the speed of gastric emptying. Therefore, concomitant administration of drugs that slow (e.g. anticholinergics, opioids) or increase (e.g. prokinetics) the rate of gastric emptying may result in a decrease or increase in the bioavailability of the product, respectively. Concomitant administration of cholestyramine reduces the absorption of paracetamol. The simultaneous intake of paracetamol and chloramphenicol can induce an increase in the half-life of chloramphenicol, with the risk of increasing its toxicity. The concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants can induce slight variations in INR values. In these cases, more frequent monitoring of INR values ​​should be conducted during concomitant use and after its discontinuation. Use with extreme caution and under strict control during chronic treatment with drugs that can cause the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutetimide, phenobarbital, carbamazepine). The same applies in cases of alcoholism and in patients treated with zidovudine. The administration of paracetamol can interfere with the determination of uric acid (using the phosphotungstic acid method) and with that of blood sugar (using the glucose-oxidase-peroxidase method).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eBelow are the side effects of paracetamol organized according to the MedDRA systemic and organic classification. There is insufficient data to establish the frequency of the individual effects listed.\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders: Thrombocytopenia, leukopenia, anemia, agranulocytosis.\u003c\/p\u003e\n\u003cp\u003eImmune system disorders: Hypersensitivity reactions (urticaria, laryngeal edema, angioedema, anaphylactic shock).\u003c\/p\u003e\n\u003cp\u003eNervous system disorders: Dizziness.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders: Gastrointestinal reaction.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders: Abnormal liver function, hepatitis.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders: Erythema multiforme, Stevens Johnson Syndrome, Epidermal necrolysis, rash.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders: Acute renal failure, interstitial nephritis, hematuria, anuria.\u003c\/p\u003e\n\u003cp\u003eVery rare cases of serious skin reactions have been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit\/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioni-avverse.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eThere is a risk of intoxication, especially in patients with liver disease, in cases of chronic alcoholism, in patients suffering from chronic malnutrition, and in patients receiving enzyme inducers. In these cases, overdose can be fatal.\u003c\/u\u003e \u003cu\u003eSymptoms\u003c\/u\u003e In case of accidental intake of very high doses of paracetamol, acute intoxication manifests itself with anorexia, nausea and vomiting followed by a profound deterioration of the general conditions; these symptoms typically appear within the first 24 hours. In case of overdose, paracetamol can cause hepatic cytolysis which can progress to massive and irreversible necrosis, resulting in hepatocellular failure, metabolic acidosis and encephalopathy, which can lead to coma and death. Simultaneously, an increase in the levels of hepatic transaminases, lactic dehydrogenase, and bilirubin are observed, and a reduction in prothrombin levels, which can occur in the 12-48 hours following ingestion. \u003cu\u003eTreatment\u003c\/u\u003e The measures to be adopted consist of early gastric emptying and hospitalization for the appropriate treatment, through administration, as early as possible, of N-acetylcysteine as an antidote: the dosage is 150 mg\/kg i.v. in glucose solution in 15 minutes, then 50 mg\/kg in the following 4 hours and 100 mg\/kg in the following 16 hours, for a total of 300 mg\/kg in 20 hours.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003ePregnancy: A large amount of data on pregnant women indicates neither malformation nor fetal\/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for the shortest possible time and with the lowest possible frequency. Breastfeeding: it is recommended to take\/administer this medicine only in cases of real need and under the direct supervision of a doctor.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eTachipirina does not alter the ability to drive or use machines.\u003c\/p\u003e","brand":"Angelini","offers":[{"title":"Default Title","offer_id":40207823241331,"sku":"012745016","price":7.25,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/products\/angelini-spa-tachipirina-sciroppo-bambini-paracetamolo-120-mg-5-ml-farmacia-dottor-tili-1213792758.png?v=1767125710"},{"product_id":"tachipirina-bambini-10-supposte-250-mg","title":"Tachipirina Children 10 Suppositories 250 mg","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eAs an antipyretic: symptomatic treatment of febrile diseases such as influenza, exanthematous diseases, acute respiratory tract diseases, etc. As an analgesic: headaches, neuralgia, myalgia and other medium-level painful manifestations of various origins.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003ci\u003eTACHIPIRINA 500 mg tablets.\u003c\/i\u003e Each tablet contains: \u003cu\u003eactive ingredient: paracetamol 500 mg.\u003c\/u\u003e \u003ci\u003eTACHIPIRINA 500 mg effervescent granules.\u003c\/i\u003e Each sachet contains: \u003cu\u003eactive ingredient: paracetamol 500 mg.\u003c\/u\u003e \u003cu\u003eexcipients with known effects: aspartame, maltitol, 12.3 mmol sodium per sachet\u003c\/u\u003e \u003ci\u003eTACHIPIRINA 125 mg effervescent granules. \u003c\/i\u003e Each sachet contains: \u003cu\u003eactive ingredient: paracetamol 125 mg.\u003c\/u\u003e \u003cu\u003eexcipients with known effects: aspartame, maltitol, 3.07 mmol sodium per sachet\u003c\/u\u003e \u003ci\u003e \u003cu\u003eTACHIPIRINA Infants 62.5 mg suppositories.\u003c\/u\u003e \u003c\/i\u003e Each suppository contains. \u003cu\u003eactive ingredient: paracetamol 62.5 mg\u003c\/u\u003e \u003ci\u003e \u003cu\u003eTACHIPIRINA Early Childhood 125 mg suppositories.\u003c\/u\u003e \u003c\/i\u003e Each suppository contains: \u003cu\u003eactive ingredient: paracetamol 125 mg.\u003c\/u\u003e \u003ci\u003e \u003cu\u003eTACHIPIRINA Children 250 mg suppositories.\u003c\/u\u003e \u003c\/i\u003e Each suppository contains: \u003cu\u003eactive ingredient: paracetamol 250 mg.\u003c\/u\u003e \u003ci\u003e \u003cu\u003eTACHIPIRINA Children 500 mg suppositories.\u003c\/u\u003e \u003c\/i\u003e Each suppository contains: \u003cu\u003eactive ingredient: paracetamol 500 mg.\u003c\/u\u003e \u003ci\u003e \u003cu\u003eTACHIPIRINA Adults 1000 mg suppositories.\u003c\/u\u003e \u003c\/i\u003e Each suppository contains: \u003cu\u003eactive ingredient: paracetamol 1000 mg.\u003c\/u\u003e For the complete list of excipients, see par. 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• \u003cu\u003eTablets:\u003c\/u\u003e microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, croscarmellose sodium. • \u003cu\u003eEffervescent granules\u003c\/u\u003e: maltitol, mannitol, sodium bicarbonate, anhydrous citric acid, citrus flavouring, aspartame, sodium docusate. • \u003cu\u003eSuppositories\u003c\/u\u003e: solid semi-synthetic glycerides.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• Hypersensitivity to paracetamol or to any of the excipients listed in paragraph 6.1. • Patients suffering from severe hemolytic anemia (this contraindication does not refer to the 500mg oral formulations). • Severe hepatocellular insufficiency (this contraindication does not refer to the 500mg oral formulations).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eFor children it is essential to respect the dosage defined according to their body weight, and therefore choose the suitable formulation. Approximate ages based on body weight are indicated for information. In adults, the maximum oral dosage is 3000 mg and rectally 4000 mg of paracetamol per day (see section 4.9). The doctor must evaluate the need for treatments for more than 3 consecutive days. The dosage schedule of Tachipirina in relation to body weight and route of administration is as follows: \u003cb\u003e500 mg tablets.\u003c\/b\u003e • \u003cu\u003eChildren weighing between 21 and 25 kg\u003c\/u\u003e (approximately between 6.5 and less than 8 years): ½ tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day (3 tablets). • \u003cu\u003eChildren weighing between 26 and 40 kg\u003c\/u\u003e (approximately between 8 and 11 years): 1 tablet at a time, to be repeated if necessary after 6 hours, without exceeding 4 doses per day. • \u003cu\u003eChildren weighing between 41 and 50 kg\u003c\/u\u003e (approximately between 12 and 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses per day. • \u003cu\u003eChildren weighing more than 50 kg\u003c\/u\u003e (approximately over 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • \u003cu\u003eAdults\u003c\/u\u003e: 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses per day. In case of severe pain or high fever, 2 tablets of 500 mg to be repeated if necessary after no less than 4 hours. \u003cb\u003e500 mg effervescent granules in sachets.\u003c\/b\u003e Dissolve the effervescent granules in a glass of water. • \u003cu\u003eChildren weighing between 26 and 40 kg\u003c\/u\u003e (approximately between 8 and 11 years): 1 sachet at a time, to be repeated if necessary after 6 hours, without exceeding 4 doses per day. • \u003cu\u003eChildren weighing between 41 and 50 kg\u003c\/u\u003e (approximately between 12 and 15 years): 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses per day. • \u003cu\u003eChildren weighing more than 50 kg\u003c\/u\u003e (approximately over 15 years): 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • \u003cu\u003eAdults\u003c\/u\u003e: 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. In case of severe pain or high fever, 2 sachets of 500 mg to be repeated if necessary after no less than 4 hours. \u003cb\u003e125 mg effervescent granules in sachets.\u003c\/b\u003e Dissolve the effervescent granules in a glass of water. • \u003cu\u003eChildren weighing between 7 and 10 kg\u003c\/u\u003e (approximately between 6 and 19 months): 1 sachet at a time, to be repeated if necessary after 6 hours, without exceeding 4 doses per day. • \u003cu\u003eChildren weighing between 11 and 12 kg\u003c\/u\u003e (approximately between 20 and 29 months): 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • \u003cu\u003eChildren weighing between 13 and 20 kg\u003c\/u\u003e (approximately between 30 months and less than 6.5 years): 2 sachets at a time (corresponding to 250 mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • \u003cu\u003eChildren weighing between 21 and 25 kg\u003c\/u\u003e (approximately between 6.5 and less than 8 years): 2 sachets at a time (corresponding to 250 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. \u003cb\u003e62.5 mg suppositories for newborns.\u003c\/b\u003e • \u003cu\u003eChildren weighing between 3.2 and 5 kg \u003c\/u\u003e(approximately between birth and 2 months): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. \u003cb\u003eEarly Childhood Suppositories 125 mg. \u003c\/b\u003e • \u003cu\u003eChildren weighing between 6 and 7 kg \u003c\/u\u003e(approximately between 3 and 5 months): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • \u003cu\u003eChildren weighing between 7 and 10 kg\u003c\/u\u003e (approximately between 6 and 19 months): 1 suppository at a time, to be repeated if necessary after 4 - 6 hours, without exceeding 5 administrations per day. • \u003cu\u003eChildren weighing between 11 and 12 kg\u003c\/u\u003e (approximately between 20 and 29 months): 1 suppository at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. \u003cb\u003eSuppositories Children 250 mg.\u003c\/b\u003e • \u003cu\u003eChildren weighing between 11 and 12 kg\u003c\/u\u003e (approximately between 20 and 29 months): 1 suppository at a time, to be repeated if necessary after 8 hours, without exceeding 3 doses per day. • \u003cu\u003eChildren weighing between 13 and 20 kg\u003c\/u\u003e (approximately between 30 months and less than 6.5 years): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. \u003cb\u003eSuppositories Children 500 mg.\u003c\/b\u003e • \u003cu\u003eChildren weighing between 21 and 25 kg\u003c\/u\u003e (approximately between 6.5 and less than 8 years): 1 suppository at a time, to be repeated if necessary after 8 hours, without exceeding 3 doses per day. • \u003cu\u003eChildren weighing between 26 and 40 kg\u003c\/u\u003e (approximately between 8 and 11 years): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. \u003cb\u003eSuppositories Adults of 1000 mg.\u003c\/b\u003e • \u003cu\u003eChildren weighing between 41 and 50 kg\u003c\/u\u003e (approximately between 12 and 15 years): 1 suppository at a time, to be repeated if necessary after 8 hours, without exceeding 3 doses per day. • \u003cu\u003eChildren weighing more than 50 kg\u003c\/u\u003e (approximately over 15 years): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • \u003cu\u003eAdults\u003c\/u\u003e: 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 doses per day. \u003ci\u003e \u003cu\u003eRenal failure.\u003c\/u\u003e \u003c\/i\u003e In case of severe renal insufficiency (creatinine clearance less than 10 ml\/min), the interval between administrations must be at least 8 hours.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eEffervescent tablets and granules\u003c\/u\u003e: no special precautions for storage. \u003cu\u003eSuppositories:\u003c\/u\u003e Store at a temperature not exceeding 25°C.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eIn rare cases of allergic reactions, administration must be suspended and appropriate treatment instituted. Use with caution in cases of chronic alcoholism, excessive alcohol intake (3 or more alcoholic drinks per day), anorexia, bulimia or cachexia, chronic malnutrition (low hepatic glutathione reserves), dehydration, hypovolemia. Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh\u003e9), acute hepatitis, in concomitant treatment with drugs that alter liver function, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia. High or prolonged doses of the product can cause even serious alterations to the kidney and blood, therefore administration to subjects with renal insufficiency must be carried out only if actually necessary and under direct medical supervision. In case of prolonged use it is advisable to monitor liver and kidney function and blood count. During treatment with paracetamol, before taking any other medicine, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur. Invite the patient to contact the doctor before combining any other drug. See also par. 4.5. \u003cb\u003e \u003cu\u003eImportant information about some excipients.\u003c\/u\u003e \u003c\/b\u003e \u003cu\u003eTachipirina 125 mg effervescent granules contains\u003c\/u\u003e \u003cu\u003e:\u003c\/u\u003e - \u003cb\u003easpartame\u003c\/b\u003e, is a source of phenylalanine. It can be harmful in case of phenylketonuria (deficiency of the enzyme phenylalanine hydroxylase) due to the risk linked to the accumulation of the amino acid phenylalanine. - \u003cb\u003emaltitol\u003c\/b\u003e: use with caution in patients suffering from rare hereditary problems of fructose intolerance. 70.6 mg of \u003cb\u003esodium\u003c\/b\u003e per sachet equivalent to 3.53% of the maximum daily intake recommended by WHO which corresponds to 2 g of sodium for an adult: to be taken into consideration in people with reduced kidney function or who follow a low-sodium diet. \u003cu\u003eTachipirina 500 mg effervescent granules contains:\u003c\/u\u003e - \u003cb\u003easpartame\u003c\/b\u003e, is a source of phenylalanine. It can be harmful in case of phenylketonuria (deficiency of the enzyme phenylalanine hydroxylase) due to the risk linked to the accumulation of the amino acid phenylalanine. - \u003cb\u003emaltitol\u003c\/b\u003e: use with caution in patients suffering from rare hereditary problems of fructose intolerance. - 283 mg of \u003cb\u003esodium\u003c\/b\u003e per sachet equivalent to 14.1% of the WHO recommended maximum daily intake which corresponds to 2 g of sodium for an adult. The maximum dose for this product is equivalent to 84.6% of the maximum daily sodium intake recommended by the WHO: to be taken into consideration in people with reduced kidney function or who follow a low-sodium diet.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eOral absorption of paracetamol depends on the speed of gastric emptying. Therefore, concomitant administration of drugs that slow (e.g. anticholinergics, opioids) or increase (e.g. prokinetics) the rate of gastric emptying may result in a decrease or increase in the bioavailability of the product, respectively. Concomitant administration of cholestyramine reduces the absorption of paracetamol. The simultaneous intake of paracetamol and chloramphenicol can induce an increase in the half-life of chloramphenicol, with the risk of increasing its toxicity. The concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants can induce slight variations in INR values. In these cases, more frequent monitoring of INR values ​​should be conducted during concomitant use and after its discontinuation. Use with extreme caution and under strict control during chronic treatment with drugs that can cause the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutetimide, phenobarbital, carbamazepine). The same applies in cases of alcoholism and in patients treated with zidovudine. The administration of paracetamol can interfere with the determination of uric acid (using the phosphotungstic acid method) and with that of blood sugar (using the glucose-oxidase-peroxidase method).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eBelow are the side effects of paracetamol organized according to the MedDRA systemic and organic classification. There is insufficient data to establish the frequency of the individual effects listed.\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders: Thrombocytopenia, leukopenia, anemia, agranulocytosis.\u003c\/p\u003e\n\u003cp\u003eImmune system disorders: Hypersensitivity reactions (urticaria, laryngeal edema, angioedema, anaphylactic shock).\u003c\/p\u003e\n\u003cp\u003eNervous system disorders: Dizziness.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders: Gastrointestinal reaction.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders: Abnormal liver function, hepatitis.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders: Erythema multiforme, Stevens Johnson Syndrome, Epidermal necrolysis, rash.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders: Acute renal failure, interstitial nephritis, hematuria, anuria.\u003c\/p\u003e\n\u003cp\u003eVery rare cases of serious skin reactions have been reported. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioni-avverse.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eThere is a risk of intoxication, especially in patients with liver disease, in cases of chronic alcoholism, in patients suffering from chronic malnutrition, and in patients receiving enzyme inducers. In these cases, overdose can be fatal.\u003c\/u\u003e \u003cu\u003eSymptoms\u003c\/u\u003e In case of accidental intake of very high doses of paracetamol, acute intoxication manifests itself with anorexia, nausea and vomiting followed by a profound deterioration of the general conditions; these symptoms typically appear within the first 24 hours. In case of overdose, paracetamol can cause hepatic cytolysis which can progress to massive and irreversible necrosis, resulting in hepatocellular failure, metabolic acidosis and encephalopathy, which can lead to coma and death. Simultaneously, an increase in the levels of hepatic transaminases, lactic dehydrogenase, and bilirubin are observed, and a reduction in prothrombin levels, which can occur in the 12-48 hours following ingestion. \u003cu\u003eTreatment\u003c\/u\u003e The measures to be adopted consist of early gastric emptying and hospitalization for the appropriate treatment, through administration, as early as possible, of N-acetylcysteine as an antidote: the dosage is 150 mg\/kg i.v. in glucose solution in 15 minutes, then 50 mg\/kg in the following 4 hours and 100 mg\/kg in the following 16 hours, for a total of 300 mg\/kg in 20 hours.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003ePregnancy: A large amount of data on pregnant women indicates neither malformation nor fetal\/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for the shortest possible time and with the lowest possible frequency. Breastfeeding: It is recommended to administer the product only in cases of actual need and under the direct supervision of a doctor.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eTachipirina does not alter the ability to drive or use machines.\u003c\/p\u003e","brand":"Angelini","offers":[{"title":"Default Title","offer_id":40207823994995,"sku":"012745042","price":6.5,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/angelini-tachipirina-bambini-10-supposte-250-mg-farmacia-dottor-tili-1258975883.jpg?v=1789562619"},{"product_id":"nurofen-febbre-e-dolore-200mg-5ml-sospensione-orale-gusto-fragola-senza-zucchero-100ml","title":"Nurofen Fever and Pain 200mg\/5ml oral suspension strawberry flavour sugar free 100ml","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSymptomatic treatment of fever and mild or moderate pain.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNUROFEN FEVER AND PAIN 200 mg\/5ml Oral Suspension Each ml of oral suspension contains active ingredient: ibuprofen 40 mg. Excipients with known effects: liquid maltitol, propylene glycol (present in the strawberry flavour), wheat starch (present in the orange flavour) and sodium. For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eNurofen Fever and Pain 200mg\/5ml oral suspension orange flavor without sugar \u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, orange flavor, domiphene bromide, purified water. \u003cu\u003eNurofen Fever and Pain 200mg\/5ml oral suspension strawberry flavor without sugar \u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, strawberry flavor, domiphene bromide, purified water.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• Hypersensitivity to ibuprofen or to any of the excipients listed in section 6.1. • Children under 2 years of age or weighing less than 10 kg. • The medicinal specialty is contraindicated in patients who show or have previously shown hypersensitivity (e.g. asthma, rhinitis, angioedema or urticaria) to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), in particular when hypersensitivity is associated with nasal polyposis and asthma. • Active peptic ulcer. • Severe renal or hepatic impairment (see section 4.4). • Severe heart failure (see section 4.4). • History of gastrointestinal bleeding or perforation related to previous NSAID-based therapy. • History of recurrent peptic hemorrhage\/ulcer (two or more distinct episodes of demonstrated ulceration or bleeding). • Concomitant use of NSAIDs, including specific COX-2 inhibitors. • During the last trimester of pregnancy (see section 4.6).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage \u003c\/u\u003e Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). \u003cb\u003e \u003cu\u003eAdults and adolescents over 12 years old\u003c\/u\u003e (\u003c\/b\u003e \u003cu\u003e≥ 43 kg body weight)\u003c\/u\u003e: 200-400 mg of ibuprofen (corresponding to 5 - 10 ml of oral suspension), 2-3 times a day. The interval between doses should not be less than 4 hours. Do not exceed the maximum dose of 1200 mg (30 ml) in 24 hours. Use in adults is especially indicated in patients with dysphagia. \u003cb\u003e \u003cu\u003eElderly\u003c\/u\u003e:\u003c\/b\u003e No changes to the dosage schedule are required. \u003cb\u003e \u003cu\u003ePediatric population\u003c\/u\u003e \u003c\/b\u003e \u003cb\u003e \u003cu\u003eChildren between 2 - 12 years (10 - 43 kg body weight)\u003c\/u\u003e \u003c\/b\u003e The daily dose is structured based on the weight and age of the patient. The daily dose of 20-30 mg\/kg of body weight, divided 3 times a day at 6-8 hour intervals, can be administered based on the following schedule (do not exceed the recommended doses).\u003c\/p\u003e\n\u003cp\u003eWeight: From 10 Kg - Approximate age: 2 - 3 years. Single dose in ml: 2.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 15 Kg - Approximate age: 4 - 6 years. Single dose in ml: 3.75 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 20 kg - Approximate age: 7 - 9 years. Single dose in ml: 5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 28 to 43 Kg - Approximate age: 10 - 12 years. Single dose in ml: 7.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eSpecial populations: in the case of post-vaccination fever, refer to the dosage indicated above, the administration of a single dose (2.5 ml) followed, if necessary, by another dose after 6 hours is recommended. Do not administer more than two doses in 24 hours. Consult your doctor if fever does not decrease. The product is intended for short-term treatments. If the use of the medicine is necessary for more than 3 days in children over 2 years of age, in adolescents and adults, or in the case of worsening of symptoms, a doctor should be consulted. \u003cu\u003eMethod of administration \u003c\/u\u003e Oral administration should take place using the measuring syringe or measuring spoon supplied with the product. The graduated scale on the body of the syringe highlights the marks for the different dosages: in particular the 2.5 ml mark corresponding to 100 mg of ibuprofen, the 3.75 ml mark corresponding to 150 mg of ibuprofen and the 5 ml mark corresponding to 200 mg of ibuprofen. The measuring spoon has two concave blades at the ends for the different doses: the 1.25 ml mark corresponding to 50 mg of ibuprofen, the 2.5 ml mark corresponding to 100 mg of ibuprofen and the 5 ml mark corresponding to 200 mg of ibuprofen. Patients suffering from stomach problems can take the medicine with meals. \u003cu\u003eInstructions for using the dosing syringe\u003c\/u\u003e: 1 - Unscrew the cap by pushing it downwards and turning it to the left. 2 - Insert the tip of the syringe fully into the hole in the undercap. 3 - Shake well. 4 - Turn the bottle upside down, then, holding the syringe firmly, gently pull the plunger downwards, allowing the suspension to flow into the syringe up to the mark corresponding to the desired dose. 5 - Put the bottle back in a vertical position and remove the syringe by rotating it gently. 6 - Introduce the tip of the syringe into your mouth and apply slight pressure on the plunger to let the suspension flow out. 7- After use, screw the cap to close the bottle and wash the syringe with hot water. Leave it to dry, keeping it out of the sight and reach of children.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eDo not store above 30°C.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSide effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). The use of Nurofen Fever and Pain must be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to this type of drugs. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have experienced such reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), nasal polyposis or previous episodes of angioedema (see section 4.2 and section 4.8). Gastrointestinal haemorrhage, ulceration and perforation: Gastrointestinal haemorrhage, ulceration and perforation, which may be fatal, have been reported at any time during treatment with all NSAIDs, with or without warning symptoms or previous history of serious gastrointestinal events. In dehydrated children and adolescents there is a risk of impaired renal function (see sections 4.3 and 4.8). Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (aspirin) (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Nurofen Fever and Pain, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Severe skin reactions: Severe skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. Masking symptoms of underlying infections: Nurofen Fever and Pain may mask symptoms of infection, which could delay the start of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofen Fever and Pain is administered for the relief of infection-related fever or pain, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Chickenpox can exceptionally cause serious infectious complications to the skin and soft tissues. To date, the contribution of NSAIDs in the worsening of these infections cannot be excluded, therefore it is advisable to avoid the use of Nurofen Fever and Pain in case of chickenpox. Caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a positive history of hypertension and\/or heart failure since fluid retention, hypertension and edema have been found in association with treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg\/day) are associated with an increased risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and\/or cerebrovascular disease should be treated with ibuprofen only after careful consideration. Similar considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). The use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatories requires particular caution: • in case of current or previous asthma or allergic diseases: possible deterioration of bronchoconstriction; • in the presence of coagulation defects: reduction of coagulability; • in the presence of kidney disease, heart disease or hypertension: possible critical reduction in renal function (especially in subjects with impaired renal or hepatic function, heart failure or being treated with diuretics), nephrotoxicity or fluid retention; • in the presence of liver disease: possible hepatotoxicity; • rehydrate the subject before starting and during treatment in case of dehydration (for example due to fever, vomiting or diarrhea). The following precautions become relevant during prolonged treatments: • monitor for signs or symptoms of gastrointestinal ulceration or bleeding; • monitor for signs or symptoms of hepatotoxicity; • monitor for signs or symptoms of nephrotoxicity; • if visual disturbances occur (blurred or reduced vision, scotomas, alteration of color perception): stop treatment and consult your ophthalmologist; • if signs or symptoms of meningitis arise: evaluate the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more frequent in subjects suffering from systemic lupus erythematosus and mixed connective tissue disease or other collagenopathies) (see section 4.8). Since Nurofen Fever and Pain contains \u003cb\u003eliquid maltitol\u003c\/b\u003e, patients with rare hereditary problems of fructose intolerance should not take this medicine. May have a mild laxative effect. The caloric value of maltitol is 2.3 kcal\/g. Nurofen Fever and Pain does not contain sugar and is therefore indicated for those patients who need to control their intake of sugars and calories. This medicinal product contains less than 1 mmol (23 mg) of \u003cb\u003esodium\u003c\/b\u003e for doses up to 12 ml, i.e. essentially \"sodium-free\". This medicine contains approximately 27.6 mg of \u003cb\u003esodium\u003c\/b\u003e for each 15 ml dose, equivalent to approximately 1.4% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult. NUROFEN FEVER AND PAIN 200 mg\/5ml oral suspension strawberry flavor without sugar contains approximately 16.45 mg of \u003cb\u003epropylene glycol\u003c\/b\u003e (present in the strawberry flavour) for 5 ml. NUROFEN FEVER AND PAIN 200 mg\/5ml sugar-free orange flavor oral suspension contains only a very small quantity of gluten (from\u003cb\u003ewheat starch\u003c\/b\u003e present in the orange flavour). This medicine is considered \"gluten-free\" and is very unlikely to cause problems for a celiac patient. A 5 ml dose contains no more than 0.315 micrograms of gluten. If the patient is allergic to wheat (condition other than celiac disease) he should not take this medicine.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eIbuprofen should be avoided in association with\u003c\/b\u003e: • Acetylsalicylic acid (aspirin): unless low-dose acetylsalicylic acid (no more than 75 mg per day), as per common clinical practice, has been advised by your doctor, as it may increase the risk of adverse reactions (see section 4.4). Experimental data indicate that ibuprofen can inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the paucity of data and the uncertainties relating to the application of data extrapolated ex vivo to the clinical situation do not allow definitive conclusions to be drawn on the regular use of ibuprofen; Clinically relevant effects resulting from occasional use of ibuprofen are unlikely (see section 5.1). • \u003cb\u003eOther NSAIDs including selective cyclooxygenase-2 inhibitors\u003c\/b\u003e: avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs: increased risk of side effects (see section 4.4). \u003cb\u003eIbuprofen should be used with caution in combination with:\u003c\/b\u003e • corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4); • quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures; • anticoagulants, such as warfarin: NSAIDs can increase the effects of anticoagulants (see section 4.4); • antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4); • antidiabetics: possible increase in the effect of sulfonylureas; • antivirals, such as ritonavir: possible increase in the concentration of NSAIDs; • ciclosporin: increased risk of nephrotoxicity; • mifepristone: NSAIDs must not be administered in the 8-12 days following taking mifepristone as they can reduce its effectiveness; • cytotoxics, such as methotrexate: reduction of excretion (increased risk of toxicity); • lithium: reduction of excretion (increased risk of toxicity); • tacrolimus: increased risk of nephrotoxicity; • uricosurics, such as probenecid: slows down the excretion of NSAIDs (increase in plasma concentrations); • methotrexate: potential increase in plasma concentrations of methotrexate; • zidovudine: increased risk of blood toxicity when NSAIDs are used in combination with zidovudine. There are demonstrations of increased risk of haemarthrosis and hematomas in HIV (+) haemophiliacs if treated simultaneously with zidovudine and ibuprofen; • diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking Nurofen Fever and Pain concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and periodically; • Cardiac glycosides: NSAIDs can worsen heart failure, reduce GFR (glomerular filtration rate) and increase plasma levels of glycosides.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes all those that have been recognized during treatment with ibuprofen for short periods of treatment and for daily doses up to a maximum of 1200 mg. In the case of high-dose therapies for chronic or prolonged pathologies, other undesirable effects may occur. Adverse reactions associated with the administration of ibuprofen are listed below according to system organ class and frequency. Frequencies are defined as\u003ci\u003e:\u003c\/i\u003e Very common (≥1\/10); Common (≥1\/100, \u003c1\/10); Uncommon (≥1\/1,000, \u003c1\/100); Rare (≥1\/10,000, \u003c1\/1,000); Very rare (\u003c1\/10,000); Not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Rare. Adverse reaction: Cystitis, rhinitis.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Very rare. Adverse reaction: Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis), in exceptional cases severe skin infections and soft tissue complications have been reported during a chickenpox infection.\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very rare. Adverse reaction: Hematopoiesis disorders ¹\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Uncommon. Adverse reaction: Hypersensitivity reactions manifested by urticaria and pruritus²\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Very rare. Adverse reaction: Severe hypersensitivity reactions including swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).\u003c\/p\u003e\n\u003cp\u003eMetabolism and nutrition disorders - Frequency: Not known. Adverse reaction: Fluid retention and decreased appetite³.\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Not known. Adverse reaction: Irritability\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Rare. Adverse reaction: Depression, insomnia, difficulty concentrating, emotional lability, visual and auditory disturbances.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse reaction: Headache, dizziness, drowsiness, convulsions.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse reaction: Aseptic meningitis4.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Rare. Adverse reaction: Cerebrovascular haemorrhage.\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Rare. Adverse reaction: Dry eyes.\u003c\/p\u003e\n\u003cp\u003eEar and labyrinth disorders - Frequency: Not known. Adverse reaction: Tinnitus.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Not known. Adverse reaction: Heart failure and edema5.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Rare. Adverse reaction: Palpitations.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Not known. Adverse reaction: Hypertension5 and shock.\u003c\/p\u003e\n\u003cp\u003eRespiratory, thoracic and mediastinal disorders - Frequency: Not known. Adverse reaction: Respiratory tract reactivity including asthma, laryngeal obstruction, bronchospasm or apnea, dyspnea.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse reaction: Abdominal pain, nausea and dyspepsia6.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Rare. Adverse reaction: Diarrhoea, flatulence, dry mouth, constipation and vomiting.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse reaction: Peptic ulcer, gastrointestinal perforation or bleeding, melena and haematemesis7. Mouth ulcerations and gastritis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Not known. Adverse reaction: Exacerbation of colitis and Crohn's disease8, pancreatitis, duodenitis, esophagitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse reaction: Liver dysfunction, hepatitis, jaundice, hepatorenal syndrome, hepatic necrosis, hepatic failure.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse reaction: Various skin rashes²\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse reaction: Bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis².\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Rare. Adverse reaction: Exfoliative dermatitis, alopecia, photosensitivity reactions.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse reaction: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG).\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Rare. Adverse reaction: Tubular necrosis, glomerular nephritis, polyuria, hematuria.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse reaction: Acute renal failure9.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Rare. Adverse reaction: Decreased hematocrit levels.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Very rare. Adverse reaction: Decreased hemoglobin levels.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some adverse reactions\u003c\/b\u003e \u003csup\u003e1\u003c\/sup\u003e Hematopoiesis disorders including anemia, aplastic anemia, hemolytic anemia (positive Coombs test), leukopenia, neutropenia, thrombocytopenia (with or without purpura), eosinophilia, pancytopenia, and agranulocytosis. The first symptoms may be: fever, sore throat, superficial mouth ulcers, flu-like symptoms, marked fatigue, nosebleeds and bleeding. Rarely congestive heart failure in patients with impaired cardiac function. ² Hypersensitivity reactions: these reactions include a) non-specific allergic reactions and anaphylaxis, fever, chills, b) respiratory tract reactivity including asthma, aggravated asthma, bronchospasm (see section 4.3 and 4.4) or dyspnoea or c) various skin conditions including various skin rashes (including maculopapular in nature), pruritus, urticaria with or without angioedema, purpura, angioedema and much rarely, bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme. ³ Decreased appetite: generally resolves rapidly upon discontinuation of treatment (see section 4.4). \u003csup\u003e4.\u003c\/sup\u003e The pathogenetic mechanism of drug-induced aseptic meningitis is not completely known. However, the data available on aseptic meningitis related to the administration of NSAIDs leads us to think of an immune reaction (due to a temporal relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of symptoms of aseptic meningitis (such as stiff neck, neck numbness, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune diseases (such as systemic lupus erythromatosus, mixed connective tissue disease). \u003csup\u003e5\u003c\/sup\u003e Heart failure and edema: Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Congestive heart failure in patients with impaired cardiac function. \u003csup\u003e6\u003c\/sup\u003e The most commonly observed adverse events are gastrointestinal in nature. Gastric discomfort can be reduced by taking the medicine on a full stomach. \u003csup\u003e7\u003c\/sup\u003e Peptic ulcers, gastrointestinal perforation or hemorrhage, melena, and sometimes fatal hematemesis may occur. \u003csup\u003e8\u003c\/sup\u003e Exacerbation of colitis and Crohn's disease (see section 4.4). \u003csup\u003e9\u003c\/sup\u003e Acute renal failure especially in case of long-term therapy, associated with increased serum urea levels and edema. Papillary necrosis may occur. \u003cb\u003eReporting of suspected adverse reactions\u003c\/b\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioni-avverse.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eToxicity \u003c\/u\u003e Signs and symptoms of toxicity were generally not observed at doses below 100 mg\/kg in children or adults. However, in some cases supportive treatment may be necessary. Children have been observed to exhibit signs and symptoms of toxicity after ingesting ibuprofen at doses of 400 mg\/kg or greater. The half-life of the drug in case of overdose is 1.5-3 hours. \u003cu\u003eSymptoms \u003c\/u\u003e Most patients who accidentally ingest clinically relevant quantities of ibuprofen will experience symptoms within 4 to 6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea and CNS and respiratory depression have also been reported rarely. Disorientation, arousal, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In cases of severe poisoning, metabolic acidosis and a prolongation of the prothrombin time (INR) may occur, probably caused by interference with the action of coagulation factors present in the circulation. In asthmatic subjects, an exacerbation of the symptoms of the disease may occur. \u003cu\u003eTreatment \u003c\/u\u003e There is no specific antidote for ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is therefore indicated and must include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilised. Particular attention is due to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic quantity. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam or lorazepam. If ibuprofen has already been absorbed, alkaline substances should be administered to promote excretion of the acidic ibuprofen in the urine. Administer bronchodilators in case of asthma. Depending on the patient's clinical condition, other support measures may be necessary. For more information, contact your local poison control center.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eChildren under the age of 12 are unlikely to become pregnant or breastfeed. Furthermore, in such circumstances the following considerations must be kept in mind. \u003cu\u003ePregnancy \u003c\/u\u003e During the first and second trimesters of pregnancy, administration of ibuprofen should be avoided. Ibuprofen is contraindicated during the third trimester of pregnancy. Inhibition of prostaglandin synthesis can negatively affect pregnancy and\/or embryo\/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was thought to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction which may progress to renal failure with oligo-hydramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. \u003cu\u003eBreastfeeding \u003c\/u\u003e There is limited data showing that ibuprofen can pass in low concentrations into breast milk and is unlikely to have any adverse effects on newborns.\u003cu\u003eFertility \u003c\/u\u003e There is evidence that medicinal products that inhibit the synthesis of cyclooxygenase\/prostaglandins can cause a weakening of female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment. The administration of Nurofen should be suspended in women who have fertility problems or who are undergoing fertility investigations.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eFor short periods of treatment, Nurofen Fever and Pain does not or negligibly alter the ability to drive and use machinery.\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51131206107463,"sku":"034102386","price":16.91,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofen-febbre-e-dolore-200mg-5ml-sospensione-orale-gusto-fragola-senza-zucchero-100ml-farmacia-dottor-tili-1213792372.jpg?v=1767142149"},{"product_id":"nurofen-febbre-e-dolore-200mg-5ml-sospensione-orale-gusto-arancia-100ml","title":"Nurofen Fever and Pain 200mg\/5ml oral suspension orange flavour 100ml","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSymptomatic treatment of fever and mild or moderate pain.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNUROFEN FEVER AND PAIN 200 mg\/5ml Oral Suspension Each ml of oral suspension contains active ingredient: ibuprofen 40 mg. Excipients with known effects: liquid maltitol, propylene glycol (present in the strawberry flavour), wheat starch (present in the orange flavour) and sodium. For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eNurofen Fever and Pain 200mg\/5ml oral suspension orange flavor without sugar \u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, orange flavor, domiphene bromide, purified water. \u003cu\u003eNurofen Fever and Pain 200mg\/5ml oral suspension strawberry flavor without sugar \u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, strawberry flavor, domiphene bromide, purified water.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• Hypersensitivity to ibuprofen or to any of the excipients listed in section 6.1. • Children under 2 years of age or weighing less than 10 kg. • The medicinal specialty is contraindicated in patients who show or have previously shown hypersensitivity (e.g. asthma, rhinitis, angioedema or urticaria) to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), in particular when hypersensitivity is associated with nasal polyposis and asthma. • Active peptic ulcer. • Severe renal or hepatic impairment (see section 4.4). • Severe heart failure (see section 4.4). • History of gastrointestinal bleeding or perforation related to previous NSAID-based therapy. • History of recurrent peptic hemorrhage\/ulcer (two or more distinct episodes of demonstrated ulceration or bleeding). • Concomitant use of NSAIDs, including specific COX-2 inhibitors. • During the last trimester of pregnancy (see section 4.6).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage \u003c\/u\u003e Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). \u003cb\u003e \u003cu\u003eAdults and adolescents over 12 years old\u003c\/u\u003e (\u003c\/b\u003e \u003cu\u003e≥ 43 kg body weight)\u003c\/u\u003e: 200-400 mg of ibuprofen (corresponding to 5 - 10 ml of oral suspension), 2-3 times a day. The interval between doses should not be less than 4 hours. Do not exceed the maximum dose of 1200 mg (30 ml) in 24 hours. Use in adults is especially indicated in patients with dysphagia. \u003cb\u003e \u003cu\u003eElderly\u003c\/u\u003e:\u003c\/b\u003e No changes to the dosage schedule are required. \u003cb\u003e \u003cu\u003ePediatric population\u003c\/u\u003e \u003c\/b\u003e \u003cb\u003e \u003cu\u003eChildren between 2 - 12 years (10 - 43 kg body weight)\u003c\/u\u003e \u003c\/b\u003e The daily dose is structured based on the weight and age of the patient. The daily dose of 20-30 mg\/kg of body weight, divided 3 times a day at 6-8 hour intervals, can be administered based on the following schedule (do not exceed the recommended doses).\u003c\/p\u003e\n\u003cp\u003eWeight: From 10 Kg - Approximate age: 2 - 3 years. Single dose in ml: 2.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 15 Kg - Approximate age: 4 - 6 years. Single dose in ml: 3.75 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 20 kg - Approximate age: 7 - 9 years. Single dose in ml: 5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 28 to 43 Kg - Approximate age: 10 - 12 years. Single dose in ml: 7.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eSpecial populations: in the case of post-vaccination fever, refer to the dosage indicated above, the administration of a single dose (2.5 ml) followed, if necessary, by another dose after 6 hours is recommended. Do not administer more than two doses in 24 hours. Consult your doctor if fever does not decrease. The product is intended for short-term treatments. If the use of the medicine is necessary for more than 3 days in children over 2 years of age, in adolescents and adults, or in the case of worsening of symptoms, a doctor should be consulted. \u003cu\u003eMethod of administration \u003c\/u\u003e Oral administration should take place using the measuring syringe or measuring spoon supplied with the product. The graduated scale on the body of the syringe highlights the marks for the different dosages: in particular the 2.5 ml mark corresponding to 100 mg of ibuprofen, the 3.75 ml mark corresponding to 150 mg of ibuprofen and the 5 ml mark corresponding to 200 mg of ibuprofen. The measuring spoon has two concave blades at the ends for the different doses: the 1.25 ml mark corresponding to 50 mg of ibuprofen, the 2.5 ml mark corresponding to 100 mg of ibuprofen and the 5 ml mark corresponding to 200 mg of ibuprofen. Patients suffering from stomach problems can take the medicine with meals. \u003cu\u003eInstructions for using the dosing syringe\u003c\/u\u003e: 1 - Unscrew the cap by pushing it downwards and turning it to the left. 2 - Insert the tip of the syringe fully into the hole in the undercap. 3 - Shake well. 4 - Turn the bottle upside down, then, holding the syringe firmly, gently pull the plunger downwards, allowing the suspension to flow into the syringe up to the mark corresponding to the desired dose. 5 - Put the bottle back in a vertical position and remove the syringe by rotating it gently. 6 - Introduce the tip of the syringe into your mouth and apply slight pressure on the plunger to let the suspension flow out. 7- After use, screw the cap to close the bottle and wash the syringe with hot water. Leave it to dry, keeping it out of the sight and reach of children.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eDo not store above 30°C.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSide effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). The use of Nurofen Fever and Pain must be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to this type of drugs. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have experienced such reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), nasal polyposis or previous episodes of angioedema (see section 4.2 and section 4.8). Gastrointestinal haemorrhage, ulceration and perforation: Gastrointestinal haemorrhage, ulceration and perforation, which may be fatal, have been reported at any time during treatment with all NSAIDs, with or without warning symptoms or previous history of serious gastrointestinal events. In dehydrated children and adolescents there is a risk of impaired renal function (see sections 4.3 and 4.8). Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (aspirin) (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Nurofen Fever and Pain, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Severe skin reactions: Severe skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. Masking symptoms of underlying infections: Nurofen Fever and Pain may mask symptoms of infection, which could delay the start of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofen Fever and Pain is administered for the relief of infection-related fever or pain, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Chickenpox can exceptionally cause serious infectious complications to the skin and soft tissues. To date, the contribution of NSAIDs in the worsening of these infections cannot be excluded, therefore it is advisable to avoid the use of Nurofen Fever and Pain in case of chickenpox. Caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a positive history of hypertension and\/or heart failure since fluid retention, hypertension and edema have been found in association with treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg\/day) are associated with an increased risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and\/or cerebrovascular disease should be treated with ibuprofen only after careful consideration. Similar considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). The use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatories requires particular caution: • in case of current or previous asthma or allergic diseases: possible deterioration of bronchoconstriction; • in the presence of coagulation defects: reduction of coagulability; • in the presence of kidney disease, heart disease or hypertension: possible critical reduction in renal function (especially in subjects with impaired renal or hepatic function, heart failure or being treated with diuretics), nephrotoxicity or fluid retention; • in the presence of liver disease: possible hepatotoxicity; • rehydrate the subject before starting and during treatment in case of dehydration (for example due to fever, vomiting or diarrhea). The following precautions become relevant during prolonged treatments: • monitor for signs or symptoms of gastrointestinal ulceration or bleeding; • monitor for signs or symptoms of hepatotoxicity; • monitor for signs or symptoms of nephrotoxicity; • if visual disturbances occur (blurred or reduced vision, scotomas, alteration of color perception): stop treatment and consult your ophthalmologist; • if signs or symptoms of meningitis arise: evaluate the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more frequent in subjects suffering from systemic lupus erythematosus and mixed connective tissue disease or other collagenopathies) (see section 4.8). Since Nurofen Fever and Pain contains \u003cb\u003eliquid maltitol\u003c\/b\u003e, patients with rare hereditary problems of fructose intolerance should not take this medicine. May have a mild laxative effect. The caloric value of maltitol is 2.3 kcal\/g. Nurofen Fever and Pain does not contain sugar and is therefore indicated for those patients who need to control their intake of sugars and calories. This medicinal product contains less than 1 mmol (23 mg) of \u003cb\u003esodium\u003c\/b\u003e for doses up to 12 ml, i.e. essentially \"sodium-free\". This medicine contains approximately 27.6 mg of \u003cb\u003esodium\u003c\/b\u003e for each 15 ml dose, equivalent to approximately 1.4% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult. NUROFEN FEVER AND PAIN 200 mg\/5ml oral suspension strawberry flavor without sugar contains approximately 16.45 mg of \u003cb\u003epropylene glycol\u003c\/b\u003e (present in the strawberry flavour) for 5 ml. NUROFEN FEVER AND PAIN 200 mg\/5ml sugar-free orange flavor oral suspension contains only a very small quantity of gluten (from\u003cb\u003ewheat starch\u003c\/b\u003e present in the orange flavour). This medicine is considered \"gluten-free\" and is very unlikely to cause problems for a celiac patient. A 5 ml dose contains no more than 0.315 micrograms of gluten. If the patient is allergic to wheat (condition other than celiac disease) he should not take this medicine.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eIbuprofen should be avoided in association with\u003c\/b\u003e: • Acetylsalicylic acid (aspirin): unless low-dose acetylsalicylic acid (no more than 75 mg per day), as per common clinical practice, has been advised by your doctor, as it may increase the risk of adverse reactions (see section 4.4). Experimental data indicate that ibuprofen can inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the paucity of data and the uncertainties relating to the application of data extrapolated ex vivo to the clinical situation do not allow definitive conclusions to be drawn on the regular use of ibuprofen; Clinically relevant effects resulting from occasional use of ibuprofen are unlikely (see section 5.1). • \u003cb\u003eOther NSAIDs including selective cyclooxygenase-2 inhibitors\u003c\/b\u003e: avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs: increased risk of side effects (see section 4.4). \u003cb\u003eIbuprofen should be used with caution in combination with:\u003c\/b\u003e • corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4); • quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures; • anticoagulants, such as warfarin: NSAIDs can increase the effects of anticoagulants (see section 4.4); • antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4); • antidiabetics: possible increase in the effect of sulphonylureas; • antivirals, such as ritonavir: possible increase in the concentration of NSAIDs; • ciclosporin: increased risk of nephrotoxicity; • mifepristone: NSAIDs must not be administered in the 8-12 days following taking mifepristone as they can reduce its effectiveness; • cytotoxics, such as methotrexate: reduction of excretion (increased risk of toxicity); • lithium: reduction of excretion (increased risk of toxicity); • tacrolimus: increased risk of nephrotoxicity; • uricosurics, such as probenecid: slows down the excretion of NSAIDs (increase in plasma concentrations); • methotrexate: potential increase in plasma concentrations of methotrexate; • zidovudine: increased risk of blood toxicity when NSAIDs are used in combination with zidovudine. There are demonstrations of increased risk of haemarthrosis and hematomas in HIV (+) haemophiliacs if treated simultaneously with zidovudine and ibuprofen; • diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking Nurofen Fever and Pain concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and periodically; • Cardiac glycosides: NSAIDs can worsen heart failure, reduce GFR (glomerular filtration rate) and increase plasma levels of glycosides.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes all those that have been recognized during treatment with ibuprofen for short periods of treatment and for daily doses up to a maximum of 1200 mg. In the case of high-dose therapies for chronic or prolonged pathologies, other undesirable effects may occur. Adverse reactions associated with the administration of ibuprofen are listed below according to system organ class and frequency. Frequencies are defined as\u003ci\u003e:\u003c\/i\u003e Very common (≥1\/10); Common (≥1\/100, \u003c1\/10); Uncommon (≥1\/1,000, \u003c1\/100); Rare (≥1\/10,000, \u003c1\/1,000); Very rare (\u003c1\/10,000); Not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Rare. Adverse reaction: Cystitis, rhinitis.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Very rare. Adverse reaction: Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis), in exceptional cases severe skin infections and soft tissue complications have been reported during a chickenpox infection.\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very rare. Adverse reaction: Hematopoiesis disorders ¹\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Uncommon. Adverse reaction: Hypersensitivity reactions manifested by urticaria and pruritus²\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Very rare. Adverse reaction: Severe hypersensitivity reactions including swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).\u003c\/p\u003e\n\u003cp\u003eMetabolism and nutrition disorders - Frequency: Not known. Adverse reaction: Fluid retention and decreased appetite³.\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Not known. Adverse reaction: Irritability\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Rare. Adverse reaction: Depression, insomnia, difficulty concentrating, emotional lability, visual and auditory disturbances.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse reaction: Headache, dizziness, drowsiness, convulsions.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse reaction: Aseptic meningitis4.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Rare. Adverse reaction: Cerebrovascular haemorrhage.\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Rare. Adverse reaction: Dry eyes.\u003c\/p\u003e\n\u003cp\u003eEar and labyrinth disorders - Frequency: Not known. Adverse reaction: Tinnitus.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Not known. Adverse reaction: Heart failure and edema5.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Rare. Adverse reaction: Palpitations.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Not known. Adverse reaction: Hypertension5 and shock.\u003c\/p\u003e\n\u003cp\u003eRespiratory, thoracic and mediastinal disorders - Frequency: Not known. Adverse reaction: Respiratory tract reactivity including asthma, laryngeal obstruction, bronchospasm or apnea, dyspnea.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse reaction: Abdominal pain, nausea and dyspepsia6.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Rare. Adverse reaction: Diarrhoea, flatulence, dry mouth, constipation and vomiting.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse reaction: Peptic ulcer, gastrointestinal perforation or bleeding, melena and haematemesis7. Mouth ulcerations and gastritis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Not known. Adverse reaction: Exacerbation of colitis and Crohn's disease8, pancreatitis, duodenitis, esophagitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse reaction: Liver dysfunction, hepatitis, jaundice, hepatorenal syndrome, hepatic necrosis, hepatic failure.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse reaction: Various skin rashes²\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse reaction: Bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis².\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Rare. Adverse reaction: Exfoliative dermatitis, alopecia, photosensitivity reactions.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse reaction: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG).\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Rare. Adverse reaction: Tubular necrosis, glomerular nephritis, polyuria, hematuria.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse reaction: Acute renal failure9.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Rare. Adverse reaction: Decreased hematocrit levels.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Very rare. Adverse reaction: Decreased hemoglobin levels.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some adverse reactions\u003c\/b\u003e \u003csup\u003e1\u003c\/sup\u003e Hematopoiesis disorders including anemia, aplastic anemia, hemolytic anemia (positive Coombs test), leukopenia, neutropenia, thrombocytopenia (with or without purpura), eosinophilia, pancytopenia, and agranulocytosis. The first symptoms may be: fever, sore throat, superficial mouth ulcers, flu-like symptoms, marked fatigue, nosebleeds and bleeding. Rarely congestive heart failure in patients with impaired cardiac function. ² Hypersensitivity reactions: these reactions include a) non-specific allergic reactions and anaphylaxis, fever, chills, b) respiratory tract reactivity including asthma, aggravated asthma, bronchospasm (see section 4.3 and 4.4) or dyspnoea or c) various skin conditions including various skin rashes (including maculopapular in nature), pruritus, urticaria with or without angioedema, purpura, angioedema and much rarely, bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme. ³ Decreased appetite: generally resolves rapidly upon discontinuation of treatment (see section 4.4). \u003csup\u003e4.\u003c\/sup\u003e The pathogenetic mechanism of drug-induced aseptic meningitis is not completely known. However, the data available on aseptic meningitis related to the administration of NSAIDs leads us to think of an immune reaction (due to a temporal relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of symptoms of aseptic meningitis (such as stiff neck, neck numbness, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune diseases (such as systemic lupus erythromatosus, mixed connective tissue disease). \u003csup\u003e5\u003c\/sup\u003e Heart failure and edema: Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Congestive heart failure in patients with impaired cardiac function. \u003csup\u003e6\u003c\/sup\u003e The most commonly observed adverse events are gastrointestinal in nature. Gastric discomfort can be reduced by taking the medicine on a full stomach. \u003csup\u003e7\u003c\/sup\u003e Peptic ulcers, gastrointestinal perforation or hemorrhage, melena, and sometimes fatal hematemesis may occur. \u003csup\u003e8\u003c\/sup\u003e Exacerbation of colitis and Crohn's disease (see section 4.4). \u003csup\u003e9\u003c\/sup\u003e Acute renal failure especially in case of long-term therapy, associated with increased serum urea levels and edema. Papillary necrosis may occur. \u003cb\u003eReporting of suspected adverse reactions\u003c\/b\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioni-avverse.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eToxicity \u003c\/u\u003e Signs and symptoms of toxicity were generally not observed at doses below 100 mg\/kg in children or adults. However, in some cases supportive treatment may be necessary. Children have been observed to exhibit signs and symptoms of toxicity after ingesting ibuprofen at doses of 400 mg\/kg or greater. The half-life of the drug in case of overdose is 1.5-3 hours. \u003cu\u003eSymptoms \u003c\/u\u003e Most patients who accidentally ingest clinically relevant quantities of ibuprofen will experience symptoms within 4 to 6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea and CNS and respiratory depression have also been reported rarely. Disorientation, arousal, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In cases of severe poisoning, metabolic acidosis and a prolongation of the prothrombin time (INR) may occur, probably caused by interference with the action of coagulation factors present in the circulation. In asthmatic subjects, an exacerbation of the symptoms of the disease may occur. \u003cu\u003eTreatment \u003c\/u\u003e There is no specific antidote for ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is therefore indicated and must include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilised. Particular attention is due to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic quantity. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam or lorazepam. If ibuprofen has already been absorbed, alkaline substances should be administered to promote excretion of the acidic ibuprofen in the urine. Administer bronchodilators in case of asthma. Depending on the patient's clinical condition, other support measures may be necessary. For more information, contact your local poison control center.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eChildren under the age of 12 are unlikely to become pregnant or breastfeed. Furthermore, in such circumstances the following considerations must be kept in mind. \u003cu\u003ePregnancy \u003c\/u\u003e During the first and second trimesters of pregnancy, administration of ibuprofen should be avoided. Ibuprofen is contraindicated during the third trimester of pregnancy. Inhibition of prostaglandin synthesis can negatively affect pregnancy and\/or embryo\/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was thought to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction which may progress to renal failure with oligo-hydramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. \u003cu\u003eBreastfeeding \u003c\/u\u003e There is limited data showing that ibuprofen can pass in low concentrations into breast milk and is unlikely to have any adverse effects on newborns.\u003cu\u003eFertility \u003c\/u\u003e There is evidence that medicinal products that inhibit the synthesis of cyclooxygenase\/prostaglandins can cause a weakening of female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment. The administration of Nurofen should be suspended in women who have fertility problems or who are undergoing fertility investigations.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eFor short periods of treatment, Nurofen Fever and Pain does not or negligibly alter the ability to drive and use machinery.\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51131258044743,"sku":"034102424","price":16.91,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofen-febbre-e-dolore-200mg-5ml-sospensione-orale-gusto-arancia-100ml-farmacia-dottor-tili-1213792296.jpg?v=1767143868"},{"product_id":"nurofen-febbre-e-dolore-bambini-100-mg-5-ml-150-ml-sospensione-senza-zucchero-gusto-arancia-con-siringa","title":"Nurofen fever and pain children 100 mg\/5 ml 150 ml sugar-free suspension orange flavour with syringe","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSymptomatic treatment of fever, including post-vaccination fever, and mild or moderate pain (such as headache, toothache, sore throat, earache).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNUROFEN FEVER AND PAIN Children 100mg\/5ml Oral Suspension Each ml of oral suspension contains: Active ingredient: ibuprofen 20 mg. Excipients with known effects: liquid maltitol, propylene glycol (present in the strawberry flavour), wheat starch (present in the orange flavour) and sodium. For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eNurofen Fever and Pain Children 100mg\/5ml oral suspension orange flavor without sugar\u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, orange flavor, domiphene bromide, purified water. \u003cu\u003eNurofen Fever and Pain Children 100mg\/5ml oral suspension strawberry flavor without sugar\u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, strawberry flavor, domiphene bromide, purified water.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• Hypersensitivity to ibuprofen or to any of the excipients listed in section 6.1. • Children younger than 3 months or weighing less than 5.6 kg. • The medicine is contraindicated in patients who show or have previously shown hypersensitivity (e.g. asthma, rhinitis, angioedema or urticaria) to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), in particular when hypersensitivity is associated with nasal polyposis and asthma. • Active peptic ulcer. • Severe renal or hepatic impairment (see section 4.4). • Severe heart failure (see section 4.4). • History of gastrointestinal hemorrhage or perforation, related to previous NSAID-based therapy. History of recurrent hemorrhage\/peptic ulcer (two or more distinct episodes of demonstrated ulceration or bleeding). • Concomitant use of NSAIDs, including specific COX-2 inhibitors. • Patients with a history of cerebrovascular bleeding or other active bleeding. • Patients with unclear blood formation disorders. • Patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake). • During the last trimester of pregnancy (see section 4.6).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage \u003c\/u\u003e The daily dose is structured based on the weight and age of the patient. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). In children aged between 3 and 6 months, limit administration to those weighing more than 5.6 kg. \u003cu\u003eMethod of administration \u003c\/u\u003e Oral administration to infants and children aged between 3 months and 12 years should take place using the measuring syringe or measuring spoon supplied with the product. Patients suffering from stomach problems can take the medicine with meals. The daily dose of 20-30 mg\/kg of body weight, divided 3 times a day at 6-8 hour intervals, can be administered based on the following schedule (do not exceed the recommended doses). The graduated scale on the body of the syringe highlights the notches for the different dosages; in particular the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark corresponding to 100 mg of ibuprofen. The measuring spoon has two marks for two different doses: the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark corresponding to 100 mg of ibuprofen.\u003c\/p\u003e\n\u003cp\u003eWeight: From 5.6 kg - Approximate age: 3 - 6 months. Single dose in ml: 2.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 7 Kg - Approximate age: 6 - 12 months. Single dose in ml: 2.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 10 Kg - Approximate age: 1 - 3 years. Single dose in ml: 5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 15 Kg - Approximate age: 4 - 6 years. Single dose in ml: 7.5 ml (5 ml + 2.5 ml). maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 20 kg - Approximate age: 7 - 9 years. Single dose in ml: 10 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 28 to 43 Kg - Approximate age: 10 - 12 years. Single dose in ml: 15 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eIn the case of post-vaccination fever, refer to the daily dosage recommended in the table above. The product is intended for short-term treatments. In infants aged between 3 and 5 months, the doctor should be consulted if symptoms persist for more than 24 hours or in the case of worsening of symptoms. If the use of the medicine is necessary for more than 3 days in infants and children over 6 months of age and in adolescents, or in the case of worsening of symptoms, a doctor should be consulted. \u003cu\u003eInstructions for using the dosing syringe\u003c\/u\u003e: 1. Unscrew the cap by pushing it downwards and turning it to the left. 2. Insert the tip of the syringe fully into the hole in the undercap. 3. Shake well. 4. Turn the bottle upside down, then, holding the syringe firmly, gently pull the plunger downwards, allowing the suspension to flow into the syringe up to the mark corresponding to the desired dose. 5. Place the bottle back upright and remove the syringe by gently twisting it. 6. Introduce the tip of the syringe into the child's mouth, and apply slight pressure on the plunger to let the suspension flow out. 7. After use, screw the cap to close the bottle and wash the syringe with hot water. Leave it to dry, keeping it out of the reach and sight of children.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNo details.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSide effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). \u003cb\u003eOther NSAIDs:\u003c\/b\u003e the use of Nurofen Fever and Pain should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors. Analgesics, antipyretics, non-steroidal anti-inflammatories can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to this type of drugs. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have experienced such reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), hay fever, nasal polyposis, chronic obstructive respiratory diseases or previous episodes of angioedema (see section 4.2 and section 4.8). \u003cb\u003eGastrointestinal (GI) effects:\u003c\/b\u003e Gastrointestinal hemorrhage, ulceration and perforation: Gastrointestinal hemorrhage, ulceration and perforation, which may be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (aspirin) (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Nurofen Fever and Pain, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). \u003cb\u003eDermatological effects: \u003c\/b\u003esevere skin reactions: serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. Masking of symptoms of underlying infections: Nurofen Fever and Pain may mask the symptoms of infection, which may delay the initiation of appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofen Fever and Pain is administered for the relief of infection-related fever or pain, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Chickenpox can exceptionally cause serious infectious complications to the skin and soft tissues. To date, the contribution of NSAIDs in the worsening of these infections cannot be excluded, therefore it is advisable to avoid the use of Nurofen Fever and Pain in case of chickenpox. \u003cb\u003eCardiovascular and cerebrovascular effects\u003c\/b\u003e: caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a positive history of hypertension and\/or heart failure since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg\/day) are associated with an increased risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and\/or cerebrovascular disease should be treated with ibuprofen only after careful consideration. Similar considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). \u003cb\u003eRenal disorders\u003c\/b\u003e: in general, the habitual use of analgesics, especially the combination of different analgesic substances, can cause permanent kidney damage, with risk of renal failure (analgesic nephropathy). In dehydrated children and adolescents there is a risk of impaired renal function (see sections 4.3 and 4.8). In patients with heart failure, renal or hepatic failure, in those taking diuretics or who have undergone major surgery resulting in dehydration, monitoring of urine output and renal function should be considered. Other considerations: Prolonged use of any type of pain reliever for headaches can make symptoms worse. If this situation occurs or is suspected, the doctor should be consulted and treatment should be suspended. The diagnosis of medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite or because of regular use of headache medications \u003cb\u003eCompromised female fertility\u003c\/b\u003e: see paragraph 4.6. The use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatories requires particular caution: • in case of current or previous asthma or allergic diseases: possible deterioration of bronchoconstriction; in the presence of coagulation defects as ibuprofen, the active ingredient of Nurofen Fever and Pain, can temporarily inhibit the function of platelets (thrombocyte aggregation). It is therefore recommended to carefully monitor patients with coagulation disorders; • in the presence of kidney disease, heart disease or hypertension: possible critical reduction in renal function (especially in subjects with impaired renal or hepatic function, heart failure or being treated with diuretics), nephrotoxicity or fluid retention; • in the presence of liver disease: possible hepatotoxicity; • rehydrate the subject before starting and during treatment in case of dehydration (for example due to fever, vomiting or diarrhea); • immediately after major surgery; • congenital disorders of porphyrin metabolism (for example, acute intermittent porphyria). The following precautions become relevant during prolonged treatments: • monitor for signs or symptoms of gastrointestinal ulceration or bleeding; • monitor for signs or symptoms of hepatotoxicity; • monitor for signs or symptoms of nephrotoxicity; • if visual disturbances occur (blurred or reduced vision, scotomas, alteration of color perception): stop treatment and consult your ophthalmologist; • if signs or symptoms of meningitis arise: evaluate the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more frequent in subjects suffering from systemic lupus erythematosus and mixed connective tissue disease or other collagenopathies) (see section 4.8). Since Nurofen Fever and Pain contains \u003cb\u003eliquid maltitol\u003c\/b\u003e, patients with rare hereditary problems of fructose intolerance should not take this medicine. May have a mild laxative effect. The caloric value of maltitol is 2.3 kcal\/g. Nurofen Fever and Pain does not contain sugar and is therefore indicated for those patients who need to control their intake of sugars and calories. This medicine contains 9.08 mg of \u003cb\u003esodium\u003c\/b\u003e per 5 ml equivalent to 0.45% of the WHO recommended maximum daily intake which corresponds to 2 g of sodium for an adult. NUROFEN FEVER AND PAIN Children 100mg\/5ml oral suspension strawberry flavor without sugar contains 11.75 mg of \u003cb\u003epropylene glycol\u003c\/b\u003e (present in the strawberry flavour) in 5 ml. Coadministration with any alcohol dehydrogenase substrate such as ethanol may induce serious adverse effects in neonates. NUROFEN FEVER AND PAIN Children 100mg\/5ml sugar-free orange flavor oral suspension contains only a very small quantity of gluten (from\u003cb\u003ewheat starch\u003c\/b\u003e present in the orange flavour). This medicine is considered (gluten-free) and is very unlikely to cause problems for a celiac patient. A 5 ml dose contains no more than 0.225 micrograms of gluten. If the patient is allergic to wheat (condition other than celiac disease) he should not take this medicine.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eIbuprofen should be avoided in association with\u003c\/b\u003e: • Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data indicate that ibuprofen can inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the paucity of data and the uncertainties relating to the application of data extrapolated ex vivo to the clinical situation do not allow definitive conclusions to be drawn on the regular use of ibuprofen; Clinically relevant effects resulting from occasional use of ibuprofen are unlikely (see section 5.1). • \u003cb\u003eOther NSAIDs including selective cyclooxygenase-2 inhibitors\u003c\/b\u003e: avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs: increased risk of side effects (see section 4.4). \u003cb\u003eIbuprofen should be used with caution in combination with:\u003c\/b\u003e • corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4); • quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures; • anticoagulants, such as warfarin: NSAIDs can increase the effects of anticoagulants (see section 4.4); • antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4); • phenytoin: Concomitant use of Nurofen Fever and Pain with phenytoin may increase serum levels of these medicines. Correct use of the drugs (administered for a maximum period of 3 days) does not normally require monitoring of serum phenytoin levels. • antidiabetics: an increase in the hypoglycaemic effect of sulfonylureas is possible. In the case of simultaneous treatment, monitoring of blood glucose levels is recommended. • antivirals, such as ritonavir: possible increase in the concentration of NSAIDs; • ciclosporin: increased risk of nephrotoxicity; • mifepristone: NSAIDs must not be administered in the 8-12 days following taking mifepristone as they can reduce its effectiveness; • cytotoxics, such as methotrexate: reduction of excretion (increased risk of toxicity); • lithium: reduction of excretion (increased risk of toxicity); • tacrolimus: increased risk of nephrotoxicity; • uricosurics, such as probenecid and sulfinpyrazone: slow the excretion of NSAIDs (increase in plasma concentrations); • methotrexate: potential increase in plasma concentrations of methotrexate; • zidovudine: increased risk of blood toxicity when NSAIDs are used in combination with zidovudine. There are demonstrations of increased risk of haemarthrosis and hematomas in HIV (+) haemophiliacs if treated simultaneously with zidovudine and ibuprofen; • anti-hypertensives, (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking Nurofen Fever and Pain concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and periodically. • potassium-sparing diuretics: concomitant administration of Nurofen Fever and Pain and potassium-sparing diuretics may lead to hyperkalaemia • CYP2C9 inhibitors: Concomitant administration of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased exposure to S(+)-ibuprofen by approximately 80% to 100% was demonstrated. Reduction of the ibuprofen dose should be considered when strong CYP2C9 inhibitors are coadministered, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole. • cardiac glycosides (Digoxin): NSAIDs can worsen heart failure, reduce VGF (glomerular filtration rate) and increase plasma glycoside levels.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes all those that have been recognized during treatment with ibuprofen for short periods of treatment and for daily doses up to a maximum of 1200 mg. In the case of high-dose therapies for chronic or prolonged pathologies, other undesirable effects may occur. Adverse reactions associated with the administration of ibuprofen are listed below according to system organ class and frequency. Frequencies are defined as: Very common (≥1\/10); Common (≥1\/100, \u003c1\/10); Uncommon (≥1\/1,000, \u003c1\/100); Rare (≥1\/10,000, \u003c1\/1,000) ; Very rare (\u003c1\/10,000); Not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Rare. Adverse reaction: Cystitis, rhinitis.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Very rare. Adverse reaction: Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis), in exceptional cases severe skin infections and soft tissue complications have been reported during a chickenpox infection.\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very rare. Adverse reaction: Hematopoiesis disorders ¹\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Uncommon. Adverse reaction: Hypersensitivity reactions manifested by urticaria and pruritus²\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Very rare. Adverse reaction: Severe hypersensitivity reactions including swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Asthma exacerbation.\u003c\/p\u003e\n\u003cp\u003eMetabolism and nutrition disorders - Frequency: Not known. Adverse reaction: Fluid retention and decreased appetite³.\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Not known. Adverse reaction: Irritability\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Rare. Adverse reaction: Depression, insomnia, difficulty concentrating, emotional lability, hearing disorders.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse reaction: Headache, dizziness, drowsiness, convulsions, agitation, tiredness.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse reaction: Aseptic meningitis4.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Rare. Adverse reaction: Cerebrovascular haemorrhage.\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Rare. Adverse reaction: Dry eyes.\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Uncommon. Adverse reaction: Visual disturbances.\u003c\/p\u003e\n\u003cp\u003eEar and labyrinth disorders - Frequency: Not known. Adverse reaction: Tinnitus.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Very rare. Adverse reaction: Myocardial infarction.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Not known. Adverse reaction: Heart failure and edema5.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Rare. Adverse reaction: Palpitations.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Not known. Adverse reaction: Hypertension5 and shock.\u003c\/p\u003e\n\u003cp\u003eRespiratory, thoracic and mediastinal disorders - Frequency: Not known. Adverse reaction: Respiratory tract reactivity including asthma, laryngeal obstruction, bronchospasm or apnea, dyspnea.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse reaction: Abdominal pain, nausea and dyspepsia6.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Rare. Adverse reaction: Diarrhoea, flatulence, dry mouth, constipation and vomiting.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse reaction: Peptic ulcer, gastrointestinal perforation or bleeding, melena and haematemesis7. Mouth ulcerations and gastritis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Not known. Adverse reaction: Exacerbation of colitis and Crohn's disease8, pancreatitis, duodenitis, esophagitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse reaction: Liver dysfunction, hepatitis, jaundice, hepatorenal syndrome, hepatic necrosis, hepatic failure.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse reaction: Various skin rashes²\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse reaction: Bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis².\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Rare. Adverse reaction: Exfoliative dermatitis, alopecia, photosensitivity reactions.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse reaction: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG).\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Rare. Adverse reaction: Tubular necrosis, glomerular nephritis, polyuria, hematuria.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse reaction: Acute renal failure9.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Rare. Adverse reaction: Decreased hematocrit levels.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Very rare. Adverse reaction: Decreased hemoglobin levels.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some adverse reactions\u003c\/b\u003e \u003csup\u003e1\u003c\/sup\u003e Hematopoiesis disorders including anemia, aplastic anemia, hemolytic anemia (positive Coombs test), leukopenia, neutropenia, thrombocytopenia (with or without purpura), eosinophilia, pancytopenia, and agranulocytosis. The first symptoms may be: fever, sore throat, superficial mouth ulcers, flu-like symptoms, marked fatigue, nosebleeds and bleeding. In these cases the patient should be advised to stop taking the medicine immediately, to avoid any self-medication medicine containing analgesics or antipyretics and to consult his doctor. Rarely congestive heart failure in patients with impaired cardiac function. ² Hypersensitivity reactions: these reactions include a) non-specific allergic reactions and anaphylaxis, fever, chills, b) respiratory tract reactivity including asthma, aggravated asthma, bronchospasm (see section 4.3 and 4.4) or dyspnoea or c) various skin conditions including various skin rashes (including maculopapular in nature), pruritus, urticaria with or without angioedema, purpura, angioedema and much rarely, bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme. ³ Decreased appetite: generally resolves rapidly upon discontinuation of treatment (see section 4.4). \u003csup\u003e4\u003c\/sup\u003e The pathogenetic mechanism of drug-induced aseptic meningitis is not completely known. However, the data available on aseptic meningitis related to the administration of NSAIDs leads us to think of an immune reaction (due to a temporal relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of symptoms of aseptic meningitis (such as stiff neck, neck numbness, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune diseases (such as systemic lupus erythromatosus, mixed connective tissue disease).\u003csup\u003e5\u003c\/sup\u003e Heart failure and edema: Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Congestive heart failure in patients with impaired cardiac function. \u003csup\u003e6\u003c\/sup\u003e The most commonly observed adverse events are gastrointestinal in nature. Gastric discomfort can be reduced by taking the medicine on a full stomach. \u003csup\u003e7\u003c\/sup\u003e Peptic ulcers, gastrointestinal perforation or hemorrhage, melena, and sometimes fatal hematemesis may occur. \u003csup\u003e8\u003c\/sup\u003e Exacerbation of colitis and Crohn's disease (see section 4.4). \u003csup\u003e9\u003c\/sup\u003e Acute renal failure especially in case of long-term therapy, associated with increased serum urea levels and edema. Papillary necrosis may occur. \u003cb\u003eReporting of suspected adverse reactions\u003c\/b\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioniavverse\u003ci\u003e. \u003c\/i\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eToxicity \u003c\/u\u003e Signs and symptoms of toxicity were generally not observed at doses below 100 mg\/kg in children or adults. However, in some cases supportive treatment may be necessary. Children have been observed to exhibit signs and symptoms of toxicity after ingesting ibuprofen at doses of 400 mg\/kg or greater. The half-life of the drug in case of overdose is 1.5-3 hours. \u003cu\u003eSymptoms \u003c\/u\u003e Most patients who accidentally ingest clinically relevant quantities of ibuprofen will experience symptoms within 4 to 6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea and CNS and respiratory depression have also been reported rarely. Disorientation, arousal, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In cases of severe poisoning, metabolic acidosis and a prolongation of the prothrombin time (INR) may occur, probably caused by interference with the action of coagulation factors present in the circulation. In asthmatic subjects, an exacerbation of the symptoms of the disease may occur. \u003cu\u003eTreatment \u003c\/u\u003e There is no specific antidote for ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is therefore indicated and must include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilised. Particular attention is due to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic quantity. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam or lorazepam. If ibuprofen has already been absorbed, alkaline substances should be administered to promote excretion of the acidic ibuprofen in the urine. Administer bronchodilators in case of asthma. Depending on the patient's clinical condition, other support measures may be necessary. For more information, contact your local poison control center.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eChildren under the age of 12 are unlikely to become pregnant or breastfeed. Furthermore, in such circumstances the following considerations must be kept in mind. \u003cu\u003ePregnancy \u003c\/u\u003e Inhibition of prostaglandin synthesis can negatively affect pregnancy and\/or embryo\/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been thought to increase with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. From the 20th\u003csup\u003ea\u003c\/sup\u003e week of pregnancy onwards, the use of ibuprofen could cause oligohydramnios resulting from fetal renal dysfunction. This condition may be experienced shortly after starting treatment and is usually reversible upon discontinuation of treatment. Additionally, cases of constriction of the ductus arteriosus have been reported following treatment in the second trimester, most of which resolved after treatment was discontinued. Therefore, during the first and second trimester of pregnancy ibuprofen should not be administered unless strictly necessary. If ibuprofen is used by a woman planning pregnancy, or during the first and second trimester of pregnancy, the lowest possible dose should be used for the shortest possible time. Following exposure to ibuprofen for several days from the 20th\u003csup\u003ea\u003c\/sup\u003e week of gestation onwards, antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered. In case of oligohydramnios or constriction of the ductus arteriosus, treatment with ibuprofen should be discontinued. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (premature constriction\/closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction (see above); the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, Nurofen Fever and Pain is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). \u003cu\u003eBreastfeeding \u003c\/u\u003e There is limited data showing that ibuprofen can pass in low concentrations into breast milk and is unlikely to have any adverse effects on newborns.\u003cu\u003eFertility \u003c\/u\u003e There is evidence that medicinal products that inhibit cyclooxygenase\/prostaglandin synthesis may cause impairment of female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNot relevant, considering the age of the patient.\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51730202722631,"sku":"034102020","price":13.3,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofen-febbre-e-dolore-bambini-100-mg-5-ml-150-ml-sospensione-senza-zucchero-gusto-arancia-con-siringa-farmacia-dottor-tili-1213791445.jpg?v=1767138210"},{"product_id":"tachipirina-bambini-500-mg-10-supposte","title":"Tachipirina children 500 mg 10 suppositories","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eAs an antipyretic: symptomatic treatment of febrile diseases such as influenza, exanthematous diseases, acute respiratory tract diseases, etc. As an analgesic: headaches, neuralgia, myalgia and other medium-level painful manifestations of various origins.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003ci\u003eTACHIPIRINA 500 mg tablets.\u003c\/i\u003e Each tablet contains: \u003cu\u003eactive ingredient: paracetamol 500 mg.\u003c\/u\u003e \u003ci\u003eTACHIPIRINA 500 mg effervescent granules.\u003c\/i\u003e Each sachet contains: \u003cu\u003eactive ingredient: paracetamol 500 mg.\u003c\/u\u003e \u003cu\u003eexcipients with known effects: aspartame, maltitol, 12.3 mmol sodium per sachet\u003c\/u\u003e \u003ci\u003eTACHIPIRINA 125 mg effervescent granules. \u003c\/i\u003e Each sachet contains: \u003cu\u003eactive ingredient: paracetamol 125 mg.\u003c\/u\u003e \u003cu\u003eexcipients with known effects: aspartame, maltitol, 3.07 mmol sodium per sachet\u003c\/u\u003e \u003ci\u003e \u003cu\u003eTACHIPIRINA Infants 62.5 mg suppositories.\u003c\/u\u003e \u003c\/i\u003e Each suppository contains. \u003cu\u003eactive ingredient: paracetamol 62.5 mg\u003c\/u\u003e \u003ci\u003e \u003cu\u003eTACHIPIRINA Early Childhood 125 mg suppositories.\u003c\/u\u003e \u003c\/i\u003e Each suppository contains: \u003cu\u003eactive ingredient: paracetamol 125 mg.\u003c\/u\u003e \u003ci\u003e \u003cu\u003eTACHIPIRINA Children 250 mg suppositories.\u003c\/u\u003e \u003c\/i\u003e Each suppository contains: \u003cu\u003eactive ingredient: paracetamol 250 mg.\u003c\/u\u003e \u003ci\u003e \u003cu\u003eTACHIPIRINA Children 500 mg suppositories.\u003c\/u\u003e \u003c\/i\u003e Each suppository contains: \u003cu\u003eactive ingredient: paracetamol 500 mg.\u003c\/u\u003e \u003ci\u003e \u003cu\u003eTACHIPIRINA Adults 1000 mg suppositories.\u003c\/u\u003e \u003c\/i\u003e Each suppository contains: \u003cu\u003eactive ingredient: paracetamol 1000 mg.\u003c\/u\u003e For the complete list of excipients, see par. 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• \u003cu\u003eTablets:\u003c\/u\u003e microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, croscarmellose sodium. • \u003cu\u003eEffervescent granules\u003c\/u\u003e: maltitol, mannitol, sodium bicarbonate, anhydrous citric acid, citrus flavouring, aspartame, sodium docusate. • \u003cu\u003eSuppositories\u003c\/u\u003e: solid semi-synthetic glycerides.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• Hypersensitivity to paracetamol or to any of the excipients listed in paragraph 6.1. • Patients suffering from severe hemolytic anemia (this contraindication does not refer to the 500mg oral formulations). • Severe hepatocellular insufficiency (this contraindication does not refer to the 500mg oral formulations).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eFor children it is essential to respect the dosage defined according to their body weight, and therefore choose the suitable formulation. Approximate ages based on body weight are indicated for information. In adults, the maximum oral dosage is 3000 mg and rectally 4000 mg of paracetamol per day (see section 4.9). The doctor must evaluate the need for treatments for more than 3 consecutive days. The dosage schedule of Tachipirina in relation to body weight and route of administration is as follows: \u003cb\u003e500 mg tablets.\u003c\/b\u003e • \u003cu\u003eChildren weighing between 21 and 25 kg\u003c\/u\u003e (approximately between 6.5 and less than 8 years): ½ tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day (3 tablets). • \u003cu\u003eChildren weighing between 26 and 40 kg\u003c\/u\u003e (approximately between 8 and 11 years): 1 tablet at a time, to be repeated if necessary after 6 hours, without exceeding 4 doses per day. • \u003cu\u003eChildren weighing between 41 and 50 kg\u003c\/u\u003e (approximately between 12 and 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses per day. • \u003cu\u003eChildren weighing more than 50 kg\u003c\/u\u003e (approximately over 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • \u003cu\u003eAdults\u003c\/u\u003e: 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses per day. In case of severe pain or high fever, 2 tablets of 500 mg to be repeated if necessary after no less than 4 hours. \u003cb\u003e500 mg effervescent granules in sachets.\u003c\/b\u003e Dissolve the effervescent granules in a glass of water. • \u003cu\u003eChildren weighing between 26 and 40 kg\u003c\/u\u003e (approximately between 8 and 11 years): 1 sachet at a time, to be repeated if necessary after 6 hours, without exceeding 4 doses per day. • \u003cu\u003eChildren weighing between 41 and 50 kg\u003c\/u\u003e (approximately between 12 and 15 years): 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses per day. • \u003cu\u003eChildren weighing more than 50 kg\u003c\/u\u003e (approximately over 15 years): 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • \u003cu\u003eAdults\u003c\/u\u003e: 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. In case of severe pain or high fever, 2 sachets of 500 mg to be repeated if necessary after no less than 4 hours. \u003cb\u003e125 mg effervescent granules in sachets.\u003c\/b\u003e Dissolve the effervescent granules in a glass of water. • \u003cu\u003eChildren weighing between 7 and 10 kg\u003c\/u\u003e (approximately between 6 and 19 months): 1 sachet at a time, to be repeated if necessary after 6 hours, without exceeding 4 doses per day. • \u003cu\u003eChildren weighing between 11 and 12 kg\u003c\/u\u003e (approximately between 20 and 29 months): 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • \u003cu\u003eChildren weighing between 13 and 20 kg\u003c\/u\u003e (approximately between 30 months and less than 6.5 years): 2 sachets at a time (corresponding to 250 mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • \u003cu\u003eChildren weighing between 21 and 25 kg\u003c\/u\u003e (approximately between 6.5 and less than 8 years): 2 sachets at a time (corresponding to 250 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. \u003cb\u003e62.5 mg suppositories for newborns.\u003c\/b\u003e • \u003cu\u003eChildren weighing between 3.2 and 5 kg \u003c\/u\u003e(approximately between birth and 2 months): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. \u003cb\u003eEarly Childhood Suppositories 125 mg. \u003c\/b\u003e • \u003cu\u003eChildren weighing between 6 and 7 kg \u003c\/u\u003e(approximately between 3 and 5 months): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • \u003cu\u003eChildren weighing between 7 and 10 kg\u003c\/u\u003e (approximately between 6 and 19 months): 1 suppository at a time, to be repeated if necessary after 4 - 6 hours, without exceeding 5 administrations per day. • \u003cu\u003eChildren weighing between 11 and 12 kg\u003c\/u\u003e (approximately between 20 and 29 months): 1 suppository at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. \u003cb\u003eSuppositories Children 250 mg.\u003c\/b\u003e • \u003cu\u003eChildren weighing between 11 and 12 kg\u003c\/u\u003e (approximately between 20 and 29 months): 1 suppository at a time, to be repeated if necessary after 8 hours, without exceeding 3 doses per day. • \u003cu\u003eChildren weighing between 13 and 20 kg\u003c\/u\u003e (approximately between 30 months and less than 6.5 years): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. \u003cb\u003eSuppositories Children 500 mg.\u003c\/b\u003e • \u003cu\u003eChildren weighing between 21 and 25 kg\u003c\/u\u003e (approximately between 6.5 and less than 8 years): 1 suppository at a time, to be repeated if necessary after 8 hours, without exceeding 3 doses per day. • \u003cu\u003eChildren weighing between 26 and 40 kg\u003c\/u\u003e (approximately between 8 and 11 years): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. \u003cb\u003eSuppositories Adults of 1000 mg.\u003c\/b\u003e • \u003cu\u003eChildren weighing between 41 and 50 kg\u003c\/u\u003e (approximately between 12 and 15 years): 1 suppository at a time, to be repeated if necessary after 8 hours, without exceeding 3 doses per day. • \u003cu\u003eChildren weighing more than 50 kg\u003c\/u\u003e (approximately over 15 years): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • \u003cu\u003eAdults\u003c\/u\u003e: 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. \u003ci\u003e \u003cu\u003eRenal failure.\u003c\/u\u003e \u003c\/i\u003e In case of severe renal insufficiency (creatinine clearance less than 10 ml\/min), the interval between administrations must be at least 8 hours.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eEffervescent tablets and granules\u003c\/u\u003e: no special precautions for storage. \u003cu\u003eSuppositories:\u003c\/u\u003e Store at a temperature not exceeding 25°C.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eIn rare cases of allergic reactions, administration must be suspended and appropriate treatment instituted. Use with caution in cases of chronic alcoholism, excessive alcohol intake (3 or more alcoholic drinks per day), anorexia, bulimia or cachexia, chronic malnutrition (low hepatic glutathione reserves), dehydration, hypovolemia. Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh\u003e9), acute hepatitis, in concomitant treatment with drugs that alter liver function, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia. High or prolonged doses of the product can cause even serious alterations to the kidney and blood, therefore administration to subjects with renal insufficiency must be carried out only if actually necessary and under direct medical supervision. In case of prolonged use it is advisable to monitor liver and kidney function and blood count. During treatment with paracetamol, before taking any other medicine, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur. Invite the patient to contact the doctor before combining any other drug. See also par. 4.5. \u003cb\u003e \u003cu\u003eImportant information about some excipients.\u003c\/u\u003e \u003c\/b\u003e \u003cu\u003eTachipirina 125 mg effervescent granules contains\u003c\/u\u003e \u003cu\u003e:\u003c\/u\u003e - \u003cb\u003easpartame\u003c\/b\u003e, is a source of phenylalanine. It can be harmful in case of phenylketonuria (deficiency of the enzyme phenylalanine hydroxylase) due to the risk linked to the accumulation of the amino acid phenylalanine. - \u003cb\u003emaltitol\u003c\/b\u003e: use with caution in patients suffering from rare hereditary problems of fructose intolerance. 70.6 mg of \u003cb\u003esodium\u003c\/b\u003e per sachet equivalent to 3.53% of the maximum daily intake recommended by WHO which corresponds to 2 g of sodium for an adult: to be taken into consideration in people with reduced kidney function or who follow a low-sodium diet. \u003cu\u003eTachipirina 500 mg effervescent granules contains:\u003c\/u\u003e - \u003cb\u003easpartame\u003c\/b\u003e, is a source of phenylalanine. It can be harmful in case of phenylketonuria (deficiency of the enzyme phenylalanine hydroxylase) due to the risk linked to the accumulation of the amino acid phenylalanine. - \u003cb\u003emaltitol\u003c\/b\u003e: use with caution in patients suffering from rare hereditary problems of fructose intolerance. - 283 mg of \u003cb\u003esodium\u003c\/b\u003e per sachet equivalent to 14.1% of the WHO recommended maximum daily intake which corresponds to 2 g of sodium for an adult. The maximum dose for this product is equivalent to 84.6% of the maximum daily sodium intake recommended by the WHO: to be taken into consideration in people with reduced kidney function or who follow a low-sodium diet.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eOral absorption of paracetamol depends on the speed of gastric emptying. Therefore, concomitant administration of drugs that slow (e.g. anticholinergics, opioids) or increase (e.g. prokinetics) the rate of gastric emptying may result in a decrease or increase in the bioavailability of the product, respectively. Concomitant administration of cholestyramine reduces the absorption of paracetamol. The simultaneous intake of paracetamol and chloramphenicol can induce an increase in the half-life of chloramphenicol, with the risk of increasing its toxicity. The concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants can induce slight variations in INR values. In these cases, more frequent monitoring of INR values ​​should be conducted during concomitant use and after its discontinuation. Use with extreme caution and under strict control during chronic treatment with drugs that can cause the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutetimide, phenobarbital, carbamazepine). The same applies in cases of alcoholism and in patients treated with zidovudine. The administration of paracetamol can interfere with the determination of uric acid (using the phosphotungstic acid method) and with that of blood sugar (using the glucose-oxidase-peroxidase method).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eBelow are the side effects of paracetamol organized according to the MedDRA systemic and organic classification. There is insufficient data to establish the frequency of the individual effects listed.\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders: Thrombocytopenia, leukopenia, anemia, agranulocytosis.\u003c\/p\u003e\n\u003cp\u003eImmune system disorders: Hypersensitivity reactions (urticaria, laryngeal edema, angioedema, anaphylactic shock).\u003c\/p\u003e\n\u003cp\u003eNervous system disorders: Dizziness.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders: Gastrointestinal reaction.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders: Abnormal liver function, hepatitis.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders: Erythema multiforme, Stevens Johnson Syndrome, Epidermal necrolysis, rash.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders: Acute renal failure, interstitial nephritis, hematuria, anuria.\u003c\/p\u003e\n\u003cp\u003eVery rare cases of serious skin reactions have been reported. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioni-avverse.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eThere is a risk of intoxication, especially in patients with liver disease, in cases of chronic alcoholism, in patients suffering from chronic malnutrition, and in patients receiving enzyme inducers. In these cases, overdose can be fatal.\u003c\/u\u003e \u003cu\u003eSymptoms\u003c\/u\u003e In case of accidental intake of very high doses of paracetamol, acute intoxication manifests itself with anorexia, nausea and vomiting followed by a profound deterioration of the general conditions; these symptoms typically appear within the first 24 hours. In case of overdose, paracetamol can cause hepatic cytolysis which can progress to massive and irreversible necrosis, resulting in hepatocellular failure, metabolic acidosis and encephalopathy, which can lead to coma and death. Simultaneously, an increase in the levels of hepatic transaminases, lactic dehydrogenase, and bilirubin are observed, and a reduction in prothrombin levels, which can occur in the 12-48 hours following ingestion. \u003cu\u003eTreatment\u003c\/u\u003e The measures to be adopted consist of early gastric emptying and hospitalization for the appropriate treatment, through administration, as early as possible, of N-acetylcysteine as an antidote: the dosage is 150 mg\/kg i.v. in glucose solution in 15 minutes, then 50 mg\/kg in the following 4 hours and 100 mg\/kg in the following 16 hours, for a total of 300 mg\/kg in 20 hours.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003ePregnancy: A large amount of data on pregnant women indicates neither malformation nor fetal\/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for the shortest possible time and with the lowest possible frequency. Breastfeeding: It is recommended to administer the product only in cases of actual need and under the direct supervision of a doctor.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eTachipirina does not alter the ability to drive or use machines.\u003c\/p\u003e","brand":"Angelini Acraf","offers":[{"title":"Default Title","offer_id":51730202984775,"sku":"012745055","price":6.56,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/angelini-a-c-r-a-f-spa-tachipirina-bambini-500-mg-10-supposte-farmacia-dottor-tili-1213791437.jpg?v=1767138407"},{"product_id":"tachipirina-prima-infanzia-125-mg-10-supposte","title":"Tachipirina Early Childhood 125 mg 10 suppositories","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eAs an antipyretic: symptomatic treatment of febrile diseases such as influenza, exanthematous diseases, acute respiratory tract diseases, etc. As an analgesic: headaches, neuralgia, myalgia and other medium-level painful manifestations of various origins.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003ci\u003eTACHIPIRINA 500 mg tablets.\u003c\/i\u003e Each tablet contains: \u003cu\u003eactive ingredient: paracetamol 500 mg.\u003c\/u\u003e \u003ci\u003eTACHIPIRINA 500 mg effervescent granules.\u003c\/i\u003e Each sachet contains: \u003cu\u003eactive ingredient: paracetamol 500 mg.\u003c\/u\u003e \u003cu\u003eexcipients with known effects: aspartame, maltitol, 12.3 mmol sodium per sachet\u003c\/u\u003e \u003ci\u003eTACHIPIRINA 125 mg effervescent granules. \u003c\/i\u003e Each sachet contains: \u003cu\u003eactive ingredient: paracetamol 125 mg.\u003c\/u\u003e \u003cu\u003eexcipients with known effects: aspartame, maltitol, 3.07 mmol sodium per sachet\u003c\/u\u003e \u003ci\u003e \u003cu\u003eTACHIPIRINA Infants 62.5 mg suppositories.\u003c\/u\u003e \u003c\/i\u003e Each suppository contains. \u003cu\u003eactive ingredient: paracetamol 62.5 mg\u003c\/u\u003e \u003ci\u003e \u003cu\u003eTACHIPIRINA Early Childhood 125 mg suppositories.\u003c\/u\u003e \u003c\/i\u003e Each suppository contains: \u003cu\u003eactive ingredient: paracetamol 125 mg.\u003c\/u\u003e \u003ci\u003e \u003cu\u003eTACHIPIRINA Children 250 mg suppositories.\u003c\/u\u003e \u003c\/i\u003e Each suppository contains: \u003cu\u003eactive ingredient: paracetamol 250 mg.\u003c\/u\u003e \u003ci\u003e \u003cu\u003eTACHIPIRINA Children 500 mg suppositories.\u003c\/u\u003e \u003c\/i\u003e Each suppository contains: \u003cu\u003eactive ingredient: paracetamol 500 mg.\u003c\/u\u003e \u003ci\u003e \u003cu\u003eTACHIPIRINA Adults 1000 mg suppositories.\u003c\/u\u003e \u003c\/i\u003e Each suppository contains: \u003cu\u003eactive ingredient: paracetamol 1000 mg.\u003c\/u\u003e For the complete list of excipients, see par. 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• \u003cu\u003eTablets:\u003c\/u\u003e microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, croscarmellose sodium. • \u003cu\u003eEffervescent granules\u003c\/u\u003e: maltitol, mannitol, sodium bicarbonate, anhydrous citric acid, citrus flavouring, aspartame, sodium docusate. • \u003cu\u003eSuppositories\u003c\/u\u003e: solid semi-synthetic glycerides.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• Hypersensitivity to paracetamol or to any of the excipients listed in paragraph 6.1. • Patients suffering from severe hemolytic anemia (this contraindication does not refer to the 500mg oral formulations). • Severe hepatocellular insufficiency (this contraindication does not refer to the 500mg oral formulations).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eFor children it is essential to respect the dosage defined according to their body weight, and therefore choose the suitable formulation. Approximate ages based on body weight are indicated for information. In adults, the maximum oral dosage is 3000 mg and rectally 4000 mg of paracetamol per day (see section 4.9). The doctor must evaluate the need for treatments for more than 3 consecutive days. The dosage schedule of Tachipirina in relation to body weight and route of administration is as follows: \u003cb\u003e500 mg tablets.\u003c\/b\u003e • \u003cu\u003eChildren weighing between 21 and 25 kg\u003c\/u\u003e (approximately between 6.5 and less than 8 years): ½ tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day (3 tablets). • \u003cu\u003eChildren weighing between 26 and 40 kg\u003c\/u\u003e (approximately between 8 and 11 years): 1 tablet at a time, to be repeated if necessary after 6 hours, without exceeding 4 doses per day. • \u003cu\u003eChildren weighing between 41 and 50 kg\u003c\/u\u003e (approximately between 12 and 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses per day. • \u003cu\u003eChildren weighing more than 50 kg\u003c\/u\u003e (approximately over 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • \u003cu\u003eAdults\u003c\/u\u003e: 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses per day. In case of severe pain or high fever, 2 tablets of 500 mg to be repeated if necessary after no less than 4 hours. \u003cb\u003e500 mg effervescent granules in sachets.\u003c\/b\u003e Dissolve the effervescent granules in a glass of water. • \u003cu\u003eChildren weighing between 26 and 40 kg\u003c\/u\u003e (approximately between 8 and 11 years): 1 sachet at a time, to be repeated if necessary after 6 hours, without exceeding 4 doses per day. • \u003cu\u003eChildren weighing between 41 and 50 kg\u003c\/u\u003e (approximately between 12 and 15 years): 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses per day. • \u003cu\u003eChildren weighing more than 50 kg\u003c\/u\u003e (approximately over 15 years): 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • \u003cu\u003eAdults\u003c\/u\u003e: 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. In case of severe pain or high fever, 2 sachets of 500 mg to be repeated if necessary after no less than 4 hours. \u003cb\u003e125 mg effervescent granules in sachets.\u003c\/b\u003e Dissolve the effervescent granules in a glass of water. • \u003cu\u003eChildren weighing between 7 and 10 kg\u003c\/u\u003e (approximately between 6 and 19 months): 1 sachet at a time, to be repeated if necessary after 6 hours, without exceeding 4 doses per day. • \u003cu\u003eChildren weighing between 11 and 12 kg\u003c\/u\u003e (approximately between 20 and 29 months): 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • \u003cu\u003eChildren weighing between 13 and 20 kg\u003c\/u\u003e (approximately between 30 months and less than 6.5 years): 2 sachets at a time (corresponding to 250 mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • \u003cu\u003eChildren weighing between 21 and 25 kg\u003c\/u\u003e (approximately between 6.5 and less than 8 years): 2 sachets at a time (corresponding to 250 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. \u003cb\u003e62.5 mg suppositories for newborns.\u003c\/b\u003e • \u003cu\u003eChildren weighing between 3.2 and 5 kg \u003c\/u\u003e(approximately between birth and 2 months): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. \u003cb\u003eEarly Childhood Suppositories 125 mg. \u003c\/b\u003e • \u003cu\u003eChildren weighing between 6 and 7 kg \u003c\/u\u003e(approximately between 3 and 5 months): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • \u003cu\u003eChildren weighing between 7 and 10 kg\u003c\/u\u003e (approximately between 6 and 19 months): 1 suppository at a time, to be repeated if necessary after 4 - 6 hours, without exceeding 5 administrations per day. • \u003cu\u003eChildren weighing between 11 and 12 kg\u003c\/u\u003e (approximately between 20 and 29 months): 1 suppository at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. \u003cb\u003eSuppositories Children 250 mg.\u003c\/b\u003e • \u003cu\u003eChildren weighing between 11 and 12 kg\u003c\/u\u003e (approximately between 20 and 29 months): 1 suppository at a time, to be repeated if necessary after 8 hours, without exceeding 3 doses per day. • \u003cu\u003eChildren weighing between 13 and 20 kg\u003c\/u\u003e (approximately between 30 months and less than 6.5 years): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. \u003cb\u003eSuppositories Children 500 mg.\u003c\/b\u003e • \u003cu\u003eChildren weighing between 21 and 25 kg\u003c\/u\u003e (approximately between 6.5 and less than 8 years): 1 suppository at a time, to be repeated if necessary after 8 hours, without exceeding 3 doses per day. • \u003cu\u003eChildren weighing between 26 and 40 kg\u003c\/u\u003e (approximately between 8 and 11 years): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. \u003cb\u003eSuppositories Adults of 1000 mg.\u003c\/b\u003e • \u003cu\u003eChildren weighing between 41 and 50 kg\u003c\/u\u003e (approximately between 12 and 15 years): 1 suppository at a time, to be repeated if necessary after 8 hours, without exceeding 3 doses per day. • \u003cu\u003eChildren weighing more than 50 kg\u003c\/u\u003e (approximately over 15 years): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • \u003cu\u003eAdults\u003c\/u\u003e: 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 doses per day. \u003ci\u003e \u003cu\u003eRenal failure.\u003c\/u\u003e \u003c\/i\u003e In case of severe renal insufficiency (creatinine clearance less than 10 ml\/min), the interval between administrations must be at least 8 hours.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eEffervescent tablets and granules\u003c\/u\u003e: no special precautions for storage. \u003cu\u003eSuppositories:\u003c\/u\u003e Store at a temperature not exceeding 25°C.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eIn rare cases of allergic reactions, administration must be suspended and appropriate treatment instituted. Use with caution in cases of chronic alcoholism, excessive alcohol intake (3 or more alcoholic drinks per day), anorexia, bulimia or cachexia, chronic malnutrition (low hepatic glutathione reserves), dehydration, hypovolemia. Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh\u003e9), acute hepatitis, in concomitant treatment with drugs that alter liver function, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia. High or prolonged doses of the product can cause even serious alterations to the kidney and blood, therefore administration to subjects with renal insufficiency must be carried out only if actually necessary and under direct medical supervision. In case of prolonged use it is advisable to monitor liver and kidney function and blood count. During treatment with paracetamol, before taking any other medicine, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur. Invite the patient to contact the doctor before combining any other drug. See also par. 4.5. \u003cb\u003e \u003cu\u003eImportant information about some excipients.\u003c\/u\u003e \u003c\/b\u003e \u003cu\u003eTachipirina 125 mg effervescent granules contains\u003c\/u\u003e \u003cu\u003e:\u003c\/u\u003e - \u003cb\u003easpartame\u003c\/b\u003e, is a source of phenylalanine. It can be harmful in case of phenylketonuria (deficiency of the enzyme phenylalanine hydroxylase) due to the risk linked to the accumulation of the amino acid phenylalanine. - \u003cb\u003emaltitol\u003c\/b\u003e: use with caution in patients suffering from rare hereditary problems of fructose intolerance. 70.6 mg of \u003cb\u003esodium\u003c\/b\u003e per sachet equivalent to 3.53% of the maximum daily intake recommended by WHO which corresponds to 2 g of sodium for an adult: to be taken into consideration in people with reduced kidney function or who follow a low-sodium diet. \u003cu\u003eTachipirina 500 mg effervescent granules contains:\u003c\/u\u003e - \u003cb\u003easpartame\u003c\/b\u003e, is a source of phenylalanine. It can be harmful in case of phenylketonuria (deficiency of the enzyme phenylalanine hydroxylase) due to the risk linked to the accumulation of the amino acid phenylalanine. - \u003cb\u003emaltitol\u003c\/b\u003e: use with caution in patients suffering from rare hereditary problems of fructose intolerance. - 283 mg of \u003cb\u003esodium\u003c\/b\u003e per sachet equivalent to 14.1% of the WHO recommended maximum daily intake which corresponds to 2 g of sodium for an adult. The maximum dose for this product is equivalent to 84.6% of the maximum daily sodium intake recommended by the WHO: to be taken into consideration in people with reduced kidney function or who follow a low-sodium diet.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eOral absorption of paracetamol depends on the speed of gastric emptying. Therefore, concomitant administration of drugs that slow (e.g. anticholinergics, opioids) or increase (e.g. prokinetics) the rate of gastric emptying may result in a decrease or increase in the bioavailability of the product, respectively. Concomitant administration of cholestyramine reduces the absorption of paracetamol. The simultaneous intake of paracetamol and chloramphenicol can induce an increase in the half-life of chloramphenicol, with the risk of increasing its toxicity. The concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants can induce slight variations in INR values. In these cases, more frequent monitoring of INR values ​​should be conducted during concomitant use and after its discontinuation. Use with extreme caution and under strict control during chronic treatment with drugs that can cause the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutetimide, phenobarbital, carbamazepine). The same applies in cases of alcoholism and in patients treated with zidovudine. The administration of paracetamol can interfere with the determination of uric acid (using the phosphotungstic acid method) and with that of blood sugar (using the glucose-oxidase-peroxidase method).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eBelow are the side effects of paracetamol organized according to the MedDRA systemic and organic classification. There is insufficient data to establish the frequency of the individual effects listed.\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders: Thrombocytopenia, leukopenia, anemia, agranulocytosis.\u003c\/p\u003e\n\u003cp\u003eImmune system disorders: Hypersensitivity reactions (urticaria, laryngeal edema, angioedema, anaphylactic shock).\u003c\/p\u003e\n\u003cp\u003eNervous system disorders: Dizziness.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders: Gastrointestinal reaction.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders: Abnormal liver function, hepatitis.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders: Erythema multiforme, Stevens Johnson Syndrome, Epidermal necrolysis, rash.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders: Acute renal failure, interstitial nephritis, hematuria, anuria.\u003c\/p\u003e\n\u003cp\u003eVery rare cases of serious skin reactions have been reported. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioni-avverse.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eThere is a risk of intoxication, especially in patients with liver disease, in cases of chronic alcoholism, in patients suffering from chronic malnutrition, and in patients receiving enzyme inducers. In these cases, overdose can be fatal.\u003c\/u\u003e \u003cu\u003eSymptoms\u003c\/u\u003e In case of accidental intake of very high doses of paracetamol, acute intoxication manifests itself with anorexia, nausea and vomiting followed by a profound deterioration of the general conditions; these symptoms typically appear within the first 24 hours. In case of overdose, paracetamol can cause hepatic cytolysis which can progress to massive and irreversible necrosis, resulting in hepatocellular failure, metabolic acidosis and encephalopathy, which can lead to coma and death. Simultaneously, an increase in the levels of hepatic transaminases, lactic dehydrogenase, and bilirubin are observed, and a reduction in prothrombin levels, which can occur in the 12-48 hours following ingestion. \u003cu\u003eTreatment\u003c\/u\u003e The measures to be adopted consist of early gastric emptying and hospitalization for the appropriate treatment, through administration, as early as possible, of N-acetylcysteine as an antidote: the dosage is 150 mg\/kg i.v. in glucose solution in 15 minutes, then 50 mg\/kg in the following 4 hours and 100 mg\/kg in the following 16 hours, for a total of 300 mg\/kg in 20 hours.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003ePregnancy: A large amount of data on pregnant women indicates neither malformation nor fetal\/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for the shortest possible time and with the lowest possible frequency. Breastfeeding: It is recommended to administer the product only in cases of actual need and under the direct supervision of a doctor.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eTachipirina does not alter the ability to drive or use machines.\u003c\/p\u003e","brand":"Angelini Acraf","offers":[{"title":"Default Title","offer_id":51730204426567,"sku":"012745079","price":5.65,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/angelini-a-c-r-a-f-spa-tachipirina-prima-infanzia-125-mg-10-supposte-farmacia-dottor-tili-1213791403.jpg?v=1767139048"},{"product_id":"algidrin-20-mg-ml-120-ml-sospensione-orale-bambini-con-siringa-da-5-ml","title":"Algidrin 20 mg\/ml 120 ml oral suspension children with 5 ml syringe","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eALGIDRIN is indicated for children over 3 months of age and adolescents: • for the symptomatic treatment of fever; • for the symptomatic treatment of mild to moderate pain.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eEach ml of oral suspension contains: 20 mg of ibuprofen (provided by 34.17 mg of ibuprofen lysine). Excipients with known effects: Sorbitol (E-420) 25 mg, maltitol (E-965) 100 mg, Allura red AC dye (E-129) 0.0786 mg, methyl para-hydroxybenzoate (E-218) 1.45 mg, ethyl para-hydroxybenzoate (E-214) 0.32 mg, propyl para-hydroxybenzoate (E-216) 0.22 mg. For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003ePurified water, Microcrystalline cellulose, Sodium carboxymethyl cellulose, Sorbitol (E-420), Maltitol (E-965), Beta-cyclodextrin, Sodium saccharin, Sucralose (E-955), Berry flavouring, Allura-AC red color (E-129), Methyl para-hydroxybenzoate (E-218), Ethyl para-hydroxybenzoate (E-214), Propyl parahydroxybenzoate (E-216).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e- Hypersensitivity to ibuprofen, to any other NSAID or to any of the excipients listed in paragraph 6.1; - Patients who have developed allergic reactions, asthma attacks, acute rhinitis, urticaria or angioneurotic edema after taking substances with similar actions (for example acetylsalicylic acid or other anti-inflammatory drugs); - A history of gastrointestinal bleeding or perforation related to previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs); - Peptic ulcer, active or recurrent gastrointestinal hemorrhage (two or more separate episodes of ulceration or hemorrhage occurring); - Patients with diseases that tend to increase bleeding; - Severe heart failure (NYHA: class IV); - Severe renal failure (glomerular filtration rate below 30 ml\/min); - Severe liver failure; - Patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake); - During the third trimester of pregnancy (see section 4.6).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage\u003c\/u\u003e The lowest effective dose necessary to control symptoms should be taken in the shortest possible time (see section 4.4). \u003cb\u003ePediatric population:\u003c\/b\u003e The dose of ibuprofen to be administered depends on the age and weight of the child. For children aged 3 months to 12 years, the recommended daily dose of ibuprofen is 20 to 30 mg\/kg of body weight, divided into three or four individual doses (see the table below). The use of this medicine is not recommended in children under 3 months of age or weighing less than 5 kg. The interval between doses depends on the course of the symptoms, but should never be less than 4 hours. The following dosing schedule is recommended as a guideline. The doses can be repeated every 6-8 hours, without exceeding the daily quantities indicated in the last column:\u003c\/p\u003e\n\u003cp\u003eDOSAGE FOR CHILDREN.\u003c\/p\u003e\n\u003cp\u003eAge\/weight: From 3 to 6 months From approximately 5 to 7.6 kg - Frequency: 3 times a day. Dose: 50 mg (2.5 ml)\/dose. Maximum daily dose: 150 mg (7.5 ml).\u003c\/p\u003e\n\u003cp\u003eAge\/weight: From 6 to 12 months From approximately 7.7 to 9 kg - Frequency: 3 to 4 times a day. Dose: 50 mg (2.5 ml)\/dose. Maximum daily dose: 150-200 mg (7.5-10 ml).\u003c\/p\u003e\n\u003cp\u003eAge\/weight: From 1 to 3 years From approximately 10 to 15 kg - Frequency: From 3 to 4 times a day. Dose: 100 mg (5 ml)\/dose. Maximum daily dose: 300-400 mg (15-20 ml).\u003c\/p\u003e\n\u003cp\u003eAge\/weight: From 4 to 6 years From approximately 16 to 20 kg - Frequency: From 3 to 4 times a day. Dose: 150 mg (7.5 ml)\/dose. Maximum daily dose: 450-600 mg (22.5-30 ml).\u003c\/p\u003e\n\u003cp\u003eAge\/weight: From 7 to 9 years From approximately 21 to 29 kg - Frequency: 3 to 4 times a day. Dose: 200 mg (10 ml)\/dose. Maximum daily dose: 600-800 mg (30-40 ml).\u003c\/p\u003e\n\u003cp\u003eAge\/weight: From 10 to 12 years From approximately 30 to 40 kg - Frequency: From 3 to 4 times a day. Dose: 300 mg (15 ml)\/dose. Maximum daily dose: 900-1200 mg (45-60 ml).\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eAdolescents (over 12 years of age): \u003c\/b\u003e The recommended dose is 10-20 ml (equivalent to 200-400 mg of ibuprofen) every 4-6 hours, if necessary, without exceeding the daily dose of 1200 mg of ibuprofen in 24 hours. Given the amount of ibuprofen in this medicinal product, the use of other packs with more suitable doses is recommended for the treatment of adults and adolescents over 12 years of age. \u003cb\u003eKidney failure: \u003c\/b\u003e Some precautions should be taken when using non-steroidal anti-inflammatory drugs (NSAIDs) in patients with renal insufficiency, since ibuprofen is generally eliminated via the kidneys. Lower doses are used for patients with mild to moderate renal dysfunction. Ibuprofen should not be used in patients with severe renal impairment (see section 4.3). \u003cb\u003eLiver failure: \u003c\/b\u003e Although no differences in the pharmacokinetic profile of ibuprofen were observed in patients with hepatic insufficiency, it is advisable to take precautions when using NSAIDs in this type of patient. Patients with mild to moderate hepatic impairment should start treatment at lower doses and be carefully monitored. Ibuprofen should not be used in patients with severe hepatic impairment (see section 4.3). \u003cu\u003eMethod of administration \u003c\/u\u003e This medicine is administered orally. It can be administered directly or diluted with water. Shake the bottle before use. The packs contain a 5 ml graduated syringe for oral use, for accurate dosing. The syringe should be unhooked from the bottle, disassembled, washed and dried well after each use. Patients with gastric problems should take the medicine with meals.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eDo not store at temperatures above 30°C.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eMasking the symptoms of underlying infections:\u003c\/u\u003e ALGIDRIN may mask the symptoms of infection, which may lead to a delay in starting appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When ALGIDRIN i is given to relieve fever or pain related to infection, monitoring of the infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen. Adverse reactions caused by the combination of the active ingredient and concomitant alcohol consumption, especially reactions related to the gastrointestinal tract or central nervous system, may be increased by the use of NSAIDs. \u003cu\u003eGastrointestinal risks:\u003c\/u\u003e Gastrointestinal bleeding, ulcers and perforations: During treatment with NSAIDs, including ibuprofen, reports of gastrointestinal bleeding, ulcers and perforations (which may be fatal) have been received at any time, with or without previous warning symptoms and with or without a previous history of serious gastrointestinal events. The risk of gastrointestinal haemorrhage, ulcer or perforation is greater with increasing doses of NSAIDs, in patients with a history of ulcer, especially if the ulcers are complicated by haemorrhage or perforation (see section 4.3) and in elderly patients. These patients should start treatment with the lowest possible dose and be prescribed concomitant treatment with protective agents (e.g., misoprostol or proton pump inhibitors); Combined treatment should also be considered for patients requiring low doses of acetylsalicylic acid or other medicinal products that may increase gastrointestinal risk factors (see section 4.5). Patients with a history of gastrointestinal toxicity, and especially elderly patients, should be advised to immediately consult a doctor in case of infrequent abdominal symptoms (especially gastrointestinal bleeding) during treatment and especially during the initial stages. Special caution is recommended for patients receiving concomitant treatments that may increase the risk of gastrointestinal ulceration or bleeding such as dicoumarin-based oral anticoagulants or antiplatelet agents such as acetylsalicylic acid (see section 4.5). Furthermore, some precautions should be taken in case of concomitant administration of oral corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants. Treatment should be stopped immediately in case of gastrointestinal bleeding or ulceration in patients receiving this medicinal product (see section 4.3). NSAIDs should be administered with caution to patients with a history of ulcerative colitis or Crohn's disease, as they may aggravate these conditions (see section 4.8). \u003cu\u003eCardiovascular and cerebrovascular risks\u003c\/u\u003e: Particular attention should be paid to patients with a history of hypertension and\/or heart failure as fluid retention and edema have been associated with NSAID treatments. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day), may be associated with a small increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke). In general, epidemiological studies do not suggest that low-dose ibuprofen (e.g. 1,200 mg\/day) is associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischemic heart disease, peripheral artery disease and\/or cerebrovascular disease, should be treated with ibuprofen only after careful evaluation and avoiding high doses (2400 mg\/day). Careful evaluation must also be carried out before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smokers), especially if they require high doses of ibuprofen (2400 mg\/day). \u003cu\u003eRisk of serious skin reactions:\u003c\/u\u003e Very rare reports of serious skin reactions, some fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been received in association with use of NSAIDs (see section 4.8). Patients appear to be at greater risk of these reactions at the start of treatment: in most cases these side effects appear during the first month of treatment. Acute generalized exanthematous pustulosis has been reported (\u003ci\u003eAcute Generalized Exanthematous Pustulosis\u003c\/i\u003e -AGEP) in relation to products containing ibuprofen. Administration of the medicine must be stopped immediately at the first symptoms of skin erythema, mucosal lesions or other signs of hypersensitivity. On exceptional occasions, chickenpox can cause infectious complications of the skin and soft tissues. To date, the role of NSAIDs in exacerbating these infections cannot be ruled out. Therefore ibuprofen should be avoided in case of chickenpox. \u003cu\u003eAllergic reactions:\u003c\/u\u003e On very rare occasions, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Treatment should be stopped when the first signs of a hypersensitivity reaction appear after taking \/ administering ibuprofen. Based on the symptoms, the necessary medical measures must be initiated by specialized personnel. Caution is required in patients who have suffered from hypersensitivity or allergic reactions to other substances, as this may increase the risk of hypersensitivity reactions to ibuprofen. Caution is required in patients suffering from seasonal allergies, nasal polyps or chronic obstructive breathing disorders, as there is a high risk of allergic reactions. These reactions may present as asthma attacks, Quincke's edema, or urticaria. \u003cu\u003e Renal and\/or hepatic insufficiency:\u003c\/u\u003e Ibuprofen should be used with caution in patients with liver or kidney disease, particularly during simultaneous treatment with diuretics, as inhibition of prostaglandins may produce fluid retention and impair renal function. If administered to these patients, the dose of ibuprofen should be as low as possible and renal function should be monitored regularly. There is a risk of renal impairment in dehydrated children, adolescents and elderly patients. In case of dehydration, ensure adequate fluid intake. Special precautions should be taken in children with severe dehydration, for example due to diarrhoea, as dehydration could act as a trigger for the development of kidney failure. In general, the habitual use of analgesics, especially the combination of different analgesic substances, can cause lasting kidney damage, with a risk of kidney failure (analgesic nephropathy). Like other NSAIDs, long-term treatment with ibuprofen may cause renal papillary necrosis and other kidney diseases. Renal toxicity has also been observed in patients whose renal prostaglandins play a compensatory role in renal perfusion. Elderly patients, patients with renal insufficiency, heart failure, hepatic dysfunction and those treated with diuretics or antihypertensives (ACE inhibitors) are at high risk of experiencing this reaction. Discontinuation of NSAID therapy normally restores the state before treatment. Like other NSAIDs, ibuprofen may produce mild transient increases in some hepatic parameters and significant increases in AST and ALT levels. Treatment must be suspended in case of a significant increase in these parameters (see sections 4.2 and 4.3). \u003cu\u003eUse in the elderly population:\u003c\/u\u003e Elderly patients suffer from a higher incidence of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which can be fatal (see section 4.2). \u003cu\u003eOthers:\u003c\/u\u003e As with other NSAIDs, anaphylactic\/anaphylactoid reactions may occur without prior exposure to the drug. It should also be used with caution in patients with a history of bronchial asthma, chronic rhinitis and allergic diseases, as cases of bronchospasm, urticaria and angioedema have been reported in these types of patients (see section 4.3). On rare occasions, cases of aseptic meningitis have been reported with the use of ibuprofen. In the majority of cases, patients suffered from some form of autoimmune disease (such as systemic lupus erythematosus or other connective tissue diseases), which was a risk factor, although cases have also been reported in patients without chronic disease (see section 4.8). The observed symptoms of aseptic meningitis were stiff neck, headache, nausea, vomiting, fever, and disorientation. Special medical supervision is required when administering to patients immediately after undergoing major surgery. Like other NSAIDs, it should only be used after a rigorous evaluation of the risk\/benefit profile in patients with acute intermittent porphyria. Renal and hepatic function, haematological function and red blood cell count should be monitored as a precautionary measure in patients on long-term treatment, given that ibuprofen, like other NSAIDs, may inhibit platelet aggregation and prolong bleeding time. Side effects can be minimized by using the lowest effective dose for as short a period as possible. \u003cu\u003eWarnings on excipients:\u003c\/u\u003e This medicine may produce allergic reactions because it contains Allura AC red dye (E-129). May cause asthma, especially in patients allergic to acetylsalicylic acid. This medicine contains maltitol (E-965) and each ml of suspension contains 25 mg of sorbitol (E-420). Patients with hereditary fructose intolerance should not take this medicine. This medicine contains methyl parahydroxybenzoate (E-218), ethyl parahydroxybenzoate (E-214) and propyl parahydroxybenzoate (E-216) and may produce allergic reactions (possibly delayed). \u003ci\u003eInterference with analytical tests:\u003c\/i\u003e Bleeding time (may be prolonged for 1 day after stopping treatment). Blood sugar levels (may be reduced). Creatinine clearance (may be reduced). Hematocrit or hemoglobin levels (may be reduced). Blood urea nitrogen concentrations and serum creatinine and potassium concentrations (may be increased). Liver function tests: increased transaminase values.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eIn general, NSAIDs should be taken with caution when used together with other drugs that may increase the risk of gastrointestinal ulceration, gastrointestinal bleeding and renal dysfunction. Interactions have been reported with the following medicines: - \u003ci\u003e \u003cu\u003eDiuretics\u003c\/u\u003e \u003c\/i\u003e: may increase the nephrotoxicity of NSAIDs, as a consequence of the reduction of renal blood flow. As with other NSAIDs, concomitant treatment with potassium-sparing diuretics may be associated with an increase in potassium levels, making it necessary to monitor plasma levels of this ion. - \u003ci\u003e \u003cu\u003eAnticoagulants\u003c\/u\u003e:\u003c\/i\u003e NSAIDs may increase the effects of dicoumarin anticoagulants such as warfarin (see section 4.4.). - \u003ci\u003e \u003cu\u003eAntiplatelet agents\u003c\/u\u003e \u003c\/i\u003e: increase the risk of gastrointestinal bleeding (see section 4.4). NSAIDs should not be combined with ticlopidine, due to the risk of an additive effect in the inhibition of platelet function. - \u003ci\u003e \u003cu\u003eCorticosteroids\u003c\/u\u003e:\u003c\/i\u003e they may also increase the risk of gastrointestinal ulceration or bleeding (see section 4.4). - \u003ci\u003e \u003cu\u003eSelective serotonin reuptake inhibitors (SSRIs)\u003c\/u\u003e \u003c\/i\u003e: may also increase the risk of gastrointestinal bleeding (see section 4.4). - \u003ci\u003e \u003cu\u003eAntihypertensive agents (including ACE inhibitors, beta blockers, and angiotensin II receptor antagonists)\u003c\/u\u003e \u003c\/i\u003e: NSAIDs may reduce the effectiveness of antihypertensive agents, including ACE inhibitors or beta-blocking agents and angiotensin II antagonists. Concurrent treatment with NSAIDs, ACE inhibitors, beta-blockers or angiotensin receptor blockers may be associated with the risk of acute renal disease, including acute renal failure, which is normally reversible. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be well hydrated and regular monitoring of renal function should be considered after initiation of concomitant treatment. - \u003ci\u003e \u003cu\u003eAcetyl salicylic acid and other NSAIDs, which include selective cyclooxygenase-2 (COX-2) inhibitors\u003c\/u\u003e)\u003c\/i\u003e: Simultaneous use should be avoided, as the administration of different NSAIDs may increase the risk of gastrointestinal ulceration and bleeding. - \u003ci\u003e \u003cu\u003eAcetylsalicylic acid\u003c\/u\u003e \u003c\/i\u003e: In general, concomitant administration of ibuprofen and acetylsalicylic acid is not recommended due to the possibility of increasing side effects. Experimental data suggest that ibuprofen can competitively inhibit the effect of low doses of acetylsalicylic acid on platelet aggregation if administered concomitantly. Although there are uncertainties regarding the extrapolation of these data to clinical situations, the possibility that long-term regular use of ibuprofen may reduce the cardioprotective effect of low doses of acetylsalicylic acid cannot be excluded. There is likely to be no clinically relevant effect with occasional use of ibuprofen (see section 5.1.). - \u003ci\u003e \u003cu\u003eLithium\u003c\/u\u003e \u003c\/i\u003e: NSAIDs may increase plasma levels of lithium, probably due to a decrease in its renal clearance. Coadministration should be avoided unless lithium levels are monitored. A reduction in the lithium dose should be considered. - \u003ci\u003e \u003cu\u003eMethotrexate administered at doses of 15 mg\/week or greater\u003c\/u\u003e \u003c\/i\u003e: If NSAIDs and methotrexate are administered within a 24-hour interval, an increase in plasma levels of methotrexate may occur (NSAIDs appear to reduce tubular secretion and renal clearance of methotrexate), with an increased risk of methotrexate toxicity. Therefore, the use of ibuprofen in patients receiving treatment with high doses of methotrexate should be avoided. - \u003ci\u003e \u003cu\u003eMethotrexate administered at low doses, below 15 mg\/week\u003c\/u\u003e \u003c\/i\u003e: Ibuprofen increases methotrexate levels. When used in combination with low-dose methotrexate, the patient's blood chemistry should be closely monitored, especially during the first few weeks of simultaneous administration. Vigilance should also be increased in cases of impaired renal function, even minimally, and in elderly patients. Renal function should be monitored to prevent any possible decrease in methotrexate clearance. - \u003ci\u003e \u003cu\u003eSulfonylureas\u003c\/u\u003e:\u003c\/i\u003e NSAIDs can strengthen the effect of sulphonylureas. Rare cases of hypoglycemia have been reported in patients treated with sulphonylureas and ibuprofen. - \u003ci\u003e \u003cu\u003eMifepristone\u003c\/u\u003e:\u003c\/i\u003e theoretically, the effectiveness of this drug may be reduced due to the antiprostaglandin properties of NSAIDs. Limited evidence suggests that concurrent administration of an NSAID on the same day as prostaglandin does not negatively impact the effects of mifepristone or prostaglandin on cervical ripening or uterine contractility and does not reduce clinical efficacy in inducing abortion. - \u003ci\u003e \u003cu\u003eCardiac glycosides (digoxin)\u003c\/u\u003e:\u003c\/i\u003e NSAIDs can exacerbate heart failure, reduce glomerular filtration rate, and increase cardiac glycoside levels, thereby increasing the risk of digoxin toxicity. \u003ci\u003e \u003cu\u003e- Pentoxifylline:\u003c\/u\u003e \u003c\/i\u003e The risk of bleeding may be increased in patients receiving ibuprofen in combination with pentoxifylline. Therefore, monitoring of bleeding time is recommended. \u003ci\u003e \u003cu\u003e- Probenecid and sulfinpyrazones\u003c\/u\u003e \u003c\/i\u003e \u003cu\u003e:\u003c\/u\u003e may cause an increase in plasma concentrations of ibuprofen; this interaction may be due to an inhibitory mechanism at the level of renal tubular secretion and glucuronidation, and the dose of ibuprofen may need to be adjusted. - \u003ci\u003e \u003cu\u003eQuinolone antibiotics\u003c\/u\u003e:\u003c\/i\u003e Data from animal studies indicate that NSAIDs may increase the risk of seizures associated with the use of quinolone antibiotics. Patients who have taken NSAIDs and quinolones may have a higher risk of experiencing seizures. \u003ci\u003e \u003cu\u003e- Hydantoins (phenytoin) and sulphonamides:\u003c\/u\u003e \u003c\/i\u003e the toxic effects of these substances may be increased. During simultaneous treatment with ibuprofen, plasma levels of phenytoin may increase. \u003ci\u003e \u003cu\u003e- Cholestyramine:\u003c\/u\u003e \u003c\/i\u003e Concomitant administration of ibuprofen and cholestyramine may reduce the absorption of ibuprofen from the gastrointestinal tract, although the clinical relevance is unknown. \u003ci\u003e \u003cu\u003e- Tacrine:\u003c\/u\u003e \u003c\/i\u003e the administration of ibuprofen together with tacrine increases the toxicity of tacrine, with episodes of delirium, due to the possible inhibition of its binding with plasma proteins. - \u003ci\u003e \u003cu\u003eCyclosporins, tacrolimus\u003c\/u\u003e:\u003c\/i\u003e Simultaneous administration of NSAIDs may increase the risk of nephrotoxicity due to a reduction in renal synthesis of prostaglandins. If administered concomitantly, renal function should be closely monitored. - \u003ci\u003e \u003cu\u003eThrombolytics\u003c\/u\u003e:\u003c\/i\u003e the risk of bleeding may increase. - \u003ci\u003e \u003cu\u003eZidovudine\u003c\/u\u003e:\u003c\/i\u003e the risk of hematological toxicity may increase when NSAIDs are administered together with zidovudine. There is an increased risk of joint bleeding and hematomas in HIV(+) patients with haemophilia receiving concomitant treatment with zidovudine and ibuprofen. - \u003ci\u003e \u003cu\u003eAminoglycosides\u003c\/u\u003e:\u003c\/i\u003e NSAIDs may reduce the excretion of aminoglycosides. - \u003ci\u003e \u003cu\u003eHerbal extracts\u003c\/u\u003e:\u003c\/i\u003e Ginkgo biloba may increase the risk of bleeding with NSAIDs. - \u003ci\u003e \u003cu\u003eAlcohol\u003c\/u\u003e:\u003c\/i\u003e Concomitant use of alcohol may increase adverse effects related to the use of NSAIDs, especially those involving the gastrointestinal tract and central nervous system (see sections 4.4 and 4.8). \u003ci\u003e \u003cu\u003e- Food:\u003c\/u\u003e \u003c\/i\u003e administration of ibuprofen with food reduces the rate of absorption, although this has no effect on the extent of absorption (see section 5.2). - \u003ci\u003e \u003cu\u003eCYP2C9 inhibitors\u003c\/u\u003e:\u003c\/i\u003e Administration of ibuprofen with CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). A study with voriconazole and fluconazole (CYP2C9 inhibitors) showed an approximately 80% to 100% increase in ibuprofen S(+) exposure. A lower dose of ibuprofen should be considered when administered concurrently with a strong CYP2C9 inhibitor, especially when ibuprofen is administered in high doses with voriconazole or fluconazole.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe most frequently observed side effects are gastrointestinal in nature. Peptide ulcers, perforation or gastrointestinal haemorrhage, in some cases fatal, may occur, especially in the elderly (see section 4.4). Cases of nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis and exacerbation of colitis and Crohn's disease have also been reported (see section 4.4). The occurrence of gastritis was observed less frequently. Undesirable effects are reported by organ or system and by frequency according to the following classification: very common (≥ 1\/10); common (≥1\/100, \u003c1\/10); uncommon (≥1\/1,000, \u003c1\/100); rare (≥1\/10,000, \u003c1\/1,000); very rare (\u003c1\/10,000); frequency not known (cannot be estimated from the available data). The frequencies shown below refer to short-term use at maximum daily doses of 1,200 mg of oral ibuprofen. \u003cb\u003eGastrointestinal disorders\u003c\/b\u003e Common: dyspepsia, diarrhoea, nausea, vomiting, abdominal pain, flatulence, constipation, melena, haematemesis, gastrointestinal haemorrhage; Uncommon: gastritis, duodenal ulcer, gastric ulcer, mouth ulcer, gastrointestinal perforation; Very rare: pancreatitis; Frequency not known: exacerbation of colitis, Crohn's disease. \u003cb\u003eSkin disorders and hypersensitivity reactions\u003c\/b\u003eUncommon: rash, urticaria, pruritus, purpura (including allergic purpura), photosensitivity reaction; Very rare: bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, erythema multiforme. Severe skin infections and soft tissue complications may exceptionally occur during chickenpox (see also “Infections and infestations” and section 4.4). Frequency not known: drug reaction with eosinophilic and systemic symptoms (Dress syndrome). Acute generalized exanthematous pustulosis (AGEP). \u003cb\u003eInfections and infestations¹\u003c\/b\u003e Uncommon: rhinitis; Rare: aseptic meningitis (see section 4.4). \u003cb\u003eImmune system disorders\u003c\/b\u003e Uncommon: hypersensitivity²; Rare: Anaphylactic reaction: Symptoms may include swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). \u003cb\u003epathologies of the central nervous system\u003c\/b\u003e Common: headache, dizziness; Uncommon: paraesthesia, drowsiness; Rare: optic neuritis. \u003cb\u003ePsychiatric disorders\u003c\/b\u003e Infrequent: insomnia, anxiety; Rare: depression, confusion, disorientation. \u003cb\u003eEar and labyrinth disorders\u003c\/b\u003e Uncommon: hearing disorders; Rare: vertigo, tinnitus. \u003cb\u003eEye pathologies\u003c\/b\u003e Uncommon: visual changes; Rare: reversible toxic amblyopia. \u003cb\u003eRespiratory, thoracic and mediastinal disorders\u003c\/b\u003e Uncommon: asthma, bronchospasm, dyspnoea. \u003cb\u003ePathologies of the blood and lymphatic system\u003c\/b\u003e Rare: thrombocytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anemia and haemolytic anemia. Initial symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, excessive tiredness and nose and skin bleeding from unknown causes. \u003cb\u003eCardiac pathologies\u003c\/b\u003e Very rare: heart failure myocardial infarction (see section 4.4). \u003cb\u003eVascular pathologies\u003csup\u003e4\u003c\/sup\u003e \u003c\/b\u003e Very rare: hypertension. \u003cb\u003eHepatobiliary disorders\u003c\/b\u003e Uncommon: hepatitis, jaundice, liver dysfunction; Rare: liver failure; Very rare: liver failure. \u003cb\u003eRenal and urinary disorders\u003c\/b\u003e Uncommon: interstitial nephritis, nephrotic syndrome, renal failure, acute renal failure, papillary necrosis (especially after prolonged use), associated with increased urea. \u003cb\u003eSystemic pathologies\u003c\/b\u003e Common: fatigue; Rare: edema. ¹\u003cu\u003eInfections and infestations: \u003c\/u\u003eAn exacerbation of infection-related inflammation (e.g. necrotizing fasciitis) has been reported concomitantly with the use of NSAIDs. You should consult a doctor as soon as possible if there are signs or worsening of the infection while using ibuprofen. ² \u003cu\u003eHypersensitivity\u003c\/u\u003e: Hypersensitivity reactions have been observed after treatment with NSAIDs. These may consist of: (a) nonspecific respiratory tract allergy and anaphylaxis; (b) respiratory tract reactivity such as asthma, aggravated asthma, bronchospasm, or dyspnea; or (c) various skin changes, including rashes of various types, pruritus, purpura, angioedema and, in very rare cases, erythema multiforme and dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrosis). \u003csup\u003e3,4\u003c\/sup\u003e \u003cu\u003eCardiac and vascular pathologies\u003c\/u\u003e: Clinical studies suggest that the use of ibuprofen, especially at high doses (2,400 mg per day) may be associated with a small increased risk of arterial thrombotic events (such as myocardial infarction or stroke, see section 4.4). \u003cu\u003eReporting of suspected adverse reactions\u003c\/u\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioni-avverse.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eMost cases of overdose are asymptomatic. Generally no signs of toxicity were observed at doses below 100 mg\/kg in children and adults. However, in some cases additional assistance may be required. Children have been observed to show signs and symptoms of toxicity after ingesting quantities equal to or greater than 400 mg\/kg. \u003ci\u003eSymptoms\u003c\/i\u003e Most patients who took significant amounts of ibuprofen showed symptoms within the next 4 to 6 hours. The most frequently reported symptoms in case of overdose include abdominal pain, nausea, vomiting, lethargy, drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, seizures, loss of consciousness, and ataxia. Rare cases of nystagmus, metabolic acidosis, hypothermia, changes in renal function, gastrointestinal haemorrhage, coma, apnea and central nervous and respiratory system depression have also been reported. Cases of cardiovascular disease, including hypotension, bradycardia and tachycardia, have been reported. In case of severe poisoning, metabolic acidosis may occur. In case of severe overdose, kidney and liver damage may occur. \u003ci\u003eTherapeutic measures for overdose:\u003c\/i\u003e Treatment is symptomatic and no specific antidote is available. For quantities where symptoms are unlikely to occur (less than 50 mg\/kg of ibuprofen) water may be administered to reduce gastrointestinal discomfort as much as possible. If large quantities have been ingested, activated charcoal should be administered. Emptying the stomach with vomiting should only be considered within 60 minutes of ingestion. Therefore, gastric lavage should not be considered unless the patient has ingested a life-threatening amount of the drug and less than 60 minutes have passed since ingestion. The benefit of measures such as forced diuresis, hemodialysis or hemoperfusion is questionable, since ibuprofen binds strongly to plasma proteins.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003ePregnancy\u003c\/u\u003e 1) First and second trimester of pregnancy The inhibition of prostaglandin synthesis negatively affects pregnancy and\/or the development of the embryo\/fetus. Data from epidemiological studies suggest an increased risk of spontaneous abortion and cardiac malformations and gastroschisis, after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk appears to increase with the dose and duration of treatment. In animals, the administration of a prostaglandin synthesis inhibitor has been shown to produce an increase in pre- and post-implantation losses and embryo\/fetal mortality. Cases of increased incidence of various malformations, including cardiovascular malformations, have also been reported in animals that were administered a prostaglandin synthesis inhibitor during the organogenic period. From the 20th\u003csup\u003ea\u003c\/sup\u003e week of pregnancy onwards, ibuprofen use may cause oligohydramnios resulting from fetal renal dysfunction. This may occur shortly after starting treatment and is usually reversible upon discontinuation of treatment. Additionally, there have been reports of constriction of the ductus arteriosus after treatment in the second trimester, most of which resolved after treatment discontinuation. Therefore, ibuprofen should not be administered during the first and second trimester of pregnancy unless considered strictly necessary. If ibuprofen is to be used in a woman who is trying to get pregnant, or during the first and second trimester of pregnancy, the dose and duration of treatment should be reduced as much as possible. Following exposure to ibuprofen for several days from the 20th\u003csup\u003ea\u003c\/sup\u003e gestational week onwards, prenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered. Treatment with ibuprofen should be discontinued if oligohydramnios or constriction of the ductus arteriosus occurs. 2) Third trimester of pregnancy During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose: - The fetus to: - cardiopulmonary toxicity (premature constriction\/closure of the ductus arteriosus and pulmonary hypertension), - renal dysfunction (see above); - The mother, at the end of pregnancy, to: - possible prolongation of the bleeding time and antiplatelet effect, which can occur even at very low doses, - inhibition of uterine contractions resulting in delayed or prolonged delivery (with a tendency towards increased bleeding in the mother and baby). Therefore, this medicinal product is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). \u003cu\u003eBreastfeeding \u003c\/u\u003e Ibuprofen and its metabolites enter breast milk at low concentrations. To date, no harmful effects have been found for newborns, so in general breastfeeding should not be interrupted during short-term treatment at the recommended dose for pain and fever. \u003cu\u003eFertility \u003c\/u\u003e The use of ibuprofen may impair female fertility and is not recommended in women trying to become pregnant. Women who have difficulty conceiving or who are undergoing fertility tests should consider discontinuing this medicine.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003ePatients who experience dizziness, vertigo, visual changes, or other central nervous system disorders while taking ibuprofen should avoid driving or operating machinery. Patients taking ibuprofen may find that their reaction times are affected; this should be kept in mind when carrying out activities that require increased alertness, such as driving or using machinery. This effect is accentuated by the simultaneous consumption of alcohol.\u003c\/p\u003e","brand":"Dicofarm","offers":[{"title":"Default Title","offer_id":51730204492103,"sku":"049108020","price":14.5,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/dicofarm-spa-algidrin-20-mg-ml-120-ml-sospensione-orale-bambini-con-siringa-da-5-ml-farmacia-dottor-tili-1230323756.jpg?v=1774885509"},{"product_id":"nurofen-febbre-e-dolore-bambini-100-mg-5-ml-150-ml-sospensione-orale-senza-zucchero-gusto-fragola","title":"Nurofen fever and pain children 100 mg\/5 ml 150 ml sugar-free oral suspension strawberry flavour","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSymptomatic treatment of fever, including post-vaccination fever, and mild or moderate pain (such as headache, toothache, sore throat, earache).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNUROFEN FEVER AND PAIN Children 100mg\/5ml Oral Suspension Each ml of oral suspension contains: Active ingredient: ibuprofen 20 mg. Excipients with known effects: liquid maltitol, propylene glycol (present in the strawberry flavour), wheat starch (present in the orange flavour) and sodium. For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eNurofen Fever and Pain Children 100mg\/5ml oral suspension orange flavor without sugar\u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, orange flavor, domiphene bromide, purified water. \u003cu\u003eNurofen Fever and Pain Children 100mg\/5ml oral suspension strawberry flavor without sugar\u003c\/u\u003e Polysorbate 80, glycerin, maltitol syrup, sodium saccharin, citric acid, sodium citrate, xanthan gum, sodium chloride, strawberry flavor, domiphene bromide, purified water.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e• Hypersensitivity to ibuprofen or to any of the excipients listed in section 6.1. • Children younger than 3 months or weighing less than 5.6 kg. • The medicine is contraindicated in patients who show or have previously shown hypersensitivity (e.g. asthma, rhinitis, angioedema or urticaria) to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), in particular when hypersensitivity is associated with nasal polyposis and asthma. • Active peptic ulcer. • Severe renal or hepatic impairment (see section 4.4). • Severe heart failure (see section 4.4). • History of gastrointestinal hemorrhage or perforation, related to previous NSAID-based therapy. History of recurrent hemorrhage\/peptic ulcer (two or more distinct episodes of demonstrated ulceration or bleeding). • Concomitant use of NSAIDs, including specific COX-2 inhibitors. • Patients with a history of cerebrovascular bleeding or other active bleeding. • Patients with unclear blood formation disorders. • Patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake). • During the last trimester of pregnancy (see section 4.6).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage \u003c\/u\u003e The daily dose is structured based on the weight and age of the patient. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). In children aged between 3 and 6 months, limit administration to those weighing more than 5.6 kg. \u003cu\u003eMethod of administration \u003c\/u\u003e Oral administration to infants and children aged between 3 months and 12 years should take place using the measuring syringe or measuring spoon supplied with the product. Patients suffering from stomach problems can take the medicine with meals. The daily dose of 20-30 mg\/kg of body weight, divided 3 times a day at 6-8 hour intervals, can be administered based on the following schedule (do not exceed the recommended doses). The graduated scale on the body of the syringe highlights the notches for the different dosages; in particular the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark corresponding to 100 mg of ibuprofen. The measuring spoon has two marks for two different doses: the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark corresponding to 100 mg of ibuprofen.\u003c\/p\u003e\n\u003cp\u003eWeight: From 5.6 kg - Approximate age: 3 - 6 months. Single dose in ml: 2.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 7 Kg - Approximate age: 6 - 12 months. Single dose in ml: 2.5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 10 Kg - Approximate age: 1 - 3 years. Single dose in ml: 5 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 15 Kg - Approximate age: 4 - 6 years. Single dose in ml: 7.5 ml (5 ml + 2.5 ml). maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 20 kg - Approximate age: 7 - 9 years. Single dose in ml: 10 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eWeight: From 28 to 43 Kg - Approximate age: 10 - 12 years. Single dose in ml: 15 ml. maximum number of administrations\/day: 3 in 24 hours.\u003c\/p\u003e\n\u003cp\u003eIn the case of post-vaccination fever, refer to the daily dosage recommended in the table above. The product is intended for short-term treatments. In infants aged between 3 and 5 months, the doctor should be consulted if symptoms persist for more than 24 hours or in the case of worsening of symptoms. If the use of the medicine is necessary for more than 3 days in infants and children over 6 months of age and in adolescents, or in the case of worsening of symptoms, a doctor should be consulted. \u003cu\u003eInstructions for using the dosing syringe\u003c\/u\u003e: 1. Unscrew the cap by pushing it downwards and turning it to the left. 2. Insert the tip of the syringe fully into the hole in the undercap. 3. Shake well. 4. Turn the bottle upside down, then, holding the syringe firmly, gently pull the plunger downwards, allowing the suspension to flow into the syringe up to the mark corresponding to the desired dose. 5. Place the bottle back upright and remove the syringe by gently rotating it. 6. Introduce the tip of the syringe into the child's mouth, and apply slight pressure on the plunger to let the suspension flow out. 7. After use, screw the cap to close the bottle and wash the syringe with hot water. Leave it to dry, keeping it out of the reach and sight of children.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNo details.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSide effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). \u003cb\u003eOther NSAIDs:\u003c\/b\u003e the use of Nurofen Fever and Pain should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors. Analgesics, antipyretics, non-steroidal anti-inflammatories can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to this type of drugs. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have experienced such reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), hay fever, nasal polyposis, chronic obstructive respiratory diseases or previous episodes of angioedema (see section 4.2 and section 4.8). \u003cb\u003eGastrointestinal (GI) effects:\u003c\/b\u003e Gastrointestinal hemorrhage, ulceration and perforation: Gastrointestinal hemorrhage, ulceration and perforation, which may be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (aspirin) (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Nurofen Fever and Pain, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). \u003cb\u003eDermatological effects: \u003c\/b\u003esevere skin reactions: serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. Masking of symptoms of underlying infections: Nurofen Fever and Pain may mask the symptoms of infection, which may delay the initiation of appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofen Fever and Pain is administered for the relief of infection-related fever or pain, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Chickenpox can exceptionally cause serious infectious complications to the skin and soft tissues. To date, the contribution of NSAIDs in the worsening of these infections cannot be excluded, therefore it is advisable to avoid the use of Nurofen Fever and Pain in case of chickenpox. \u003cb\u003eCardiovascular and cerebrovascular effects\u003c\/b\u003e: caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a positive history of hypertension and\/or heart failure since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg\/day) are associated with an increased risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and\/or cerebrovascular disease should be treated with ibuprofen only after careful consideration. Similar considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). \u003cb\u003eRenal disorders\u003c\/b\u003e: in general, the habitual use of analgesics, especially the combination of different analgesic substances, can cause permanent kidney damage, with risk of renal failure (analgesic nephropathy). In dehydrated children and adolescents there is a risk of impaired renal function (see sections 4.3 and 4.8). In patients with heart failure, renal or hepatic failure, in those taking diuretics or who have undergone major surgery resulting in dehydration, monitoring of urine output and renal function should be considered. Other considerations: Prolonged use of any type of pain reliever for headaches can make symptoms worse. If this situation occurs or is suspected, the doctor should be consulted and treatment should be suspended. The diagnosis of medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite or because of regular use of headache medications \u003cb\u003eCompromised female fertility\u003c\/b\u003e: see paragraph 4.6. The use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatories requires particular caution: • in case of current or previous asthma or allergic diseases: possible deterioration of bronchoconstriction; in the presence of coagulation defects as ibuprofen, the active ingredient of Nurofen Fever and Pain, can temporarily inhibit the function of platelets (thrombocyte aggregation). It is therefore recommended to carefully monitor patients with coagulation disorders; • in the presence of kidney disease, heart disease or hypertension: possible critical reduction in renal function (especially in subjects with impaired renal or hepatic function, heart failure or being treated with diuretics), nephrotoxicity or fluid retention; • in the presence of liver disease: possible hepatotoxicity; • rehydrate the subject before starting and during treatment in case of dehydration (for example due to fever, vomiting or diarrhea); • immediately after major surgery; • congenital disorders of porphyrin metabolism (for example, acute intermittent porphyria). The following precautions become relevant during prolonged treatments: • monitor for signs or symptoms of gastrointestinal ulceration or bleeding; • monitor for signs or symptoms of hepatotoxicity; • monitor for signs or symptoms of nephrotoxicity; • if visual disturbances occur (blurred or reduced vision, scotomas, alteration of color perception): stop treatment and consult your ophthalmologist; • if signs or symptoms of meningitis arise: evaluate the rare possibility that it is due to the use of ibuprofen (aseptic meningitis; more frequent in subjects suffering from systemic lupus erythematosus and mixed connective tissue disease or other collagenopathies) (see section 4.8). Since Nurofen Fever and Pain contains \u003cb\u003eliquid maltitol\u003c\/b\u003e, patients with rare hereditary problems of fructose intolerance should not take this medicine. May have a mild laxative effect. The caloric value of maltitol is 2.3 kcal\/g. Nurofen Fever and Pain does not contain sugar and is therefore indicated for those patients who need to control their intake of sugars and calories. This medicine contains 9.08 mg of \u003cb\u003esodium\u003c\/b\u003e per 5 ml equivalent to 0.45% of the WHO recommended maximum daily intake which corresponds to 2 g of sodium for an adult. NUROFEN FEVER AND PAIN Children 100mg\/5ml oral suspension strawberry flavor without sugar contains 11.75 mg of \u003cb\u003epropylene glycol\u003c\/b\u003e (present in the strawberry flavour) in 5 ml. Coadministration with any alcohol dehydrogenase substrate such as ethanol may induce serious adverse effects in neonates. NUROFEN FEVER AND PAIN Children 100mg\/5ml sugar-free orange flavor oral suspension contains only a very small quantity of gluten (from\u003cb\u003ewheat starch\u003c\/b\u003e present in the orange flavour). This medicine is considered (gluten-free) and is very unlikely to cause problems for a celiac patient. A 5 ml dose contains no more than 0.225 micrograms of gluten. If the patient is allergic to wheat (condition other than celiac disease) he should not take this medicine.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eIbuprofen should be avoided in association with\u003c\/b\u003e: • Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data indicate that ibuprofen can inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the paucity of data and the uncertainties relating to the application of data extrapolated ex vivo to the clinical situation do not allow definitive conclusions to be drawn on the regular use of ibuprofen; Clinically relevant effects resulting from occasional use of ibuprofen are unlikely (see section 5.1). • \u003cb\u003eOther NSAIDs including selective cyclooxygenase-2 inhibitors\u003c\/b\u003e: avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs: increased risk of side effects (see section 4.4). \u003cb\u003eIbuprofen should be used with caution in combination with:\u003c\/b\u003e • corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4); • quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures; • anticoagulants, such as warfarin: NSAIDs can increase the effects of anticoagulants (see section 4.4); • antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4); • phenytoin: Concomitant use of Nurofen Fever and Pain with phenytoin may increase serum levels of these medicines. Correct use of the drugs (administered for a maximum period of 3 days) does not normally require monitoring of serum phenytoin levels. • antidiabetics: an increase in the hypoglycaemic effect of sulfonylureas is possible. In the case of simultaneous treatment, monitoring of blood glucose levels is recommended. • antivirals, such as ritonavir: possible increase in the concentration of NSAIDs; • ciclosporin: increased risk of nephrotoxicity; • mifepristone: NSAIDs must not be administered in the 8-12 days following taking mifepristone as they can reduce its effectiveness; • cytotoxics, such as methotrexate: reduction of excretion (increased risk of toxicity); • lithium: reduction of excretion (increased risk of toxicity); • tacrolimus: increased risk of nephrotoxicity; • uricosurics, such as probenecid and sulfinpyrazone: slow the excretion of NSAIDs (increase in plasma concentrations); • methotrexate: potential increase in plasma concentrations of methotrexate; • zidovudine: increased risk of blood toxicity when NSAIDs are used in combination with zidovudine. There are demonstrations of increased risk of haemarthrosis and hematomas in HIV (+) haemophiliacs if treated simultaneously with zidovudine and ibuprofen; • anti-hypertensives, (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking Nurofen Fever and Pain concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and periodically. • potassium-sparing diuretics: concomitant administration of Nurofen Fever and Pain and potassium-sparing diuretics may lead to hyperkalaemia • CYP2C9 inhibitors: Concomitant administration of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased exposure to S(+)-ibuprofen by approximately 80% to 100% was demonstrated. Reduction of the ibuprofen dose should be considered when strong CYP2C9 inhibitors are coadministered, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole. • cardiac glycosides (Digoxin): NSAIDs can worsen heart failure, reduce VGF (glomerular filtration rate) and increase plasma glycoside levels.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes all those that have been recognized during treatment with ibuprofen for short periods of treatment and for daily doses up to a maximum of 1200 mg. In the case of high-dose therapies for chronic or prolonged pathologies, other undesirable effects may occur. Adverse reactions associated with the administration of ibuprofen are listed below according to system organ class and frequency. Frequencies are defined as: Very common (≥1\/10); Common (≥1\/100, \u003c1\/10); Uncommon (≥1\/1,000, \u003c1\/100); Rare (≥1\/10,000, \u003c1\/1,000) ; Very rare (\u003c1\/10,000); Not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Rare. Adverse reaction: Cystitis, rhinitis.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Very rare. Adverse reaction: Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis), in exceptional cases severe skin infections and soft tissue complications have been reported during a chickenpox infection.\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very rare. Adverse reaction: Hematopoiesis disorders ¹\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Uncommon. Adverse reaction: Hypersensitivity reactions manifested by urticaria and pruritus²\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Very rare. Adverse reaction: Severe hypersensitivity reactions including swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Asthma exacerbation.\u003c\/p\u003e\n\u003cp\u003eMetabolism and nutrition disorders - Frequency: Not known. Adverse reaction: Fluid retention and decreased appetite³.\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Not known. Adverse reaction: Irritability\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Rare. Adverse reaction: Depression, insomnia, difficulty concentrating, emotional lability, hearing disorders.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse reaction: Headache, dizziness, drowsiness, convulsions, agitation, tiredness.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse reaction: Aseptic meningitis4.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Rare. Adverse reaction: Cerebrovascular haemorrhage.\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Rare. Adverse reaction: Dry eyes.\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Uncommon. Adverse reaction: Visual disturbances.\u003c\/p\u003e\n\u003cp\u003eEar and labyrinth disorders - Frequency: Not known. Adverse reaction: Tinnitus.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Very rare. Adverse reaction: Myocardial infarction.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Not known. Adverse reaction: Heart failure and edema5.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Rare. Adverse reaction: Palpitations.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Not known. Adverse reaction: Hypertension5 and shock.\u003c\/p\u003e\n\u003cp\u003eRespiratory, thoracic and mediastinal disorders - Frequency: Not known. Adverse reaction: Respiratory tract reactivity including asthma, laryngeal obstruction, bronchospasm or apnea, dyspnea.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse reaction: Abdominal pain, nausea and dyspepsia6.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Rare. Adverse reaction: Diarrhoea, flatulence, dry mouth, constipation and vomiting.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse reaction: Peptic ulcer, gastrointestinal perforation or bleeding, melena and haematemesis7. Mouth ulcerations and gastritis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Not known. Adverse reaction: Exacerbation of colitis and Crohn's disease8, pancreatitis, duodenitis, esophagitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse reaction: Liver dysfunction, hepatitis, jaundice, hepatorenal syndrome, hepatic necrosis, hepatic failure.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse reaction: Various skin rashes²\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse reaction: Bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis².\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Rare. Adverse reaction: Exfoliative dermatitis, alopecia, photosensitivity reactions.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse reaction: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG).\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Rare. Adverse reaction: Tubular necrosis, glomerular nephritis, polyuria, hematuria.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse reaction: Acute renal failure9.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Rare. Adverse reaction: Decreased hematocrit levels.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Very rare. Adverse reaction: Decreased hemoglobin levels.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some adverse reactions\u003c\/b\u003e \u003csup\u003e1\u003c\/sup\u003e Hematopoiesis disorders including anemia, aplastic anemia, hemolytic anemia (positive Coombs test), leukopenia, neutropenia, thrombocytopenia (with or without purpura), eosinophilia, pancytopenia, and agranulocytosis. The first symptoms may be: fever, sore throat, superficial mouth ulcers, flu-like symptoms, marked fatigue, nosebleeds and bleeding. In these cases the patient should be advised to stop taking the medicine immediately, to avoid any self-medication medicine containing analgesics or antipyretics and to consult his doctor. Rarely congestive heart failure in patients with impaired cardiac function. ² Hypersensitivity reactions: these reactions include a) non-specific allergic reactions and anaphylaxis, fever, chills, b) respiratory tract reactivity including asthma, aggravated asthma, bronchospasm (see section 4.3 and 4.4) or dyspnoea or c) various skin conditions including various skin rashes (including maculopapular in nature), pruritus, urticaria with or without angioedema, purpura, angioedema and much rarely, bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme. ³ Decreased appetite: generally resolves rapidly upon discontinuation of treatment (see section 4.4). \u003csup\u003e4\u003c\/sup\u003e The pathogenetic mechanism of drug-induced aseptic meningitis is not completely known. However, the data available on aseptic meningitis related to the administration of NSAIDs leads us to think of an immune reaction (due to a temporal relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of symptoms of aseptic meningitis (such as stiff neck, neck numbness, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune diseases (such as systemic lupus erythromatosus, mixed connective tissue disease).\u003csup\u003e5\u003c\/sup\u003e Heart failure and edema: Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Congestive heart failure in patients with impaired cardiac function. \u003csup\u003e6\u003c\/sup\u003e The most commonly observed adverse events are gastrointestinal in nature. Gastric discomfort can be reduced by taking the medicine on a full stomach. \u003csup\u003e7\u003c\/sup\u003e Peptic ulcers, gastrointestinal perforation or hemorrhage, melena, and sometimes fatal hematemesis may occur. \u003csup\u003e8\u003c\/sup\u003e Exacerbation of colitis and Crohn's disease (see section 4.4). \u003csup\u003e9\u003c\/sup\u003e Acute renal failure especially in case of long-term therapy, associated with increased serum urea levels and edema. Papillary necrosis may occur. \u003cb\u003eReporting of suspected adverse reactions\u003c\/b\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioniavverse\u003ci\u003e. \u003c\/i\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eToxicity \u003c\/u\u003e Signs and symptoms of toxicity were generally not observed at doses below 100 mg\/kg in children or adults. However, in some cases supportive treatment may be necessary. Children have been observed to exhibit signs and symptoms of toxicity after ingesting ibuprofen at doses of 400 mg\/kg or greater. The half-life of the drug in case of overdose is 1.5-3 hours. \u003cu\u003eSymptoms \u003c\/u\u003e Most patients who accidentally ingest clinically relevant quantities of ibuprofen will experience symptoms within 4 to 6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea and CNS and respiratory depression have also been reported rarely. Disorientation, arousal, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In cases of severe poisoning, metabolic acidosis and a prolongation of the prothrombin time (INR) may occur, probably caused by interference with the action of coagulation factors present in the circulation. In asthmatic subjects, an exacerbation of the symptoms of the disease may occur. \u003cu\u003eTreatment \u003c\/u\u003e There is no specific antidote for ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is therefore indicated and must include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilised. Particular attention is due to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic quantity. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam or lorazepam. If ibuprofen has already been absorbed, alkaline substances should be administered to promote excretion of the acidic ibuprofen in the urine. Administer bronchodilators in case of asthma. Depending on the patient's clinical condition, other support measures may be necessary. For more information, contact your local poison control center.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eChildren under the age of 12 are unlikely to become pregnant or breastfeed. Furthermore, in such circumstances the following considerations must be kept in mind. \u003cu\u003ePregnancy \u003c\/u\u003e Inhibition of prostaglandin synthesis can negatively affect pregnancy and\/or embryo\/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been thought to increase with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. From the 20th\u003csup\u003ea\u003c\/sup\u003e week of pregnancy onwards, the use of ibuprofen could cause oligohydramnios resulting from fetal renal dysfunction. This condition may be experienced shortly after starting treatment and is usually reversible upon discontinuation of treatment. Additionally, cases of constriction of the ductus arteriosus have been reported following treatment in the second trimester, most of which resolved after treatment was discontinued. Therefore, during the first and second trimester of pregnancy ibuprofen should not be administered unless strictly necessary. If ibuprofen is used by a woman planning pregnancy, or during the first and second trimester of pregnancy, the lowest possible dose should be used for the shortest possible time. Following exposure to ibuprofen for several days from the 20th\u003csup\u003ea\u003c\/sup\u003e week of gestation onwards, antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered. In case of oligohydramnios or constriction of the ductus arteriosus, treatment with ibuprofen should be discontinued. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (premature constriction\/closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction (see above); the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, Nurofen Fever and Pain is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). \u003cu\u003eBreastfeeding \u003c\/u\u003e There is limited data showing that ibuprofen can pass in low concentrations into breast milk and is unlikely to have any adverse effects on newborns.\u003cu\u003eFertility \u003c\/u\u003e There is evidence that medicinal products that inhibit cyclooxygenase\/prostaglandin synthesis may cause impairment of female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNot relevant, considering the age of the patient.\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51730205016391,"sku":"034102261","price":13.3,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofen-febbre-e-dolore-bambini-100-mg-5-ml-150-ml-sospensione-orale-senza-zucchero-gusto-fragola-farmacia-dottor-tili-1213791387.jpg?v=1767139331"},{"product_id":"nurofen-junior-125-mg-10-supposte-bambini","title":"Nurofen Junior 125 mg 10 suppositories children","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eShort-term symptomatic treatment of mild and moderate pain. Short-term symptomatic treatment of fever. Nurofenjunior suppositories are indicated when oral administration is not recommended, e.g. in case of vomiting. Nurofenjunior is indicated in children from 12.5 kg (2 years) to 20.5 kg (6 years) body weight\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eEach suppository contains: ibuprofen 125 mg For the complete list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSolid semi-synthetic glycerides\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eHypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Patients who have previously shown hypersensitivity reactions (e.g. bronchospasm, angioedema, asthma, rhinitis or urticaria) associated with acetylsalicylic acid, ibuprofen or other non-steroidal anti-inflammatory medicinal products. History of gastrointestinal bleeding or perforation associated with previous treatment with NSAIDs. In the presence or history of recurrent peptic ulcer\/haemorrhage (two or more confirmed episodes of ulceration or bleeding). Patients with severe renal insufficiency, severe hepatic insufficiency or severe heart failure. Patients with a history of cerebrovascular bleeding or other active bleeding. Patients with unexplained disorders of blood formation. Patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake). In the last trimester of pregnancy (see section 4.6). Children weighing less than 12.5 kg (under 2 years of age).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage\u003c\/u\u003e Only for a short period of treatment. The maximum daily dose of ibuprofen is 20-30 mg\/kg of body weight, divided into 3 or 4 administrations. This means: Children with a body weight between 12.5 and 17 kg (between 2 and 4 years): 1 suppository at the beginning of treatment, to be repeated, if necessary, after at least 6-8 hours. No more than 3 suppositories should be administered in any 24 hour period. Children with a body weight between 17 and 20.5 kg (between 4 and 6 years): 1 suppository at the beginning of treatment, to be repeated if necessary, after at least 6 hours. No more than 4 suppositories should be administered in any 24 hour period. Nurofenjunior 125 mg suppositories are contraindicated in children weighing less than 12.5 kg (under 2 years of age), as lower dosage suppositories are required (see also section 4.3). Administration in patients with renal or hepatic insufficiency must take place after consulting the doctor. If this medicine is required for more than 3 days, or if symptoms worsen, a doctor should be consulted. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). \u003cu\u003eMethod of administration\u003c\/u\u003e Rectal use\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eDo not store above 25°C\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eSide effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see gastrointestinal and cardiovascular effects below). \u003cb\u003eElderly people\u003c\/b\u003e: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Elderly people have an increased risk of consequences from adverse reactions. Caution is required in patients with: • Systemic lupus erythematosus or mixed connective tissue disease, due to the increased risk of aseptic meningitis (see section 4.8). • Congenital disorders of porphyrin metabolism (e.g., acute intermittent porphyria). • Gastrointestinal disorders and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease) (see section 4.8). • History of hypertension and\/or heart failure since fluid retention and edema have been reported in association with NSAID therapy • Renal damage, as renal function may worsen (see sections 4.3 and 4.8). • Liver dysfunction (see sections 4.3 and 4.8) • Immediately after major surgery • Hay fever, nasal polyps or chronic obstructive respiratory disease, as there is an increased risk of allergic reactions in these patients. These may manifest as asthma attacks (so-called “analgesic asthma”), Quincke's edema or urticaria • In patients who have already experienced allergic reactions to other substances, as they are at higher risk of developing hypersensitivity reactions following the administration of Nurofenjunior \u003cb\u003eOther NSAIDs\u003c\/b\u003e: the use of Nurofenjunior in children should be avoided concomitantly with the administration of other NSAIDs including selective cyclooxygenase-2 inhibitors. \u003cb\u003eMasking of symptoms of underlying infections\u003c\/b\u003e Nurofenjunior may mask the symptoms of infection, which could delay starting appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Nurofenjunior is administered for the relief of fever or pain related to infection, monitoring of the infection is recommended. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. \u003cb\u003eCardiovascular and cerebrovascular effects\u003c\/b\u003e: caution is required (advice from a doctor or pharmacist) before administering Nurofenjunior to patients with a history of hypertension and\/or heart failure, since fluid retention, hypertension and edema have been reported following NSAID therapy. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg\/day) and for long-term treatments, may be associated with a modest increase in the risk of events arterial thrombosis (e.g. myocardial infarction or stroke). In general, epidemiological studies do not indicate that low doses of ibuprofen (e.g. ≤ 1200 mg\/day) are associated with an increased risk of myocardial infarction. \u003cb\u003eGastrointestinal (GI) effects\u003c\/b\u003e: During treatment with all NSAIDs, gastrointestinal bleeding, ulceration or perforation, which may be fatal, have been reported at any time, with or without warning symptoms or previous history of serious gastrointestinal events, disorders of the rectum and anus. The risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs, in patients with a history of ulcer, particularly if complicated by haemorrhage or perforation (see section 4.3) and in the elderly. These patients should start treatment with the lowest dose. For these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events, the concomitant use of gastroprotective agents (e.g. misoprostol or proton pump inhibitors) should be considered (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly if elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Nurofenjunior, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). \u003cb\u003eRespiratory\u003c\/b\u003e: Bronchospasm may worsen in patients with or with a history of bronchial asthma, chronic rhinitis, sinusitis, nasal polyposis, or allergic disease. \u003cb\u003eOther considerations:\u003c\/b\u003e Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely. At the first signs of hypersensitivity reaction after administration\/taking of Nurofenjunior, therapy should be discontinued. Medical rescue measures, in line with the symptoms, must be undertaken by specialized personnel. Ibuprofen, the active ingredient in Nurofenjunior, can temporarily inhibit the function of platelets (thrombocyte aggregation). It is therefore recommended to carefully monitor patients with coagulation disorders. In case of prolonged administration of Nurofenjunior, regular monitoring of liver values, renal function as well as blood counts is required. Prolonged use of any type of pain reliever for headaches can worsen symptoms. If this situation occurs or is suspected, the doctor should be consulted and treatment should be suspended. The diagnosis of medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite or because of regular use of headache medications. Side effects related to the active ingredient, in particular those relating to the gastrointestinal tract or central nervous system, may be increased by taking NSAIDs in combination with alcohol. In patients with heart failure, renal or hepatic failure, in those taking diuretics or who have undergone major surgery resulting in dehydration, monitoring of urine output and renal function should be considered. \u003cb\u003eRenal disorders\u003c\/b\u003e: in general, the habitual use of analgesics, especially the combination of different analgesic substances, can cause permanent kidney damage, with risk of renal failure (analgesic nephropathy). \u003cb\u003ePediatric population\u003c\/b\u003e: There is a risk of kidney damage in dehydrated children. \u003cb\u003eCompromised female fertility\u003c\/b\u003e: see paragraph 4.6. \u003cb\u003eSevere skin reactions\u003c\/b\u003e: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Nurofenjunior should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity. Chickenpox can exceptionally cause serious infectious complications to the skin and soft tissues. It is advisable to avoid using Nurofenjunior in case of chickenpox.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eIbuprofen should not be used in combination with:\u003c\/b\u003e Acetylsalicylic acid (aspirin): unless low-dose acetylsalicylic acid, as per common clinical practice, has been advised by the doctor, as it may increase the risk of adverse reactions (see section 4.4). Other NSAIDs including selective cyclooxygenase 2 inhibitors: avoid concomitant use of two or more NSAIDs as it may increase the risk of adverse reactions (see section 4.4) Experimental data suggest that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the paucity of data and the uncertainties relating to the application of data extrapolated ex vivo to the clinical situation do not allow definitive conclusions to be drawn for the regular use of ibuprofen and no relevant clinical effect is considered probable in case of occasional use of ibuprofen (see section 5.1). \u003cb\u003eIbuprofen (like other NSAIDs) should be used with caution in association with:\u003c\/b\u003e - Corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4) - Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4) - Phenytoin: concomitant use of Nurofenjunior with phenytoin may increase the serum levels of these medicines. Correct use of the drugs (administered for a maximum period of 3 days) does not normally require monitoring of serum phenytoin levels. - Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): may increase the risk of gastrointestinal bleeding (see section 4.4). - Anti-hypertensives (ACE inhibitors, beta-blockers and angiotensin II antagonists) and diuretics: NSAIDs can decrease the effectiveness of these medicines. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor, a beta-blocker or an angiotensin II antagonist and agents that inhibit cyclooxygenases may lead to a further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and at regular intervals thereafter. Diuretics may increase the risk of NSAID nephrotoxicity. - Lithium: there is evidence to support a potential increase in plasma lithium levels. Correct use of the drugs (administered for a maximum period of 3 days) does not normally require monitoring of serum lithium levels. - Probenecid and sulfinpyrazone: Medicines containing probenecid or sulfinpyrazone may delay the excretion of ibuprofen. - Potassium-sparing diuretics: concomitant administration of Nurofenjunior and potassium-sparing diuretics may lead to hyperkalemia (monitoring of serum potassium is recommended). - Cardiac glucosides (Digoxin): NSAIDs can worsen heart failure, reduce GFR and plasma levels of glucosides. Concomitant use of Nurofenjunior with digoxin preparations may increase serum levels of these medicines. Correct use of the drugs (administered for a maximum period of 3 days) does not normally require monitoring of serum digoxin levels. - Methotrexate: there is evidence to support a potential increase in plasma levels of methotrexate. Administration of Nurofenjunior in the 24 hours before and after the administration of methotrexate may lead to high concentrations of methotrexate and an increase in its toxic effects. - Tacrolimus: the risk of nephrotoxicity increases if the two medicines are administered simultaneously. - Ciclosporin: there is limited evidence to support a possible interaction between the two medicines with consequent increased risk of nephrotoxicity. - Zidovudine: there is evidence of an increased risk of haemarthrosis and haematoma in HIV-positive haemophilia patients treated concomitantly with zidovudine and ibuprofen. - Sulfonylureas: clinical studies have shown interactions between nonsteroidal anti-inflammatory drugs and antidiabetics (sulfonylureas). Although no interactions between ibuprofen and sulphonylureas have been described so far, monitoring of blood glucose values ​​is recommended as a precautionary measure during concomitant intake. - Quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. - CYP2C9 inhibitors: Concomitant administration of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased exposure to S(+)-ibuprofen by approximately 80% to 100% was demonstrated. Reduction of the ibuprofen dose should be considered when strong CYP2C9 inhibitors are coadministered, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe list of the following side effects includes all side effects that have been recognized during treatment with ibuprofen, even those observed during prolonged high-dose therapy in patients with rheumatism. The frequencies reported, which extend beyond reports of very rare side effects, refer to short periods of treatment for daily doses up to a maximum of 1,200 mg of ibuprofen for oral pharmaceutical forms and up to a maximum of 1,800 mg for suppositories. It should be taken into account that the following adverse reactions are predominantly dose-dependent and vary from individual to individual. Adverse reactions associated with the administration of ibuprofen are listed below according to system organ class and frequency. Frequencies are defined as: very common (≥1\/10), common (≥1\/100, \u003c1\/10), uncommon (≥1\/1,000, \u003c1\/100), rare (≥1\/10,000, \u003c1\/1,000), very rare (\u003c1\/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness. The most often observed adverse reactions are gastrointestinal in nature. Adverse reactions are in most cases dose-dependent. In particular, the risk of gastrointestinal bleeding depends on the dosage and duration of treatment. Peptic ulcers, perforation or gastrointestinal haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of ibuprofen (see section 4.4). Less frequently, gastritis was observed. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2,400 mg per day) and for long-term treatment, may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis) associated with the use of non-steroidal anti-inflammatory drugs has been described. This is probably due to the mechanism of action of non-steroidal anti-inflammatory drugs. If signs of an infection occur or worsen while using Nurofenjunior, the patient is recommended to contact a doctor immediately to assess whether anti-infective\/antibiotic therapy is necessary. For prolonged treatments blood counts should be checked regularly. If any symptoms of hypersensitivity reactions occur, the patient should be instructed to immediately inform the doctor and stop taking Nurofenjunior; this can also happen upon first use, in which case immediate medical assistance is required. The patient should be instructed to stop taking the medicine and consult a doctor immediately if severe pain in the upper abdomen or melena or haematemesis occurs.\u003c\/p\u003e\n\u003cp\u003eInfections and infestations - Frequency: Very rare. Adverse reaction: Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis), in exceptional cases severe skin infections and soft tissue complications have been reported during a chickenpox infection.\u003c\/p\u003e\n\u003cp\u003eBlood and lymphatic system disorders - Frequency: Very rare. Adverse reaction: Hematopoietic disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding and bruising. In these cases the patient should be advised to stop taking the medicine immediately, to avoid any self-medication medicine containing analgesics or antipyretics and to consult his doctor.\u003c\/p\u003e\n\u003cp\u003ePsychiatric disorders - Frequency: Very rare. Adverse reaction: Psychotic reactions, depression.\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Adverse reaction: Hypersensitivity reactions consisting of:¹\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Uncommon. Adverse reaction: Urticaria and itching.\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Very rare. Adverse reaction: Severe hypersensitivity reactions. Symptoms may be: swelling of the face, tongue and larynx, dyspnea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Asthma exacerbation.\u003c\/p\u003e\n\u003cp\u003eImmune system disorders - Frequency: Not known. Adverse reaction: Respiratory tract reactivity including asthma, bronchospasm, or dyspnea.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Uncommon. Adverse reaction: Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or tiredness.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders - Frequency: Very rare. Adverse reaction: Aseptic meningitis²\u003c\/p\u003e\n\u003cp\u003eEye disorders - Frequency: Uncommon. Adverse reaction: Visual disturbances.\u003c\/p\u003e\n\u003cp\u003eEar and labyrinth disorders - Frequency: Rare. Adverse reaction: Tinnitus.\u003c\/p\u003e\n\u003cp\u003eCardiac disorders - Frequency: Very rare. Adverse reaction: Heart failure, palpitations and edema, myocardial infarction.\u003c\/p\u003e\n\u003cp\u003eVascular disorders - Frequency: Very rare. Adverse reaction: Hypertension, vasculitis.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Common. Adverse reaction: Gastrointestinal problems, such as abdominal pain, nausea and dyspepsia. Diarrhea, flatulence, constipation, heartburn, vomiting and slight blood loss in the stomach and\/or intestines which in exceptional cases can cause anemia.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Uncommon. Adverse reaction: Gastrointestinal ulcers, perforation or gastrointestinal bleeding. Ulcerative stomatitis, worsening of colitis or Crohn's disease (see section 4.4), gastritis, localized rectal irritation.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders - Frequency: Very rare. Adverse reaction: Esophagitis and formation of diaphragmatic-like intestinal structures, pancreatitis.\u003c\/p\u003e\n\u003cp\u003eHepatobiliary disorders - Frequency: Very rare. Adverse reaction: Liver dysfunction, liver damage, particularly in long-term therapy, liver failure, acute hepatitis.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse reaction: Various skin rashes.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Very rare. Adverse reaction: Severe forms of skin reactions such as bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis, alopecia.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders - Frequency: Not known. Adverse reaction: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Acute generalized exanthematous pustulosis (PEAG). Photosensitivity reactions.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Rare. Adverse reaction: Rarely, kidney tissue damage (papillary necrosis) may occur.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Rare. Adverse reaction: and high concentrations of urea in the blood.\u003c\/p\u003e\n\u003cp\u003eRenal and urinary disorders - Frequency: Very rare. Adverse reaction: Formation of edema particularly in patients with arterial hypertension or renal failure, nephrotic syndrome, interstitial nephritis which may be accompanied by acute renal failure.\u003c\/p\u003e\n\u003cp\u003eDiagnostic tests - Frequency: Rare. Adverse reaction: Decreased hemoglobin level in the blood.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eDescription of some selected adverse reactions\u003c\/b\u003e \u003csup\u003e1\u003c\/sup\u003e Hypersensitivity reactions have been reported following treatment with ibuprofen. These reactions may include a) non-specific allergic reactions and anaphylaxis, b) respiratory tract reactivity including asthma, worsening of asthma, bronchospasm or dyspnea, or c) various skin conditions including various skin rashes, pruritus, urticaria, purpura, angioedema and very rarely bullous and exfoliative dermatitis (including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme)² The pathogenetic mechanism of drug-induced aseptic meningitis is not completely known. However, the data available on aseptic meningitis related to NSAIDs leads us to think of an immune reaction (due to a temporary relationship with the intake of the medicine and the disappearance of symptoms after discontinuation of treatment). Of note, individual cases of symptoms of aseptic meningitis (such as numb neck, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with pre-existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease). \u003cb\u003eReporting of suspected adverse reactions\u003c\/b\u003e Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https:\/\/www.aifa.gov.it\/content\/segnalazioni-reazioni-avverse\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe risk of toxicity may occur for doses higher than 200 mg\/kg. a) Symptoms of overdose: Symptoms of overdose may include nausea, vomiting, abdominal pain or more rarely diarrhoea. Nystagmus, blurred vision, tinnitus, headache, and gastrointestinal bleeding are also possible. In more serious cases of poisoning, central nervous system toxicity is observed, manifested by vertigo, dizziness, drowsiness, occasionally excitation and disorientation, loss of consciousness or coma. Occasionally patients develop seizures. In cases of severe poisoning, metabolic acidosis may occur. Hypothermia and hyperkalemia may occur, and prothrombin time\/INR may be prolonged, possibly due to interference with the action of circulating coagulation factors. Acute renal failure, liver damage, hypotension, respiratory depression and cyanosis may also occur. In asthmatic subjects, asthma exacerbation may occur. b) Treatment of overdose: There is no specific antidote. Treatment should be symptomatic and supportive and should include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilized. If frequent or prolonged, seizures should be treated with intravenous diazepam or lorazepam. Administer bronchodilators in case of asthma. The local poison center should be contacted for medical advice.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003ePregnancy\u003c\/u\u003e Inhibition of prostaglandin synthesis can negatively influence pregnancy and\/or embryo\/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformations and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations was increased from less than 1% to approximately 1.5%. The risk is thought to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular ones, has been reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. During the first and second trimester of pregnancy, ibuprofen should not be administered unless strictly necessary. If ibuprofen is used by a woman trying to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction which may progress to renal failure with oligo-hydramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.\u003cu\u003eBreastfeeding\u003c\/u\u003e Ibuprofen and metabolites pass into breast milk only in small quantities. Since to date there are no known side effects in infants, interruption of breastfeeding is usually not required if the medicine is taken at the recommended doses for fever and pain for short-term treatments. \u003cu\u003eFertility\u003c\/u\u003e There is evidence that medicinal products that inhibit cyclooxygenase\/prostaglandin synthesis may cause impairment of female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eFor short-term treatments, Nurofenjunior has negligible or no effect on the ability to drive or use machines.\u003c\/p\u003e","brand":"Reckitt Benckiser","offers":[{"title":"Default Title","offer_id":51730205409607,"sku":"041610027","price":11.4,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/reckitt-benckiser-h-it-spa-nurofen-junior-125-mg-10-supposte-bambini-farmacia-dottor-tili-1213791380.jpg?v=1767139548"}],"url":"https:\/\/www.dottortili.com\/en\/collections\/febbre-e-dolore-nei-bambini.oembed","provider":"Farmacia Dottor Tili","version":"1.0","type":"link"}