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EVOREL 25

Active substance(s): ESTRADIOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Evorel®
Estradiol
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 5.

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 Safety of HRT
4 How to use Evorel
5 Possible side effects
6 How to store Evorel
7 Contents of the pack and other information

1 What Evorel is and what it is used for
The name of your medicine is Evorel. It belongs to a group
of medicines called hormone replacement therapy (HRT).
Evorel contains an oestrogen (estradiol) which is a female
hormone. It comes in 4 different sizes: Evorel 25, Evorel 50,
Evorel 75 and Evorel 100.
Evorel comes in a ‘memory pack’. This can be used to help you
remember when to change your patches. Each pack contains
eight patches. Evorel 50 also comes in packs of two and
twenty-four 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 (see ‘What is the menopause?’)

Evorel 50, 75 and 100 can also be used to

• Prevent osteoporosis (fragile bones) in women who have had
the menopause and are most likely to have bone problems.
Evorel 50, 75 and 100 are only used if other medicines for
osteoporosis have been tried first and they have not worked.

What is the menopause?

Women produce oestrogen hormones from their ovaries
throughout their adult life. These hormones are important
in sexual development and control of the menstrual cycle.
The menopause happens when the level of hormones produced
by the ovaries goes down. This is a gradual process. During this
time the levels of oestrogen can go up and down.
This can cause:
• Hot flushes, night sweats or mood swings
• Vaginal problems such as dryness or itching
• Uncomfortable or painful sexual intercourse

You may get the same symptoms if you have had your ovaries
taken out in an operation.

How Evorel works

Evorel patches replace the oestrogen that is normally released
by the ovaries. However, in women who still have a womb, taking
an oestrogen hormone regularly may cause the lining of your
womb to build up and get thicker.
• This means it is necessary to add a progestogen hormone to the
oestrogen
• This helps shed the lining of the womb and stop any problems
happening
Evorel is not a contraceptive.

2 What you need to know before you use Evorel
Do not use Evorel if:

• You are allergic to anything in the patches (listed in section 7)
• You have (or have ever had) or think you may have breast cancer
• You have (or are suspected of having) or ever had a cancer that
is made worse by oestrogens (such as endometrial cancer)
• You have a thickening of the lining of the womb which has
not been treated
• You have vaginal bleeding you cannot explain
• You have ever had blood clots in a vein (thrombosis) or a blood
clot that has travelled to your lung (pulmonary embolism)
• You have problems with your blood which increases the
likelihood of developing a blood clot (thrombosis) (such as
protein C, protein S or antithrombin deficiency)
• You have (or have ever had) a liver disease and your liver
function tests have not returned to normal
• You have ever had blocked arteries (arterial thrombo-embolic
disease) that gave you angina or a heart attack or resulted
in a stroke
• You have a blood problem called ‘porphyria’
Do not use this medicine if any of the above applies to you. If you
are not sure, talk to your doctor or pharmacist before using
Evorel. Stop using Evorel at once if any of the above appears for
the first time and talk to your doctor immediately.
Evorel should not be used by children.

Medical check-ups

Evorel®
© J-C 2016
GB - AW_113457

Before taking HRT, your doctor should ask about you and your
family’s medical history. Your doctor may decide to examine your
breasts or your tummy, and may do an internal examination.
They will only do this if it is necessary for you, or if you have any
special concerns.
Once you have started on HRT, see your doctor for regular
check-ups (at least once a year). At these check-ups, your doctor
may discuss the benefits and risks of continuing to take HRT.

Make sure that you:

• Go for regular breast screening and cervical smear tests
• Regularly check your breasts for any changes such as
dimpling of the skin, changes in the nipple, or any lumps you
can see or feel

Tell your doctor if you have ever had any of the
following. You may need these checks more often.
• A problem caused by growth of the womb lining
- Inside the womb (fibroids)
- Outside the womb (endometriosis)
- Thickening of the lining of the womb (endometrial hyperplasia)
• Increased risk of blood clots (see ‘Blood clots’ in section 3 below)
• A family history of increased risk of cancers related
to oestrogens (see ‘Breast cancer’ in section 3 below)
• High blood pressure (hypertension). Your doctor may tell you
to stop using Evorel if your blood pressure goes up
• Diabetes
• Gallstones
• Migraine or severe headaches
• Systemic Lupus Erythematosus (SLE). This is an allergic
condition that causes joint pain, skin rashes and fever
• Epilepsy
• Asthma
• A disease affecting the eardrum (otosclerosis)
• Liver, heart or kidney problems
• High levels of fat (triglycerides) in your blood, as you may have
a higher risk of pancreatitis (inflammation of the pancreas,
which causes severe pain in the abdomen and back)
• Any breast problems
• History of sudden swelling of the face or throat, which may
cause difficulty in swallowing or breathing, rapid swelling of the
hands and feet and, stomach cramps
You may still be able to use Evorel, but you should discuss this
with your doctor first. Also tell your doctor if these illnesses return
or get worse while you are using Evorel.
If you have had a premature menopause the risk of using HRT
may be different. Talk to your doctor about the risks.

Other conditions

• If you have brown patches on your face or body (chloasma)
or have a history of them, you may need to keep out of the sun
or away from sunbeds (these patches may not completely
disappear again)

Other medicines and Evorel

In particular, tell your doctor or pharmacist if you are
taking any of the following:
• Medicines for epilepsy such as phenobarbital, phenytoin
or carbamazepine
• Certain medicines for infections such as rifampicin, rifabutin,
nevirapine, efavirenz, ritonavir or nelfinavir
• Bosentan - for high blood pressure in the blood vessels of the
lungs
• St. John’s Wort - for depression
Taking these medicines with Evorel can stop it from working as well.
Because of this you may get some bleeding, like a period, when
you are not expecting it.
• A medicine for epilepsy called lamotrigine. Using Evorel with
lamotrigine could affect control of your epilepsy

Operations or tests

Tell your doctor if you are going to have surgery. You may need
to stop taking HRT about 4 to 6 weeks before the operation
to reduce the risk of a blood clot. Your doctor will tell you
when you can start taking HRT again.
If you visit a hospital or your family doctor for a blood or urine
test, tell them that you are taking Evorel. This is because this
medicine may affect the results of the tests.

Pregnancy and breast-feeding

Do not use this medicine if you are pregnant, think you may
be pregnant or might become pregnant. This is because it may
affect the baby.
If you become pregnant, contact your doctor straight away and
remove the patch.
Do not use this medicine if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.

Driving or using machines

There is no information about whether Evorel affects your ability
to drive or use machines. See how this medicine affects you
before you drive or use any tools or machines.

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This includes medicines
that you buy without a prescription or herbal medicines.

3 Safety of HRT
As well as benefits, HRT has some risks. Consider the following
when deciding to take or continue HRT.

Heart disease

HRT is not recommended for women who have had heart
disease recently. If you have ever had heart disease, talk to your
doctor to see if you should be taking HRT.
HRT will not help to prevent heart disease.
Studies of HRT (containing both oestrogen and progestogen) have
shown that women may be slightly more likely to get heart disease.
If you get a pain in your chest that spreads to your arm and neck
• See a doctor as soon as possible
• Do not take any more HRT until your doctor says you can
This pain may be a sign of heart disease.

Stroke

Research suggests that HRT slightly increases the risk of having
a stroke. Other things that can increase the risk of stroke include:
• Getting older
• High blood pressure
• Smoking
• Drinking too much alcohol
• An irregular heartbeat
If you are worried about any of these things, or if you have had
a stroke in the past, talk to your doctor to see if you should take HRT.
How likely is a stroke?
Looking at women in their 50s, on average, over 5 years:
• In women not taking HRT - 3 in 1000 would be expected
to have a stroke
• In women taking HRT - 4 in 1000 would be expected to have
a stroke
Looking at women in their 60s, on average, over 5 years:
• In women not taking HRT - 11 in 1000 would be expected
to have a stroke
• In women taking HRT - 15 in 1000 would be expected to have
a stroke
If you get migraine-type headaches which you cannot explain
• See a doctor as soon as possible
• Do not take any more HRT until your doctor says you can
These headaches may be an early warning sign of a stroke.

Blood clots

HRT may increase the risk of blood clots in the veins (also called
deep vein thrombosis, or DVT), especially during the first year
of taking it.

These blood clots are not always serious. However, if a clot travels
to the lungs, it can cause chest pain, breathlessness, collapse or
even death. This is called pulmonary embolism, or PE.
You are more likely to get a blood clot if:
• You are very overweight (BMI above 30 kg/m2)
• You have had a blood clot before
• You are taking medicine containing an oestrogen
• You are getting older
• You have cancer
• You have just had a baby
• Any of your close family have had blood clots
• You have had one or more miscarriages
• You have any blood clotting problem that needs treatment with
a medicine such as warfarin
• You are off your feet for a long time because of major surgery,
injury or illness
• You are going on a long journey and will not be moving about
for some time
• You have a rare illness called SLE (Systemic Lupus Erythematosus)
If any of these things apply to you, talk to your doctor to see
if you should take HRT.
How likely is a blood clot?
Looking at women in their 50s, on average, over 5 years:
• In women not taking HRT - 3 in 1000 would be expected
to get a blood clot
• In women taking HRT - 7 in 1000 would be expected to get
a blood clot
Looking at women in their 60s, on average, over 5 years:
• In women not taking HRT - 8 in 1000 would be expected
to get a blood clot
• In women taking HRT - 17 in 1000 would be expected to get
a blood clot
If you get painful swelling in your leg, sudden chest pain or have
difficulty breathing
• See a doctor as soon as possible
• Do not take any more HRT until your doctor says you can
These may be signs of a blood clot.

Breast cancer

Women who have breast cancer, or have had breast cancer
in the past, should not take HRT.
Taking HRT slightly increases the risk of breast cancer. The risk
is also slightly increased if you have a later menopause.
• Postmenopausal women taking oestrogen-only HRT for 5 years the risk is about the same as for a woman of the same age who
is still having periods over that time, and not taking HRT

• Women taking oestrogen plus progestogen HRT - the risk
is higher than for oestrogen-only HRT. However, oestrogen
plus progestogen HRT is beneficial for the endometrium
(see ‘Endometrial cancer’)
For all kinds of HRT, the extra risk of breast cancer goes up the
longer you take it. However, it returns to normal within about
5 years after stopping HRT.
Your risk of breast cancer is also higher if:
• You have a close relative (mother, sister or grandmother)
who has had breast cancer
• You are very overweight
How likely is breast cancer?
Looking at women aged 50 to 79, on average, over the next
5 years:
• In women not taking combined HRT between 9 and
17 in 1000 will get breast cancer
• In women taking oestrogen-progestogen HRT at age 50 to
79 and take it for 5 years, between 15 and 21 in 1000 will get
breast cancer (an extra 4-6 cases)
If you notice any changes in your breast, such as:
• Dimpling of the skin
• Changes in the nipple
• Any lumps you can see or feel
Make an appointment to see your doctor as soon as possible.

Endometrial cancer (cancer of the lining
of the womb)

Taking oestrogen-only HRT for a long time can increase the
risk of cancer of the lining of the womb (the endometrium).
Taking a progestogen as well as the oestrogen helps to lower
the extra risk.
If you still have your womb, your doctor will usually prescribe
a progestogen as well as oestrogen. These may be prescribed
separately, or as a combined HRT product.
If you have had your womb removed (a hysterectomy),
your doctor will discuss with you whether you can safely take
oestrogen without a progestogen.
If you have had your womb removed because
of endometriosis, any endometrium left in your body may be at
risk of cancer. This means your doctor may prescribe HRT that
includes a progestogen as well as an oestrogen.
Your product, Evorel, is an oestrogen-only HRT.

3 Safety of HRT (continued)
How likely is endometrial cancer?
Looking at women aged 50 who still have a womb, on average,
over the next 15 years:
• In women not taking HRT - 5 in 1000 will get endometrial cancer
• In women taking oestrogen-only HRT, the number will be
2 to 12 times higher, depending on the dose and how long
you take it for
The addition of a progestogen to oestrogen-only HRT substantially
reduces the risk of endometrial cancer.
If you get breakthrough bleeding or spotting, it is usually nothing
to worry about, especially during the first few months of taking HRT.

But if the bleeding or spotting:
• Carries on for more than the first few months
• Starts after you have been on HRT for a while
• Carries on even after you’ve stopped taking HRT
Make an appointment to see your doctor as soon as possible.
It could be a sign that your endometrium has become thicker.

Ovarian cancer

Ovarian cancer (cancer of the ovaries) is rare, much rarer than
breast cancer. The use of oestrogen-only or combined
oestrogen-progestogen HRT has been associated with a slightly
increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, in women
aged 50 to 54 who are not taking HRT, about 2 women in 2000
will be diagnosed with ovarian cancer over a 5-year period.
For women who have been taking HRT for 5 years, there will be
about 3 cases per 2000 users (i.e. about 1 extra case).

Dementia

Evorel and medicines like it will not stop memory loss
(dementia). Women who start using medicines like Evorel after
the age of 65 may have a small increase in the risk of dementia.

4 How to use Evorel
Always use Evorel exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure. Evorel patches are available in 4 different sizes: Evorel 25,
Evorel 50, Evorel 75 and Evorel 100. These contain different
amounts of the oestrogen hormone, estradiol. Your doctor will
aim to reduce your symptoms with the lowest possible dose for
the shortest amount of time.
The highest dose you should have is 100 micrograms of estradiol
in a day. This is the amount delivered by an Evorel 100 patch
each day.

When to start using Evorel

You may put an Evorel patch on at any time if:
• You have not used HRT before your menopause and no longer
have menstrual periods
• Your menstrual cycles are not regular and you are not pregnant
• You are changing from HRT that does not give you a
withdrawal bleed

To help you remember your two “patch change” days, mark them
here or on the pack. They are written on the pack like this:

Where to apply the patch

Stick the patch onto a hairless area of skin below the waist.
Most women prefer to wear the patch on the thigh or bottom.
• Do not apply on or near the breasts
• Do not put it on top of cuts, spots or anywhere the skin is irritated
• Do not use cream, moisturiser or talc before applying the patch
• Do not apply the patch on the same area of skin twice in a row
• It can be worn under loose areas of clothing.
• Do not wear a patch under elasticated areas or a tight waistband
• Apply the patch to clean, dry, cool skin as soon as you open
the protective pouch

Put an Evorel patch on within 5 days of the start
of bleeding if:
• You are not currently using HRT and still having regular periods
Put an Evorel patch on at the end of a treatment cycle
or one week after you finish using another HRT product if:
• You are changing from an HRT medicine that gives you
a withdrawal bleed
If you are using another type of HRT:
• The day you start will depend on the type of HRT you have
been using
Talk to your doctor if you are not sure which type of HRT you are
using.

Using the patches

The patches need to be changed twice a week.
Start a new pack of Evorel as soon as you finish one. Do not
leave a break between packs.

Changing your patches

• You must change the patches twice a week to give your body
a steady supply of hormones. There is enough hormone
in each patch to last for several days
• Change your patch on the same two days every week. This will
mean that one patch is on for three days and the next patch for
four days
• For example, if you apply your first patch on a Monday, change
it on Thursday and again on the following Monday. You can
work out your two days from the following table, starting from
the first day of use:
If you put your first
patch on:
Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday


Change on:
Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday

&
&
&
&
&
&
&

Change again on:
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday

If you use more Evorel than you should

It is unlikely that you will have too much of the hormones
in Evorel. The most common symptoms of having too much
oestrogen in your body are:
• Tender or painful breasts
• Feeling sick (nausea) or being sick
• Unexpected vaginal bleeding
• Stomach pain or bloating
Removing the patch can reverse the effects of too much
oestrogen. Talk to your doctor or pharmacist before using any
more patches. Your doctor may decide to change the size
of patch.

Contraception while using Evorel

The levels of hormone from the patches are too low to act
as a contraceptive. Use non-hormonal contraceptive methods
(such as a condom, diaphragm or coil) until your periods have
completely stopped.

Everyday activities
Putting a patch on

Do not use a patch if its protective pouch
is already open.
Step 1: Open and Peel
• Using the notches as a guide, tear along two
edges of the pouch. Remove the patch

• You can have a bath or shower as normal. Do not scrub too
hard as this can loosen the edges of the patch
• You can go swimming. The patch will not be affected
• You can exercise and play sports. However, do not wear the
patch under tight clothing or waist bands
• You can sunbathe. However, keep the patch covered,
out of direct sunlight
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

• With the protective backing facing you,
bend and peel off half the backing.
Don’t touch the sticky side - it may not stick
properly
Step 2: Apply and Press
• Apply the open half of the patch to your skin
• Remove the remaining backing and press
down the rest of the patch
• Press the patch with the palm of your hand
to make sure it is firmly stuck

Removing a patch

• Peel an edge of the patch smoothly away from
the skin
• Fold the patch in half, so that the sticky side
sticks to itself
• Put it in with the household rubbish, safely out
of the reach of children and pets
• Do not flush used patches down the toilet
When you remove the patch some glue may remain on your skin.
It will disappear with time, or you can use baby oil to remove it.

If a patch falls off

Apply a new patch but keep to your original ‘patch change’ days.
If you have just had a bath or shower, wait until your skin cools
before applying a new patch.
Talk to your doctor if you need more patches.

If you forget to change the patch

Change it as soon as you remember and then keep to your
original ‘patch change’ days. You may get some bleeding and
spotting like a period during this time.

5 Possible side effects
Like all medicines, Evorel can cause side effects, although not
everybody gets them. Side effects may happen more often with
the larger size patches. Some side effects may be due to any
progestogen that is being taken at the same time.
The following diseases are reported more often in women using
HRT compared to women not using HRT:
• breast cancer;
• abnormal growth or cancer of the lining of the womb
(endometrial hyperplasia or cancer);
• ovarian cancer;
• blood clots in the veins of the legs or lungs (venous
thromboembolism);
• heart disease;
• stroke;
• probable memory loss if HRT is started over the age of 65;
For more information about these side effects, see Section 3.
Take off the patch and tell your doctor straight away if you
notice or suspect any of the following. You may need
urgent medical treatment.
• Sudden swelling of the face or throat which may cause difficulty
in swallowing or breathing. This may be a sign of an allergic
reaction. This only happens in a small number of people
• Blood clots (thrombosis), a heart attack or stroke
• Yellowing of the skin or whites of the eyes (jaundice), or other
liver problems
• Migraine-type headaches for the first time or more frequent
(affects less than 1 in 10 people)
• An increase in blood pressure
• Breast or ovarian cancer, endometrial cancer or hyperplasia
(long, heavy or irregular vaginal bleeding)
• Convulsions or fits (frequency not known)

Tell your doctor if you notice any of the following side
effects while using Evorel:
Very common (affects more than 1 in 10 people)
• Irritated, itchy skin and rash where the patch is applied
Common (affects less than 1 in 10 people)
• Red, puffy skin where the patch is applied
• Breast pain
• Rash or feeling itchy
• Feeling dizzy
• Feeling depressed
• Headache
• Feeling sick or having stomach pains
• Diarrhoea
• Pain, including pain in joints
• Break through bleeding, spotting or periods
• Weight gain
Uncommon (affects less than 1 in100 people)
• Vaginal thrush
• Wind
• Being aware of your heart beat (palpitations)
• Fuller breasts
• Painful periods
• Swelling of hands and feet (peripheral oedema)
• Water retention or build-up of fluid under the skin (oedema)
• Muscle pain
• Allergic reactions (hypersensitivity)
Rare (affects less than 1 in 1,000 people)
• Bloated feeling
• Gallstones
The following side effects have been reported with other HRTs:
Common (affects less than 1 in 10 people)
• Weight decrease
• Feeling sick

Uncommon (affects less than 1 in100 people)
• Problems with sight
• Indigestion
• Painful reddish skin nodules (erythema nodosum)
• Tender breasts
Rare (affects less than 1 in 1,000 people)
• Feeling anxious
• Increase or loss in sex drive
• Being sick
• Contact lenses may feel uncomfortable
• Excess hair growth
• Acne
• Muscle cramps
• Discharge from the vagina, premenstrual syndrome (PMS)
• Feeling tired
The following side effects have been reported in association
with oestrogen/progestogen treatment
• Gall bladder disease
• Brown patches on your face or body (chloasma)
• Rash with target -shaped reddening or sores
(erythema multiforme)
• Bruising on the legs
• Loss of memory (Dementia) (see section 3)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard .
By reporting side effects you can help provide more information
on the safety of this medicine.

6 How to store Evorel
Keep this medicine out of the sight and reach of children. Do not
store above 25°C. Keep in the original pouch and carton.

Do not use Evorel after the expiry date which is stated on the
label. The expiry date refers to the last day of that month.

Do not use a patch if the protective pouch is already open.

7 Contents of the pack and other information
The active substance in Evorel is estradiol.
Evorel 25 contains 1.6 mg estradiol and delivers 25 micrograms
of estradiol a day
Evorel 50 contains 3.2 mg estradiol and delivers 50 micrograms
of estradiol a day
Evorel 75 contains 4.8 mg estradiol and delivers 75 micrograms
of estradiol a day
Evorel 100 contains 6.4 mg estradiol and delivers
100 micrograms of estradiol a day
The other ingredients are Duro-Tak 387-2287 (this makes the
patches sticky), guar gum and Hostaphan MN19 (backing film).

What Evorel looks like and contents of the pack
Evorel comes in a memory pack containing eight patches.
Evorel 50 also comes in packs of two and twenty four patches.
Evorel 25 is marked CE25 and has a surface area of 8 sq cm
Evorel 50 is marked CE50 and has a surface area of 16 sq cm
Evorel 75 is marked CE75 and has a surface area of 24 sq cm
Evorel 100 is marked CE100 and has a surface area of 32 sq cm
The patches are square with rounded corners. They are clear
with a sticky backing that can be stuck to the skin. Each patch
comes in a protective sealed pouch.
The product licence is held by:
JANSSEN-CILAG LTD, 50 -100 Holmers Farm Way, High
Wycombe, Buckinghamshire HP12 4EG, UK

Evorel is made by:
Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse,
Belgium
OR
McGregor Cory Ltd, Middleton Road, Banbury, Oxfordshire
OX16 4RS, UK

For information in large print,
tape, CD or Braille, telephone
0800 7318450.
This leaflet was last revised in April 2016.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Evorel®
Estradiol
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 5.

What is in this leaflet
1 What Evorel is and what it is used for

5

2 What you need to know before
you use Evorel

9

3 Safety of HRT

18

4 How to use Evorel

31

5 Possible side effects

43

6 How to store Evorel

50

7 Contents of the pack and
other information

51

1 What Evorel is and
what it is used for
The name of your medicine is Evorel. It belongs
to a group of medicines called hormone
replacement therapy (HRT).
Evorel contains an oestrogen (estradiol) which
is a female hormone. It comes in 4 different sizes:
Evorel 25, Evorel 50, Evorel 75 and Evorel 100.
Evorel comes in a ‘memory pack’. This can
be used to help you remember when to change
your patches. Each pack contains eight patches.
Evorel 50 also comes in packs of two and
twenty-four patches.
The hormone is spread evenly in each patch.
It passes slowly into your body through the skin.
5

Evorel is used for

• The symptoms of the menopause (see ‘What
is the menopause?’ on the next page)

Evorel 50, 75 and 100 can also
be used to

• Prevent osteoporosis (fragile bones) in women
who have had the menopause and are most
likely to have bone problems. Evorel 50, 75
and 100 are only used if other medicines for
osteoporosis have been tried first and they
have not worked.

6

What is the menopause?

Women produce oestrogen hormones from their
ovaries throughout their adult life. These hormones
are important in sexual development and control
of the menstrual cycle.
The menopause happens when the level
of hormones produced by the ovaries goes
down. This is a gradual process. During this time
the levels of oestrogen can go up and down.
This can cause:
• Hot flushes, night sweats or mood swings
• Vaginal problems such as dryness or itching
• Uncomfortable or painful sexual intercourse
You may get the same symptoms if you have
had your ovaries taken out in an operation.

7

How Evorel works

Evorel patches replace the oestrogen that
is normally released by the ovaries. However,
in women who still have a womb, taking
an oestrogen hormone regularly may cause the
lining of your womb to build up and get thicker.
• This means it is necessary to add a
progestogen hormone to the oestrogen
• This helps shed the lining of the womb and
stop any problems happening
Evorel is not a contraceptive.

8

2 What you need to know
before you use Evorel
Do not use Evorel if:

• You are allergic to anything in the patches
(listed in section 7)
• You have (or have ever had) or think you may
have breast cancer
• You have (or are suspected of having) or ever
had a cancer that is made worse by oestrogens
(such as endometrial cancer)
• You have a thickening of the lining of the
womb which has not been treated
• You have vaginal bleeding you cannot explain
• You have ever had blood clots in a vein
(thrombosis) or a blood clot that has travelled
to your lung (pulmonary embolism)
9

• You have problems with your blood which
increases the likelihood of developing a blood
clot (thrombosis) (such as protein C, protein S
or antithrombin deficiency)
• You have (or have ever had) a liver disease
and your liver function tests have not returned
to normal
• You have ever had blocked arteries (arterial
thrombo-embolic disease) that gave you
angina or a heart attack or resulted in a stroke
• You have a blood problem called ‘porphyria’
Do not use this medicine if any of the above
applies to you. If you are not sure, talk to your
doctor or pharmacist before using Evorel.
Stop using Evorel at once if any of the above
appears for the first time and talk to your doctor
immediately.
Evorel should not be used by children.
10

Medical check-ups

Before taking HRT, your doctor should ask about
you and your family’s medical history. Your doctor
may decide to examine your breasts or your
tummy, and may do an internal examination.
They will only do this if it is necessary for you,
or if you have any special concerns.
Once you have started on HRT, see your doctor
for regular check-ups (at least once a year).
At these check-ups, your doctor may discuss
the benefits and risks of continuing to take HRT.

Make sure that you:

• Go for regular breast screening and cervical
smear tests
• Regularly check your breasts for any changes
such as dimpling of the skin, changes in the
nipple, or any lumps you can see or feel
11

Tell your doctor if you have ever had
any of the following. You may need
these checks more often.

• A problem caused by growth of the womb lining
• Inside the womb (fibroids)
• Outside the womb (endometriosis)
• Thickening of the lining of the womb
(endometrial hyperplasia)
• Increased risk of blood clots
(see ‘Blood clots’ in section 3 below)
• A family history of increased risk of cancers
related to oestrogens
(see ‘Breast cancer’ in section 3 below)
• High blood pressure (hypertension).
Your doctor may tell you to stop using Evorel
if your blood pressure goes up
• Diabetes
12

Tell your doctor if you have ever had
any of the following. You may need
these checks more often.

• Gallstones
• Migraine or severe headaches
• Systemic Lupus Erythematosus (SLE).
This is an allergic condition that causes joint
pain, skin rashes and fever
• Epilepsy
• Asthma
• A disease affecting the eardrum (otosclerosis)
• Liver, heart or kidney problems
• High levels of fat (triglycerides) in your blood,
as you may have a higher risk of pancreatitis
(inflammation of the pancreas, which causes
severe pain in the abdomen and back)
• Any breast problems
13

• History of sudden swelling of the face
or throat, which may cause difficulty
in swallowing, or breathing, rapid swelling
of the hands and feet and, stomach cramps
You may still be able to use Evorel, but you
should discuss this with your doctor first. Also
tell your doctor if these illnesses return or get
worse while you are using Evorel.
If you have had a premature menopause the risk
of using HRT may be different. Talk to your
doctor about the risks.

Other conditions

• If you have brown patches on your face
or body (chloasma) or have a history of them,
you may need to keep out of the sun or away
from sunbeds (these patches may not
completely disappear again)
14

Other medicines and Evorel

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines that you buy
without a prescription or herbal medicines.
In particular, tell your doctor or pharmacist
if you are taking any of the following:
• Medicines for epilepsy such as phenobarbital,
phenytoin or carbamazepine
• Certain medicines for infections such as
rifampicin, rifabutin, nevirapine, efavirenz,
ritonavir or nelfinavir
• Bosentan - for high blood pressure in the
blood vessels of the lungs
• St. John’s Wort - for depression
Taking these medicines with Evorel can stop
it from working as well. Because of this you may
get some bleeding, like a period, when you are
not expecting it.

15

In particular, tell your doctor or pharmacist
if you are taking any of the following:
• A medicine for epilepsy called lamotrigine.
Using Evorel with lamotrigine could affect
control of your epilepsy

Operations or tests

Tell your doctor if you are going to have surgery.
You may need to stop taking HRT about 4 to
6 weeks before the operation to reduce the risk
of a blood clot. Your doctor will tell you when you
can start taking HRT again.
If you visit a hospital or your family doctor for
a blood or urine test, tell them that you are taking
Evorel. This is because this medicine may affect
the results of the tests.

16

Pregnancy and breast-feeding

Do not use this medicine if you are pregnant,
think you may be pregnant or might become
pregnant. This is because it may affect the baby.
If you become pregnant, contact your doctor
straight away and remove the patch.
Do not use this medicine if you are breast-feeding.
Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant
or breast-feeding.

Driving or using machines

There is no information about whether Evorel
affects your ability to drive or use machines.
See how this medicine affects you before you
drive or use any tools or machines.
17

3 Safety of HRT
As well as benefits, HRT has some risks.
Consider the following when deciding to take
or continue HRT.

Heart disease

HRT is not recommended for women who have
had heart disease recently. If you have ever had
heart disease, talk to your doctor to see if you
should be taking HRT.
HRT will not help to prevent heart disease.
Studies of HRT (containing both oestrogen and
progestogen) have shown that women may
be slightly more likely to get heart disease.
18

If you get a pain in your chest that spreads
to your arm and neck
• See a doctor as soon as possible
• Do not take any more HRT until your doctor
says you can
This pain may be a sign of heart disease.

Stroke

Research suggests that HRT slightly increases
the risk of having a stroke. Other things that can
increase the risk of stroke include:
• Getting older
• High blood pressure
• Smoking
• Drinking too much alcohol
• An irregular heartbeat
If you are worried about any of these things,
or if you have had a stroke in the past, talk to your
doctor to see if you should take HRT.
19

How likely is a stroke?
Looking at women in their 50s, on average,
over 5 years:
• In women not taking HRT - 3 in 1000 would
be expected to have a stroke
• In women taking HRT - 4 in 1000 would
be expected to have a stroke
Looking at women in their 60s, on average,
over 5 years:
• In women not taking HRT - 11 in 1000 would
be expected to have a stroke
• In women taking HRT - 15 in 1000 would
be expected to have a stroke

20

If you get migraine-type headaches which you
cannot explain
• See a doctor as soon as possible
• Do not take any more HRT until your doctor
says you can
These headaches may be an early warning sign
of a stroke.

Blood clots

HRT may increase the risk of blood clots in the
veins (also called deep vein thrombosis, or DVT),
especially during the first year of taking it.
These blood clots are not always serious.
However, if a clot travels to the lungs, it can cause
chest pain, breathlessness, collapse or even
death. This is called pulmonary embolism, or PE.

21

You are more likely to get a blood clot if:
• You are very overweight (BMI above 30 kg/m2)
• You have had a blood clot before
• You are taking medicine containing an oestrogen
• You are getting older
• You have cancer
• You have just had a baby
• Any of your close family have had blood clots
• You have had one or more miscarriages
• You have any blood clotting problem that needs
treatment with a medicine such as warfarin
• You are off your feet for a long time because
of major surgery, injury or illness
• You are going on a long journey and will not
be moving about for some time
• You have a rare illness called SLE
(Systemic Lupus Erythematosus)
If any of these things apply to you, talk to your
doctor to see if you should take HRT.
22

How likely is a blood clot?
Looking at women in their 50s, on average,
over 5 years:
• In women not taking HRT - 3 in 1000 would
be expected to get a blood clot
• In women taking HRT - 7 in 1000 would
be expected to get a blood clot
Looking at women in their 60s, on average,
over 5 years:
• In women not taking HRT - 8 in 1000 would
be expected to get a blood clot
• In women taking HRT - 17 in 1000 would
be expected to get a blood clot
If you get painful swelling in your leg, sudden
chest pain or have difficulty breathing
• See a doctor as soon as possible
• Do not take any more HRT until your doctor
says you can
These may be signs of a blood clot.

23

Breast cancer

Women who have breast cancer, or have
had breast cancer in the past, should not
take HRT.
Taking HRT slightly increases the risk of breast
cancer. The risk is also slightly increased if you
have a later menopause.
• Postmenopausal women taking oestrogenonly HRT for 5 years - the risk is about the
same as for a woman of the same age who
is still having periods over that time, and not
taking HRT
• Women taking oestrogen plus progestogen
HRT - the risk is higher than for oestrogen-only
HRT. However, oestrogen plus progestogen
HRT is beneficial for the endometrium
(see ‘Endometrial cancer’)
24

For all kinds of HRT, the extra risk of breast
cancer goes up the longer you take it. However,
it returns to normal within about 5 years after
stopping HRT.
Your risk of breast cancer is also higher if:
• You have a close relative (mother, sister
or grandmother) who has had breast cancer
• You are very overweight
How likely is breast cancer?
Looking at women aged 50 to 79, on average,
over the next 5 years:
• In women not taking combined HRT between
9 and 17 in 1000 will get breast cancer
• In women taking oestrogen-progestogen HRT
at age 50 to 79 and take it for 5 years, between
15 and 21 in 1000 will get breast cancer (an
extra 4-6 cases)
25

If you notice any changes in your breast,
such as:
• Dimpling of the skin
• Changes in the nipple
• Any lumps you can see or feel
Make an appointment to see your doctor
as soon as possible.

26

Endometrial cancer
(cancer of the lining of the womb)

Taking oestrogen-only HRT for a long time
can increase the risk of cancer of the lining
of the womb (the endometrium). Taking
a progestogen as well as the oestrogen helps
to lower the extra risk.
If you still have your womb, your doctor will
usually prescribe a progestogen as well
as oestrogen. These may be prescribed
separately, or as a combined HRT product.
If you have had your womb removed
(a hysterectomy), your doctor will discuss with
you whether you can safely take oestrogen
without a progestogen.

27

If you have had your womb removed
because of endometriosis, any endometrium
left in your body may be at risk of cancer.
This means your doctor may prescribe HRT that
includes a progestogen as well as an oestrogen.
Your product, Evorel, is an oestrogen-only HRT.
How likely is endometrial cancer?
Looking at women aged 50 who still have a womb,
on average, over the next 15 years:
• In women not taking HRT - 5 in 1000 will get
endometrial cancer
• In women taking oestrogen-only HRT,
the number will be 2 to 12 times higher,
depending on the dose and how long you take
it for
The addition of a progestogen to oestrogen-only
HRT substantially reduces the risk of endometrial
cancer.
28
3

If you get breakthrough bleeding or spotting,
it is usually nothing to worry about, especially
during the first few months of taking HRT.
But if the bleeding or spotting:
• Carries on for more than the first few months
• Starts after you have been on HRT for a while
• Carries on even after you’ve stopped taking
HRT
Make an appointment to see your doctor as
soon as possible. It could be a sign that your
endometrium has become thicker.

29

Ovarian cancer

Ovarian cancer (cancer of the ovaries) is rare,
much rarer than breast cancer. The use of
oestrogen-only or combined oestrogenprogestogen HRT has been associated with a
slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age.
For example, in women aged 50 to 54 who are
not taking HRT, about 2 women in 2000 will be
diagnosed with ovarian cancer over a 5-year
period. For women who have been taking HRT
for 5 years, there will be about 3 cases per
2000 users (i.e. about 1 extra case).

Dementia

Evorel and medicines like it will not stop memory
loss (dementia). Women who start using
medicines like Evorel after the age of 65 may
have a small increase in the risk of dementia.
30

4 How to use Evorel
Always use Evorel exactly as your doctor has
told you. You should check with your doctor
or pharmacist if you are not sure. Evorel patches
are available in 4 different sizes: Evorel 25,
Evorel 50, Evorel 75 and Evorel 100. These
contain different amounts of the oestrogen
hormone, estradiol. Your doctor will aim to reduce
your symptoms with the lowest possible dose for
the shortest amount of time.
The highest dose you should have is
100 micrograms of estradiol in a day. This is the
amount delivered by an Evorel 100 patch each
day.

31

When to start using Evorel

You may put an Evorel patch on at any time if:
• You have not used HRT before your menopause
and no longer have menstrual periods
• Your menstrual cycles are not regular and you
are not pregnant
• You are changing from HRT that does not give
you a withdrawal bleed
Put an Evorel patch on within 5 days
of the start of bleeding if:
• You are not currently using HRT and still having
regular periods
Put an Evorel patch on at the end
of a treatment cycle or one week after you
finish using another HRT product if:
• You are changing from an HRT medicine that
gives you a withdrawal bleed
32

If you are using another type of HRT:
• The day you start will depend on the type
of HRT you have been using
Talk to your doctor if you are not sure which type
of HRT you are using.

Using the patches

The patches need to be changed twice a week.
Start a new pack of Evorel as soon as you finish
one. Do not leave a break between packs.

Changing your patches

• You must change the patches twice a week
to give your body a steady supply of hormones.
There is enough hormone in each patch to last
for several days

33

• Change your patch on the same two days
every week. This will mean that one patch
is on for three days and the next patch for four
days
• For example, if you apply your first patch
on a Monday, change it on Thursday and again
on the following Monday. You can work out
your two days from the following table, starting
from the first day of use:
If you put your
first patch on:
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday
34

Change on:








Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday

Change again on:
&
&
&
&
&
&
&

Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday

To help you remember your two “patch change”
days, mark them here or on the pack. They are
written on the pack like this:

Where to apply the patch

Stick the patch onto a hairless area of skin below
the waist. Most women prefer to wear the patch
on the thigh or bottom.
• Do not apply on or near the breasts
• Do not put it on top of cuts, spots or anywhere
the skin is irritated
• Do not use cream, moisturiser or talc before
applying the patch
• Do not apply the patch on the same area
of skin twice in a row
• It can be worn under loose areas of clothing.
35

• Do not wear a patch under elasticated areas
or a tight waistband
• Apply the patch to clean, dry, cool skin as soon
as you open the protective pouch

Putting a patch on

Do not use a patch if its protective pouch
is already open.
Step 1: Open and Peel
• Using the notches as a guide,
tear along two edges of the
pouch. Remove the patch
36

• With the protective backing
facing you, bend and peel off
half the backing. Don’t touch
the sticky side - it may not
stick properly
Step 2: Apply and Press
• Apply the open half of the
patch to your skin
• Remove the remaining backing
and press down the rest
of the patch
• Press the patch with the palm
of your hand to make sure
it is firmly stuck

37

Removing a patch

• Peel an edge of the patch
smoothly away from the skin
• Fold the patch in half, so that
the sticky side sticks to itself
• Put it in with the household
rubbish, safely out of the reach
of children and pets
• Do not flush used patches
down the toilet
When you remove the patch some glue may
remain on your skin. It will disappear with time,
or you can use baby oil to remove it.

38

If a patch falls off

Apply a new patch but keep to your original
‘patch change’ days. If you have just had a bath
or shower, wait until your skin cools before
applying a new patch.
Talk to your doctor if you need more patches.

If you forget to change the patch

Change it as soon as you remember and then
keep to your original ‘patch change’ days.
You may get some bleeding and spotting like
a period during this time.

39

If you use more Evorel than you
should

It is unlikely that you will have too much
of the hormones in Evorel. The most common
symptoms of having too much oestrogen in your
body are:
• Tender or painful breasts
• Feeling sick (nausea) or being sick
• Unexpected vaginal bleeding
• Stomach pain or bloating
Removing the patch can reverse the effects
of too much oestrogen. Talk to your doctor
or pharmacist before using any more patches.
Your doctor may decide to change the size
of patch.

40

Contraception while using Evorel

The levels of hormone from the patches are too
low to act as a contraceptive. Use non-hormonal
contraceptive methods (such as a condom,
diaphragm or coil) until your periods have
completely stopped.

41

Everyday activities

• You can have a bath or shower as normal.
Do not scrub too hard as this can loosen
the edges of the patch
• You can go swimming. The patch will not
be affected
• You can exercise and play sports. However,
do not wear the patch under tight clothing
or waist bands
• You can sunbathe. However, keep the patch
covered, out of direct sunlight
If you have any further questions on the use
of this product, ask your doctor or pharmacist.

42

5 Possible side effects
Like all medicines, Evorel can cause side
effects, although not everybody gets them. Side
effects may happen more often with the larger
size patches. Some side effects may be due
to any progestogen that is being taken at the
same time.
The following diseases are reported more often
in women using HRT compared to women not
using HRT:
• breast cancer;
• abnormal growth or cancer of the lining of the
womb (endometrial hyperplasia or cancer);
• ovarian cancer;
• blood clots in the veins of the legs or lungs
(venous thromboembolism);
• heart disease;
43

• stroke;
• probable memory loss if HRT is started over
the age of 65;
For more information about these side effects,
see Section 3.
Take off the patch and tell your doctor
straight away if you notice or suspect any
of the following. You may need urgent
medical treatment.
• Sudden swelling of the face or throat which
may cause difficulty in swallowing or breathing.
This may be a sign of an allergic reaction.
This only happens in a small number of people
• Blood clots (thrombosis), a heart attack or stroke

44

Take off the patch and tell your doctor
straight away if you notice or suspect any
of the following. You may need urgent
medical treatment.
• Yellowing of the skin or whites of the eyes
(jaundice), or other liver problems
• Migraine-type headaches for the first time
or more frequent (affects less than 1 in 10 people)
• An increase in blood pressure
• Breast or ovarian cancer, endometrial cancer
or hyperplasia (long, heavy or irregular vaginal
bleeding)
• Convulsions or fits (frequency not known)
Tell your doctor if you notice any of
the following side effects while using Evorel:
Very common (affects more than 1 in 10 people)
• Irritated, itchy skin and rash where the patch
is applied
45

Common (affects less than 1 in 10 people)
• Red, puffy skin where the patch is applied
• Breast pain
• Rash or feeling itchy
• Feeling dizzy
• Feeling depressed
• Headache
• Feeling sick or having stomach pains
• Diarrhoea
• Pain, including pain in joints
• Break through bleeding, spotting or periods
• Weight gain
Uncommon (affects less than 1 in100 people)
• Vaginal thrush
• Wind
• Being aware of your heart beat (palpitations)
• Fuller breasts
• Painful periods
• Swelling of hands and feet (peripheral oedema)
46

• Water retention or build-up of fluid under the
skin (oedema)
• Muscle pain
• Allergic reactions (hypersensitivity)
Rare (affects less than 1 in 1,000 people)
• Bloated feeling
• Gallstones
The following side effects have been
reported with other HRTs:
Common (affects less than 1 in 10 people)
• Weight decrease
• Feeling sick
Uncommon (affects less than 1 in 100 people)
• Problems with sight
• Indigestion
• Painful reddish skin nodules (erythema
nodosum)
• Tender breasts
47

Rare (affects less than 1 in 1,000 people)
• Feeling anxious
• Increase or loss in sex drive
• Being sick
• Contact lenses may feel uncomfortable
• Excess hair growth
• Acne
• Muscle cramps
• Discharge from the vagina, premenstrual
syndrome (PMS)
• Feeling tired

48

The following side effects have been
reported in association with oestrogen/
progestogen treatment
• Gall bladder disease
• Brown patches on your face or body
(chloasma)
• Rash with target -shaped reddening or sores
(erythema multiforme)
• Bruising on the legs
• Loss of memory (Dementia) (see section 3)

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
49

6 How to store Evorel
Keep this medicine out of the sight and reach of
children. Do not store above 25°C. Keep in the
original pouch and carton.
Do not use Evorel after the expiry date which
is stated on the label. The expiry date refers
to the last day of that month.
Do not use a patch if the protective pouch is
already open.

50

7 Contents of the pack
and other information
The active substance in Evorel is estradiol.
Evorel 25 contains 1.6 mg estradiol and delivers
25 micrograms of estradiol a day
Evorel 50 contains 3.2 mg estradiol and delivers
50 micrograms of estradiol a day
Evorel 75 contains 4.8 mg estradiol and delivers
75 micrograms of estradiol a day
Evorel 100 contains 6.4 mg estradiol and delivers
100 micrograms of estradiol a day
The other ingredients are Duro-Tak 387-2287
(this makes the patches sticky), guar gum and
Hostaphan MN19 (backing film).

51

What Evorel looks like and contents
of the pack

Evorel comes in a memory pack containing eight
patches.
Evorel 50 also comes in packs of two and twenty
four patches.
Evorel 25 is marked CE25 and has a surface area
of 8 sq cm
Evorel 50 is marked CE50 and has a surface area
of 16 sq cm
Evorel 75 is marked CE75 and has a surface area
of 24 sq cm
Evorel 100 is marked CE100 and has a surface
area of 32 sq cm
The patches are square with rounded corners.
They are clear with a sticky backing that can
be stuck to the skin. Each patch comes
in a protective sealed pouch.
52

The product licence is held by:
JANSSEN-CILAG LTD,
50 -100 Holmers Farm Way, High Wycombe,
Buckinghamshire HP12 4EG, UK
Evorel is made by:
Janssen Pharmaceutica NV, Turnhoutseweg 30,
B-2340 Beerse, Belgium
OR
McGregor Cory Ltd, Middleton Road, Banbury,
Oxfordshire OX 16 4RS, UK

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaflet was last revised in April 2016
53

Evorel®

© J-C 2016
GB - AW_113460

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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