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Package Leaflet: information for the user

<TRADENAME> 2.5 mg tablets

For adult use

Active substance: Tibolone

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

What is in this leaflet

1.    What <TRADENAME> is and what it is used for

2.    What you need to know before you take <TRADENAME>

3.    How to take <TRADENAME>

4.    Possible side effects

5.    How to store <TRADENAME>

6.    Contents of the pack and other information

1. What <TRADENAME> is and what it is used for

<TRADENAME> 2.5 mg tablet The active substance is: tibolone.

<TRADENAME> is a Hormone Replacement Therapy (HRT). <TRADENAME> is used in postmenopausal women with at least 12 months since their last natural period.

<TRADENAME> 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"). <TRADENAME> alleviates these symptoms after menopause. You will only be prescribed <TRADENAME> if your symptoms seriously hinder your daily life.

2. What you need to know before you take <TRADENAME>

Medical History and regular check-ups

The use of HRT or <TRADENAME> carries risks that 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 or <TRADENAME> may be different. Please talk to your doctor.

Before you start taking (or restart) HRT or <TRADENAME>

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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.

^Tell your doctor if you have any medical problems or illnesses.

Regular check-ups

Once you have started on <TRADENAME>, 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 <TRADENAME>.

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

Do not take <TRADENAME>

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 this medicine

•    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 venous 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 tibolone or any of the other ingredients of <TRADENAME> (listed in section 6)

•    If you are pregnant or think you might be pregnant.

•    If you are breastfeeding.

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

If you have started the menopause you should not take <TRADENAME> until 12 months after your last natural period. If you take it sooner than this you may have irregular bleeding.

When to take special care with <TRADENAME>

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 <TRADENAME>. If so, you should see your doctor more often for check-ups:

•    fibroids inside your womb

•    growth of the 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 having a mother, sister or grandmother who has had breast cancer)

•    high blood pressure

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•    a liver disorder, such as a benign liver tumour

•    diabetes

•    gallstones

•    migraine or severe headaches

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

•    epilepsy

•    asthma

•    a disease affecting the eardrum and hearing (otosclerosis)

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

•    fluid retention due to cardiac or kidney problems

Stop taking <TRADENAME> and see a doctor immediately

If you notice any of the following when taking HRT or <TRADENAME> :

•    any of the conditions mentioned in the "Do not take <TRADENAME> " 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: <TRADENAME> 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)

The results obtained from clinical studies are inconsistent. A clinical study indentified the highest risk of endometrial cancer for women who had not been screened for endometrial anomalies at the beginning of the study (LIFT study, average age 68 years). In this study, four cases of endometrial cancer were diagnosed in the group of Tibolone users after 2.9 years, compared with no cases of endometrial cancer diagnosed in women treated with placebo (dummy medication with no active ingredient). This corresponds to a diagnosis of 0.8 additional cases of endometrial cancer in every 1000 women who used Tibolone for one year in the context of this study.

Observation studies have consistently shown that users of Tibolone have an increased risk for diagnosis of cancer of the lining of the womb. This risk rises with increasing duration of treatment.

An increase in the thickness of the lining of the womb was measured with ultrasound in users of Tibolone.

Irregular bleeding

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You may have irregulär bleeding or drops of blood (spotting) during the first 3-6 months of taking <TRADENAME>. But if the bleeding or spotting:

•    Carries on for more than the first 6 months

•    Starts after you have been taking <TRADENAME> for more than 6 months

•    Carries on even after you’ve stopped taking <TRADENAME>

^•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.

Compare

Women taking <TRADENAME> have a lower risk than women using combined HRT and a comparable risk with oestrogen-only HRT.

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

•    Dimpling or sinking of the skin

•    Changes in the nipple

•    Any lumps you can see or feel

^■Make an appointment to see your doctor as soon as possible 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.

Compare

For 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).

With use of <TRADENAME>, the increased risk of ovarian cancer is similar to other types of HRT.

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 apply to you:

•    you are pregnant or recently had a baby

•    you use oestrogens

•    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)

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•    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 <TRADENAME> and see a doctor immediately”. Compare

Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.

For women in their 50s who 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).

With use of <TRADENAME>, the increased risk of getting a blood clot in a vein is lower than with other types of HRT.

Heart disease (heart attack)

There is no evidence that HRT or <TRADENAME> will prevent a heart attack.

Women over the age of 60 who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.

Stroke

The risk of getting 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.

Compare

Looking at women in their 50s who are not taking tibolone- on average, over a 5-yaer period, 3 in 1000 would be expected to have a stroke. For women in their 50s who are taking livial, the figure would be 7 in 1000 (i.e. an extra 4 cases).

Looking at women in their 60s who are not taking tibolone - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.

For women in their 60s who are taking tibolone, the figure would be 24 in 1000 (i.e. an extra 13 cases).

Other conditions

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

Using other medicines

Some medicines may interfere with the effect of <TRADENAME>. This might lead to irregular bleeding. This applies to the following medicines:

•    Medicines against blood clotting (such as warfarin)

•    Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepin)

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

•    Medicines for tuberculosis (such as rifampicin)

•    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

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

Taking <TRADENAME> with Food and Drink

You can eat or drink normally while you are taking <TRADENAME>.

Pregnancy and Breast-Feeding

<TRADENAME> is for use in postmenopausal women only. If you become pregnant, stop taking <TRADENAME> and contact your doctor.

Driving and Using Machines

<TRADENAME> has no known effect on the ability to drive or use machines.

<TRADENAME> contains Lactose

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

If you are worried about anything in this section, talk to your doctor about the risks and benefits of HRT.

3. How to take <TRADENAME>

Always use <TRADENAME> exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much <TRADENAME> should you take and how often

Unless otherwise prescribed by the doctor, the usual dose is:

One tablet daily after a meal, preferably at the same time each day.

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

Do not take a progestogen preparation in addition to <TRADENAME>.

How to take <TRADENAME>

You should take the tablets with a little water or other beverage, preferably at the same time every day.

What to take into account when you start treatment with <TRADENAME>

If the menopause occurred naturally in your case, you should start taking <TRADENAME> at the earliest 1 year after your last natural monthly bleeding. If your ovaries have been removed by surgery, you can start taking <TRADENAME> immediately.

If you wish to start taking <TRADENAME> and have had irregular or unexpected vaginal bleeding, please ensure that you contact the doctor who is treating you before starting <TRADENAME> treatment, so that any malignant disease can be excluded.

If you wish to switch over to <TRADENAME> from a medicinal product that contains an oestrogen and a progestogen, please ask your doctor what you should take into account.

If you need to have surgery

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If you are going to have surgery, teil the surgeon that you are taking <TRADENAME>. You may need to stop taking <TRADENAME> 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 <TRADENAME> again.

If you have the impression that the effect of the <TRADENAME> is too strong or too weak, please consult your doctor or pharmacist.

If you take more <TRADENAME> than you should

Toxic symptoms are unlikely even if several tablets are taken at the same time. In case of acute overdose, nausea, vomiting and withdrawal bleeding may occur. If necessary, please contact your doctor so that these symptoms can be treated.

If you forget to take <TRADENAME>

If you forget to take a tablet at the usual time, you should take it as soon as possible unless more than 12 hours have passed since the time at which it was due. In this case, skip the missed tablet and take the next tablet at the usual time.

If you have any further questions on the use of <TRADENAME>, please ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, <TRADENAME> can cause side effects, although not everybody gets them. Most side effects are mild.

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

•    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.

Tell your doctor or pharmacist if you are worried about any side effects which you think may be due to <TRADENAME> see also section 2 'Stop taking <TRADENAME> and see a doctor immediately'

Serious side effects - see a doctor straight away

If you think you may have signs of a serious side effect, see a doctor straight away.

You may need to stop taking <TRADENAME>:

• If your blood pressure rises

• If your skin or the whites of your eyes go yellow (jaundice)

• If you suddenly have migraine-type headaches (see section 2 above)

• If you have signs of a blood clot (see section 2 above)

• If you get any of the problems listed in section 2 (Do not take <TRADENAME> )

Other side effects

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Common (affect up to 1 in 10 women):

•    breast pain

•    stomach or pelvic pain

•    unusual hair growth

•    vaginal bleeding or spotting.

This is usually nothing to worry about in the first few months of taking HRT. If bleeding continues, or starts after you have been on HRT for a while see Section 2.

•    vaginal problems such as more secretions, itching, irritation and thrush

•    thickening of the lining of the womb or the lining of the cervix

•    weight gain.

Uncommon (affects up to 1 in 100 women):

•    acne

•    painful nipples or breasts feeling uncomfortable

•    vaginal infections

Some women taking <TRADENAME> have also reported:

•    depression, dizziness, headache

•    joint pain or muscle pain

•    skin problems such as rash or itching

•    swollen hands, ankles or feet - a sign of fluid retention

•    tummy upset

•    loss of vision or blurred vision

•    changes in liver tests

There have been reports of breast cancer and of an increased cell growth or cancer of the lining of the womb in women using <TRADENAME>.

^Tell your doctor if any of the above mentioned side effects continues or becomes troublesome.

The following side effects have been reported with other HRTs:

•    gall bladder disease

•    various skin disorders:

-    discolouration of the skin especially of the face or neck known as “pregnancy patches” (chloasma)

-    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 in this leaflet. You can also report side effects directly via [to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store <TRADENAME>

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

Do not use <TRADENAME> after the expiry date which is stated on the carton/blister pack after EXP: The expiry date refers to the last day of that month.

Do not use this medicine if you notice the blister pack is damaged or even missing, despite the package being intact.

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 protect the environment.

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This medicinal product does not require any special storage conditions.

6. Contents of the pack and other information

What <TRADENAME> contains

The active substance is Tibolone.

One tablet contains 2.5 mg Tibolone.

The other ingredients are:

Potato starch, lactose monohydrate, magnesium stearate (Ph.Eur.) [vegetable origin], palmitoyl ascorbic acid (Ph.Eur.)

What <TRADENAME> looks like and contents of the pack

<TRADENAME> are white to whitish, flat round tablets of approximately 6 mm diameter. <TRADENAME> is available in packs of 1 x 28 tablets, 3 x 28 tablets and 6x28 tablets.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

{Name and address}

<{tel}>

<{fax}>

<{e-mail}>

This medicinal product is authorised in the Member States of the EEA under the following names:

<{Name of the Member State}> <{Name of the medicinal product}>

<{Name of the Member State}> <{Name of the medicinal product}>

This Package Leaflet was last revised in [month YYYY].

Please include the series of numbers after Batch: (batch code) in all correspondence.