Country: Malta
Tungumál: enska
Heimild: Medicines Authority
CILOSTAZOL
Labormed Pharma SA 44B Theodor Pallady Blvd., 3rd District, Bucharest, Romania
B01AC23
CILOSTAZOL 100 mg
TABLET
CILOSTAZOL 100 mg
POM
ANTITHROMBOTIC AGENTS
Withdrawn
2013-09-24
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CILOSTAZOL LABORMED 100 MG TABLETS Cilostazol This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 THIS LEAFLET 1. What Cilostazol Labormed is and what it is used for 2. What do you need to know before you take Cilostazol Labormed 3. How to take Cilostazol Labormed 4. Possible side effects 5. How to store Cilostazol Labormed 6. Contents of the pack and other information 1. WHAT CILOSTAZOL LABORMED IS AND WHAT IT IS USED FOR Cilostazol Labormed belongs to a group of medicines called phosphodiesterase type 3 inhibitors. It has several actions which include widening of some blood vessels and reducing the clotting activity (clumping) of some blood cells called platelets inside your vessels. You have been prescribed Cilostazol Labormed for "intermittent claudication". Intermittent claudication is the cramp-like pain in your legs when you walk and is caused by insufficient blood supply in your legs. Cilostazol Labormed can increase the distance you can walk without pain since it improves the blood circulation in your legs. Cilostazol is only recommended for patients whose symptoms have not improved sufficiently after making life-style modifications (such as stopping smoking and increasing exercise) and after other appropriate interventions. It is important that y Lestu allt skjalið
1 Version 9.1, 06/2015 SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Cilostazol Labormed 100 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 100 mg of cilostazol. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet Cilostazol Labormed 100 mg tablets are white round tablets scored in one side, with an approximate diameter of 8 mm. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cilostazol Labormed is indicated for the improvement of the maximal and pain-free walking distances in patients with intermittent claudication, who do not have rest pain and who do not have evidence of peripheral tissue necrosis (peripheral arterial disease Fontaine stage II). Cilostazol Labormed is for second-line use, in patients in whom lifestyle modifications (including stopping smoking and [supervised] exercise programs) and other appropriate interventions have failed to sufficiently improve their intermittent claudication symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dosage of cilostazol is 100 mg twice a day. Cilostazol should be taken 30 minutes before breakfast and the evening meal. Taking cilostazol with food has been shown to increase the maximum plasma concentrations (C max ) of cilostazol, which may be associated with an increased frequency of adverse reactions. Cilostazol should be initiated by physicians experienced in the management of intermittent claudication (see also section 4.4). The physician should reassess the patient after 3 months of treatment with a view to discontinuing cilostazol where an inadequate effect is observed or symptoms have not been improved. Patients receiving treatment with cilostazol should co Lestu allt skjalið