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FEMSEVEN SEQUI

Active substance(s): ESTRADIOL HEMIHYDRATE / LEVONORGESTREL / ESTRADIOL HEMIHYDRATE / LEVONORGESTREL / ESTRADIOL HEMIHYDRATE / LEVONORGESTREL

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S1324 LEAFLET Femseven 20170710

S1324 LEAFLET Femseven 20170710

If you forget to take Femseven Sequi, Patch

Reporting of side effects



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 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



If you have not used Femseven Sequi, Patch for several
successive days, you may get stop bleeding. If you are in doubt,
consult your doctor.
If you stop using Femseven Sequi, Patch
The postmenopausal signs linked to a lack of oestrogen may
reappear.
If you have any further questions, ask your doctor or your
pharmacist.
4. Possible side effects
Like all medicines, Femseven Sequi, Patch can cause side effects,
although not everybody gets them.
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.

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


Tightness or pain in the breasts.



Headaches.



Nausea, vomiting.



Irregular bleeding, spotting



Increase or decrease in sexual desire.

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


Benign breast tumour.



Painful periods.



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



High blood pressure.



Bloating or pain in the abdomen.



Fatigue.



Weight gain or loss.



Migraine.



Vertigo.



Cramp in the legs.

 Swelling (water retention, oedema).
The following side effects may occur but are rare (1 to 10
people in 10,000):

PATIENT INFORMATION LEAFLET

By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Femseven Sequi, Patch
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Keep this leaflet. You may need to read it again.



Do not store Femseven Sequi patches above 30°C.



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



Keep your patches in the original package.





Do not use patches after the expiry date on the pack.



Take unused patches or patches that have passed their expiry
date back to the pharmacist for disposal.

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 the patches look tampered with or shows any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.



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.

6. Further information
What Femseven Sequi, Patch contains


This pack contains two types of patches:



Phase 1 patches contain 1.5 milligrams of estradiol hemihydrate
as the active ingredient. The patches deliver 50 micrograms of
estradiol in each 24 hour period.





Phase 2 patches contain 1.5 milligrams estradiol hemihydrate
and 1.5 milligrams levonorgestrel as active ingredients. The
patches deliver 50 micrograms of estradiol and 10 micrograms
of levonorgestrel in each 24 hour period.
The inactive ingredients are: transparent polyethylene
terephthalate foil, styrene-isoprene-styrene block copolymer,
glycerine esters of completely hydrogenated resins and the
removable siliconised transparent polyethylene terephthalate
foil.

What Femseven Sequi, Patch looks like and contents of the
pack


Femseven Sequi, patches are octagonal, transparent, flexible
patches with rounded edges. Each patch is coated with
adhesive and is mounted on an oversized, removable,
protective liner. The adhesive is made of a mixture of polymer
and modified resin containing the active ingredients.

These products are manufactured by TEVA PHARMACEUTICALS



Gall stones

EUROPE B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands



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 you have, or your doctor thinks you might have, breast,
uterine or any other cancer requiring a hormone to develop
(oestrogen-dependent 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, Patch 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).

Take special care with Femseven Sequi, Patch



If you have high blood pressure,

4. Possible side effects



If you have an increased risk of developing blood clots (see
“HRT and effects on heart or blood circulation”),

6. Further information



If you have a high blood sugar level (diabetes) with or without
vascular disorders

1. What Femseven Sequi, Patch is and what it is used for



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

Femseven Sequi, Patch is a sequential combined Hormone
Replacement Therapy (HRT). It contains an oestrogen (estradiol)
and a progestogen (levonorgestrel). Femseven Sequi, Patch is
suitable for postmenopausal women.



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),

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,
Patch alleviates these symptoms after menopause.



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

The experience treating women above the age of 65 is limited.


If you suffer from epilepsy,

2. Before you use Femseven Sequi, Patch



If you have severe headaches or migraines,

You should fully inform your doctor about your personal medical
history and that of your immediate family, before starting with
hormone replacement therapy (HRT)



If you have asthma,



If you have a serious immune disease that affects your skin in
particular (lupus),

Medical examinations and tests

 If you have a disease causing loss of hearing (otosclerosis).
Stop using Femseven Sequi, Patch immediately

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.

Benign tumour in the uterus (uterine fibroma).

Formation of a blood clot in a vein in the leg (phlebitis) or lungs
(pulmonary embolus).

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

3. How to use Femseven Sequi, Patch

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Limited, Chemilines House,
Alperton Lane, Wembley, Middlesex, HA0 1DX.







2. Before you use Femseven Sequi, Patch

1. What Femseven Sequi, Patch is and what it is used for

 Each pack contains four (2 x Phase 1 and 2 x Phase 2).
Product Licence holder

Manufacturer

Breast cancer or uterine (endometrial) cancer.

if you have thrombophilic disorders (e.g. protein C, protein S, or
anthithrombin deficiency)

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 Femseven Sequi, Patch.

In this leaflet:

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.

Leaflet revision date: 10 July 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
FemSeven is a trademark of Merck KGaA, Germany.
S1324 LEAFLET Femseven 20170710



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;

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.



you become pregnant.



PL : 19488/1324

If you experience any of the disorders mentioned under “Do not use
Femseven Sequi, Patch”, or if any of the following situations occurs:

Your doctor may ask you to have a mammography.

Do not use Femseven Sequi, Patch
POM



5. How to store Femseven Sequi, Patch

Yellowing of the skin and whites of the eye (jaundice).



Your medicine is known by name FemSeven Sequi
50mcg/10mcg/24 hours but will be referred to as Femseven Sequi,
Patch throughout the following leaflet.
Read all of this leaflet carefully before you start using this
medicine.





 Depression.
The following side effects can also occur:

®

FemSeven Sequi
50mcg/10mcg/24 hours
(estradiol /levonorgestrel)

Note: Femseven Sequi, Patch is not a transdermal contraceptive
and does not prevent you from becoming pregnant.
You must also inform your doctor if:

if you are allergic (hypersensitive) to one of the active
substances (Estradiol or Levonorgestrel) or any of the other
ingredients of Femseven Sequi, Patch (see also section 6).



You are to undergo surgery.



You have to remain immobilised for a long period.



If you have, have had or your doctor thinks you might have
breast cancer.



You have contracted another disease.



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

What risks are associated with the use of Femseven Sequi,
Patch?
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, Patch. This could be a
sign of venous thrombosis or a lung embolism while, in which
case you must stop using Femseven Sequi, Patch immediately.
HRT increases the risk of VTE 1.3-3 fold, especially during the first
year of taking it.

HRT and risks of developing cancer

Taking or using other medicines

Overgrowth of the lining of the womb (endometrial hyperplasia) and
cancer of the womb lining (endometrial cancer).

Some medications can alter the effectiveness of Femseven Sequi,
Patch in particular if you are taking:

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 an 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.



a medicine to treat epilepsy (carbamazepin, phenobarbital,
phenytoin),

4. 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.



a medicine to treat tuberculosis or other infectious diseases
(rifampicin, rifabutin),

5. Remove the other part of the plastic liner and press down on
the corresponding area of the patch.



a medicine to treat AIDS (ritonavir, nelfinavir, nevirapine,
efavirenz),



a medicine containing St. John’s Wort (Hypericum perforatum).

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.

During the first months of treatment irregular bleeding may occur.
Contact your doctor if


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;



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 longterm
treatment with a medicine used to prevent blood clots



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, Patch temporarily. You may need to stop as
early 4-6 weeks before planned surgery.

such bleeding carries on for more that the first few months of
treatment



starts after you have been on Femseven Sequi, Patch for a
while



carries on even after you have stopped using Femseven Sequi,
Patch

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.
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 extracases 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.
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.

It is unclear whether having varicose veins leads to an increased
risk of venous thrombosis.

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.

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.

Your doctor may advice you to undergo a check up including
mammography.

Disorders of the coronary arteries:
Stop using Femseven Sequi, Patch 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 oestrogenprogestogen use is very low in healthy women
close to menopause, but will rise with more advanced age.
Risk of stroke:
Stop using Femseven Sequi, Patch 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 agedependent, the overall risk of stroke in women who use HRT will
increase with age.

Compare

For women in their 50s who are taking HRT over 5 years, the
number of extra cases will be 3 in 1000 users.

You should not use Femseven Sequi, Patch 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, Patch
Always use Femseven Sequi, Patch 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.

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.

If you are transferring from a sequential HRT regimen, treatment
should begin the day following completion of the prior regimen.

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.

1. Apply a Phase 1 patch once a week for the first 2 weeks of your
cycle.

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.
Ovarian cancer:
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.
HRT and other disorders:

Frequency of application:

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, Patch must be applied immediately after being
removed from its sachet.



If you suffer from cardiac or kidney dysfunction you will have to
be monitored while using Femseven Sequi, Patch



1. To open the sachet, tear the two edges in the direction of the
arrow.

If you have very high triglyceride levels in your blood
(hypertriglyceridaemia) you will have to be monitored when
using Femseven Sequi, Patch.

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.

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.

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

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.

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.

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 take more Femseven Sequi, Patch 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.

S1324 LEAFLET Femseven 20170710

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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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