Country: Malta
Language: English
Source: Medicines Authority
DIPYRIDAMOLE
Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus
B01AC07
DIPYRIDAMOLE 100 mg
COATED TABLET
DIPYRIDAMOLE 100 mg
POM
ANTITHROMBOTIC AGENTS
Authorised
2006-12-29
page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PERAZODIN 25 MG COATED TABLETS PERAZODIN 75 MG COATED TABLETS PERAZODIN 100 MG COATED TABLETS 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 Perazodin is and what it is used for 2. What you need to know before you take Perazodin 3. How to take Perazodin 4. Possible side effects 5. How to store Perazodin 6. Contents of the pack and other information 1. WHAT PERAZODIN IS AND WHAT IT IS USED FOR The name of your medicine is Perazodin. It contains a substance called dipyridamole. This belongs to a group of medicines called ‘anti-thrombotic agents’, which are used to help stop blood clots forming. Perazodin helps stop blood clots which may occur if you have had your heart valves replaced. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERAZODIN DO NOT TAKE PERAZODIN • if you are allergic (hypersensitive) to dipyridamole or to any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Perazodin if: • you have angina or other heart problems (including heart valve or circulation problems) or have had a recent heart attack. • you have myasthenia gravis (a rare muscle problem). • you have any bleeding problems. page 2 of 5 • you are pregnant or planning to become pregnant or are breast-feeding. • you have been told by your doctor that you have an intolerance to some sugars. If you are not sure if any of the above apply to you, talk to your doct Read the complete document
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Perazodin 100 mg coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Perazodin 100 mg coated tablets: Each coated tablet contains 100 mg dipyridamole. Excipient(s) with known effect This product contains 53.6 mg lactose monohydrate and 95.099 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet. White, round, coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS An adjunct to oral anti-coagulation for prophylaxis of thrombo-embolism associated with prosthetic heart valves. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults: _ 300-600 mg daily in three or four doses. _Children: _ Perazodin is not recommended for children. _ _ Perazodin should usually be taken before meals. Page 2 of 9 Method of administration Oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to ‘Special warnings and precautions for use’) the use of the product is contraindicated. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Among other properties, dipyridamole acts as a vasodilator. It should be used with caution in patients with severe coronary artery disease, including unstable angina and/or recent myocardial infarction, left ventricular outflow obstruction or haemodynamic instability (e.g. decompensated heart failure). Patients being treated with regular oral doses of Perazodin 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, readjustment of therapy may be necessary after changes in dipyridamo Read the complete document