Land: Malta
Språk: engelsk
Kilde: Medicines Authority
PARACETAMOL
Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta
N02BE01
PARACETAMOL 500 mg
TABLET
PARACETAMOL 500 mg
POM
ANALGESICS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-04-22
Page 1 of 3 PACKAGE LEAFLET INFORMATION PARACETAMOL 500MG TABLETS Please read all of this leaflet carefully before you start taking this medicine. Keep the leaflet, you may need to read it again. If you have any questions or are not sure about anything, ask your doctor or pharmacist. In this leaflet 1. What this medicine is and what it is used for 2. Before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Further information 1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR Paracetamol is an analgesic (pain killer) and an antipyretic (helps to reduce body temperature when you have a fever). This medicine is used for the relief of headache, migraine, neuralgia and rheumatic aches and pains. Also for the relief of symptoms of colds and influenza 2. BEFORE USING THIS MEDICINE DO NOT TAKE THESE TABLETS IF : • you are allergic to paracetamol or any of the other ingredients (see section 6). DO NOT TAKE anything else containing paracetamol while taking this medicine. CHECK WITH YOUR DOCTOR BEFORE TAKING THESE TABLETS IF: • you suffer from any liver or kidney problems • you suffer from alcohol dependence TAKING OTHER MEDICINES: Check with your doctor or pharmacist before taking these Tablets if you are taking other medicines, including any that you can buy without a prescription. This is especially important if you are taking: • anticoagulants to thin the blood e.g. warfarin • colestyramine (to lower cholesterol levels) • metoclopramide or domperidone (for feeling sick or being sick) • flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used. PREGNANCY AND BREAST FEEDING Check with your doctor before taking if you a read_full_document
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 500 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500.00 mg of Paracetamol BP 3 PHARMACEUTICAL FORM White, capsule shaped tablets, plain on one side and with a breakline on the other side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paracetamol is indicated for the relief of headaches, migraine, neuralgia, rheumatic aches and pains. For the relief of colds and influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Unless otherwise directed by the doctor: Posology Adults, the elderly and children 16 years and over: One or two tablets every 4 – 6 hours when necessary to a maximum of 4 doses in 24 hours. Paediatric population Children 12 to15 years: One to one and a half tablets every 4 – 6 hours when necessary to a maximum of 4 doses in 24 hours. Children 10 to 12 years: One tablet every 4 – 6 hours when necessary to a maximum of 4 doses in 24 hours. Children 6 to 10 years: Half a tablet every 4 – 6 hours when necessary to a maximum of 4 doses in 24 hours. Not recommended for children under 6 years. Method of administration For oral use. To be swallowed with some water. Page 2 of 6 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol and/or other constituents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Do not exceed the recommended dose. If symptoms persist, consult your doctor. Keep out of the reach and sight of children. Immediate medical advice should be sought in the event of an overdose even if you feel well, because of the risk of delayed serious liver damage. Do not take with any other paracetamol-containing products. Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high ani read_full_document