Tachipirina Flashtab 500mg 16 orodispersible tablets

Tachipirina Flashtab 500mg 16 orodispersible tablets is a medicine designed for the symptomatic treatment of mild to moderate pain and fever . Each tablet contains paracetamol 500 mg , an active ingredient known for its analgesic and antipyretic properties. Orodispersible tablets are easy to take, as they dissolve quickly in the mouth without the need for water, offering a practical option for those who have difficulty swallowing traditional tablets. This format is particularly useful for rapid relief from symptoms, making Tachipirina Flashtab an effective choice for managing pain and fever.

ACTIVE INGREDIENTS

Active ingredients contained in Tachipirina Flashtab 500mg 16 orodispersible tablets - What is the active ingredient of Tachipirina Flashtab 500mg 16 orodispersible tablets?

Each orodispersible tablet contains paracetamol 500 mg (as coated paracetamol crystals). Excipients with known effect: Each tablet also contains 40 mg aspartame (E951). For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Tachipirina Flashtab 500mg 16 orodispersible tablets - What does Tachipirina Flashtab 500mg 16 orodispersible tablets contain?

Coated paracetamol crystals: Basic butylated methacrylate copolymer, 30% polyacrylate dispersion, Silica, colloidal hydrophobic. Tablet : Mannitol (granules, powder), crospovidone, aspartame (E951), blackcurrant flavour, magnesium stearate.

DIRECTIONS

Therapeutic indications Tachipirina Flashtab 500mg 16 orodispersible tablets - Why is Tachipirina Flashtab 500mg 16 orodispersible tablets used? What is it used for?

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

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Tachipirina Flashtab 500mg 16 orodispersible tablets - When should Tachipirina Flashtab 500mg 16 orodispersible 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 500mg 16 orodispersible tablets - How do you take Tachipirina Flashtab 500mg 16 orodispersible tablets?

Dosage This medicine is FOR ADULTS ONLY. The maximum recommended dosage is 3000 mg of paracetamol per day, corresponding to 6 tablets per day. The usual dosage is 1 tablet of 500 mg, to be repeated if necessary after not less than four hours. In case of severe pain or high fever, 2 tablets of 500 mg to be repeated if necessary after not less than four hours. Do not exceed 6 tablets of 500 mg in 24 hours. Maximum recommended dosage : the total dose of paracetamol must not exceed 3 g per day for adults (see section 4.9 “Overdose”). Frequency of administration - In adults, administration should be performed at intervals of at least 4 hours. Renal insufficiency In case of severe renal insufficiency, the interval between 2 administrations must be at least 8 hours . Method of administration . Oral route. The tablet should be sucked and not chewed. It can be dispersed in half a glass of water.

CONSERVATION

Storage Tachipirina Flashtab 500mg 16 orodispersible tablets - How is Tachipirina Flashtab 500mg 16 orodispersible tablets stored?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Tachipirina Flashtab 500mg 16 orodispersible tablets - About Tachipirina Flashtab 500mg 16 orodispersible 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. This medicinal product contains aspartame, a source of phenylalanine, equivalent to 0.2 mg per tablet and, therefore, is 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 paragraph 4.2). In case of high fever, or signs of secondary infection, or persistence of symptoms beyond 3 days, a reassessment of the treatment should be carried out. During prolonged treatment with analgesic drugs, carried out with doses higher than those indicated in the package leaflet, headache may occur which should not be treated with higher doses of the medicine. In general, the habitual use of analgesics, especially the combination of different analgesic drugs, may lead to permanent kidney damage with the risk of renal failure (analgesic nephropathy). If this situation occurs or is suspected, a doctor should be consulted and treatment should be discontinued. The diagnosis of “analgesic overuse headache” should be considered in patients who suffer from frequent or daily headaches despite (or because of) the regular use of headache medications. 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 500mg 16 orodispersible tablets - Which medicines or foods can modify the effect of Tachipirina Flashtab 500mg 16 orodispersible 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 per day for at least 4 days) with oral anticoagulants may induce slight variations in INR values ​​with consequent increase in the 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 500mg 16 orodispersible tablets can cause side effects - What are the side effects of Tachipirina Flashtab 500mg 16 orodispersible 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 500mg 16 orodispersible tablets - What are the risks of Tachipirina Flashtab 500mg 16 orodispersible 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 can 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 to 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 500mg 16 orodispersible 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 duration 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 500mg 16 orodispersible tablets before driving or using machines - Does Tachipirina Flashtab 500mg 16 orodispersible tablets affect driving or using machines?

Not relevant.