EVOREL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ESTRADIOL HEMIHYDRATE

Available from:

Janssen-Cilag Ltd

ATC code:

G03CA03

INN (International Name):

ESTRADIOL HEMIHYDRATE

Dosage:

50 Microgram/day

Pharmaceutical form:

Transdermal Patch

Prescription type:

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

Therapeutic area:

estradiol

Authorization status:

Marketed

Authorization date:

1994-06-10

Patient Information leaflet

- 1 –
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. It belongs to a group of
medicines called
hormone replacement therapy (HRT).
Evorel contains an oestrogen (estradiol) which is a female hormone.
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 the symptoms of the menopause. These symptoms may be caused by a
lack of naturally occurring oestrogens and progestogens. (see ‘What
is the
menopause?’ below)
•
To prevent osteoporosis (fragile bones) in women who have had the
menopause and are most likely to have bone problems. It is suitable
for women
who have not had a period (menstrual bleed) for at least 18 months. It
is only
used if other medicines for osteoporosis have been tried first and
they have not
worked.
- 2 –
WHAT IS THE MENOPAUSE?
The menopause is a natural process and happens to

Summary of Product characteristics

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 the symptomatic relief of
oestrogen deficiency.
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 endometrial
effects, e.g. hyperplasia and cancer. The regimen may be either