Land: Israël
Taal: Engels
Bron: Ministry of Health
ACETYLSALICYLIC ACID
BAYER ISRAEL LTD
B01AC06
TABLETS ENTERIC COATED
ACETYLSALICYLIC ACID 100 MG
PER OS
Not required
BAYER BITTERFELD GMBH, GERMANY
ACETYLSALICYLIC ACID
ACETYLSALICYLIC ACID
The primary prevention of coronary heart disease in patients at increased risk and the secondary prevention of thrombotic cerebrovascular or cardiovascular disease.
2015-02-28
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SPC/Aspirin cardio 03/2016 PRESCRIBING INFORMATION (SUMMARY OF PRODUCT CHARACTERISTICS / SPC) 1. NAME OF DRUG PRODUCT ASPIRIN CARDIO 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 enteric-coated tablet contains: 100 mg acetylsalicylic acid. For a complete list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Enteric-coated tablets 4. CLINICAL PARTICULARS 4.1 INDICATIONS Aspirin® Cardio is indicated for the primary prevention of coronary heart disease in patients at increased risk and the secondary prevention of thrombotic cerebrovascular or cardiovascular disease. Note: Aspirin Cardio is not suitable for the treatment of pain due to its amount of active substance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: A daily dose of one Aspirin Cardio enteric-coated tablet (equivalent to 100 mg acetylsalicylic acid per day) is recommended. Method of administration: The gastro-resistant tablets should be taken with plenty of water possibly at least 30 minutes before a meal. In order to ensure that the active substance is released in the alkaline environment of the intestine, the gastro-resistant tablets should not be split, crushed or chewed. Aspirin cardio is intended for long-term use. The attending doctor must decide on the length of the treatment. 4.3 CONTRAINDICATIONS Aspirin Cardio must not be used: - in cases of hypersensitivity to the active ingredient acetylsalicylic acid, other salicylates or any of the other ingredients listed in section 6.1. - by patients with a history of asthma attacks, which were caused by salicylates or substances with a similar action, especially nonsteroidal anti-inflammatory drugs (NSAIDs). - by patients with acute gastrointestinal ulcers. - by patients with haemorrhagic diathesis. - by patients with liver or kidney failure. - by patients with severe heart failure for which they are not receiving adequate treatment. 2 - in combination with methotrexate at a weekly dosage of 15 mg or more (see section 4.5). - in the last trimester of pregnancy at dosages above 150 mg acetylsa Lees het volledige document