Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aspirin
Bristol Laboratories Ltd
B01AC06
Aspirin
75mg
Dispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02090000; GTIN: 5060013941344 5060013941283
Dispersible Aspirin 75 mg Tablets 0155 Insert SAME SIZE ARTWORK 430 x 130 mm Front 30 mm 430 mm 130 mm IXXXXXX Package Leaflet: Information for the user DISPERSIBLE ASPIRIN 75MG TABLETS Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, or pharmacist or nurse. • 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 your doctor, or pharmacist or nurse. 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 • Each tablet contains the active ingredient Aspirin 75 mg of medicines called antiplatelet agents that help prevent your blood cells sticking together and forming a blood clot • Aspirin are principally used to prevent blood clots forming following a heart attack or stroke or to help prevent heart attacks and strokes in patients who have previously suffered from these conditions. They may have been prescribed for you if you have recently had by-pass surgery. 2. What you need to know before you take Aspirin Do not take this medicine if you: • are allergic to acetylsalicylic acid or any of the ingredients in this medicine (see section 6) • are allergic to other salicylates or nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used for arthritis or rheumatism and pain • have had an asthma attack or swelling of some parts of the body e.g. face, lips, throat or tongue (angioedema) after taking salicylates or NSAIDs • currently have or have ever had an ulcer in your stomach Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dispersible Aspirin 75 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains aspirin 75 mg as the active ingredient. Excipients with known effect: Also contains lactose monohydrate 27.5 mg For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Dispersible Tablets White, flat tablets, debossedon one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following by –pass surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For the management of cardiovascular or cerebrovascular disease: The advice of a doctor should be sought before commencing therapy for the first time. The usual dosage, for long term use, is 75-150mg once daily. In some circumstances a higher dose may be appropriate, especially in the short term, and up to 300mg a day may be used on the advice of a doctor. In general, acetylsalicylic acids should be used with caution in elderly patients who are more prone to adverse events. The usual adult dose is recommended in the absence of severe renal or hepatic insufficiency (see sections 4.3 and 4.4). Treatment should be reviewed at regular intervals. CHILDREN: Aspirin 75mg Tablets is not indicated for use in children and young people less than 16 years of age (see 'Special Warnings and Precautions for Use'). Method of administration Oral administration, after dissolution in water. 4.3 CONTRAINDICATIONS • Hypersensitivity to salicylic acid compounds or prostaglandin synthetase inhibitors (e.g. certain asthma patients who may suffer an attack or faint and certain patients who may suffer from bronchospasm, rhinitis and urticaria) and to any of the excipients listed in section 6.1 • Active, or history of recurrent peptic ulcer and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhages. • Haemorrhagic diathesis; coagulation disorders such as haemophi Leggi il documento completo