Tachipirina Flashtab 12 Tablets 250 mg

WARNINGS
Do not exceed the recommended dose. Prolonged use of the product, other than medical supervision, can be harmful. This product should only be used if strictly necessary. Doses higher than those recommended carry a risk of very serious liver damage. Treatment with an antidote should be performed as soon as possible. To avoid the risk of overdose, patients should be advised to avoid concomitant use of other medicines containing paracetamol. The total dose of paracetamol should not exceed 80 mg / kg / day in children weighing less than 37 kg and 3 g per day in adults and children weighing 38 kg or more. It is to be avoided the intake of undissolved tablets in children under 6 years of age as this could lead to their inhalation. This medicine contains aspartame, a source of phenylalanine, equivalent to 0.15 mg per tablet and, therefore, is contraindicated in subjects with phenylketonuria. Paracetamol should be used with caution in case of: adults weighing less than 50 kg; mild to moderate hepatocellular insufficiency (note: paracetamol is contraindicated in cases of severe hepatocellular insufficiency); chronic alcoholism; chronic malnutrition (low reserves of hepatic glutathione); dehydration; severe renal insufficiency (creatinine clearance <= 10 ml / min). In children treated with 60 mg / kg / day of paracetamol, the association with another antipyretic is not justified unless the treatment is ineffective. In case of high fever, or signs of secondary infection, or persistence of symptoms beyond 3 days, a re-evaluation of the treatment should be carried out.
PHARMACOTHERAPEUTIC CATEGORY
Analgesics and antipyretics, anilides.
STORAGE
This medicine does not require any special storage conditions.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to paracetamol or to any of the listed excipients. Phenylketonuria (due to the presence of aspartame). Severe hepatocellular insufficiency.
NAME
TACHIPIRINA FLASHTAB 250 MG DISPERSIBLE TABLETS
EXCIPIENTS
Coated paracetamol crystals: basic butylated methacrylate copolymer; 30% polyacrylate dispersion; silica, colloidal hydrophobic. Tablet: mannitol (granules, powder); crospovidone; aspartame (E951); banana flavor; magnesium stearate.
SIDE EFFECTS
Hepatobiliary disorders. Rare (> = 1/10000 to <1/1000): hepatic transaminase levels increased. Disorders of the immune system. Very rare (<1/10000), not known: hypersensitivity reaction '(from simple skin rash or urticaria, up to anaphylactic shock requiring treatment interruption). Disorders of the blood and lymphatic system. Very rare, not known: thrombocytopenia, leukopenia, neutropenia (sporadic reports).
PREGNANCY AND BREASTFEEDING
Epidemiological data on the use of therapeutic oral doses of paracetamol show no adverse effects on pregnancy or on the health of the fetus / newborn. Prospective data on pregnancies exposed to overdoses did not show an increase in the risk of malformations. Reproduction studies performed with oral administration did not show any malformation or fetotoxic effects. Consequently, in normal conditions of use, paracetamol can 'be used during pregnancy after an assessment of the risk-benefit ratio. During pregnancy, paracetamol should not be taken for long periods, in high doses or in combination with other medicines, since the safety of use in these cases has not been established. After oral administration, paracetamol is excreted in breast milk in small quantities. No undesirable effects have been reported in breastfed infants. Therapeutic doses of this medicine can be taken during breastfeeding.
INDICATIONS
Symptomatic treatment of mild to moderate pain and / or fever.
INTERACTIONS
Probenecid causes at least a 2-fold reduction in paracetamol clearance through inhibition of its conjugation with glucuronic acid. In case of concomitant treatment with probenecid a dose reduction of paracetamol should be considered. Salicylamide may prolong the elimination half-life of paracetamol. Paracetamol should be used with caution in case of concomitant intake of enzyme inducers (such as carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort or St. John's wort) or potentially hepatotoxic substances. Metoclopramide and domperidone: accelerate the absorption of paracetamol. Cholestyramine: reduces the absorption of paracetamol. The concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants can induce slight variations in the INR values with a consequent increase in the risk of bleeding. In these cases, more frequent monitoring of INR values should be performed during concomitant use and after its discontinuation. Interactions with clinical tests: the administration of paracetamol can alter the dosage of uric acid in the blood, obtained with the phosphotungstic acid method, and the dosage of glycaemia obtained with the glucose oxidase-peroxidase method.
DOSAGE
This formulation is reserved for children weighing between 13 and 50 kg (approximately from 2 to 15 years). For children it is essential to respect the dosage defined according to their body weight and therefore to choose the suitable formulation. Approximate ages as a function of body weight are given for information only. The recommended daily dose of paracetamol is approximately 60 mg / kg / day, to be divided into 4 or 6 daily administrations, i.e. approximately 15 mg / kg every 6 hours or 10 mg / kg at 4 hour intervals. For children weighing between 13 and 20 kg (approximately between 2 and 7 years): 1 tablet at a time, to be repeated if necessary after 6 hours, without exceeding 4 tablets per day. For children weighing between 21 and 25 kg (approximately between 6 and 10 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 tablets per day. For children weighing between 26 and 40 kg (approximately between 8 and 13 years): 2 tablets at a time, to be repeated if necessary after 6 hours, without exceeding 8 tablets per day. For children weighing between 41 and 50 kg (approximately between 12 and 15 years): 2 tablets at a time, to be repeated if necessary after 4 hours, without exceeding 12 tablets per day. Maximum daily dose: the total dose of paracetamol should not exceed 80 mg / kg / day in children weighing less than 37 kg and 3 g per day in adults and children weighing 38 kg or more. Frequency of administration: In children, administration should be performed at regular intervals, including overnight, preferably at 6-hour intervals, or at intervals of not less than 4 hours. Renal insufficiency: in case of severe renal insufficiency (creatinine clearance less than 10 ml / min), the minimum interval between 2 administrations should be 8 hours. Method of administration: oral route. For children under 6 years of age, the tablets must be dissolved in a tablespoon of water or milk (fruit juice can give a bitter taste) before being administered. For children over 6 years of age, the tablets can be sucked: they dissolve very quickly in the mouth on contact with saliva.
ACTIVE PRINCIPLES
Each dispersible tablet contains 250 mg paracetamol (as coated paracetamol crystals).