Alkazol tablets

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

cilostazol

Tersedia dari:

Alkaloid AD Skopje

Kode ATC:

B01AC23

INN (Nama Internasional):

cilostazol

Dosis:

100mg

Bentuk farmasi:

tablets

Unit dalam paket:

(30/1x30/) in blister

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2018-06-13

Karakteristik produk

Alkazol
®
100 mg tablets
Summary of Product Characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Alkazol
®
100 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of cilostazol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
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
Alkazol 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).
Alkazol 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 of cardiovascular events.
Cilostazol is not a substitute for
such treatments.
Alkazol
®
100 mg tablets
S