TACHIPIRINA FLASHTAB 12CPR 250

TACHIPIRINA FLASHTAB 250 MG COMPRESENT

active ingredients

Each dispersible tablet contains 250 mg paracetamol (such as coated paracetamol crystals). Excipients with known effects: each tablet also contains 30 mg of aspartame (E951). For the full list of excipients, see paragraph 6.1.

Excellent

Paracetamol crystals covered: Basic butylated methacrylate copolymer, Dispersion of polyacrylate at 30%, Silice, colloidal hydrofoba. Tablet: Mannitol (granules, powder), Crospovidone, Aspartame (E951), Banana aroma, Magnesium stearate.

Therapeutic indications

Symptomatic treatment of mild to moderate pain and/or fever.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. - Fenilchetonuria (for aspartame). - Severe hepatocellular failure.

Dosage

Dosage This formulation is reserved for children weighing between 13 and 50 kg (about 2 to 15 years). For children it is indispensable respect the defined dosage according to their body weight and then choose the suitable formulation. Approximate ages according to body weight are indicated as information. The recommended daily dose of paracetamol is approximately 60 mg/kg/die, to be divided into 4 or 6 daily administrations, that is approximately 15 mg/kg every 6 hours or 10 mg/kg at intervals of 4 hours. • For children weighing included between 13 and 20 kg (approximately between 2 and 7 years): 1 tablet per time, to be repeated if necessary after 6 hours, without exceeding 4 tablets per day. • For children weighing included between 21 and 25 kg (approximately between 6 and 10 years): 1 tablet per time, to be repeated if necessary after 4 hours, without exceeding 6 tablets per day. • For children weighing included 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 including weight 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/die in children weighing less than 37 kg and 3 g per day in adults and children weighing 38 kg or more (see paragraph 4.9 “Soversage”). Frequency of administration In children administration must be performed at regular intervals, also during the night, , preferably at intervals of 6 hours, or at intervals of no less than 4 hours. Renal insufficiency In case of severe renal failure (creatiny clearance less than 10 ml/min), the minimum interval between 2 administrations must be 8 hours. Method of administration Orally. -For children under the age of 6, tablets should be dissolved in a spoon of water or milk (fruit juice can give a bitter taste) before being administered. -For children older than 6 years the tablets can be sucked: they dissolve very quickly in the mouth to contact with the saliva.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Warnings Do not exceed the recommended dose. Prolonged use of the product, other than medical control, may be harmful. This product should only be used if strictly necessary. Doses higher than recommended ones involve a very serious hepatic damage. Treatment with an antidote must be performed as soon as possible. See paragraph 4.9. To avoid the risk of overdose, advise patients to avoid the contemporary use of other medicines containing paracetamol. The total dose of paracetamol should not exceed 80 mg/kg/die in children weighing less than 37 kg and 3 g per day in adults and children weighing 38 kg or more (see paragraph 4.9 “Soversage”). It is to avoid taking 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 suffering from phenylchetonuria (see paragraph 4.3). No clinical or non-clinical studies are available on the use of aspartame in children under 12 weeks of age. Precautions for use Paracetamol should be used with caution in case of: - Adults weighing less than 50 Kg - Hepatocellular insufficiency from mild to moderate (note: the paracetamol is contraindicated in cases of severe hepatocellular insufficiency) - Chronic alcoholism - Chronic malnutrition (low liver glutathione reserves) - Disidratation - Severe kidney failure (creain ≤ 10 ml/min). In children treated with 60 mg/kg/die paracetamol, the association with another antipyretic is not justified if not in case of ineffective treatment. In case of high fever, or signs of secondary infection, or persistence of symptoms over 3 days, a revaluation of treatment must be carried out. It is recommended caution if the paracetamol is administered in conjunction with flucloxacillin due to increased risk of metabolic acidosis with high anionic gap (HAGMA), in particular in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as in those using the daily maximum doses of paracetamine. Careful monitoring is recommended, including the measurement of 5-oxoproline urinary.

Interactions

• Propenenecid causes a reduction of at least 2 times of paracetamol clearance through the inhibition of its conjugation with glucuronic acid. In case of concomitant treatment with probenecid, a reduction in the dose of paracetamol should be considered. • Salicylamide can prolong the half-life of paracetamol elimination. • Paracetamol should be used with caution in case of concurrent induction of enzymatic inductors (such as carbamazepine, phenobarbital, phenytoin, primidone, rifampin, Hyperico or St John's Grass) or potentially hepatotoxic substances (see paragraph 4.9). • Metoclopramide and domperidone: accelerate the absorption of paracetamol. • Colestiramine: reduces the absorption of paracetamol. • Concurrent use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants can induce slight variations in INR values resulting in increased bleeding risk. In these cases a more frequent monitoring of INR values should be carried out during concurrent use and after its interruption • It should be taken care of when the paracetamol is used in conjunction with flucloxacillin since concurrent intake has been associated with metabolic acidosis with high anionic gap, especially in patients with risk factors (see paragraph 4.4). Interactions with clinical tests: Paracetamol administration can alter the dosage of uric acid in the blood, obtained by the method to phosphotungs, and the dosage of blood glucose obtained by the method of oxidase-peroxidase of glucose.

Effects

Organic systemic classification	Rari (from ≥1/10.000 to	Very rare (
Hepatobiliary diseases	- increased levels of hepatic transaminasis
Immune system disorders		- reaction of hypersensitivity (from the simple rash or hive, to the anaphylactic shock requiring the interruption of treatment)
Emolinfopoietic system pathologies		- thrombocytopenia, leucopenia, neutropenia (sporadic signs)
Pathologies of skin and subcutaneous tissue		Very rare cases of severe skin reactions have been reported.

Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.aifa.gov.it/content/ reports-reactions-adverse.

Overdosing

There is a risk of liver damage (which includes hepatitis lightning, liver failure, cholestatic hepatitis, hepatic cytolysis), especially in elderly individuals, in small children, in patients with liver disease, in case of chronic alcoholism, in patients with chronic malnutrition and in patients receiving enzymatic inductors. In these cases, overdose can be fatal. Symptoms generally appear in the first 24 hours and include: nausea, vomiting, anorexia, pallor and abdominal pain. Overdose, 7.5 g or more of paracetamol in a single administration in adult or 140 mg/kg body weight in a single administration in the child, due to necrosis of hepatocytes that makes it likely to induce a complete and irreversible necrosis, which involves hepatocellular insufficiency, metabolic acidosis and encephalopathy that can lead to coma and death. At the same time, there is an increase in the levels of hepatic transaminasis (AST, ALT), lactic-dehydrogenase and bilirubin, together with an increase in the time of protrombine that may appear from 12 to 48 hours after administration. Clinical symptoms of liver damage usually appear after two days and reach a maximum after 4 - 6 days. Acute kidney failure can be developed with acute tubular necrosis even in the absence of severe liver damage. Other non-hepatic symptoms that have been reported following overdose of the paracetamol include myocardial abnormalities and pancreatititis. Emergency behaviour: • immediate transfer to the hospital, although there are no significant precocious symptoms • withdrawal of a blood sample for an initial dose of plasma paracetamol concentration • gastric lavender • intravenous (or oral if possible) administration of the N-acetylcystein antidote possibly first ten hours after ingestion. N-acetylcysteine can provide, however, a certain degree of protection even after 10 hours, and up to 48 hours, but in these cases prolonged treatment is performed. • Syntomatic treatment should be performed • Methionine by mouth can be used as an alternative to N-acetylcysteine as long as it is administered as soon as possible after overdosing and, in any case, within 10 hours of the same.

Pregnancy A large amount of data on pregnant women do not indicate neither malformative toxicity, nor fetal/neonatal toxicity. Epidemiological studies on neurological development in children exposed to paracetamol in uterus show non-conclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for as short as possible and with the lowest frequency possible. Food After oral administration, paracetamol is excreted in human milk in small amounts. No side effects have been reported on breastfed infants. Therapeutic doses of this medicine may be taken during breast-feeding.

Source: Farmadati