PROGYNOVA estradiol valerate 2 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

estradiol valerate, Quantity: 2 mg

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Tablet, sugar coated

Composition:

Excipient Ingredients: magnesium stearate; macrogol 6000; sucrose; glycol montanate; calcium carbonate; povidone; maize starch; lactose monohydrate; purified talc

Administration route:

Oral

Units in package:

2 x 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 19 July 2004: Short term treatment of climacteric complaints after the cessation of monthly bleeding, or deficiency symptoms after oophorectomy or radiological castration for non-carcinomatous diseases, such as hot flushes, outbreaks of sweat, sleep disturbances, depressive moods, irritability, headaches, dizziness. Progynova has also a favourable influence on bladder irritation (a not infrequent occurrence in the climacteric), signs of cutaneous and mucosal involution (particularly in the genital region) which normally occur with advancing age.

Product summary:

Visual Identification: White sugar coated tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-02-06

Patient Information leaflet

PROGYNOVA® CMI Vx0.1
1
PROGYNOVA®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING PROGYNOVA®?
PROGYNOVA® contains the active ingredient estradiol valerate.
PROGYNOVA® provides hormone replacement therapy (HRT)
for the treatment of menopausal complaints after the cessation of
monthly bleeding, after surgical removal of the ovaries
(oophorectomy) or due to radiotherapy.
For more information, see Section 1. Why am I using PROGYNOVA®?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PROGYNOVA®?
Do not use if you have ever had an allergic reaction to estradiol
valerate or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
PROGYNOVA®?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with PROGYNOVA® and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE PROGYNOVA®?
Take one tablet at the same time each day. Swallow the tablets whole
with a glass of water.
More instructions can be found in Section 4. How do I use PROGYNOVA®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PROGYNOVA®?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
PROGYNOVA®.
•
If you become pregnant while taking this medicine, tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not take PROGYNOVA® to treat any other complaints unless your
doctor tells you to.
•
Do not give your medicine to anyone else, even if they have the same
condition as you.
DRIVING OR USING
MACHINES
•
Be

Summary of Product characteristics

PROGYNOVA PI V1.0, CCDS 14
1
AUSTRALIAN PRODUCT INFORMATION
PROGYNOVA
® (ESTRADIOL VALERATE) TABLETS
WARNING
Estrogens with or without progestogens should not be used for the
prevention of cardiovascular
disease or dementia.
The Women’s Health Initiative (WHI) study reported increased risks
of stroke and deep vein
thrombosis in postmenopausal women (50 to 79 years of age) during 6.8
years of treatment with
conjugated estrogens (0.625 mg) relative to placebo (see
Clinical trials and 4.4 Special warnings and
precautions for use).
The WHI study reported increased risks of myocardial infarction,
stroke, invasive breast cancer,
pulmonary emboli, and deep vein thrombosis in postmenopausal women (50
to 79 years of age)
during
5
years
of
treatment
with
conjugated
estrogen
s
(0.625
mg)
combined
with
medroxyprogesterone acetate (2.5 mg) relative to placebo (see Clinical
trials and 4.4 Special
warnings and precautions for use).
The Women’s Health Initiative Memory Study (WHIMS), a sub-study of
WHI, reported increased risk
of developing probable dementia in postmenopausal women 65 years of
age or older during 4 to
5.2 years of treatment with conjugated estrogens, with or without
medroxyprogesterone acetate,
relative to placebo. It is unknown whether this finding applies to
younger postmenopausal women
(see Clinical trials and 4.4 Special warnings and precautions for
use).
Other doses of conjugated estrogens and medroxyprogesterone acetate,
and other combinations
and dosage forms of estrogens and progestogens were not studied in the
WHI clinical trials and, in
the absence of comparable data, these risks should be assumed to be
similar. Because of these
risks, estrogens with or without progestogens should be prescribed at
the lowest effective doses
and for the shortest duration consistent with treatment goals and
risks for the individual woman.
1
NAME OF THE MEDICINE
Estradiol valerate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROGYNOVA 1 mg: each tablet contains 1 mg estradiol valerate.
PROGYNOVA 2 mg: each tablet conta