Tachipyrin flashtab paracetamol 250 mg children - analgesic-antipyretic 12 buccal tablets

Product Description

Analgesic and antipyretic drug for children, based on paracetamol.

Indications

Tachipirina Flashtab is a drug useful for lowering fever in children and for treating pain in cases of headaches, myalgia, neuralgia and other mild pain conditions.

The use of Tachipirina Flashtab tablets is reserved for children weighing between 13 and 50 kg (approximately 2 to 5 years).

Dosage

The administration of Tachipirina Flashtab 250 mg dispersible tablets should be chosen based on the child's body weight.
The ages indicated, in correspondence with body weight, are for information purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, to be divided into 4 or 6 daily administrations, for example, 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• For children weighing between 13 and 20 kg (approximately between 2 and 7 years): 1 tablet at a time, to be repeated if necessary after 6 hours, without exceeding 4 tablets per day.
• For children weighing between 21 and 25 kg (approximately between 6 and 10 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 tablets per day.
• For children weighing between 26 and 40 kg (approximately between 8 and 13 years): 2 tablets at a time, to be repeated if necessary after 6 hours, without exceeding 8 tablets per day.
• For children weighing between 41 and 50 kg (approximately between 12 and 15 years): 2 tablets at a time, to be repeated if necessary after 4 hours, without exceeding 12 tablets per day.

Frequency of administration: Flashtab Tachipirina 250 mg for children should be administered at regular intervals, including during the night.
Do not administer two tablets in less than 4 hours.

Maximum daily dose: the total dose of paracetamol must not exceed 80 mg/kg/day in children weighing less than 37 kg and 3 g per day in adults and children weighing 38 kg or more.

Do not administer for more than 3 days without medical advice.

Renal insufficiency

In case of severe renal insufficiency (creatinine clearance less than 10 ml/min), the minimum interval between 2 administrations must be 8 hours.

Directions for use

Children under 6 years of age can take these tablets dissolved in a glass of water or milk. It is advisable to avoid dissolving them in fruit juices because they may be irritating to the kidneys. may have a bitter taste.

Children over 6 years of age can take the tablets by letting them dissolve directly in the mouth.

Components

Active ingredient: paracetamol 250 mg, as coated paracetamol crystals.
Excipients: basic butylated methacrylate copolymer; 30% polyacrylate dispersion; colloidal hydrophobic silica. Tablet: mannitol (granules, powder); crospovidone; aspartame (E951); banana flavour; magnesium stearate.

Contraindications

Tachipirina Flashtab should not be taken in case of:

• Hypersensitivity to the active substance or to any of the excipients listed;
• phenylketonuria, as it contains aspartame;
• severe liver disease.

Warnings

Do not exceed the recommended dose. Prolonged use of the product without medical supervision can be harmful. This product should be used only if strictly necessary. Doses higher than recommended carry a risk of very serious liver damage. Treatment with an antidote should be administered as soon as possible.

To avoid the risk of overdose, avoid the simultaneous use of other medicines containing paracetamol.

The ingestion of undissolved tablets should be avoided in children under 6 years of age as this could lead to their inhalation.

This medicine contains aspartame, a source of phenylalanine, equivalent to 0.15 mg per tablet and is therefore contraindicated in subjects with phenylketonuria.

Paracetamol should be used with caution in case of:

• adults weighing less than 50 kg;
• mild to moderate hepatocellular insufficiency (note: paracetamol is contraindicated in cases of severe hepatocellular insufficiency);
• chronic alcoholism;
• chronic malnutrition (low hepatic glutathione reserves);
• dehydration;
• severe renal insufficiency (creatinine clearance <= 10 ml/min).

In children treated with 60 mg/kg/day of paracetamol, the combination with another antipyretic is not justified unless the treatment is ineffective. In case of high fever, or signs of secondary infection, or if symptoms persist for more than 3 days, the treatment must be reassessed with your doctor.

Interactions

Probenecid causes a reduction of at least 2-fold in the clearance of paracetamol by inhibiting its conjugation with glucuronic acid. In case of concomitant treatment with probenecid, a reduction in the dosage of paracetamol should be considered.
Salicylamide may prolong the elimination half-life of paracetamol.
Paracetamol should be used with caution in case of concomitant use of enzyme inducers (such as carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's Wort or St. John's Wort) or potentially hepatotoxic substances.
Metoclopramide and domperidone: accelerate the absorption of paracetamol.
Cholestyramine: reduces the absorption of paracetamol.
Concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants may induce slight variations in INR values ​​with a consequent increase in the risk of bleeding. In these cases, more frequent monitoring should be conducted. Frequent changes in INR values ​​during concomitant use and after its discontinuation.

Interactions with clinical tests: The administration of paracetamol may alter the measurement of uric acid in the blood, obtained with the phosphotungstic acid method, and the measurement of blood glucose obtained with the glucose oxidase-peroxidase method.

Undesirable effects

System organ class: rare (from >=1/10,000 to <1/1,000); very rare (<1/10,000), not known.

Hepatobiliary disorders: increased levels of hepatic transaminases.
Immune system disorders: hypersensitivity reaction (from simple skin rash or urticaria to anaphylactic shock requiring discontinuation of treatment).
Blood and lymphatic system disorders: thrombocytopenia, leukopenia, neutropenia (sporadic reports).
Skin and subcutaneous tissue disorders: very rare cases of serious skin reactions have been reported.

Pregnancy and breastfeeding

Epidemiological data on the use of therapeutic oral doses of paracetamol show no adverse effects on pregnancy or on the health of the fetus/newborn. Prospective data on pregnancies exposed to overdoses have not shown an increased risk of malformations. Reproduction studies performed with oral administration have not shown any malformations or fetotoxic effects. Consequently, under normal conditions of use, paracetamol can be used during pregnancy after an assessment of the risk-benefit ratio. During pregnancy, paracetamol should not be taken for long periods, at high doses, or in combination with other medications, as its safety has not been established. After oral administration, paracetamol is excreted in breast milk in small amounts. No adverse effects on breastfed infants have been reported. Therapeutic doses of this medicine can be taken during breastfeeding.

Format

Blister pack containing 12 dispersible tablets.