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EVOREL SEQUI TRANSDERMAL PATCHES

Active substance(s): ESTRADIOL HEMIHYDRATE MICRONISED / NORETHISTERONE ACETATE MICRONISED

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Package Leaflet: Information for the User

Evorel® Sequi Transdermal Patches
(estradiol hemihydrate / norethisterone acetate)
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 effects and they become serious or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist

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

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

Taking these medicines with Evorel Sequi can stop it from working as
well. Because of this you may get some bleeding like a period, when you
are not expecting it.

1. What Evorel Sequi is and what it is used for
The name of your medicine is Evorel Sequi. It belongs to a group of
medicines called hormone replacement therapy (HRT).
Evorel Sequi contains two medicines:
• An oestrogen (estradiol)
• A progestogen (norethisterone)
They are both female hormones.
Evorel Sequi comes in a ‘memory pack’. This can be used to help you
remember when to change your patches. Each pack contains eight
patches:
• Four ‘Evorel 50’ patches marked CE50 (containing estradiol only)
• Four ‘Evorel Conti’ patches marked CEN1 (containing estradiol and
norethisterone)
The hormones are spread evenly in each patch. They pass slowly into
your body through the skin.
What Evorel Sequi is used for
Evorel Sequi is used:
• For the symptoms of the menopause (see ‘What is the menopause?’).
It is only used in women who still have a womb. It is suitable for
women who have had the menopause (postmenopausal) or who are
around the time of the menopause (perimenopausal)
• To prevent osteoporosis (fragile bones) in women who have had the
menopause and are most likely to have bone problems. Evorel Sequi
is 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 Sequi works
Evorel Sequi is known as ‘continuous sequential’ HRT. This is because
two hormones are used one after another:
• Estradiol is used by itself for two weeks
• Then estradiol and norethisterone are used together for the next two
weeks
Evorel Sequi patches replace the oestrogen that is normally released by
the ovaries. However, 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 Conti patches used during weeks 3 and 4 contain
this progestogen
The shedding of the lining of the womb will probably give a ‘withdrawal
bleed’. This will be like having a period each month. The withdrawal
bleed will start during week 4, before you finish an Evorel Sequi pack.
Evorel Sequi is not a contraceptive.
2. Before you use Evorel Sequi
Do not use Evorel Sequi if:
• You are allergic to anything in the patches (listed in section 7 overleaf)
• 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 ever had blocked arteries (arterial thrombo-embolic disease)
that gave you angina or a heart attack or a stroke
• You have (or have ever had) a liver disease and your liver function
tests have not returned to normal
• 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
Sequi. Stop using Evorel Sequi at once if any of the above appears for
the first time and talk to your doctor immediately.
Evorel Sequi 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
Take special care with Evorel Sequi
Tell your doctor if you have ever had any of the following. You may need
to have checks more often.
• Vaginal bleeding which you could not explain
• 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 Sequi 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 and hearing (otosclerosis)
• Liver, heart or kidney problems
• High levels of triglycerides (a type of fat) 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 Sequi, 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 Sequi.
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)
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.

• A medicine for epilepsy called lamotrigine. Using Evorel Sequi 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 Sequi. 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 Sequi affects your ability to
drive or use machines. See how this medicine affects you before you
drive or use any tools or machines.
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 use 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 use any more HRT until your doctor says you can
These headaches may be an early warning sign of a stroke.
Blood clots
HRT is not recommended for women who have ever had a blood clot.
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 > 30 kg/m2)
• You have had a blood clot before
• 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)
• You have cancer
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 use 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)
HRT is not recommended for women who have ever had 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 Sequi, contains a progestogen. Evorel Sequi is only
used in women who still have a womb (see Section 1 ‘What Evorel Sequi
is used for’).
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 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 Sequi than you should
It is unlikely that you will have too much of the hormones in Evorel Sequi.
The most common symptoms of having too much oestrogen or
progestogen in your body are:
• Tender 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 and/
or progestogen. Talk to your doctor or pharmacist before using any more
patches.
Contraception while using Evorel Sequi
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

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, 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.
Dementia
Evorel Sequi and medicines like it will not stop memory loss (dementia).
Women who start using medicines like Evorel Sequi after the age of 65
may have a small increase in the risk of dementia.
4. How to use Evorel Sequi
Always use Evorel Sequi 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 Sequi
You may put an Evorel 50 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 50 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 50 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. You must use the
patches in the right order.
Weeks 1 and 2
Use the four Evorel 50 patches one at a time.
Weeks 3 and 4
Use the four Evorel Conti patches one at a time. As soon as you remove
your fourth Evorel 50 patch, replace it with the first Evorel Conti patch.
Start a new pack of Evorel Sequi 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:

Like all medicines, Evorel Sequi 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.
• Blood clots (thrombosis), 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 10 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 vaginal bleeding)
• Widespread rash with peeling skin and blistering in the mouth, eyes
and genitals (Stevens-Johnson syndrome) (frequency not known)
• Convulsions or fits (frequency not known)
Tell your doctor if you notice any of the following side effects while
using Evorel Sequi:
Very common (affects more than 1 in 10 people)
• Irritated, itchy red skin where the patch is applied
Common (affects less than 1 in 10 people)
• Feeling depressed or nervous
• Inappropriate signs of emotion
• Being unable to sleep
• Headache
• Itchy skin or red rash
• Feeling sick (nausea), or having stomach pain wind or other stomach
upsets
• Diarrhoea
• Pain including pain in the back, muscles, joints
• Breast pain
• Feeling generally unwell
• Weight gain
• Heavy vaginal bleeding, painful periods
• Water retention or build-up of fluid under the skin (oedema)
Uncommon (affects less than 1 in 100 people)
• Concentration problems
• Feeling dizzy
• More or less interest in sex than usual
• Allergic reaction (hypersensitivity)
• A fungal infection called thrush
• Feeling tired
• Being aware of your heartbeat (palpitations)
• Numb or tingling hands or feet, less skin sensitivity
• Breast lumps (non-cancerous)
• Fuller breasts
• Irregular vaginal bleeding
• Thickening of the lining of the womb
Frequency not known
• Mood swings
• Bloated feeling
• Gallstones
• Swelling of the hands and feet (peripheral oedema)
• Puffy skin where the patch is applied
If any of the side effects gets serious, or if you notice any other side
effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. 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 Sequi





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, moisturizer 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

Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package.
Do not use Evorel Sequi after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
• If your medicine shows any sign of deterioration, return it to your
pharmacist.
• Medicines should not be disposed of via wastewater 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
What Evorel Sequi contains
Each Evorel 50 transdermal patch contains 3.2mg estradiol (absorption
rate approximately 50 micrograms of estradiol in 24 hours).
Each Evorel Conti transdermal patch contains 3.2mg estradiol
(absorption rate approximately 50 micrograms estradiol in 24 hours) and
11.2mg norethisterone acetate (absorption rate approximately 170
micrograms of norethisterone acetate in 24 hours).
Each patch also contains siliconised polyethylene terephthalate foil which
is removed before application

The other ingredients are acrylate-vinylacetate copolymer, guar gum,
polyester film
What Evorel Sequi looks like and contents of the pack.
Evorel 50 is a square-shaped transparent patch with rounded corners
marked ‘CE 50’ and a metallic adhesive backing with an ‘S’-shaped split
for easy removal. Evorel Conti is a square-shaped transparent patch with
rounded corners marked ‘CEN1’ and has a transparent adhesive backing
with an ‘S’-shaped split for easy removal.
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
• With the protective backing facing you, bend
and peel off half the backing. Don’t touch the
sticky side - it may not stick properly if you do

Manufacturer
This medicine is manufactured by Janssen Pharmaceutica NV.
Belgium
Procured from within the EU by the Product Licence holder
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by xxxxxxxxxxxxxxxxxxxxxxxxxxxx
PL: 33532/0219

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 of the same type. If you have just had a bath or
shower, wait until your skin cools before applying the new patch.
It is always useful to keep a spare pack that you can use to replace
patches that have fallen off. Talk to your doctor if you need more
patches.

Leaflet dated 12th January 2015
Leaflet coded xxxxxxxxx
Evorel® is a registered trademark of Johnson & Johnson.
POM

Package Leaflet: Information for the User

Evorel® Sequi Transdermal Patches
(estradiol hemihydrate / norethisterone acetate)
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 effects and they become serious or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist

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

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

Taking these medicines with Evorel Sequi can stop it from working as
well. Because of this you may get some bleeding like a period, when you
are not expecting it.

1. What Evorel Sequi is and what it is used for
The name of your medicine is Evorel Sequi. It belongs to a group of
medicines called hormone replacement therapy (HRT).
Evorel Sequi contains two medicines:
• An oestrogen (estradiol)
• A progestogen (norethisterone)
They are both female hormones.
Evorel Sequi comes in a ‘memory pack’. This can be used to help you
remember when to change your patches. Each pack contains eight
patches:
• Four ‘Evorel 50’ patches marked CE50 (containing estradiol only)
• Four ‘Evorel Conti’ patches marked CEN1 (containing estradiol and
norethisterone)
The hormones are spread evenly in each patch. They pass slowly into
your body through the skin.
What Evorel Sequi is used for
Evorel Sequi is used:
• For the symptoms of the menopause (see ‘What is the menopause?’).
It is only used in women who still have a womb. It is suitable for
women who have had the menopause (postmenopausal) or who are
around the time of the menopause (perimenopausal)
• To prevent osteoporosis (fragile bones) in women who have had the
menopause and are most likely to have bone problems. Evorel Sequi
is 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 Sequi works
Evorel Sequi is known as ‘continuous sequential’ HRT. This is because
two hormones are used one after another:
• Estradiol is used by itself for two weeks
• Then estradiol and norethisterone are used together for the next two
weeks
Evorel Sequi patches replace the oestrogen that is normally released by
the ovaries. However, 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 Conti patches used during weeks 3 and 4 contain
this progestogen
The shedding of the lining of the womb will probably give a ‘withdrawal
bleed’. This will be like having a period each month. The withdrawal
bleed will start during week 4, before you finish an Evorel Sequi pack.
Evorel Sequi is not a contraceptive.
2. Before you use Evorel Sequi
Do not use Evorel Sequi if:
• You are allergic to anything in the patches (listed in section 7 overleaf)
• 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 ever had blocked arteries (arterial thrombo-embolic disease)
that gave you angina or a heart attack or a stroke
• You have (or have ever had) a liver disease and your liver function
tests have not returned to normal
• 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
Sequi. Stop using Evorel Sequi at once if any of the above appears for
the first time and talk to your doctor immediately.
Evorel Sequi 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
Take special care with Evorel Sequi
Tell your doctor if you have ever had any of the following. You may need
to have checks more often.
• Vaginal bleeding which you could not explain
• 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 Sequi 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 and hearing (otosclerosis)
• Liver, heart or kidney problems
• High levels of triglycerides (a type of fat) 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 Sequi, 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 Sequi.
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)
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.

• A medicine for epilepsy called lamotrigine. Using Evorel Sequi 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 Sequi. 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 Sequi affects your ability to
drive or use machines. See how this medicine affects you before you
drive or use any tools or machines.
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 use 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 use any more HRT until your doctor says you can
These headaches may be an early warning sign of a stroke.
Blood clots
HRT is not recommended for women who have ever had a blood clot.
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 > 30 kg/m2)
• You have had a blood clot before
• 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)
• You have cancer
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 use 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)
HRT is not recommended for women who have ever had 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 Sequi, contains a progestogen. Evorel Sequi is only
used in women who still have a womb (see Section 1 ‘What Evorel Sequi
is used for’).
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 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 Sequi than you should
It is unlikely that you will have too much of the hormones in Evorel Sequi.
The most common symptoms of having too much oestrogen or
progestogen in your body are:
• Tender 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 and/
or progestogen. Talk to your doctor or pharmacist before using any more
patches.
Contraception while using Evorel Sequi
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

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, 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.
Dementia
Evorel Sequi and medicines like it will not stop memory loss (dementia).
Women who start using medicines like Evorel Sequi after the age of 65
may have a small increase in the risk of dementia.
4. How to use Evorel Sequi
Always use Evorel Sequi 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 Sequi
You may put an Evorel 50 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 50 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 50 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. You must use the
patches in the right order.
Weeks 1 and 2
Use the four Evorel 50 patches one at a time.
Weeks 3 and 4
Use the four Evorel Conti patches one at a time. As soon as you remove
your fourth Evorel 50 patch, replace it with the first Evorel Conti patch.
Start a new pack of Evorel Sequi 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:

Like all medicines, Evorel Sequi 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.
• Blood clots (thrombosis), 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 10 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 vaginal bleeding)
• Widespread rash with peeling skin and blistering in the mouth, eyes
and genitals (Stevens-Johnson syndrome) (frequency not known)
• Convulsions or fits (frequency not known)
Tell your doctor if you notice any of the following side effects while
using Evorel Sequi:
Very common (affects more than 1 in 10 people)
• Irritated, itchy red skin where the patch is applied
Common (affects less than 1 in 10 people)
• Feeling depressed or nervous
• Inappropriate signs of emotion
• Being unable to sleep
• Headache
• Itchy skin or red rash
• Feeling sick (nausea), or having stomach pain wind or other stomach
upsets
• Diarrhoea
• Pain including pain in the back, muscles, joints
• Breast pain
• Feeling generally unwell
• Weight gain
• Heavy vaginal bleeding, painful periods
• Water retention or build-up of fluid under the skin (oedema)
Uncommon (affects less than 1 in 100 people)
• Concentration problems
• Feeling dizzy
• More or less interest in sex than usual
• Allergic reaction (hypersensitivity)
• A fungal infection called thrush
• Feeling tired
• Being aware of your heartbeat (palpitations)
• Numb or tingling hands or feet, less skin sensitivity
• Breast lumps (non-cancerous)
• Fuller breasts
• Irregular vaginal bleeding
• Thickening of the lining of the womb
Frequency not known
• Mood swings
• Bloated feeling
• Gallstones
• Swelling of the hands and feet (peripheral oedema)
• Puffy skin where the patch is applied
If any of the side effects gets serious, or if you notice any other side
effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. 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 Sequi





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, moisturizer 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

Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package.
Do not use Evorel Sequi after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
• If your medicine shows any sign of deterioration, return it to your
pharmacist.
• Medicines should not be disposed of via wastewater 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
What Evorel Sequi contains
Each Evorel 50 transdermal patch contains 3.2mg estradiol (absorption
rate approximately 50 micrograms of estradiol in 24 hours).
Each Evorel Conti transdermal patch contains 3.2mg estradiol
(absorption rate approximately 50 micrograms estradiol in 24 hours) and
11.2mg norethisterone acetate (absorption rate approximately 170
micrograms of norethisterone acetate in 24 hours).
Each patch also contains siliconised polyethylene terephthalate foil which
is removed before application

The other ingredients are acrylate-vinylacetate copolymer, guar gum,
polyester film
What Evorel Sequi looks like and contents of the pack.
Evorel 50 is a square-shaped transparent patch with rounded corners
marked ‘CE 50’ and a metallic adhesive backing with an ‘S’-shaped split
for easy removal. Evorel Conti is a square-shaped transparent patch with
rounded corners marked ‘CEN1’ and has a transparent adhesive backing
with an ‘S’-shaped split for easy removal.
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
• With the protective backing facing you, bend
and peel off half the backing. Don’t touch the
sticky side - it may not stick properly if you do

Manufacturer
This medicine is manufactured by Janssen Pharmaceutica NV.
Belgium
Procured from within the EU by the Product Licence holder
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by xxxxxxxxxxxxxxxxxxxxxxxxxxxx
PL: 33532/0219

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 of the same type. If you have just had a bath or
shower, wait until your skin cools before applying the new patch.
It is always useful to keep a spare pack that you can use to replace
patches that have fallen off. Talk to your doctor if you need more
patches.

Leaflet dated 12th January 2015
Leaflet coded xxxxxxxxx
Evorel® is a registered trademark of Janssen-Cilag Ltd.
POM

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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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