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LIVIAL TABLETS 2.5MG

Active substance: TIBOLONE

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Package leaflet: Information for the user

Livialtablets
2.5 mg
®

TIBOLONE

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

1. What Livial is and what it is used for

• 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.

2. What you need to know before you take Livial

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

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 side effects not listed in this leaflet. See section 4.
In this leaflet:

3. How to take Livial
4. Possible side effects
5. How to store Livial

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

6. Contents of the pack and other information

Talk to your doctor, pharmacist or nurse before taking Livial.

1. What Livial is and what it is used
for

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 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
• 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

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
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.

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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

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 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 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 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.

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.

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 oestrogenprogestogen 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

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.

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).

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.

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.
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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.

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.

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

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

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

3.5

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
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)…

Wait before taking Livial
(see Section 2.1)…

Start taking Livial straight away

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.

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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.

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.
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

Livial contains Lactose

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.

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

2.12

If you take more Livial than you should

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 (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. You can also report

side effects directly (see details below). By reporting side affects you
can help provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Malta: ADR Reporting. Website: www.medicinesauthority.gov.mt/adrportal

5. How to store Livial
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton after ‘EXP’. The expiry date refers to the last day of that month.
Store below 25°C. Do not refrigerate. Store in the original package. Keep
the blister in the outer carton, in order to protect from light and moisture.
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.

6. Contents of the pack and
other information
What Livial contains
The active substance is tibolone.
The other ingredients are potato starch, lactose monohydrate, ascorbyl
palmitate and magnesium stearate.
What Livial looks like and the contents of the pack
Livial tablets are white, and marked Organon* on one side, and “MK2”
on the other side.
They come in packs of one or three strips of 28 tablets.
The Marketing Authorisation Holder is:
Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
The manufacturer is:
NV Organon,
PO Box 20, 5340 BH Oss
Netherlands
This leaflet was revised in December 2014.

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.

To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Livial 2.5mg tablets
Reference number: PL 00025/0599
This is a service provided by the Royal National Institute
for Blind People.
© Merck Sharp & Dohme Limited 2015. All rights reserved.
PIL.LIV.14.UK.4451.IB-QRD

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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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