البلد: السويد
اللغة: السويدية
المصدر: Läkemedelsverket (Medical Products Agency)
dipyridamol
Actavis Group PTC ehf.
B01AC07
dipyridamole
200 mg
Depotkapsel, hård
dipyridamol 200 mg Aktiv substans
Receptbelagt
Förpacknings: Burk, 30 kapslar; Burk, 60 kapslar; Burk, 100 (2 x 50) kapslar
Avregistrerad
2017-01-19
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DIPYRIDAMOL ACTAVIS 200 MG PROLONGED-RELEASE CAPSULES, HARD dipyridamole 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. - 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 doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Dipyridamol Actavis is and what it is used for 2. What you need to know before you take Dipyridamol Actavis 3. How to take Dipyridamol Actavis 4. Possible side effects 5. How to store Dipyridamol Actavis 6. Contents of the pack and other information 1. WHAT DIPYRIDAMOL ACTAVIS IS AND WHAT IT IS USED FOR Dipyridamol Actavis contains the active substance dipyridamole. This belongs to a group of medicines called ‘anti-thrombotic agents’, which are used to stop blood clots forming. Dipyridamol Actavis is used: - To reduce the risk of having another stroke in people who have had a stroke caused by a blood clot in the brain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIPYRIDAMOL ACTAVIS DO NOT TAKE DIPYRIDAMOL ACTAVIS: - if you are allergic to dipyridamole or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Dipyridamol Actavis: - If you have angina or other heart diseases or have had a recent heart attack - If you have myasthenia gravis (muscle weakness) - If you have any bleeding problems IF YOU ARE HAVING HEART TESTS Dipyridamol Actavis contains dipyridamole. Dipyridamole is also sometimes given as an injection during tests to see if the heart is working properly (also called ‘myocardial imaging’). This means that the test and your medicine اقرأ الوثيقة كاملة
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dipyridamol Actavis 200 mg prolonged-release capsules, hard. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release capsule contains dipyridamole 200 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release capsule, hard. Hard gelatin capsule, 23.5 mm, with a reddish-brown (orange) opaque body and cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Secondary prevention of ischaemic stroke and transient ischaemic attacks either alone or in conjunction with acetylsalicylic acid. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one capsule twice daily, usually one in the morning and one in the evening, which can be taken with or without food. _Paediatric population_ Dipyridamol Actavis is not recommended for children since the safety and efficacy of dipyridamole in children has not yet been established. Method of administration For oral administration. The capsules should be swallowed whole without chewing. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Among other properties, dipyridamole acts as a potent vasodilator. It should therefore be used with caution in patients with severe coronary artery disease including unstable angina and/or recent 2 myocardial infarction, left ventricular outflow obstruction or haemodynamic instability (e.g. decompensated heart failure). Patients being treated with regular oral doses of Dipyridamol Actavis should not receive additional intravenous dipyridamole. Clinical experience suggests that patients being treated with oral dipyridamole who also require pharmacological stress testing with intravenous dipyridamole should discontinue drugs containing oral dipyridamole for twenty-four hours prior to stress testing. In patients with myasthenia gravis readjustments of therapy may be necessary after changes in dipyridamole dosage اقرأ الوثيقة كاملة