Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
Alliance Healthcare (Distribution) Ltd
N02BE01
Paracetamol
500mg
Effervescent tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100
PACKAGE LEAFLET: INFORMATION FOR THE USER PARACETAMOL 500 MG SOLUBLE TABLETS (paracetamol) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice • If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4. • You must contact a doctor if your symptoms do not go away after 3 days WHAT IS IN THIS LEAFLET: 1. What Paracetamol 500 mg Soluble Tablets are and what they are used for 2. What you need to know before you take Paracetamol 500 mg Soluble Tablets 3. How to take Paracetamol 500 mg Soluble Tablets 4. Possible side effects 5. How to store Paracetamol 500 mg Soluble Tablets 6. Contents of the pack and other information 1. WHAT PARACETAMOL 500 MG SOLUBLE TABLETS ARE AND WHAT THEY ARE USED FOR These tablets contain paracetamol which is an analgesic (pain-killer) and antipyretic (brings down the body temperature in case of fever). Paracetamol Soluble Tablets are used for headache, migraine, tension headaches, toothache, neuralgia, rheumatic and muscle pain, period pain, sore throat and for relieving the fever, aches and pains of cold and flu. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL 500 MG SOLUBLE TABLETS DO NOT TAKE PARACETAMOL 500 MG SOLUBLE TABLETS IF YOU: • are allergic to paracetamol or to any of the other ingredients of this medicine (listed in Section 6 and end of Section 2) • are taking any other products that contain paracetamol WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Paracetamol 500 mg Soluble Tablets if you: • suffer from severe liver disease (including alcoholic liver disease). • suffer from severe kidney disease. OTHER MEDICINES AND PARACETAMOL 500 MG SOLUBLE TABLETS Tell Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 500mg Soluble Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg of paracetamol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent tablet. Flat white tablets scored on one side and plain on the reverse. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paracetamol Soluble is a mild analgesic and antipyretic. The tablets are recommended for the treatment of most painful conditions for example, headache, including migraine, toothache, sore throat, dysmenorrhoea, rheumatic pains and the symptomatic relief of colds and influenza. 4.2 Posology and method of administration POSOLOGY Adults, Elderly and Children over 16 years: Two tablets in at least half a tumbler full of water, up to 4 times daily as required. Do not take for more than 3 days without consulting your doctor. These doses should not be given more frequently than every 4 hours, and not more than 4 doses should be given in any 24 hour period. PAEDIATRIC POPULATION Not recommended for children under the age of 10 years. Children aged 10 to 15 years One tablet every four to six hours when necessary to a maximum of four doses in 24 hours. Do not take for more than 3 days without consulting your doctor. METHOD OF ADMINISTRATION The tablets should be dissolved in water and are for oral administration only. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 4.4 Special warnings and precautions for use PAEDIATRIC POPULATION - Not recommended for children under the age of 10 years. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Do not exceed the recommended dose. Do not take with any other paracetamol-containing products. If symptoms persist consult your doctor. Keep out of the reach of children. Immediate medical Lire le document complet