Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cilostazol
Stephar (U.K.) Ltd
B01AC23
Cilostazol
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060400
PACKAGE LEAFLET: INFORMATION FOR THE USER PLETAL® 100MG 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. • Keep this leaflet. You may need to read it again. • If you have any further questions, please ask your doctor or your 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. The name of your medicine is Pletal 100mg Tablets but will be referred to as Pletal throughout the remainder of the leaflet. IN THIS LEAFLET: 1. What Pletal is and what it is used for 2. Before you take Pletal 3. How to take Pletal 4. Possible side effects 5. How to store Pletal 6. Contents of the pack and other information 1. WHAT PLETAL IS AND WHAT IT IS USED FOR Pletal 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 Pletal 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. Pletal 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 you continue the modifications you have made to your life-style whi Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 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 Pletal 100 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 100 mg of cilostazol. For a full list of excipients, see section 6.1 . 3 PHARMACEUTICAL FORM Tablet White, round, flat faced tablets debossed with “OG30” on one side. 4.1 THERAPEUTIC INDICATIONS Pletal 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). Pletal 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 continue with their life-style modifications (smoking cessation and exercise), and pharmacological interventions (such as lipid lowering and antiplatelet treatment) to reduce the risk Baca dokumen lengkapnya