TACHIPIRINA OROSOL*12BS 500MG

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

--

Therapeutic indications

OROSOLUBLE TACHIPIRINA 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 individual doses depends on the symptoms and the maximum daily dose. In any case, it must not be less than 4 hours. OROSOLUBLE TACHIPIRINA must not be used for more than three days without consulting your doctor. 500 mg sachets

Body weight (age)	Single dose [sachet]	Maximum daily dose [sachets]
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 of 500 mg)

Method of administration: For oral use only. The granules must be taken by placing them directly on the tongue and must be swallowed without water. TACHIPIRINA OROSOLUBILE 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 interval between administrations should be prolonged. Patients with renal insufficiency: In patients with severe renal insufficiency (creatinine clearance < 10 ml/min.), a time interval of at least 8 hours between administrations should be respected. Chronic alcoholism: Chronic alcohol consumption can lower the toxicity threshold of paracetamol. In these patients, the time interval between two doses should be at least 8 hours. The dose of 2 g of paracetamol per day must not be exceeded. Elderly patients: Dose adjustment is not required in the elderly. Low weight children and adolescents. Paracetamol 500 mg sachets: Paracetamol 500 mg sachets are not suitable for children under 8 years of age and with a body weight of less than 26 kg. For this group of patients, other formulations and dosages are available. For all indications: Adults, 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 before four hours. Renal insufficiency: The dose must be reduced in case of renal insufficiency.

Glomerular filtration	Dose
10 - 50 ml/min.	500 mg every 6 hours
< 10 ml/min.	500 mg every 8 hours

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; 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. To older children (4 - 12 years) 250 - 500 mg can be administered every 4 - 6 hours up to a maximum of 4 doses within 24 hours.

Contraindications

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

Side effects

The MedDRA system organ class is used with the following frequencies: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (<1/10,000).

SOC/FREQUENCY	Adverse reactions
Pathologies of the blood and lymphatic system
Rare	anemia, non-hemolytic anemias and bone marrow depression; thrombocytopenia
Vascular pathologies :
Rare	edema
Gastrointestinal disorders
Rare	exocrine pancreas conditions, acute and chronic pancreatitis, gastrointestinal bleeding, abdominal pain, diarrhea, nausea, vomiting
Hepatobiliary disorders
Rare	hepatic failure, hepatic necrosis, jaundice
Immune system disorders
Rare	allergic conditions, anaphylactic reaction, allergies to foods, food additives, drugs and other chemicals
Pathologies of the skin and subcutaneous tissue
Rare	urticaria, itching, rash, sweating, purpura, angioedema
Very rare	Very rare cases of serious skin reactions have been reported
Renal and urinary disorders
Rare	nephropathies, nephropathies and tubular disorders

Very rare cases of serious 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 that occur 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 is necessary to check that any other drugs taken concurrently 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 alter liver function, deficiency of glucose-6-phosphate dehydrogenase, haemolytic anemia, chronic alcohol abuse, severe renal failure (creatinine clearance < 10 ml/min. [see section 4.2]). If there is a high fever or signs of 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 analgesics at high doses, headache episodes may occur which should not be treated with higher doses of the drug. In general, the habitual intake of analgesics, especially a combination of different analgesic substances, can cause 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 products containing paracetamol at the same time. Taking multiple daily doses in a single administration can seriously damage the liver. In this case, the patient does not lose consciousness, but a doctor should be consulted immediately. Prolonged use without medical supervision may be harmful. In children treated with 60 mg/kg per day of paracetamol, the association with another antipyretic is not justified except in cases of ineffectiveness. Suddenly stopping taking analgesics after a prolonged period of incorrect use, at high doses, can cause headache, fatigue, muscle pain, nervousness and autonomic symptoms. These withdrawal symptoms resolve within a few days. Until that time, further intake of painkillers should be avoided and should not be resumed without consulting your doctor. Caution should be exercised if paracetamol is taken in association with CYP3A4 inducers or the use of substances that induce hepatic enzymes such as rifampicin, cimetidine and antiepileptics such as glutethimide, phenobarbital and carbamazepine. Caution should be exercised when administering paracetamol to patients with renal insufficiency (creatinine clearance ≤ 30 ml/min., see section 4.2). Consumption of alcohol 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 in case of 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. TACHIPIRINA OROSOLUBILE contains: - sorbitol : this medicine contains 801.30 mg of sorbitol per sachet. Patients with hereditary fructose intolerance should not be given this medicine; The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and 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 suffering from 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. Coadministration with any alcohol dehydrogenase substrate such as ethanol may induce serious adverse effects in neonates; - sodium : this medicine 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 carried out. Doses higher than recommended imply the risk of very serious liver injury. Treatment with the antidote should be administered 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 indicates neither malformation nor fetal/neonatal toxicity. Epidemiological studies on neurodevelopment 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 with the lowest possible frequency. Breastfeeding: 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 medicine can be used during breastfeeding.

Expiration and conservation

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

The intake of probenecid inhibits the binding of paracetamol to glucuronic acid, resulting in a reduction in the clearance of paracetamol approximately twofold. 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 drugs. Concomitant administration of paracetamol and AZT (zidovudine) increases the tendency to neutropenia. Therefore, co-administration of this drug together with AZT should only take place on the advice of your doctor. Concomitant intake of drugs that accelerate gastric emptying, such as metoclopramide, accelerates the absorption and onset of action of paracetamol. The concomitant use 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 until one hour has passed after administration of paracetamol. Repeated intake of paracetamol for periods longer than one week increases the effect of anticoagulants, particularly warfarin. Therefore, long-term administration of paracetamol in patients treated with anticoagulants should only take place under medical supervision. Occasional intake of paracetamol has no significant effect on bleeding tendency. Effects on laboratory tests Paracetamol can interfere with uric acid determinations that use phosphotungstic acid and with blood glucose determinations that use 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 elderly people, 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, 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 necrosis of liver cells which may lead to complete necrosis and irreversible, resulting in hepatocellular failure, 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 increased levels of prothrombin which may appear 12 - 48 hours after administration. Emergency procedure: Immediate hospitalization Taking blood samples to determine the initial plasma concentration of paracetamol Gastric lavage IV administration (or oral if possible) of the antidote N-acetylcysteine ​​as soon as possible and before 10 hours have passed since the 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 lauryl sulphate 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-identical 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)