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EVOREL CONTI TRANSDERMAL PATCHES

Active substance(s): ESTRADIOL HEMIHYDRATE / NORETHISTERONE ACETATE

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Contraception while using Evorel Conti
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
• 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.

5

Possible side effects

Like all medicines, Evorel Conti can cause side effects, although not
everybody gets them.
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) (affects less than 1 in 1000 people) or stroke
(frequency not known)
• 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 100 people)
• An increase in blood pressure (affects less than 1 in 10 people)
• Breast or ovarian cancer, endometrial cancer or hyperplasia (long, heavy or
irregular periods)
• Widespread rash with peeling skin and blistering in the mouth, eyes and
genitals (Stevens-Johnson syndrome) (frequency not known)
• Convulsions or fits (affects less than 1 in 1,000 people)
Tell your doctor if you notice any of the following side effects while
using Evorel Conti:
Very common (affects more than 1 in 10 people)
• Irritated, itchy, red skin and rash where the patch is applied
Common (affects less than 1 in 10 people)
• Allergic reaction (hypersensitvity)
• Being unable to sleep
• Feeling depressed, nervous or anxious
• Headache
• Being aware of your heartbeat (palpitations)
• Varicose veins
• Flushing, skin reddening
• Breast pain
• Numb or tingling hands or feet
• Feeling sick (nausea)
• Diarrhoea
• Stomach ache
• Pain including pain in the back or joints
• Painful periods
• Discharge from the vagina
• Irregular, heavy or prolonged bleeding from the vagina, including after sex
• Water retention or build-up of fl uid under the skin (oedema)
• Feeling tired
• Weight gain
Uncommon (affects less than 1 in 100 people)
• Vaginal infections such as thrush
• Less interest in sex than usual
• Wind
• Itchy skin
• Rash
• Swelling of the hands and feet (peripheral oedema)
• Muscle pain
Frequency not known
• Mood swings
• Feeling dizzy
• Bloated feeling
• Gallstones
• Fuller breasts
Page 4

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

6

How to store Evorel Conti

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Do not use a patch if its protective sachet is open.
Do not take this medicine after the expiry date shown on the carton or sachet
label. If your doctor tells you to stop taking the medicine, take any
remaining medicine back to the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration,
ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via waterwaste or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

7

Further information

The active substances in Evorel Conti are estradiol hemihydrate and
norethisterone acetate. Each Evorel Conti patch contains 3.2 mg of estradiol
hemihydrate and 11.2 mg of norethisterone acetate. Each Evorel Conti patch
delivers 50 micrograms of estradiol and 170 micrograms of norethisterone
acetate a day.
The other ingredients are acrylate copolymer, guar gum, polyester and
polyethylene terephthalate.
What Evorel Conti looks like and contents of the pack
Evorel Conti comes in a memory pack containing eight patches.
The patches are square with rounded corners. They are clear with a sticky
backing that can be stuck to the skin. Each patch has a surface area of
16 cm2 and is marked in the centre of the lower margin on the outside of the
backing film: CEN1. Each patch is enclosed in a protective,
hermetically-sealed sachet.
Manufacturer and Licence Holder
The patches are manufactured by Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse, Belgium and are procured from within
the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.

POM

PL Number:

15184/1350

Evorel ® Conti Transdermal Patches
(estradiol hemihydrate, norethisterone acetate)

Patient Information Leaflet
Your medicine is called Evorel Conti Transdermal Patches, and will be
referred to as Evorel Conti throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine.
• 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. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours
• If you get side eff ects and they become serious or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:
1 What Evorel Conti is and what it is used for
2 Before you use Evorel Conti
3 Safety of HRT
4 How to use Evorel Conti
5 Possible side effects
6 How to store Evorel Conti
7 Further Information

1

What Evorel Conti is and what it is used for

The name of your medicine is Evorel Conti. 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 hormones.
Evorel Conti comes in a ‘memory pack’. This can be used to help you
remember when to change your patches. 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?’). It is
suitable for women who have not had a period (menstrual bleed) for at
least 18 months
• To prevent osteoporosis (weakening of the bones) in women who have had
the menopause and are most likely to have bone problems. Evorel Conti is
only used if other medicines for osteoporosis have been tried first and they
have not worked

Evorel is a registered trademark of Janssen-Cilag.
Leaflet revision date: 13/05/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref:1350/130515/1/F

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. This is called a hysterectomy.
How Evorel Conti works
Evorel Conti is known as ‘continuous combined’ HRT. This is because both
hormones in the patch are released all the time.
Evorel Conti 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
Most women do not have a regular monthly period with Evorel Conti.
However, bleeding or spotting does often occur in the first few months until
treatment settles down.

2

Before you use Evorel Conti

Do not use Evorel Conti 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 ever had a cancer that was 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 ever had blood clots (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)
• 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 Conti.
Take special care with Evorel Conti
Check with your doctor before using Evorel Conti if:
• You have ever had vaginal bleeding which you could not explain
• The lining of your womb has ever got thicker (endometrial hyperplasia)
• You have ever had liver problems
You may still be able to use Evorel Conti, but you should discuss this with
your doctor first.
Evorel Conti should not be used by children.
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
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)
• 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 Conti 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
• Bone formation in the ear (otosclerosis)
• Liver, heart or kidney problems
• High levels of 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
Tell your doctor if these illnesses return or get worse while you are using
Evorel Conti.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
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
Page 1

• Medicines for infections such as rifampicin, rifabutin, nevirapine or
efavirenz

• Bosentan - for high blood pressure in the blood vessels of the lungs
• St. John’s Wort - for depression
Taking these medicines with Evorel Conti can stop Evorel Conti 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 Conti 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 Conti. 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.

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.

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.

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.

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.

You are more likely to get a blood clot if:
• You are very overweight
• You are getting older
• You have had a blood clot before
• Any of your close family have had blood clots
• You are pregnant or have just had a baby.
• 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 applies to you, talk to your doctor to see if you should
take HRT.

Ask your doctor or pharmacist for advice before taking any medicine if you
are pregnant or breast-feeding.

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

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

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

Do not use this medicine if you are breast-feeding.

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 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.
Page 2

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, on average, over the next 15 years:
• In women not taking HRT - 32 in 1000 will get breast cancer
• In women taking oestrogen-only HRT at age 50 and take it for 5 years,
between 33 and 34 in 1000 will get breast cancer
• In women taking oestrogen-only HRT for 10 years - 37 in 1000 will get
breast cancer
• In women taking oestrogen plus progestogen HRT at age 50 and take it
for 5 years - 38 in 1000 will get breast cancer
• In women taking oestrogen plus progestogen HRT for 10 years - 51 in
1000 will get breast cancer
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.

Your product, Evorel Conti, contains a progestogen.
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.

If you put your first patch on:
Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday


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:
MON
THUR

TUE
FRI

WED
SAT

THUR
SUN

FRI
MON

SAT
TUE

SUN
WED

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
sachet

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. It could be a sign that your
endometrium has become thicker.
Ovarian cancer
Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be
difficult to diagnose.
This is because there are often no obvious signs of the disease. Some
studies have suggested that taking HRT for more than 5 years may increase
the risk of ovarian cancer.

Change on:
```Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday

Correct area for
applying patch

NEVER apply patch
in this area

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

• With the protective backing facing you, bend and peel
Dementia
Evorel Conti and medicines like it will not stop memory loss (dementia).
Women who start using medicines like Evorel Conti after the age of 65 may
have a small increase in the risk of dementia.

4

How to use Evorel Conti

Always use Evorel Conti exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure. Your doctor will aim
to reduce your symptoms with the lowest possible dose for the shortest
amount of time.
When to start using Evorel Conti
You may put an Evorel Conti patch on at any time if:
• You have not been using another type of HRT
Put an Evorel Conti 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 Conti 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:

off half the backing. Don’t touch the sticky side - it may
not stick properly if you do
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 a shower, wait until your skin cools before applying the
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.
If you use more Evorel Conti than you should
It is unlikely that you will have too much of the hormones in Evorel Conti.
The most common symptoms of having too much oestrogen or progestogen
in your body are:
• Tender breasts
• Feeling sick (nausea)
• Unexpected vaginal bleeding
• Stomach pain or bloating
Removing the patch can reverse the effects of too much oestrogen and/or
progestogen. Talk to your doctor or pharmacist before using any more
patches.

Ref:1350/130515/1/B

Page 3

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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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