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FEMTAB 2MG TABLETS

Active substance(s): ESTRADIOL VALERATE / ESTRADIOL VALERATE / ESTRADIOL VALERATE

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If you forget to take Progynova
If you forget to take a tablet at your usual time and you are less
than 12 hours late, take it as soon as possible. Take the next tablet
at the usual time.
If you are more than 12 hours late, leave the forgotten tablet in the
pack. Continue to take the rest of the tablets at the usual time every
day. You may experience breakthrough bleeding.
If you stop taking Progynova
You may begin to feel the usual symptoms of menopause again,
which may include hot flushes, trouble sleeping, nervousness,
dizziness or vaginal dryness. Consult your doctor or pharmacist if
you want to stop taking Progynova tablets.

The following side effects have been reported with other HRTs:
 various skin disorders:

PACKAGE LEAFLET: INFORMATION FOR THE USER



painful reddish skin nodules (erythema nodosum)



rash with target-shaped reddening or sores (erythema
multiforme)

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Medical history and regular check-ups

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

United Kingdom

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

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.

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

5. How to store Progynova


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on carton label or blister
strip



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

4. Possible side effects

The following diseases are reported more often in women using
HRT compared to women not using HRT:

2. What you need to know before you take Progynova

 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.

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 necessary.

What is in this leaflet

Once you have started on Progynova, 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 to take
Progynova.

1. WHAT PROGYNOVA IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PROGYNOVA
Medical history and regular check-ups
Do not take Progynova
Warnings and precautions

6. Contents of the pack and other information

HRT and cancer

What Progynova contains

Effects of HRT on heart or circulation

 breast cancer




 ovarian cancer
 blood clots in the veins of the legs or lungs (venous
thromboembolism)
 heart disease

Do not take Progynova:

Progynova Tablets also contain the following inactive
ingredients: lactose monohydrate, maize starch, povidone
25000, talc, magnesium stearate, sucrose, povidone 700000,
macrogol 6000, calcium carbonate, titanium dioxide (E171),
glycerol, montan glycol wax, indigo carmine (E132) and purified
water.

Stroke

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

It is an unmarked blue sugar coated tablet.

For more information about these side effects see section 2.

Progynova Tablets are available as 1 or 3 blister packs of 28 tablets
in each carton.

 breast pain, tenderness or enlargement, breast discharge
 painful periods, changes in vaginal secretions, pre-menstrual
symptoms, increased size of fibroids in the womb, thrush,
changes to the neck of the womb

 changes in body weight and sex drive, increased appetite
 muscle cramps, leg pains
 nose bleeds, visual disturbances (such as blurred vision),
discomfort with contact lenses, allergic-type reactions, a
worsening of glucose tolerance, bladder inflammation, rare
disorders (porphyria, chorea)

Other medicines and Progynova
Laboratory tests

Progynova contains lactose monohydrate and sucrose

 If you have any unexplained vaginal bleeding

3. HOW TO TAKE PROGYNOVA

If you take more Progynova than you should
If you forget to take Progynova
If you stop taking Progynova
If you need to have surgery
4. POSSIBLE SIDE EFFECTS

This product is manufactured by

5. HOW TO STORE PROGYNOVA



Bayer Pharma AG, 13353, Berlin, Germany.

6. CONTENTS OF THE PACK AND OTHER INFORMATION



Bayer Weimar GmbH und Co. KG, 99427 Weimar, Germany.



Delpharm Lille SAS, Rue de Toufflers, 59390 Lys-lez-Lannoy,
France.
PL: 19488/0301

Leaflet revision date: 27 April 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.
Progynova® is a registered trade mark of Bayer Intellectual Property
GmbH, Germany.
S301 LEAFLET Progynova 20170427

 If you have or have ever had breast cancer, or if you are
suspected of having it

Driving and using machines

Manufacturer

POM

Do not take Progynova

 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

Pregnancy and breast-feeding

When to start

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

 fluid retention leading to swelling of parts of the body

Other conditions

About the pack

 During the first few months of treatment you may experience
some vaginal bleeding at unexpected times (breakthrough
bleeding and spotting). These symptoms normally lessen with
continued treatment. If they don’t, contact your doctor (see
section 2 ‘HRT and cancer/Excessive thickening of the lining of
the womb (endometrial hyperplasia) and cancer of the lining of
the womb (endometrial cancer)’ for more information)

 fast or irregular heartbeat (palpitations), high blood pressure,
inflammation of veins usually in the legs

 regularly check your breasts for any changes such as
dimpling of the skin, changes in the nipple, or any lumps you
can see or feel.

Heart disease (heart attack)

 probable memory loss if HRT is started over the age of 65

 headache, migraine, dizziness, anxiety or depressive
symptoms, fatigue

 go for regular breast screening and cervical smear tests, as
recommended by your doctor.

Blood clots in a vein (thrombosis)

What Progynova looks like and contents of the pack

 skin rashes or discolouration, itching, eczema, acne, unusual
hair loss or hair growth, increased skin pigment especially on
the face (chloasma – see section 2‘other conditions’ for more
information), some rare skin problems

Be sure to:

Each tablet contains 2.0mg of the active ingredient, estradiol
valerate.

 stroke

 indigestion, a feeling of being bloated, passing wind, feeling or
being sick, abdominal pain, gall bladder disease

The experience in treating women with a premature menopause
(due to ovarian failure or surgery) is limited. If you have a premature
menopause the risks of using HRT may be different. Please talk to
your doctor.

 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.

Serious side effects

Other side effects that have been linked to the use of Progynova
and other oral hormone replacement therapies:

If you are at an increased risk of fractures due to osteoporosis and
other medicines are not suitable for you, you can use Progynova to
prevent osteoporosis after menopause.

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 (see details below). By reporting
side effects you can help provide more information on the safety of
this medicine.

Website: www.mhra.gov.uk/yellowcard

 abnormal growth or cancer of the lining of the womb
(endometrial hyperplasia or cancer)

After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all available options with your
doctor.

Your medicine is known as above but will be referred to as
Progynova throughout the following leaflet.

If you need to have surgery

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

PROGYNOVA® 2mg TABLETS
(Estradiol Valerate)

Prevention of osteoporosis

Reporting of side effects

Yellow Card Scheme

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

S301 LEAFLET Progynova 20170427

1. What Progynova is and what it is used for
What Progynova is
Progynova is a Hormone Replacement Therapy (HRT). It contains
the female hormone, oestrogen. Your ovaries gradually make less
of this hormone as you get older and will no longer produce it after
you have been through the menopause. Progynova can be used in
peri-and postmenopausal women.
What Progynova 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”). Progynova alleviates these
symptoms after menopause. You will only be prescribed Progynova
if your symptoms seriously hinder your daily life.

 If you have excessive thickening of the womb lining
(endometrial hyperplasia) that is not being treated
 If you have or have ever had a blood clot in a vein
(thrombosis) such as in the legs (deep vein 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 normal
 If you have a rare blood problem called “porphyria” which is
passed down in families (inherited)
 If you are allergic to estradiol valerate or any of the other
ingredients of this medicine (listed in section 6)
 If you have been told to avoid lactose, that you have a rare
hereditary condition called Lapp lactase deficiency or
glucose-galactose malabsorption
 If you have any reason to believe that you either are, or may be,
pregnant, or if you are producing milk (lactating) and breastfeeding. (See also the ‘Pregnancy and breast-feeding’ section
of this leaflet)


If any of the above conditions appear for the first time
while taking Progynova, stop taking it at once and consult
your doctor immediately.

Warnings and precautions

Compare

Talk to your doctor or pharmacist before taking Progynova

In women who still have a womb and who are not taking HRT, on
average, 5 in 1000 will be diagnosed with endometrial cancer
between the ages of 50 and 65.

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 Progynova. If so, you should see your
doctor more often for check-ups:
 fibroids inside your womb
 growth of womb lining outside your womb (endometriosis) or a
history of excessive growth of the womb lining (endometrial
hyperplasia)
 increased risk of developing blood clots (see “Blood clots in a
vein (thrombosis)”)
 increased risk of getting an oestrogen-sensitive cancer (such as
mother, sister or grandmother who has had breast cancer)
 high blood pressure

For women, aged 50 to 65, who still have a womb and who take
oestrogen-only HRT, between 10 and 60 women in 1000 will be
diagnosed with endometrial cancer (i.e. between 5 and 55 extra
cases), depending on the dose and how long it is taken.
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 5) after stopping treatment.

 diabetes

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.

 gallstones

Your risk of breast cancer is also higher:

 migraine or severe headaches

 if you have a close relative (mother, sister or grandmother) who
has had breast cancer

 a liver disorder, such as a benign liver tumour

 any of your close relatives has ever had a blood clot in the leg,
lung or any other organ
 you have had one or more miscarriages
 you have systemic lupus erythematosus (SLE)
 you have cancer
For signs of a blood clot, see “Stop taking Progynova and see a
doctor immediately”.
Compare
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 are taking oestrogenprogestogen HRT,
for over 5 years, there will be 9 – 12 cases in 1000 (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 1000 users (i.e. 1 extra case)

 if you are seriously overweight

 epilepsy

Compare

 asthma

Other conditions

Women aged 50 to 79 who are not taking HRT, on average, 9 to 17
in 1000 will be diagnosed with breast cancer over a 5-year period.
For women aged 50 to 79 who are taking oestrogen-progestogen
HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e.
an extra 4 to 6 cases).

 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.

Regularly check your breasts. See your doctor if you notice
any changes in your breast such as:

 If you have pre-existing elevated triglycerides (a type of blood
fat) your doctor should monitor you closely during oestrogen
replacement therapy or HRT. Rare cases of large increases of
plasma triglycerides (hypertriglyceridemia) leading to
inflammation of the pancreas (pancreatitis) have been reported
with oestrogen replacement therapy.

 a disease affecting the eardrum and hearing (otosclerosis)
 a very high level of fat in your blood (triglycerides)
 fluid retention due to cardiac or kidney problems
Stop taking Progynova and see a doctor immediately
If you notice any of the following when taking HRT:
 any of the conditions mentioned in the ‘DO NOT take
Progynova’ section

 dimpling of the skin

 yellowing of your skin or the whites of your eyes (jaundice).
These may be signs of a liver disease

 any lumps you can see or feel

 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 signs of a blood clot, such as:

 changes in the nipple

 If you have heart or kidney problems, your doctor should
examine you carefully as oestrogens may cause fluid retention
resulting in swelling.

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.

 If you have a tendency to develop blotchy brown patches
(chloasma) on the face you should avoid exposure to the sun or
ultraviolet light whilst using Progynova.
 Your doctor will monitor you carefully if you have terminal
kidney insufficiency as the blood levels of the active
substances in Progynova will probably increase



painful swelling and redness of the legs



sudden chest pain

Ovarian cancer

Other medicines and Progynova



difficulty in breathing

Ovarian cancer (cancer of the ovaries) is rare -much rarer than
breast cancer. It can be difficult to diagnose, because there are
often no obvious signs of the disease. The use of oestrogen-only or
combined oestrogen-progestogen HRT has been associated with a
slightly increased risk of ovarian cancer.

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

for more information, see ‘Blood clots in a vein (thrombosis)’
Note: Progynova is not a contraceptive. 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.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial
hyperplasia) and cancer of the lining of the womb (endometrial
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).

Some medicines may interfere with the effect of Progynova. This
might lead to irregular bleeding. This applies to the following
medicines:
 medicines for epilepsy (such as barbiturates, phenytoin,
primidone, carbamazepine and possibly oxcarbazepine,
topiramate and felbamate)
 medicines for tuberculosis (such as rifampicin, rifabutin)
 medicines for HIV and Hepatitis C Virus infections (so-called
protease inhibitors and non-nucleoside reverse transcriptase
inhibitors such as nevirapine, efavirenz, ritonavir and nelfinavir)

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).

Effects of HRT on heart or circulation
Blood clots in a vein (thrombosis)

 herbal remedies containing St. John’s wort (Hypericum
perforatum)

Taking a progestogen in addition to the oestrogen for at least 12
days of each 28 day cycle protects you from this extra risk. If you
still have your womb, your doctor will prescribe a progestogen
separately.

The risk of blood clots in the veins (also called deep vein
thrombosis, or DVT) is about 1.3 to 3–times higher in HRT users
than non-users, especially during the first year of taking it.

 Medicines for treatment of fungal infections (such as
griseofulvin, fluconazole, itraconazole, ketoconazole and
voriconazole)

If you have had your womb removed (a hysterectomy), discuss with
your doctor whether you can safely take this product without a
progestogen.
If you’ve had your womb removed because of endometriosis, any
endometrium left in your body may be at risk. So your doctor may
prescribe HRT that includes a progestogen as well as an oestrogen.

Blood clots can be serious, and if one travels to the lungs, it can
cause chest pain, breathlessness, fainting or even death. This
condition is called pulmonary embolism, or PE.
DVT and PE are examples of a condition called venous
thromboembolism, or VTE.
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. Inform your doctor if any
of these situations apply to you:
 you are unable to walk for a long time because of major
surgery, injury or illness (see also section 3, “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

Progynova is for use in post-menopausal women only. Do not take
if you are pregnant or breast-feeding.
If you become pregnant, stop taking Progynova immediately and
contact your doctor.
Driving and using machines
No effects on ability to drive and use machines have been observed
in users of Progynova.
Progynova contains lactose monohydrate and sucrose
Progynova contains lactose and sucrose (types of sugar). If you
have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.
3. How to take Progynova

Compare
Looking at women in their 50s who are not taking HRT, on average,
8 in 1000 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 1000 users, over 5 years (i.e. an extra 3 cases).

 a disease of the immune system that affects many organs of
the body (systemic lupus erythematosus, SLE)

Pregnancy and breast-feeding

 Medicines for treatment of bacterial infections (such as
clarithromycin and erythromycin)
 Medicines for treatment of certain heart diseases, high
blood pressure (such as verapamil and diltiazem)
 Grapefruit juice
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that
you are taking Progynova, because this medicine can affect the
results of some tests.

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet of Progynova 2 mg to be
taken daily.
Use in children and adolescents
Progynova is not for use in adolescents or children.
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.
About the pack
This pack is designed to help you remember to take your medicine.
Each tablet is placed in a section marked with the day of the week
on which it should be taken. The arrows between tablets show the
order in which they must be taken. Your doctor may tell you when to
start (see “when to start” for further information).
ZON/DIM/SON = Sunday DON/JEU/DON = Thursday
MAA/LUN/MON = Monday VRI/VEN/FRE = Friday
DIN/MAR/DIE = Tuesday ZAT/SAM/SAM = Saturday
WOE/MER/MIT = Wednesday
On the day you start, take your first tablet from the blue section of
the pack (top row of tablets) marked with the correct day. For
instance, if you start on a Tuesday, press out the tablet from the
blister marked ‘DIN/MAR/DIE’.
Take one tablet each day, following the directions of the arrows,
until you have finished all 28 tablets in the memo strip. When you
have finished each memo strip, start the next memo strip on the
following day. Do not leave a break between memo strips. It is best
to take your tablet at the same time each day. You can take
Progynova with or without food. The tablet should be swallowed
whole with a glass of water or milk.
Your doctor may prescribe the hormone progestogen in addition to
Progynova for at least 12 -14 days each month:
 if you still have your womb
 if you have a history of endometriosis
When to start
If you have been taking other HRT preparations: carry on until
you have finished your current pack and have taken all the tablets
for that month. Take your first Progynova tablet the next day. Do not
leave a break between your old tablets and the Progynova tablets.
If this is your first HRT treatment and you are still having
regular periods: start your Progynova tablets on the first day of
bleeding
If this is your first HRT treatment and your periods have
become very infrequent or have stopped completely: you can
start your Progynova tablets at any time if you are sure you are not
pregnant.
If you take more Progynova than you should
If you have taken too many Progynova tablets by mistake, you may
feel sick, vomit or have some menstruation-like bleeding. No
specific treatment is necessary but you should consult your doctor
or pharmacist if you are worried.
S301 LEAFLET Progynova 20170427

If you forget to take Estradiol Valerate
If you forget to take a tablet at your usual time and you are less
than 12 hours late, take it as soon as possible. Take the next tablet
at the usual time.
If you are more than 12 hours late, leave the forgotten tablet in the
pack. Continue to take the rest of the tablets at the usual time every
day. You may experience breakthrough bleeding.
If you stop taking Estradiol Valerate
You may begin to feel the usual symptoms of menopause again,
which may include hot flushes, trouble sleeping, nervousness,
dizziness or vaginal dryness. Consult your doctor or pharmacist if
you want to stop taking Estradiol Valerate tablets.

The following side effects have been reported with other HRTs:
 various skin disorders:

S301 LEAFLET Estradiol Valerate 20170427

PACKAGE LEAFLET: INFORMATION FOR THE USER



painful reddish skin nodules (erythema nodosum)



rash with target-shaped reddening or sores (erythema
multiforme)

ESTRADIOL VALERATE 2mg TABLETS
(Estradiol Valerate)

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 (see details below). By reporting
side effects you can help provide more information on the safety of
this medicine.

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Medical history and regular check-ups

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

United Kingdom

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

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.

2. What you need to know before you take Estradiol Valerate

Website: www.mhra.gov.uk/yellowcard

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

 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.

5. How to store Estradiol Valerate

 If you get any side effects, talk to your doctor or



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on carton label or blister
strip



4. Possible side effects


The following diseases are reported more often in women using
HRT compared to women not using HRT:

pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.

What is in this leaflet

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ESTRADIOL VALERATE

1. WHAT ESTRADIOL VALERATE IS AND WHAT IT IS USED
FOR

Medical history and regular check-ups
Do not take Estradiol Valerate

6. Contents of the pack and other information

Warnings and precautions

Serious side effects

What Estradiol Valerate contains

HRT and cancer

 breast cancer



Effects of HRT on heart or circulation

 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

Each tablet contains 2.0mg of the active ingredient, estradiol
valerate.
Estradiol Valerate Tablets also contain the following inactive
ingredients: lactose monohydrate, maize starch, povidone
25000, talc, magnesium stearate, sucrose, povidone 700000,
macrogol 6000, calcium carbonate, titanium dioxide (E171),
glycerol, montan glycol wax, indigo carmine (E132) and purified
water.

What Estradiol Valerate looks like and contents of the pack

 probable memory loss if HRT is started over the age of 65

It is an unmarked blue sugar coated tablet.

For more information about these side effects see section 2.

Estradiol Valerate Tablets are available as 1 or 3 blister packs of 28
tablets in each carton.

Other side effects that have been linked to the use of Estradiol
Valerate and other oral hormone replacement therapies:
 During the first few months of treatment you may experience
some vaginal bleeding at unexpected times (breakthrough
bleeding and spotting). These symptoms normally lessen with
continued treatment. If they don’t, contact your doctor (see
section 2 ‘HRT and cancer/Excessive thickening of the lining of
the womb (endometrial hyperplasia) and cancer of the lining of
the womb (endometrial cancer)’ for more information)
 breast pain, tenderness or enlargement, breast discharge
 painful periods, changes in vaginal secretions, pre-menstrual
symptoms, increased size of fibroids in the womb, thrush,
changes to the neck of the womb

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

 muscle cramps, leg pains
 nose bleeds, visual disturbances (such as blurred vision),
discomfort with contact lenses, allergic-type reactions, a
worsening of glucose tolerance, bladder inflammation, rare
disorders (porphyria, chorea)

Other conditions
Other medicines and Estradiol Valerate
Laboratory tests
Pregnancy and breast-feeding
Driving and using machines
Estradiol Valerate contains lactose monohydrate and
sucrose
3. HOW TO TAKE ESTRADIOL VALERATE
About the pack
When to start

This product is manufactured by

If you stop taking Estradiol Valerate



Bayer Pharma AG, 13353, Berlin, Germany.

If you need to have surgery



Bayer Weimar GmbH und Co. KG, 99427 Weimar, Germany.

4. POSSIBLE SIDE EFFECTS



Delpharm Lille SAS, Rue de Toufflers, 59390 Lys-lez-Lannoy,
France.

5. HOW TO STORE ESTRADIOL VALERATE

Leaflet revision date: 27 April 2017

 changes in body weight and sex drive, increased appetite

Stroke

If you forget to take Estradiol Valerate

 skin rashes or discolouration, itching, eczema, acne, unusual
hair loss or hair growth, increased skin pigment especially on
the face (chloasma – see section 2‘other conditions’ for more
information), some rare skin problems

 fluid retention leading to swelling of parts of the body

Heart disease (heart attack)

Manufacturer

POM

 fast or irregular heartbeat (palpitations), high blood pressure,
inflammation of veins usually in the legs

Blood clots in a vein (thrombosis)

If you take more Estradiol Valerate than you should

 indigestion, a feeling of being bloated, passing wind, feeling or
being sick, abdominal pain, gall bladder disease

 headache, migraine, dizziness, anxiety or depressive
symptoms, fatigue

If you are at an increased risk of fractures due to osteoporosis and
other medicines are not suitable for you, you can use Estradiol
Valerate to prevent osteoporosis after menopause.

Your medicine is known as above but will be referred to as Estradiol
Valerate throughout the following leaflet.

If you need to have surgery

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all available options with your
doctor.

Reporting of side effects

Yellow Card Scheme

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

Prevention of osteoporosis

PL: 19488/0301

S301 LEAFLET Estradiol Valerate 20170427

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 necessary.
Once you have started on Estradiol Valerate, you should see your
doctor for regular check-ups (at least once a year). At these checkups, discuss with your doctor the benefits and risks of continuing to
take Estradiol Valerate.
Be sure to:
 go for regular breast screening and cervical smear tests, as
recommended by your doctor.
 regularly check your breasts for any changes such as
dimpling of the skin, changes in the nipple, or any lumps you
can see or feel.
Do not take Estradiol Valerate:
If any of the following applies to you. If you are not sure about any
of the points below, talk to your doctor before taking Estradiol
Valerate,
Do not take Estradiol Valerate
 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 unexplained vaginal bleeding
 If you have excessive thickening of the womb lining
(endometrial hyperplasia) that is not being treated
 If you have or have ever had a blood clot in a vein
(thrombosis) such as in the legs (deep vein 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 normal

6. CONTENTS OF THE PACK AND OTHER INFORMATION

 If you have a rare blood problem called “porphyria” which is
passed down in families (inherited)

1. What Estradiol Valerate is and what it is used for

 If you are allergic to estradiol valerate or any of the other
ingredients of this medicine (listed in section 6)

What Estradiol Valerate is

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.

The experience in treating women with a premature menopause
(due to ovarian failure or surgery) is limited. If you have a premature
menopause the risks of using HRT may be different. Please talk to
your doctor.

Estradiol Valerate is a Hormone Replacement Therapy (HRT). It
contains the female hormone, oestrogen. Your ovaries gradually
make less of this hormone as you get older and will no longer
produce it after you have been through the menopause. Estradiol
Valerate can be used in peri-and postmenopausal women.
What Estradiol Valerate 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”). Estradiol Valerate alleviates these
symptoms after menopause. You will only be prescribed Estradiol
Valerate if your symptoms seriously hinder your daily life.

 If you have been told to avoid lactose, that you have a rare
hereditary condition called Lapp lactase deficiency or
glucose-galactose malabsorption
 If you have any reason to believe that you either are, or may be,
pregnant, or if you are producing milk (lactating) and breastfeeding. (See also the ‘Pregnancy and breast-feeding’ section
of this leaflet)


If any of the above conditions appear for the first time
while taking Estradiol Valerate, stop taking it at once and
consult your doctor immediately.

Warnings and precautions

Compare

Talk to your doctor or pharmacist before taking Estradiol Valerate

In women who still have a womb and who are not taking HRT, on
average, 5 in 1000 will be diagnosed with endometrial cancer
between the ages of 50 and 65.

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 Estradiol Valerate. If so, you should
see your doctor more often for check-ups:
 fibroids inside your womb
 growth of womb lining outside your womb (endometriosis) or a
history of excessive growth of the womb lining (endometrial
hyperplasia)
 increased risk of developing blood clots (see “Blood clots in a
vein (thrombosis)”)
 increased risk of getting an oestrogen-sensitive cancer (such as
mother, sister or grandmother who has had breast cancer)
 high blood pressure

For women, aged 50 to 65, who still have a womb and who take
oestrogen-only HRT, between 10 and 60 women in 1000 will be
diagnosed with endometrial cancer (i.e. between 5 and 55 extra
cases), depending on the dose and how long it is taken.
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 5) after stopping treatment.

 diabetes

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.

 gallstones

Your risk of breast cancer is also higher:

 migraine or severe headaches

 if you have a close relative (mother, sister or grandmother) who
has had breast cancer

 a liver disorder, such as a benign liver tumour

 any of your close relatives has ever had a blood clot in the leg,
lung or any other organ
 you have had one or more miscarriages
 you have systemic lupus erythematosus (SLE)
 you have cancer
For signs of a blood clot, see “Stop taking Estradiol Valerate and
see a doctor immediately”.
Compare
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 are taking oestrogenprogestogen HRT,
for over 5 years, there will be 9 – 12 cases in 1000 (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 1000 users (i.e. 1 extra case)

 if you are seriously overweight

 epilepsy

Compare

 asthma

Other conditions

Women aged 50 to 79 who are not taking HRT, on average, 9 to 17
in 1000 will be diagnosed with breast cancer over a 5-year period.
For women aged 50 to 79 who are taking oestrogen-progestogen
HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e.
an extra 4 to 6 cases).

 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.

Regularly check your breasts. See your doctor if you notice
any changes in your breast such as:

 If you have pre-existing elevated triglycerides (a type of blood
fat) your doctor should monitor you closely during oestrogen
replacement therapy or HRT. Rare cases of large increases of
plasma triglycerides (hypertriglyceridemia) leading to
inflammation of the pancreas (pancreatitis) have been reported
with oestrogen replacement therapy.

 a disease affecting the eardrum and hearing (otosclerosis)
 a very high level of fat in your blood (triglycerides)
 fluid retention due to cardiac or kidney problems
Stop taking Estradiol Valerate and see a doctor immediately
If you notice any of the following when taking HRT:
 any of the conditions mentioned in the ‘DO NOT take Estradiol
Valerate’ section

 dimpling of the skin

 yellowing of your skin or the whites of your eyes (jaundice).
These may be signs of a liver disease

 any lumps you can see or feel

 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 signs of a blood clot, such as:

 changes in the nipple

 If you have heart or kidney problems, your doctor should
examine you carefully as oestrogens may cause fluid retention
resulting in swelling.

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.

 If you have a tendency to develop blotchy brown patches
(chloasma) on the face you should avoid exposure to the sun or
ultraviolet light whilst using Estradiol Valerate.
 Your doctor will monitor you carefully if you have terminal
kidney insufficiency as the blood levels of the active
substances in Estradiol Valerate will probably increase



painful swelling and redness of the legs



sudden chest pain

Ovarian cancer

Other medicines and Estradiol Valerate



difficulty in breathing

Ovarian cancer (cancer of the ovaries) is rare -much rarer than
breast cancer. It can be difficult to diagnose, because there are
often no obvious signs of the disease. The use of oestrogen-only or
combined oestrogen-progestogen HRT has been associated with a
slightly increased risk of ovarian cancer.

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

for more information, see ‘Blood clots in a vein (thrombosis)’
Note: Estradiol Valerate is not a contraceptive. 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.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial
hyperplasia) and cancer of the lining of the womb (endometrial
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).

Some medicines may interfere with the effect of Estradiol Valerate.
This might lead to irregular bleeding. This applies to the following
medicines:
 medicines for epilepsy (such as barbiturates, phenytoin,
primidone, carbamazepine and possibly oxcarbazepine,
topiramate and felbamate)
 medicines for tuberculosis (such as rifampicin, rifabutin)
 medicines for HIV and Hepatitis C Virus infections (so-called
protease inhibitors and non-nucleoside reverse transcriptase
inhibitors such as nevirapine, efavirenz, ritonavir and nelfinavir)

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).

Effects of HRT on heart or circulation
Blood clots in a vein (thrombosis)

 herbal remedies containing St. John’s wort (Hypericum
perforatum)

Taking a progestogen in addition to the oestrogen for at least 12
days of each 28 day cycle protects you from this extra risk. If you
still have your womb, your doctor will prescribe a progestogen
separately.

The risk of blood clots in the veins (also called deep vein
thrombosis, or DVT) is about 1.3 to 3–times higher in HRT users
than non-users, especially during the first year of taking it.

 Medicines for treatment of fungal infections (such as
griseofulvin, fluconazole, itraconazole, ketoconazole and
voriconazole)

If you have had your womb removed (a hysterectomy), discuss with
your doctor whether you can safely take this product without a
progestogen.
If you’ve had your womb removed because of endometriosis, any
endometrium left in your body may be at risk. So your doctor may
prescribe HRT that includes a progestogen as well as an oestrogen.

Blood clots can be serious, and if one travels to the lungs, it can
cause chest pain, breathlessness, fainting or even death. This
condition is called pulmonary embolism, or PE.
DVT and PE are examples of a condition called venous
thromboembolism, or VTE.
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. Inform your doctor if any
of these situations apply to you:
 you are unable to walk for a long time because of major
surgery, injury or illness (see also section 3, “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

Estradiol Valerate is for use in post-menopausal women only. Do
not take if you are pregnant or breast-feeding.
If you become pregnant, stop taking Estradiol Valerate immediately
and contact your doctor.
Driving and using machines
No effects on ability to drive and use machines have been observed
in users of Estradiol Valerate.
Estradiol Valerate contains lactose monohydrate and sucrose
Estradiol Valerate contains lactose and sucrose (types of sugar). If
you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.
3. How to take Estradiol Valerate

Compare
Looking at women in their 50s who are not taking HRT, on average,
8 in 1000 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 1000 users, over 5 years (i.e. an extra 3 cases).

 a disease of the immune system that affects many organs of
the body (systemic lupus erythematosus, SLE)

Pregnancy and breast-feeding

 Medicines for treatment of bacterial infections (such as
clarithromycin and erythromycin)
 Medicines for treatment of certain heart diseases, high
blood pressure (such as verapamil and diltiazem)
 Grapefruit juice
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that
you are taking Estradiol Valerate, because this medicine can affect
the results of some tests.

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet of Estradiol Valerate 2 mg to
be taken daily.
Use in children and adolescents
Estradiol Valerate is not for use in adolescents or children.
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.
About the pack
This pack is designed to help you remember to take your medicine.
Each tablet is placed in a section marked with the day of the week
on which it should be taken. The arrows between tablets show the
order in which they must be taken. Your doctor may tell you when to
start (see “when to start” for further information).
ZON/DIM/SON = Sunday DON/JEU/DON = Thursday
MAA/LUN/MON = Monday VRI/VEN/FRE = Friday
DIN/MAR/DIE = Tuesday ZAT/SAM/SAM = Saturday
WOE/MER/MIT = Wednesday
On the day you start, take your first tablet from the blue section of
the pack (top row of tablets) marked with the correct day. For
instance, if you start on a Tuesday, press out the tablet from the
blister marked ‘DIN/MAR/DIE’.
Take one tablet each day, following the directions of the arrows,
until you have finished all 28 tablets in the memo strip. When you
have finished each memo strip, start the next memo strip on the
following day. Do not leave a break between memo strips. It is best
to take your tablet at the same time each day. You can take
Estradiol Valerate with or without food. The tablet should be
swallowed whole with a glass of water or milk.
Your doctor may prescribe the hormone progestogen in addition to
Estradiol Valerate for at least 12 -14 days each month:
 if you still have your womb
 if you have a history of endometriosis
When to start
If you have been taking other HRT preparations: carry on until
you have finished your current pack and have taken all the tablets
for that month. Take your first Estradiol Valerate tablet the next day.
Do not leave a break between your old tablets and the Estradiol
Valerate tablets.
If this is your first HRT treatment and you are still having
regular periods: start your Estradiol Valerate tablets on the first
day of bleeding
If this is your first HRT treatment and your periods have
become very infrequent or have stopped completely: you can
start your Estradiol Valerate tablets at any time if you are sure you
are not pregnant.
If you take more Estradiol Valerate than you should
If you have taken too many Estradiol Valerate tablets by mistake,
you may feel sick, vomit or have some menstruation-like bleeding.
No specific treatment is necessary but you should consult your
doctor or pharmacist if you are worried.
S301 LEAFLET Estradiol Valerate 20170427

If you forget to take FemTab
If you forget to take a tablet at your usual time and you are less
than 12 hours late, take it as soon as possible. Take the next tablet
at the usual time.
If you are more than 12 hours late, leave the forgotten tablet in the
pack. Continue to take the rest of the tablets at the usual time every
day. You may experience breakthrough bleeding.
If you stop taking FemTab
You may begin to feel the usual symptoms of menopause again,
which may include hot flushes, trouble sleeping, nervousness,
dizziness or vaginal dryness. Consult your doctor or pharmacist if
you want to stop taking FemTab tablets.

The following side effects have been reported with other HRTs:
 various skin disorders:

PACKAGE LEAFLET: INFORMATION FOR THE USER



painful reddish skin nodules (erythema nodosum)



rash with target-shaped reddening or sores (erythema
multiforme)

After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all available options with your
doctor.
If you are at an increased risk of fractures due to osteoporosis and
other medicines are not suitable for you, you can use FemTab to
prevent osteoporosis after menopause.

Your medicine is known as above but will be referred to as FemTab
throughout the following leaflet.

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 (see details below). By reporting
side effects you can help provide more information on the safety of
this medicine.

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Medical history and regular check-ups

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

United Kingdom

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

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.

If you need to have surgery

Website: www.mhra.gov.uk/yellowcard

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

5. How to store FemTab


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on carton label or blister
strip



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.

FEMTAB 2mg TABLETS
(Estradiol Valerate)

Prevention of osteoporosis

Reporting of side effects

Yellow Card Scheme

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

S301 LEAFLET FemTab 20170427

The following diseases are reported more often in women using
HRT compared to women not using HRT:

2. What you need to know before you take FemTab

 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.

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 necessary.

What is in this leaflet

Once you have started on FemTab, 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 to take
FemTab.

1. WHAT FEMTAB IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEMTAB
Medical history and regular check-ups
Do not take FemTab
Warnings and precautions
HRT and cancer

6. Contents of the pack and other information

The experience in treating women with a premature menopause
(due to ovarian failure or surgery) is limited. If you have a premature
menopause the risks of using HRT may be different. Please talk to
your doctor.

Effects of HRT on heart or circulation

Be sure to:
 go for regular breast screening and cervical smear tests, as
recommended by your doctor.
 regularly check your breasts for any changes such as
dimpling of the skin, changes in the nipple, or any lumps you
can see or feel.

Serious side effects

What FemTab contains

 breast cancer

Blood clots in a vein (thrombosis)



Heart disease (heart attack)

Do not take FemTab:

 abnormal growth or cancer of the lining of the womb
(endometrial hyperplasia or cancer)

Each tablet contains 2.0mg of the active ingredient, estradiol
valerate.



FemTab Tablets also contain the following inactive ingredients:
lactose monohydrate, maize starch, povidone 25000, talc,
magnesium stearate, sucrose, povidone 700000, macrogol
6000, calcium carbonate, titanium dioxide (E171), glycerol,
montan glycol wax, indigo carmine (E132) and purified water.

Stroke

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

 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.

What FemTab looks like and contents of the pack
It is an unmarked blue sugar coated tablet.
FemTab Tablets are available as 1 or 3 blister packs of 28 tablets in
each carton.

 During the first few months of treatment you may experience
some vaginal bleeding at unexpected times (breakthrough
bleeding and spotting). These symptoms normally lessen with
continued treatment. If they don’t, contact your doctor (see
section 2 ‘HRT and cancer/Excessive thickening of the lining of
the womb (endometrial hyperplasia) and cancer of the lining of
the womb (endometrial cancer)’ for more information)
 breast pain, tenderness or enlargement, breast discharge
 painful periods, changes in vaginal secretions, pre-menstrual
symptoms, increased size of fibroids in the womb, thrush,
changes to the neck of the womb

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

When to start
If you take more FemTab than you should
If you forget to take FemTab
If you need to have surgery

 If you have any unexplained vaginal bleeding
 If you have excessive thickening of the womb lining
(endometrial hyperplasia) that is not being treated
 If you have or have ever had a blood clot in a vein
(thrombosis) such as in the legs (deep vein 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

Bayer Pharma AG, 13353, Berlin, Germany.

5. HOW TO STORE FEMTAB



Bayer Weimar GmbH und Co. KG, 99427 Weimar, Germany.

6. CONTENTS OF THE PACK AND OTHER INFORMATION



 If you have or have ever had a liver disease, and your liver
function tests have not returned to normal

Delpharm Lille SAS, Rue de Toufflers, 59390 Lys-lez-Lannoy,
France.

1. What FemTab is and what It is used for

 If you have a rare blood problem called “porphyria” which is
passed down in families (inherited)

What FemTab is

PL: 19488/0301

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.

 muscle cramps, leg pains
 nose bleeds, visual disturbances (such as blurred vision),
discomfort with contact lenses, allergic-type reactions, a
worsening of glucose tolerance, bladder inflammation, rare
disorders (porphyria, chorea)

FemTab contains lactose monohydrate and sucrose
3. HOW TO TAKE FEMTAB

 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



Leaflet revision date: 27 April 2017

 changes in body weight and sex drive, increased appetite

Driving and using machines

 If you have or have ever had breast cancer, or if you are
suspected of having it

4. POSSIBLE SIDE EFFECTS

 skin rashes or discolouration, itching, eczema, acne, unusual
hair loss or hair growth, increased skin pigment especially on
the face (chloasma – see section 2‘other conditions’ for more
information), some rare skin problems

 fluid retention leading to swelling of parts of the body

Pregnancy and breast-feeding

Do not take FemTab

This product is manufactured by

POM

 fast or irregular heartbeat (palpitations), high blood pressure,
inflammation of veins usually in the legs

Laboratory tests

If you stop taking FemTab
Manufacturer

 indigestion, a feeling of being bloated, passing wind, feeling or
being sick, abdominal pain, gall bladder disease

 headache, migraine, dizziness, anxiety or depressive
symptoms, fatigue

Other medicines and FemTab

About the pack

Product Licence holder
Other side effects that have been linked to the use of FemTab and
other oral hormone replacement therapies:

Other conditions

S301 LEAFLET FemTab 20170427

FemTab is a Hormone Replacement Therapy (HRT). It contains the
female hormone, oestrogen. Your ovaries gradually make less of
this hormone as you get older and will no longer produce it after you
have been through the menopause. FemTab can be used in periand postmenopausal women.
What FemTab 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”). FemTab alleviates these symptoms
after menopause. You will only be prescribed FemTab if your
symptoms seriously hinder your daily life.

 If you are allergic to estradiol valerate or any of the other
ingredients of this medicine (listed in section 6)
 If you have been told to avoid lactose, that you have a rare
hereditary condition called Lapp lactase deficiency or
glucose-galactose malabsorption
 If you have any reason to believe that you either are, or may be,
pregnant, or if you are producing milk (lactating) and breastfeeding. (See also the ‘Pregnancy and breast-feeding’ section
of this leaflet)


If any of the above conditions appear for the first time
while taking FemTab, stop taking it at once and consult
your doctor immediately.

Warnings and precautions

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Talk to your doctor or pharmacist before taking FemTab

In women who still have a womb and who are not taking HRT, on
average, 5 in 1000 will be diagnosed with endometrial cancer
between the ages of 50 and 65.

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 FemTab. If so, you should see your
doctor more often for check-ups:
 fibroids inside your womb
 growth of womb lining outside your womb (endometriosis) or a
history of excessive growth of the womb lining (endometrial
hyperplasia)
 increased risk of developing blood clots (see “Blood clots in a
vein (thrombosis)”)
 increased risk of getting an oestrogen-sensitive cancer (such as
mother, sister or grandmother who has had breast cancer)
 high blood pressure

For women, aged 50 to 65, who still have a womb and who take
oestrogen-only HRT, between 10 and 60 women in 1000 will be
diagnosed with endometrial cancer (i.e. between 5 and 55 extra
cases), depending on the dose and how long it is taken.
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 5) after stopping treatment.

 diabetes

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.

 gallstones

Your risk of breast cancer is also higher:

 migraine or severe headaches

 if you have a close relative (mother, sister or grandmother) who
has had breast cancer

 a liver disorder, such as a benign liver tumour

 any of your close relatives has ever had a blood clot in the leg,
lung or any other organ
 you have had one or more miscarriages
 you have systemic lupus erythematosus (SLE)
 you have cancer
For signs of a blood clot, see “Stop taking FemTab and see a
doctor immediately”.
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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 are taking oestrogenprogestogen HRT,
for over 5 years, there will be 9 – 12 cases in 1000 (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 1000 users (i.e. 1 extra case)

 if you are seriously overweight

 epilepsy

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 asthma

Other conditions

Women aged 50 to 79 who are not taking HRT, on average, 9 to 17
in 1000 will be diagnosed with breast cancer over a 5-year period.
For women aged 50 to 79 who are taking oestrogen-progestogen
HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e.
an extra 4 to 6 cases).

 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.

Regularly check your breasts. See your doctor if you notice
any changes in your breast such as:

 If you have pre-existing elevated triglycerides (a type of blood
fat) your doctor should monitor you closely during oestrogen
replacement therapy or HRT. Rare cases of large increases of
plasma triglycerides (hypertriglyceridemia) leading to
inflammation of the pancreas (pancreatitis) have been reported
with oestrogen replacement therapy.

 a disease affecting the eardrum and hearing (otosclerosis)
 a very high level of fat in your blood (triglycerides)
 fluid retention due to cardiac or kidney problems
Stop taking FemTab and see a doctor immediately
If you notice any of the following when taking HRT:
 any of the conditions mentioned in the ‘DO NOT take FemTab’
section

 dimpling of the skin

 yellowing of your skin or the whites of your eyes (jaundice).
These may be signs of a liver disease

 any lumps you can see or feel

 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 signs of a blood clot, such as:

 changes in the nipple

 If you have heart or kidney problems, your doctor should
examine you carefully as oestrogens may cause fluid retention
resulting in swelling.

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.

 If you have a tendency to develop blotchy brown patches
(chloasma) on the face you should avoid exposure to the sun or
ultraviolet light whilst using FemTab.
 Your doctor will monitor you carefully if you have terminal
kidney insufficiency as the blood levels of the active
substances in FemTab will probably increase



painful swelling and redness of the legs



sudden chest pain

Ovarian cancer

Other medicines and FemTab



difficulty in breathing

Ovarian cancer (cancer of the ovaries) is rare -much rarer than
breast cancer. It can be difficult to diagnose, because there are
often no obvious signs of the disease. The use of oestrogen-only or
combined oestrogen-progestogen HRT has been associated with a
slightly increased risk of ovarian cancer.

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

for more information, see ‘Blood clots in a vein (thrombosis)’
Note: FemTab is not a contraceptive. 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.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial
hyperplasia) and cancer of the lining of the womb (endometrial
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).

Some medicines may interfere with the effect of FemTab. This
might lead to irregular bleeding. This applies to the following
medicines:
 medicines for epilepsy (such as barbiturates, phenytoin,
primidone, carbamazepine and possibly oxcarbazepine,
topiramate and felbamate)
 medicines for tuberculosis (such as rifampicin, rifabutin)
 medicines for HIV and Hepatitis C Virus infections (so-called
protease inhibitors and non-nucleoside reverse transcriptase
inhibitors such as nevirapine, efavirenz, ritonavir and nelfinavir)

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).

Effects of HRT on heart or circulation
Blood clots in a vein (thrombosis)

 herbal remedies containing St. John’s wort (Hypericum
perforatum)

Taking a progestogen in addition to the oestrogen for at least 12
days of each 28 day cycle protects you from this extra risk. If you
still have your womb, your doctor will prescribe a progestogen
separately.

The risk of blood clots in the veins (also called deep vein
thrombosis, or DVT) is about 1.3 to 3–times higher in HRT users
than non-users, especially during the first year of taking it.

 Medicines for treatment of fungal infections (such as
griseofulvin, fluconazole, itraconazole, ketoconazole and
voriconazole)

If you have had your womb removed (a hysterectomy), discuss with
your doctor whether you can safely take this product without a
progestogen.
If you’ve had your womb removed because of endometriosis, any
endometrium left in your body may be at risk. So your doctor may
prescribe HRT that includes a progestogen as well as an oestrogen.

Blood clots can be serious, and if one travels to the lungs, it can
cause chest pain, breathlessness, fainting or even death. This
condition is called pulmonary embolism, or PE.
DVT and PE are examples of a condition called venous
thromboembolism, or VTE.
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. Inform your doctor if any
of these situations apply to you:
 you are unable to walk for a long time because of major
surgery, injury or illness (see also section 3, “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

FemTab is for use in post-menopausal women only. Do not take if
you are pregnant or breast-feeding.
If you become pregnant, stop taking FemTab immediately and
contact your doctor.
Driving and using machines
No effects on ability to drive and use machines have been observed
in users of FemTab.
FemTab contains lactose monohydrate and sucrose
FemTab contains lactose and sucrose (types of sugar). If you have
been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
3. How to take FemTab

Compare
Looking at women in their 50s who are not taking HRT, on average,
8 in 1000 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 1000 users, over 5 years (i.e. an extra 3 cases).

 a disease of the immune system that affects many organs of
the body (systemic lupus erythematosus, SLE)

Pregnancy and breast-feeding

 Medicines for treatment of bacterial infections (such as
clarithromycin and erythromycin)
 Medicines for treatment of certain heart diseases, high
blood pressure (such as verapamil and diltiazem)
 Grapefruit juice
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that
you are taking FemTab, because this medicine can affect the
results of some tests.

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet of FemTab 2 mg to be taken
daily.
Use in children and adolescents
FemTab is not for use in adolescents or children.
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.
About the pack
This pack is designed to help you remember to take your medicine.
Each tablet is placed in a section marked with the day of the week
on which it should be taken. The arrows between tablets show the
order in which they must be taken. Your doctor may tell you when to
start (see “when to start” for further information).
ZON/DIM/SON = Sunday DON/JEU/DON = Thursday
MAA/LUN/MON = Monday VRI/VEN/FRE = Friday
DIN/MAR/DIE = Tuesday ZAT/SAM/SAM = Saturday
WOE/MER/MIT = Wednesday
On the day you start, take your first tablet from the blue section of
the pack (top row of tablets) marked with the correct day. For
instance, if you start on a Tuesday, press out the tablet from the
blister marked ‘DIN/MAR/DIE’.
Take one tablet each day, following the directions of the arrows,
until you have finished all 28 tablets in the memo strip. When you
have finished each memo strip, start the next memo strip on the
following day. Do not leave a break between memo strips. It is best
to take your tablet at the same time each day. You can take
FemTab with or without food. The tablet should be swallowed whole
with a glass of water or milk.
Your doctor may prescribe the hormone progestogen in addition to
FemTab for at least 12 -14 days each month:
 if you still have your womb
 if you have a history of endometriosis
When to start
If you have been taking other HRT preparations: carry on until
you have finished your current pack and have taken all the tablets
for that month. Take your first FemTab tablet the next day. Do not
leave a break between your old tablets and the FemTab tablets.
If this is your first HRT treatment and you are still having
regular periods: start your FemTab tablets on the first day of
bleeding
If this is your first HRT treatment and your periods have
become very infrequent or have stopped completely: you can
start your FemTab tablets at any time if you are sure you are not
pregnant.
If you take more FemTab than you should
If you have taken too many FemTab tablets by mistake, you may
feel sick, vomit or have some menstruation-like bleeding. No
specific treatment is necessary but you should consult your doctor
or pharmacist if you are worried.
S301 LEAFLET FemTab 20170427

Expand Transcript

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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