Tachipirina Syrup Children Paracetamol 120 mg/5 ml

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

As 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.

ACTIVE INGREDIENTS

TACHIPIRINA 120mg/5 ml syrup 5 ml of syrup contain active ingredient: paracetamol 120 mg excipients with known effects: sucrose, methyl parahydroxybenzoate, sodium. TACHIPIRINA 100mg/ ml oral drops, solution 1 ml of solution contains active ingredient: paracetamol 100 mg excipients with known effects: sorbitol, propylene glycol For the complete list of excipients, see par. 6.1.

EXCIPIENTS

• Syrup: sucrose, sodium citrate, sodium saccharin, methyl parahydroxybenzoate, potassium sorbate, Macrogol 6000, citric acid monohydrate, strawberry flavour, mandarin flavour, purified water. • Oral drops: propylene glycol, Macrogol 6000, sorbitol, sodium saccharin, citrus vanilla flavouring, propyl gallate, caramel (E150a), sodium edetate, purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

• 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).

DOSAGE

In 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.

TACHIPIRINA DROPS.

Weight: from 3.2 kg - Age (approximate): 0-30 days. Single dose: 8 drops. Daily dose: Up to 4 times (every 6 hours).

Weight: from 4.3 kg - Age (approximate): 1 month. Single dose: 10 drops. Daily dose: Up to 4 times (every 6 hours).

Weight: from 5.3 kg - Age (approximate): 2 months. Single dose: 13 drops. Daily dose: Up to 4 times (every 6 hours).

Weight: from 6.1 kg - Age (approximate): 3 months. Single dose: 22 drops. Daily dose: Up to 4 times (every 6 hours).

Weight: from 6.7 kg - Age (approximate): 4 months. Single dose: 25 drops. Daily dose: Up to 4 times (every 6 hours).

Weight: from 7.2 kg - Age (approximate): 5-6 months. Single dose: 27 drops. Daily dose: Up to 4 times (every 6 hours).

Weight: from 8 kg - Age (approximate): 7-10 months. Single dose: 30 drops. Daily dose: Up to 4 times (every 6 hours).

Weight: from 9 kg - Age (approximate): 11-14 months. Single dose: 33 drops. Daily dose: Up to 4 times (every 6 hours).

Weight: from 10 kg - Age (approximate): 15-19 months. Single dose: 36 drops. Daily dose: Up to 4 times (every 6 hours).

Weight: from 11 kg - Age (approximate): 20-23 months. Single dose: 39 drops. Daily dose: Up to 4 times (every 6 hours).

The dosage scheme of Tachipirina syrup is as follows.

TACHIPIRINA SYRUP.

Weight: from 7.2 kg - Age (approximate): 5-6 months. Single dose: 4.5 ml. Daily dose: Up to 4 times (every 6 hours).

Weight: from 8 kg - Age (approximate): 7-10 months. Single dose: 5 ml. Daily dose: Up to 4 times (every 6 hours).

Weight: from 9 kg - Age (approximate): 11-14 months. Single dose: 5.5 ml. Daily dose: Up to 4 times (every 6 hours).

Weight: from 10 kg - Age (approximate): 15-19 months. Single dose: 6 ml. Daily dose: Up to 4 times (every 6 hours).

Weight: from 11 kg - Age (approximate): 20-23 months. Single dose: 6.5 ml. Daily dose: Up to 4 times (every 6 hours).

Weight: from 12 kg - Age (approximate): 2 years. Single dose: 7.5 ml. Daily dose: Up to 4 times (every 6 hours).

Weight: from 14 kg - Age (approximate): 3 years. Single dose: 8.5 ml. Daily dose: Up to 4 times (every 6 hours).

Weight: from 16 kg - Age (approximate): 4 years. Single dose: 10 ml. Daily dose: Up to 4 times (every 6 hours).

Weight: from 18 kg - Age (approximate): 5 years. Single dose: 11ml. Daily dose: Up to 4 times (every 6 hours).

Weight: from 20 kg - Age (approximate): 6 years. Single dose: 12.5 ml. Daily dose: Up to 4 times (every 6 hours).

Weight: from 22 kg - Age (approximate): 7 years. Single dose: 13.5 ml. Daily dose: Up to 4 times (every 6 hours).

Weight: from 25 kg - Age (approximate): 8 years. Single dose: 15.5 ml. Daily dose: Up to 4 times (every 6 hours).

Weight: from 28 kg - Age (approximate): 9 years. Single dose: 17.5 ml. Daily dose: Up to 4 times (every 6 hours).

Weight: from 31 kg up to 32 kg - Age (approximate): 10 years. Single dose: 19 ml. Daily dose: Up to 4 times (every 6 hours).

In 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. Method of administration 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 Syrup 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. Drops 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. Renal failure In case of severe renal insufficiency (creatinine clearance less than 10 ml/min), the interval between administrations must be at least 8 hours.

CONSERVATION

This medicinal product does not require any special storage conditions.

WARNINGS

In 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>9), 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). Important information about some excipients Tachipirina drops, solution contains: - 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 Tachipirina drops, solution It is made of latex rubber. May cause serious allergic reactions. Tachipirina syrup contains: - 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.

INTERACTIONS

Oral 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).

SIDE EFFECTS

Below 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.

Blood and lymphatic system disorders: Thrombocytopenia, leukopenia, anemia, agranulocytosis.

Immune system disorders: Hypersensitivity reactions (urticaria, laryngeal edema, angioedema, anaphylactic shock).

Nervous system disorders: Dizziness.

Gastrointestinal disorders: Gastrointestinal reaction.

Hepatobiliary disorders: Abnormal liver function, hepatitis.

Skin and subcutaneous tissue disorders: Erythema multiforme, Stevens Johnson Syndrome, Epidermal necrolysis, rash.

Renal and urinary disorders: Acute renal failure, interstitial nephritis, hematuria, anuria.

Very 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.

OVERDOSE

There 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. Symptoms 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. Treatment 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.

PREGNANCY AND BREASTFEEDING

Pregnancy: 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.

EFFECTS ON DRIVING ABILITY

Tachipirina does not alter the ability to drive or use machines.