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FEMSEVEN SEQUI

Active substance(s): ESTRADIOL HEMIHYDRATE / LEVONORGESTREL

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Package Leaflet: information for the user

FemSeven® Sequi
50 micrograms/10 micrograms/24 hours transdermal patch
estradiol/levonorgestrel
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 any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
In this leaflet:
1. What FEMSEVEN SEQUI®, PATCH is and what it is
used for
2. Before you use FEMSEVEN SEQUI ®, PATCH
3. How to use FEMSEVEN SEQUI ®, PATCH
4. Possible side effects
5. How to store FEMSEVEN SEQUI®, PATCH
6. Further information

1. WHAT FEMSEVEN SEQUI®, PATCH IS
AND WHAT IT IS USED FOR
FEMSEVEN SEQUI® is a sequential combined
Hormone Replacement Therapy (HRT). It contains an
oestrogen (estradiol) and a progestogen
(levonorgestrel). FEMSEVEN SEQUI® is 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®
alleviates these symptoms after menopause.
The experience treating women above the age of 65
is limited.

2. BEFORE YOU USE FEMSEVEN SEQUI®,
PATCH
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®, PATCH

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• if you are allergic (hypersensitive) to one of the
active substances (Estradiol or Levonorgestrel) or
any of the other ingredients of FEMSEVEN SEQUI®
(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 (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® 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

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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®.
• If you have high blood pressure,
• 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
• If you have a disease leading to the presence of
uterine mucosa outside your uterus causing pain
and bleeding (endometriosis),
• 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),
• 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),
• 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),
• If you have a disease causing loss of hearing
(otosclerosis).

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If you experience any of the disorders mentioned
under “Do not use FEMSEVEN SEQUI®, PATCH”, 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.
Note: FEMSEVEN SEQUI® is not a transdermal
contraceptive and does not prevent you from
becoming pregnant.
You must also inform your doctor if:
• You are to undergo surgery.
• You have to remain immobilised for a long period.
• You have contracted another disease.

What risks are associated with the use of
FEMSEVEN SEQUI® PATCH?

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Stop using FEMSEVEN SEQUI® immediately

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.
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
long-term 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.
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.
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 oestrogen-progestogen 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 oestrogenonly 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
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.
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 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.
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
• 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 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.
Breast cancer:
Evidence suggests that taking combined oestrogenprogestogen 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 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.
Additionally, you are advised to join mammography
screening programs when offered to you.
For mammogram screening, it is important that you
inform the nurse/healthcare professional who is
actually taking the x-ray that you use HRT, as this
medication may increase the density of your breasts
which may affect the outcome of the mammogram.
Where the density of the breast is increased,
mammography may not detect all lumps.
Ovarian cancer:
Ovarian cancer is rare - much rarer than breast cancer.
The use of oestrogen-only or combined oestrogenprogestagen HRT has been associated with a slightly
increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For
example, in women aged 50 to 54 who are not
taking HRT, about 2 women in 2000 will be
diagnosed with ovarian cancer over a 5- year period.
For women who have been taking HRT for 5 years,
there will be about 3 cases per 2000 users
(i.e. about 1 extra case).
HRT and other disorders:
• If you suffer from cardiac or kidney dysfunction
you will have to be monitored while using
FEMSEVEN SEQUI® PATCH
• If you have very high triglyceride levels in your
blood (hypertriglyceridaemia) you will have to be
monitored when using FEMSEVEN SEQUI® PATCH.
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® in particular if you are taking:

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• a medicine to treat epilepsy (carbamazepin,
phenobarbital, phenytoin),
• 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® 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® 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® 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.
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.
5. Remove the other part of the plastic liner and press
down on the corresponding area of the patch.
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.

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

5. HOW TO STORE FEMSEVEN SEQUI®,
PATCH
Keep out of the reach and sight of children.
Do not use a FEMSEVEN SEQUI® PATCH after the
expiry date which is stated on the box. The expiry
date refers to the last day of that month.
Store below 30°C.
Do not use a FEMSEVEN SEQUI® PATCH if you notice
any visible signs of deterioration of the patch.
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
• The active substances are:
• Phase 1 patch: Estradiol hemihydrate (1.50 mg)
for 15 cm2 patch providing 50 micrograms
Estradiol every 24 hours.
• Phase 2 patch: Estradiol hemihydrate (1.50 mg)
and Levonorgestrel (1.50 mg) for 15 cm2 patch
providing 50 micrograms Estradiol and 10
micrograms Levonorgestrel every 24 hours.
• The other ingredients are:
• Liner: transparent polyethylene terephtalate
(PET) film.
• Adhesive component: styrene-isoprene-styrene
copolymer beads, glycerin esters of totally
hydrogenated resin acids.
• Backing: silicon-coated transparent polyethylene
terephtalate (PET) film.

What FEMSEVEN SEQUI®, PATCH looks like
and contents of the pack

How to remove the patch?
To remove a FEMSEVEN SEQUI®, 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® 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 take FEMSEVEN SEQUI®,
PATCH
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.

The product is a transparent, flexible, octagonal
patch with rounded edges. The backing is larger and
detachable.
Each box contains 4 patches (2 Phase 1 patches and
2 Phase 2 patches) or 12 patches (6 Phase 1 patches
and 6 Phase 2 patches), each individually wrapped.
Not all box sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder:
TEVA UK Limited, Eastbourne, BN22 9AG.
Company Responsible for Manufacture:
LTS Lohmann Therapie-Systeme AG, Lohmannstr.2,
56626, Andernach, GERMANY
This medicinal product is authorised in the Member
States of the EEA under the following names:
Germany, Luxemburg:
FEM7 COMBI® 50 microgams/10 micrograms/
24 hours, transdermal patch
Austria, Finland:
FEMSEVENCOMBI® 50 microgams/10 micrograms/
24 hours, dispositif transdermique
Belgium:
FEMINOVA PLUS® 50 microgams/10 micrograms/
24 hours, dispositif transdermique
Spain:
COMBIFEM® 50 microgams/10 micrograms/
24 hours, dispositif transdermique
France:
FEMSEPTCOMBI® 50 microgams/10 micrograms/
24 hours, dispositif transdermique
United Kingdom:
FEMSEVEN SEQUI® 50 microgams/10 micrograms/
24 hours, dispositif transdermique
Italy:
COMBISEVEN® 50 microgams/10 micrograms/
24 hours, dispositif transdermique
Netherlands:
FEM7 SEQUI® 50 microgams/10 micrograms/
24 hours, dispositif transdermique
Portugal:
FEMSETE COMBI® 50 microgams/10 micrograms/
24 hours, dispositif transdermique
This leaflet was last approved in February 2016
PL 00289/1803

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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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