Country: Malta
Language: English
Source: Medicines Authority
ACETYLSALICYLIC ACID
Wockhardt UK Limited
B01AC06
ACETYLSALICYLIC ACID
GASTRO-RESISTANT TABLET
ACETYLSALICYLIC ACID 75 mg
OTC
ANTITHROMBOTIC AGENTS
Authorised
2006-05-26
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ASPIRIN 75MG GASTRO-RESISTANT TABLETS Aspirin 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 have 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. - You must talk to a doctor if you do not feel better or if you feel worse after 3 days. The name of your medicine is Aspirin 75 mg Gastro-resistant Tablets. In the rest of this leaflet, it is called Aspirin Tablets. WHAT IS IN THIS LEAFLET 1. What Aspirin Tablets are and what they are used for 2. What you need to know before you take Aspirin Tablets 3. How to take Aspirin Tablets 4. Possible side effects 5. How to store Aspirin Tablets 6. Contents of the pack and other information 1. WHAT ASPIRIN TABLETS ARE AND WHAT THEY ARE USED FOR The active ingredient in your medicine is Aspirin. Aspirin belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Aspirin thins the blood which helps to reduce the likelihood of having a heart attack. These tablets have been specially coated (enteric coating) to help minimise stomach upset and feeling sick (sometimes experienced as side effects of these tablets – see Section 4). Aspirin Tablets are used to reduce the likelihood of further heart attacks or strokes in patients with a previous history of these conditions, when taken regularly. They can also be taken following bypass surgery. Due to the slow release of Aspirin, this product is not useful for relieving acute pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN TABLETS 2. BEFORE YOU TAKE ASPIRIN TABLETS THERE IS A POSSIBLE ASSOCIATION BETWEEN ASPIRIN AND REYE’S SYNDROME WHEN GIVEN TO C Read the complete document
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aspirin 75mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Aspirin 75mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant tablet White circular tablet, plain on both sides. 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 The advice of a doctor should be sought before commencing therapy for the first time. The usual dosage, for long-term use, is 75mg-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. Method of administration Take the tablet with water, do not cut, chew or crush the tablet. Swallow whole. _ Paediatric population _ Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease). Gastro-intestinal irritation may be reduced by taking aspirin with or immediately after food. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Page 2 of 10 In patients with a history of hypersensitivity to aspirin (or any of the excipients) or any other NSAIDs and in patients in whom attacks of asthma, angioedema, urticaria or rhinitis have been precipitated by aspirin or other NSAIDs. Active peptic ulceration or history of peptic ulceration Haemophilia, other coagulopathies or concurrent anticoagulant therapy Gout Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease). Doses > 100mg/day during the third trimester of pregnancy. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution should be exercised in patients with asthma, allergic disease, , impairment of hepatic or renal function (avoid if severe), impaired cardiac function, Read the complete document