Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
PARACETAMOL
Actavis Group PTC ehf
N02BE01
PARACETAMOL
500 Milligram
Film Coated Tablet
Product not subject to medical prescription
paracetamol
Marketed
2011-06-29
_Continued top of next column_ BBBA1682 _Continued over page_ PARACETAMOL 500 MG FILM-COATED TABLETS Paracetamol PACKAGE LEAFLET: INFORMATION FOR THE USER 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 have 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 effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse after 3 days. WHAT IS IN THIS LEAFLET: 1 WHAT PARACETAMOL IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL 3 HOW TO TAKE PARACETAMOL 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE PARACETAMOL 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT PARACETAMOL IS AND WHAT IT IS USED FOR Paracetamol contains paracetamol which belongs to a group of medicines called analgesics (painkillers). Paracetamol is used to relieve mild to moderate pain and reduce fever. Paracetamol can be used for the relief of headache, toothache, period pains, muscle pain and fever in connection with common cold. PARACETAMOL “CONTAINS PARACETAMOL” 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL DO NOT TAKE PARACETAMOL • if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Paracetamol should not be used in combination with alcohol, as it may severely damage your liver. The effect of alcohol will not be enhanced by the addition of paracetamol. Talk to your doctor before taking Paracetamol: • if you have kidney or liver disease (including Gilbert’s syndrome or hepatitis); • if you regularly consume large amount of alcohol. You may need lower doses and to limit the use for a short period of time, otherwise your li Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 500 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg paracetamol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule-shaped, white film-coated tablet, with break-line on one side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of mild to moderate pain and/or fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Paracetamol 500 mg film-coated tablets are not intended for children weighing less than 26 kg. _POSOLOGY_ _Adults and adolescents (weighing more than 50 kg)_ The usual dose is 500 mg to 1,000 mg every 4 to 6 hours as needed, to a maximum of 3 g daily. Maximum single dose is 1,000 mg. Maximal daily dose should not be exceeded due to risk of serious hepatic damage (see sections 4.4 and 4.9). _Paediatric population (weighing 20–50 kg)_ The recommended total daily dose of paracetamol is approximately 60 mg/kg divided in 4 or 6 separate doses, or approximately 15 mg/kg every 6 hours or 10 mg/kg every 4 hours. Maximal daily dose should not be exceeded due to risk of serious hepatic damage (see sections 4.4 and 4.9). Paediatric dosage should be based on body weight and suitable dosage form used. Information on the age of children within each weight group given below is for guidance only. Regular administration minimizes pain and fever oscillation. In children administration should be regular, including night times, preferably at 6 hours intervals, otherwise at intervals of minimum 4 hours. _Children and adolescents weighing 43_ - _50 kg (about 12_ - _15 years)_ The usual dose is 500 mg every 4 hours as needed, to a maximum of 2.5 g daily. _Children weighing 34_ - _43 kg (about 11_ - _12 years)_ The usual dose is 500 mg every 6 hours as needed, to a maximum of 2 g daily. _Children weighing 26_ - _34 kg (about 8_ - _11 years)_ The usual dose is 250 mg every 4 hours or 500 mg every 6 hou Przeczytaj cały dokument