Oestrogel Pump-Pack 750 micrograms/actuation Gel

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Estradiol hemihydrate

Tersedia dari:

Laboratoires Besins International

Kode ATC:

G03CA03

INN (Nama Internasional):

Estradiol hemihydrate

Dosis:

750 microgram(s)

Bentuk farmasi:

Gel

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

estradiol

Status otorisasi:

Marketed

Tanggal Otorisasi:

2006-07-14

Selebaran informasi

1
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PACKAGE LEAFLET: INFORMATION FOR THE USER
OESTROGEL® PUMP-PACK 750 MICROGRAMS/ACTUATION GEL
ESTRADIOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Oestrogel is and what it is used for
2.
What you need to know before you use Oestrogel
3.
How to use Oestrogel
4.
Possible side effects
5.
How to store Oestrogel
6.
Contents of the pack and other information
1.
WHAT OESTROGEL IS AND WHAT IT IS USED FOR
The full name of your medicine is Oestrogel Pump-Pack 750
micrograms/actuation gel. It is called
Oestrogel in this leaflet.
Oestrogel is a Hormone Replacement Therapy (HRT). It contains the
female hormone oestrogen.
Oestrogel is used in postmenopausal women.
OESTROGEL IS USED FOR:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can
cause symptoms such as hot face, neck and chest (“hot flushes”).
Oestrogel alleviates these symptoms
after menopause. You will only be prescribed Oestrogel if your
symptoms seriously hinder your daily
life.
PREVENTION OF OSTEOPOROSIS
After the 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 Oestrogel to
prevent osteoporosis after
menopause.
HOW OESTROGEL WORKS
Oestrogel works by replacing the oestrogen in your body. This is so
that you have a similar amount of
oestrogen as b

Karakteristik produk

Health Products Regulatory Authority
16 January 2024
CRN00DZH9
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oestrogel Pump-Pack 750 micrograms/actuation Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of gel contains 0.6 mg of the active ingredient, Estradiol
(0.06% w/w).
Each pump actuation delivers 1.25 g of gel which contains 0.75 mg of
Estradiol.
Excipients with known effect: Ethanol.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Transdermal gel.
A clear, colourless gel with an odour of alcohol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
• Hormone replacement therapy (HRT) for oestrogen 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)
The experience treating women older than 65 years is limited.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Oestrogel is an oestrogen-only product indicated only for women
without a uterus. Oestrogel should be administered daily on
a continuous basis.
In women with an intact uterus it is recommended to add a progestogen
(e.g. a progesterone) for at least 12 days of each
month, in accordance with the manufacturers' recommendations.
_MENOPAUSAL AND POSTMENOPAUSAL SYMPTOMS:_
Each metered dose (1 pump actuation) from the dispenser is 1.25 g of
Oestrogel. Two pumps (2.5 g) of Oestrogel once daily
(1.5 mg Estradiol) is the usual starting dose, which in the majority
of women will provide effective relief of symptoms. If after
one month's treatment effective relief is not obtained, the dosage may
be increased accordingly to a maximum of four pumps
(5 g) of Oestrogel daily (3.0 mg Estradiol). The lowest effective dose
should be used for maintenance therapy.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose for the shortest duration
(see a