Evorel 50 micrograms per 24 hours Transdermal Patch

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Estradiol hemihydrate

Tillgänglig från:

Theramex Ireland Limited

ATC-kod:

G03CA; G03CA03

INN (International namn):

Estradiol hemihydrate

Dos:

50 microgram(s)/24 hours

Läkemedelsform:

Transdermal patch

Terapiområde:

Natural and semisynthetic estrogens, plain; estradiol

Bemyndigande status:

Marketed

Bipacksedel

– 1 –
PACKAGE LEAFLET
– 2 –
PACKAGE LEAFLET: INFORMATION FOR THE USER
EVOREL® 50 MICROGRAMS PER 24 HOURS TRANSDERMAL PATCH
Estradiol hemihydrate
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 is and what it is used for
2.
What you need to know before you use Evorel
3.
How to use Evorel
4.
Possible side effects
5.
How to store Evorel
6.
Contents of the pack and other information
1.
WHAT EVOREL IS AND WHAT IT IS USED FOR
The name of your medicine is Evorel 50 micrograms per 24 hours
Transdermal Patch. It
is called Evorel in this leaflet. Evorel is a Hormone Replacement
Therapy (HRT). It
contains the female hormone oestrogen. Evorel is used in
postmenopausal women
with at least 18 months since their last natural period.
Evorel 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 IS USED FOR:

RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
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 alleviates these symptoms after menopause. You will only be
prescribed
Evorel if your symptoms seriously hinder your daily life.

PREVENTION OF OSTEOPOROSIS
After the menopause some women may develop fragile bones
(osteoporosis). You
should discuss all available options with yo

Produktens egenskaper

Health Products Regulatory Authority
20 February 2024
CRN00DZHM
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Evorel 50 micrograms per 24 hours Transdermal Patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3.2 mg estradiol hemihydrate per patch, releasing a nominal 50
micrograms (μg) estradiol per 24 hours.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch
Evorel is a matrix type transdermal patch.
Description of Product
Patches are square with rounded corners and are 0.1 mm thick.Patches
are made of a flat, two-layer laminate.The outer layer is
a flexible, translucent and nearly colourless backing film.The inner
layer is a monolayer 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 pouch.
Evorel 50 is marked on the outer side with ‘CE50’ and has a
surface area of 16 cm
2
.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For treatment of post-menopausal symptoms, the lowest effective dose
should be used.
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
- _Treatment of oestrogen deficiency symptoms_
For women with an intact uterus, a progestogen must be added to Evorel
for the prevention of adverse