PROGYNOVA 2MG TABLETS

Active substance: ESTRADIOL VALERATE

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Pg 4

CUSTOMER:

Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Progynova 2mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/1890G

DATE OF PROOF:

18/07/14

DATE:

DATE:

MANUFACTURER No: MULTI MANUFACTURERS

TVT CHECKED

PROOF HISTORY:
v.1 - waymade - 18/07/14

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED MAY 2013

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

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

skin rashes or discolouration, itching, eczema, acne, unusual hair loss or hair growth,
increased skin pigment especially on the face (chloasma – see section 2 ‘other
conditions’ for more information), some rare skin problems

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

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

fluid retention leading to swelling of parts of the body

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).
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)

5. How to store Progynova
Keep out of the sight and reach of children.
There are no special storage conditions for Progynova tablets.
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.
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.
If the tablets become brittle, discoloured or show any other signs of deterioration, you should ask
your pharmacist who will tell you what to do.

6. Further information
Your medicine is called Progynova 2mg Tablets.
Each 2mg tablet contains 2mg of the active ingredient estradiol valerate, in a film-coated, blue,
round, unmarked tablet with a white core.
Progynova 2mg Tablets also contain the following inactive ingredients:
Lactose monohydrate, maize starch, povidone, talc, magnesium stearate, sucrose, macrogol 6000,
calcium carbonate, glycerol, wax and titanium dioxide (E171).
Progynova 2mg tablets also contain the colouring indigo carmine (E132).
Progynova 2mg tablets are available as packs of one or three calendar packs. Each calendar pack
contains 28 tablets and is marked with arrows. This helps you remember when to take your tablets.
POM

PL No: 6464/1890

This product is manufactured by Bayer Schering Pharma AG, D-13342 Berlin, Germany and/or Bayer
Pharma AG,Müllerstrasse 170-178,13353 Berlin,Germany and/or Bayer Weimar GmbH und Co. KG.,
Döbereinerstrasse 20, 99427 Weimar, Germany and procured within the EU and repackaged by the
Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex, SS14 3FR
Leaflet revision and issue date (Ref.) 18.07.2014
Progynova® is a registered trademark of Bayer Intellectual Property GmbH

PROGYNOVA 2mg TABLETS
(estradiol valerate)
Patient Information Leaflet
This product is known by the above name but will usually 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.
In this leaflet:
1. What Progynova is and what it is used for
2. Before you take Progynova
Medical history and regular check-ups
Do not take Progynova
When you need to take special care with Progynova
HRT and cancer
Effects of HRT on heart or circulation
Blood clots in a vein (thrombosis)
Heart disease (heart attack)
Stroke
Other conditions
Using other medicines
Laboratory tests
Pregnancy and breast-feeding
Driving or using machines
Important information about some of the ingredients of Progynova
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. Further Information

1. What Progynova is and what it is used for
What Progynova is
Progynova is a Hormone Replacement Therapy (HRT). It contains the female hormone, oestrogen. Your
ovaries gradually make less of this hormone as you get older and will no longer produce it after you have
been through the menopause. Progynova can be used in peri-and postmenopausal women.
What Progynova is used for
Relief of symptoms occuring after menopause
During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause
symptoms such as hot face, neck and chest (“hot flushes”). Progynova alleviates these symptoms after
menopause. You will only be prescribed Progynova if your symptoms seriously hinder your daily life.
Prevention of osteoporosis
After the menopause some women may develop fragile bones (osteoporosis). You should discuss all
available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you,
you can use Progynova to prevent osteoporosis after menopause.

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

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

If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining
(endometrium), or if you are suspected of having it

If you have any unexplained vaginal bleeding

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

If you have or have ever had a blood clot in a vein (thrombosis) such as in the legs (deep vein
thrombosis) or the lungs (pulmonary embolism)

If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)

If you have or recently have had a disease caused by blood clots in the arteries, such as a heart
attack, stroke or angina

If you have or have ever had a liver disease, and your liver function tests have not returned to
normal

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

If you are allergic (hypersensitive) to estradiol valerate or to any of the other ingredients in
Progynova (listed in section 6 “Further information”)

If you have been told to avoid lactose, that you have a rare hereditary condition called Lapp
lactase deficiency or glucose-galactose malabsorption

If you have any reason to believe that you either are, or may be, pregnant, or if you are
producing milk (lactating) and 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:

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
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CUSTOMER:

Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Progynova 2mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/1890G

DATE OF PROOF:

18/07/14

DATE:

DATE:

MANUFACTURER No: MULTI MANUFACTURERS

TVT CHECKED

PROOF HISTORY:
v.1 - waymade - 18/07/14

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED MAY 2013

Pg 2












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 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).
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

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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.

Compare
Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be
diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5
years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).

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).
On the day you start, take your first tablet from the top row of tablets marked with the correct day. For
instance, if you start on a Tuesday, press out the tablet from the blister marked 'TUE'.
Take one tablet each day, following the directions of the arrows, until you have finished all 28 tablets
in the memo strip. When you have finished each memo strip, start the next memo strip on the
following day. Do not leave a break between memo strips. It is best to take your tablet at the same
time each day. You can take Progynova with or without food. The tablet should be swallowed whole
with a glass of water or milk.

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.

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

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 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”.

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.

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.

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 oestrogen-only therapy there is no
increased risk of developing a heart disease.
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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.
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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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