البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aspirin
Accord-UK Ltd
N02BA01
Aspirin
300mg
Dispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5012617011121 5012617017109
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ASPIRIN 300MG DISPERSIBLE TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • The full name of this medicine is Aspirin 300mg Dispersible Tablets but within this leaflet it will be referred to as aspirin dispersible tablets. WHAT IS IN THIS LEAFLET 1. WHAT ASPIRIN DISPERSIBLE TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN DISPERSIBLE TABLETS 3. HOW TO TAKE ASPIRIN DISPERSIBLE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ASPIRIN DISPERSIBLE TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT ASPIRIN DISPERSIBLE TABLETS ARE AND WHAT THEY ARE USED FOR Aspirin dispersible tablets belong to a group of medicines which have analgesic (pain relieving), anti-inflammatory (inflammation reducing) and anti-pyretic (temperature reducing) properties. These tablets may be used for the relief of: • headache, toothache, migraine, neuralgia (nerve pain), sore throat or period pains. symptoms of influenza, feverishness, rheumatic pains, sciatica (nerve pain of the leg/back), lumbago (lower back pain), fibrositis (muscular rheumatism), muscular aches and pains. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN DISPERSIBLE TABLETS DO NOT TAKE aspirin dispersible tablets and TELL your doctor if you: • are allergic to aspirin, salicylates or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6). You may have developed difficulty breathing, a runny nose, itchy skin or swelling after taking aspirin or a NSAI اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aspirin 300mg Dispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300mg Aspirin. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Dispersible Tablets. Dispersible Aspirin are circular, white, uncoated tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aspirin has analgesic, antipyretic and anti-inflammatory actions. It is indicated for: 1) The relief of headache, toothache, migraine, neuralgia, sore throat, dysmenorrhoea. 2) The symptomatic relief of influenza, feverishness, rheumatic pains, sciatica, lumbago, fibrositis, muscular aches and pains. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The tablets should be dispersed in water before administration. _Adults including elderly: _1-2 tablets at intervals of not less than 4 hours, to a maximum of four doses in 24 hours. _Children:_ Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease). To be dispersed in water for oral use. 4.3 CONTRAINDICATIONS Aspirin should not be taken by patients with the following conditions: • Known hypersensitivity to aspirin, other ingredients in the product, other salicylates or non-steroidal anti-inflammatory drugs (a patient may have developed anaphylaxis, angioedema, asthma, rhinitis or urticaria induced by aspirin or other NSAIDs). • Nasal polyps associated with asthma (high risk of severe sensitivity reactions). • Active, or history of recurrent peptic ulcer, dyspepsia and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhages. • Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia. • Concurrent anticoagulant therapy should be avoided. • Severe hepatic impairment • Severe renal impairment • Severe cardiac failure • Doses >100 mg/day during the third trimester of pregnancy (see section 4.6); • Methotrexate used at doses >15mg/week (see section 4.5). • children اقرأ الوثيقة كاملة