EVOREL 50MCG/24H TRANSDERMAL PATCH

Land: Cyprus

Taal: Grieks

Bron: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Werkstoffen:

ESTRADIOL

Beschikbaar vanaf:

JANSSEN-CILAG INTERNATIONAL NV (0000003494) TURNHOUTSEWEG, 30, BEERSE, B-2340

ATC-code:

G03CA03

INN (Algemene Internationale Benaming):

ESTRADIOL

Dosering:

50MCG/24H

farmaceutische vorm:

TRANSDERMAL PATCH

Samenstelling:

ESTRADIOL (0000050282) 3.2MG

Toedieningsweg:

TRANSDERMAL USE

Prescription-type:

Εθνική Διαδικασία

Therapeutisch gebied:

ESTRADIOL

Product samenvatting:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 8 PATCHES (980053701) 8 PIECE(S) - Εγκεκριμένο - Με Ιατρική Συνταγή

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
EVOREL
®
Estradiol
Evorel is a registered trademark
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 only for you. 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 5.
WHAT IS IN THIS LEAFLET
1.
What Evorel 50 is and what it is used for
2.
What you need to know before you use Evorel 50
3.
Safety of HRT
4.
How to use Evorel 50
5.
Possible side effects
6.
How to store Evorel 50
7.
Contents of the pack and other information
1. WHAT EVOREL 50 IS AND WHAT IT IS USED FOR
The name of your medicine is Evorel 50. It belongs to a group of
medicines called hormone
replacement therapy (HRT).
Evorel 50 contains an oestrogen (estradiol) which is a female hormone.
Evorel 50 comes in a ‘memory pack’. This can be used to help you
remember when to change
your patches. Each pack contains eight patches.
The hormone is spread evenly in each patch. It passes slowly into your
body through the
skin.
EVOREL 50 IS USED FOR
•
The symptoms of the menopause (see ‘What is the menopause?’)
EVOREL 50 CAN ALSO BE USED TO
•
Prevent osteoporosis (fragile bones) in women who have had the
menopause and are
most likely to have bone problems. Evorel 50 is only used if other
medicines for
osteoporosis have been tried first and they have not worked.
WHAT IS THE MENOPAUSE?
Women produce oestrogen hormones from their ovaries throughout their
adult life. These
hormones are important in sexual development and control of the
menstrual cycle.
The menopause happens when the level of hormones produced by the
ovaries goes down. This
is a gradual process. During this time the levels of

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
EVOREL
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Evorel 50 patch contains estradiol 3.20 mg.
3
PHARMACEUTICAL FORM
Evorel is a square shaped, transparent, self-adhesive transdermal
therapeutic system (patch) of
surface area 16sq. cm and 0.2 mm thickness, for application to the
skin surface. It consists of a
monolayered adhesive matrix throughout which 17β estradiol is
uniformly distributed. The
adhesive matrix is protected on the outside surface (from clothes
etc.) by a polyethylene
teraphthalate backing foil, while the adhesive surface of the patch is
covered by a polyester sheet
(the release liner) which is removed before placing the patch on the
body surface. This release liner
has an S-shaped incision which facilitates easy removal from the
patch.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
peri- and post-
menopausal 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 Section 4.4)
The experience treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS_
Evorel is an oestrogen-only HRT patch applied to the skin twice
weekly.
For initiation and continuation of treatment of menopausal symptoms,
the lowest effective
dose for the shortest duration (see also Section 4.4) should be used.
_TREATMENT OF OESTROGEN DEFICIENCY SYMPTOMS_
Therapy should be started with one Evorel 50 patch (delivering 50
micrograms of estradiol/24
hours) and the dose adjusted after the first month if necessary
depending on efficacy and signs of
over-oestrogenisation (eg breast tenderness). For maintenance therapy
the lowest effective dose
should be used; a maximum dose of 100 micrograms of estradiol/24 hours
should not be
exceeded.
_PREVENTION OF POST-MENOPAUSAL OSTEOPOROSIS_
Therapy should be s