国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aspirin
Waymade Healthcare Plc
N02BA01
Aspirin
300mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100
PATIENT INFORMATION LEAFLET ASPIRIN 300MG TABLETS BP READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may want to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Aspirin is and what it is used for 2. What you need to know before you take Aspirin 3. How to take Aspirin 4. Possible side effects 5. How to store Aspirin 6. Contents of the pack and other information 1. WHAT ASPIRIN IS AND WHAT IT IS USED FOR Aspirin belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) that work by relieving pain and reducing inflammation, high temperature and fever. Your medicine is for effective relief from: mild to moderate pain including headache, migraine, sharp nerve pain (neuralgia), toothache, sore throat, period pains and aches and pains, symptomatic relief of sprains, strains, rheumatic pain, nerve pain of the lower back or legs (sciatica), lower back pain (lumbago), chronic muscle pain, sometimes with tiredness and skin sensitivity (fibrositis), muscular aches and pains, joint swelling and stiffness, influenza, feverishness and feverish colds. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN Please read the following information. DO NOT TAKE ASPIRIN IF YOU: • are allergic to aspirin or any of the other ingredients of this medicine listed in section 6 • are under the age of 16 • are receiving anticoagulant therapy • have ever had a stomach ulcer, perforation or bleeding. • suffer from haemophilia (your blood does not clot well) or from gout • are in late stages of pregnancy • are breast feeding WARNINGS AND PRECAU 完全なドキュメントを読む
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: • 完全なドキュメントを読む