Land: Malta
Tungumál: enska
Heimild: Medicines Authority
ACETYLSALICYLIC ACID
Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus
B01AC06
ACETYLSALICYLIC ACID 75 mg
GASTRO-RESISTANT TABLET
ACETYLSALICYLIC ACID 75 mg
OTC
ANTITHROMBOTIC AGENTS
Authorised
2006-11-01
mt-pl-aspirem-ec-tabs-a3 Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ASPIREM 75 MG GASTRO-RESISTANT TABLETS Acetylsalicylic acid 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 after taking the medicine. WHAT IS IN THIS LEAFLET 1. What Aspirem is and what it is used for 2. What you need to know before you take Aspirem 3. How to take Aspirem 4. Possible side effects 5. How to store Aspirem 6. Contents of the pack and other information 1. WHAT ASPIREM IS AND WHAT IT IS USED FOR Aspirem contains the active substance acetylsalicylic acid. Acetylsalicylic acid is used: • to prevent recurrence of heart attacks or strokes by thinning the blood. If someone who has previously had a heart attack or stroke takes Aspirem regularly, it reduces the risk of a blood clot occurring in the heart or brain. This can prevent further heart attacks or strokes. IF YOU TAKE ACETYLSALICYLIC ACID IN HIGH DOSES OR OVER A LONG PERIOD OF TIME, IT CAN IRRITATE YOUR STOMACH LINING. TO PREVENT STOMACH IRRITATION, THESE TABLETS HAVE A SPECIAL COATING (CALLED ENTERIC) SO THAT THE ACETYLSALICYLIC ACID IS NOT RELEASED UNTIL IT HAS PASSED THROUGH THE STOMACH. Acetylsalicylic acid is released slowly from these tablets, so Aspirem is not suitable for the short-term relief of pain, such as headaches or toothache. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIREM DO NOT TAKE ASPIREM • if you are allergic to acetylsalicylic acid or any of the ingredients in this medicine (listed in section 6). • if you have had a cerebral ha Lestu allt skjalið
mt-spc-aspirem-ec-tabs-v04-r00-a0 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS _ _ 1. NAME OF THE MEDICINAL PRODUCT Aspirem 75 mg gastro-resistant tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 75 mg acetylsalicylic acid. Excipient(s) with known effect This product contains 37.1 mg lactose and 1.9 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet. White, round, gastro-resistant tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acetylsalicylic acid has an antithrombotic action, mediated through inhibition of platelet activation, which has been shown to be useful in secondary prophylaxis following myocardial infarction and in patients with unstable angina or ischaemic stroke. Aspirem is indicated when prolonged dosage of acetylsalicylic acid is required. The special coating resists dissolution in gastric juice, but will dissolve readily in the relatively less acid environment of the duodenum. Owing to the delay that the coating imposes on the release of the active ingredient, Aspirem is unsuitable for the short-term relief of pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION_ _ _ _ Aspirem is for oral administration to adults only. Posology Antithrombotic action: The usual dose is 75 mg, daily. When rapid absorption is required (e.g., following acute myocardial infarction), two tablets (150 mg) should be taken together and chewed. _ _ _ _ _The elderly_ : As for adults. mt-spc-aspirem-ec-tabs-v04-r00-a0 Page 2 of 12 In general, acetylsalicylic acid should be used with particular caution in elderly patients who are more prone to adverse events. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Treatment should be reviewed at regular intervals. _Children: _ do not give to children and adolescents aged under 16 years, except on medical advice, where the benefit outweighs the risk (see section 4.4). Method of adm Lestu allt skjalið