ESTRADERM MX 25 estradiol 25 microgram/24 hours transdermal drug delivery system sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

estradiol hemihydrate, Quantity: 0.77 mg (Equivalent: estradiol, Qty 0.75 mg)

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Drug delivery system, transdermal

Composition:

Excipient Ingredients: isopropyl palmitate; polyethylene terephthalate; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane

Administration route:

Transdermal

Units in package:

8 sachets, 2 sachets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Menopausal symptoms: Short-term treatment of signs and symptoms of oestrogen deficiency due to menopause, whether natural or surgically induced. In women with an intact uterus, oestrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals (Refer to section 5.1 Pharmacodynamic properties - Clinical Trials and section 4.2 Dose and method of administration). Estraderm MX 25 is not indicated for the prevention of post-menopausal bone mineral density loss. Combination HRT should not be used in hysterectomised women because it is not needed in these women and it may increase risk of breast cancer

Product summary:

Visual Identification: A translucent, colorless system, about 3.5 cm square, with rounded corners, on an oversized, transparent protective liner.,The product identification code is heat-stamped on the backing film as CG GRG.; Container Type: Sachet; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1999-02-15

Patient Information leaflet

ESTRADERM MX
1
ESTRADERM MX
_oestradiol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about the menopause
("change of life"), hormone
replacement therapy and Estraderm
MX.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHEN YOU MUST NOT
USE ESTRADERM MX
DO NOT USE ESTRADERM MX OR OTHER
OESTROGENS, WITH OR WITHOUT A
PROGESTOGEN TO PREVENT HEART
ATTACKS, STROKE OR DEMENTIA.
A study called the Women's Health
Initiative indicated increased risk of
heart attack, stroke, breast cancer,
and blood clots in the legs or lungs in
women receiving treatment with a
product containing conjugated
oestrogens 0.625 mg and the
progestogen medroxyprogesterone
acetate (MPA). The researchers
stopped the study after 5 years when
it was determined the risks were
greater than the benefits in this
group. The Women's Health
Initiative Memory Study indicated
increased risk of dementia in women
aged 65-79 years taking conjugated
oestrogens and MPA. There are no
comparable data currently available
for other doses of conjugated
oestrogens and MPA or other
combinations of oestrogens and
progestogens. Therefore, you should
assume the risks will be similar for
other medicines containing oestr

Summary of Product characteristics

Australian Product Information
Juno Pharmaceuticals Pty Ltd
Estraderm PI
Page | 1
AUSTRALIAN PRODUCT INFORMATION
_ESTRADERM MX _
_(ESTRADIOL) TRANSDERMAL PATCH _
_ _
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
SECTION
5.1
PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS and SECTION 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 estrogens
(0.625 mg) combined
with
medroxyprogesterone
acetate
(2.5
mg)
relative
to
placebo
(See
SECTION
5.1
PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS and SECTION 4.4 SPECIAL
WARNINGS AND
PRECAUTIONS FOR USE).
The Women’s Health Initiative Memory Study (WHIMS), a substudy 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 SECTION 5.1 PHARMACODYNAMIC
PROPERTIES -
CLINICAL TRIALS and SECTION 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 ris