国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
Bell,Sons & Co (Druggists) Ltd
N02BE01
Paracetamol
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5017848251872
PL 16028/0053 – LABEL/LEAFLET/GENERIC TEXT – GALPHARM LIVERY. LABEL PARACETAMOL 500MG TABLETS Effective Pain Relief 16 Tablets Please read the attached leaflet carefully before use. Keep out of the reach and sight of children. For dosage instructions please see attached leaflet. _ _ _Batch No: _ _Exp. Date: _ Each tablet contains 500mg Paracetamol. Also contains E223. Galpharm Healthcare Ltd., South Yorkshire, EX33 2DL PL 16028/0053 GSL Barcode LEAFLET PATIENT INFORMATION PATIENT INF ORMATION READ THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Ask your pharmacist if you need more information or advice. • You must contact a doctor if your symptoms worsen or do not improve after 3 days. 1. WHAT THIS MEDICINE IS FOR Paracetamol relieves pain and brings down high temperatures (reduces fever). Paracetamol 500mg Tablets are used for relief of: • mild to moderate pain including headache, migraine, nerve pain (neuralgia), toothache, sore throat and period pains. • symptoms of rheumatic and muscular aches and pains, sciatica, back pain (lumbago), joint swelling and stiffness. • symptoms of colds and flu. 2. BEFORE YOU TAKE THE MEDICINE DO NOT TAKE PARACETAMOL 500MG TABLETS: • if you are allergic to paracetamol, sodium metabisulphite or any of the other ingredients listed in section 6. DO NOT TAKE ANYTHING ELSE CONTAINING PARACETAMOL WHILE TAKING THIS MEDICINE. TALK TO YOUR PHARMACIST OR DOCTOR BEFORE TAKING IF: • you suffer from severe liver or kidney disease, including alcoholic liver disease IF YOU ARE TAKING OTHER MEDICINES: Talk to your pharmacist or doctor before taking the tablets if you are taking any of the following: • medicines for nausea or sickness, such as metoclopramide or domperidone. • colestyramine for high cholesterol or high blood fats • warfarin (or other medicines used to thin the blood and reduce the risk of clotting). The risk of bleeding may be increased if you take paracetamol daily over a long period of time. However you can take occasional dos 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 500mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500.00 mg of Paracetamol BP 3 PHARMACEUTICAL FORM Tablet White, capsule-shaped tablets, plain on one side and with a breakline on the other side. 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 ADULTS, THE ELDERLY AND CHILDREN 16 YEARS AND OVER: Take one or two tablets up to 4 times a day. CHILDREN 10 TO 15 YEARS OF AGE: Take one tablet up to 4 times a day. NOT RECOMMENDED FOR CHILDREN UNDER 10 YEARS OF AGE The dose should not be repeated more frequently than every 4 hours and not more than 4 doses should be taken in any 24 hour period. Route of administration: Oral 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 noncirrhotic 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. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Cholestyramine: The speed of absorption of paracetamol is reduced by cholestyramine. Therefore, the cholestyramine should not be taken within one hour if maximal analgesia is required. Metoclopramide and Domperidone: The absorption of paracetamol is increased by metoclopramide and domperidone. However, concurrent use need not be avoided. Warfarin: The anticoagulant effect of warfarin and oth 阅读完整的文件