国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
Aspar Pharmaceuticals Ltd
N02BE01
Paracetamol
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5024071210040 5024071210194 5024071210002
! ? 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 500mg Tablets 3. How to take Paracetamol 500mg Tablets 4. Possible side effects 5. How to store Paracetamol 500mg Tablets 6 Contents of the pack and other information 1. W HAT P ARACETAMOL IS AND WHAT IT IS USED FOR These tablets contain Paracetamol and are used to treat mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pain, flu, fever, aches and pains including muscles pains, back ache and rheumatic aches and pains. 2. W HAT YOU NEED TO KNOW BEFORE YOU TAKE P ARACETAMOL 500 MG T ABLETS DO NOT TAKE THESE TABLETS IF YOU: • Are allergic to Paracetamol or any of the other ingredients listed in section 6 (see section 4 – possible side effects) • Suffer from liver or kidney problems • Suffer from alcohol dependency • Suffer from non-serious arthritis and need to take painkillers every day OTHER MEDICINES AND PARACETAMOL Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines: • Blood thinning medicines such as Warfarin • Metoclopramide and Domperidone (for sickness and digestive disorders) • Colestyramine (to help control cholesterol levels) • Any drugs that affect the liver • Any other anti-inflammatory drugs e.g. aspirin • Any other paracetamol containing products • 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, BREAST-FEEDING AND FERTILITY If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 3. H OW TO TAKE P 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: - Paracetamol Ph.Eur. 500mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Uncoated tablet. A white capsule shaped tablet with break line marked ap/500. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A mild analgesic and antipyretic, recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, tooth ache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat and for relieving the fever, aches and pains of colds and flu. Also recommended for the symptomatic relief of pain due to non- serious arthritis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: _ADULTS, THE ELDERLY AND CHILDREN 16 YEARS AND OVER:_ One or two tablets to be taken every four to six hours, when necessary up to four times daily. Maximum dose of 8 tablets in 24 hours. _ _ _CHILDREN 10 - 15 YEARS_: One tablet to be taken every four to six hours, when necessary to a maximum of four doses in 24 hours. _ _ _ _ _Not suitable for children under 10 years of age_. Children should not be given tablets for more than 3 days without consulting a doctor. These doses should not be repeated more frequently than every four to six hours nor should more than four doses be administrated in any 24 hour period. Method of administration: Paracetamol tablets to be administered orally only. 4.3 CONTRAINDICATIONS Hypersensitivity to Paracetamol or any of the other constituents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non- cirrhotic alcoholic liver disease. Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), par 阅读完整的文件