Cilozek tablets

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

cilostazol

متاح من:

Adamed Pharma S.A.

ATC رمز:

B01AC23 վերարտադրված դեղի առաջին դեղաձև, դեղաչափ

INN (الاسم الدولي):

cilostazol

جرعة:

100mg (30/3x10/) in blister

الشكل الصيدلاني:

tablets

الوحدات في الحزمة:

100mg (30/3x10/) in blister

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2021-02-27

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Cilozek, 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, off-white, round, flat-faced ,8 mm diameter debossed “100”
on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cilozek 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).
Cilozek 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 (Cmax) 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).
Method of administration
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 of cardiovascular events.
Cilostazol is not a substitute for such
treatments.
Reduction of the dose to 50 mg twice daily is recommended in patients
receiving medicines that
strongly inhibit