Tachipirina Flashtab 250 mg 12 dispersible tablets

Tachipirina Flashtab 250 mg 12 dispersible tablets is a paracetamol -based medicine, specifically formulated for the symptomatic treatment of fever and mild to moderate pain in children . Each tablet contains 250 mg of paracetamol, an active ingredient recognized for its antipyretic and analgesic properties, ideal for combating headaches , colds , exanthematous diseases and other painful disorders typical of pediatric age. The dispersible formulation makes the product particularly suitable for children: the tablets can be easily dissolved in the mouth , in water or milk, ensuring simple and pleasant administration even for the little ones.

Thanks to its rapid action , Tachipirina Flashtab 250 mg is the ideal solution to provide rapid relief from the symptoms of fever and pain in children weighing between 13 and 50 kg (approximately 2 to 15 years). The orosoluble tablets are banana-flavoured, making them more pleasant to take and facilitating compliance in the little ones. The product is indicated for the symptomatic treatment of fever and for the symptomatic treatment of pain of various origins, such as muscle pain, headache, cold pain and pain associated with exanthematous diseases.

The pack contains 12 tablets in a practical blister, ideal for home or travel use. Tachipirina Flashtab 250 mg is a medicine for children with proven efficacy, chosen by pediatricians and parents for its safety and ease of use. Its formulation allows you to adapt the dosage based on the child's body weight, ensuring personalized and safe treatment. Choose Tachipirina Flashtab 250 mg to guarantee your children rapid relief from fever and pain , with maximum convenience and tolerability.

ACTIVE INGREDIENTS

Active ingredients contained in Tachipirina Flashtab 250 mg 12 dispersible tablets - What is the active ingredient of Tachipirina Flashtab 250 mg 12 dispersible tablets?

Each dispersible tablet contains paracetamol 250 mg (as coated paracetamol crystals). Excipients with known effect: Each tablet also contains 30 mg aspartame (E951). For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Tachipirina Flashtab 250 mg 12 dispersible tablets - What does Tachipirina Flashtab 250 mg 12 dispersible tablets contain?

Coated paracetamol crystals : Basic butylated methacrylate copolymer, 30% polyacrylate dispersion, Silica, colloidal hydrophobic. Tablet : Mannitol (granules, powder), Crospovidone, Aspartame (E951), Banana flavour, Magnesium stearate.

DIRECTIONS

Therapeutic indications Tachipirina Flashtab 250 mg 12 dispersible tablets - Why is Tachipirina Flashtab 250 mg 12 dispersible tablets used? What is it used for?

Symptomatic treatment of mild to moderate pain and/or fever.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Tachipirina Flashtab 250 mg 12 dispersible tablets - When should Tachipirina Flashtab 250 mg 12 dispersible tablets not be used?

- Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. - Phenylketonuria (due to the presence of aspartame). - Severe hepatocellular insufficiency.

DOSAGE

Quantity and method of taking Tachipirina Flashtab 250 mg 12 dispersible tablets - How do you take Tachipirina Flashtab 250 mg 12 dispersible tablets?

Dosage This formulation is reserved for children weighing between 13 and 50 kg (approximately 2 to 15 years). For children, it is essential to respect the dosage defined according to their body weight and therefore choose the appropriate formulation. The approximate ages according to body weight are given 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, i.e. approximately 15 mg/kg every 6 hours or 10 mg/kg at intervals of 4 hours . • For children weighing between 13 and 20 kg (approximately 2 to 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 6 to 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 8 to 13 years): 2 tablets at a time, to be repeated if necessary after 6 hours, without exceeding 8 tablets per day . • For adolescents weighing between 41 and 50 kg (approximately 12 to 15 years): 2 tablets at a time, to be repeated if necessary after 4 hours, without exceeding 12 tablets per day . 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 adolescents weighing 38 kg or more (see section 4.9 “Overdose”). Frequency of administration In children, administration should be performed at regular intervals, including during the night , preferably at intervals of 6 hours , or at intervals of not less than 4 hours. Renal insufficiency In case of severe renal insufficiency (creatinine clearance less than 10 ml/min), the minimum interval between 2 administrations should be 8 hours. Method of administration Oral route. -For children under 6 years of age, the tablets should be dissolved in a spoonful of water or milk (fruit juice may give a bitter taste) before being administered. -For children over 6 years of age, the tablets can be sucked: they dissolve very quickly in the mouth on contact with saliva.

CONSERVATION

Storage Tachipirina Flashtab 250 mg 12 dispersible tablets - How is Tachipirina Flashtab 250 mg 12 dispersible tablets stored?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Tachipirina Flashtab 250 mg 12 dispersible tablets - About Tachipirina Flashtab 250 mg 12 dispersible tablets it is important to know that:

Warnings Do not exceed the recommended dose. Prolonged use of the product, outside of medical supervision, may be harmful. This product should be used only if strictly necessary. Doses higher than those recommended carry a risk of very serious liver damage. Treatment with an antidote should be administered as soon as possible. See section 4.9. To avoid the risk of overdose, patients should be advised to avoid the concomitant use of other medicinal products containing paracetamol. The total dose of paracetamol should 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 (see section 4.9 “Overdose”). The ingestion of undissolved tablets should be avoided in children under 6 years of age as this could lead to their inhalation. This medicinal product contains aspartame, a source of phenylalanine, equivalent to 0.15 mg per tablet and is therefore contraindicated in subjects with phenylketonuria (see section 4.3). There are no non-clinical or clinical studies available on the use of aspartame in children under 12 weeks of age. Precautions for use 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 reserves of hepatic glutathione) - Dehydration - Severe renal insufficiency (creatinine clearance ≤ 10 ml/min - see section 4.2). In children treated with 60 mg/kg/day of paracetamol, the association 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 beyond 3 days, a review of the treatment should be performed. Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to the increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as in those using maximum daily doses of paracetamol. Careful monitoring, including measurement of urinary 5-oxoproline, is recommended.

INTERACTIONS

Interactions Tachipirina Flashtab 250 mg 12 dispersible tablets - Which medicines or foods can modify the effect of Tachipirina Flashtab 250 mg 12 dispersible tablets?

• 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 intake of enzyme inducers (such as carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's Wort or St. John's Wort) or potentially hepatotoxic substances (see section 4.9). • Metoclopramide and domperidone: accelerate the absorption of paracetamol. • Cholestyramine: reduces the absorption of paracetamol. • Concomitant use of paracetamol (4 g daily for at least 4 days) with oral anticoagulants may induce slight variations in INR values ​​with consequent increased risk of bleeding. In these cases, more frequent monitoring of INR values ​​should be performed during concomitant use and after its discontinuation. • Caution should be exercised when paracetamol is used concomitantly with flucloxacillin since concomitant intake has been associated with high anion gap metabolic acidosis, especially in patients with risk factors (see section 4.4). 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.

SIDE EFFECTS

Like all medicines, Tachipirina Flashtab 250 mg 12 dispersible tablets can cause side effects - What are the side effects of Tachipirina Flashtab 250 mg 12 dispersible tablets?

Systemic organic classification	Rare (≥1/10,000 to <1/1,000)	Very rare (<1/10,000), not known (frequency cannot be estimated from the available data)
Hepatobiliary pathologies	- increased levels of liver transaminases
Immune system disorders		- hypersensitivity reaction (ranging from simple skin rash or urticaria to anaphylactic shock requiring discontinuation of treatment)
Pathologies of the haemolymphopoietic system		- thrombocytopenia, leukopenia, neutropenia (sporadic reports)
Skin and subcutaneous tissue disorders		Very rare cases of serious skin reactions have been reported.

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued 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 http://www.aifa.gov.it/content/ segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Tachipirina Flashtab 250 mg 12 dispersible tablets - What are the risks of Tachipirina Flashtab 250 mg 12 dispersible tablets in case of overdose?

There is a risk of liver damage (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, hepatic cytolysis), particularly in elderly subjects, in young children, in patients with liver disease, in chronic alcoholism, in patients with chronic malnutrition and in patients receiving enzyme inducers. In these cases, overdose may be fatal. Symptoms generally appear in the first 24 hours and include: nausea, vomiting, anorexia, pallor and abdominal pain. Overdose, 7.5 g or more of paracetamol in a single administration in adults or 140 mg/kg of body weight in a single administration in children, causes necrosis of hepatocytes which makes it likely to induce complete and irreversible necrosis, resulting in hepatocellular failure, metabolic acidosis and encephalopathy which may lead to coma and death. Concomitantly, an increase in the levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin is observed, together with an increase in prothrombin time which may appear 12 to 48 hours after administration. Clinical symptoms of liver damage usually appear after two days and reach a maximum after 4 - 6 days. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Other non-hepatic symptoms that have been reported following paracetamol overdose include myocardial abnormalities and pancreatitis. Emergency treatment : • immediate transfer to hospital, even if there are no significant early symptoms • collection of a blood sample for initial measurement of plasma paracetamol concentration • gastric lavage • intravenous (or oral if possible) administration of the antidote N-acetylcysteine ​​if possible within ten hours of ingestion. N-acetylcysteine ​​can, however, provide a certain degree of protection even after 10 hours, and up to 48 hours, but in these cases prolonged treatment is performed. • symptomatic treatment must be performed • oral methionine can be used as an alternative to N-acetylcysteine ​​provided that it is administered as soon as possible after the overdose and, in any case, within 10 hours of the overdose.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Tachipirina Flashtab 250 mg 12 dispersible tablets.

Pregnancy A large amount of data on pregnant women indicate neither malformative nor fetal/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 with the lowest possible frequency. Breastfeeding After oral administration, paracetamol is excreted in breast milk in small quantities. No undesirable effects on breast-fed children have been reported. Therapeutic doses of this medicinal product can be taken during breastfeeding.

DRIVING AND USE OF MACHINERY

Taking Tachipirina Flashtab 250 mg 12 dispersible tablets before driving or using machines - Does Tachipirina Flashtab 250 mg 12 dispersible tablets affect driving or using machines?

Not relevant.