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Package Leaflet: information for the user

FemSeven® 100 100 micrograms/24 hours, transdermal patch
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
• 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 only. Do not pass it on to others. It may harm them, even if
their signs of illness 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.
What is in this leaflet:
1. What FemSeven is and what it is used for
2. What you need to know before you use FemSeven
3. How to use FemSeven
4. Possible side effects
5. How to store FemSeven
6. Contents of the pack and other information

What is FemSeven?
FemSeven is a Hormone Replacement Therapy (HRT)
containing an oestrogen, estradiol hemihydrate,
which is a sexual female hormone. FemSeven is used
in postmenopausal women more than one year
after menopause.
FemSeven is used for:
Relief of symptoms occurring after menopause
During the menopause, the amount of the
oestrogen produced by a woman’s body drops.
This can cause symptoms such as hot face, neck
and chest (“hot flushes”). FemSeven alleviates these
symptoms after menopause. You will only be
prescribed FemSeven if your symptoms seriously
hinder your daily life.
Experience of treatment in women aged over
65 years is limited.
Prevention of osteoporosis
After the menopause some women may develop
fragile bones (osteoporosis). You should discuss all
available options with your doctor.
If you are an increased risk of fractures due to
osteoporosis and other medicines are not suitable
for you, you can use FemSeven to prevent
osteoporosis after menopause.
Femseven is suitable for women who have undergone
a hysterectomy (an operation to remove the womb).
If you have not had a hysterectomy, your doctor will
normally prescribe another hormone supplement
(called a progestogen) for you to use in addition to
this one. The progestogen helps to protect the
endometrium (lining of the womb). If you have had a
hysterectomy because you had endometriosis, your
doctor may also prescribe a progestogen, to protect
any endometrium left behind.

Medical history and regular check-ups
The use of HRT carries risks which need to be
considered when deciding whether to start taking it,
or whether to carry on taking it.
The experience treating women with a premature
menopause (due to early cessation of ovarian
function or ovarian surgery) is limited. If you have a
premature menopause the risk of using HRT may be
different. Please talk to your doctor.
Before you start (or restart) HRT, your doctor will ask
about your own and your family’s medical history.
Your doctor may decide to perform a physical
examination. This may include an examination of
your breasts and/or an internal examination, if
Once you have started on Femseven you should see
your doctor for regular check-ups (at least once a
year). At these check-ups, discuss with your doctor
the benefits and risks of continuing with Femseven.
Go for regular breast screening, as recommended by
your doctor.
Pantone Black - 15%

Do not use FemSeven
If any of following applies to you. If you are not sure
about any of the points below, talk to your doctor
before taking Femseven

Do not use Femseven






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Warning and precautions
Talk to your doctor or pharmacist before using
FemSeven is not a contraceptive. As a consequence:
• For women who still have their womb, a treatment
with progestogen hormone will be added for the
last twelve days of treatment with FemSeven at
• If it is less than 12 months since your last
menstrual period or you are under 50 years old,
you may still need to use additional contraception
to prevent pregnancy.
Speak to your doctor for advice.
Before you start the treatment:
Tell your doctor if you have ever had any of the
following problems, before you start the treatment,
as these may return or become worse during
treatment with FemSeven. If so, you should see your
doctor more often for check-ups:
• benign tumors of the womb (fibroids inside your
• a growth of womb lining outside your womb
• a history of abnormal growth of the womb lining
(endometrial hyperplasia);
• increased risk of developing blood clots (see “Blood
clots in a vein (thrombosis)”);
• an increased risk of getting a cancer which needs
estrogens for its development (such as having a
mother, sister or grandmother who has had breast
• high blood pressure;


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• If you have or have ever had breast cancer, or if
you are suspected of having it.
• If you have cancer which is sensitive to
oestrogens, such as cancer of the womb lining
(endometrium), or if you are suspected of having it.
• If you have any vaginal bleeding for which the
cause is not known.
• If you have excessive thickening of the womb
lining (endometrial hyperplasia) that is not being
• If you have or have ever had a blood clot in a vein
(thrombosis), such as in the legs (deep venous
thrombosis) or the lungs (pulmonary embolism).
• If you have a blood clotting disorder (such as
protein C, protein S, or antithrombin deficiency).
• If you have or recently have had a disease caused
by blood clots in the arteries, such as a heart
attack, stroke or angina.
• If you have or have ever had a liver disease and
your liver function tests have not returned to
• If you have an inherited disease (porphyria)
characterised by an accumulation of toxic
compounds (prophyrins) in the body.
• If you are allergic (hypersensitive) to Estradiol
hemihydrate or any of the other ingredients of
Femseven. (listed in section “6. Content of the pack
and other information”))
If you are not sure of any of the above, consult your
doctor before using FemSeven.
If any of the above conditions appear for the first
time while using Femseven, stop using it at once
and consult your doctor immediately.

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• a liver disorder, such as a benign liver tumour;
• diabetes;
• gallstones;
• migraine or severe headaches;
• a disease of the immune system that affects many
organs of the body (systemic lupus erythematosus);
• epilepsy;
• asthma;
• a disease affecting the eardrum and hearing
• a very high level of fat in your blood (triglycerides);
• an increase in the amount of water in your body
(fluid retention) due to cardiac or kidney problems.

If you need to have surgery
If you are going to have surgery, tell the surgeon
that you are using FemSeven. You may need to stop
using FemSeven about 4 to 6 weeks before the
operation to reduce the risk of a blood clot (see
section 2, Blood clots in a vein). Ask your doctor
when you can start using FemSeven again.

Stop using FemSeven and see a doctor
If you notice any of the following when using HRT:
• if you develop any of the conditions mentioned in
the “Do not use FemSeven” section
• a yellowing of your skin or the whites of your eyes
(jaundice). These may be signs of a liver disease;
• a large rise in your blood pressure (symptoms may
be headache, tiredness, dizziness);
• migraine-like headaches which happen for the
first time;
• If you become pregnant;
• If you notice a signs of a blood clot, such as:
- painful swelling and redness of the legs;
- sudden chest pain;
- difficulty breathing.
For more information, see “Blood clots in a vein
HRT and cancer
Excessive thickening of the lining of the womb
(endometrial hyperplasia) and cancer of the
lining of the womb (endometrial cancer)
Taking oestrogen-only HRT will increase the risk of
excessive thickening of the lining of the womb
(endometrial hyperplasia) and cancer of the womb
lining (endometrial cancer).
Taking a treatment containing a progestogen in
addition to the oestrogen for at least 12 days of
each 28 day cycle protects you from this extra risk.
So your doctor will prescribe a treatment containing
a progestogen separately if you still have your
womb. If you have had your womb removed (a
hysterectomy), discuss with your doctor whether
you can safely take this product without a treatment
containing a progestogen.
In women who still have a womb and who are not
taking HRT, on average, 5 in 1 000 will be diagnosed
with endometrial cancer between the age of 50
and 65.
For women aged 50 to 65 who still have a womb
and who take oestrogen-only HRT, between 10 and
60 women in 1 000 will be diagnosed with
endometrial cancer (i.e. between 5 and 55 extra cases),
depending on the dose and for how long it is taken.
FemSeven contains a higher dose of oestrogens
than other oestrogen-only HRT products. The risk of
endometrium cancer when using FemSeven
together with a treatment containing a progestogen
is not known.
Breast cancer: Evidence suggests that taking
combined oestrogen-progestogen and possibly also
oestrogen-only HRT increases the risk of breast
cancer. The extra risk depends on how long you take
HRT. The additional risk becomes clear within a few
years. However, it returns to normal within a few
years (at most five) after stopping treatment.
For women who have had their womb removed and
who are using oestrogen-only HRT for 5 years, little
or no increase in breast cancer risk is shown.
Women aged 50 to 79 who are not taking HRT, on
average, 9 to 17 in 1 000 will be diagnosed with
breast cancer over a 5-year period. For women aged
50 to 79 who are taking HRT containing both
oestrogen and progestogen hormones over 5 years,
there will be 13 to 23 cases in 1 000 users (i.e. an
extra 4 to 6 cases)
• Regularly check your breasts. See your doctor if
you notice any changes such as:
• dimpling of the skin;
• changes in the nipple;
• any lumps you can see or feel.
Additionally you should attend your mammography
appointment when you are invited for screening
between your 50th and 53rd birthday, although in
some areas you’ll be invited from the age of 47 as
part of the trial extension of the programme.
For the mammogram appointment it is important
that you inform the nurse or doctor who is actually
taking the X ray that you are on HRT as this
medication may increase the density of your breast
which will affect the outcome of the mammogram.
Where the density of the breast is increased the
mammogram may not detect all lumps.
Ovarian cancer:
Ovarian cancer is rare - much rarer than breast
cancer. The use of oestrogen-only or combined
oestrogen-progestagen 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 2 000 will be diagnosed
with ovarian cancer over a 5 year period. For women
who have been taking HRT for 5 years, there will be
3 cases per 2 000 users (i.e. about 1 extra case).

Effects of HRT on your heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to
3- times higher in HRT users than in non-users,
especially during the first year of taking it.
Blood clots can be serious, and if one travels to the
lungs, it can cause chest pain, breathlessness,
fainting or even death.
You are more likely to get a blood clot in your veins
as you get older and if any of the following applies
to you. You will find the signs of a blood clot in the
section “Stop using FemSeven and see a doctor
Inform your doctor if any of these situations applies
to you:
• you are unable to walk for a long time because of
major surgery, injury or illness (see also section 2,
if you need to have surgery);
• you are seriously overweight (BMI>30 kg/m2);
• you have any blood clotting problem that needs
long-term treatment with a medicine used to
prevent blood clots;
• if any of your close relatives has ever had a blood
clot in the leg, lung or another organ;
• you have an immune system disease that affects
many body organs (systemic lupus erythematosus);
• you have cancer.

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Looking at women in their 50s who are not taking
HRT, on average, over a 5-year period, 4 to 7 in 1000
would be expected to get a blood clot in a vein.
For women in their 50s who have been taking HRT
containing both oestrogen-progestogen hormones
for over 5 years, there will be 9 to 12 cases in 1 000
users (i.e. an extra 5 cases).
For women in their 50s who have had their womb
removed and have been taking oestrogen-only HRT
for over 5 years, there will be 5 to 8 cases in 1 000
users (i.e. 1 extra case)
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart
Women over the age of 60 years who use HRT
containing both oestrogen-progestogen hormones
are slightly more likely to develop heart disease than
those not taking any HRT.
For women who have had their womb removed and
are taking oestrogen-only therapy there is no
increased risk of developing heart disease.

The risk of getting stroke is about 1.5-times higher
in HRT users than in non-users. The number of extra
cases of stroke due to use of HRT will increase with
Looking at women in their 50s who are not taking
HRT, on average, 8 in 1 000 would be expected to
have a stroke over a 5-year period. For women in
their 50s who are taking HRT, there will be 11 cases
in 1 000 users, over 5 years (i.e. an extra 3 cases).

Other conditions
• HRT will not prevent memory loss. There is some
evidence of a higher risk of memory loss in women
who start using HRT after the age of 65. Speak to
your Doctor for advice.

Other medicines and FemSeven
Some medicines may interfere with the effect of
FemSeven. This might lead to irregular bleeding. This
applies to the following medicines:
• Medicines for epilepsy (such as phenobarbital,
phenytoin and carbamazepin);
• Medicines for tuberculosis (such as rifampicin,
• Medicines for HIV infection (such as nevirapine,
efavirenz, ritonavir and nelfinavir);
• Herbal remedies containing St John’s Wort
(Hypericum perforatum).
Please tell your doctor or pharmacist if you are
using, have recently used or might use any other
medicines including medicines obtained without a
prescription, herbal medicines or other natural

Laboratory tests
If you need a blood test, tell your doctor or the
laboratory staff that you are using FemSeven,
because this medicine can affect the results of some

Pregnancy and breast-feeding
FemSeven is for use in postmenopausal women
only. If you become pregnant, stop using FemSeven
and contact your doctor.
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby ask your
doctor or pharmacist for advice before taking this

FemSeven is an oestrogen-only patch that should be
applied to the skin once weekly on a continuous
basis, i.e. each patch is replaced with a new one after
7 days.
Always use FemSeven exactly as your doctor has
told you. Check with your doctor or pharmacist if
you are not sure.
Children: FemSeven is not recommended for use in
Adults and the elderly: Your doctor will aim to
prescribe the lowest dose to treat your symptom for
as short as necessary. Speak to your doctor if you
think this dose is too strong or not strong enough.
You can normally start treatment on any convenient
day, unless you still have your womb and are
changing to FemSeven from a sequential HRT
product. In that case, you should start FemSeven
straight after your withdrawal bleed has ended. Each
patch is worn for 7 days and replaced with a new
one on the next day so that you are always wearing
a patch. You will normally wear one patch at a time.

Method of administration
Putting on the patch:
1. Remove the patch from its pouch as shown in
pictures 1 and 2
2. Peel off half the protective liner at the ‘S-shaped
notch and apply the patch to the skin as in
pictures 3 and 4. Avoid touching the adhesive side
of the patch with your fingers as this may prevent
it sticking properly later on.
3. Remove the other half of the protective liner then
press the patch against your skin with the palm of
your hand for at least 30 seconds shown in
pictures 5 and 6. The warmth of your body will
make the patch stick better.
Choose a place where there is least wrinkling of the
skin and where it will not be rubbed off by clothing,
for example on your buttocks, hips or abdomen
(avoid the waist).


If you forget to change your patch at the right time,
change it as soon as possible, then resume your
original schedule. If you still have your womb,
breakthrough bleeding is more likely if you forget to
change your patch on time.

If you use more FemSeven than you should
If you apply too many patches, overdose is unlikely –
removal of the patches is the only action required.

If you forget to use FemSeven
Do not use a double dose to make up for a forgotten
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

Like all medicines, FemSeven can cause side effects;
although not every body gets them.
For a list of side effects requiring discontinuation of
treatment, see Section 2. “Stop using FemSeven and
see a doctor immediately”
The following effects are reported more often in
women using HRT compared to women not using it:
• breast cancer;
• abnormal growth or cancer of the lining of the
womb (endometrial hyperplasia or cancer);
• ovarian cancer;
• blood clots in the veins of the legs or lungs
(venous thromboembolism);
• heart disease;
• stroke;
• probable memory loss if HRT is started over the
age of 65;
For more information about these side effects, see
section 2.
The following side effects may occur very
commonly (in more than 1 in 10 people):
Application site reactions:
• Itching (purities);
• Redness (erythema);
• Eczema;
• Urticaria;
• Swilling (oedema);
• Changes in skin pigmentation
They were mostly mild skin reactions and usually
disappeared 2 or 3 days after patch removal.
The following side effects may occur commonly
(up to 1 in 10 people):
• Headache;
• Breast discomfort (e.g. mastalgia/ mastopathies,
breast enlargement).
The following side effects may occur uncommonly
(up to 1 in 100 people):
• Hair changes, sweating increased;
• Joint pain (arthralgia), leg cramps;
• Dizziness, tingling in fingers or toes (paresthesia),
• Anxiety, appetite increase, depression, difficulty
sleeping (insomnia), nervousness;
• Nausea, indigestion (dyspepsia), abdominal pain,
• Blood pressure changes;
• Chest pain;
• Vein disorders;
• Vaginal discharge, breakthrough bleeding;
• Swelling (oedema), fatigue, weight changes.
The following potential side effects may occur
rarely (up to 1 people in 1 000):
• Worsening of uterine fibroids (benign growths of
the womb).
The following side effects have been reported
with other HRTs:
• gall bladder disease
• various skin disorders:
- discoloration of the skin especially of the face or
neck known as “pregnancy patches” (cholasma);
- painful reddish nodules (erythema nodosum);
- rash with target-shaped reddening or sores
(erythema multiforme);
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.
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:
By reporting side effects you can help provide more
information on the safety of this medicine.

Keep out of the reach and sight of children.
Do not use FemSeven after the expiry date which is
stated on the patch. The expiry date refers to the last
day of that month.
Do not store FemSeven transdermal patches above
Keep your patches in the sachets they come in until
just before you need each one
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.

What FemSeven contains
• The active substance is: estradiol hemihydrate
(3 milligrams).
• The other ingredients are: transparent
polyethylene terephthalate foil, styrene-isoprene
block copolymer and glycerine esters of
completely hydrogenated resins.
The patches deliver 100 micrograms of estradiol in
each 24 hour period.

What FemSeven looks like and contents of
the pack
FemSeven transdermal patches are octagonal
transparent, flexible, patches with rounded edges.
Each patch is coated with adhesive and mounted on
an oversized, removable, protective liner. The
adhesive is made of a mixture of polymer and
modified resin containing the active ingredients.
Each pack contains 4 or 12 patches to provide you
with one month’s or 3 months treatment

Marketing Authorisation Holder and
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 leaflet was last approved in January 2017
PL 00289/1801

Do not put a patch on or near your breasts.
Do not put a new patch on the same area of skin as
the one you have just removed. Make sure the area
of skin you use is clean and dry, and not broken or
If you have applied the patch properly there is little
risk of it coming off when you take a bath, shower
or swim. You should not expose the patch to
To remove the FemSeven patch simply lift off one
edge and pull. Fold the patch in half (adhesive
against adhesive) and throw it away. If the patch
starts to come off before 7 days are up, you should
take it off completely and apply a new patch.
Replace it when you would normally have done.

Detailed information on this medicine is available on
the web site of the Medicines and Healthcare
products Regulatory Agency (MHRA).



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Teva Pharmaceuticals Europe B.V

Signed by
Michael Silvester


Meaning of Signature
Regulatory Affairs Approval

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Server Date
19-Jan-2017 03:55:42 PM

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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.