Progynova 1mg Tablet

Country: Malaysia

Language: English

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

Active ingredient:

ESTRADIOL VALERATE

Available from:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (International Name):

ESTRADIOL VALERATE

Units in package:

28Tablet Tablets

Manufactured by:

DELPHARM LILLE S.A.S.

Summary of Product characteristics

Reference : Progynova / Film-coated tablets / CCDS / Version 12 / 14 Jul 2015
Pro gynova ® 1 mg and 2 mg
Film-Coated Tablets
1. NAME OF THE MEDICINAL PRODUCT
Prog ynova Tablet 1mg and 2mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each beige coated tablet contains estradiol valerate 1.0 mg
Each blue coated tablet contains estradiol valerate 2.0 mg
3. PHARMACEUTICAL FORM
Coated tablets
4. CLINICAL PARTICULARS
4.1 Indication (s)
Hormone replacement therapy (HRT) for the treatment of signs and symptoms of estrogen deficiency due to natural
menopause or castration.
Prevention of postmenopausal osteoporosis.
4.2 Dosage and method of administration
4.2.1 Method of administration
Oral use
4.2.2 Dosage regimen
► How to start Progynova
Hysterectomized patients may start at any time.
If the patient has an intact uterus and is still menstruating, a combination regimen with Progynova and a progestogen (see
section ‘Combination regimen’ ) should begin within the first 5 days of menstruation.
Patients with amenorrhea or very infrequent periods or who are postmenopausal, may start a combination regimen (see
section ‘Combination regimen’ ) at any time, provided pregnancy has been excluded.
Change from other HRT (cyclic, sequential, or continuous combined)
Women changing from other HRT should complete the current cycle of therapy before initiating Progynova therapy.
► Dosage
One beige Progynova tablet 1.0 mg (or one blue Progynova tablet 2.0 mg) is taken daily.
► Administration
Each pack covers 28 days of treatment. Treatment is continuous HRT, which means that the next pack follows immediately
without a break.
Combination regimen:
In women with intact uterus, the concomitant use of an appropriate progestogen is advised for 10-14 days every 4 weeks
(continuous sequential or cyclic HRT) or with each tablet of estrogen (continuous c ombined HRT).
Adequate provision should be made by the physician to facilitate and assure a proper compliance of the patient with the
recommended combined regimen.
The tablets are to be