Skip to Content

FEMTAB 2MG TABLETS

Active substance(s): ESTRADIOL VALERATE

View full screen / Print PDF » Download PDF ⇩
Transcript
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.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on the 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.

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



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

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.

6. Further Information

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

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.

 probable memory loss if HRT is started over the age of 65
For more information about these side effects see Section 2.
Other side effects that have been linked to the use of Progynova
and other oral hormone replacement therapies:

 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
 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

What Progynova looks like and contents of the pack

 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)
Reporting of side effects:
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.
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
Progynova throughout the following leaflet.
Read all of this leaflet carefully before you start taking this
medicine.

 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.

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.

 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.

Be sure to:

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.

1. What Progynova is and what it is used for
2. Before you take Progynova

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

It is an unmarked blue sugar coated tablet.

Medical history and regular check-ups

Do not take Progynova:

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

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,

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.

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)
Heart disease (heart attack)

Manufacturer

Stroke

This product is manufactured by

Other conditions



Bayer Pharma AG, 13353, Berlin, Germany.

Using other medicines



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

Laboratory tests



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

Pregnancy and breast-feeding
Driving or using machines
Important information about some of the

POM

PL: 19488/0301

ingredients of Progynova
3. How to take Progynova

Leaflet revision date: 15 January 2016

About the pack
When to start

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

PROGYNOVA 2mg TABLETS
(Estradiol Valerate)

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



 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)

PACKAGE LEAFLET: INFORMATION FOR USER

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

 ovarian cancer

 stroke

S301 LEAFLET progynova 20160115

5. How to store Progynova

Progynova is a registered trade mark of Bayer Schering Pharma
AG.
S301 LEAFLET progynova 20160115

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
5. How to store Progynova
6. Further information
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.

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:

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)

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.

 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

Compare

If you get:

3. How to take Progynova

 a liver disorder, such as a benign liver tumour

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).

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

Progynova is not for use in adolescents or children.

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

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

 asthma

 dimpling of the skin

 a disease affecting the eardrum and hearing (otosclerosis)

 changes in the nipple

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

 any lumps you can see or feel

 fluid retention due to cardiac or kidney problems

Ovarian cancer

Stop taking Progynova and see a doctor immediately

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.

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).

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).

 migraine-like headaches which happen for the first time.



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

Stroke

About the pack

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.

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.

Other things that can increase the risk of stroke include:

The days are translated as follows:

 high blood pressure

ZON/DIM/SON = Sunday DON/JEU/DON = Thursday

 smoking

MAA/LUN/MON = Monday VRI/VEN/FRE = Friday

 drinking too much alcohol

DIN/MAR/DIE = Tuesday ZAT/SAM/SAM = Saturday

 an irregular heartbeat

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).

Compare

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’.

Looking at women in their 50s who are not taking HRT, on average,
8 in 1000 would be expected to have a stroke over a 5-year period.
For women in their 50s who are taking HRT, there will be 11 cases
in 1000 users, over 5 years (i.e. an extra 3 cases).

Effects of HRT on heart or circulation

Other conditions

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

Blood clots in a vein (thrombosis)

 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.

 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.

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.

HRT and cancer

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:

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

 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”)

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).

 you are seriously overweight (BMI >30 kg/m2)

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.

 any of your close relatives has ever had a blood clot in the leg,
lung or any other organ

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.

 you have any blood clotting problem that needs longterm
treatment with a medicine used to prevent blood clots.

 you have had one or more miscarriages
 you have systemic lupus erythematosus (SLE)
 you have cancer
For signs of a blood clot, see “Stop taking Progynova and see a
doctor immediately”.
Compare
Looking at women in their 50s who are not taking HRT, on average,
over a 5-year period, 4 to 7 in 1000 would be expected to get a
blood clot in a vein.
For women in their 50s who are taking oestrogen-progestogen HRT
for over 5 years, there will be 9 – 12 cases in 1000 (i.e. an extra 5
cases).

 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
Using other medicines
Some medicines may interfere with the effect of Progynova.
This might lead to irregular bleeding. This applies to the following
medicines:
 medicines for epilepsy (such as phenobarbital, phenytoin,
carbamazepine)
 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.

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).

Laboratory tests

Breast cancer

Heart disease (heart attack)

Pregnancy and breast-feeding

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.

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

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

For women who have had their womb removed and who are using
oestrogen-only HRT for 5 years, little or no increase in breast
cancer risk is shown.

Women over the age of 60 years who use oestrogen-progestogen

Driving or using machines

HRT are slightly more likely to develop heart disease than those not
taking any HRT.

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

Your risk of breast cancer is also higher:

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

Important information about some of the ingredients of
Progynova

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

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.

WOE/MER/MIT = Wednesday

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.

 if you become pregnant
 painful swelling and redness of the legs

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.

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

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

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
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.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking
Progynova. You may need to stop taking Progynova about 4 to 6
weeks before the operation to reduce the risk of a blood clot (see
section 2, “Blood clots in a vein (thrombosis)”).
Ask your doctor when you can start taking Progynova again.
S301 LEAFLET progynova 20160115

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.

5. How to store Estradiol Valerate
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on the 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.

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



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

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

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

6. Further Information

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

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.

 heart disease
 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
 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

ESTRADIOL VALERATE 2mg TABLETS
(estradiol valerate)

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

 ovarian cancer

 stroke

PACKAGE LEAFLET: INFORMATION FOR USER



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

S301 LEAFLET Estradiol Valerate 20160115

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



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

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

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.

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

Do not take Estradiol Valerate:

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

When you need to take special care with 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

Do not take Estradiol Valerate

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.

Blood clots in a vein (thrombosis)
Heart disease (heart attack)
Stroke

Manufacturer

Other conditions

This product is manufactured by

Using other medicines



Bayer Pharma AG, 13353, Berlin, Germany.

Laboratory tests



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

Pregnancy and breast-feeding



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

Driving or using machines
Important information about some of the
ingredients of Estradiol Valerate

POM

PL: 19488/0301

3. How to take Estradiol Valerate
About the pack

Leaflet revision date: 15 January 2016

When to start
If you forget to take Estradiol Valerate

 painful reddish skin nodules (erythema nodosum)

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.

It is an unmarked blue sugar coated tablet.

 muscle cramps, leg pains

 various skin disorders:

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 Estradiol Valerate looks like and contents of the pack

If you take more Estradiol Valerate than you should

The following side effects have been reported with other HRTs:

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.

 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.

2. Before you take Estradiol Valerate

 changes in body weight and sex drive, increased appetite
 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).

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

S301 LEAFLET Estradiol Valerate 20160115

If you stop taking Estradiol Valerate
If you need to have surgery
4. Possible side effects
5. How to store Estradiol Valerate
6. Further information
1. What Estradiol Valerate is and what it is used for
What Estradiol Valerate is
Estradiol Valerate is a Hormone Replacement Therapy (HRT). It
contains the female hormone, oestrogen. Your ovaries gradually
make less of this hormone as you get older and will no longer
produce it after you have been through the menopause. Estradiol
Valerate can be used in peri- and postmenopausal women.
What Estradiol Valerate is used for

 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.

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

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
 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).

Compare

If you get:

3. How to take Estradiol Valerate

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).

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

Estradiol Valerate is not for use in adolescents or children.

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

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 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

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.
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

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..

Other things that can increase the risk of stroke include:

The days are translated as follows:

 high blood pressure

ZON/DIM/SON = Sunday DON/JEU/DON = Thursday

 smoking

MAA/LUN/MON = Monday VRI/VEN/FRE = Friday

 drinking too much alcohol

DIN/MAR/DIE = Tuesday ZAT/SAM/SAM = Saturday

 an irregular heartbeat

 you have systemic lupus erythematosus (SLE)
 you have cancer

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).

WOE/MER/MIT = Wednesday

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 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).

Compare

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’.

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).
 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 had your womb removed (a hysterectomy), discuss with
your doctor whether you can safely take this product without a
progestogen.

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.

About the pack

The risk of getting a stroke is about 1.5–times higher in HRT users
than in non–users. The number of extra cases of stroke due to HRT
use will increase with age.

Other 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.

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.

Stroke

Blood clots in a vein (thrombosis)

 you have had one or more miscarriages

Compare

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.

Effects of HRT on heart or circulation

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’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.



 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

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 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

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.

 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

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

Using other medicines

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.

Some medicines may interfere with the effect of Estradiol Valerate.
This might lead to irregular bleeding. This applies to the following
medicines:
 medicines for epilepsy (such as phenobarbital, phenytoin,
carbamazepine)
 medicines for tuberculosis (such as rifampicin, rifabutin)
 medicines for HIV infection (such as nevirapine, efavirenz,
ritonavir and nelfinavir)
 herbal remedies containing St. John’s wort (Hypericum
perforatum)


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.

If you take more Estradiol Valerate than you should
If you have taken too many Estradiol Valerate tablets by mistake,
you may feel sick, vomit or have some menstruation-like bleeding.
No specific treatment is necessary but you should consult your
doctor or pharmacist if you are worried.
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.

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).

Laboratory tests

If you stop taking Estradiol Valerate

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.

Heart disease (heart attack)

Pregnancy and breast-feeding

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.

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

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

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.

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

Women over the age of 60 years who use oestrogen-progestogen

Driving or using machines

HRT are slightly more likely to develop heart disease than those not
taking any HRT.

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

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

Important information about some of the ingredients of
Estradiol Valerate
Estradiol Valerate contains lactose (a type of sugar). If you have an
intolerance to some sugars, check with your doctor before taking
Estradiol Valerate.

If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking
Estradiol Valerate. You may need to stop taking Estradiol Valerate
about 4 to 6 weeks before the operation to reduce the risk of a
blood clot (see section 2, “Blood clots in a vein (thrombosis)”).
Ask your doctor when you can start taking Estradiol Valerate again.
S301 LEAFLET Estradiol Valerate 20160115

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 the 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.

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



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

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

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

6. Further Information

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

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.

 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
 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

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



 heart disease
 stroke

PACKAGE LEAFLET: INFORMATION FOR USER
FEMTAB 2mg TABLETS
(estradiol valerate)



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

S301 LEAFLET FemTab 20160115

5. How to store FemTab

 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 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:
1. What FemTab is and what it is used for
2. Before you take FemTab

 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.

When you need to take special care with FemTab

Do not take FemTab:

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 FemTab,

Effects of HRT on heart or circulation
Product Licence holder

Blood clots in a vein (thrombosis)

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.

Heart disease (heart attack)
Stroke
Other conditions

Manufacturer

Using other medicines

This product is manufactured by

Laboratory tests



Bayer Pharma AG, 13353, Berlin, Germany.

Pregnancy and breast-feeding



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

Driving or using machines



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

Important information about some of the
ingredients of FemTab
3. How to take FemTab

POM

About the pack

PL: 19488/0301

When to start
Femtab is a registered trade mark of Merck KGaA, Germany.

If you forget to take FemTab

S301 LEAFLET FemTab 20160115

If you stop taking FemTab
If you need to have surgery
4. Possible side effects
5. How to store FemTab
6. Further information

 painful reddish skin nodules (erythema nodosum)

1. What FemTab is and what it is used for

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

What FemTab is

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

Be sure to:

Do not take FemTab

 muscle cramps, leg pains

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.

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.

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

If you take more FemTab than you should

Reporting of side effects:

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.

Medical history and regular check-ups

Leaflet revision date: 15 January 2016

 various skin disorders:

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.

It is an unmarked blue sugar coated tablet.

 changes in body weight and sex drive, increased appetite

The following side effects have been reported with other HRTs:

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.

What FemTab looks like and contents of the pack

 fluid retention leading to swelling of parts of the body

 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).

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

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.

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)


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

If 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
 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).

Compare

If you get:

3. How to take FemTab

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).

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

FemTab is not for use in adolescents or children.

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

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 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

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.
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

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.

Other things that can increase the risk of stroke include:

The days are translated as follows:

 high blood pressure

ZON/DIM/SON = Sunday DON/JEU/DON = Thursday

 smoking

MAA/LUN/MON = Monday VRI/VEN/FRE = Friday

 drinking too much alcohol

DIN/MAR/DIE = Tuesday ZAT/SAM/SAM = Saturday

 an irregular heartbeat

 you have systemic lupus erythematosus (SLE)
 you have cancer

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).

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).

Compare

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’.

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 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
Using 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 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.

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).

Laboratory tests

Heart disease (heart attack)

Pregnancy and breast-feeding

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

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

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.

WOE/MER/MIT = Wednesday

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.

 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 had your womb removed (a hysterectomy), discuss with
your doctor whether you can safely take this product without a
progestogen.

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.

About the pack

The risk of getting a stroke is about 1.5–times higher in HRT users
than in non–users. The number of extra cases of stroke due to HRT
use will increase with age.

Other 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.

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.

Stroke

Blood clots in a vein (thrombosis)

 you have had one or more miscarriages

Compare

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.

Effects of HRT on heart or circulation

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’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.



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.

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

Women over the age of 60 years who use oestrogen-progestogen

Driving or using machines

HRT are slightly more likely to develop heart disease than those not
taking any HRT.

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

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

Important information about some of the ingredients of
FemTab
FemTab contains lactose (a type of sugar). If you have an
intolerance to some sugars, check with your doctor before taking
FemTab.

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
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.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking
FemTab. You may need to stop taking FemTab about 4 to 6 weeks
before the operation to reduce the risk of a blood clot (see section
2, “Blood clots in a vein (thrombosis)”).
Ask your doctor when you can start taking FemTab again.
S301 LEAFLET FemTab 20160115

Expand view ⇕

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.

Hide