国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
Teva UK Ltd
N02BE01
Paracetamol
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5017007051718 5017007051619
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 and the elderly: Take one or two tablets Children: 6-8 years: Take half a tablet 8-10 years: Take half to three quarters tablet 10-12 years: Take one tablet 12-15 years: Take one to one & half tablet Not recommended for children under 6 years of age. The does should only be taken every 4-6 hours when necessary to a maximum of 4 doses in 24 hours. Route of administration: Oral 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol and/or other constituents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Special warnings and precautions for use Not recommended for children under 10 years of age. 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 take more medicine than the label tells you to. If you do not get better, talk to your doctor. Keep out of the sight and reach of children. Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. Do not take anything else containing paracetamol while taking this medicine. Patients should be advised that paracetamol may cause severe skin reactions. If a skin reaction such as skin reddening, blisters, or rash occurs, they should stop use and seek medical assistance right away. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Cholestyramine: The speed of abs 阅读完整的文件