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:

Bayer Weimar GmbH und Co. KG

Patient Information leaflet

PROGYNOVA 28
Corporate Patient Information
Page:
1
of
9
valid as per:17.03.2006
THE NAME OF YOUR MEDICATION IS:
PROGYNOVA 28
Dear Patient,
Please read this leaflet carefully before you start using Progynova
28. This leaflet will provide
information about the benefits and risks of using Progynova 28. It
will also advise you about
how to take Progynova 28 properly and when to tell your doctor about
health-related conditions.
If you have any questions or need more advice, ask your doctor,
professional health care
provider or pharmacist. This product has been prescribed for you
personally and you should not
pass it on to others.
WHAT DOES PROGYNOVA 28 CONTAIN? (COMPOSITION)
Each blister pack of Progynova 28 contains 28 tablets, each containing
1.0 mg estradiol
valerate or 2.0 mg estradiol valerate as active substance.
Progynova 28 also contains the following other ingredients: lactose
monohydrate; maize starch;
polyvidone 25 000; talc; magnesium stearate; sucrose; polyvidone 700
000; macrogol 6 000;
calcium carbonate; glycerol 85 %; titanium dioxide; ferric oxide
pigment, yellow; indigo carmine
lake; montanglycol wax.
WHAT IS PROGYNOVA 28? (PHARMACEUTICAL FORM AND PHARMACO-THERAPEUTIC
GROUP)
Progynova 28 is a sugar-coated tablet for hormone replacement therapy
(HRT).
WHAT PACK SIZES OF PROGYNOVA 28 ARE AVAILABLE?

HOW DOES PROGYNOVA 28 WORK? (PROPERTIES OF PREPARATION)
Progynova 28 contains estradiol valerate, a prodrug of the natural
human estradiol. During the
climacteric ('the change of life') the estradiol production of the
ovaries declines. Although the
change of life is natural, it often causes distressing symptoms, which
are connected with the
gradual loss of the hormones produced by the ovaries. In addition the
loss of these hormones
may, in some women, lead to thinning of the bones in later life
(postmenopausal osteoporosis).
Progynova 28 replaces the hormone estradiol that the body no longer
makes. The estradiol
prevents or relieves troublesome symptoms (climacteric complaint

Summary of Product characteristics

Reference :
Progynova / Film-coated tablets / CCDS / Version 1213+ 14 / 14 Jul
201513 Apr 2021
RESTRICTED
PROGYNOVA
®
1 mg and 2 mg
Film-Coated Tablets
1.
NAME OF THE MEDICINAL PRODUCT
Progynova 1 mg coated tablets
Progynova 2 mg coated tabletsTablet 1mg and 2mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each beige coated tablet contains estradiol valerate 1.0 mg
Each white 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 white 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 combined HRT).
Adequate provision should be made by the physician to facilitate and
assure a proper compliance of