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LIVIAL 2.5 MG TABLETS

Active substance(s): TIBOLONE

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Package leaflet: Information for the user

Livial® 2.5 mg tablets/
Tibolone 2.5 mg tablets

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

(tibolone)
This medicine is available as any of the above names but will be
referred to as Livial throughout this 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

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











2. What you need to know before you take Livial

Some women should not take
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.

3. How to take Livial



4. Possible side effects




5. How to store 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.

6. Contents of the pack and other information

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.

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

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 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

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.

Medical History and regular check-ups

2.4
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.

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

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 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
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).

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
carbamazepine)
• 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

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
monohydrate

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

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.
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.

Livial with food and drink

You can eat or drink normally while you are taking Livial.

2.10

If you are changing over from another type of HRT

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 note
below)…

If you have never used HRT
before
Start taking Livial straight
away
If you were prescribed HRT
because you have had a
hysterectomy…

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

→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

5. How to store Livial
Keep 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.
Do not store above 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.
If your medicine become discoloured or show signs of any
deterioration, consult your doctor or pharmacist who will tell you what
to do.

6. Contents of the pack and other
information

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.

What Livial contains
The active substance is tibolone. Each tablet contains 2.5 mg of
tibolone.

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

PL: 15814/1219

→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

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)…

4. Possible side effects

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.

Rare (may affect 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

The other ingredients are potato starch, magnesium stearate,
ascorbyl palmitate and lactose monohydrate.
What Livial looks like and the contents of the pack
Livial are white, round and flat tablets with beveled edges and coded
“MK” above “2” on one side and “Organon*” on the other side.
They are available in blister packs of 30 tablets.
POM

Livial is manufactured by N.V. Organon, Oss, The Netherlands.
Procured from within the EU and repackaged by the Product Licence
holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts
WD24 4PR.
Leaflet revision and issue date (Ref.): 18.04.2016.

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.
Livial is a trade mark of Merck Sharp & Dohme B.V.
To request a copy of this leaflet in Braille, large print or audio please
call 01923 332 796.

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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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