Paracetamol 330 mg + 200 mg - antipyretic analgesic 20 effervescent tablets

Product Description

Effervescent Tablets

Composition:

One tablet contains. Active substances: paracetamol 330 mg; ascorbic acid 200 mg. For the full list of excipients, see section 6.1.

Excipients

Sodium bicarbonate, potassium bicarbonate, sorbitol, citric acid, sodium benzoate, sodium docusate, povidone.

Therapeutic indications

Symptomatic treatment of mild to moderate pain and febrile conditions in adults and children. Symptomatic treatment of arthritic pain.

Contraindications

Hypersensitivity to paracetamol or propacetamol hydrochloride (paracetamol precursor) or to any of the excipients.

Dosage

Method of administration: Oral use. Dissolve the tablet completely in a glass of water and drink immediately. Due to the presence of vitamin C, avoid taking the medicine at the end of the day.Dosage: EFFERALGAN 330 mg effervescent tablets with vitamin C are reserved for adults and children weighing 26 kg or more (approximately 8 years or older). In children, dosage schedules based on body weight must be followed and therefore it is necessary to choose an appropriate formulation. The correspondence between age and weight is only indicative. Children weighing 26 kg to 30 kg (approximately 8 to 10 years old): The dosage is 1 effervescent tablet per administration, to be repeated, if necessary, after an interval of at least 6 hours, without exceeding 5 effervescent tablets per day. Children weighing 31 kg to 40 kg (approximately 10 to 13 years old): The dosage is 1–2 effervescent tablets per administration, to be repeated, if necessary, after an interval of at least 6 hours, without exceeding 6 effervescent tablets per day. Adolescents weighing 41 kg to 50 kg (approximately 12 to 15 years old): The dosage is 1–2 effervescent tablets per administration, to be repeated, if necessary, after an interval of at least 6 hours, without exceeding 7 effervescent tablets per day. Adults and adolescents weighing more than 50 kg (approximately 15 years or more): the dosage is 1 or 2 effervescent tablets per administration, to be repeated, if necessary, after an interval of 4 hours, without exceeding 9 effervescent tablets per day. An interval of at least 4 hours must always be respected between administrations. Frequency of administration Regular administrations avoid fluctuations in pain or fever levels. • in children, the interval between administrations must be regular, both day and night, and should preferably be at least 6 hours; • in adults and adolescents, an interval of at least 4 hours must always be respected between administrations. Renal impairment In case of severe renal impairment (creatinine clearance less than 10 ml/min), the interval between administrations must be at least 8 hours. Maximum recommended dosage: In adults and adolescents weighing more than 40 kg, the total dose of paracetamol should not exceed 3 g/day.

Warnings and precautions

Paracetamol should be administered with caution to patients with mild to moderate hepatic impairment (including Gilbert's syndrome), severe hepatic impairment (Child-Pugh >9), acute hepatitis, concomitant treatment with drugs that alter liver function, glucose-6-phosphate-dehydrogenase deficiency, haemolytic anaemia. Do not administer during chronic treatment with drugs that can induce hepatic monooxygenases or in case of exposure to substances that can have this effect (see section 4.5). Paracetamol should be administered with caution to patients with renal impairment (creatinine clearance < 90 mL/min).