Progynova

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Estradiol valerate 1mg

Available from:

Bayer New Zealand Limited

INN (International Name):

Estradiol valerate 1 mg

Dosage:

1 mg

Pharmaceutical form:

Coated tablet

Composition:

Active: Estradiol valerate 1mg Excipient: Calcium carbonate Glycerol as glycerol 85% Glycol montanate Iron oxide yellow Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone as polyvidone 700,000   Purified talc   Sucrose Titanium dioxide as titanium dioxide E 171

Units in package:

Calendar pack, 'credit-card' format, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer AG

Therapeutic indications:

Hormone replacement therapy (HRT) for the treatment of signs and symptoms of oestrogen deficiency due to the menopause (whether natural or surgically induced).

Product summary:

Package - Contents - Shelf Life: Calendar pack, 'credit-card' format - 28 tablets - 60 months from date of manufacture stored at or below 25°C - Calendar pack, 2x28, 'credit-card' format - 56 tablets - 60 months from date of manufacture stored at or below 25°C - Calendar pack, 3x28, 'credit-card' format - 84 tablets - 60 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Patient Information leaflet

PROGYNOVA
®
CMI Vx1.0
1
PROGYNOVA
®
(PRO·GUY·NO·VA)
_estradiol valerate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some of the
common questions about Progynova
tablets. It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Progynova
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING PROGYNOVA, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it
again.
WHAT PROGYNOVA IS
USED FOR
Progynova provides hormone
replacement therapy (HRT) for the
treatment of menopausal complaints
after the cessation of monthly
bleeding, or after surgical removal
of the ovaries (oophorectomy).
Progynova is only intended for
short term use.
Progynova contains estradiol
valerate, a precursor of the hormone
estradiol. During menopause, the
estradiol production of the ovaries
declines. Although menopause is
natural, it often causes distressing
symptoms, which are connected
with the gradual loss of the
hormones produced by the ovaries.
Progynova replaces the hormone
estradiol that the body no longer
makes and prevents or relieves
symptoms such as hot flushes,
sweats, sleep disturbances,
depressive moods, irritability,
dizziness, headaches as well as
vaginal dryness and burning.
If you have not had your uterus
removed (hysterectomy) your
doctor will prescribe another
hormone progestogen to take with
Progynova.
In addition, the loss of the
hormones produced by the ovaries
leads to thinning of the bones. In
some women this effect may be
extensive (postmenopausal
osteoporosis) resulting in fractures
of the bones in later life. Your
doctor may also prescribe
Progynova to prevent osteoporosis.
PROGYNOVA IS NOT A CONTRACEPTIVE.
It will not prevent you from falling
pregnant.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may h

Summary of Product characteristics

PROGYNOVA DATA SHEET XV2.0, CCDS 14
Page 1 of 13
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
PROGYNOVA 1 mg tablets
PROGYNOVA 2 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 1mg of estradiol valerate- Progynova 1mg.
One tablet contains 2 mg of estradiol valerate- Progynova 2 mg.
3
PHARMACEUTICAL FORM
PROGYNOVA 1 mg: The memo-pack holds 28 beige, biconvex, round tablets,
each containing 1.0 mg
estradiol valerate.
PROGYNOVA 2 mg: The memo-pack holds 28 light white, biconvex, round
tablets, each containing 2.0
mg estradiol valerate.
All tablets have a lustrous sugar coating and are approximately 7mm in
diameter.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Hormone replacement therapy (HRT) for the treatment of signs and
symptoms of estrogen deficiency
due to the menopause (whether natural or surgically induced).
Prevention of postmenopausal osteoporosis.
4.2
Dose and method of administration
Hormonal contraception should be stopped when HRT is started and the
patient should be advised to
take non-hormonal contraceptive precautions, if required.
Hysterectomised patients may start at any time.
If the patient is still menstruating and has an intact uterus, a
combination regimen of PROGYNOVA
and a progestogen should begin within the first 5 days of menstruation
(see below for Combination
Regimen).
Patients
whose
periods
are
very
infrequent
or
with
amenorrhoea
or
who
are
postmenopausal may start at any time, provided pregnancy has been
excluded.
Women changing from other HRT should complete the current cycle of
therapy before initiating
PROGYNOVA therapy.
_Continuous Regimen _
It does not matter at what time of day the patient takes her
tablet(s), but once she has selected a
particular time, she should keep to it every day. If she forgets to
take a tablet at the usual time, she
may take it within the following 12 to 24 hours. If the treatment is
discontinued for longer, irregular
bleeding may occur.
One tablet is taken daily (either one beige 1 mg tablet or one white 2
mg tablet).
PROGYNOVA DA