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FEMTAB 2MG TABLETS

Active substance(s): 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)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed on this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in
the Google Play or Apple App Store. By reporting side effects,
you can help provide more information on the safety of this
medicine.
5. How to store Progynova

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.



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
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

®

PROGYNOVA 2mg TABLETS
(Estradiol Valerate)
Your medicine is known as above but will be referred to as
Progynova 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.

If you need to have surgery

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

S301 LEAFLET Progynova 20171205

Be sure 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PROGYNOVA

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

Do not take Progynova
Warnings and precautions

What Progynova contains


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



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.

HRT and cancer
Effects of HRT on heart or circulation

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

Stroke
Other conditions
Other medicines and Progynova

 stroke

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

Driving and using machines

 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
 indigestion, a feeling of being bloated, passing wind, feeling or
being sick, abdominal pain, gall bladder disease
 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
 headache, migraine, dizziness, anxiety or depressive
symptoms, fatigue
 fast or irregular heartbeat (palpitations), high blood pressure
inflammation of veins usually in the legs
 fluid retention leading to swelling of parts of the body
 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)

Progynova contains lactose monohydrate and sucrose
3. HOW TO TAKE PROGYNOVA

Product Licence holder

About the pack

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 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



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



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

6. CONTENTS OF THE PACK AND OTHER INFORMATION



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

1. What Progynova is and what it is used for



Delpharm Lille SAS, Parc d‟Activites, Roubaix-Est, 22 Rue de
Toufflers, CS 50070, 59452 Lys-Lez-Lannoy, France

POM

PL: 19488/0301

5. HOW TO STORE PROGYNOVA

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.

Leaflet revision date: 05 December 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 20171205

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

Pregnancy and breast-feeding

This product is manufactured by

Do not take Progynova:

Heart disease (heart attack)

It is an unmarked blue sugar coated tablet.

Manufacturer

 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.

Blood clots in a vein (thrombosis)

 heart disease

 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)

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.

1. WHAT PROGYNOVA IS AND WHAT IT IS USED FOR

Laboratory tests

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

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.

What is in this leaflet

What Progynova looks like and contents of the pack

For more information about these side effects see section 2.

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 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.

 blood clots in the veins of the legs or lungs (venous
thromboembolism)

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

Medical history and regular check-ups

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.

6. Contents of the pack and other information

 ovarian cancer

2. What you need to know before you take Progynova

 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.

Medical history and regular check-ups

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

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.

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

 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 Progynova, stop taking it at once and consult
your doctor immediately.

Warnings and precautions
Talk to your doctor or pharmacist before taking Progynova
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
 a liver disorder, such as a benign liver tumour
 diabetes
 gallstones
 migraine or severe headaches
 a disease of the immune system that affects many organs of
the body (systemic lupus erythematosus, SLE)
 epilepsy
 asthma
 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
 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.

Your risk of breast cancer is also higher:
 if you have a close relative (mother, sister or grandmother) who
has had breast cancer
 if you are seriously overweight
Compare
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).
Regularly check your breasts. See your doctor if you notice
any changes in your breast such as:
 dimpling of the skin
 changes in the nipple
 any lumps you can see or feel
Additionally, you are advised to join mammography screening
programs when offered to you. For mammogram screening, it is
important that you inform the nurse/healthcare professional who is
actually taking the x-ray that you use HRT, as this medication may
increase the density of your breasts which may affect the outcome
of the mammogram. Where the density of the breast is increased,
mammography may not detect all lumps.
Ovarian cancer
Ovarian cancer (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.
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).
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)

Compare

 you have cancer

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 signs of a blood clot, see “Stop taking Progynova and see a
doctor immediately”.

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.

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)
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack. 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.

Pregnancy and breast-feeding

For women who have had their womb removed and are taking
oestrogen-only therapy there is no increased risk of developing a
heart disease.

If you become pregnant, stop taking Progynova immediately and
contact your doctor.

If you get:
 a pain in your chest that spreads to your arm or neck
 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.

Progynova is for use in post-menopausal women only. Do not take
if you are pregnant or breast-feeding.

Driving and using machines
No effects on ability to drive and use machines have been observed
in users of Progynova.

Stroke

Progynova contains lactose monohydrate and sucrose

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.

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.

Other things that can increase the risk of stroke include:
 high blood pressure
 smoking

3. How to take Progynova

 drinking too much alcohol

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

 an irregular heartbeat
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).

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.

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

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.

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)

Your doctor may prescribe the hormone progestogen in addition to
Progynova for at least 12 -14 days each month:

 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)

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.

 herbal remedies containing St. John’s wort (Hypericum
perforatum)
 Medicines for treatment of fungal infections (such as
griseofulvin, fluconazole, itraconazole, ketoconazole and
voriconazole)
 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.

 if you still have your womb
 if you have a history of endometriosis
When to start

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
Overdose may cause nausea and vomiting and irregular bleeding.
No specific treatment is necessary but you should consult your
doctor or pharmacist if you are concerned.
S301 LEAFLET Progynova 20171205

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)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed on this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in
the Google Play or Apple App Store. By reporting side effects,
you can help provide more information on the safety of this
medicine.
5. How to store FemTab

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.



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
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

FEMTAB 2mg TABLETS
(Estradiol Valerate)
Your medicine is known as above but will be referred to as FemTab
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.

If you need to have surgery

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

S301 LEAFLET FemTab 20171205

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.

 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.

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.

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.

What is in this leaflet

Be sure 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.

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

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

Do not take FemTab
6. Contents of the pack and other information
What FemTab contains


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.

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

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.

 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.

Warnings and precautions
HRT and cancer

Do not take FemTab:

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

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,

Heart disease (heart attack)

Do not take FemTab

Stroke

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

Other conditions

 blood clots in the veins of the legs or lungs (venous
thromboembolism)

What FemTab looks like and contents of the pack

Laboratory tests

 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

It is an unmarked blue sugar coated tablet.

Pregnancy and breast-feeding

 If you have any unexplained vaginal bleeding

 heart disease

FemTab Tablets are available as 1 or 3 blister packs of 28 tablets in
each carton.
Product Licence holder

Driving and using machines

 If you have excessive thickening of the womb lining
(endometrial hyperplasia) that is not being treated

 ovarian cancer

 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:
 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
 indigestion, a feeling of being bloated, passing wind, feeling or
being sick, abdominal pain, gall bladder disease
 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
 headache, migraine, dizziness, anxiety or depressive
symptoms, fatigue
 fast or irregular heartbeat (palpitations), high blood pressure
inflammation of veins usually in the legs
 fluid retention leading to swelling of parts of the body
 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)

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.

FemTab contains lactose monohydrate and sucrose
3. HOW TO TAKE FEMTAB
About the pack
When to start
If you take more FemTab than you should
If you forget to take FemTab

Manufacturer

If you stop taking FemTab

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.



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



Delpharm Lille SAS, Parc d‟Activites, Roubaix-Est, 22 Rue de
Toufflers, CS 50070, 59452 Lys-Lez-Lannoy, France

POM

Other medicines and FemTab

PL: 19488/0301

Leaflet revision date: 05 December 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.
S301 LEAFLET FemTab 20171205

If you need to have surgery
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE FEMTAB
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. What FemTab is and what it is used for
What FemTab is
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

 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.

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

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)”)
 increased risk of getting an oestrogen-sensitive cancer (such as
mother, sister or grandmother who has had breast cancer)
 high blood pressure
 a liver disorder, such as a benign liver tumour
 diabetes
 gallstones
 migraine or severe headaches
 a disease of the immune system that affects many organs of
the body (systemic lupus erythematosus, SLE)
 epilepsy
 asthma
 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
 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.

Your risk of breast cancer is also higher:
 if you have a close relative (mother, sister or grandmother) who
has had breast cancer
 if you are seriously overweight
Compare
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).
Regularly check your breasts. See your doctor if you notice
any changes in your breast such as:
 dimpling of the skin
 changes in the nipple
 any lumps you can see or feel
Additionally, you are advised to join mammography screening
programs when offered to you. For mammogram screening, it is
important that you inform the nurse/healthcare professional who is
actually taking the x-ray that you use HRT, as this medication may
increase the density of your breasts which may affect the outcome
of the mammogram. Where the density of the breast is increased,
mammography may not detect all lumps.
Ovarian cancer
Ovarian cancer (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.
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).
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)

Compare

 you have cancer

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 signs of a blood clot, see “Stop taking FemTab and see a
doctor immediately”.

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.

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)
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack. 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.

Pregnancy and breast-feeding

For women who have had their womb removed and are taking
oestrogen-only therapy there is no increased risk of developing a
heart disease.

If you become pregnant, stop taking FemTab immediately and
contact your doctor.

If you get:
 a pain in your chest that spreads to your arm or neck
 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.

FemTab is for use in post-menopausal women only. Do not take if
you are pregnant or breast-feeding.

Driving and using machines
No effects on ability to drive and use machines have been observed
in users of FemTab.

Stroke

FemTab contains lactose monohydrate and sucrose

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.

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.

Other things that can increase the risk of stroke include:
 high blood pressure

3. How to take FemTab

 smoking

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

 drinking too much alcohol
 an irregular heartbeat
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.

The recommended dose is one tablet of FemTab 2 mg to be taken
daily.

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).

FemTab is not for use in adolescents or children.

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 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
Other medicines and FemTab
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
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)
 herbal remedies containing St. John’s wort (Hypericum
perforatum)
 Medicines for treatment of fungal infections (such as
griseofulvin, fluconazole, itraconazole, ketoconazole and
voriconazole)
 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.

Use in children and adolescents
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
Overdose may cause nausea and vomiting and irregular bleeding.
No specific treatment is necessary but you should consult your
doctor or pharmacist if you are concerned.
S301 LEAFLET FemTab 20171205

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:

PACKAGE LEAFLET: INFORMATION FOR THE USER



painful reddish skin nodules (erythema nodosum)



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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed on this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in
the Google Play or Apple App Store. By reporting side effects,
you can help provide more information on the safety of this
medicine.

If you need to have surgery

5. How to store Estradiol Valerate

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.



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 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

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.

What Estradiol Valerate contains


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.

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

What Estradiol Valerate looks like and contents of the pack

 heart disease

It is an unmarked blue sugar coated tablet.

 stroke

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

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:

ESTRADIOL VALERATE 2mg 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.

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.

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

 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
Warnings and precautions

Do not take Estradiol Valerate:

HRT and cancer

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,

Effects of HRT on heart or circulation
Blood clots in a vein (thrombosis)
Heart disease (heart attack)
Stroke
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

If you forget to take Estradiol Valerate



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

If you stop taking Estradiol Valerate



4. POSSIBLE SIDE EFFECTS

 breast pain, tenderness or enlargement, breast discharge

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



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

6. CONTENTS OF THE PACK AND OTHER INFORMATION



Delpharm Lille SAS, Parc d‟Activites, Roubaix-Est, 22 Rue de
Toufflers, CS 50070, 59452 Lys-Lez-Lannoy, France

 headache, migraine, dizziness, anxiety or depressive
symptoms, fatigue
 fast or irregular heartbeat (palpitations), high blood pressure
inflammation of veins usually in the legs
 fluid retention leading to swelling of parts of the body
 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)

If you need to have surgery
5. HOW TO STORE ESTRADIOL VALERATE

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

Leaflet revision date: 05 December 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.
S301 LEAFLET Estradiol Valerate 20171205

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.

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

This product is manufactured by

 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

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.

Be sure to:

If you take more Estradiol Valerate than you should

PL: 19488/0301

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.

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

When to start

POM

Medical history and regular check-ups

What is in this leaflet

Manufacturer

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

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

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.

 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

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.

 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.

Medical history and regular check-ups
6. Contents of the pack and other information

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

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

S301 LEAFLET Estradiol Valerate 20171205

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.

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
 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 Estradiol Valerate, stop taking it at once and
consult your doctor immediately.

What Estradiol Valerate is used for
Relief of symptoms occurring after menopause

Warnings and precautions

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.

Talk to your doctor or pharmacist before taking Estradiol Valerate

Prevention of osteoporosis

 fibroids inside your womb

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

 growth of womb lining outside your womb (endometriosis) or a
history of excessive growth of the womb lining (endometrial
hyperplasia)

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:

 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
 a liver disorder, such as a benign liver tumour
 diabetes
 gallstones
 migraine or severe headaches
 a disease of the immune system that affects many organs of
the body (systemic lupus erythematosus, SLE)
 epilepsy
 asthma
 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
 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.

Your risk of breast cancer is also higher:
 if you have a close relative (mother, sister or grandmother) who
has had breast cancer
 if you are seriously overweight
Compare
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).
Regularly check your breasts. See your doctor if you notice
any changes in your breast such as:
 dimpling of the skin
 changes in the nipple
 any lumps you can see or feel
Additionally, you are advised to join mammography screening
programs when offered to you. For mammogram screening, it is
important that you inform the nurse/healthcare professional who is
actually taking the x-ray that you use HRT, as this medication may
increase the density of your breasts which may affect the outcome
of the mammogram. Where the density of the breast is increased,
mammography may not detect all lumps.
Ovarian cancer
Ovarian cancer (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.
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).
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)

Compare

 you have cancer

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 signs of a blood clot, see “Stop taking Estradiol Valerate and
see a doctor immediately”.

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.

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)
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack. 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.

Pregnancy and breast-feeding

For women who have had their womb removed and are taking
oestrogen-only therapy there is no increased risk of developing a
heart disease.

If you become pregnant, stop taking Estradiol Valerate immediately
and contact your doctor.

If you get:
 a pain in your chest that spreads to your arm or neck
 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.

Estradiol Valerate is for use in post-menopausal women only. Do
not take if you are pregnant or breast-feeding.

Driving and using machines
No effects on ability to drive and use machines have been observed
in users of Estradiol Valerate.

Stroke

Estradiol Valerate contains lactose monohydrate and sucrose

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.

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.

Other things that can increase the risk of stroke include:
 high blood pressure
 smoking

3. How to take Estradiol Valerate

 drinking too much alcohol

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

 an irregular heartbeat
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).

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.

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

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.

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)

Your doctor may prescribe the hormone progestogen in addition to
Estradiol Valerate for at least 12 -14 days each month:

 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)

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.

 herbal remedies containing St. John’s wort (Hypericum
perforatum)
 Medicines for treatment of fungal infections (such as
griseofulvin, fluconazole, itraconazole, ketoconazole and
voriconazole)
 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.

 if you still have your womb
 if you have a history of endometriosis
When to start

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
Overdose may cause nausea and vomiting and irregular bleeding.
No specific treatment is necessary but you should consult your
doctor or pharmacist if you are concerned.
S301 LEAFLET Estradiol Valerate 20171205

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