TACHIPIRINA FLASHTAB 16CPR 500

TACHIPIRINA FLASHTAB 500 MG ORODISPERABLE

active ingredients

Each golddispersible tablet contains 500 mg paracetamol (such as coated paracetamol crystals). Excipients with known effects: each tablet also contains 40 mg of aspartame (E951). For the full list of excipients, see paragraph 6.1.

Excellent

Paracetamol crystals coated: Basic butylated methacrylate copolymer, Dispersion of polyacrylate at 30%, Silice, colloidal hydrofoba. Tablet: Mannitol (granules, powder), chrospovidone, aspartame (E951), aroma of currant, 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.

Population

Population This medicine is ONLY FOR ADULTS. The recommended maximum dosage is 3000 mg paracetamol per day, corresponding to 6 daily tablets. The usual dosage is 1 500 mg tablet, to be repeated if necessary after not less than four hours. In case of severe pain or high fever, 2 tablets of 500 mg to be repeated if necessary after not less than four hours. Do not exceed 6 500 mg tablets in 24 hours. Recommended maximum dosage: the total dose of paracetamol should not exceed 3 g per day for adults (see paragraph 4.9 “Soversage”). Frequency of administration - In adults the administration should be performed at intervals of at least 4 hours. Renal insufficiency In case of severe kidney failure, the interval between 2 administrations must be at the minimum of 8 hours. . Method of administration . Orally. The tablet must be sucked and not chewed. It can be dispersed in half a glass of water.

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. This medicine contains aspartame, a source of phenylalanine, equivalent to 0.2 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 case of high fever, or signs of secondary infection, or persistence of symptoms over 3 days, a revaluation of treatment must be carried out. During prolonged treatment with analgesic drugs, performed with doses greater than those provided in the leaflet, it may be a headache that should not be treated with higher doses of the medicinal product. In general, the usual use of analgesics, especially the combination of different analgesic drugs, may result in permanent kidney injury with the risk of kidney failure (nephropathy from analgesics). If this situation arises or suspects the onset, consult the doctor and stop the treatment. Diagnosis of “analgesic abuse headaches” should be taken into account in patients suffering from frequent or daily headaches despite (or per) regular use of drugs for cephales. 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 • Colestiramina: 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 conducted during concurrent use and after its interruption. • Be careful when paracetamol is used in conjunction with flucloxacillin since concurrent intake was 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 even if there are no significant early symptoms • withdrawal of a blood sample for an initial dose of plasma paracetamol concentration • gastric lavender • intravenous (or oral if possible) administration of N-acetylcysteine 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 must be carried out. • oral methionin 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, the paracetamol is excreted in breast milk in small quantities. No side effects have been reported on breast-feededed children. Therapeutic doses of this medicine may be taken during breastfeeding.

Source: Farmadati