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FEMTAB 1MG TABLETS

Active substance(s): OESTRADIOL VALERATE

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S300 LEAFLET Progynova 20160802

If you stop taking Progynova

Reporting of side effects:

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.

If you get any side effects, talk to your doctor, pharmacist or nurse.
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 need to have surgery

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

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.
4. Possible Side Effects
Like all medicines, Progynova can cause side effects, although not
everybody gets them.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Progynova

 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

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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Read all of this leaflet carefully before you start taking this
medicine



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.



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, ask your doctor or
pharmacist.
 This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.

6. Further Information

 If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:

What Progynova contains

1. What Progynova is and what it is used for

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

2. Before you take Progynova
Medical history and regular check-ups

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

PACKAGE LEAFLET: INFORMATION FOR USER

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.

Do not take Progynova
When you need to take special care with Progynova
HRT and cancer
Effects of HRT on heart or circulation
Blood clots in a vein (thrombosis)

 probable memory loss if HRT is started over the age of 65
For more information about these side effects see Section 2.

What Progynova looks like and contents of the pack

Heart disease (heart attack)

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

Progynova is an unmarked beige sugar coated tablet.

Stroke

 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)

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

 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

Product Licence holder

Pregnancy and breast-feeding

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.

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 Progynova



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

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

Leaflet revision date: 02 August 2016

 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)

Important information about some of the
3. How to take Progynova

Manufacturer

POM

 changes in body weight and sex drive, increased appetite

Driving or using machines
ingredients of Progynova

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

 fluid retention leading to swelling of parts of the body

Using other medicines
Laboratory tests

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

Other conditions

If you take more Progynova than you should
If you stop taking Progynova
If you need to have surgery
4. Possible side effects
5. How to store Progynova

PL: 19488/0300

6. Further information

Progynova is a registered trade mark of Bayer Intellectual Property
GmbH, Germany.
S300 LEAFLET Progynova 20160802

1. What Progynova is and what it is used for
What Progynova is
Progynova is a Hormone Replacement Therapy (HRT). It contains
the female hormone, oestrogen. Your ovaries gradually make less
of this hormone as you get older and will no longer produce it after
you have been through the menopause. Progynova can be used in
peri- and postmenopausal women.
What Progynova is used for
Relief of symptoms occuring 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.

2. 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 (hypersensitive) to estradiol valerate or to
any of the other ingredients in Progynova (listed in section 6
“Further information”)
 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.

When you need to take special care with
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)

Your risk of breast cancer is also higher:

 high blood pressure

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

 a liver disorder, such as a benign liver tumour

 if you are seriously overweight

 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).

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

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 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.

 asthma
 a disease affecting the eardrum and hearing (otosclerosis)

 dimpling of the skin

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

 changes in the nipple

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.

 fluid retention due to cardiac or kidney problems
Stop taking Progynova and see a doctor immediately

 any lumps you can see or feel

Other things that can increase the risk of stroke include:

Ovarian cancer

 high blood pressure

If you notice any of the following when taking HRT:

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.

 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

Compare
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).

Stroke

 an irregular heartbeat

Compare

Blood clots in a vein (thrombosis)

Other conditions

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.

 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

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
seperately.
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.

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 if
these situations apply to you:
 you are unable to walk for a long time because of major
surgery, injury or illness (see also sections 3, “If you need to
have surgery”)
 you are seriously overweight (BMI >30 kg/m2)
 you have any blood clotting problem that needs longterm
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

Using other medicines

 you have systemic lupus erythematosus (SLE)

Some medicines may interfere with the effect of Progynova.

 you have cancer

This might lead to irregular bleeding. This applies to the following
medicines:

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).

Progynova contains lactose (a type of sugar). If you have an
intolerance to some sugars, check with your doctor before taking
Progynova.
3. How to take Progynova

About the pack
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.

 difficulty in breathing

Excessive thickening of the lining of the womb (endometrial
hyperplasia) and cancer of the lining of the womb (endometrial
cancer)

Important information about some of the ingredients of

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.

Effects of HRT on heart or circulation

HRT and cancer

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

 drinking too much alcohol

 sudden chest pain

DVT and PE are examples of a condition called venous
thromboembolism, or VTE.

Driving or using machines

Progynova is not for use in adolescents or children.

 painful swelling and redness of the legs

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.

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

 smoking

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).

 if you notice signs of a blood clot, such as:

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

Progynova

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

 any of the conditions mentioned in the ‘DO NOT take
Progynova’ section

Pregnancy and breast-feeding

 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)


Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines including
medicines obtained without a prescription, herbal
medicines or other natural products.

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
If this is your first HRT treatment and your periods have
become very infrequent or have stopped completely: you can
start your Progynova tablets at any time if you are sure you are not
pregnant.
If you take more Progynova than you should
If you have taken too many Progynova tablets by mistake, you may
feel sick, vomit or have some menstruation-like bleeding. No
specific treatment is necessary but you should consult your doctor
or pharmacist if you are worried.
If you forget to take Progynova

Heart disease (heart attack)

Laboratory tests

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

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.

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.

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.

S300 LEAFLET Progynova 20160802

S300 LEAFLET FemTab 20160802

If you stop taking FemTab

Reporting of side effects:

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 get any side effects, talk to your doctor, pharmacist or nurse.
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.

PACKAGE LEAFLET: INFORMATION FOR USER
FEMTAB 1mg TABLETS
(estradiol valerate)

If you need to have surgery

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

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

5. How to store FemTab

Read all of this leaflet carefully before you start taking this
medicine

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.
4. Possible Side Effects
Like all medicines, FemTab can cause side effects, although not
everybody gets them.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.



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.

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

 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or
pharmacist.

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

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.

 breast cancer

What FemTab contains

2. Before you take FemTab

 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:
 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, premenstrual
symptoms, increased size of fibroids in the womb, thrush,
changes to the neck of the womb

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.

Medical history and regular check-ups
Do not take FemTab
When you need to take special care with FemTab
HRT and cancer
Effects of HRT on heart or circulation
Blood clots in a vein (thrombosis)
Heart disease (heart attack)

What FemTab looks like and contents of the pack

Stroke

FemTab is an unmarked beige sugar coated tablet.

Other conditions

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

Using other medicines
Laboratory tests
Pregnancy and breast-feeding

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.

Driving or using machines
Important information about some of the
ingredients of FemTab
3. How to take FemTab
About the pack

Manufacturer
This product is manufactured by

When to start



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

If you take more FemTab than you should



 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

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

If you stop taking FemTab



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

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

POM

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

Leaflet revision date: 02 August 2016

 fluid retention leading to swelling of parts of the body

FemTab is a registered trade mark of Merck KGaA, Germany.

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

 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)

If you need to have surgery
4. Possible side effects
5. How to store FemTab

1. What FemTab is and what it is used for

 changes in body weight and sex drive, increased appetite
 muscle cramps, leg pains

If you forget to take FemTab

6. Further information

PL: 19488/0300

S300 LEAFLET FemTab 20160802

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 any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
1. What FemTab is and what it is used for

 ovarian cancer

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.

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.

6. Further Information
Each tablet contains 1.0mg of the active ingredient, 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.

 This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.

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

2. Before you take FemTab
Medical history and regular check-ups

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
Relief of symptoms occuring 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.

Do not take FemTab:
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,
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 (hypersensitive) to estradiol valerate or to
any of the other ingredients in FemTab (listed in section 6
“Further information”)
 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.
When you need to take special care with
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

Your risk of breast cancer is also higher:

 a liver disorder, such as a benign liver tumour

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

 diabetes
 gallstones

 if you are seriously overweight

 migraine or severe headaches

Compare

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

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).

 epilepsy
 asthma
 a disease affecting the eardrum and hearing (otosclerosis)
 a very high level of fat in your blood (triglycerides)

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

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 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.

 fluid retention due to cardiac or kidney problems
Stop taking FemTab and see a doctor immediately

 dimpling of the skin
 changes in the nipple

If you notice any of the following when taking HRT:

 any lumps you can see or feel

Other things that can increase the risk of stroke include:

 any of the conditions mentioned in the ‘DO NOT take FemTab’
section

Ovarian cancer

 high blood pressure

 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:

Compare
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).

 an irregular heartbeat

Compare

Other conditions

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.

 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

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
seperately.
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.

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 if
these situations apply to you:
 you are unable to walk for a long time because of major
surgery, injury or illness (see also sections 3, “If you need to
have surgery”)
 you are seriously overweight (BMI >30 kg/m2)
 you have any blood clotting problem that needs longterm
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

Using other medicines

 you have systemic lupus erythematosus (SLE)

Some medicines may interfere with the effect of FemTab.

 you have cancer

This might lead to irregular bleeding. This applies to the following
medicines:

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).

FemTab contains lactose (a type of sugar). If you have an
intolerance to some sugars, check with your doctor before taking
FemTab.
3. How to take FemTab

About the pack
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.

Blood clots in a vein (thrombosis)

Excessive thickening of the lining of the womb (endometrial
hyperplasia) and cancer of the lining of the womb (endometrial
cancer)

Important information about some of the ingredients of

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.

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

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

 drinking too much alcohol

Effects of HRT on heart or circulation

 difficulty in breathing

Driving or using machines

FemTab is not for use in adolescents or children.

for more information, see ‘Blood clots in a vein (thrombosis)’

 sudden chest pain

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

 smoking

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).

 painful swelling and redness of the legs

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

FemTab

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.

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.

Pregnancy and breast-feeding

 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)


Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines including
medicines obtained without a prescription, herbal
medicines or other natural products.

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 ‘TUE’.
Take one tablet each day, following the directions of the arrows,
until you have finished all 28 tablets in the memo strip. When you
have finished each memo strip, start the next memo strip on the
following day. Do not leave a break between memo strips. It is best
to take your tablet at the same time each day. You can take
FemTab with or without food. The tablet should be swallowed whole
with a glass of water or milk.
Your doctor may prescribe the hormone progestogen in addition to
FemTab for at least 12-14 days each month:
 if you still have your womb
 if you have a history of endometriosis
When to start
If you have been taking other HRT preparations: carry on until
you have finished your current pack and have taken all the tablets
for that month. Take your first FemTab tablet the next day. Do not
leave a break between your old tablets and the FemTab tablets.
If this is your first HRT treatment and you are still having
regular periods: start your FemTab tablets on the first day of
bleeding
If this is your first HRT treatment and your periods have
become very infrequent or have stopped completely: you can
start your FemTab tablets at any time if you are sure you are not
pregnant.
If you take more FemTab than you should
If you have taken too many FemTab tablets by mistake, you may
feel sick, vomit or have some menstruation-like bleeding. No
specific treatment is necessary but you should consult your doctor
or pharmacist if you are worried.
If you forget to take FemTab

Heart disease (heart attack)

Laboratory tests

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

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.

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.

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.

S300 LEAFLET FemTab 20160802

S300 LEAFLET Estradiol Valerate 20160802

If you stop taking Estradiol Valerate

Reporting of side effects:

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 get any side effects, talk to your doctor, pharmacist or nurse.
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.

PACKAGE LEAFLET: INFORMATION FOR USER

If you need to have surgery

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

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

5. How to store Estradiol Valerate

Read all of this leaflet carefully before you start taking this
medicine

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.
4. Possible Side Effects
Like all medicines, Estradiol Valerate can cause side effects,
although not everybody gets them.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

ESTRADIOL VALERATE 1mg TABLETS
(estradiol valerate)



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



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

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



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

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.

 This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



If 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 any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

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

In this leaflet:

Serious side effects

6. Further Information

 breast cancer

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

What Estradiol Valerate contains

2. Before you take Estradiol Valerate

 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, premenstrual
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

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

Medical history and regular check-ups

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.

When you need to take special care with Estradiol Valerate

What Estradiol Valerate looks like and contents of the pack

About the pack
When to start



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

If you take more Estradiol Valerate than you should

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

If you stop taking Estradiol Valerate

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

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

If you forget to take Estradiol Valerate
If you need to have surgery
4. Possible side effects
5. How to store Estradiol Valerate
6. Further information

PL: 19488/0300

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

 fluid retention leading to swelling of parts of the body

 painful reddish skin nodules (erythema nodosum)

ingredients of Estradiol Valerate

This product is manufactured by

Leaflet revision date: 02 August 2016

 various skin disorders:

Important information about some of the

Manufacturer

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

The following side effects have been reported with other HRTs:

Driving or using machines

3. How to take Estradiol Valerate

POM

 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).

Laboratory tests
Pregnancy and breast-feeding

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

 muscle cramps, leg pains

Stroke
Using other medicines



S300 LEAFLET Estradiol Valerate 20160802

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:

Do not take Estradiol Valerate

Blood clots in a vein (thrombosis)

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



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.

Effects of HRT on heart or circulation

Other conditions

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.

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 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,

Estradiol Valerate is an unmarked beige sugar coated tablet.

Product Licence holder

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.

HRT and cancer

Heart disease (heart attack)

 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

 changes in body weight and sex drive, increased appetite

Do not take Estradiol Valerate

2. Before you take Estradiol Valerate
Medical history and regular check-ups

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 occuring after menopause
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can cause symptoms such as hot face,
neck and chest (“hot flushes”). Estradiol Valerate alleviates these
symptoms after menopause. You will only be prescribed Estradiol
Valerate if your symptoms seriously hinder your daily life.

 If you have 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 (hypersensitive) to estradiol valerate or to
any of the other ingredients in Estradiol Valerate (listed in
section 6 “Further information”)
 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.

When you need to take special care with
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)”)
 increased risk of getting an oestrogen-sensitive cancer (such as
mother, sister or grandmother who has had breast cancer)

 high blood pressure

Your risk of breast cancer is also higher:

 a liver disorder, such as a benign liver tumour
 diabetes

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

 gallstones

 if you are seriously overweight

 migraine or severe headaches

Compare

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

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).

 epilepsy
 asthma
 a disease affecting the eardrum and hearing (otosclerosis)
 a very high level of fat in your blood (triglycerides)

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

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 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.

 fluid retention due to cardiac or kidney problems
Stop taking Estradiol Valerate and see a doctor immediately

 dimpling of the skin
 changes in the nipple

If you notice any of the following when taking HRT:

 any lumps you can see or feel

Other things that can increase the risk of stroke include:

 any of the conditions mentioned in the ‘DO NOT take Estradiol
Valerate’ section

Ovarian cancer

 high blood pressure

 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

Compare
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).

 an irregular heartbeat

Compare

Other conditions

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.

 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

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
seperately.
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

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 if
these situations apply to you:
 you are unable to walk for a long time because of major
surgery, injury or illness (see also sections 3, “If you need to
have surgery”)
 you are seriously overweight (BMI >30 kg/m2)
 you have any blood clotting problem that needs longterm
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

Using other medicines

 you have systemic lupus erythematosus (SLE)

Some medicines may interfere with the effect of Estradiol Valerate.

 you have cancer

This might lead to irregular bleeding. This applies to the following
medicines:

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.

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.

Breast cancer

Compare

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).

Estradiol Valerate contains lactose (a type of sugar). If you have an
intolerance to some sugars, check with your doctor before taking
Estradiol Valerate.
3. How to take Estradiol Valerate

About the pack
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.

Blood clots in a vein (thrombosis)

DVT and PE are examples of a condition called venous
thromboembolism, or VTE.

Important information about some of the ingredients of

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.

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.

Excessive thickening of the lining of the womb (endometrial
hyperplasia) and cancer of the lining of the womb (endometrial
cancer)

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

 drinking too much alcohol

Effects of HRT on heart or circulation

HRT and cancer

Driving or using machines

Estradiol Valerate is not for use in adolescents or children.

for more information, see ‘Blood clots in a vein (thrombosis)’

 difficulty in breathing

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

 smoking

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).

 sudden chest pain

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

Estradiol Valerate

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.

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.

Pregnancy and breast-feeding

 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)


Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines including
medicines obtained without a prescription, herbal
medicines or other natural products.

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

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 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)

Laboratory tests

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.
If you forget to take Estradiol Valerate

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.

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

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 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.

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.

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.
S300 LEAFLET Estradiol Valerate 20160802

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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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