OESTROGEL

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

ESTRADIOL

Предлага се от:

Besins Healthcare S.A.

АТС код:

G03CA03

INN (Международно Name):

ESTRADIOL

дозиране:

0.06 %w/w

Лекарствена форма:

Gel

Вид предписание :

Product subject to prescription which may be renewed (B)

Терапевтична област:

estradiol

Статус Оторизация:

Not Marketed

Дата Оторизация:

1997-12-11

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
OESTROGEL 750 MICROGRAMS / METERED DOSE GEL PUMP-PACK
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. 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 check
(“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 before your menopause.
2.
WHAT YOU

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oestrogel 750 micrograms/metered dose Gel Pump-Pack.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of 1.25 g of gel (1 pump) contains 750 micrograms
Estradiol (as hemihydrate) 0.06% w/w.
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 considered at risk of developing fractures who are intolerant
of,
or contraindicated for, other medicinal products approved for the
prevention of osteoporosis (see section 4.4).
Oestrogel is indicated for women with or without a uterus. Advice on
the addition of a progestogen is given in section
4.2 for women with a uterus.
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 1.25g of
Oestrogel.
Two pumps (2.5g) of Oestrogel once
daily (1.5mg 17ß-oestradiol) 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 (5g) of Oestrogel daily (3.0mg 17ß-oestradiol).
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 also section 4.