PLETAAL 50mg tab.

מדינה: מצרים

שפה: אנגלית

מקור: EDA (Egyptian Drug Authority)

זמין מ:

OTSUKA PHARMACEUTICAL-JAPAN

כמות:

50 mg

טופס פרצבטיות:

tablet

יחידות באריזה:

10 tablets

תוצרת:

OTSUKA EGYPT

תאריך אישור:

2003-09-02

מאפייני מוצר

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