Evorel Conti patches

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Norethisterone acetate; Estradiol

Verfügbar ab:

Theramex HQ UK Ltd

ATC-Code:

G03FB05

INN (Internationale Bezeichnung):

Norethisterone acetate; Estradiol

Dosierung:

170microgram/24hour ; 50microgram/24hour

Darreichungsform:

Transdermal patch

Verabreichungsweg:

Transdermal

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 06040101; GTIN: 5012946314153 5012946314290

Gebrauchsinformation

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
EVOREL
®
CONTI
Estradiol hemihydrate, norethisterone acetate
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 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 5.
WHAT IS IN THIS LEAFLET
1. What Evorel Conti is and what it is used for
2. What you need to know before you use Evorel Conti
3. Safety of HRT
4. How to use Evorel Conti
5. Possible side effects
6. How to store Evorel Conti
7. Contents of the pack and other information
1. WHAT EVOREL CONTI IS AND WHAT IT IS USED FOR
The name of your medicine is Evorel Conti. It belongs to a group of
medicines
called hormone replacement therapy (HRT).
Evorel Conti contains two medicines:
•
An oestrogen (estradiol)
•
A progestogen (norethisterone)
They are both female hormones.
Evorel Conti comes in a ‘memory pack’. This can be used to help
you remember
when to change your patches. Each pack contains eight or twenty-four
patches.
The hormones are spread evenly in each patch. They pass slowly into
your
body through the skin.
WHAT EVOREL CONTI IS USED FOR
Evorel Conti is used:
•
For the symptoms of the menopause (see ‘What is the menopause?’).
It is
suitable for women who have not had a period (menstrual bleed) for at
least
18 months
•
To prevent osteoporosis (fragile bones) in women who have had the
menopause and are most likely to have bone problems. Evorel Conti is
only
used if other medicines for osteoporosis have been tried first and
they have
not worked
- 2 -
WHAT IS THE MENOPAUSE?
Women produce oestrogen hormones from their ovaries th

Fachinformation

OBJECT 1
EVOREL CONTI
Summary of Product Characteristics Updated 23-Jun-2016 | Janssen-Cilag
Ltd
1. Name of the medicinal product
EVOREL CONTI
_International non-proprietary name_
estradiol
norethisterone acetate
2. Qualitative and quantitative composition
EVORELCONTI
3.2 mg of estradiol hemihydrate
11.2 mg of norethisterone acetate
3. Pharmaceutical form
The EVOREL CONTI Transdermal Delivery System (TDS), or transdermal
patch, is a flat two-layer
laminate which is 0.1 mm in thickness. The first layer is a flexible,
translucent, and nearly colourless
backing film. The second layer is a monolayer adhesive film (matrix)
composed of acrylic adhesive and
guar gum and contains the hormones. This system is protected by a
polyester foil release liner, which is
affixed to the adhesive matrix and is removed prior to application of
the patch to the skin. The polyester
foil used is coated with silicone on both sides. The release liner has
a S-shaped opening to facilitate its
removal prior to use. Each TDS is enclosed in a protective,
hermetically-sealed sachet.
EVOREL CONTI has a surface area of 16 sq cm and contains 3.2 mg of
estradiol corresponding to a
nominal release of 50 micrograms of estradiol per 24 hours and 11.2 mg
of norethisterone acetate
corresponding to a nominal release of 170 micrograms of norethisterone
acetate per 24 hours. Each TDS
is marked in the centre of the lower margin on the outside of the
backing film: CEN1
4. Clinical particulars
4.1 Therapeutic indications
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
post-menopausal women
more than 6 months post-menopause (or 18 months since last period).
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
_Adults_
Evorel Conti is a continuous combined HRT preparati