TACHIPIRINA OROSOL*12BS 500MG

Buccal Tachypirine is indicated for the symptomatic treatment of mild to moderate pain and fever

Therapeutic indications

Buccal Tachypirine 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 to 75 mg/kg for the total daily dose. The time interval between the individual doses depends on the symptoms and the maximum daily dose. In any case, it must not be less than 4 hours. Buccal Tachypirine should not be used for more than three days without consulting your doctor. Sachets of 500 mg

Method of administration: For oral use only. The granulate is taken by placing it directly on the tongue and must be swallowed without water. Buccal Tachypirine must 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 between doses should be prolonged. Patients with renal insufficiency: In patients with severe renal insufficiency (creatinine clearance < 10 ml/min.), a time interval between administrations of at least 8 hours should be respected. Chronic alcoholism: Chronic alcohol consumption can lower the toxicity threshold of acetaminophen. In these patients, the time interval between two doses should be at least 8 hours. The dose of 2 g of paracetamol per day should not be exceeded. Elderly patients: No dose adjustment is required in the elderly. Low weight children and adolescents. Paracetamol 500 mg sachets: Paracetamol 500 mg sachets is not suitable for children under 8 years of age and weighing less than 26 kg. For this patient group, other formulations and strengths are available. For all indications: Adults, the elderly and children over 12 years of age: The usual dose is 500 - 1000 mg every 4 - 6 hours up to a maximum of 3 g per day. The dose should not be repeated for four hours. Renal insufficiency: The dose should be reduced in case of renal insufficiency.

The effective daily dose should be considered, not exceeding 60 mg/kg/day (not exceeding 3 g/day), in the following situations: Adults weighing less than 50 kg; Hepatocellular insufficiency (mild to moderate); Chronic alcoholism; Dehydration; chronic malnutrition; Liver or kidney failure. In patients with hepatic or renal insufficiency or Gilbert's syndrome, the dose should be reduced or the dosing interval should be prolonged. 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 in 24 hours.

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 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).

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 suspected adverse reactions after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. 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 should be checked that any other medicines 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 affecting liver function, of glucose-6-phosphate dehydrogenase, haemolytic anaemia, chronic alcohol abuse, severe renal insufficiency (creatinine clearance < 10 ml/min. [see section 4.2]). If you have a high fever or signs of a secondary infection, or if symptoms persist for more than 3 days, you should consult your doctor. In general, medicines containing paracetamol can only be taken for a few days and in low doses without consulting your doctor or dentist. In case of prolonged incorrect use of high dose analgesics, headaches may occur which should not be treated with higher doses of the drug. In general, the habitual intake of analgesics, especially a combination of several analgesic substances, can lead to permanent kidney damage with the risk of renal failure (analgesic nephropathy). Prolonged or frequent use is not recommended. Patients should be advised not to take other paracetamol-containing products concurrently. Taking multiple daily doses in a single administration can severely damage the liver. In this case, the patient does not lose consciousness, but a doctor should be consulted immediately. Prolonged use without medical supervision can be harmful. In children treated with 60 mg/kg per day of paracetamol, the association with another antipyretic is not justified except in case of ineffectiveness. Abrupt discontinuation of analgesics after a prolonged period of incorrect use, in high doses, can lead to headache, fatigue, muscle pain, nervousness and autonomic symptoms. These withdrawal symptoms resolve within a few days. Until then, further intake of analgesics should be avoided and should not be restarted without consulting your doctor. Care should be taken when taking paracetamol in combination with inducers of cytochrome CYP3A4 or when using substances that induce liver enzymes such as rifampicin, cimetidine and antiepileptics such as glutethimide, phenobarbital and carbamazepine. Care should be taken when administering paracetamol to patients with renal insufficiency (creatinine clearance ≤ 30 ml/min., see section 4.2). Alcohol consumption should be avoided during treatment with paracetamol. The risks of overdose are greater in patients with non-cirrhotic alcoholic liver disease. Caution should be exercised if you have chronic alcoholism. In patients with alcohol abuse the dose should be reduced (see section 4.2). In this case, the daily dose should not exceed 2 grams. Buccal Tachypirine contains: - sorbitol : this medicinal product contains 801.30 mg of sorbitol per sachet. Patients with hereditary fructose intolerance should not be given this medicinal product; The additive effect of co-administration of medicinal products containing sorbitol (or fructose) 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 oral medicinal products. - sucrose patients 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 may induce serious adverse effects in the neonate; - sodium : this medicinal product contains less than 1 mmol (23 mg) sodium per sachet, i.e. "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 the treatment should be performed. Doses higher than recommended carry the risk of very serious liver injury. Treatment with the antidote should be given as soon as possible (see section 4.9). Paracetamol should be used with caution in cases of dehydration and chronic malnutrition.

Pregnancy and breastfeeding

Pregnancy: A large amount of data on pregnant women indicate neither malformative nor foeto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for the shortest possible time and as little frequency as possible. Lactation: After oral intake, paracetamol is excreted in breast milk in small quantities. No side effects have been reported in breastfed infants. Therapeutic doses of this medicinal product may be used during lactation.

Expiration and conservation

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

Interactions with other drugs

Taking 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 receiving enzyme-inducing medicinal products such as rifampicin and some antiepileptics (carbamazepine, phenytoin, phenobarbital, primidone). Some isolated reports describe unexpected hepatotoxicity in patients taking enzyme-inducing drugs. Concomitant administration of paracetamol and AZT (zidovudine) increases the tendency to neutropenia. Therefore, co-administration of this drug together with AZT should only be on the advice of the doctor. Concomitant intake of drugs that accelerate gastric emptying, such as metoclopramide, accelerates the absorption and onset of action of paracetamol. Concomitant intake of drugs that slow gastric emptying can delay the absorption and onset of action of paracetamol. Cholestyramine reduces the absorption of paracetamol and, therefore, cannot be administered earlier than one hour after administration of the paracetamol. Repeated intake of paracetamol for periods longer than one week increases the effect of anticoagulants, especially warfarin. Therefore, the long-term administration of paracetamol in patients treated with anticoagulants should only take place under medical supervision. The occasional intake of paracetamol has no significant effect on the bleeding tendency. Effects on laboratory tests Paracetamol can interfere with determinations of uric acid using phosphotungstic acid and with those of glycemia using the glucose-oxidase-peroxidase reaction. Probenecid causes an almost two-fold reduction in paracetamol clearance by inhibiting its conjugation with glucuronic acid. A reduction of paracetamol should be considered in case of concomitant treatment with probenecid. Paracetamol increases the 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 generally appear within the first 24 hours and include: nausea, vomiting, anorexia, pallor, 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 of body weight in a single dose in children, causes necrosis of liver cells which may lead to complete necrosis and irreversible, resulting in hepatocellular failure, metabolic acidosis, and encephalopathy that can lead to coma and death. Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed, together with increased prothrombin levels which may appear 12 - 48 hours after administration. Emergency procedure: Immediate hospitalization Blood sampling to determine the initial plasma paracetamol concentration Gastric lavage IV (or oral if possible) administration of the antidote N-acetylcysteine ​​as soon as possible and before 10 hours after the overdose Implement the symptomatic treatment.

Active principles

One sachet contains 500 mg of paracetamol. Excipients with known effect: 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 lauryl sulfate 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 nature identical flavoring substances, propylene glycol (E1520), triacetin (E1518), maltol (E636)) Vanilla flavor (contains maltodextrin, natural flavoring substances and/or nature identical, propylene glycol (E1520), sucrose)