PACKAGE LEAFLET INFORMATION FOR THE USER

Bedol Film-Coated Tablets

17-fi estradiol hemihydrate

Read all of this leaflet carefully before you start using this medicine.

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

-    If you have further questions, please 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 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.

The name of your medicine is Bedol Film-Coated Tablets. In the rest of this leaflet it is called Bedol Tablets.

In this leaflet:

1.    What Bedol Tablets are and what they are used for

2.    Before you take Bedol Tablets

3.    How to take Bedol Tablets

4.    Possible side effects

5.    How to store Bedol Tablets

6.    Contents of the pack and other information

1. WHAT BEDOL TABLETS ARE AND WHAT THEY ARE USED FOR

Bedol Tablets are a hormone replacement therapy (HRT). They contain the female hormone estradiol (a type of oestrogen).

Bedol Tablets are 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"). Bedol Tablets alleviates these symptoms after menopause. You will only be prescribed Bedol Tablets if your symptoms seriously hinder your daily life. Bedol Tablets help to relieve these symptoms.

•    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 Bedol Tablets to prevent osteoporosis after menopause.

2. BEFORE YOU TAKE BEDOL TABLETS 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 Bedol 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 with Bedol.

Go for regular breast screening, as recommended by your doctor.

Do not take Bedol

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 Bedol,

Do NOT take Bedol Tablets if you:

•    are allergic to estradiol or any of the other ingredients of Bedol Tablets (listed in section 6)

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

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

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

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

•    have a rare blood problem called "porphyria" which is passed down in families (inherited)

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

•    have unexplained vaginal bleeding which has not been diagnosed

• have excessive thickening of the womb lining (endometrial hyperplasia) that is not been treated

• have or have ever had a liver disease and your liver function tests have not returned to normal

•    are pregnant or think you might be pregnant (you should use extra non-hormone contraceptive precautions whilst taking Bedol Tablets)

•    are breast-feeding.

If any of the above conditions appear for the first time while taking Bedol Tablets, stop taking it at once and consult your doctor immediately.

When to take special care with Bedol Tablets

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 Bedol Tablets. If so, you should see your doctor more often for check-ups:

•    epilepsy

•    migraine or severe headaches

•    asthma

•    high blood pressure

•    increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer - see Section "Bedol Tablets and cancer")

•    fibroids (growths inside your womb)

•    growth of womb lining outside your womb (endometriosis)

•    a history of excessive growth of the womb lining (endometrial hyperplasia)

•    gall stones

•    diabetes

•    a disease affecting the eardrum and hearing (otosclerosis)

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

•    increased risk of developing blood clots (see "Blood clots in a vein (thrombosis)")

•    a liver disorder, such as a benign liver tumour

•    fluid retention due to cardiac or kidney problems

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

Stop taking Bedol Tablets and see a doctor immediately

If you notice any of the following when taking HRT:

• yellowing of your skin or the whites of your eyes	• if you become pregnant	• signs of a blood clot, such as:
(jaundice). These may be signs of a liver disease	• migraine-like headaches which happen for the first time	~ painful swelling and redness of the legs ~ sudden chest pain
• a large rise in your blood pressure (symptoms may		~ difficulty in breathing
be headache, tiredness, dizziness)	• any of the conditions listed in the	For more information, see 'Blood clots in a vein
	'Do NOT take Bedol Tablets' section.	(thrombosis)'

Note: Bedol Tablets are 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. So your doctor will prescribe a progestogen separately if you still have your womb. If you have had your womb removed (a hysterectomy), discuss with your doctor whether you can safely take this product without a progestogen.

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 for how long it is taken.

Unexpected bleeding

You will have a bleed once a month (so-called withdrawal bleed) while taking Bedol Tablets. But, if you have unexpected bleeding or drops of blood (spotting) besides your monthly bleeding, which:

•    carries on for more than the first 6 months

•    starts after you have been taking Bedol Tablets more than 6 months

•    carries on after you have stopped taking Bedol Tablets see your doctor as soon as possible

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.

How likely is breast cancer?

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

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

~ dimpling of the skin ~ changes in the nipple ~ any lumps you can see or feel

Ovarian cancer

Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.

How likely is ovarian cancer?

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

Effect of HRT on heart and circulation

Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT users than in 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.

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 applies to you:

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

•    you are seriously overweight (BMI >30 kg/m2)

•    you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots

•    if any of your close relatives has ever had a blood clot in the leg, lung or another organ

•    you have systemic lupus erythematosus (SLE)

•    you have cancer.

For signs of a blood clot, see "Stop taking Bedol Tablets and see a doctor immediately".

How likely is a blood clot?

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 have been taking oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e.an extra 5 cases).

For women in their 50s who have had their womb removed and have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1000 users (i.e. 1 extra case).

Heart disease (heart attack)

There is no evidence that HRT will prevent a heart attack.

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.

Stroke

The risk of having a stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.

How likely is a stroke?

Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases).Other things that can increase the risk of stroke include:

•getting older    •high blood pressure    •drinking too much alcohol    •being overweight or obese

• family history of stroke    • smoking    • high cholesterol    • an irregular heartbeat.

If you are worried about any of the above or if you have had a stroke in the past, speak to your doctor to see if you should take Bedol Tablets.

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. Using other medicines

Some medicines may interfere with the effect of Bedol Tablets. 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, 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 Bedol Tablets, because this medicine can affect the results of some tests.

Pregnancy and breast-feeding

You should not take Bedol Tablets if you are pregnant or trying to become pregnant. If you become pregnant whilst taking Bedol Tablets, you should stop taking the tablets and contact your doctor immediately.

Bedol Tablets are not an oral contraceptive; nor will they restore fertility. You should use additional non-hormone methods of contraception whilst you are taking Bedol Tablets. Bedol Tablets are not recommended if you are breast-feeding.

Bedol Tablets contain lactose

Lactose - If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE BEDOL TABLETS

Always follow your doctor's instructions completely and also follow any special instructions or warnings which appear on the label which the pharmacist has put on the package. If you do not understand, or are in any doubt, ask your doctor or pharmacist.

When to take the tablets

•    Bedol Tablets are provided in a calendar pack of 28 white tablets.

•    One tablet is taken each day; a treatment cycle consists of 28 days.

•    You should take the tablets at a regular time each day, either in the morning or in the evening.

•    The next pack is usually taken without a break in therapy. However your doctor will aim to give you the lowest dose for the shortest time    to    treat you.

If you have not been taking another type of HRT

•    If you have had your womb removed or you have gone through the menopause you can start straight away.

• If you are still having periods, you should take your first tablet in the first 5 days of bleeding.

• If you doctor has given you other instructions, these should be followed precisely.

If you are changing from another type of HRT

•    If you are having periods, you should complete your current course of tablets and then take your first Bedol Tablet the next day without a    break    in    treatment.

•    If you are not having periods, then you may start taking Bedol Tablets at any time according to any instructions given to you by your doctor.

•    If your doctor has given you other instructions, these should be followed precisely. If you still have your womb or have had endometriosis (the growth of tissue from the womb outside the womb) your doctor may also prescribe a progesterone (another female hormone).

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking Bedol Tablets. You may need to stop taking Bedol Tablets about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start taking Bedol Tablets again.

If you take more Bedol Tablets than you should

If you accidentally take too many tablets, you may experience nausea or vomiting. If you are worried or have any unusual symptoms you should contact your doctor. You should take your usual tablet the following day or follow the advice given to you by your doctor.

If you forget to take Bedol Tablets

If you forget to take a dose, take a tablet as soon as you remember. If a whole day has passed, do not take two Bedol Tablets at the same time. Carry on taking one tablet a day until you have finished the 28 tablets in the pack and then carry on taking new packs of tablets as usual. You might notice some bleeding or spotting if you miss a tablet.

4. POSSIBLE SIDE EFFECTS

Like many medicines Bedol Tablets can cause side effects, although not everybody gets them. Tell your doctor or pharmacist if you are worried about any side effects which you think may be due to Bedol Tablets.

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

Serious side effects - see your doctor immediately

Tell your doctor immediately and STOP taking Bedol Tablets if you experience any of the following:

side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE BEDOL TABLETS

Keep out this medicine of the sight and reach of children.

Do not take this medicine if the expiry date on the pack has passed. The expiry date refers to the last day of that month.

Bedol Tablets should not be taken if they show signs of deterioration such as discoloration. Do not store above 25°C. Store in the original container or package in order to protect from light and moisture. Do not transfer the tablets to another container.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Bedol Tablets contain

The active ingredient in Bedol Tablets is 17-fi estradiol hemihydrate. The white tablets contain 2mg of 17-fi estradiol.

Other ingredients are lactose (see end of Section 2 for further information on lactose), crospovidone, povidone, talc, magnesium stearate, Opadry white Y-I-7000 HSE (methocel E5, titanium dioxide E171, propylene glycol).

What Bedol Tablets look like and contents of the pack

There are 28 round, white biconvex (curved on both sides) film coated tablets in each calendar blister pack enclosed in a cardboard carton.

Marketing Authorisation Holder: ReSource Medical UK Ltd, 2 Carlton Avenue, Staincliff, Batley, WF17 7AQ, UK.

Manufacturer: Pharbil Waltrop GmbH, Im Wirringen 25, 45731 Waltrop, Germany.    This leaflet was last revised in September 2012.