ESTROGEL estradiol (as hemihydrate) 0.06% w/w gel pump pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

estradiol hemihydrate, Quantity: 0.06 % w/w (Equivalent: estradiol, Qty 0.06 % w/w)

Tilgjengelig fra:

Besins Healthcare Australia Pty Ltd

Legemiddelform:

Gel

Sammensetning:

Excipient Ingredients: carbomer 980; trolamine; ethanol; purified water

Administreringsrute:

Transdermal

Enheter i pakken:

3 x 80 grams, 2 x 80 grams, 1 x 80 grams, 1 x 80 grams starter pack

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

- Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women.,- Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. (see also Section 4.4 Special warnings and precautions for use),The experience treating women older than 65 years is limited. The lowest effective dose should be used for the shortest duration (see Sections 4.2 Dose and method of administration and 4.4 Special warnings and precautions for use).

Produkt oppsummering:

Visual Identification: Clear colouless gel with an odour of alcohol; Container Type: Bottle, with integral pump - manual actuated; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

2019-05-08

Informasjon til brukeren

Version 07/1020
1
ESTROGEL

_estradiol (0.06% w/w)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Estrogel.
It does not contain all the available
information. It does not take the place
of talking to your pharmacist or doctor.
All medicines have risks and benefits
.
Your pharmacist or doctor has weighed
the risks of you taking Estrogel against
the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ESTROGEL IS USED
FOR
Estrogel is a Hormone Replacement
Therapy (HRT). It contains the female
hormone estrogen. Estrogel is used in
postmenopausal women who have not
had a natural period within the last 6
months.
ESTROGEL IS USED FOR:
RELIEF OF SYMPTOMS OCCURRING AFTER
MENOPAUSE
During menopause, the amount of the
estrogen produced by a woman’s body
drops. This can cause symptoms such
as hot face, neck and chest (“hot
flushes”). Estrogel alleviates these
symptoms after menopause. You will
only be prescribed Estrogel if your
symptoms seriously hinder your daily
life.
PREVENTION OF OSTEOPOROSIS
After menopause some women may
develop fragile bones (osteoporosis).
You should discuss all available
options with your doctor.
If you are at an increased risk of
fractures due to osteoporosis and other
medicines are not suitable for you, you
can use Estrogel to prevent
osteoporosis after menopause.
Estrogel works by replacing the
estrogen in your body. This is so that
you have a similar amount of estrogen
as before your menopause.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
YOUR DOCTOR MAY HAVE PRESCRIBED IT
FOR ANOTHER REASON.
BEFORE YOU USE
ESTROGEL
_WHEN YOU MUST NOT USE IT _
DO NOT USE ESTROGEL IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing estradiol
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may

Preparatomtale

Estrogel estradiol (as hemihydrate) 0.06% w/w gel pump pack
Product Information
Version 0421
1
AUSTRALIAN PRODUCT INFORMATION
ESTROGEL
® (ESTRADIOL HEMIHYDRATE) GEL
1
NAME OF THE MEDICINE
Estradiol hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Estrogel contains the active ingredient estradiol (as hemihydrate).
One gram of gel contains 0.6
mg (0.06% w/w) estradiol.
Each pump actuation delivers 1.25 g of gel which contains 0.75 mg of
estradiol.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Estrogel transdermal gel is a clear, colourless gel with an odour of
alcohol.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Hormone replacement therapy (HRT) for estrogen deficiency symptoms in
postmenopausal women.
•
Prevention of osteoporosis in postmenopausal women at high risk of
future
fractures who are intolerant of, or contraindicated for, other
medicinal products
approved for the prevention of osteoporosis. (see also Section 4.4
Special warnings
and precautions for use)
The experience treating women older than 65 years is limited. The
lowest effective dose should
be used for the shortest duration (see Sections 4.2 Dose and method of
administration and 4.4
Special warnings and precautions for use).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Estrogel as an estrogen only product is indicated only for women
without a uterus. Estrogel should
be administered daily on a continuous basis.
In women with an intact uterus it is recommended to add a progestogen
(e.g. progesterone) for at
least 12 days of each month, in accordance with the manufacturers’
recommendations.
_MENOPAUSAL SYMPTOMS: _
Each metered dose (1 pump actuation) from the dispenser is 1.25 g of
Estrogel. Although some
women will respond to 1.25 g daily, the most usual starting dose is
two pumps (2.5 g which
contains 1.5 mg estradiol) of Estrogel once daily. In the majority of
women this dose will provide
Estrogel estradiol (as hemihydrate) 0.06% w/w gel pump pack
Product Information
Version 0421
2