Oestrogel Pump-Pack 0.06% gel

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Estradiol

Commercializzato da:

Besins Healthcare (UK) Ltd

Codice ATC:

G03CA03

INN (Nome Internazionale):

Estradiol

Dosaggio:

600microgram/1gram

Forma farmaceutica:

Transdermal gel

Via di somministrazione:

Transdermal

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 06040101; GTIN: 3700039500539

Foglio illustrativo

OESTROGEL® PUMP-PACK
0.06% GEL
17Β-OESTRADIOL
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
Oestrogel is a Hormone Replacement Therapy (HRT). It contains the
female hormone oestrogen.
Oestrogel is used in postmenopausal women with at least 6 months since
their last natural period.
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 before your menopause.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OESTROGEL
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT carri

Scheda tecnica

OBJECT 1
OESTROGEL PUMP-PACK
Summary of Product Characteristics Updated 08-Jan-2018 | Besins
Healthcare (UK) Ltd
1. Name of the medicinal product
Oestrogel Pump-Pack
2. Qualitative and quantitative composition
One gram of gel contains 0.6 mg of the active ingredient,
17β-oestradiol (0.06% w/w).
Each pump actuation delivers 1.25 g of gel which contains 0.75 mg of
17β-oestradiol.
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 SYMPTOMS: _
Each metered dose (1 pump actuation) from the dispenser is 1.25 g of
Oestrogel. The usual starting dose
is two pumps (2.5 g which contains 1.5 mg oestradiol) of Oestrogel
once daily. In the majority of women
this dose will provide effective relief of menopausal 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 which
contains 3.0 mg oestradiol) of Oestrogel daily.
_PREVENTION OF OSTEOPOROSIS: _
The minimum effective dose is 2.5 g of Oestrogel once daily for most
patients.
Use with progestogen:
In women with an intact uterus the recommended dose of a progestogen
should be administere