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Livial 2.5mg Tablets/Tibolone 2.5mg Tablets

(tibolone)

In this leaflet:

1)    What Livial does

2)    Make sure Livial is OK for you

3)    Taking Livial

4)    Possible side effects

5)    How to store Livial

6)    Further information

1)    What Livial does

Livial is one of a group of medicines called Hormone Replacement Therapy (HRT). It's used for problems that start affecting women when their body no longer produces certain hormones (for example after the change of life (the menopause).

It's also used to prevent bones becoming brittle (osteoporosis) if you are unable to use other treatments.

There are three different kinds of HRT:

•    Oestrogen-only HRT

•    Combined HRT, containing two kinds of female hormone, an oestrogen and a progestagen

•    Livial, which contains a substance called tibolone

Livial is different from other HRT. Instead of actual hormones (such as oestrogen and progestagen) it contains tibolone. Your body breaks down tibolone to make hormones. Its effects and benefits are similar to combined HRT.

The benefits of Livial Replacing lost hormones

At the time of the menopause (or after an operation to remove the ovaries) a woman's body stops producing the female hormone, oestrogen.

You may also have too little oestrogen if you are being treated for endometriosis. Whatever the reason, too little oestrogen may cause a range of problems: hot flushes, night sweats, vaginal dryness or irritation, depression or reduced sex drive. Livial can help and you should notice an improvement after a few weeks.

Preventing brittle bones

Too little oestrogen may also cause brittle bones (osteoporosis). As you get older, the bones become porous, which means they become brittle and break more easily.

If you are at an increased risk of fractures due to osteoporosis (thinning of the bones) but are unable to take other treatments, or if other treatments don't work for you, you may be able to use HRT. Your doctor should discuss all the available options with you.

2)    Make sure Livial is OK for you

For information on when you can start taking Livial, (including after a hysterectomy) see Section 3.1 (overleaf).

As well as benefits, HRT has some risks that you need to consider when you're deciding whether to start taking it, or whether to carry on taking it. This is especially important if you are more than 60 years old.

Before you start taking HRT

Your doctor should ask about your own and your family's medical history. Your doctor may decide to examine your breasts and/or your abdomen, and may do an internal examination - but only if these examinations are necessary for you, or if you have any special concerns.

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

Regular check-ups

Once you've started on HRT, you should see your doctor for regular check-ups (at least once a year). During these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.

Be sure to:

•    go for regular breast screening and cervical smear tests

•    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.

2.1    Some women shouldn't take Livial Don’t take Livial

•    if you have had breast cancer or any other cancer (especially a hormone-dependent cancer)

•    if you are pregnant or breastfeeding

•    if you have or have had a blood circulation disorder such as blood clots (in the veins of the legs, or the lungs)

•    if you have or have had a stroke or a mini-stroke (transient ischaemic attack)

•    if you have or have had a heart condition such as angina or a heart attack

•    if you have ever had an allergic reaction to tibolone, lactose or any of the other ingredients in Livial tablets

•    if you have porphyria (an inherited disorder)

•    if you have recently had unexpected vaginal bleeding

•    if you have abnormal growth of the lining of the womb

•    if you have liver disease

—► if you have any of these above you should not take these tablets.

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

2.2    Some women need special care

With some medical problems, your doctor will want to keep a close watch on you as HRT can make them worse.

Do you have (or have you had):

•    asthma

•    blood clots

•    relatives who have had blood clots

•    close relatives (mother, sister or grandmother) who has had breast cancer or cancer of the lining of the womb

•    diabetes

•    epilepsy

•    gallstones

•    high blood pressure

•    liver disease

•    migraine or severe headache

•    otosclerosis (a hearing disorder)

•    a rare disease called systemic lupus erythematosus

•    uterine fibroids or endometriosis

•    endometrial hyperplasia (overgrowth of the lining of the womb)

If you have any of these, have you talked it over with your doctor?

—► If you haven't, talk to your doctor as soon as you can before taking these tablets. He or she may want to do some tests, or give you more advice about taking Livial.

Whatever your history, your doctor will arrange regular check-ups.

2.3    Reasons to stop taking Livial

•    If your blood pressure increases your doctor may decide that you should stop taking Livial.

•    Your doctor may do liver tests. If the results aren't normal, your doctor may decide that you should stop taking Livial.

•    if your skin goes yellow (jaundice)

•    If you begin to get migraine, or severe headaches

•    If you get painful swelling in your leg, sudden chest pain or difficulty in breathing.

•    if you start to have any of the conditions listed earlier in the Section 2.1 'Some women shouldn't take Livial'

—► stop taking Livial and talk to your doctor straight away.

2.4    Livial and cancer

Endometrial cancer (cancer of the lining of the womb)

There have been reports of an increased cell growth or cancer of the lining of the womb in women using tibolone. The risk of cancer of the lining of the womb increases the longer you take the medicine.

If you get breakthrough vaginal bleeding or spotting, it's usually nothing to worry about, especially during the first few months of taking HRT.

But if the bleeding or spotting:

•    carries on for more than 6 months

•    starts after you've been on HRT for a while

•    carries on even after you've stopped taking HRT

—► Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

Breast cancer

Women who have breast cancer, or have had breast cancer in the past, should not take HRT.

Taking HRT for 5 years or more may slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking oestrogen-only HRT for 5 years is about the same as for a woman of the same age who's still having periods over that time and not taking HRT.

For all kinds of HRT, the extra risk of breast cancer goes up the longer you take HRT, but returns to normal within about 5 years after stopping HRT.

Women using Livial have a lower risk than women using Combined HRT, and about the same risk as those taking oestrogen-only HRT.

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 ^{1 2}

Blood clots

Oestrogen-only and Combined HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it. It's not known if Livial increases the risk in the same way.

These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse 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:

•    if you are seriously overweight

•    if you have had a blood clot before

•    if any of your close family have had blood clots

•    if you have had one or more miscarriages

•    if you have any blood clotting problem that needs treatment with a medicine such as warfarin

•    if you're off your feet for a long time because of major surgery, injury or illness

•    if you have a rare condition called SLE

—► If any of these things apply to you, talk to your doctor to see if you

should take HRT.

If you get:

•    painful swelling in your leg

•    sudden chest pain

•    difficulty in breathing

—► See a doctor as soon as possible and do not take any more HRT

until your doctor says you can. These may be signs of a blood clot.

2.6    Having an Operation

If you're going to have an operation, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot.

Your doctor will tell you when you can start taking HRT again.

2.7    Taking other medicines

Tell your doctor or pharmacist if you are taking (or about to take) any other medicines, Remember to mention medicines you bought over the counter, without a prescription.

Other medicines may influence the effects of Livial, or Livial may affect other medicines especially:

•    medicines for blood clotting problems such as warfarin, as your doctor may need to change the dose of these medicines

2.8    Taking Livial with food and drink

You can eat or drink normally while you're taking Livial.

2.9    Pregnancy and breast-feeding

Do not use Livial if you are pregnant, or if you think you might be pregnant. Do not use Livial if you are breast-feeding.

2.10    Driving and using machines

Livial has no known effect on the ability to drive or use machines.

2.11    Livial contains Lactose

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

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

3) Taking Livial

3.1 When can you start taking Livial?

If it is not yet 12 months since your last natural period...	Wait before taking Livial’ (see Section 2.1).
If you are changing over from a period-free HRT ... (see the note below)...	Start taking Livial straight away
If you have never used HRT before ...
If you were prescribed HRT because you have had a hysterectomy ...
If you are being treated for endometriosis (a condition in which parts of the womb lining move around the body) ...	Wait for your next period. Start taking Livial as soon as your period ends.
If you are changing over from another type of HRT with which you have periods ... (see the note below)...

If you are changing over from another type of HRT:

There are several different types of HRT, such as tablets patches and gels. Most contain either oestrogen, or oestrogen and a progestogen. With some you still have periods, and with some you don't (these are called period-free HRT).

3.2    How to take Livial

The usual dose is one tablet every day. Take this dose unless your doctor or pharmacist told you to do something different.

Press the tablet so that it comes through the foil. Swallow the tablet with some water or other drink, without chewing. Take Livial at the same time each day.

3.3    If you take more Livial than you should

It is unlikely that taking more than one tablet will do you any harm, but you may feel sick, be sick or have some vaginal bleeding.

3.4    If you forget to take Livial

If you forget to take a tablet, take it as soon as you remember, unless you are more than 12 hours late. If you are more than 12 hours late, just skip it, and take your next tablet at the usual time. Don't take a double dose.

4) Possible side effects

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.

Like all medicines, Livial may have side effects, although not everybody gets them. Most side effects are mild.

•    If you have signs of a blood clot (see section 2.5 above)

•    If you get any of the problems listed in section 2.1 (Do not take Livial)

4.2 Other side effects

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 2.4.

•    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):

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

•    stomach upset

•    acne

•    painful nipples or breasts feeling uncomfortable

•    vaginal infections

Rare (affects up to 1 in 1000 women):

•    itchy skin

Some women taking Livial have also reported:

•    depression, dizziness, headache

•    joint pain or muscle pain

•    skin problems such as rash or itching

•    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 Livial.

—^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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

United Kingdom

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5)    How to store Livial

•    Keep all medicines out of the sight and reach of children.

•    Do not use after the expiry date printed on the carton, label or blister strip.

•    Store in the original container, in a dry place away from the light. Do not store above 25°C.

•    If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.

•    If the tablets become discoloured or show signs of deterioration, you should seek the advice of 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.

6)    Further information What Livial contains

Each tablet contains 2.5mg of the active ingredient tibolone.

Livial also contain the following ingredients:

potato starch, magnesium stearate, ascorbyl palmitate and lactose.

What Livial looks like and contents of the pack

Livial tablets are white, round tablet coded ‘MK2' on one side and ‘ORGANON²' on the reverse.

Livial tablets are available as blister packs of 30 tablets.

PL 10383/0632 |POM|

Who makes and repackages your medicine?

Your medicine is manufactured by N.V.Organon, Oss, Holland. Procured from within the EU and repackaged by the Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

More about Livial

The most important natural sex hormones in women are oestrogens and progesterone.

These hormones are produced in the ovaries. They are needed for normal sexual development, and control the menstrual cycle.

The menopause is the time (usually around the age of 50) when the ovaries gradually stop producing oestrogens. If the ovaries are removed surgically before the menopause, the decrease in hormone production occurs very quickly. The decrease in hormone production often leads to symptoms such as hot flushes and night sweats. The shortage of sex hormones may also cause the lining of the vagina to become thin and dry. So sexual intercourse may be painful and vaginal infections may occur more frequently. Some women also experience mood changes, nervousness, depression, irritability and loss of sexual desire.

Oestrogens are also important for bone formation. Bone is built up during youth, and peak bone mass is reached between the age of 20 and 30. After that, bone mass decreases, at first slowly, but later in life more quickly, especially after the menopause. Gradually, the bones become brittle and may easily break (osteoporosis), especially in your spine, hip and wrists. Osteoporosis may also cause back pain, loss of height and a curved back.

Livial contains tibolone, a substance that has beneficial effects on different tissues in the body, such as the brain, vagina and bone. This results in the relief of symptoms such as hot flushes and night sweats, and a improvement in the lining of the vagina, mood and sexual desire. Livial can also stop the process of bone loss that occurs in your spine, hip and wrists after the menopause. Unlike some hormone replacement therapies, Livial does not stimulate the lining of the womb. So treatment with Livial does not cause monthly vaginal bleeding.

Leaflet date: 16.04.2014

—Tell your doctor or pharmacist if you are worried about any side effects which you think may be due to Livial. (see also section 2.3, 'Stop taking Livial and see a doctor immediately')

4.1 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 Livial:

•    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 2.5 above)

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If you notice these changes in your breast, such as:

•    dimpling 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 (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease. Some studies have indicated that taking oestrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT or Livial increase the risk in the same way.

2.5 Livial and your heart or circulation Heart disease

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.

HRT will not help to prevent heart disease.

Studies with one type of HRT (containing conjugated oestrogen plus the progestagen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.

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

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

Recent research suggests that HRT and Livial slightly increases the risk of having a stroke.

The increased risk is seen mainly in women over 60 years old. Other things that can increase the risk of stroke include:

•    getting older

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   high blood pressure

•    smoking

•    drinking too much alcohol

•    an irregular heartbeat

If you are worried about any of these things, talk to your doctor to see if you should take HRT.

If you get:

•    unexplained migraine-type headaches, with or without disturbed vision —► See a doctor as soon as possible and do not take any more HRT

until your doctor says you can. These headaches may be an early warning sign of a stroke.