Tachipirina 120 mg 5 ml sciroppo angelini

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012745016

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WARNINGS
In rare cases of allergic reactions, administration should be suspended and appropriate treatment instituted. Use with caution in case of chronic alcoholism, excessive alcohol intake (3 or more alcoholic drinks per day), anorexia, bulimia or cachexia, chronic malnutrition (low reserves of hepatic glutathione), 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, concomitant treatment with drugs that impair liver function, deficiency of glucose-6-phosphate dehydrogenase, haemolytic anemia. High or prolonged doses of the product can cause alterations in the kidney and blood, even serious, therefore the administration in 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 drug, check that it does not contain the same active ingredient, as if paracetamol is taken in high doses, serious adverse reactions may occur. . Tachipirina drops, solution contains. Sorbitol: Use with caution in patients with rare hereditary problems of fructose intolerance. Propylene glycol which can cause symptoms similar to those caused by alcohol. The syrup contains sucrose: use with caution in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency; this should also be taken into account for use in diabetic patients and in patients who follow low-calorie diets. Methyl parahydroxybenzoate which can cause allergic reactions (even delayed).
PHARMACOTHERAPEUTIC CATEGORY
Analgesics and antipyretics.
STORAGE
Syrup and oral drops, solution: no special storage precautions.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to paracetamol or to any of the excipients Patients with severe haemolytic anemia (this contraindication does not refer to oral formulations of 500mg). Severe hepatocellular insufficiency (this contraindication does not refer to oral formulations of 500 mg).
NAME
TACHIPIRINA SYRUP - ORAL DROPS, SOLUTION
EXCIPIENTS
Syrup: sucrose, sodium citrate, sodium saccharin, methyl parahydroxybenzoate, potassium sorbate, macrogol 6000, citric acid monohydrate, strawberry flavor, mandarin flavor, purified water. Oral drops: propylene glycol, macrogol 6000, sorbitol, sodium saccharin, citrus fruit flavor, propyl gallate, caramel (E150a), sodium edetate, purified water.
SIDE EFFECTS
Disorders of the blood and lymphatic system: thrombocytopenia, leukopenia, anemia, agranulocytosis. Immune system disorders: hypersensitivity reactions' (urticaria, larynx 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, haematuria, anuria.
PREGNANCY AND BREASTFEEDING
Although clinical studies in pregnant or lactating patients have not shown particular contraindications to the use of paracetamol nor caused unwanted effects affecting the mother or child, it is recommended to administer the product only in cases of actual necessity and under the direct control of doctor.
INDICATIONS
As antipyretic: symptomatic treatment of febrile diseases such as influenza, exanthematous diseases, acute respiratory tract diseases, etc. As an analgesic: headaches, neuralgia, myalgia and other painful manifestations of medium entity, of various origins.
INTERACTIONS
Oral absorption of paracetamol depends on the rate of gastric emptying. Therefore, concomitant administration of drugs that slow down (e.g. anticholinergics, opioids) or increase (e.g. prokinetics) the rate of gastric emptying may result in a decrease or an 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 elevating its toxicity'. The concomitant use of paracetamol (4 g daily for at least 4 days) with oral anticoagulants may induce slight variations in INR values. In these cases, more frequent monitoring of INR values should be performed during concomitant use and after Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital , carbamazepine). The same is true in cases of alcoholism and in patients treated with zidovudine. The administration of paracetamol can interfere with the determination of uric acid (by the method of phosphotungstic acid) and with that of blood sugar (by the method of glucose-oxidase-peroxidase).
DOSAGE
For children it is essential to respect the dosage defined according to their body weight, and therefore to choose the suitable formulation. Approximate ages according to body weight are indicated by information title. Below three months, in case of jaundice, it is advisable to reduce the single oral dose. In adults, the maximum oral dose is 3000 mg of paracetamol per day. 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. Syrup of 120 mg / 5 ml The package is accompanied by a measuring cup with indicated level marks corresponding to the capacities of 5 ml, 7.5 ml, 10 ml, 15 ml and 20 ml. Children weighing between 7 and 10 kg (approximately between 6 and 18 months): 5 ml at a time (corresponding to 120 mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding 4 doses per day. Children weighing between 11 and 12 kg (approximately between 18 and 24 months): 5 ml at a time (corresponding to 120 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 doses per day. Children weighing between 13 and 20 kg (approximately between 2 and 7 years): 7.5 - 10 ml at a time (corresponding respectively to 180 and 240mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day. Children weighing between 21 and 25 kg (approximately between 6 and 10 years): 10 ml at a time (corresponding to 240 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 doses per day. Children weighing between 26 and 40 kg (approximately between 8 and 13 years): 15 - 20 ml at a time (corresponding respectively to 360 and 480 mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. Boys weighing between 41 and 50 kg (approximately between 12 and 15 years): 20 ml at a time (corresponding to 480 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 doses per day. Children weighing more than 50 kg (approximately over 15 years): 20 ml at a time (corresponding to 480 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 doses per day. Adults: 20 ml at a time (corresponding to 480 mg), to be repeated if necessary after 4 hours, without exceeding 6 doses per day. The syrup package contains a dosage rule to facilitate the calculation of the dose of the product as a function of body weight. Oral drops, 100 mg / ml solution: One drop of oral drops corresponds to 3.1 mg. Children weighing between 3.2 and 6 kg (approximately between birth and 6 months): 14-20 drops at a time (corresponding respectively to 43.4 and 62 mg of paracetamol), to be repeated if necessary after 6 hours, without exceed 4 doses per day. Children weighing between 7 and 10 kg (approximately between 6 and 18 months): 35-40 drops at a time (corresponding respectively to 108.5 and 124 mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day. Children weighing between 11 and 12 kg (approximately between 18 and 24 months): 35-40 drops at a time (corresponding respectively to 108.5 and 124 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding the 6 administrations per day. Renal insufficiency: In case of severe renal insufficiency (creatinine clearance less than 10 ml / min), the interval between dosing should be at least 8 hours.
ACTIVE PRINCIPLES
Syrup; 5 ml of syrup contains 120 mg paracetamol. Oral drops, solution: 1 ml of solution contains 100 mg paracetamol.

Reference 012745016

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