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FEMTAB 1MG TABLETS

Active substance(s): OESTRADIOL VALERATE

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S300 LEAFLET Progynova 20160830

If you forget to take Progynova

Reporting of side effects

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 get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

If you 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 need to have surgery
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)”).

PROGYNOVA® 1mg TABLETS
(Estradiol Valerate)

By reporting side effects, you can help provide more information on
the safety of this medicine.

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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

Ask your doctor when you can start taking Progynova again.

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

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

Read all of this leaflet carefully before you start taking 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.


6. CONTENTS OF THE PACK AND OTHER INFORMATION

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.

4. POSSIBLE SIDE EFFECTS

What Progynova contains

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

Each tablet contains 1.0mg of the active ingredient, estradiol
valerate.

What is in this leaflet

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

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, iron oxide (E172) and purified water.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PROGYNOVA

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

HRT and cancer

Progynova is an unmarked beige sugar coated tablet.

Effects of HRT on heart or circulation

Progynova is available as 1 or 3 calendar blister packs of 28 tablets
in each carton.

Stroke
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.

Other medicines and Progynova

Driving and using machines
Progynova contains lactose monohydrate and sucrose

This product is manufactured by
Bayer Pharma AG, Mullerstrasse 170-178, 13353, Berlin,
Germany.



Bayer Weimar GmbH und Co. KG, Dobereinerstrasse 20,
99427 Weimar, Germany.

When to start



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

If you forget to take Progynova

The following side effects have been reported with other HRTs:
 various skin disorders:
 painful reddish skin nodules (erythema nodosum)
 rash with target-shaped reddening or sores (erythema
multiforme)

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

Leaflet revision date: 30 August 2016

 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).

3. HOW TO TAKE PROGYNOVA



 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

 muscle cramps, leg pains

Laboratory tests
Pregnancy and breast-feeding

POM

 changes in body weight and sex drive, increased appetite

Heart disease (heart attack)
Other conditions

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

 fluid retention leading to swelling of parts of the body

Blood clots in a vein (thrombosis)

Product Licence holder

 breast pain, tenderness or enlargement, breast discharge

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

Do not take Progynova
Warnings and precautions

Manufacturer

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

Medical history and regular check-ups

What Progynova looks like and contents of 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)
 painful periods, changes in vaginal secretions, pre-menstrual
symptoms, increased size of fibroids in the womb, thrush,
changes to the neck of the womb

1. WHAT PROGYNOVA IS AND WHAT IT IS USED FOR

PL: 19488/0300

5. HOW TO STORE PROGYNOVA
6. CONTENTS OF THE PACK AND OTHER INFORMATION

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PROGYNOVA
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 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.
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 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.
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 Progynova:
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,
Do not take Progynova
 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
 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)


1. WHAT PROGYNOVA IS AND WHAT IT IS USED FOR

®

Progynova is a registered trade mark of Bayer Intellectual Property
GmbH, Germany.
S300 LEAFLET Progynova 20160830

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.

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
Talk to your doctor or pharmacist before taking Progynova

What Progynova is used for

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:

Relief of symptoms occurring after menopause

 fibroids inside your womb

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.

 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)”)

Your risk of breast cancer is also higher:

Heart disease (heart attack)

Laboratory tests

 high blood pressure

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

There is no evidence that HRT will prevent a heart attack.

 a liver disorder, such as a benign liver tumour

 if you are seriously overweight

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.

 diabetes

Compare

 gallstones

Women aged 50 to 79 who are not taking HRT, on average, 9 to 14
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 20 cases in 1000 users (i.e.
an extra 4 to 6 cases).

 increased risk of getting an oestrogen-sensitive cancer (such as
mother, sister or grandmother who has had breast cancer)

 migraine or severe headaches
 a disease of the immune system that affects many organs of
the body (systemic lupus erythematosus, SLE)
 epilepsy

HRT is not recommended for women who have heart disease,
or have had heart disease recently. If you have ever had heart
disease, talk to your doctor to see if you should be taking HRT.
Women over the age of 60 years who use oestrogen-progestogen
HRT 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 a
heart disease.

Pregnancy and breast-feeding
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

 asthma

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

 a disease affecting the eardrum and hearing (otosclerosis)

 dimpling of the skin

If you get:

Progynova contains lactose monohydrate and sucrose

 a very high level of fat in your blood (triglycerides)

 changes in the nipple

 a pain in your chest that spreads to your arm or neck

 fluid retention due to cardiac or kidney problems

 any lumps you can see or feel

Stop taking Progynova and see a doctor immediately

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.

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.

If you notice any of the following when taking HRT:
 any of the conditions mentioned in the ‘DO NOT take
Progynova’ section
 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 signs of a blood clot, such as:
 painful swelling and redness of the legs
 sudden chest pain
 difficulty in breathing
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)
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 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.
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.
Compare
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.
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.
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.



Ovarian cancer
Ovarian cancer (cancer of the ovaries) is rare. It can be difficult to
diagnose, because there are often no obvious signs of the disease.
A slightly increased risk of ovarian cancer has been reported in
women taking HRT for at least 5 to 10 years.

See a doctor as soon as possible and do not take any
more HRT until your doctor says you can. This pain could
be a sign of heart disease.

Stroke
The risk of getting a stroke is about 1.5–times higher in HRT users
than in non–users. The number of extra cases of stroke due to HRT
use will increase with age.
Other things that can increase the risk of stroke include:
 high blood pressure
 smoking
 drinking too much alcohol

Compare

 an irregular heartbeat

Women aged 50 to 69 who are not taking HRT, on average about 2
women in 1000 will be diagnosed with ovarian cancer over a 5-year
period. For women who have been taking HRT for 5 years, there
will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra
case).

If you are worried about any of these things, or if you have had
a stroke in the past, talk to your doctor to see if you should take
HRT.
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).

Effects of HRT on heart or circulation
Blood clots in a vein (thrombosis)
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.
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”)
2

 you are seriously overweight (BMI >30 kg/m )
 you have any blood clotting problem that needs long-term
treatment with a medicine used to prevent blood clots.
 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 oestrogen-progestogen 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).

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.
 If you have heart or kidney problems, your doctor should
examine you carefully as oestrogens may cause fluid retention
resulting in swelling
 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
 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
Other medicines and Progynova
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 phenobarbital, phenytoin,
carbamazepine)

There is nothing to suggest that the use of Progynova affects
driving or use of machines.

3. HOW TO TAKE PROGYNOVA
Always take this medicine exactly as your doctor has told you.
Check with your doctor if you are not sure.
The recommended dose is one tablet of Progynova 1 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 days are translated as follows:
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
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).
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

 medicines for HIV infection (such as nevirapine, efavirenz,
ritonavir and nelfinavir)

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.

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

If you take more Progynova than you should

 medicines for tuberculosis (such as rifampicin, rifabutin)



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

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.
S300 LEAFLET Progynova 20160830

S300 LEAFLET FemTab 20160830

If you forget to take FemTab

Reporting of side effects

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 get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

If you 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.

By reporting side effects, you can help provide more information on
the safety of this medicine.

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.
If you need to have surgery
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)”).

PACKAGE LEAFLET: INFORMATION FOR THE USER

FEMTAB 1mg TABLETS
(Estradiol Valerate)
Your medicine is known as above but will be referred to as FemTab
throughout the following leaflet.

5. HOW TO STORE FEMTAB


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



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

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

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



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.



Ask your doctor when you can start taking FemTab again.

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.

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

 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEMTAB
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 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.
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 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.
Be sure to:
 go for regular breast screening and cervical smear tests, as
recommended by your doctor.

4. POSSIBLE SIDE EFFECTS

What FemTab contains

What is in this leaflet

 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.

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

Each tablet contains 1.0mg of the active ingredient, estradiol
valerate.

1. WHAT FEMTAB IS AND WHAT IT IS USED FOR

Do not take FemTab:

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEMTAB

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

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, iron oxide (E172) and purified water.

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,

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Serious side effects
 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.
Other side effects that have been linked to the use of FemTab and
other oral hormone replacement therapies:

HRT and cancer
Blood clots in a vein (thrombosis)

FemTab is an unmarked beige sugar coated tablet.

Heart disease (heart attack)

FemTab is available as 1 or 3 calendar blister packs of 28 tablets in
each carton.

Stroke
Other conditions
Other medicines and FemTab

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.

Laboratory tests
Pregnancy and breast-feeding
Driving and using machines
FemTab contains lactose monohydrate and sucrose

 breast pain, tenderness or enlargement, breast discharge

 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

Warnings and precautions

What FemTab looks like and contents of the pack

Manufacturer

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

Do not take FemTab

Effects of HRT on heart or circulation

 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)
 painful periods, changes in vaginal secretions, pre-menstrual
symptoms, increased size of fibroids in the womb, thrush,
changes to the neck of the womb

Medical history and regular check-ups

3. HOW TO TAKE FEMTAB

This product is manufactured by

About the pack



Bayer Pharma AG, Mullerstrasse 170-178, 13353, Berlin,
Germany.

When to start



Bayer Weimar GmbH und Co. KG, Dobereinerstrasse 20,
99427 Weimar, Germany.

If you forget to take FemTab



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

If you need to have surgery

POM

If you take more FemTab than you should
If you stop taking FemTab
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE FEMTAB

PL: 19488/0300

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Leaflet revision date: 30 August 2016
1. WHAT FEMTAB IS AND WHAT IT IS USED FOR
S300 LEAFLET FemTab 20160830

What FemTab is

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

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.

 fluid retention leading to swelling of parts of the body

What FemTab is used for

 changes in body weight and sex drive, increased appetite

Relief of symptoms occurring after menopause

 muscle cramps, leg pains

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.

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

 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).
The following side effects have been reported with other HRTs:
 various skin disorders:
 painful reddish skin nodules (erythema nodosum)
 rash with target-shaped reddening or sores (erythema
multiforme)

Do not take FemTab
 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
 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 FemTab, stop taking it at once and consult
your doctor immediately.

Warnings and precautions
Talk to your doctor or pharmacist before taking FemTab
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)”)

Your risk of breast cancer is also higher:

Heart disease (heart attack)

Laboratory tests

 high blood pressure

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

There is no evidence that HRT will prevent a heart attack.

 a liver disorder, such as a benign liver tumour

 if you are seriously overweight

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.

 diabetes

Compare

 gallstones

Women aged 50 to 79 who are not taking HRT, on average, 9 to 14
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 20 cases in 1000 users (i.e.
an extra 4 to 6 cases).

 increased risk of getting an oestrogen-sensitive cancer (such as
mother, sister or grandmother who has had breast cancer)

 migraine or severe headaches
 a disease of the immune system that affects many organs of
the body (systemic lupus erythematosus, SLE)
 epilepsy

HRT is not recommended for women who have heart disease,
or have had heart disease recently. If you have ever had heart
disease, talk to your doctor to see if you should be taking HRT.
Women over the age of 60 years who use oestrogen-progestogen
HRT 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 a
heart disease.

Pregnancy and breast-feeding
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

 asthma

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

 a disease affecting the eardrum and hearing (otosclerosis)

 dimpling of the skin

If you get:

FemTab contains lactose monohydrate and sucrose

 a very high level of fat in your blood (triglycerides)

 changes in the nipple

 a pain in your chest that spreads to your arm or neck

 fluid retention due to cardiac or kidney problems

 any lumps you can see or feel

Stop taking FemTab and see a doctor immediately

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.

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.

If you notice any of the following when taking HRT:
 any of the conditions mentioned in the ‘DO NOT take FemTab’
section
 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 signs of a blood clot, such as:
 painful swelling and redness of the legs
 sudden chest pain
 difficulty in breathing
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)
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 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.
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.
Compare
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.
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.
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.



Ovarian cancer
Ovarian cancer (cancer of the ovaries) is rare. It can be difficult to
diagnose, because there are often no obvious signs of the disease.
A slightly increased risk of ovarian cancer has been reported in
women taking HRT for at least 5 to 10 years.

See a doctor as soon as possible and do not take any
more HRT until your doctor says you can. This pain could
be a sign of heart disease.

Stroke
The risk of getting a stroke is about 1.5–times higher in HRT users
than in non–users. The number of extra cases of stroke due to HRT
use will increase with age.
Other things that can increase the risk of stroke include:
 high blood pressure
 smoking
 drinking too much alcohol

Compare

 an irregular heartbeat

Women aged 50 to 69 who are not taking HRT, on average about 2
women in 1000 will be diagnosed with ovarian cancer over a 5-year
period. For women who have been taking HRT for 5 years, there
will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra
case).

If you are worried about any of these things, or if you have had
a stroke in the past, talk to your doctor to see if you should take
HRT.
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).

Effects of HRT on heart or circulation
Blood clots in a vein (thrombosis)
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.
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”)
2

 you are seriously overweight (BMI >30 kg/m )
 you have any blood clotting problem that needs long-term
treatment with a medicine used to prevent blood clots.
 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”.
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 oestrogen-progestogen 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).

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

There is nothing to suggest that the use of FemTab affects driving
or use of machines.

3. HOW TO TAKE FEMTAB
Always take this medicine exactly as your doctor has told you.
Check with your doctor if you are not sure.
The recommended dose is one tablet of FemTab 1 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 days are translated as follows:
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
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).
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.

 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 may prescribe the hormone progestogen in addition to
FemTab for at least 12-14 days each month:

 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

 if you have a history of endometriosis

Other medicines and FemTab
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 phenobarbital, phenytoin,
carbamazepine)
 medicines for tuberculosis (such as rifampicin, rifabutin)
 medicines for HIV infection (such as nevirapine, efavirenz,
ritonavir and nelfinavir)
 herbal remedies containing St. John’s wort (Hypericum
perforatum)


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

 if you still have your womb
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.
S300 LEAFLET FemTab 20160830

If you forget to take Estradiol Valerate

Reporting of side effects

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 get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

If you 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.

By reporting side effects, you can help provide more information on
the safety of this medicine.

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.
If you need to have surgery
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)”).

5. HOW TO STORE ESTRADIOL VALERATE


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.

Ask your doctor when you can start taking Estradiol Valerate again.

S300 LEAFLET Estradiol Valerate 20160830

PACKAGE LEAFLET: INFORMATION FOR THE USER

ESTRADIOL VALERATE 1mg TABLETS
(Estradiol Valerate)
Your medicine is known as above but will be referred to as Estradiol
Valerate throughout the following leaflet.
Read all of this leaflet carefully before you start taking 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

 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 Estradiol Valerate contains

What is in this leaflet

Each tablet contains 1.0mg of the active ingredient, estradiol
valerate.

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

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, iron oxide (E172) and purified water.

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

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
The following diseases are reported more often in women using
HRT compared to women not using HRT:
Serious side effects
 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.
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

What Estradiol Valerate looks like and contents of the pack
Estradiol Valerate is an unmarked beige sugar coated tablet.
Estradiol Valerate is available as 1 or 3 calendar blister packs of 28
tablets in each carton.

 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).
The following side effects have been reported with other HRTs:
 various skin disorders:
 painful reddish skin nodules (erythema nodosum)
 rash with target-shaped reddening or sores (erythema
multiforme)

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 excessive thickening of the womb lining
(endometrial hyperplasia) that is not being treated

Laboratory tests
Pregnancy and breast-feeding
Driving and using machines

This product is manufactured by

Estradiol Valerate contains lactose monohydrate and
sucrose



Bayer Pharma AG, Mullerstrasse 170-178, 13353, Berlin,
Germany.

3. HOW TO TAKE ESTRADIOL VALERATE



Bayer Weimar GmbH und Co. KG, Dobereinerstrasse 20,
99427 Weimar, Germany.

When to start

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

If you forget to take Estradiol Valerate

About the pack
If you take more Estradiol Valerate than you should
If you stop taking Estradiol Valerate
If you need to have surgery

PL: 19488/0300

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 have any unexplained vaginal bleeding

Other medicines and Estradiol Valerate



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.

Heart disease (heart attack)

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.
Manufacturer

Medical history and regular check-ups

Blood clots in a vein (thrombosis)

Other conditions

Leaflet revision date: 30 August 2016

 changes in body weight and sex drive, increased appetite

Effects of HRT on heart or circulation

Product Licence holder

 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

HRT and cancer

Stroke

POM

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

Do not take Estradiol Valerate
Warnings and precautions

 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

Medical history and regular check-ups

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

4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ESTRADIOL VALERATE
6. CONTENTS OF THE PACK AND OTHER INFORMATION

 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)


S300 LEAFLET Estradiol Valerate 20160830

1. WHAT ESTRADIOL VALERATE IS AND WHAT IT IS USED
FOR
What Estradiol Valerate is
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 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
Talk to your doctor or pharmacist before taking Estradiol Valerate
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)”)

Your risk of breast cancer is also higher:

Heart disease (heart attack)

Laboratory tests

 high blood pressure

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

There is no evidence that HRT will prevent a heart attack.

 a liver disorder, such as a benign liver tumour

 if you are seriously overweight

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.

 diabetes

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 gallstones

Women aged 50 to 79 who are not taking HRT, on average, 9 to 14
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 20 cases in 1000 users (i.e.
an extra 4 to 6 cases).

 increased risk of getting an oestrogen-sensitive cancer (such as
mother, sister or grandmother who has had breast cancer)

 migraine or severe headaches
 a disease of the immune system that affects many organs of
the body (systemic lupus erythematosus, SLE)
 epilepsy

HRT is not recommended for women who have heart disease,
or have had heart disease recently. If you have ever had heart
disease, talk to your doctor to see if you should be taking HRT.
Women over the age of 60 years who use oestrogen-progestogen
HRT 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 a
heart disease.

Pregnancy and breast-feeding
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

 asthma

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

 a disease affecting the eardrum and hearing (otosclerosis)

 dimpling of the skin

If you get:

Estradiol Valerate contains lactose monohydrate and sucrose

 a very high level of fat in your blood (triglycerides)

 changes in the nipple

 a pain in your chest that spreads to your arm or neck

 fluid retention due to cardiac or kidney problems

 any lumps you can see or feel

Stop taking Estradiol Valerate and see a doctor immediately

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.

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.

If you notice any of the following when taking HRT:
 any of the conditions mentioned in the ‘DO NOT take Estradiol
Valerate’ section
 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 signs of a blood clot, such as:
 painful swelling and redness of the legs
 sudden chest pain
 difficulty in breathing
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)
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 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.
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.
Compare
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.
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.
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.



Ovarian cancer
Ovarian cancer (cancer of the ovaries) is rare. It can be difficult to
diagnose, because there are often no obvious signs of the disease.
A slightly increased risk of ovarian cancer has been reported in
women taking HRT for at least 5 to 10 years.

See a doctor as soon as possible and do not take any
more HRT until your doctor says you can. This pain could
be a sign of heart disease.

Stroke
The risk of getting a stroke is about 1.5–times higher in HRT users
than in non–users. The number of extra cases of stroke due to HRT
use will increase with age.
Other things that can increase the risk of stroke include:
 high blood pressure
 smoking
 drinking too much alcohol

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 an irregular heartbeat

Women aged 50 to 69 who are not taking HRT, on average about 2
women in 1000 will be diagnosed with ovarian cancer over a 5-year
period. For women who have been taking HRT for 5 years, there
will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra
case).

If you are worried about any of these things, or if you have had
a stroke in the past, talk to your doctor to see if you should take
HRT.
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).

Effects of HRT on heart or circulation
Blood clots in a vein (thrombosis)
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.
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”)
2

 you are seriously overweight (BMI >30 kg/m )
 you have any blood clotting problem that needs long-term
treatment with a medicine used to prevent blood clots.
 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 oestrogen-progestogen 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).

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.
 If you have heart or kidney problems, your doctor should
examine you carefully as oestrogens may cause fluid retention
resulting in swelling
 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
 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
Other medicines and Estradiol Valerate
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 phenobarbital, phenytoin,
carbamazepine)
 medicines for tuberculosis (such as rifampicin, rifabutin)
 medicines for HIV infection (such as nevirapine, efavirenz,
ritonavir and nelfinavir)
 herbal remedies containing St. John’s wort (Hypericum
perforatum)


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

There is nothing to suggest that the use of Estradiol Valerate affects
driving or use of machines.

3. HOW TO TAKE ESTRADIOL VALERATE
Always take this medicine exactly as your doctor has told you.
Check with your doctor if you are not sure.
The recommended dose is one tablet of Estradiol Valerate 1 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 days are translated as follows:
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
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).
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.
S300 LEAFLET Estradiol Valerate 20160830

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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