Evorel Conti 50/170 micrograms per 24 hours transdermal patch

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Estradiol; Norethisterone acetate

Disponible depuis:

PCO Manufacturing Ltd.

Code ATC:

G03FA01

DCI (Dénomination commune internationale):

Estradiol; Norethisterone acetate

forme pharmaceutique:

Transdermal patch

Domaine thérapeutique:

norethisterone and estrogen

Date de l'autorisation:

2022-01-21

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
EVOREL
® CONTI 50/170 MICROGRAMS PER 24
HOURS TRANSDERMAL PATCH
estradiol/norethisterone acetate
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 is it 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 IS IT 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 older.
Women produce oestrogen hormones

Résumé des caractéristiques du produit

Health Products Regulatory Authority
24 January 2022
CRN00CPSM
Page 1 of 2
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 estradiol hemihydrate
equivalent to 3.1 mg estradiol and 11.2 mg norethisterone
acetate, in a patch size of 16 cm
2
, releasing a nominal 50 microgram estradiol and 170 microgram
norethisterone acetate per
24 hours.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch
_Product imported from Poland_
Each patch has an area of 16 cm
2
. Patches are square with rounded corners. A patch is made of a flat,
two-layer laminate. The
outer layer is a 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. The adhesive layer is protected by a
clear release liner, which is removed prior to application.
The release liner has a S-shaped incision to facilitate its removal
prior to use.
4 CLINICAL PARTICULARS
As per PA22668/009/001
5 PHARMACOLOGICAL PROPERTIES
As per PA22668/009/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Adhesive:
Acrylic copolymer
Guar gum
Backing film:
Polyester
Release liner:
Polyethylene terephthalate
6.2 INCOMPATIBILITIES
No creams, lotions, or powders should be applied to the skin area
where the patch is to be applied to prevent interference with
the adhesive properties of the patch.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
sachet and outer carton of the product as marketed in the
country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C. Keep in the original sachet and carton.
Health Products Regulatory Authority
24 January 2022
CRN00CPSM
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Each carton has 8 transdermal patches in individual sachets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Patches should be place