Evorel 50 micrograms per 24 hours Transdermal Patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Estradiol hemihydrate

Available from:

Janssen Sciences Ireland UC

ATC code:

G03CA; G03CA03

INN (International Name):

Estradiol hemihydrate

Dosage:

50 microgram(s)/24 hours

Pharmaceutical form:

Transdermal patch

Therapeutic area:

Natural and semisynthetic estrogens, plain; estradiol

Authorization status:

Marketed

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

HealthProductsRegulatoryAuthority
01April2019
CRN008NZR
Page1of14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Evorel50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