EVOREL SEQUI

Active substance: NORETHISTERONE ACETATE MICRONISED

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Evorel® Sequi
Estradiol hemihydrate, norethisterone acetate
Evorel is a registered trademark
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 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

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 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.

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What Evorel Sequi is used for
Evorel Sequi is used:
For the symptoms of the menopause (see „What is the menopause?‟ on the
next page). 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 (weakening of the 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. This is called a hysterectomy.
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.

2. Before you use Evorel Sequi
Do not use Evorel Sequi if:
You are allergic to anything in the patches (listed in section 7 below)
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
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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
Do not use this medicine if any of the above applies to you.
Do not use Evorel Sequi if:
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.
Take special care with Evorel Sequi
Check with your doctor before using Evorel Sequi 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 Sequi, but you should discuss this with your
doctor first.
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
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 Sequi if your blood pressure goes up
Diabetes
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Tell your doctor if these illnesses return or get worse while you are using
Evorel Sequi.

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
Bone formation in the ear (otosclerosis)
Heart or kidney problems
High levels of triglycerides in your blood
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
Tell your doctor if these illnesses return or get worse while you are using Evorel
Sequi.
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.
In particular, tell your doctor or pharmacist if you are taking any of the
following:
Medicines for epilepsy such as phenobarbital, phenytoin or carbamazepine
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 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.
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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 with one type of HRT (containing a different oestrogen and progestogen
to that in Evorel Sequi) have shown that women may be slightly more likely to
get heart disease during the first year of taking that type of HRT. For other types
of HRT (like Evorel Sequi) the risk is likely to be similar. However, this is not yet
certain.
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
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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
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)
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?

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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

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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.

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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. 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 oestrogen-only HRT for
more than 5 years may increase the risk of ovarian cancer. It is not yet known
whether other kinds of HRT increase the risk in the same way.

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.
Do not use a patch if its protective pouch is open.
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.

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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:
If you put your
first patch on:
Monday



Change on:
Thursday

&

Change again on:
Monday

Tuesday



Friday

&

Tuesday

Wednesday



Saturday

&

Wednesday

Thursday



Sunday

&

Thursday

Friday



Monday

&

Friday

Saturday



Tuesday

&

Saturday

Sunday



Wednesday

&

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
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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 skin as soon as you open the protective
pouch

Putting a patch on
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
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.

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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.
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
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 periods)
Widespread rash with peeling skin and blistering in the mouth, eyes and
genitals (Stevens-Johnson syndrome) (frequency not known)
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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, redskin 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.

6. How to store Evorel Sequi
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Keep out of the reach and sight of children. It should be stored at room
temperature (at or below 25°C).
Do not use Evorel Sequi 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 its protective pouch is open.

7. Further information
The active substances in Evorel Sequi are estradiol hemihydrate and
norethisterone acetate.
Each Evorel 50 patch contains 3.2 mg of estradiol hemihydrate. Each Evorel 50
patch delivers 50 micrograms of estradiol a day.
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 a day.
The other ingredients are Duro-Tak 387-2287 (this makes the patches sticky),
guar gum and Hostaphan MN19 (backing film).
What Evorel Sequi looks like and contents of the pack
Evorel Sequi comes in a memory pack containing four Evorel 50 patches
(marked CE50) and four Evorel Conti patches (marked CEN1).
Both types of patch 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 and has a surface area of 16 sq cm.
The product licence is held by:
JANSSEN-CILAG LTD, 50-100 Holmers Farm Way, High Wycombe,
Buckinghamshire HP12 4EG, UK
Evorel Sequi is made by:
Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
OR
McGregor Cory Ltd, Middleton Close, Banbury, Oxfordshire OX16 4RS, UK

For information in large print, tape, CD or Braille, telephone
0800 7318450.
This leaflet was last approved in April 2012

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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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