ESTRADIOL VALERATE 2MG TABLETS

Active substance: ESTRADIOL VALERATE

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

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

• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• probable memory loss If HRT is started over the age of 65
For more information about these side effects see Section 2.
Other side effects that have been linked to the use of 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)

What is in your medicine
Each tablet contains 2mg of estradiol valerate as the active ingredient.
Progynova 2mg also contains the following inactive ingredients: lactose
monohydrate, maize starch, povidone 25 000, talc, magnesium stearate
(E572), sucrose, povidone 700 000, macrogol 6000, calcium carbonate
(E170), titanium dioxide (E171), glycerol 85% (E422), montan glycol wax,
indigo carmine (E132) and purified water.
Manufacturer and Licence Holder
Progynova 2mg is manufactured by Bayer Weimar GmbH und Co. KG,
Dobereinerstrasse 20, 99427 Weimar, Germany and is procured from within
the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.

POM

PL Number:

15184/0905

Progynova ® 2mg Tablets / Estradiol Valerate 2mg Tablets

2

What Progynova is and what it is used for

1

How to store progynova

Possible side effects

4

How to take progynova
About the pack
When to start
If you take more Progynova than you should
If you forget to take Progynova
If you stop taking Progynova
If you need to have surgery

3

What Progynova is and what it is used for

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

Before you start (or restart) HRT, your doctor should ask you about your own
and your family’s medical history. Your doctor may decide to perform a
physical examination. This may include an examination on your breasts
and/or an internal examination, if necessary.
Once you’ve started on Progynova, you should see your doctor for regular
check-ups (at least once a year). At these check-ups, discuss with your
doctor the benefits and risks of continuing to take Progynova.
Be sure to:
- go for regular breast screening and cervical smear tests, as
recommended by your doctor.
- regularly check your breasts for any changes such as dimpling of the
skin, changes in the nipple, or any lumps you can see or feel.
Do not take Progynova
If any of the following applies to you. If you are not sure about any of the
points below, talk to your doctor before taking Progynova,
Do not take progynova
• If you have or have ever had breast cancer, or if you are suspected of
having it
• If you have cancer which is sensitive to oestrogens, such as cancer of
the womb lining (endometrium) or if you are suspected of having it.
• If you have any unexplained vaginal bleeding
• If you have excessive thickening of the womb lining
(endometrial hyperplasia) that is not being treated
• If you have or have ever had a blood clot in a vein (thrombosis) such as
in the legs (deep vein thrombosis) or the lungs (pulmonary embolism)
• If you have a blood clotting disorder
(such as protein C, protein S, or antithrombin deficiency)
• If you have or recently have had a disease caused by blood clots in the
arteries, such as a heart attack, stroke or angina
• If you have or have ever had a liver disease, and your liver function tests
have not returned to normal
• If you have a rare blood problem called “porphyria” which is passed down
in families (inherited)
• If you are allergic (hypersensitive) to estradiol valerate or to any of the
the 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 breast-feeding.
(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:





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.

Further information

Your medicine
Progynova is a round, pale blue, sugar-coated tablet.
Progynova is available in blister packs of 28 or 3 x 28 tablets.

Ref: 905/060514/1/F

(estradiol valerate)

Patient Information Leaflet
Your medicine is called Progynova 2mg Tablets / Estradiol Valerate 2mg
Tablets, and will be referred to as Progynova throughout this leaflet.
Read all of this leaflet carefully before you start taking
this medicine.
• 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. 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.



Leaflet revision date: 06/05/14
In this leaflet:
Progynova is a registered trademark of Schering Aktiengesellschaft.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Before you take Progynova
Medical history and regular check-ups
Do not take Progynova if you have
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)
Stroke
Other conditions
Progynova and using other medicines
Laboratory tests
Pregnancy and breast-feeding
Driving or using machines
Important information about some of the ingredients of Progynova

Further information

6

5

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)

1
5






KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN
If your tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
Do not use an Progynova after the expiry date which is stated on the
blister label and on the carton after “EXP”. The expiry date refers to the
last day of that month.

6








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

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.









fibroids inside your womb
growth of the womb lining outside your womb (endometriosos) 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

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.

Page 4

Page 1

Stop taking Progynova and see a doctor immediately

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

Blood clots in a vein (thrombosis)

HRT and cancer

Effects of HRT on heart or circulation

If you notice any of the following when taking HRT:
• any of the conditions mentioned in the ‘DO NOT take Progynova’
section
• yellowing of your skin or the whites of your eyes (jaundice).
These may be signs of a liver disease
• a large rise in your blood pressure
(symptoms may be headache, tiredness, dizziness).
• migraine-like headaches which happen for the first time.
• if you become pregnant
• if you notice signs of a blood clot, such as:
- painful swelling and redness of the legs
- sudden chest pain
- difficulty in breathing
for more information, see ‘Blood clots in a vein (thrombosis)’
Note: Progynova is not a contraceptive. If it is less than 12 months since
your last menstrual period or you are under 50 years old, you may still
need to use additional contraception to prevent pregnancy. Speak to
your doctor for advice.

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 the extra risk.
If you still have your womb, your doctor will prescribe a progestogen
seperately.
If you have had your womb removed (a hysterectomy), discuss with your
doctor whether you can safely take this product without a progestogen.
If you've had your womb removed because of endometriosis, any
endometrium left in your body may be at risk.
So your doctor may prescribe HRT that includes a progestogen as well
as an oestrogen.
Compare
In women who still have a womb and who are not taking HRT,
on average, 5 in 1000 will be diagnosed with endometrial cancer
between the ages of 50 and 65.
For women, aged 50 to 65, who still have a womb and who take
oestrogen-only HRT, between 10 and 60 women in 1000 will be
diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases),
depending on the dose and how long it is taken.
Breast cancer
Evidence suggests that taking combined oestrogen-progestogen
and possibly also oestrogen-only HRT increases the risk of breast cancer.
The extra risk depends on how long you take HRT. The additional risk
becomes clear within a few years. However, it returns to normal within
a few years (at most 5) after stopping treatment.
For women who have had their womb removed and who are using
oestrogen-only HRT for 5 years, little or no increase in breast cancer
risk is shown.
Your risk of breast cancer is also higher:
• if you have a close relative (mother, sister or grandmother) who has
had breast cancer

• if you are seriously overweight

Compare
Women aged 50 to 79 who are not taking HRT, on average, 9 to 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).

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).

The risk of blood clots in the veins (also called deep vein thrombosis, or
DVT) is about 1.3 to 3–times higher in HRT users than non-users, especially
during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause
chest pain, breathlessness, fainting or even death. This condition is called
pulmonary embolism, or PE.
DVT and PE are examples of a condition called venous thromboembolism,
or VTE.
You are more likely to get a blood clot in your veins as you get older and if
any of the following applies to you. Inform your doctor if any 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 long-term treatment with
a medicine used to prevent blood clots
• any of your close relatives has ever a had blood clot in the leg, lung
or any other organ

• you have had one or more miscarriages
• you have systemic lupus erythematosus (SLE)
• you have cancer
For signs of a blood clot, see “Stop taking Progynova and see a doctor
immediately”.
Compare
Looking at women in their 50s who are not taking HRT, on average, over a
5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
For women in their 50s who are taking oestrogen-progestogen HRT, for
over 5 years, there will be 9 – 12 cases in 1000 (i.e. an extra 5 cases).
For women in their 50s who have had their womb removed and have been
taking oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in
1000 users (i.e. 1 extra case)

Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
HRT is not recommended for women who have heart disease, or have
had heart disease recently. If you have ever had heart disease, talk to
your doctor to see if you should be taking HRT.
Women over the age of 60 years who use oestrogen-progestogen HRT are
slightly more likely to develop heart disease than those not taking any HRT.
For women who have had their womb removed and are taking oestrogenonly therapy there is no increased risk of developing a heart disease.
If you get:
• a pain in your chest that spreads to your arm or neck
See a doctor as soon as possible and do not take any more HRT
until your doctor says you can. This pain could be a sign of heart disease.
Stroke
The risk of getting a stroke is about 1.5–times higher in HRT users than in
non–users. The number of extra cases of stroke due to HRT use will
increase with age.

Other things that can increase the risk of stroke include:
• high blood pressure
• smoking
• drinking too much alcohol
• 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 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.
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 or using machines
There is nothing to suggest that the use of Progynova affects driving or use
of machines.
Important information about some of the ingredients of Progynova
Progynova contains lactose (a type of sugar). If you have an intolerance to
some sugars, check with your doctor before taking Progynova.

3

How to take Progynova

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).

Translation of days:
LUN = MONDAY
MAA
MON

JEU = THURSDAY
DON
DON
VEN = FRIDAY
VRI
FRE

MAR = TUESDAY
DIN
DIE

DIM = SUNDAY
ZON
SON

SAM = SATURDAY
ZAT
SAM

MER = WEDNESDAY
WOE
MIT

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 'MAR’.
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.

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.

Page 3

Page 2

Ref:905/060514/1/B

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

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

• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• probable memory loss If HRT is started over the age of 65
For more information about these side effects see Section 2.
Other side effects that have been linked to the use of 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)

What is in your medicine
Each tablet contains 2mg of estradiol valerate as the active ingredient.
Progynova 2mg also contains the following inactive ingredients: lactose
monohydrate, maize starch, povidone 25 000, talc, magnesium stearate
(E572), sucrose, povidone 700 000, macrogol 6000, calcium carbonate
(E170), titanium dioxide (E171), glycerol 85% (E422), montan glycol wax,
indigo carmine (E132) and purified water.
Manufacturer and Licence Holder
Progynova 2mg is manufactured by Bayer Weimar GmbH und Co. KG,
Dobereinerstrasse 20, 99427 Weimar, Germany and is procured from within
the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE

Progynova ® 2mg Tablets / Estradiol Valerate 2mg Tablets

15184/0905

In this leaflet:
1
2

What Progynova is and what it is used for

How to store progynova

Possible side effects

How to take progynova
About the pack
When to start
If you take more Progynova than you should
If you forget to take Progynova
If you stop taking Progynova
If you need to have surgery

3

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.

How to store Progynova

What Progynova is used for

Before you start (or restart) HRT, your doctor should ask you about your own
and your family’s medical history. Your doctor may decide to perform a
physical examination. This may include an examination on your breasts
and/or an internal examination, if necessary.
Once you’ve started on Progynova, you should see your doctor for regular
check-ups (at least once a year). At these check-ups, discuss with your
doctor the benefits and risks of continuing to take Progynova.
Be sure to:
- go for regular breast screening and cervical smear tests, as
recommended by your doctor.
- regularly check your breasts for any changes such as dimpling of the
skin, changes in the nipple, or any lumps you can see or feel.
Do not take Progynova
If any of the following applies to you. If you are not sure about any of the
points below, talk to your doctor before taking Progynova,
Do not take progynova
• If you have or have ever had breast cancer, or if you are suspected of
having it
• If you have cancer which is sensitive to oestrogens, such as cancer of
the womb lining (endometrium) or if you are suspected of having it.
• If you have any unexplained vaginal bleeding
• If you have excessive thickening of the womb lining
(endometrial hyperplasia) that is not being treated
• If you have or have ever had a blood clot in a vein (thrombosis) such as
in the legs (deep vein thrombosis) or the lungs (pulmonary embolism)
• If you have a blood clotting disorder
(such as protein C, protein S, or antithrombin deficiency)
• If you have or recently have had a disease caused by blood clots in the
arteries, such as a heart attack, stroke or angina
• If you have or have ever had a liver disease, and your liver function tests
have not returned to normal
• If you have a rare blood problem called “porphyria” which is passed down
in families (inherited)
• If you are allergic (hypersensitive) to estradiol valerate or to any of the
ther 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 breast-feeding.
(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:





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.

Further information

Ref: 905/060514/2/F

(estradiol valerate)

Patient Information Leaflet
Your medicine is called Progynova 2mg Tablets / Estradiol Valerate 2mg
Tablets, and will be referred to as Progynova throughout this leaflet.
Read all of this leaflet carefully before you start taking
this medicine.
• 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. 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.


POM PL Number:
Leaflet revision date: 06/05/14
Progynova is a registered trademark of Schering Aktiengesellschaft.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Before you take Progynova
Medical history and regular check-ups
Do not take Progynova if you have
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)
Stroke
Other conditions
Progynova and using other medicines
Laboratory tests
Pregnancy and breast-feeding
Driving or using machines
Important information about some of the ingredients of Progynova

Further information

6

4
5

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)

1
5






KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN
If your tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
Do not use an Progynova after the expiry date which is stated on the
blister label and on the carton after “EXP”. The expiry date refers to the
last day of that month.

6








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

Your medicine
Progynova is a round, pale blue, sugar-coated tablet.
Progynova is available in blister packs of 28 or 3 x 28 tablets.

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.

Page 4









fibroids inside your womb
growth of the womb lining outside your womb (endometriosos) 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

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.
Page 1

Stop taking Progynova and see a doctor immediately

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

Blood clots in a vein (thrombosis)

HRT and cancer

Effects of HRT on heart or circulation

If you notice any of the following when taking HRT:
• any of the conditions mentioned in the ‘DO NOT take Progynova’
section
• yellowing of your skin or the whites of your eyes (jaundice).
These may be signs of a liver disease
• a large rise in your blood pressure
(symptoms may be headache, tiredness, dizziness).
• migraine-like headaches which happen for the first time.
• if you become pregnant
• if you notice signs of a blood clot, such as:
- painful swelling and redness of the legs
- sudden chest pain
- difficulty in breathing
for more information, see ‘Blood clots in a vein (thrombosis)’
Note: Progynova is not a contraceptive. If it is less than 12 months since
your last menstrual period or you are under 50 years old, you may still
need to use additional contraception to prevent pregnancy. Speak to
your doctor for advice.

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 the extra risk.
If you still have your womb, your doctor will prescribe a progestogen
seperately.
If you have had your womb removed (a hysterectomy), discuss with your
doctor whether you can safely take this product without a progestogen.
If you've had your womb removed because of endometriosis, any
endometrium left in your body may be at risk.
So your doctor may prescribe HRT that includes a progestogen as well
as an oestrogen.
Compare
In women who still have a womb and who are not taking HRT,
on average, 5 in 1000 will be diagnosed with endometrial cancer
between the ages of 50 and 65.
For women, aged 50 to 65, who still have a womb and who take
oestrogen-only HRT, between 10 and 60 women in 1000 will be
diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases),
depending on the dose and how long it is taken.
Breast cancer
Evidence suggests that taking combined oestrogen-progestogen
and possibly also oestrogen-only HRT increases the risk of breast cancer.
The extra risk depends on how long you take HRT. The additional risk
becomes clear within a few years. However, it returns to normal within
a few years (at most 5) after stopping treatment.
For women who have had their womb removed and who are using
oestrogen-only HRT for 5 years, little or no increase in breast cancer
risk is shown.
Your risk of breast cancer is also higher:

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

• if you are seriously overweight
Compare
Women aged 50 to 79 who are not taking HRT, on average, 9 to 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).

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).

The risk of blood clots in the veins (also called deep vein thrombosis, or
DVT) is about 1.3 to 3–times higher in HRT users than non-users, especially
during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause
chest pain, breathlessness, fainting or even death. This condition is called
pulmonary embolism, or PE.
DVT and PE are examples of a condition called venous thromboembolism,
or VTE.
You are more likely to get a blood clot in your veins as you get older and if
any of the following applies to you. Inform your doctor if any 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 long-term treatment with
a medicine used to prevent blood clots
• any of your close relatives has ever a had blood clot in the leg, lung
or any other organ

• you have had one or more miscarriages
• you have systemic lupus erythematosus (SLE)
• you have cancer
For signs of a blood clot, see “Stop taking Progynova and see a doctor
immediately”.
Compare
Looking at women in their 50s who are not taking HRT, on average, over a
5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
For women in their 50s who are taking oestrogen-progestogen HRT, for
over 5 years, there will be 9 – 12 cases in 1000 (i.e. an extra 5 cases).
For women in their 50s who have had their womb removed and have been
taking oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in
1000 users (i.e. 1 extra case)

Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
HRT is not recommended for women who have heart disease, or have
had heart disease recently. If you have ever had heart disease, talk to
your doctor to see if you should be taking HRT.
Women over the age of 60 years who use oestrogen-progestogen HRT are
slightly more likely to develop heart disease than those not taking any HRT.
For women who have had their womb removed and are taking oestrogenonly therapy there is no increased risk of developing a heart disease.

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 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.
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 or using machines
There is nothing to suggest that the use of Progynova affects driving or use
of machines.
Important information about some of the ingredients of Progynova
Progynova contains lactose (a type of sugar). If you have an intolerance to
some sugars, check with your doctor before taking Progynova.

3

How to take Progynova

About the pack
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).

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.

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.

If you get:
• a pain in your chest that spreads to your arm or neck
See a doctor as soon as possible and do not take any more HRT
until your doctor says you can. This pain could be a sign of heart disease.

Translation of days:
LUN = MONDAY
MAA
MON

JEU = THURSDAY
DON
DON
VEN = FRIDAY
VRI
FRE

MAR = TUESDAY
DIN
DIE

DIM = SUNDAY
ZON
SON

SAM = SATURDAY
ZAT
SAM

MER = WEDNESDAY
WOE
MIT

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 'MAR’.
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 are you 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.

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.

Page 3

Ref:905/060514/2/B

Page 2

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Source: Medicines and Healthcare Products Regulatory Agency

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

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