Informations for option: Progynova 1mg Tablets, show other option

Select option:

1. Progynova 1mg Tablets
2. Progynova 1mg Tablets

Document: document 4 change

• document 0
• document 1
• document 2
• document 3
• document 4
• document 5
• document 6

---

02-1808

DT

18799/2525    05/04/13

UK PIL DATED SEPTEMBER 2012

Pg4

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking Progynova. You may need to stop taking Progynova about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, "Blood clots in a vein (thrombosis)”).

Ask your doctor when you can start taking Progynova again.

4. Possible side effects

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 1mg Tablets.

Each 1mg tablet contains 1mg of the active ingredient estradiol valerate, in a film-coated, yellow, round, unmarked tablet with a white core.

Progynova 1mg 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 1mg tablets also contain the colouring iron oxide (E172).

Progynova 1mg 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: 18799/2525

This product is manufactured by Bayer Schering Pharma AG, D-13342 Berlin, Germany and procured within the EU and repackaged by the Product Licence holder:

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, UK.

Leaflet revision and issue date (Ref.) 20.04.2015

Progynova® is a registered trademark of SCHERING AG

Pg 1

PROGYNOVA 1mg 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.

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

•    a liver disorder, such as a benign liver tumour

•    diabetes

•    gallstones

•    migraine or severe headaches

PROOF HISTORY:

v.1    - 05/04/13 Leaflet Flat Size = 296 x 420

ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 10 BRIDGED TO TRANSTEC

Pg 2

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

•    epilepsy

•    asthma

•    a disease affecting the eardrum and hearing (otosclerosis)

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

•    fluid retention due to cardiac or kidney problems

Stop taking Progynova and see a doctor immediately

If you notice any of the following when taking HRT:

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

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

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

•    migraine-like headaches which happen for the first time.

•    if you become pregnant

•    if you notice signs of a blood clot, such as:

•    painful swelling and redness of the legs

•    sudden chest pain

•    difficulty in breathing

for more information, see ‘Blood clots in a vein (thrombosis)'

Note: Progynova is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.

HRT and cancer

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)

Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).

Taking a progestogen in addition to the oestrogen for at least 12 days of each 28 day cycle protects you from this extra risk.

If you still have your womb, your doctor will prescribe a progestogen separately.

If you have had your womb removed (a hysterectomy), discuss with your doctor whether you can safely take this product without a progestogen.

If you've had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an oestrogen.

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

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.

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 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”.

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.

Pg 3

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.

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

Using other medicines

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

This applies to the following medicines:

•    medicines for epilepsy (such as phenobarbital, phenytoin, carbamazepine)

•    medicines for tuberculosis (such as rifampicin, rifabutin)

•    medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir)

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

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, herbal medicines or other natural products.

Laboratory tests

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

Pregnancy and breast-feeding

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

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

Driving or using machines

There is nothing to suggest that the use of Progynova affects driving or use of machines.

Important information about some of the ingredients of Progynova

Progynova contains lactose (a type of sugar). If you have an intolerance to some sugars, check with your doctor before taking Progynova.

3. How to take Progynova

Progynova is not for use in adolescents or children.

Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.

About the pack

This pack is designed to help you remember to take your medicine. Each tablet is placed in a section marked with the day of the week on which it should be taken. The arrows between tablets show the order in which they must be taken.

Your doctor may tell you when to start (see "when to start” for further information).

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.

Your doctor may prescribe the hormone progestogen in addition to Progynova for at least 12-14 days each month:

•    if you still have your womb

•    if you have a history of endometriosis

When to start

If you have been taking other HRT preparations: carry on until you have finished your current pack and have taken all the tablets for that month. Take your first Progynova tablet the next day. Do not leave a break between your old tablets and the Progynova tablets.

If this is your first HRT treatment and you are still having regular periods: start your Progynova tablets on the first day of bleeding

If this is your first HRT treatment and your periods have become very infrequent or have stopped completely: you can start your Progynova tablets at any time if you are sure you are not pregnant.

If you take more Progynova than you should

If you have taken too many Progynova tablets by mistake, you may feel sick, vomit or have some menstruation-like bleeding. No specific treatment is necessary but you should consult your doctor or pharmacist if you are worried.

If you forget to take Progynova

If you forget to take a tablet at your usual time and you are less than 12 hours late, take it as soon as possible. Take the next tablet at the usual time.

If you are more than 12 hours late, leave the forgotten tablet in the pack. Continue to take the rest of the tablets at the usual time every day. You may experience breakthrough bleeding.

If you stop taking Progynova

You may begin to feel the usual symptoms of menopause again, which may include hot flushes, trouble sleeping, nervousness, dizziness or vaginal dryness. Consult your doctor or pharmacist if you want to stop taking Progynova tablets.