Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aspirin
Teva UK Ltd
N02BA01
Aspirin
300mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5017007050711
ASPIRIN 300MG GASTRO-RESISTANT TABLETS (acetylsalicylic acid) PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE * Keep this leaflet. You may need to read it again. * If you have any further questions, ask your doctor or pharmacist. * This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. * If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. Your medicine is called Aspirin 300mg Gastro-resistant Tablets but will be referred to as Aspirin 300mg throughout the rest of this leaflet. IN THIS LEAFLET: What Aspirin 300mg is and what it is taken for Check before you take Aspirin 300mg How to take Aspirin 300mg Possible side effects How to store Aspirin 300mg Further information WHAT ASPIRIN 300MG IS AND WHAT IT IS TAKEN FOR Aspirin 300mg is used: * as an anti-inflammatory analgesic which can relieve pain and swelling * to bring down high body temperatures * to prevent recurrence of heart attacks or strokes by thinning the blood. If someone who has previously had a heart attack or stroke takes Aspirin 300mg 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 ASPIRIN 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 ASPIRIN IS NOT RELEASED UNTIL IT HAS PASSED THROUGH THE STOMACH. Aspirin is released slowly from these tablets, so Aspirin 300mg is not suitable for the short-term relief of pain, such as headaches or toothache. CHECK BEFORE YOU TAKE ASPIRIN 300MG DO NOT TAKE ASPIRIN 300MG: * if you are allergic to aspirin or if you are allergic to any of the ingredients in Aspirin 300mg (see Section 6 Further information) * if you have ever had the problem of your blood not clotting properly * Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aspirin 300mg Gastro-resistant Tablets Postmi 300mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300mg Aspirin For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet Round, cylindrical biconvex tablets with a glossy pink coating, printed POSTMI 300EC or Aspirin 300EC in black on one side. 4.1 THERAPEUTIC INDICATIONS Aspirin 300mg Tablets contain an anti-pyretic, anti inflammatory and analgesic, and are gastro-resistant to reduce the gastric side-effects of aspirin in rheumatoid arthritis and in conditions requiring continued management with aspirin. Aspirin may be used to reduce the risk of myocardial infarction in patients with unstable angina or in patients with a previous history of myocardial infarction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Analgesic, anti-inflammatory, anti-pyretic; Adults (including the elderly) and children over 16 years: 3 tablets (900mg) 3-4 times daily as required, at least 4 hours apart. Anti-thrombotic effect – to reduce the risk of myocardial infarction: One tablet daily Paediatric population Do not give to children under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease). Method of administration For oral administration. Aspirin must not be chewed or crushed. The tablets are best taken before meals. 4.3 CONTRAINDICATIONS Aspirin should not be administered to patients: • with hypersensitivity to the active substance, other NSAIDs, or to any of the excipients listed in section 6.1; • with active peptic ulceration or a history of peptic ulceration and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhages; • with haemophilia and other bleeding disorders; • for the treatment of gout; • who are breastfeeding (see section 4.6). • with severe hepatic impairment; • with severe renal impairment; • taking Methotrexate used at doses >15mg/week (see Leggi il documento completo