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FEMTAB 1MG TABLETS

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

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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.

The following side effects have been reported with other HRTs:

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

PROGYNOVA® 1mg TABLETS
(Estradiol Valerate)

 painful reddish skin nodules (erythema nodosum)
 rash with target-shaped reddening or sores (erythema
multiforme)

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.

S300 LEAFLET Progynova 20170427

 various skin disorders:

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

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

If you stop taking Progynova

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

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.

5. How to store Progynova


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

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)”).

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.

Ask your doctor when you can start taking Progynova again.



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

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 because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or
pharmacist.
 This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.


If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

Warnings and precautions

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

HRT and cancer
Effects of HRT on heart or circulation

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

Stroke
Other conditions
Laboratory tests

Progynova is an unmarked beige sugar coated tablet.

Pregnancy and breast-feeding

 heart disease

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

Driving and using machines

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:
 During the first few months of treatment you may experience
some vaginal bleeding at unexpected times (breakthrough
bleeding and spotting). These symptoms normally lessen with
continued treatment. If they don’t, contact your doctor (see
section 2 ‘HRT and cancer/Excessive thickening of the lining of
the womb (endometrial hyperplasia) and cancer of the lining of
the womb (endometrial cancer)’ for more information)
 breast pain, tenderness or enlargement, breast discharge
 painful periods, changes in vaginal secretions, pre-menstrual
symptoms, increased size of fibroids in the womb, thrush,
changes to the neck of the womb
 indigestion, a feeling of being bloated, passing wind, feeling or
being sick, abdominal pain, gall bladder disease
 skin rashes or discolouration, itching, eczema, acne, unusual
hair loss or hair growth, increased skin pigment especially on
the face (chloasma – see section 2‘other conditions’ for more
information), some rare skin problems
 headache, migraine, dizziness, anxiety or depressive
symptoms, fatigue
 fast or irregular heartbeat (palpitations), high blood pressure,
inflammation of veins usually in the legs
 fluid retention leading to swelling of parts of the body
 changes in body weight and sex drive, increased appetite
 muscle cramps, leg pains
 nose bleeds, visual disturbances (such as blurred vision),
discomfort with contact lenses, allergic-type reactions, a
worsening of glucose tolerance, bladder inflammation, rare
disorders (porphyria, chorea).

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

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.

About the pack
When to start
If you take more Progynova than you should
If you forget to take Progynova

Manufacturer

If you stop taking Progynova

This product is manufactured by

If you need to have surgery



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

4. POSSIBLE SIDE EFFECTS



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

6. CONTENTS OF THE PACK AND OTHER INFORMATION



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

1. What Progynova is and What it is used for

5. HOW TO STORE PROGYNOVA

What Progynova is
POM

PL: 19488/0300

Leaflet revision date: 27 April 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
Progynova® is a registered trade mark of Bayer Intellectual Property
GmbH, Germany.
S300 LEAFLET Progynova 20170427

 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

Other medicines and Progynova

Product Licence holder

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

Heart disease (heart attack)

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

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

Do not take Progynova

Blood clots in a vein (thrombosis)

What Progynova looks like and contents of the pack

 stroke

 go for regular breast screening and cervical smear tests, as
recommended by 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 Progynova,

What Progynova contains

 ovarian cancer

Be sure to:

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PROGYNOVA

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

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

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.

Do not take Progynova:

Do not take Progynova

 breast cancer

Before you start (or restart) HRT, your doctor will ask about your
own and your family’s medical history. Your doctor may decide to
perform a physical examination. This may include an examination of
your breasts and/or an internal examination, if necessary.

1. WHAT PROGYNOVA IS AND WHAT IT IS USED FOR

6. Contents of the pack and other information

Serious side effects

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

What is in this leaflet

Medical history and regular check-ups

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.

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.

4. Possible side effects

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

2. What you need to know before you take Progynova
Medical history and regular check-ups

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

 If you have or have ever had a blood clot in a vein
(thrombosis) such as in the legs (deep vein thrombosis) or the
lungs (pulmonary embolism)
 If you have a blood clotting disorder (such as protein C,
protein S, or antithrombin deficiency)
 If you have or recently have had a disease caused by blood
clots in the arteries, such as a heart attack, stroke or angina
 If you have or have ever had a liver disease, and your liver
function tests have not returned to normal
 If you have a rare blood problem called “porphyria” which is
passed down in families (inherited)
 If you are allergic to estradiol valerate or any of the other
ingredients of this medicine (listed in section 6)
 If you have been told to avoid lactose, that you have a rare
hereditary condition called Lapp lactase deficiency or
glucose-galactose malabsorption
 If you have any reason to believe that you either are, or may be,
pregnant, or if you are producing milk (lactating) and breastfeeding. (See also the ‘Pregnancy and breast-feeding’ section
of this leaflet)


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

Warnings and precautions
Talk to your doctor or pharmacist before taking Progynova

What Progynova is used for

Tell your doctor if you have ever had any of the following problems,
before you start the treatment, as these may return or become
worse during treatment with Progynova. If so, you should see your
doctor more often for check-ups:

Relief of symptoms occurring after menopause

 fibroids inside your womb

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

 growth of womb lining outside your womb (endometriosis) or a
history of excessive growth of the womb lining (endometrial
hyperplasia)
 increased risk of developing blood clots (see “ Blood clots in a
vein (thrombosis)”)

Your risk of breast cancer is also higher:

Heart disease (heart attack)

 high blood pressure

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

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

 a liver disorder, such as a benign liver tumour

 if you are seriously overweight

 diabetes

Compare

 gallstones

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

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

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

HRT is not recommended for women who have heart disease,
or have had heart disease recently. If you have ever had heart
disease, talk to your doctor to see if you should be taking HRT.
HRT are slightly more likely to develop heart disease than those not
taking any HRT.
For women who have had their womb removed and are taking
oestrogen-only therapy there is no increased risk of developing a
heart disease.

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

 a disease affecting the eardrum and hearing (otosclerosis)

 dimpling of the skin

If you get:

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

 changes in the nipple

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

 fluid retention due to cardiac or kidney problems

 any lumps you can see or feel

Stop taking Progynova and see a doctor immediately

Additionally, you are advised to join mammography screening
programs when offered to you. For mammogram screening, it is
important that you inform the nurse/healthcare professional who is
actually taking the x-ray that you use HRT, as this medication may
increase the density of your breasts which may affect the outcome
of the mammogram. Where the density of the breast is increased,
mammography may not detect all lumps.

 any of the conditions mentioned in the ‘DO NOT take
Progynova’ section
 yellowing of your skin or the whites of your eyes (jaundice).
These may be signs of a liver disease
 a large rise in your blood pressure (symptoms may be
headache, tiredness, dizziness).
 migraine-like headaches which happen for the first time.
 if you become pregnant
 if you notice signs of a blood clot, such as:
 painful swelling and redness of the legs

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



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

Stroke
The risk of getting a stroke is about 1.5–times higher in HRT users
than in non–users. The number of extra cases of stroke due to HRT
use will increase with age.
Other things that can increase the risk of stroke include:
 high blood pressure
 drinking too much alcohol
 an irregular heartbeat
If you are worried about any of these things, or if you have had
a stroke in the past, talk to your doctor to see if you should take
HRT.
Compare

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.

Effects of HRT on heart or circulation

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 and cancer

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.

 difficulty in breathing
for more information, see ‘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)
Taking oestrogen-only HRT will increase the risk of excessive
thickening of the lining of the womb (endometrial hyperplasia) and
cancer of the womb lining (endometrial cancer).
Taking a progestogen in addition to the oestrogen for at least 12
days of each 28 day cycle protects you from this extra risk. If you
still have your womb, your doctor will prescribe a progestogen
separately.
If you have had your womb removed (a hysterectomy), discuss with
your doctor whether you can safely take this product without a
progestogen.

Blood clots in a vein (thrombosis)

Blood clots can be serious, and if one travels to the lungs it can
cause chest pain, breathlessness, fainting or even death. This
condition is called pulmonary embolism or PE.
DVT and PE are examples of a condition called venous
thromboembolism, or VTE.
You are more likely to get a blood clot in your veins as you get older
and if any of the following applies to you. Inform your doctor if any
of these situations apply to you:
 you are unable to walk for a long time because of major
surgery, injury or illness (see also section 3, “If you need to
have surgery”)
 you are seriously overweight (BMI >30 kg/m2)

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 have any blood clotting problem that needs long-term
treatment with a medicine used to prevent blood clots.

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.

 you have had one or more miscarriages

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.

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

Other conditions
 HRT will not prevent memory loss. There is some evidence of a
higher risk of memory loss in women who start using HRT after
the age of 65. Speak to your doctor for advice.
 If you have heart or kidney problems, your doctor should
examine you carefully as oestrogens may cause fluid retention
resulting in swelling
 If you have pre-existing elevated triglycerides (a type of blood
fat) your doctor should monitor you closely during oestrogen
replacement therapy or HRT. Rare cases of large increases of
plasma triglycerides (hypertriglyceridemia) leading to
inflammation of the pancreas (pancreatitis) have been reported
with oestrogen replacement therapy
 If you have a tendency to develop blotchy brown patches
(chloasma) on the face you should avoid exposure to the sun or
ultraviolet light whilst using Progynova
 Your doctor will monitor you carefully if you have terminal
kidney insufficiency as the blood levels of the active
substances in Progynova will probably increase

 you have systemic lupus erythematosus (SLE)

Other medicines and Progynova

 you have cancer

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

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

Some medicines may interfere with the effect of Progynova. This
might lead to irregular bleeding. This applies to the following
medicines:

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.

 medicines for epilepsy (such as barbiturates, phenytoin,
primidone, carbamazepine and possibly oxcarbazepine,
topiramate and felbamate)

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).

 medicines for tuberculosis (such as rifampicin, rifabutin)

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).

 Grapefruit juice
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that
you are taking Progynova, because this medicine can affect the
results of some tests.
Pregnancy and breast-feeding
Progynova is for use in post-menopausal women only. Do not take
if you are pregnant or breast-feeding.
If you become pregnant, stop taking Progynova immediately and
contact your doctor.
Driving and using machines
No effects on ability to drive and use machines have been observed
in users of Progynova.
Progynova contains lactose monohydrate and sucrose
Progynova contains lactose and sucrose (types of sugar). If you
have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.

 smoking

The risk of ovarian cancer varies with age. For example, in women
aged 50 to 54 who are not taking HRT, about 2 women in 2000 will
be diagnosed with ovarian cancer over a 5-year period. For women
who have been taking HRT for 5 years, there will be about 3 cases
per 2000 users (i.e. about 1 extra case).

 sudden chest pain

 Medicines for treatment of certain heart diseases, high
blood pressure (such as verapamil and diltiazem)

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

 asthma

If you notice any of the following when taking HRT:

 Medicines for treatment of bacterial infections (such as
clarithromycin and erythromycin)

 medicines for HIV and Hepatitis C Virus infections (so-called
protease inhibitors and non-nucleoside reverse transcriptase
inhibitors such as nevirapine, efavirenz, ritonavir and nelfinavir)
 herbal remedies containing St. John’s wort (Hypericum
perforatum)
 Medicines for treatment of fungal infections (such as
griseofulvin, fluconazole, itraconazole, ketoconazole and
voriconazole)

3. How to take Progynova
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet of Progynova 1 mg to be
taken daily.
Use in children and adolescents
Progynova is not for use in adolescents or children.
Your doctor will aim to prescribe the lowest dose to treat your
symptom for as short as necessary. Speak to your doctor if you
think this dose is too strong or not strong enough.
About the pack
This pack is designed to help you remember to take your medicine.
Each tablet is placed in a section marked with the day of the week
on which it should be taken. The arrows between tablets show the
order in which they must be taken. Your doctor may tell you when to
start (see “when to start” for further information).
ZON/DIM/SON = Sunday DON/JEU/DON = Thursday
MAA/LUN/MON = Monday VRI/VEN/FRE = Friday
DIN/MAR/DIE = Tuesday ZAT/SAM/SAM = Saturday
WOE/MER/MIT = Wednesday
On the day you start, take your first tablet from the blue section of
the pack (top row of tablets) marked with the correct day. For
instance, if you start on a Tuesday, press out the tablet from the
blister marked ‘DIN/MAR/DIE’.
Take one tablet each day, following the directions of the arrows,
until you have finished all 28 tablets in the memo strip. When you
have finished each memo strip, start the next memo strip on the
following day. Do not leave a break between memo strips. It is best
to take your tablet at the same time each day. You can take
Progynova with or without food. The tablet should be swallowed
whole with a glass of water or milk.
Your doctor may prescribe the hormone progestogen in addition to
Progynova for at least 12-14 days each month:
 if you still have your womb
 if you have a history of endometriosis
When to start
If you have been taking other HRT preparations: carry on until
you have finished your current pack and have taken all the tablets
for that month. Take your first Progynova tablet the next day. Do not
leave a break between your old tablets and the Progynova tablets.
If this is your first HRT treatment and you are still having
regular periods: start your Progynova tablets on the first day of
bleeding
If this is your first HRT treatment and your periods have
become very infrequent or have stopped completely: you can
start your Progynova tablets at any time if you are sure you are not
pregnant.
S300 LEAFLET Progynova 20170427

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.

The following side effects have been reported with other HRTs:

PACKAGE LEAFLET: INFORMATION FOR THE USER

 painful reddish skin nodules (erythema nodosum)

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.

FEMTAB 1mg TABLETS
(Estradiol Valerate)

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

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.

S300 LEAFLET FemTab 20170427

 various skin disorders:

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

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

If you stop taking FemTab

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

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.

5. How to store FemTab


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

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)”).

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.

Ask your doctor when you can start taking FemTab again.



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

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 because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or
pharmacist.
 This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.


If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

Medical history and regular check-ups

HRT and cancer
Effects of HRT on heart or circulation

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

What FemTab looks like and contents of the pack

 heart disease

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

 stroke
 probable memory loss if HRT is started over the age of 65
For more information about these side effects see section 2.
Other side effects that have been linked to the use of FemTab and
other oral hormone replacement therapies:
 During the first few months of treatment you may experience
some vaginal bleeding at unexpected times (breakthrough
bleeding and spotting). These symptoms normally lessen with
continued treatment. If they don’t, contact your doctor (see
section 2 ‘HRT and cancer/Excessive thickening of the lining of
the womb (endometrial hyperplasia) and cancer of the lining of
the womb (endometrial cancer)’ for more information)
 breast pain, tenderness or enlargement, breast discharge
 painful periods, changes in vaginal secretions, pre-menstrual
symptoms, increased size of fibroids in the womb, thrush,
changes to the neck of the womb
 indigestion, a feeling of being bloated, passing wind, feeling or
being sick, abdominal pain, gall bladder disease
 skin rashes or discolouration, itching, eczema, acne, unusual
hair loss or hair growth, increased skin pigment especially on
the face (chloasma – see section 2‘other conditions’ for more
information), some rare skin problems
 headache, migraine, dizziness, anxiety or depressive
symptoms, fatigue
 fast or irregular heartbeat (palpitations), high blood pressure,
inflammation of veins usually in the legs
 fluid retention leading to swelling of parts of the body
 changes in body weight and sex drive, increased appetite
 muscle cramps, leg pains
 nose bleeds, visual disturbances (such as blurred vision),
discomfort with contact lenses, allergic-type reactions, a
worsening of glucose tolerance, bladder inflammation, rare
disorders (porphyria, chorea).

FemTab is an unmarked beige sugar coated tablet.

Warnings and precautions

Blood clots in a vein (thrombosis)
Heart disease (heart attack)
Stroke
Other conditions
Other medicines and FemTab
Laboratory tests
Pregnancy and breast-feeding
Driving and using machines
FemTab contains lactose monohydrate and sucrose
3. HOW TO TAKE FEMTAB

Product Licence holder

About the pack

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

When to start
If you take more FemTab than you should
If you forget to take FemTab
If you stop taking FemTab

Manufacturer

If you need to have surgery

This product is manufactured by

4. POSSIBLE SIDE EFFECTS



5. HOW TO STORE FEMTAB

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



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



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

POM

PL: 19488/0300

Leaflet revision date: 27 April 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
S300 LEAFLET FemTab 20170427

 go for regular breast screening and cervical smear tests, as
recommended by 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 FemTab,

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

 ovarian cancer

Be sure to:

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEMTAB

What FemTab contains

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

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.

Do not take FemTab:

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

 breast cancer

Before you start (or restart) HRT, your doctor will ask about your
own and your family’s medical history. Your doctor may decide to
perform a physical examination. This may include an examination of
your breasts and/or an internal examination, if necessary.

1. WHAT FEMTAB IS AND WHAT IT IS USED FOR

Do not take FemTab

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.

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

What is in this leaflet

6. Contents of the pack and other information

Serious side effects

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.

4. Possible side effects

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

2. What you need to know before you take FemTab
Medical history and regular check-ups

6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. What FemTab is and what it is used for
What FemTab is
FemTab is a Hormone Replacement Therapy (HRT). It contains the
female hormone, oestrogen. Your ovaries gradually make less of
this hormone as you get older and will no longer produce it after you
have been through the menopause. FemTab can be used in periand postmenopausal women.
What FemTab is used for
Relief of symptoms occurring after menopause
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can cause symptoms such as hot face,
neck and chest (“hot flushes”). FemTab alleviates these symptoms
after menopause. You will only be prescribed FemTab if your
symptoms seriously hinder your daily life.

Do not take FemTab
 If you have or have ever had breast cancer, or if you are
suspected of having it
 If you have cancer which is sensitive to oestrogens, such as
cancer of the womb lining (endometrium), or if you are
suspected of having it
 If you have any unexplained vaginal bleeding
 If you have excessive thickening of the womb lining
(endometrial hyperplasia) that is not being treated
 If you have or have ever had a blood clot in a vein
(thrombosis) such as in the legs (deep vein thrombosis) or the
lungs (pulmonary embolism)
 If you have a blood clotting disorder (such as protein C,
protein S, or antithrombin deficiency)
 If you have or recently have had a disease caused by blood
clots in the arteries, such as a heart attack, stroke or angina
 If you have or have ever had a liver disease, and your liver
function tests have not returned to normal
 If you have a rare blood problem called “porphyria” which is
passed down in families (inherited)
 If you are allergic to estradiol valerate or any of the other
ingredients of this medicine (listed in section 6)
 If you have been told to avoid lactose, that you have a rare
hereditary condition called Lapp lactase deficiency or
glucose-galactose malabsorption
 If you have any reason to believe that you either are, or may be,
pregnant, or if you are producing milk (lactating) and breastfeeding. (See also the ‘Pregnancy and breast-feeding’ section
of this leaflet)


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

Warnings and precautions
Talk to your doctor or pharmacist before taking FemTab
Tell your doctor if you have ever had any of the following problems,
before you start the treatment, as these may return or become
worse during treatment with FemTab. If so, you should see your
doctor more often for check-ups:
 fibroids inside your womb
 growth of womb lining outside your womb (endometriosis) or a
history of excessive growth of the womb lining (endometrial
hyperplasia)
 increased risk of developing blood clots (see “ Blood clots in a
vein (thrombosis)”)

Your risk of breast cancer is also higher:

Heart disease (heart attack)

 high blood pressure

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

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

 a liver disorder, such as a benign liver tumour

 if you are seriously overweight

 diabetes

Compare

 gallstones

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

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

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

HRT is not recommended for women who have heart disease,
or have had heart disease recently. If you have ever had heart
disease, talk to your doctor to see if you should be taking HRT.
HRT are slightly more likely to develop heart disease than those not
taking any HRT.
For women who have had their womb removed and are taking
oestrogen-only therapy there is no increased risk of developing a
heart disease.

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

 a disease affecting the eardrum and hearing (otosclerosis)

 dimpling of the skin

If you get:

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

 changes in the nipple

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

 fluid retention due to cardiac or kidney problems

 any lumps you can see or feel

Stop taking FemTab and see a doctor immediately

Additionally, you are advised to join mammography screening
programs when offered to you. For mammogram screening, it is
important that you inform the nurse/healthcare professional who is
actually taking the x-ray that you use HRT, as this medication may
increase the density of your breasts which may affect the outcome
of the mammogram. Where the density of the breast is increased,
mammography may not detect all lumps.

 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)’

Ovarian cancer
Ovarian cancer (cancer of the ovaries) is rare – much rarer than
breast cancer. It can be difficult to diagnose, because there are
often no obvious signs of the disease. The use of oestrogen- only
or combined oestrogen-progestogen HRT has been associated with
a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, in women
aged 50 to 54 who are not taking HRT, about 2 women in 2000 will
be diagnosed with ovarian cancer over a 5-year period. For women
who have been taking HRT for 5 years, there will be about 3 cases
per 2000 users (i.e. about 1 extra case).

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.

Effects of HRT on heart or circulation

HRT and cancer

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.

Excessive thickening of the lining of the womb (endometrial
hyperplasia) and cancer of the lining of the womb (endometrial
cancer)
Taking oestrogen-only HRT will increase the risk of excessive
thickening of the lining of the womb (endometrial hyperplasia) and
cancer of the womb lining (endometrial cancer).
Taking a progestogen in addition to the oestrogen for at least 12
days of each 28 day cycle protects you from this extra risk. If you
still have your womb, your doctor will prescribe a progestogen
separately.
If you have had your womb removed (a hysterectomy), discuss with
your doctor whether you can safely take this product without a
progestogen.

Blood clots in a vein (thrombosis)

Blood clots can be serious, and if one travels to the lungs it can
cause chest pain, breathlessness, fainting or even death. This
condition is called pulmonary embolism or PE.
DVT and PE are examples of a condition called venous
thromboembolism, or VTE.
You are more likely to get a blood clot in your veins as you get older
and if any of the following applies to you. Inform your doctor if any
of these situations apply to you:
 you are unable to walk for a long time because of major
surgery, injury or illness (see also section 3, “If you need to
have surgery”)
 you are seriously overweight (BMI >30 kg/m2)

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 have any blood clotting problem that needs long-term
treatment with a medicine used to prevent blood clots.

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.

 you have had one or more miscarriages

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.

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



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.

Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that
you are taking FemTab, because this medicine can affect the
results of some tests.
Pregnancy and breast-feeding
FemTab is for use in post-menopausal women only. Do not take if
you are pregnant or breast-feeding.
If you become pregnant, stop taking FemTab immediately and
contact your doctor.
Driving and using machines
No effects on ability to drive and use machines have been observed
in users of FemTab.
FemTab contains lactose monohydrate and sucrose

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

FemTab contains lactose and sucrose (types of sugar). If you have
been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

Other things that can increase the risk of stroke include:
 high blood pressure
 smoking
 drinking too much alcohol
 an irregular heartbeat
If you are worried about any of these things, or if you have had
a stroke in the past, talk to your doctor to see if you should take
HRT.
Compare
Looking at women in their 50s who are not taking HRT, on average,
8 in 1000 would be expected to have a stroke over a 5-year period.
For women in their 50s who are taking HRT, there will be 11 cases
in 1000 users, over 5 years (i.e. an extra 3 cases).
Other conditions
 HRT will not prevent memory loss. There is some evidence of a
higher risk of memory loss in women who start using HRT after
the age of 65. Speak to your doctor for advice.
 If you have heart or kidney problems, your doctor should
examine you carefully as oestrogens may cause fluid retention
resulting in swelling
 If you have pre-existing elevated triglycerides (a type of blood
fat) your doctor should monitor you closely during oestrogen
replacement therapy or HRT. Rare cases of large increases of
plasma triglycerides (hypertriglyceridemia) leading to
inflammation of the pancreas (pancreatitis) have been reported
with oestrogen replacement therapy
 If you have a tendency to develop blotchy brown patches
(chloasma) on the face you should avoid exposure to the sun or
ultraviolet light whilst using FemTab
 Your doctor will monitor you carefully if you have terminal
kidney insufficiency as the blood levels of the active
substances in FemTab will probably increase
Other medicines and FemTab

 you have cancer

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Some medicines may interfere with the effect of FemTab. This
might lead to irregular bleeding. This applies to the following
medicines:

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.

 medicines for epilepsy (such as barbiturates, phenytoin,
primidone, carbamazepine and possibly oxcarbazepine,
topiramate and felbamate)

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).

 medicines for tuberculosis (such as rifampicin, rifabutin)

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).

 Grapefruit juice

Stroke

 you have systemic lupus erythematosus (SLE)
For signs of a blood clot, see “Stop taking FemTab and see a
doctor immediately”.
Compare

 Medicines for treatment of certain heart diseases, high
blood pressure (such as verapamil and diltiazem)

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

 asthma

If you notice any of the following when taking HRT:

 Medicines for treatment of bacterial infections (such as
clarithromycin and erythromycin)

 medicines for HIV and Hepatitis C Virus infections (so-called
protease inhibitors and non-nucleoside reverse transcriptase
inhibitors such as nevirapine, efavirenz, ritonavir and nelfinavir)
 herbal remedies containing St. John’s wort (Hypericum
perforatum)
 Medicines for treatment of fungal infections (such as
griseofulvin, fluconazole, itraconazole, ketoconazole and
voriconazole)

3. How to take FemTab
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet of FemTab 1 mg to be taken
daily.
Use in children and adolescents
FemTab is not for use in adolescents or children.
Your doctor will aim to prescribe the lowest dose to treat your
symptom for as short as necessary. Speak to your doctor if you
think this dose is too strong or not strong enough.
About the pack
This pack is designed to help you remember to take your medicine.
Each tablet is placed in a section marked with the day of the week
on which it should be taken. The 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).
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
On the day you start, take your first tablet from the blue section of
the pack (top row of tablets) marked with the correct day. For
instance, if you start on a Tuesday, press out the tablet from the
blister marked ‘DIN/MAR/DIE’.
Take one tablet each day, following the directions of the arrows,
until you have finished all 28 tablets in the memo strip. When you
have finished each memo strip, start the next memo strip on the
following day. Do not leave a break between memo strips. It is best
to take your tablet at the same time each day. You can take
FemTab with or without food. The tablet should be swallowed whole
with a glass of water or milk.
Your doctor may prescribe the hormone progestogen in addition to
FemTab for at least 12-14 days each month:
 if you still have your womb
 if you have a history of endometriosis
When to start
If you have been taking other HRT preparations: carry on until
you have finished your current pack and have taken all the tablets
for that month. Take your first FemTab tablet the next day. Do not
leave a break between your old tablets and the FemTab tablets.
If this is your first HRT treatment and you are still having
regular periods: start your FemTab tablets on the first day of
bleeding
If this is your first HRT treatment and your periods have
become very infrequent or have stopped completely: you can
start your FemTab tablets at any time if you are sure you are not
pregnant.
S300 LEAFLET FemTab 20170427

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.

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

PACKAGE LEAFLET: INFORMATION FOR THE USER

 painful reddish skin nodules (erythema nodosum)
 rash with target-shaped reddening or sores (erythema
multiforme)

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

If you stop taking Progynova

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

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.

5. How to store Estradiol valerate


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

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)”).

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.

Ask your doctor when you can start taking Progynova again.



4. Possible side effects

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

Reporting of side effects

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

S300 LEAFLET Estradiol Valerate 20170427

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. Contents of the pack and other information

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or
pharmacist.
 This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
 If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. WHAT ESTRADIOL VALERATE IS AND WHAT IT IS USED
FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ESTRADIOL VALERATE
Medical history and regular check-ups
Do not take Estradiol Valerate

2. What you need to know before you take Progynova
Medical history and regular check-ups
The use of HRT carries risks which need to be considered when
deciding whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause
(due to ovarian failure or surgery) is limited. If you have a premature
menopause the risks of using HRT may be different. Please talk to
your doctor.
Before you start (or restart) HRT, your doctor will ask about your
own and your family’s medical history. Your doctor may decide to
perform a physical examination. This may include an examination of
your breasts and/or an internal examination, if necessary.
Once you have started on Progynova, you should see your doctor
for regular check-ups (at least once a year). At these check-ups,
discuss with your doctor the benefits and risks of continuing to take
Progynova.
Be sure to:
 go for regular breast screening and cervical smear tests, as
recommended by your doctor.
 regularly check your breasts for any changes such as
dimpling of the skin, changes in the nipple, or any lumps you
can see or feel.
Do not take Progynova:
If any of the following applies to you. If you are not sure about any
of the points below, talk to your doctor before taking Progynova,
Do not take Progynova
 If you have or have ever had breast cancer, or if you are
suspected of having it

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

What Estradiol Valerate contains

Warnings and precautions

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

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

HRT and cancer

 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

Effects of HRT on heart or circulation

Serious side effects

 If you have any unexplained vaginal bleeding

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.

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

Blood clots in a vein (thrombosis)
Heart disease (heart attack)
Stroke
Other conditions
Other medicines and Estradiol Valerate

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

What Estradiol Valerate looks like and contents of the pack

Laboratory tests

 heart disease

Estradiol Valerate is an unmarked beige sugar coated tablet.

Pregnancy and breast-feeding

 stroke

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

Driving and using machines

 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:
 During the first few months of treatment you may experience
some vaginal bleeding at unexpected times (breakthrough
bleeding and spotting). These symptoms normally lessen with
continued treatment. If they don’t, contact your doctor (see
section 2 ‘HRT and cancer/Excessive thickening of the lining of
the womb (endometrial hyperplasia) and cancer of the lining of
the womb (endometrial cancer)’ for more information)
 breast pain, tenderness or enlargement, breast discharge
 painful periods, changes in vaginal secretions, pre-menstrual
symptoms, increased size of fibroids in the womb, thrush,
changes to the neck of the womb
 indigestion, a feeling of being bloated, passing wind, feeling or
being sick, abdominal pain, gall bladder disease
 skin rashes or discolouration, itching, eczema, acne, unusual
hair loss or hair growth, increased skin pigment especially on
the face (chloasma – see section 2‘other conditions’ for more
information), some rare skin problems
 headache, migraine, dizziness, anxiety or depressive
symptoms, fatigue
 fast or irregular heartbeat (palpitations), high blood pressure,
inflammation of veins usually in the legs
 fluid retention leading to swelling of parts of the body
 changes in body weight and sex drive, increased appetite
 muscle cramps, leg pains
 nose bleeds, visual disturbances (such as blurred vision),
discomfort with contact lenses, allergic-type reactions, a
worsening of glucose tolerance, bladder inflammation, rare
disorders (porphyria, chorea).

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.

This product is manufactured by


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



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



Delpharm Lille SAS, Rue de Toufflers, 59390 Lys-lez-Lannoy,
France.
PL: 19488/0300

Leaflet revision date: 27 April 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
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leaflet in large print, tape, CD
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S300 LEAFLET Estradiol Valerate 20170427

 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

3. HOW TO TAKE ESTRADIOL VALERATE

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

About the pack
When to start
If you take more Estradiol Valerate than you should
If you stop taking Estradiol Valerate
If you need to have surgery
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ESTRADIOL VALERATE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. What Progynova is and what it is used for
What Progynova is

POM

 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)

Estradiol Valerate contains lactose monohydrate and
sucrose

If you forget to take Estradiol Valerate

Manufacturer

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

Progynova is a Hormone Replacement Therapy (HRT). It contains
the female hormone, oestrogen. Your ovaries gradually make less
of this hormone as you get older and will no longer produce it after
you have been through the menopause. Progynova can be used in
peri- and postmenopausal women.
What Progynova is used for
Relief of symptoms occurring after menopause
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can cause symptoms such as hot face,
neck and chest (“hot flushes”). Progynova alleviates these
symptoms after menopause. You will only be prescribed Progynova
if your symptoms seriously hinder your daily life.

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


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

Warnings and precautions
Talk to your doctor or pharmacist before taking Progynova
Tell your doctor if you have ever had any of the following problems,
before you start the treatment, as these may return or become
worse during treatment with Progynova. If so, you should see your
doctor more often for check-ups:
 fibroids inside your womb
 growth of womb lining outside your womb (endometriosis) or a
history of excessive growth of the womb lining (endometrial
hyperplasia)
 increased risk of developing blood clots (see “ Blood clots in a
vein (thrombosis)”)

Your risk of breast cancer is also higher:

Heart disease (heart attack)

 high blood pressure

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

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

 a liver disorder, such as a benign liver tumour

 if you are seriously overweight

 diabetes

Compare

 gallstones

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

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

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

HRT is not recommended for women who have heart disease,
or have had heart disease recently. If you have ever had heart
disease, talk to your doctor to see if you should be taking HRT.
HRT are slightly more likely to develop heart disease than those not
taking any HRT.
For women who have had their womb removed and are taking
oestrogen-only therapy there is no increased risk of developing a
heart disease.

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

 a disease affecting the eardrum and hearing (otosclerosis)

 dimpling of the skin

If you get:

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

 changes in the nipple

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

 fluid retention due to cardiac or kidney problems

 any lumps you can see or feel

Stop taking Progynova and see a doctor immediately

Additionally, you are advised to join mammography screening
programs when offered to you. For mammogram screening, it is
important that you inform the nurse/healthcare professional who is
actually taking the x-ray that you use HRT, as this medication may
increase the density of your breasts which may affect the outcome
of the mammogram. Where the density of the breast is increased,
mammography may not detect all lumps.

 any of the conditions mentioned in the ‘DO NOT take
Progynova’ section
 yellowing of your skin or the whites of your eyes (jaundice).
These may be signs of a liver disease
 a large rise in your blood pressure (symptoms may be
headache, tiredness, dizziness).
 migraine-like headaches which happen for the first time.
 if you become pregnant
 if you notice signs of a blood clot, such as:
 painful swelling and redness of the legs

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



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

Stroke
The risk of getting a stroke is about 1.5–times higher in HRT users
than in non–users. The number of extra cases of stroke due to HRT
use will increase with age.
Other things that can increase the risk of stroke include:
 high blood pressure
 drinking too much alcohol
 an irregular heartbeat
If you are worried about any of these things, or if you have had
a stroke in the past, talk to your doctor to see if you should take
HRT.
Compare

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.

Effects of HRT on heart or circulation

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 and cancer

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.

 difficulty in breathing
for more information, see ‘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)
Taking oestrogen-only HRT will increase the risk of excessive
thickening of the lining of the womb (endometrial hyperplasia) and
cancer of the womb lining (endometrial cancer).
Taking a progestogen in addition to the oestrogen for at least 12
days of each 28 day cycle protects you from this extra risk. If you
still have your womb, your doctor will prescribe a progestogen
separately.
If you have had your womb removed (a hysterectomy), discuss with
your doctor whether you can safely take this product without a
progestogen.

Blood clots in a vein (thrombosis)

Blood clots can be serious, and if one travels to the lungs it can
cause chest pain, breathlessness, fainting or even death. This
condition is called pulmonary embolism or PE.
DVT and PE are examples of a condition called venous
thromboembolism, or VTE.
You are more likely to get a blood clot in your veins as you get older
and if any of the following applies to you. Inform your doctor if any
of these situations apply to you:
 you are unable to walk for a long time because of major
surgery, injury or illness (see also section 3, “If you need to
have surgery”)
 you are seriously overweight (BMI >30 kg/m2)

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 have any blood clotting problem that needs long-term
treatment with a medicine used to prevent blood clots.

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.

 you have had one or more miscarriages

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.

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

Other conditions
 HRT will not prevent memory loss. There is some evidence of a
higher risk of memory loss in women who start using HRT after
the age of 65. Speak to your doctor for advice.
 If you have heart or kidney problems, your doctor should
examine you carefully as oestrogens may cause fluid retention
resulting in swelling
 If you have pre-existing elevated triglycerides (a type of blood
fat) your doctor should monitor you closely during oestrogen
replacement therapy or HRT. Rare cases of large increases of
plasma triglycerides (hypertriglyceridemia) leading to
inflammation of the pancreas (pancreatitis) have been reported
with oestrogen replacement therapy
 If you have a tendency to develop blotchy brown patches
(chloasma) on the face you should avoid exposure to the sun or
ultraviolet light whilst using Progynova
 Your doctor will monitor you carefully if you have terminal
kidney insufficiency as the blood levels of the active
substances in Progynova will probably increase

 you have systemic lupus erythematosus (SLE)

Other medicines and Progynova

 you have cancer

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

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

Some medicines may interfere with the effect of Progynova. This
might lead to irregular bleeding. This applies to the following
medicines:

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.

 medicines for epilepsy (such as barbiturates, phenytoin,
primidone, carbamazepine and possibly oxcarbazepine,
topiramate and felbamate)

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).

 medicines for tuberculosis (such as rifampicin, rifabutin)

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).

 Grapefruit juice
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that
you are taking Progynova, because this medicine can affect the
results of some tests.
Pregnancy and breast-feeding
Progynova is for use in post-menopausal women only. Do not take
if you are pregnant or breast-feeding.
If you become pregnant, stop taking Progynova immediately and
contact your doctor.
Driving and using machines
No effects on ability to drive and use machines have been observed
in users of Progynova.
Progynova contains lactose monohydrate and sucrose
Progynova contains lactose and sucrose (types of sugar). If you
have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.

 smoking

The risk of ovarian cancer varies with age. For example, in women
aged 50 to 54 who are not taking HRT, about 2 women in 2000 will
be diagnosed with ovarian cancer over a 5-year period. For women
who have been taking HRT for 5 years, there will be about 3 cases
per 2000 users (i.e. about 1 extra case).

 sudden chest pain

 Medicines for treatment of certain heart diseases, high
blood pressure (such as verapamil and diltiazem)

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

 asthma

If you notice any of the following when taking HRT:

 Medicines for treatment of bacterial infections (such as
clarithromycin and erythromycin)

 medicines for HIV and Hepatitis C Virus infections (so-called
protease inhibitors and non-nucleoside reverse transcriptase
inhibitors such as nevirapine, efavirenz, ritonavir and nelfinavir)
 herbal remedies containing St. John’s wort (Hypericum
perforatum)
 Medicines for treatment of fungal infections (such as
griseofulvin, fluconazole, itraconazole, ketoconazole and
voriconazole)

3. How to take Progynova
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet of Progynova 1 mg to be
taken daily.
Use in children and adolescents
Progynova is not for use in adolescents or children.
Your doctor will aim to prescribe the lowest dose to treat your
symptom for as short as necessary. Speak to your doctor if you
think this dose is too strong or not strong enough.
About the pack
This pack is designed to help you remember to take your medicine.
Each tablet is placed in a section marked with the day of the week
on which it should be taken. The 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).
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
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.
S300 LEAFLET Estradiol Valerate 20170427

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

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

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