Estradiol valerate 2mg tablets

Main information

  • Trade name:
  • Estradiol valerate 2mg tablets
  • Dosage:
  • 2mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Estradiol valerate 2mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 06040101

Status

  • Source:
  • eMC
  • Last update:
  • 11-07-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Progynova 2mg Tablets / Estradiol Valerate 2mg Tablets

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

because it contains important information for you.

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

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

This medicine has been prescribed for you only. Do not pass it on to

others. It may harm them, even if their signs of illness are the same as

yours.

If you get any side effects, talk to your doctor or pharmacist. This includes

any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Progynova is and what it is used for

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

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

Possible side effects

How to store progynova

Contents of the pack and other information

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 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.

Prevention of osteoporosis

After the menopause some women may develop fragile bones

(osteoporosis). You should discuss all available options with your doctor.

If you are at an increased risk of fractures due to osteoporosis

and other medicines are not suitable for you, you can use Progynova to

prevent osteoporosis after menopause.

If 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.

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:

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)

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 or pharmacist. This includes

any possible side effects not listed on this leaflet. You can also report side

effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store. By

reporting side effects, you can help provide more information on the safety of

this medicine.

How to store Progynova

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.

Contents of the pack and other 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.

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 and 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.

PL Number:

15184/0905

Leaflet revision date: 05/12/17

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 to obtain the leaflet

in a format suitable for you

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 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.

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)

POM

Ref: 0905/051217/1/F

1

6

4

5

2

3

1

2

6

5

®

(estradiol valerate)

Page 1

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4

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 2 mg to be taken daily.

Translation of days:

LUN = MONDAY JEU = THURSDAY DIM = SUNDAY

MAA DON ZON

MON DON

SON

MAR = TUESDAY VEN = FRIDAY

DIN

VRI

DIE

FRE

MER = WEDNESDAY SAM = SATURDAY

WOE

ZAT

MIT

SAM

Use in children and adolescents

Progynova is not for use in adolescents or children.

Your doctor will aim to prescribe the lowest dose to treat your symptom for as

short as necessary. Speak to your doctor if you think this dose is too strong

or not strong enough.

About the pack

This pack is designed to help you remember to take your medicine. Each

tablet is placed in a section marked with the day of the week on which it

should be taken. The arrows between tablets show the order in which they

must be taken. Your doctor may tell you when to start (see “when to start” for

further information).

On the day you start, take your first tablet from the blue section of the pack

(top row of tablets) marked with the correct day. For instance, if you start on

a Tuesday, press out the tablet from the blister marked ‘TUE’.

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

Overdose may cause nausea and vomiting and irregular bleeding.

No specific treatment is necessary but you should consult your doctor or

pharmacist if you are concerned.

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.

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.

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

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

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.

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

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are

taking Progynova, because this medicine can affect the results of some tests.

Pregnancy and breast-feeding

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

pregnant or breast-feeding.

If you become pregnant, stop taking Progynova immediately and contact your

doctor.

Driving and using machines

No effects on ability to drive and use machines have been observed in users

of Progynova.

Progynova contains lactose monohydrate and sucrose

Progynova contains lactose and sucrose (types of sugar). If you have been

told by your doctor that you have an intolerance to some sugars, contact

your doctor before taking this medicinal product.

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.

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.

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/

you have any blood clotting problem that needs longterm treatment with a

medicine used to prevent blood clots

any of your close relatives has ever had a blood clot in the leg,

lung or any other organ

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”.

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.

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.

Ref: 0905/051217/1/B

3

Page 2

Page 3

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.

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

oestrogenprogestogen HRT over 5 years, there will be 13 to 23 cases in

1000 users (i.e. an extra 4 to 6 cases).

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).

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 oestrogenprogestogen

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)

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).

Progynova 2mg Tablets / Estradiol Valerate 2mg Tablets

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

because it contains important information for you.

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

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

This medicine has been prescribed for you only. Do not pass it on to

others. It may harm them, even if their signs of illness are the same as

yours.

If you get any side effects, talk to your doctor or pharmacist. This includes

any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Progynova is and what it is used for

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

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

Possible side effects

How to store progynova

Contents of the pack and other information

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 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.

Prevention of osteoporosis

After the menopause some women may develop fragile bones

(osteoporosis). You should discuss all available options with your doctor.

If you are at an increased risk of fractures due to osteoporosis

and other medicines are not suitable for you, you can use Progynova to

prevent osteoporosis after menopause.

If 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.

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:

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)

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 or pharmacist. This includes

any possible side effects not listed on this leaflet. You can also report side

effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store. By

reporting side effects, you can help provide more information on the safety of

this medicine.

How to store Progynova

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.

Contents of the pack and other 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.

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 AG, Mullerstrasse 170-178,

13353, Berlin, 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.

PL Number:

15184/0905

Leaflet revision date: 05/12/17

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 to obtain the leaflet

in a format suitable for you

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 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.

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)

POM

Ref: 0905/050917/2/F

1

6

4

5

2

3

1

2

6

5

®

(estradiol valerate)

Page 1

Page 4

4

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 2 mg to be taken daily.

Translation of days:

LUN = MONDAY JEU = THURSDAY DIM = SUNDAY

MAA DON ZON

MON DON

SON

MAR = TUESDAY VEN = FRIDAY

DIN

VRI

DIE

FRE

MER = WEDNESDAY SAM = SATURDAY

WOE

ZAT

MIT

SAM

Use in children and adolescents

Progynova is not for use in adolescents or children.

Your doctor will aim to prescribe the lowest dose to treat your symptom for as

short as necessary. Speak to your doctor if you think this dose is too strong

or not strong enough.

About the pack

This pack is designed to help you remember to take your medicine. Each

tablet is placed in a section marked with the day of the week on which it

should be taken. The arrows between tablets show the order in which they

must be taken. Your doctor may tell you when to start (see “when to start” for

further information).

On the day you start, take your first tablet from the blue section of the pack

(top row of tablets) marked with the correct day. For instance, if you start on

a Tuesday, press out the tablet from the blister marked ‘TUE’.

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

Overdose may cause nausea and vomiting and irregular bleeding.

No specific treatment is necessary but you should consult your doctor or

pharmacist if you are concerned.

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.

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.

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

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

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.

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

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are

taking Progynova, because this medicine can affect the results of some tests.

Pregnancy and breast-feeding

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

pregnant or breast-feeding.

If you become pregnant, stop taking Progynova immediately and contact your

doctor.

Driving and using machines

No effects on ability to drive and use machines have been observed in users

of Progynova.

Progynova contains lactose monohydrate and sucrose

Progynova contains lactose and sucrose (types of sugar). If you have been

told by your doctor that you have an intolerance to some sugars, contact

your doctor before taking this medicinal product.

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.

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.

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/

you have any blood clotting problem that needs longterm treatment with a

medicine used to prevent blood clots

any of your close relatives has ever had a blood clot in the leg,

lung or any other organ

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”.

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.

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.

Ref:0905/051217/2/B

3

Page 2

Page 3

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.

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

oestrogenprogestogen HRT over 5 years, there will be 13 to 23 cases in

1000 users (i.e. an extra 4 to 6 cases).

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).

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 oestrogenprogestogen

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)

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).

Progynova 2mg Tablets / Estradiol Valerate 2mg Tablets

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

because it contains important information for you.

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

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

This medicine has been prescribed for you only. Do not pass it on to

others. It may harm them, even if their signs of illness are the same as

yours.

If you get any side effects, talk to your doctor or pharmacist. This includes

any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Progynova is and what it is used for

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

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

Possible side effects

How to store progynova

Contents of the pack and other information

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 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.

Prevention of osteoporosis

After the menopause some women may develop fragile bones

(osteoporosis). You should discuss all available options with your doctor.

If you are at an increased risk of fractures due to osteoporosis

and other medicines are not suitable for you, you can use Progynova to

prevent osteoporosis after menopause.

If 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.

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:

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)

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 or pharmacist. This includes

any possible side effects not listed on this leaflet. You can also report side

effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store. By

reporting side effects, you can help provide more information on the safety of

this medicine.

How to store Progynova

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.

Contents of the pack and other 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.

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 Delpharm Lille SAS, Rue de

Toufflers 59390 Lys-Lez-Lannoy, France 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.

PL Number:

15184/0905

Leaflet revision date: 05/12/17

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 to obtain the leaflet

in a format suitable for you

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 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.

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)

POM

Ref: 0905/050917/3/F

1

6

4

5

2

3

1

2

6

5

®

(estradiol valerate)

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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 2 mg to be taken daily.

Translation of days:

LUN = MONDAY JEU = THURSDAY DIM = SUNDAY

MAA DON ZON

MON DON

SON

MAR = TUESDAY VEN = FRIDAY

DIN

VRI

DIE

FRE

MER = WEDNESDAY SAM = SATURDAY

WOE

ZAT

MIT

SAM

Use in children and adolescents

Progynova is not for use in adolescents or children.

Your doctor will aim to prescribe the lowest dose to treat your symptom for as

short as necessary. Speak to your doctor if you think this dose is too strong

or not strong enough.

About the pack

This pack is designed to help you remember to take your medicine. Each

tablet is placed in a section marked with the day of the week on which it

should be taken. The arrows between tablets show the order in which they

must be taken. Your doctor may tell you when to start (see “when to start” for

further information).

On the day you start, take your first tablet from the blue section of the pack

(top row of tablets) marked with the correct day. For instance, if you start on

a Tuesday, press out the tablet from the blister marked ‘TUE’.

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

Overdose may cause nausea and vomiting and irregular bleeding.

No specific treatment is necessary but you should consult your doctor or

pharmacist if you are concerned.

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.

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.

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

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

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.

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

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are

taking Progynova, because this medicine can affect the results of some tests.

Pregnancy and breast-feeding

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

pregnant or breast-feeding.

If you become pregnant, stop taking Progynova immediately and contact your

doctor.

Driving and using machines

No effects on ability to drive and use machines have been observed in users

of Progynova.

Progynova contains lactose monohydrate and sucrose

Progynova contains lactose and sucrose (types of sugar). If you have been

told by your doctor that you have an intolerance to some sugars, contact

your doctor before taking this medicinal product.

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.

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.

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/

you have any blood clotting problem that needs longterm treatment with a

medicine used to prevent blood clots

any of your close relatives has ever had a blood clot in the leg,

lung or any other organ

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”.

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.

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.

Ref:0905/051217/3/B

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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.

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

oestrogenprogestogen HRT over 5 years, there will be 13 to 23 cases in

1000 users (i.e. an extra 4 to 6 cases).

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).

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 oestrogenprogestogen

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)

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).