Tachipirina orosolubile 500 mg - antipyretic analgesic buccal granules - 12 sachets

Product Description

A drug formulated based on paracetamol, useful in case of fever and pain of various kinds.

Indications

Tachipirina Orosolubile 500 mg is an analgesic and antipyretic drug that works to lower fever and relieve pain. In particular, this paracetamol-based drug can be used:

• in case of fever associated with influenza, acute respiratory tract diseases or exanthematous diseases;
• to relieve mild pain.

It can be used in combination with other medicines. Administer Tachipirina Orosolubile 500 mg to children weighing more than 26 kg, adolescents and adults.

Dosage

The usual dose is 10/15 mg of paracetamol per kg of body weight as a single dose, up to a total daily dose of 60/75 mg per kg of body weight. At least 6 hours must pass between the administration of one dose and the next: this means that Tachipirina Orosolubile can be administered up to 4 times a day.

If the symptoms persist for more than 24 hours, consult a doctor immediately. than 3 days, you should consult a doctor.

Tachipirina Orosolubile 500 mg is not suitable for children under 8 years of age and weighing less than 26 kg.

The daily dose of Tachipirina Orosolubile to be administered must be based on the data reported in the following table.

Hepatic or renal insufficiency

In patients with hepatic or renal insufficiency, the dose should be reduced or the administration interval should be prolonged.

Chronic alcoholism

In these patients, the administration interval between two doses should be at least 8 hours. 2 g of paracetamol per day should not be exceeded as it may cause a decrease in the risk of serious alcoholism. Alcohol lowers the toxicity threshold of paracetamol.

How to use

How to take Tachipirina Orosolubile? The administration of this medicine, which has a pleasant strawberry and vanilla flavor, is very simple: it can be dissolved in the mouth, under the tongue, and swallowed without the aid of water.

Composition

Active ingredient: one sachet contains 500 mg of paracetamol.
Excipients: Sorbitol, Talc, Butyl methacrylate basic copolymer, Light magnesium oxide, Hypromellose, Sodium carmellose, 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 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).

Contraindications

Tachipirina Orosolubile should not be administered in case of:

• allergy to paracetamol or to any of the other ingredients of this medicine
• severe liver disease (severe hepatocellular insufficiency).

Warnings and Precautions

In rare cases of allergic reactions, administration must be suspended and appropriate treatment must be initiated. Use with caution in case of chronic alcoholism, excessive alcohol intake (3 or more alcoholic drinks per day), anorexia, bulimia or cachexia, chronic malnutrition (low hepatic glutathione reserves), dehydration, hypovolemia.

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, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia.

Caution should be exercised when administering paracetamol to patients with renal insufficiency (creatinine clearance ≤ 30 ml/min.) or hepatocellular insufficiency (mild to moderate). High or prolonged doses of the product may cause alterations to the kidney and liver. Even severe blood disorders may occur, so administration to patients with renal insufficiency should be performed only if truly necessary and under direct medical supervision. In case of prolonged use, it is advisable to monitor liver and kidney function and blood counts.

During treatment with paracetamol, before taking any other medication, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur.

Contact your doctor before combining any other medication.

In children treated with 60 mg/kg per day of paracetamol, the combination with another antipyretic is not justified unless in case of ineffectiveness.

The risks of overdose are greater in patients with non-cirrhotic alcoholic liver disease. Caution is required in case of chronic alcoholism. In this case, the daily dose should not exceed 2 grams.

In case of high fever or If signs of secondary infection or symptoms persist for more than 3 days, treatment should be reevaluated.

Paracetamol should be used with caution in cases of dehydration and chronic malnutrition.

Pregnancy and Breastfeeding

Although studies conducted during pregnancy and breastfeeding have not highlighted any particular contraindications to the use of paracetamol nor have it caused any adverse effects on the mother or child, it is recommended to take this medicine only in cases of real need and under the direct supervision of a doctor. During pregnancy, paracetamol should not be taken for long periods, at high doses, or in combination with other medicines.

Although paracetamol passes into breast milk in very small quantities, breastfeeding is possible; however, during breastfeeding, it is recommended to take this medicine only in cases of real need and under the direct supervision of a doctor.

Interactions

Oral absorption of paracetamol depends on the rate of gastric emptying. Therefore, concomitant administration of drugs that slow (e.g., anticholinergics, opioids) or increase (e.g., prokinetics) the rate of gastric emptying may result in a decrease or increase in the bioavailability of the product, respectively. Concomitant administration of cholestyramine reduces the absorption of paracetamol. Concomitant administration of paracetamol and chloramphenicol may lead to an increase in the half-life of chloramphenicol, with the risk of increasing its toxicity. Concomitant use of paracetamol (4 g daily for at least 4 days) with oral anticoagulants may lead to slight variations in INR values. In these cases, more frequent monitoring of INR values ​​should be conducted during concomitant use and after its discontinuation. Use with extreme caution and under close supervision during chronic treatment with drugs that can cause induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example, rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine). The same applies in cases of alcoholism and in patients treated with zidovudine. The administration of paracetamol may interfere with the determination of uric acid (by the phosphotungstic acid method) and blood glucose (by the glucose-oxidase-peroxidase method).

Undesirable effects

The following are the undesirable effects of paracetamol organized according to the MedDRA system organ classification. There are insufficient data to establish the frequency of the individual effects listed.

Blood and lymphatic system disorders: Thrombocytopenia, leukopenia, anemia, agranulocytosis.
Immune system disorders: Hypersensitivity reactions (urticaria, laryngeal edema, angioedema, anaphylactic shock).
Nervous system disorders: Dizziness.
Gastrointestinal disorders: Gastrointestinal reaction.
Hepatobiliary disorders: Abnormal liver function, hepatitis.
Skin and subcutaneous tissue disorders: Erythema multiforme, Stevens-Johnson syndrome, epidermal necrolysis, rash.
Renal and urinary disorders: Acute renal failure, interstitial nephritis, haematuria, anuria.

In addition, very rare cases of serious skin reactions have been reported.

Format

12 sachets from 500 mg