Tachipirina Flashtab 500mg 16 orodispersible tablets

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

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

CONTRAINDICATIONS

- 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.

WARNINGS AND PRECAUTIONS FOR USE

Warnings Do not exceed the recommended dose. Prolonged use of the product, outside of medical supervision, may be harmful. This product should only be used if strictly necessary. Doses higher than recommended carry a risk of very serious liver damage. Treatment with an antidote should be carried out as soon as possible. See paragraph 4.9. To avoid the risk of overdose, patients should be advised to avoid the concomitant use of other medicines containing paracetamol. This medicinal product contains aspartame, a source of phenylalanine, equivalent to 0.2 mg per tablet and, therefore, is contraindicated in subjects suffering from 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 hepatic glutathione reserves) - 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 re-evaluation of the treatment should be carried out. During prolonged treatment with analgesic drugs, carried out with doses higher than those foreseen in the information leaflet, headache may occur which must not be treated with higher doses of the medicine. In general, the habitual use of analgesics, especially the combination of different analgesic drugs, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy). If this situation occurs or you suspect its onset, you should consult your doctor and stop treatment. The diagnosis of “analgesic overuse headache” should be considered in those patients who suffer from frequent or daily headaches despite (or because of) the regular use of headache medications. Caution is advised if acetaminophen is administered concurrently 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 acetaminophen. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.

INTERACTIONS

• Probenecid causes at least a 2-fold reduction in paracetamol clearance through inhibition of 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. • The concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants can induce slight variations in INR values ​​with a consequent increase in the risk of bleeding. In these cases, more frequent monitoring of INR values ​​should be conducted during concomitant use and after its discontinuation. • Caution should be exercised when paracetamol is used concomitantly with flucloxacillin as concomitant use has been associated with high anion gap metabolic acidosis, especially in patients with risk factors (see section 4.4). Interactions with clinical trials: The administration of paracetamol can alter the measurement of uric acid in the blood, obtained with the phosphotungstic acid method, and the measurement of blood sugar obtained with the glucose oxidase-peroxidase method.

SIDE EFFECTS

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 disorders | Rare (≥1/10,000 to <1/1,000): - increased levels of liver transaminases

Immune system disorders | Very rare (<1/10,000), not known (frequency cannot be estimated from the available data): - hypersensitivity reaction (from simple skin rash or urticaria, up to anaphylactic shock requiring interruption of treatment)

Pathologies of the blood and lymphatic system | Very rare (<1/10,000), not known (frequency cannot be estimated from the available data): - thrombocytopenia, leukopenia, neutropenia (sporadic reports)

Pathologies of the skin and subcutaneous tissue | Very rare (<1/10,000), not known (frequency cannot be estimated from the available data): Very rare cases of serious skin reactions have been reported.

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 http://www.aifa.gov.it/content/segnali-reazioni-avverse