Evorel 50 Patch

Land: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

ESTRADIOL

Fáanlegur frá:

Janssen-Cilag International NV Turnhoutsewes 30, B-2340 Beerse, Belgium

ATC númer:

G03CA03

INN (Alþjóðlegt nafn):

ESTRADIOL 50 µg

Lyfjaform:

TRANSDERMAL PATCH

Samsetning:

ESTRADIOL 50 µg

Gerð lyfseðils:

POM

Lækningarsvæði:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Leyfisstaða:

Withdrawn

Leyfisdagur:

2006-12-20

Upplýsingar fylgiseðill

Page 1 of 12
PACKAGE LEAFLET: INFORMATION FOR THE USER
EVOREL
®
50
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 tim

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
EVOREL 50
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.
For women with an intact uterus progestogen should normally be added
to Evorel for the
prevention of adverse endometrial effects, e.g. hyperplasia and
cancer. The regimen may be either
cyclic or continuous sequential.
Only progestogens approved for addition to oestrogen treatment may be
prescribed (e.g. oral
norethisterone, 1 mg/day or medroxyprogesterone acetate, 2.5 mg/day)
and should be added for at
least 12-14 days every month/28 day cycle.
Unless there is a previous diagnosis of