CLIMEN 28 SUGAR COATED TABLET

País: Malásia

Língua: inglês

Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes ativos:

ESTRADIOL VALERATE; ESTRADIOL VALERATE; CYPROTERONE ACETATE

Disponível em:

BAYER CO. (MALAYSIA) SDN. BHD.

DCI (Denominação Comum Internacional):

ESTRADIOL VALERATE; ESTRADIOL VALERATE; CYPROTERONE ACETATE

Unidades em pacote:

28Tablet Tablets

Fabricado por:

DELPHARM LILLE S.A.S.

Folheto informativo - Bula

Not Applicable

Características técnicas

Reference : Climen 28 / tablets / CCDS / Version 14 / 14 Jul 2015 , Indication
CLIMEN 28 SUGAR COATED TABLET
1. NAME OF THE MEDICINAL PRODUCT
Climen 28
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white sugar -coated tablet contains estradiol valerate 2.0 mg
Each pink sugar -coated tablet contains estradiol valerate 2.0 mg and cyproterone acetate 1.0 mg
For a full list of excipient(s) see section “List of excipients”
3. PHARMACEUTICAL FORM
Sugar -coated tablet
4. CLINICAL PARTICULARS
4.1 Indication(s)
Hormonal replacement therapy (HRT) in climacteric complaints, signs of involution of the skin and
urogenital tract, deficiency symptoms after ovarietomy for non -carcinomatous disease.
Prevention of postmenopausal osteoporosis.
HRT should only be continued as long as the benefit in alleviation of severe symptoms o utweighs the
risks of HRT.
4.2 Dosage and method of administration
4.2.1 Method of administration
Oral use
4.2.2 Dosage regimen
How to start Climen 28
If the patient is still menstruating, treatment should begin in the course of the 5 days of menstruat ion.
Patients with amenorrhea or very infrequent periods or who are postmenopausal may start at any time,
provided pregnancy has been excluded (see section ’Pregnancy and lactation ’).
Dosage
One white tablet is taken daily for the first 16 days, followed by one pink tablet daily for 12 days.
Administration
Each pack covers 28 days of treatment. Treatment is continuous, which means that the next pack
follows immediately without a break.
The tablets are to be swallowed whole with some liquid.
The tablets should preferably be taken at the same time every day.
Missed tablets
In case a tablet is forgotten, it should be taken as soon as possible. If more than 24 hours have elapsed,
no extra tablet needs to be taken. If several tablets are forgotten, bleeding may occur.
Bleeding usually occurs within the last few days of one pack and/or the first week of the next.