国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aspirin
OBG Pharmaceuticals Ltd
N02BA01
Aspirin
300mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100
Aspirin 300 MG Tablets 16’s ’Pull Out’ leaflet LABEL (Seven Panel) V1 NEW LABEL-Leaflet Layout PLEASE REMOVE THIS CUTTER GUIDE BEFORE PRINTING THIS LABEL - LEAFLET WAS ORIGINALY CREATED ON 17.03.14, PLEASE CHECK ALL BARCODES, PHARMACODES AND ITEM CODES PRIOR TO FINAL PRINTING, THANK YOU 16 Tablets Item Code AVL020/9 (to be confirmed) Print Colours Cyan P485 (K) black 100% Patient Information Leaflet for Aspirin 300 mg Tablets _Read this leaflet carefully before taking these tablets._ _It does not contain all the information about your medicine _ _that you may need to know, so ask your doctor or pharmacist _ _if you have any questions._ _This leaflet only applies to Aspirin 300 mg Tablets._ 1. WHAT THESE TABLETS DO These tablets contain Aspirin which is a type of painkiller. It is used to relieve pain, swelling and high temperature. It can be used to treat headaches, migraine, neuralgia, toothache, sore throat, period pains and for the relief of sprains, strains, rheumatic pain, sciatica, lumbago, muscle aches, fibrositis, joint swelling and stiffness. 2. CHECK BEFORE YOU TAKE Do not take these tablets if you: • Are allergic to Aspirin, NSAIDs which includes those when in attacks of asthma, angioedema, uticaria or rhinitis have been precipitated by aspirin or any other NSAID or any of the other ingredients listed in section 6 • Have a stomach ulcer or have had problems with ulcers in the past • Suffer from haemophilia or any other bleeding condition • Suffer from gout or had in the past • Are in the last 3 months of pregnancy or are breast feeding. Important warning: Do not give this medicine to children under the age of 16 unless your doctor tells you. This is because there is a possible association between Aspirin and Reye’s Syndrome when given to children. Reye’s syndrome is a very rare disease, which can be fatal. Take special care and tell your doctor if you: • Are intolerant to some sugars as these tablets contain lactose • Have asthma or have ever had it in the past • Have dehydrat 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aspirin 300mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet containsAspirin 300mg. For excipients see Section 6.1 3 PHARMACEUTICAL FORM Tablet White circular with break line on one face 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Anti-inflammatory indications: Symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, muscular aches, fibrositis, joint swelling and stiffness. Analgesic and antipyretic indications: Mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, symptomatic relief of influenza and feverish colds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Adults & children over 16 years: 1 - 3 tablets every four hours, or as directed by a doctor. Not more than 4 doses in 24 hours. Do not give to children aged under 16 years, unless Aspirin has been specifically prescribed for that child (e.g. for Kawasaki’s disease). Elderly: A lower dose is recommended. The tablets to be taken orally with water. 4.3 CONTRAINDICATIONS Aspirin is contraindicated in patients with; • active peptic ulceration or a history of peptic ulceration. • Haemophilia, haemorrhagic disease or a history of bleeding disorders. • Gout or a history of gout. • Hypersensitivity to aspirin (e.g. asthma, rhinitis, angioedema or urticaria), other NSAIDs or other tablet excipients • During the third trimester of pregnancy 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE There is a possible association between aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which affects the brain and liver and can be fatal. For this reason aspirin should not be given to children under 16 years unless specifically indicated (e.g. for Kawasaki’s disease). Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose- galactose malabsorption should not take aspirin. Patients should be warned: • 阅读完整的文件