Evorel Conti 50/170 micrograms per 24 hours Transdermal Patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Estradiol hemihydrate; Norethisterone acetate

Available from:

Theramex Ireland Limited

ATC code:

G03CA; G03CA53

INN (International Name):

Estradiol hemihydrate; Norethisterone acetate

Dosage:

50 microg/24h +170 microgram(s)/24 hours

Pharmaceutical form:

Transdermal patch

Therapeutic area:

Natural and semisynthetic estrogens, plain; estradiol, combinations

Authorization status:

Marketed

Patient Information leaflet

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PACKAGE LEAFLET
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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. Evorel Conti is a Hormone
Replacement Therapy (HRT). It
contains two types of female hormones, an oestrogen and a progestogen.
Evorel Conti is used in
postmenopausal women with at least 18 months since their last natural
period.
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
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").
Evorel Conti alleviates these
symptoms after menopause. You will only be prescribed Evorel Conti if
your symptoms seriously
hinder your daily life. It is suitable for women who hav

Summary of Product characteristics

Health Products Regulatory Authority
28 February 2024
CRN00DZHV
Page 1 of 14
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
Posology
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 C