Land: Egypte
Taal: Engels
Bron: EDA (Egyptian Drug Authority)
OTSUKA PHARMACEUTICAL-JAPAN
50 mg
tablet
10 tablets
OTSUKA EGYPT
2003-09-02
1 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 PLETAAL TABLETS 50 MG AND 100 MG 1. NAME OF THE MEDICINAL PRODUCT Pletaal 50 mg tablets Pletaal 100 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 50 mg of cilostazol. 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 “OG31” on one side. White, round, flat faced tablets debossed with “OG30” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pletaal 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). Pletaal 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 Lees het volledige document