ESTRADOT 100 estradiol 100 microgram transdermal drug delivery system sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

estradiol, Quantity: 1.56 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Drug delivery system, transdermal

Composition:

Excipient Ingredients: dipropylene glycol; povidone; oleyl alcohol; ethyl acetate; simethicone; dimeticone; xylene; cyclomethicone; toluene; acrylates/VA copolymer; ethylene/vinyl acetate copolymer; 1,1-dichloroethylene, chloroethylene polymer; polyethylene; sodium carbonate; polyethylene terephthalate; polyvinylidene flouride

Administration route:

Transdermal

Units in package:

8 patches, 2 patches

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Short term treatment of symptoms of oestrogen deficiency due to the 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 (see CLINICAL TRAILS and DOSAGE AND ADMINISTRATION). Combination HRT should not be used in hysterectomised women because it is not needed in these women and it may increase the risk of breast cancer.

Product summary:

Visual Identification: Rectangular patch with round corners, comprising an adhesive layer with a translucent polymeric backing on one side and a release liner on the other side.; Container Type: Sachet; Container Material: Al laminated with PE/paper; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2004-02-05

Patient Information leaflet

ESTRADOT
®
_estradiol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about the menopause
("change of life"), hormone
replacement therapy and Estradot.
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 Estradot
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT
USING 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 ESTRADOT
DO NOT USE ESTRADOT OR OTHER
ESTROGENS, 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
estrogens 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
estrogens and MPA. There are no
comparable data currently available
for other doses of conjugated
estrogens and MPA or other
combinations of estrogens and
progestogens. Therefore, you should
assume the risks will be similar for
other medicines containing estrogen
and progestogen combinations.

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
ESTRADOT®
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 risks for the
individual woman.
1
NAME OF THE MEDICINE
Estradiol.
2
QUALITATIVE AND QUANTITATIVE COM