PROGYNOVA estradiol valerate 1mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

estradiol valerate, Quantity: 1 mg

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Tablet, sugar coated

Composition:

Excipient Ingredients: iron oxide yellow; glycerol; povidone; macrogol 6000; magnesium stearate; calcium carbonate; sucrose; titanium dioxide; glycol montanate; maize starch; purified talc; lactose monohydrate

Administration route:

Oral

Units in package:

2 x 28 tablets

Class:

Medicine Registered

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: Cream sugar coated tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

1991-08-19

Patient Information leaflet

PROGYNOVA
®
CMI
1
CONSUMER MEDICINE INFORMATION
PROGYNOVA
®
_ _
_estradiol valerate_
WARNING
The Women’s Health Initiative (WHI) trial examined the health
benefits and risks of combined _estrogen _
_plus progestogen_ therapy (n=16,608) and _ estrogen-alone_ therapy
(n=10,739) in postmenopausal
women aged 50 to 79 years.
The _ estrogen plus progestogen_ arm of the WHI trial indicated an
increased risk of _ myocardial _
_infarction (MI), stroke, invasive breast cancer, pulmonary embolism
and deep vein thrombosis _ in
postmenopausal women receiving treatment with combined conjugated
equine estrogens (CEE, 0.625
mg/day) and medroxyprogesterone acetate (MPA, 2.5 mg/day) for 5.2
years compared to those
receiving placebo.
The _ estrogen-alone_ arm of the WHI trial indicated an increased risk
of_ stroke and deep vein _
_thrombosis _in hysterectomized women treated with CEE-alone (0.625
mg/day) for 6.8 years compared
to those receiving placebo.
Other doses of oral conjugated estrogens with 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.
Therefore, the following should be given serious consideration at the
time of prescribing:
•
Estrogens with or without progestogens should not be prescribed for
primary or secondary
prevention of cardiovascular diseases.
•
Estrogens with or without progestogens should be prescribed at the
lowest effective dose for
the approved indication.
•
Estrogens with or without progestogens should be prescribed for the
shortest period possible
for the approved indication.
•
For the prevention of osteoporosis, estrogen treatment should be
considered in light of other
available therapies.
PROGYNOVA
®
CMI
2
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 t

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