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FEMSEVEN- SEQUI PATCHES

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PATIENT INFORMATION LEAFLET

FEMSEVEN® SEQUI PATCHES
50 MICROGRAMS/10 MICROGRAMS/
24 HOURS TRANSDERMAL PATCHES
Estradiol Hemihydrate and Levonorgestrel

Your medicine is available using the above name but will be referred to
as FemSeven Sequi Patches 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.

Take special care with FemSeven Sequi Patches

Stop using FemSeven Sequi Patches and contact your doctor
immediately, if you get a pain in your chest that spreads to your
arm or neck. The pain may be a sign of a heart disease.
There is no evidence that HRT will help to prevent heart disease.
Women taking oestrogen-progestogen HRT are slightly more likely to
get heart disease than those not taking any HRT. As the risk of CAD
strongly depends on age, the number of extra cases of CAD due to
oestrogen-progestogen use is very low in healthy women close to
menopause, but will rise with more advanced age.

If you have an increased risk of developing blood clots (see “HRT
and effects on heart or blood circulation”),
If you have a high blood sugar level (diabetes) with or without
vascular disorders,

Stop using FemSeven Sequi Patches and contact your doctor
immediately if you get: unexplained migraine-like headaches, with or
without disturbed vision. Such headaches can be an early sign of a
stroke.
Combined oestrogen-progestogen and oestrogen-only HRT increase the
risk of stroke up to 1.5-fold. The risk of users compared to non-users
does not change with age or time since menopause. However, as the
risk of stroke is strongly age-dependent, the overall risk of stroke in
women who use HRT will increase with age.

If you have a benign tumour in your uterus (uterine fibroma),
If you have a history of excessive proliferation of cells in the inner
lining (endometrial hyperplasia),

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 have an increased risk of developing tumours related to the
levels of oestrogens in the blood (such as having a close relative
with breast cancer),

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

If you have liver or gallbladder disease (hepatic adenoma,
gallstones),

In this leaflet:

What FemSeven Sequi Patches are and what they are used for
Before you use FemSeven Sequi Patches
How to use FemSeven Sequi Patches
Possible side effects
How to store FemSeven Sequi Patches
Further information

1. What FemSeven Sequi Patches are and what
they are used for
FemSeven Sequi Patches are a sequential combined Hormone
Replacement Therapy (HRT). They contain an oestrogen (estradiol) and
a progestogen (levonorgestrel). FemSeven Sequi Patches are suitable
for postmenopausal women.
During the menopause, the amount of oestrogen produced by a
woman’s body drops. For some women this can cause symptoms such
as hot face, neck and chest ("hot flushes"). FemSeven Sequi Patches
alleviate these symptoms after menopause.
The experience treating women above the age of 65 is limited.

2. Before you use FemSeven Sequi Patches
You should fully inform your doctor about your personal medical history
and that of your immediate family, before starting with hormone
replacement therapy (HRT).

Medical examinations and tests

Your doctor will ask you to undergo a medical examination before
beginning treatment then regularly during the treatment (at least once
a year) to check whether your body is tolerating the medication.
Your breasts will be regularly examined by your doctor, especially if you
have any lumps (cysts or nodules) or if anybody in your family has
already had breast cancer.
Your doctor may ask you to have a mammography.
From time to time, at least once a year, the risks and benefits of HRT
treatment should be carefully reassessed to determine if the treatment
should be continued.

Do not use FemSeven Sequi Patches

if you are allergic (hypersensitive) to one of the active substances
(Estradiol or Levonorgestrel) or any of the other ingredients of
FemSeven Sequi Patches (see also section 6).
If you have, have had or your doctor thinks you might have breast
cancer.
if you have previously had a blockage of one of your veins in your
leg or lungs (deep venous thrombosis or lung embolism), or if you
currently have such a blockage.
if you have thrombophilic disorders (e.g. protein C, protein S, or
anthithrombin deficiency).
if you currently have or have recently had a blockage of an artery,
for example, angina pectoris (heart cramp due to an oxygen
deficiency) a heart attack or stroke.
If you have, or your doctor thinks you might have, breast, uterine
or any other cancer requiring a hormone to develop (oestrogendependent cancer).
If there is excessive proliferation of cells in the inner lining
(endometrial hyperplasia) that has not been treated yet.
If you experience unexplained vaginal bleeds.
If you currently have or have previously had a liver disorder. You
must not use FemSeven Sequi Patches for as long as the liver
function has not returned to normal
If you have a (herediatary) disorder in the composition of the blood
pigment (porphyria).

HRT will not improve thought processes. There are hints of an increased
risk of probable dementia in women who start using HRT after the age
of 65.
Consult your doctor if one of the above-mentioned warnings should
apply to you, or if it has previously applied to you.

Taking or using other medicines

Some medications can alter the effectiveness of FemSeven Sequi
Patches in particular if you are taking:
a medicine to treat epilepsy (carbamazepin, phenobarbital,
phenytoin),

Risk of stroke:

If you have a disease leading to the presence of uterine mucosa
outside your uterus causing pain and bleeding (endometriosis),

If you have any further questions, ask your doctor or pharmacist.

1.
2.
3.
4.
5.
6.

Disorders of the coronary arteries:

Tell your doctor if you have or have previously had any of the following
disorders and/or if these conditions have been aggravated during
pregnancy or previous hormone therapy, before you start using
FenSeven Sequi Patches.
If you have high blood pressure,

Compare
Looking at women in their 50s who are not taking HRT, on average,
over a 5-year period, 8 in 1000 would be expected to have a stroke.
For women in their 50s who are taking HRT over 5 years, the number of
extra cases will be 3 in 1000 users.

If you suffer from epilepsy,
If you have severe headaches or migraines,
If you have asthma,
If you have a serious immune disease that affects your skin in
particular (lupus),

HRT and risks of developing cancer

Overgrowth of the lining of the womb (endometrial hyperplasia) and
cancer of the womb lining (endometrial cancer).
Long-term use of estrogen increases the risk of overgrowth of the lining
of the womb (endometrial hyperplasis) and the risk of endometrial
cancer in women with a uterus. To reduce this risk it is necessary to
take the estrogens in combination with progestogen tablets for at least
12 days of each month.
During the first months of treatment irregular bleeding may occur.
Contact your doctor if
such bleeding carries on for more that the first few months of
treatment

If you have a disease causing loss of hearing (otosclerosis).

Stop using FemSeven Sequi Patches immediately

If you experience any of the disorders mentioned under “Do not use
FemSeven Sequi Patches”, or if any of the following situations occurs:
you experience a yellowing of the skin (jaundice) or your liver
function deteriorates;
your blood pressure suddenly becomes much higher;
you get a migraine-like headache for the first time;
you become pregnant.

starts after you have been on FemSeven Sequi Patches for a while

Note: FemSeven Sequi Patches is not a transdermal contraceptive and
does not prevent you from becoming pregnant.

carries on even after you have stopped using FemSeven Sequi
Patches

You must also inform your doctor if:

Your doctor will examine what the cause is which may include a biopsy
of the womb lining in order to find out whether you have cancer of the
womb lining.

You are to undergo surgery.

You have to remain immobilised for a long period.
You have contracted another disease.

Compare
Looking at women who still have a womb and who are not taking HRT,
on average 5 in 1000 will be diagnosed with endometrial cancer.
For women who take oestrogen-only HRT, the number of extra-cases
will be between 5 and 55 in 1000 users between the ages of 50 and 65
depending on the dose and for how long it is taken.
The addition of a progestogen to oestrogen-only HRT substantially
reduces the risk of endometrial cancer.

What risks are associated with the use of FemSeven
Sequi Patches?
HRT and effects on heart or blood circulation

Blood clots (thrombosis):
Immediately inform your doctor if you have painful swelling of
one of your legs, sudden pain in the chest, or shortness of
breath while using FemSeven Sequi Patches. This could be a sign
of venous thrombosis or a lung embolism while, in which case
you must stop using FemSeven Sequi Patches immediately.
HRT increases the risk of VTE 1.3-3 fold, especially during the first year
of taking it.

Breast cancer:

Evidence suggests that taking combined oestrogen-progestogen
and possibly also oestrogen-only HRT increases the risk of breast
cancer. This depends on how long you take HRT, and the extra risk is
visible after about 3 years. However, it returns to normal within a few
(at most five) years after stopping.
Contact your doctor if you notice changes to your breasts, such as:
dimpling of the breast, skin changes in the nipple, lumps that you can
see or feel.
Your doctor may advice you to undergo a check up including
mammography.

Compare
Looking at women in their 50s who are not taking HRT, on average,
over a 5-year period, 4 in 1000 would be expected to get a blood clot.
For women in their 50s who are taking HRT over 5 years, the number of
extra cases will be 5 in 1000 users.
The risk of venous thrombosis is greater:
If you use oestrogens;
With older age;

Compare
Looking at women aged 50 to 65 who are not taking HRT, on average
9-12 in 1000 will be diagnosed with breast cancer over a 5 year period.
For women aged 50-65 who are taking oestrogen plus progestogen HRT
over 5 years the number of extra-cases will be 6 in 1000 users.
Looking at women aged 50 to 79 who are not taking HRT, on average
14 in 1000 will be diagnosed with breast cancer over a 5 year period.
For women aged 50-79 who are taking oestrogen plus progestogen HRT
over 5 years the number of extra cases will be 4 in 1000 users.

If you have a cancer;
During pregnancy and postpartum period;
If there is venous thrombosis in your immediate family;
If you are severely overweight;
If you have systemic lupus erythematosus (a disorder of the
immune system);
If you have any blood clotting problem that needs long-term
treatment with a medicine used to prevent blood clots

Ovarian cancer:

If you are immobilised for long periods (e.g. when you must have
bed rest), have an accident or a major surgery. In these
circumstances it might be necessary for you to stop using
FemSeven Sequi Patches temporarily. You may need to stop as
early 4-6 weeks before planned surgery.

a medicine to treat tuberculosis or other infectious diseases
(rifampicin, rifabutin),
a medicine to treat AIDS (ritonavir, nelfinavir, nevirapine,
efavirenz),
a medicine containing St. John’s Wort (Hypericum perforatum).
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.

Pregnancy and breast-feeding

You should not use FemSeven Sequi Patches if you are pregnant or
breastfeeding.
If you discover that you are pregnant while using this medication, stop
the treatment and discuss the situation with your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No specific side effect is expected.

3. How to use FemSeven Sequi Patches
Always use FemSeven Sequi Patches exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not
sure.
You should apply the patch once a week i.e. replace it every 7 days
without a break in treatment: as soon as you remove one patch, you
should apply another one to your skin.
There are 2 types of patches in the box, depending on when you apply
one:
Phase 1 patches (1st and 2nd weeks of your cycle): they contain
only one active substance (Estradiol).
Phase 2 patches (3rd and 4th weeks of your cycle): they contain
both active substances (Estradiol and Levonorgestrel).
If you are not taking HRT or you switch from a continuous combined
HRT product, treatment may be started on any convenient day.
If you are transferring from a sequential HRT regimen, treatment should
begin the day following completion of the prior regimen.

Frequency of application:
1.

Apply a Phase 1 patch once a week for the first 2 weeks of your
cycle.
2. Remove the Phase 1 patch and apply a Phase 2 patch in its place,
once a week for the following 2 weeks.
You must apply the patches in the correct order.
Bleeding similar to periods usually occurs at the end of the use of the
Phase 2 patches. The bleeding is light and lasts for 4 to 5 days on
average.
If the bleeding is heavy or irregular, consult your doctor.

Method of administration

This medicine should be applied to the skin.

How to apply a patch?

Each sachet contains one patch.
FemSeven Sequi Patches must be applied immediately after being
removed from its sachet.
1. To open the sachet, tear the two edges in the
direction of the arrow.

2.

Remove the patch from the sachet. A patch
has two sections: the patch itself, which must
be applied to the skin, and the protective
liner.

3.

Remove one-half of the liner, starting at the
S-shaped notch and taking care not to touch
the adhesive side of the patch with your
fingers. If you do, it may not adhere correctly
and you may alter the active ingredients.

Ovarian cancer is much rarer than breast cancer. Longterm (at least
5-10 years) use of oestrogen-only HRT products is thought to carry a
slightly increased risk of ovarian cancer. Some studies suggest that the
long-term use of combined HRTs may carry a similar, or slightly
smaller, risk. For women who are taking HRT over 5 years there will be
one extra case per 2500 users.

It is unclear whether having varicose veins leads to an increased risk of
venous thrombosis.
If any of these situations apply to you, please inform your doctor. If you
are using an anticoagulant, the risks and benefits of using HRT have to
be carefully evaluated.

HRT and other disorders:

If you suffer from cardiac or kidney dysfunction you will have to be
monitored while using FemSeven Sequi Patches
If you have very high triglyceride levels in your blood
(hypertriglyceridaemia) you will have to be monitored when using
FemSeven Sequi Patches.

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4.

5.

Apply the patch immediately, using the
palm of your hand, to a dry, clean area of
skin. It should not be red or covered with
cream or lotion. The location should not
have any significant wrinkles and it should
not be rubbed by clothing (avoid placing at
the waist and do not wear very tight
clothing). The patch may be applied, for
example, to the buttocks, thighs, abdomen
etc.
Remove the other part of the plastic liner
and press down on the corresponding area
of the patch.

4. Possible side effects

6. Further Information

Like all medicines, FemSeven Sequi Patches can cause side effects,
although not everybody gets them.

What FemSeven Sequi Patches contain?

This pack contains two types of patches:
Phase 1: Each patch contains 1.5mg of estradiol hemihydrate as the
active ingredient. The patches deliver 50 micrograms of Estradiol in
each 24 hour period.

The following side effects may occur the most frequently
(in more than 1 in 10 patients treated).
Skin reaction (itching, irritation, redness) in the area in which the
patch is applied. These signs are not serious and usually disappear
2 or 3 days after removing the patch. If they persist, place the
patch in a different area.

Phase 2: Each patch contains 1.5mg of estradiol hemihydrate and
1.5mg of levonorgestrel as the active ingredients. The patches deliver
50 micrograms of Estradiol and 10 micrograms of Levonorgestrel in
each 24 hour period.

The following side effects may occur frequently (in
1 to 10 people in 100):

Estradiol and levonorgestrel are both hormones. Estradiol is a type of
oestrogen and levonorgestrel is a type of progestogen.

Tightness or pain in the breasts.

The inactive ingredients are: transparent polyethylene terephthalate
(PET) foil, styrene-isoprene-styrene block copolymer,
glycerine esters of completely hydrogenated resins and
siliconised transparent polyethylene terephthalate (PET) foil.

Headaches.
Nausea, vomiting.
Irregular bleeding, spotting.
6.

Keep the palm of your hand on the patch
for at least 30 seconds to ensure that it is
adhering correctly, especially round the
edges. The pressure and heat of the hand
are essential to ensure maximum adhesion.

Increase or decrease in sexual desire.

What FemSeven Sequi Patches look like and contents of
the pack

The following potential side effects are less frequent
(in 1 to 10 people in 1,000):

Abnormal development of the lining of the uterus (endometrial
hyperplasia).

How to remove the patch?

To remove a FemSeven Sequi Patch, simply free up one edge and pull it
off gently so as not to irritate the skin. If any of the adhesive remains
on the skin, you can remove it by rubbing the skin gently with a cream
or an oily lotion.
After use, the patch still contains active substances, but in too small a
quantity for it to remain effective. Fold the patch in half (adhesive to
adhesive) before discarding it.

Precautions for use

Do not apply a FemSeven Sequi Patch:
to your breasts.
Twice in the same place: leave at least 1 week between
2 applications in the same place.
During the course of treatment:
You must not expose the patch directly to the sun once you have
applied it to your skin.
You can shower or take a bath with the patch on your skin.
If the patch becomes unstuck before the end of its use i.e. before
the 7th day (for example if you have undertaken intense physical
effort or perspire abundantly or the skin is rubbed by clothes), use a
new patch (from the same phase) and remove it at the initially
scheduled date.

Duration of treatment

Your doctor will decide on the duration of treatment.
Contact your doctor if you want to stop the treatment.

If you use more FemSeven Sequi Patches than you
should
Overdose is unlikely but it can cause the following:
pain in the breasts,

bloating in the abdomen, flatulence, nausea and vomiting,
irritability, anxiety,
vaginal bleeding.
No specific treatment is required. The signs will disappear when the
patch is removed.

If you forget to use FemSeven Sequi Patches

If you have forgotten to change the patch on the scheduled day,
replace it immediately then follow the treatment normally, changing
the patch again on the initially scheduled day.
Do not use 2 patches at the same time to make up for the single
dose that you have forgotten.
If you have not used FemSeven Sequi Patches for several
successive days, you may get stop bleeding. If you are in doubt,
consult your doctor.

If you stop using FemSeven Sequi Patches

The postmenopausal signs linked to a lack of oestrogen may reappear.
If you have any further questions, ask your doctor or your pharmacist.

Painful periods.

FemSeven Sequi Patches are octagonal, transparent, flexible, roundededge transdermal matrix patches located on an oversized removable
protective liner.
Each pack contains four (2 x Phase 1 and 2 x Phase 2) patches to
provide you with one month’s treatment respectively.

High blood pressure.

Manufacturer

Benign breast tumour.

Bloating or pain in the abdomen.

FemSeven Sequi Patches are manufactured by:
Laboratoire THERAMEX, Monaco, France.
Or
Merck KGaA, Darmstadt, Germany.

Fatigue.
Weight gain or loss.
Migraine.

Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Vertigo.
Cramp in the legs.

Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

Swelling (water retention, oedema).

The following side effects may occur but are rare
(1 to 10 people in 10,000):

PL No: 08929/0269

POM

Leaflet revision and issue date (Ref): 22.02.12

Yellowing of the skin and whites of the eye (jaundice).
Benign tumour in the uterus (uterine fibroma).

FemSeven® is a registered trademark of Merck KGaA.

Gall stones.
Depression.

The following side effects can also occur:
Breast cancer or uterine (endometrial) cancer.

Formation of a blood clot in a vein in the leg (phlebitis) or lungs
(pulmonary embolus).
Formation of a blood clot in brain (stroke) or heart (heart attack).
Gallbladder problems.
Mental disorders (dementia).
Disorders of the skin, or subcutaneous disorders such as:
Formation of brown spots on the face after exposure to sunlight,
also referred to as a mask of pregnancy (chloasma).
Skin disease with spots in the form of red marks and blisters
filled with liquid (erythema multiforme).
Skin disease with the formation of lumps under the skin that are
red and painful (erythema nodosum).
Minor skin bleeds (Henoch-Schönlein purpura).
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store FemSeven Sequi Patches
Do not store above 30°C.
KEEP THEM OUT OF THE REACH AND SIGHT OF CHILDREN.
Keep your patches in the sachets they come in until just before you
need each one.
Do not use the patches after the expiry date which is printed on the
box label and sachet label.
Do not use your patches if you notice any visible signs of
deterioration.
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.

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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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