TACHIPIRINA OROSOL 12BS 500MG

TACHIPIRINA OROSOLUBLE 500 MG FREE GUSTO FRAGOLA-VANIGLIA

active ingredients

A bag contains 500 mg of paracetamol. Excipients with known effects: A bag contains: sorbitol (E420) 801,30 mg, sucrose 0.14 mg, propylene glycol 1,315 mg and sodium. For the full list of excipients, see paragraph 6.1.

Excellent

Sorbitol Talco Butile methacrylate basic copolymer Magnesium light oxide Ipromellosa Carmellosa sodium Stearic acid Laurilsulphate Magnesium stearate (Ph.Eur.) Titanium dioxide (E 171) Sucralose Simethicone N,2,3-trimethyl-2-(propan-2-yl) butanamide Strawberry flavour (contains maltodextrin, gum arabic (E414), natural and/or nature-identical flavouring substances, propylene glycol (E1520), triacetin (E1518), maltol (E636)) Vanilla flavour (contains maltodextrin, natural and/or nature-identical flavouring substances, propylene glycol (E1520), sucrose)

Therapeutic indications

TACHIPIRINA OROSOLUBILE is indicated for the symptomatic treatment of mild to moderate pain and fever.

Contraindications

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

Population

The doses depend on body weight and age. A single dose ranges from 10 to 15 mg/kg 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 should not be less than 4 hours. TACHIPIRINA OROSOLUBILE should not be used for more than three days without consulting your doctor.500 mg sachets

Body weight (age)	Single dose [bustina]	Maximum daily dose [bustine]
26 - 40 kg (8 - 12 years)	500 mg paracetamol (1 sachet)	1500 mg paracetamol (3 sachets)
> 40 kg (children over 12 years and adults)	500 - 1000 mg paracetamol (1 - 2 sachets)	3000 mg paracetamol (6 sachets 500 mg)

Method of administration: Just for oral use. The granulate should be taken by placing it directly on the tongue and must be swallowed without water. TACHIPIRINA OROSOLUBILE should not be taken on a full stomach. Special popularity. Hepatic or kidney failure: In patients with hepatic or kidney failure or Gilbert syndrome, the dose must be reduced or the time interval between administrations must be extended. Patients with kidney failure: In patients with severe kidney failure (clearance of creatinine Glomerular Filtration Dose 10 - 50 ml/min. 500 mg every 6 hours 500 mg every 8 hours The effective daily dose must 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 (from mild to moderate); Chronic alcoholism; Dehydration; Chronic malnutrition; Hepatic or kidney failure. In patients with liver or kidney failure or Gilbert syndrome, the dose must be reduced or the interval of administration must be extended. The formulation in bags is not recommended in children under 4 years of age. Children aged (4 - 12 years) can administer 250 - 500 mg every 4 - 6 hours up to a maximum of 4 doses within 24 hours.

Conservation

Store in the original packaging to protect the medicine from light and moisture.

Warnings

To avoid the risk of overdose, it is necessary to check that any other medications taken in conjunction do not contain paracetamol. Paracetamol must be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe liver failure (Child-Pugh >9), acute hepatitis, in concomitant treatment with drugs that alter liver function, glucose-6 phosphate dehydrogenase deficiency, severe haemolysis, chronic alcohol abuse this medicine contains 801.30 mg of sorbitol per bag. Patients with hereditary intolerance to fructose should not be given this medicine; The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet must be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medications co- administered. - sucrose patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose mal absorption or isomaltase sucrasis failure, should not take this medicine; - propylene glycol: this medicine contains 1,315 mg of glycol propylene per bag. Co-administration with any dihydrogenase alcohol substrate as ethanol can induce severe adverse effects in infants; - sodium: this medicine contains less than 1 mmol (23 mg) of sodium per bag, i.e. “essentially without sodium”. In the presence of high fever or signs of secondary infection or persistence of symptoms over 3 days, a revaluation of treatment must be carried out. Doses higher than recommended imply the risk of severe liver injury. Treatment with antidote should be administered as soon as possible (see paragraph 4.9). Paracetamol should be used with caution in case of chronic dehydration and malnutrition.

Interactions

The intake of probenecid inhibits the binding of the paracetamol to glucuronic acid, resulting in a reduction of the clearance of the paracetamol approximately twice. In patients taking probenecid at the same time, the dose of paracetamol should be reduced. Paracetamol metabolism has increased in patients taking medications that induce enzymes, such as rifampin and some antiepileptics (carbamazepine, phenytoin, phenobarbital, primidone). Some isolated reports describe hepatotoxicity unforeseen in patients taking medicines that enzymatic inductors. Concurrent administration of paracetamol and AZT (zidovudine) increases the tendency to neutropenia. Therefore, the co-administration of this drug along with the AZT should only take place on medical advice. Concurrent intake of drugs that accelerate gastric emptying, such as metoclopramide, accelerates absorption and onset of paracetamol action. Concurrent intake of drugs that slow gastric emptying can delay absorption and onset of paracetamol action. Cholesteramine reduces the absorption of paracetamol and, therefore, cannot be administered before it is spent an hour by the administration of paracetamol. Repeated intake of paracetamol for periods over a week increases the effect of anticoagulants, especially warfarin. Therefore, the administration of long-term paracetamol in patients treated with anticoagulants should only take place under the supervision of the doctor. The occasional intake of paracetamol has no significant effects on the tendency to bleeding. Effects on laboratory tests Paracetamol may interfere with the determinations of the urcemia that use phosphotungstic acid and glycemia that use the glucose-oxidase-peroxidase reaction. Propenenecid causes a reduction of almost twice of paracetamol clearance by inhibiting conjugation with glucuronic acid. A reduction of the paracetamol should be taken into consideration in case of treatment with probenecid. Paracetamol increases the plasma levels of acetylsalicylic acid and chloramphenicol.

Effects

MedDRA classification is used for systems/organs with the following frequencies: very common (≥ 1/10), common (≥ 1/100, COMPUTER Adverse reactions Emolinfopoietic system pathologies Rare anemia, non-hemolytic anemies and midollar depression; trombocitopenes Vascular diseases: Rare edema Gastrointestinal diseases Rare conditions of exocrine pancreas, acute and chronic pancreatis, gastrointestinal bleeding, abdominal pain, diarrhea, nausea, vomiting Hepatobiliary diseases Rare liver failure, liver necrosis, jaundice Immune system disorders Rare allergic conditions, anaphylactic reaction, food allergies, food additives, drugs and other chemicals Pathologies of skin and subcutaneous tissue Rare hives, itching, rash, sweating, purple, angioedema Very rare Very rare cases of severe skin reactions have been reported Kidney and urinary pathologies Rare nephropathy, nephropathy and tubular disorders Very rare cases of severe skin reactions have been reported. Nephrotoxic effects are infrequent and have not been reported in combination with therapeutic doses, except after prolonged administration. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

There is a risk of poisoning, especially in elderly people, in small children, in patients with hepatopathy, in case of chronic alcoholism and in 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. the administration of 10 g paracetamol or more in a single dose in adults or the administration of 150 mg/kg body weight in a single dose in children, causes the necrosis of liver cells that can induce a complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy that can lead to coma and death. At the same time, the increase in the levels of hepatic transaminasis (AST, ALT), hydrogenase lactate and bilirubin, together with the increase in protrombine levels that may appear 12 to 48 hours after administration. Emergency procedure: Immediate recovery in hospital Blood samples withdrawal to determine the initial plasma concentration of paracetamol Gastric lavender EV (or oral if possible) of the N-acetylcystein antidote as soon as possible and before 10 hours have passed since overdosage Implement symptomatic treatment.

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.

Nursing:

After oral intake, the paracetamol is excreted in breast milk in small quantities. No side effects were reported in breast-feededed babies. During breastfeeding, therapeutic doses of this medicine may be used.

Source: Farmadati