Tachipirina Syrup Children Paracetamol 120 mg/5 ml

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 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.

CONTRAINDICATIONS

• 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).

WARNINGS AND PRECAUTIONS FOR USE

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.

Pathologies of the blood and lymphatic system | 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

Pathologies of the skin and subcutaneous tissue | 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.