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TIBOLONE 2.5MG TABLETS

Active substance(s): TIBOLONE

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Livial® 2.5mg Tablets/Livial® Tablets/Tibolone 2.5mg Tablets
(tibolone)
Your medicine is known by one of the above names but will be referred to
as Livial throughout this leaflet.
Patient Information 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, pharmacist or
nurse.
• 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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See
section 4.
In this leaflet:
1) What Livial is and what it is used for
2) What you need to know before you take Livial
3) How to take Livial
4) Possible side effects
5) How to store Livial
6) Contents of the pack and other information

1) What Livial is and what it is used for
Livial 2.5 mg tablet
The active substance is: tibolone.
This medicine is a Hormone Replacement Therapy (HRT). It contains
tibolone, a substance that has favourable effects on different tissues in the
body, such as brain, vagina and bone. This medicine is used in
postmenopausal women with at least 12 months (1 year) since their last
natural period.
This medicine 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”). Livial alleviates these symptoms after menopause.
You will only be prescribed this medicine 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 Livial to prevent
osteoporosis after menopause.
There are three different kinds of HRT:
• Oestrogen-only HRT
• Combined HRT, containing two kinds of female hormone, an oestrogen
and a progestogen.
• Livial, which contains a substance called tibolone
Livial is different from other HRT. Instead of actual hormones (such as
oestrogen and progestogen) it contains tibolone. Your body breaks
down tibolone to make hormones. Its effects and benefits are similar to
combined HRT.
In section 6, ‘Contents of the pack and other information’ you can find more
information about Livial and what it is used for.

2) What you need to know before you take Livial











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

2.3 Stop taking Livial and see a doctor immediately
If you notice any of the following when taking Livial:

any of the conditions mentioned in the “Do not take Livial” 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: Livial 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.
2.4 HRT and Cancer
Excessive thickening of the lining of the womb (endometrial
hyperplasia) and cancer of the lining of the womb (endometrial
cancer)
There have been reports of an increased cell growth or cancer of the lining
of the womb in women using Livial. The risk of cancer of the lining of the
womb increases the longer you take the medicine.
Irregular bleeding
You may have irregular bleeding or drops of blood (spotting) during the first
3-6 months of taking Livial. But if the bleeding or spotting:
• Carries on for more than the first 6 months
• Starts after you have been taking Livial for more than 6 months
• Carries on even after you’ve stopped taking Livial

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 Livial 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:
o
dimpling or sinking of the skin
o
changes in the nipple
o
any lumps you can see or feel



Make an appointment to see your doctor as soon as possible

For information on when you can start taking Livial, (including after a
hysterectomy) see Section 3.1 (overleaf).
Medical History and regular check-ups
The use of HRT or Livial carries risks that need to be considered when
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.
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 Livial may be different. Please talk to your doctor.
Before you start taking or restart HRT or Livial
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 Livial, 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 Livial.
Go for regular breast screening, as recommended by your doctor.
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 should not take Livial
Do not take Livial
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 Livial













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 to tibolone or any of the other ingredients of this
medicine (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 Livial,
stop taking it at once and consult your doctor immediately.
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 Warning and precautions
Talk to your doctor, pharmacist or nurse before taking Livial.
If you have ever had any of the following problems, tell your doctor before
you start the treatment, as these may return or become worse during
treatment with Livial. If so, you should see your doctor more often for checkups:
• 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
• a liver disorder, such as a benign liver tumour

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer. The use of
oestrogen-only or combined oestrogen-progestagen HRT has been
associated with a slightly increased risk of ovarian cancer.
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).
With use of Livial, the increased risk of ovarian cancer is similar to other
types of HRT.
2.5 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)
• 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 Livial 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 oestrogenprogestogen HRT for over 5 years, there will be 9 to 12 cases in 1000
users (i.e. an extra 5 cases).
With use of Livial, 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 Livial 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.
As the risk of heart disease strongly depends on age, the number of extra
cases of heart disease due to use of oestrogen-progestogen HRT is very
low in healthy women close to menopause, but will rise with more advanced
age.
There is no evidence to suggest that the risk of myocardial infarction with
Livial is different to the risk of other HRT.
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
• 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
Compare
Looking at women in their 50s who are not taking Livial – on average,
over a 5-year 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 Livial – 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 Livial, the figure would be
24 in 1000 (i.e. an extra 13 cases)

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, this medicine can cause side effects, although not
everybody gets them. Most side effects are mild.

2.6 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.
Livial is not intended for contraceptive use.
Treatment with Livial results in a marked dose-dependent decrease in HDL
cholesterol (from -16.7% with a 1.25 mg dose to -21.8% for the 2.5 mg dose
after 2 years). Total triglycerides and lipoprotein(a) levels were also
reduced. The decrease in total cholesterol and VLDL-C levels was not
dose-dependent. Levels of LDL-C were unchanged. The clinical implication
of these findings is not yet known.
Oestrogens may cause fluid retention, and therefore patients with cardiac or
renal dysfunction should be carefully observed.
Women with pre-existing hypertriglyceridaemia should be followed closely
during oestrogen replacement or Hormone replacement therapy, since rare
cases of large increases of plasma triglycerides leading to pancreatitis have
been reported with oestrogen therapy in this condition.
Treatment with Livial results in a very minor decrease of thyroid binding
globulin (TBG) and total T4. Levels of total T3 are unaltered. Livial
decreases the level of sex-hormone-binding globulin (SHBG), whereas the
levels of corticoid binding globulin (CBG) and circulating cortisol are
unaffected.
2.7 Other medicines and Livial
Some medicines may interfere with the effect of Livial. 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 tuberculosis (such as rifampicin)
• Herbal remedies containing St John’s Wort (Hypericum perforatum).
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. This includes medicines obtained without a
prescription, herbal medicines or other natural products.



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)
• 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 (may 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 (may affect 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 (may affect up to 1 in 1000 women):
• itchy skin

2.8 Having an Operation
If you are 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.
2.9 Livial with food and drink
You can eat or drink normally while you are taking Livial.

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.

2.10 Pregnancy and breast-feeding
Livial is for use in postmenopausal women only. If you become pregnant,
stop taking Livial and contact your doctor.
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
2.11 Driving and using machines
Livial has no known effect on the ability to drive or use machines.
2.12 Livial contains Lactose
Patients with rare hereditary problems of galactose intolerance, the Lapp
lactase deficiency or glucose-galactose malabsorption should not take this
medicine.
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) How to take Livial
3.1 When can you start taking Livial?
If it is not yet 12 months since your last
natural period…
If you are changing over from a period
free HRT… (see note below)…
If you have never used HRT before

Wait before taking Livial
(see Section 2.1)…

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)…
If you are changing over from another type
of HRT with which you have periods…
(see the note below)…

Start taking Livial straight
away

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. 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.
Do not store above 25°C.
Store in the original package in order to protect from light and moisture.
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) Contents of the pack and other information

Wait for your next period.
Start taking Livial as soon as
your period ends

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 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
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 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.
The strips of tablets are marked with the days of the week. Start by taking a
tablet marked with the current day. For example, if it is Monday, take a
tablet marked Monday on the top row of the strip. Follow the arrows until the
strip is empty. Start the next strip the next day. Do not leave a break
between strips or packs.
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.
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.
3.5 If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking Livial.
You may need to stop taking Livial 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 Livial again.

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
‘ORGANON’ on the reverse.
Livial tablets are available as blister packs of 28 or 84 tablets.
PL 10383/0505

POM

Who makes and repackages your medicine?
Your medicine is manufactured by N.V.Organon, Oss, The Netherlands.
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 an
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: 22.09.2016
Livial is a registered trademark of Merck Sharp & Dohme B.V., The
Netherlands.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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