EVOREL CONTI

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

NORETHISTERONE ACETATE ; ESTRADIOL HEMIHYDRATE

Available from:

Janssen-Cilag Ltd

ATC code:

G03CA53

INN (International Name):

NORETHISTERONE ACETATE ; ESTRADIOL HEMIHYDRATE

Dosage:

50/170 Microgram

Pharmaceutical form:

Transdermal Patch

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

estradiol, combinations

Authorization status:

Marketed

Authorization date:

1998-04-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
EVOREL
®
CONTI 50/170 MICROGRAMS PER 24
HOURS TRANSDERMAL PATCH
Estradiol (as 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 4.
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 How to use Evorel Conti
4 Possible side effects
5 How to store Evorel Conti
6 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 50/170 micrograms per 24
hours
Transdermal patch. It is called Evorel Conti in this leaflet. 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 pack that helps you to remember when to change
your
patches (see section 3 ‘How to use Evorel Conti’). Each pack
contains eight
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?’
below).
It is suitable for women who have been post-menopausal for 6 months.
This
is usually taken to be 18 months after the last period (menstrual
bleed), but
your doctor will advise you.
WHAT IS THE MENOPAUSE?
The menopause is a natural process and happens to every woman as she
grows

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Evorel Conti 50/170 micrograms per 24 hours Transdermal Patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each transdermal patch contains:
3.2 mg of estradiol hemihydrate equivalent to 3.1 mg estradiol
11.2 mg of norethisterone acetate equivalent to 9.82 mg norethisterone
Each patch releases a nominal 50 µg estradiol and 170 µg
norethisterone acetate over 24 hours.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Transdermal Patch
Evorel Conti is a matrix type transdermal patch.
_Description of the product_
Each patch has an area of 16 cm
2
. Patches are square with rounded corners and are 0.1 mm thick. A
patch is made of a
flat, two-layer laminate. The outer layer is a flexible, translucent
and nearly colourless backing film. It is marked on the
outer side with “CEN1” in the centre of the lower edge. The inner
layer is an adhesive film (matrix) composed of
acrylic adhesive and guar gum, which contains the active ingredients.
This adhesive layer is protected by a polyester
foil release liner, which is removed prior to application of the patch
to the skin. The polyester foil used is coated with
silicone on both sides. It has an S-shaped incision to facilitate its
removal prior to use. Each patch is individually
enclosed in a protective, hermetically sealed, labelled sachet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for the relief of menopausal
symptoms in post-menopausal women more than 6
months post-menopause.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose for the shortest
duration (see also Section 4.4) should be used.
_Adults_
Guidance on how to start therapy:
Post-menopausal women currently not on HRT may start Evorel Conti at
any time.
Women on continuous sequential HRT wishing to switch to Evorel Conti
may start Evorel Conti immediately after a
cycle of the sequential HRT or after a