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PROGYNOVA 1MG TABLET

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

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Package leaflet: Information for the user
Progynova® 1 mg Tablets
(estradiol valerate)
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.
The name of your medicine is called Progynova 1 mg Tablets but will
be referred to as Progynova throughout the remainder of the leaflet.
What is in this leaflet:
1. WHAT PROGYNOVA IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PROGYNOVA
Medical history and regular check-ups
Do not take Progynova
Warnings and precautions
HRT and cancer
Effects of HRT on heart or circulation
Blood clots in a vein (thrombosis)
Heart disease (heart attack)
Stroke
Other conditions
Other medicines and Progynova
Laboratory tests
Pregnancy and breast-feeding
Driving and using machines
Progynova contains lactose monohydrate and sucrose
3. 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
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PROGYNOVA
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. What Progynova is and what it is used for
What Progynova is
Progynova is a Hormone Replacement Therapy (HRT). It contains
the female hormone, oestrogen. Your ovaries gradually make less of
this hormone as you get older and will no longer produce it after you
have been through the menopause. Progynova can be used in periand 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.
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

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 glucosegalactose malabsorption

If you have any reason to believe that you either are, or may be
pregnant, or if you are producing milk (lactating) and breastfeeding. (See also the ‘Pregnancy and breast-feeding’ section
of this leaflet)
• If any of the above conditions appear for the first
time while taking Progynova, stop taking it
at once and consult your doctor immediately.
Warnings and precautions
Talk to your doctor or pharmacist before taking Progynova.
Tell your doctor if you have ever had any of the following problems,
before you start the treatment, as these may return or become worse
during treatment with Progynova. If so, you should see your doctor
more often for check-ups:

fibroids inside your womb

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

increased risk of developing blood clots (see “Blood clots in a
vein (thrombosis)”)

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

high blood pressure

a liver disorder, such as a benign liver tumour

diabetes

gallstones

migraine or severe headaches

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

epilepsy

asthma

a disease affecting the eardrum and hearing (otosclerosis)

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

fluid retention due to cardiac or kidney problems
Stop taking Progynova and see a doctor immediately
If you notice any of the following when taking HRT:

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

yellowing of your skin or the whites of your eyes (jaundice).
These may be signs of a liver disease

a large rise in your blood pressure (symptoms may be
headache, tiredness, dizziness).

migraine-like headaches which happen for the first time.

if you become pregnant



if you notice signs of a blood clot, such as:
• painful swelling and redness of the legs
• sudden chest pain
• difficulty in breathing
for more information, see ‘Blood clots in a vein (thrombosis)’
Note: Progynova is not a contraceptive. If it is less than 12 months
since your last menstrual period or you are under 50 years old, you
may still need to use additional contraception to prevent pregnancy.
Speak to your doctor for advice.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial
hyperplasia) and cancer of the lining of the womb (endometrial
cancer)
Taking oestrogen-only HRT will increase the risk of excessive
thickening of the lining of the womb (endometrial hyperplasia) and
cancer of the womb lining (endometrial cancer).
Taking a progestogen in addition to the oestrogen for at least 12 days
of each 28 day cycle protects you from this extra risk.
If you still have your womb, your doctor will prescribe a progestogen
separately.
If you have had your womb removed (a hysterectomy), discuss with
your doctor whether you can safely take this product without a
progestogen.
If you’ve had your womb removed because of endometriosis, any
endometrium left in your body may be at risk. So your doctor may
prescribe HRT that includes a progestogen as well as an oestrogen.
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 over weight

Ovarian cancer
Ovarian cancer (cancer of the ovaries) is rare – much rarer than
breast cancer. It can be difficult to diagnose, because there are often
no obvious signs of the disease. The use of oestrogen only or
combined oestrogen-progestogen HRT has been associated with a
slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, in
women aged 50 to 54 who are not taking HRT, about 2 women in
2000 will be diagnosed with ovarian cancer over a 5-year period. For
women who have been taking HRT for 5 years, there will be about 3
cases per 2000 users (i.e. about 1 extra case).
Effects of HRT on heart or circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins (also called deep vein
thrombosis, or DVT) is about 1.3 to 3 times higher in HRT users
than non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs it can
cause chest pain, breathlessness, fainting or even death. This
condition is called pulmonary embolism or PE.
DVT and PE are examples of a condition called venous
thromboembolism, or VTE.
You are more likely to get a blood clot in your veins as you get older
and if any of the following applies to you. Inform your doctor if any of
these situations apply to you:

you are unable to walk for a long time because of major surgery,
injury or illness (see also section 3, “If you need to have
surgery“)

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 had a blood clot in the leg,
lung or any other organ.

you have had one or more miscarriages

you have systemic lupus erythematosus (SLE)

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.

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

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.

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

dimpling of the skin

changes in the nipple

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

Women who have had their womb removed and are taking
oestrogen-only therapy there is no increased risk of developing a
heart disease.
If you get:

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

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

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.

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.

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).

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).

Other conditions

HRT will not prevent memory loss. There is some evidence of a
higher risk of memory loss in women who start using HRT after
the age of 65. Speak to your doctor for advice.

If you have heart or kidney problems, your doctor should
examine you carefully as oestrogens may cause fluid retention
resulting in swelling.

If you have pre-existing elevated triglycerides (a type of blood
fat) your doctor should monitor you closely during oestrogen
replacement therapy or HRT. Rare cases of large increases of
plasma triglycerides (hypertriglyceridemia) leading to
inflammation of the pancreas (pancreatitis) have been reported
with oestrogen replacement therapy.

If you have a tendency to develop blotchy brown patches
(chloasma) on the face you should avoid exposure to the sun or
ultraviolet light whilst using Progynova

Your doctor will monitor you carefully if you have terminal
kidney insufficiency as the blood levels of the active
substances in Progynova will probably increase.
Other medicines and Progynova
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines may interfere with the effect of Progynova.
This might lead to irregular bleeding. This applies to the
following medicines:

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

medicines for tuberculosis (such as rifampicin, rifabutin)

medicines for HIV and Hepatitis C Virus infections (so-called
protease inhibitors and non-nucleoside reverse transcriptase
inhibitors such as nevirapine, efavirenz, ritonavir and nelfinavir)

herbal remedies containing St. John’s wort (Hypericum
perforatum)

Medicines for treatment of fungal infections (such as
griseofulvin, fluconazole, itraconazole, ketoconazole and
voriconazole)

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

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

Grapefruit juice

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.

Your tablets are available in a days of the week blister. Below is a
translation of the days of the week.
MAN
TIR ONS TOR FRE LØR
SØN
MON
TUE WED THU
FRI
SAT
SUN
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
‘TIR’.
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.

Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that
you are taking Progynova, because this medicine can affect the
results of some tests.

If you 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.

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.

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.

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.

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.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The following diseases are reported more often in women using HRT
compared to women not using HRT:

5. Storing your medicine
Do not use Progynova after the expiry date which is printed on the
label after “EXP”. The expiry date refers to the last day of the month
stated.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not dispose of medicines down the drain or in the household
rubbish. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Progynova contains
Each tablet contains 1 mg of estradiol valerate and the following
inactive ingredients: lactose monohydrate, maize starch, povidone,
magnesium stearate, sucrose, macrogol 6000, calcium carbonate,
talc, glycerol, montan glycol wax, titanium dioxide (E171), yellow iron
oxide (E172).

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.

What Progynova looks like and the contents of the pack
Each yellow, round, sugar coated tablet is plain on both sides.
Progynova 1mg Tablets are available in calendar blister packs of 3 x
28.

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).

PL 20774/0980

Progynova 1mg Tablets are manufactured by Bayer Pharma AG. D13342 Berlin, Germany or Bayer Weimar GmbH & Co. KG, Weimar,
Germany. Procured from within the EU. Product Licence holder:
Quadrant Pharmaceuticals Ltd. Lynstock House, Lynstock Way,
Lostock, Bolton, BL6 4SA. Repackaged by Maxearn Ltd, Bolton, BL6
4SA.

POM

Leaflet revision date 3rd April 2017
Progynova is a registered trademark of Bayer Schering Pharma

Blind or partially sighted?
Is this leaflet hard to see or read?
Contact Quadrant Pharmaceuticals
Ltd, Tel: 01204 473081

The following side effects have been reported with other HRTs:

various skin disorders:
• painful reddish skin nodules (erythema nodosum)
• rash with target-shaped reddening or sores
(erythema multiforme)
Reporting of side effects
If you get any side effects, talk to your doctor pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

PP9/0980/V1

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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