TACHIPIRINA OROSOL * 12BS 500MG

TACHIPIRINA OROSOL * 12BS 500MG

Therapeutic indications

OROSOLUBLE TACHIPIRIN is indicated for the symptomatic treatment of mild to moderate pain and fever.

Dosage and method of use

Doses depend on body weight and age. A single dose ranges from 10 to 15 mg / kg of body weight up to a maximum of 60 - 75 mg / kg for the total daily dose. The time interval between individual doses depends on the symptoms and the maximum daily dose. In any case, it must not be less than 4 hours. OROSOLUBLE TACHIPIRIN should not be used for more than three days without consulting your doctor. 500 mg sachets

For oral use only. The granulate is taken by placing it directly on the tongue and must be swallowed without water. TACHIPIRIN OROSOLUBILE should not be taken on a full stomach. Special populations. Hepatic or renal insufficiency: In patients with hepatic or renal insufficiency or Gilbert's syndrome, the dose should be reduced or the time interval between administrations extended. Patients with renal insufficiency: In patients with severe renal insufficiency (creatinine clearance

The effective daily dose should be considered, without exceeding 60 mg / kg / day (without exceeding 3 g / day), in the following situations: Adults weighing less than 50 kg; Hepatocellular insufficiency (mild to moderate); Chronic alcoholism; Dehydration; Chronic malnutrition; Hepatic or renal insufficiency. In patients with hepatic or renal insufficiency or Gilbert's syndrome, the dose should be reduced or the dosing interval extended. The sachet formulation is not recommended for children under 4 years of age. Older children (4 - 12 years) can be given 250 - 500 mg every 4 - 6 hours up to a maximum of 4 doses over a 24 hour period.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • severe kidney failure • alcohol abuse

Side effects

The MedDRA system organ classification is used with the following frequencies: very common (≥ 1/10), common (≥ 1/100,

Very rare cases of severe skin reactions have been reported. Nephrotoxic effects are infrequent and have not been reported in association with therapeutic doses, except after prolonged administration. Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. 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.

Special warnings

To avoid the risk of overdose, it is necessary to check that any other drugs taken concomitantly do not contain paracetamol. 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 glucose-6-phosphate dehydrogenase, haemolytic anemia, chronic alcohol abuse, severe renal insufficiency (creatinine clearance sorbitol: this medicine contains 801.30 mg sorbitol per sachet. Patients with hereditary fructose intolerance should not be given this medicine ; The additive effect of co-administration of sorbitol (or fructose) containing medicinal products and the daily dietary intake of sorbitol (or fructose) should be considered. The sorbitol content in oral medicinal products may modify the bioavailability of other co-administered medicinal products for oral use.sucrosepatients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine; -propylene glycol:this medicine contains 1.315 mg of propylene glycol per sachet. Co-administration with any alcohol dehydrogenase substrate such as ethanol can induce severe adverse effects in neonates; -sodium: This medicine contains less than 1 mmol (23 mg) sodium per sachet, ie “essentially sodium-free”. In the presence of high fever or signs of secondary infection or persistence of symptoms beyond 3 days, a re-evaluation of treatment should be carried out. Doses higher than recommended involve the risk of very serious liver injury. Treatment with antidote should be given as soon as possible (see section 4.9). Paracetamol should be used with caution in cases of chronic dehydration and malnutrition.

Pregnancy and breastfeeding

Pregnancy:A large amount of data on pregnant women indicate neither malformative nor fetal / neonatal toxicity. Epidemiological studies of neurodevelopmental in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.Feeding time:After oral intake, 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 used during breastfeeding.

Expiration and retention

Do not store above 30 ° C. Store in the original package in order to protect the medicine from light and moisture.

Interactions with other drugs

Intake of probenecid inhibits the binding of paracetamol to glucuronic acid, resulting in an approximately two-fold reduction in paracetamol clearance. In patients taking probenecid concomitantly, the dose of paracetamol should be reduced. The metabolism of paracetamol is increased in patients taking enzyme-inducing medicines, such as rifampicin and some antiepileptics (carbamazepine, phenytoin, phenobarbital, primidone). Some isolated reports describe unexpected hepatotoxicity in patients taking enzyme-inducing medicinal products. Concomitant administration of paracetamol and AZT (zidovudine) increases the tendency to neutropenia. Therefore, co-administration of this drug together with AZT should only be done on the advice of the physician. Concomitant intake of drugs that accelerate gastric emptying, such as metoclopramide, accelerates the absorption and onset of action of paracetamol. Concomitant use of drugs that slow gastric emptying can delay the absorption and the onset of action of paracetamol. Cholestyramine reduces the absorption of paracetamol and therefore cannot be administered until one hour has elapsed after paracetamol administration. Repeated intake of paracetamol for periods longer than a week increases the effect of anticoagulants, especially warfarin. Therefore, long-term administration of paracetamol in patients treated with anticoagulants should only take place under the supervision of the physician. Occasional paracetamol intake has no significant effect on bleeding tendency. Effects on laboratory tests Paracetamol can interfere with uric acid determinations using phosphotungstic acid and with blood glucose determinations using the glucose-oxidase-peroxidase reaction. Probenecid causes an almost two-fold reduction in the clearance of paracetamol by inhibiting its conjugation with glucuronic acid. A reduction in paracetamol should be considered in case of concomitant treatment with probenecid. Paracetamol increases plasma levels of acetylsalicylic acid and chloramphenicol.

Overdose

There is a risk of poisoning, especially in the elderly, young children, patients with liver disease, chronic alcoholism and patients with chronic malnutrition. Overdose can be fatal in these cases. Symptoms usually appear within the first 24 hours and include: nausea, vomiting, anorexia, paleness, and abdominal pain. Overdose, i.e. administration of 10 g of paracetamol or more in a single dose in adults or administration of 150 mg / kg body weight in a single dose in children, causes liver cell necrosis which can lead to complete necrosis and irreversible, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which can lead to coma and death. At the same time, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed, together with the increase in prothrombin levels which may appear 12 - 48 hours after administration. Emergency procedure: Immediate hospitalization Taking blood samples to determine initial plasma paracetamol concentration Gastric lavage IV (or oral if possible) administration of the N-acetylcysteine antidote as soon as possible and before 10 hours have elapsed after overdose Implement the symptomatic treatment.

Active principles

One sachet contains 500 mg of paracetamol. Excipients with known effects: One sachet contains: sorbitol (E420) 801.30 mg, sucrose 0.14 mg, propylene glycol 1.315 mg and sodium. For the full list of excipients, see section 6.1.

Excipients

Sorbitol Talc Butyl methacrylate basic copolymer Magnesium oxide light Hypromellose Carmellose sodium Stearic acid Sodium laurilsulfate Magnesium stearate (Ph.Eur.) Titanium dioxide (E 171) Sucralose Simethicone N, 2,3-trimethyl-2- (propan-2-yl) butanamide Strawberry flavor (contains maltodextrin, gum arabic (E414), natural and / or natural flavoring substances, propylene glycol (E1520), triacetin (E1518), maltol (E636)) Vanilla flavor (contains maltodextrin, natural flavoring substances and / or identical to natural ones, propylene glycol (E1520), sucrose)