Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aspirin
Bristol Laboratories Ltd
N02BA01
Aspirin
300mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5060013941368 5060013941399
Package leaflet: Information for the user ASPIRIN 300MG TABLETS BP (ASPIRIN) WHAT IS IN THIS LEAFLET 1. What Aspirin 300mg Tablets are and what they are used for 2. What you need to know before you take Aspirin 300mg Tablets 3. How to take Aspirin 300mg Tablets 4. Possible side effects 5. How to store Aspirin 300mg Tablets 6. Contents of the pack and other information 1. WHAT ASPIRIN 300MG TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Aspirin 300mg Tablets. It contains the active ingredient Aspirin 300 mg. Aspirin belongs to a group of medicines called the non-steroidal anti- inflammatory drugs (NSAIDs). It relieves mild to moderate pain, reduces inflammation and lowers temperature when you have a fever. It is recommended for: - Relief of headache, toothache, migraine, neuralgia, sore throat, period pains, aches and pains. - Relief of the symptoms of inflammatory conditions including sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness.. - Relief of the symptoms of cold and influenza. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN 300MG 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 or pharmacist 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4. You must talk to a doctor if you do not feel better or if you feel worse. Do not take this medicine if you: are allergic to Aspirin or any other painkillers (NSAIDs) or to any of the other ingredients contained in the tablets. You may have developed difficulty breathing, runny nose, rash, or swollen face or lips, after taking aspirin or a NSAID previously (see section 6) Baca dokumen lengkap
1 NAME OF THE MEDICINAL PRODUCT Aspirin 300mg Tablets BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300mg of Aspirin BP Excipent with known effect: Also contains 29mg of Lactose For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Plain white uncoated biconvex tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anti-inflammatory: Symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness. Analgesic and anti-pyretic: Symptomatic relief of influenza, feverishness, mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults including elderly: 1 - 2 tablets (300-600 mg) every 3-4 hours as required, to a maximum of 12 tablets (3.6g) daily in divided doses. Children: Do not give to children aged 16 years, unless specifically indicated (e.g. for Kawasaki’s disease). Method of administration: For oral administration. 4.3 CONTRAINDICATIONS Aspirin should not be taken by patients with the following conditions: • Hypersensitivity to aspirin or to any of the excipients listed in section 6.1 • 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 peptic ulceration or a past history of ulceration or dyspepsia. • Haemophilia or other haemorrhagic disorder (including thrombocytopenia) as there is an increased risk of bleeding. • Concurrent anticoagulant therapy should be avoided. • Severe hepatic impairment • Severe renal impairment • Severe cardiac failure • third trimester of pregnancy • Methotrexate used at doses >15mg/week (see section 4.5). • children under 16 years old, unless specifically indicated (e.g. Kawasaki’s disease). • Gout 4.4 Baca dokumen lengkap