Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
PARACETAMOL
Accord Healthcare Limited
N02BE01
PARACETAMOL
500 Milligram
Tablets
Product not subject to medical prescription
paracetamol
Marketed
2015-07-10
_Continued over page_ PARACETAMOL 500 MG TABLETS paracetamol PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _Continued top of next column_ BBBA1617 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 or nurse 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 or nurse. 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 TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL TABLETS 3 HOW TO TAKE PARACETAMOL TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE PARACETAMOL TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT PARACETAMOL TABLETS ARE AND WHAT THEY ARE USED FOR Paracetamol Tablets contain the active substance paracetamol which belongs to a group of medicines called analgesics (painkillers). Paracetamol Tablets are used to relieve pain and help reduce fever. The tablets can treat mild to moderate pain and/or fever. Paracetamol Tablets may be used in adults and adolescents but are not suitable for use in children below 6 years. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL TABLETS DO NOT TAKE PARACETAMOL TABLETS • If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). • If you are below 6 years of age. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist or nurse before taking Paracetamol Tablets • if you are taking other paracetamol containing medicines, as it may severely damage the liver. • if you have kidney or liver disease (including Gilbert’s syndrome or acute hepatitis). • if you have a deficiency of a certain enzy Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 500mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Paracetamol 500.0 mg. Excipients(s): For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, uncoated capsule shape tablet marked with “B score T” on one side and plain on the other side. Length, width and thickness of the tablet is 16.50±0.20 mm, 8.20±0.20 mm and 5.10±0.30 mm respectively. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of mild to moderate pain and/or fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: For oral use only. Adults and adolescents 15 years (> 55 kg body weight) 1 to 2 tablets (500-1000 mg) at a time, up to 6 tablets (3000 mg) per 24 hours. Children and young people up to 15 years 6-9 years: ½ tablet at a time, up to 4-6 times per 24 hours 9-12 years: 1 tablet at a time, up to 3-4 times in 24 hours 12-15 years: 1 tablet at time, up to 4-6 times per 24 hours Direction for use: - Paracetamol tablet is not suitable for children below 6 years. - The dosing interval should be at least 4 hours. - Do not use in combination with other paracetamol-containing products. - The indicated dose should not be exceeded due to risk of serious damage to the liver (see section 4.4 and 4.9). - The lower frequency of administration is intended for children in the lower limit of the relevant age group. - Depending on the onset of symptoms (fever and pain) repeated administration is allowed. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Přečtěte si celý dokument