TIBOLONE 2.5 MG TABLETS

Active substance: TIBOLONE

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PATIENT INFORMATION LEAFLET

2515
01.10.13[4]

Livial® 2.5 mg Tablets
(tibolone)
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions or need more advice, ask your doctor,
family planning nurse or pharmacist
 This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
 If you get any side effects talk to your doctor, family planning nurse or
pharmacist.
This includes any side effects not listed in this leaflet.
Your medicine will be referred to as Livial in this leaflet.
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 2.5 mg tablets
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
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, ‘More about Livial’ you can find more information about Livial
and what it is used for.
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)
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.

 If you are allergic (hypersensitive) to tibolone or any of the other
ingredients of Livial (listed in section 6 More about Livial)
 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 this
medicine, 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 When to take special care with Livial
Tell your doctor if you have ever had any of the following problems,
before you start the treatment, as these may return or become worse
during treatment with 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 HRT or 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.

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.

Regularly check your breasts. See your doctor if you notice any
changes such as:
 Dimpling or sinking of the skin
 Changes in the nipple
 Any lumps you can see or feel

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

Make an appointment to see your doctor as soon as possible

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

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.

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 this medicine
 If you have or have ever had breast cancer, or if you are suspected of
having it
 If you have cancer which is sensitive to oestrogens, such as cancer
of the womb lining (endometrium), or if you are suspected of having it
 If you have any unexplained vaginal bleeding
 If you have excessive thickening of the womb lining (endometrial
hyperplasia) that is not being treated.
 If you have or have ever had a blood clot in a vein (thrombosis), such
as in the legs (deep venous thrombosis) or the lungs (pulmonary
embolism)
 If you have a blood clotting disorder (such as protein C, protein S, or
antithrombin deficiency)
 If you have or recently have had a disease caused by blood clots in the
arteries, such as a heart attack, stroke or angina
 If you have or have ever had a liver disease and your liver function
tests have not returned to normal
 If you have a rare blood problem called “porphyria” which is passed
down in families (inherited)

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 nonusers, 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.
2.7 Using other medicines
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).
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines including medicines obtained without a
prescription, herbal medicines or other natural products.
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 Taking 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.
2.11 Driving and Using Machines
Livial has no known effect on the ability to drive or use machines.
2.12 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…
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
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.
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.
The following is a translation of the days of a week on blister
MAN- MON
FRE-FRI
TIRS-TUE
LØR-SAT
ONS-WED
SØN-SUN
TORS-THU
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.
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.
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 (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)
5. How to store Livial
 Keep out of the sight and reach of children.
 Do not use after the ‘Expiry’ date on the pack. The expiry date refers to
the last day of that month.
 Do not store above 25°C. Store in the original package.
 Keep container in outer carton. Protect from light. Protect from
moisture.
 If your tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
 Medicines should not be disposed of via wastewater or household
waste. Ask you pharmacist how to dispose of medicine no longer
required. These measures will help to protect the environment.

6. Further information
What Livial contains
Each tablet contains 2.5 milligrams tibolone.
Each tablet also contains the inactive ingredients, potato starch, lactose
monohydrate, ascorbyl palmitate and magnesium stearate.
What Livial looks like and the contents of the pack
Livial are white, round and flat tablets with beveled edges coded ‘MK’
above ‘2’ on one side and ‘ORGANON*’ on the other side.
They come in packs of one or three strips of 28 tablets.
Manufacturer and Product Licence Holder
Manufactured by N.V. Organon, PO Box 20, 5340 BH Oss, The
Netherlands. Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL No: 20636/2515

Leaflet revision and issue date (Ref.) 01.10.13[4]
Livial is a trademark of Merck Sharp & Dohme B.V.
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.

PATIENT INFORMATION LEAFLET

2515
01.10.13[4]

Tibolone 2.5 mg Tablets
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 or need more advice, ask your doctor,
family planning nurse or pharmacist
 This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
 If you get any side effects talk to your doctor, family planning nurse or
pharmacist.
This includes any side effects not listed in this leaflet.
Your medicine will be referred to as Tibolone in this leaflet.
In this leaflet:
1. What Tibolone does
2. Make sure Tibolone is OK for you
3. Taking Tibolone
4. Possible side effects
5. How to store Tibolone
6. Further Information
1. What Tibolone does
Tibolone 2.5 mg Tablets
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
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”). Tibolone 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 Tibolone 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.
 Tibolone, which contains a substance called tibolone
Tibolone 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, ‘More about Tibolone’ you can find more information about
Tibolone and what it is used for.
2. Make sure Tibolone is OK for you
For information on when you can start taking Tibolone, (including after a
hysterectomy) see Section 3.1 (overleaf)
Medical History and regular check-ups
The use of HRT or Tibolone 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 Tibolone may be different. Please talk to your
doctor.
Before you start taking or restart HRT or Tibolone
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 Tibolone, 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 Tibolone.
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 Tibolone
Do not take Tibolone
If any of the following applies to you. If you are not sure about any of the
points below, talk to your doctor before taking this medicine
 If you have or have ever had breast cancer, or if you are suspected of
having it
 If you have cancer which is sensitive to oestrogens, such as cancer
of the womb lining (endometrium), or if you are suspected of having it
 If you have any unexplained vaginal bleeding
 If you have excessive thickening of the womb lining (endometrial
hyperplasia) that is not being treated.
 If you have or have ever had a blood clot in a vein (thrombosis), such
as in the legs (deep venous thrombosis) or the lungs (pulmonary
embolism)
 If you have a blood clotting disorder (such as protein C, protein S, or
antithrombin deficiency)
 If you have or recently have had a disease caused by blood clots in the
arteries, such as a heart attack, stroke or angina
 If you have or have ever had a liver disease and your liver function
tests have not returned to normal
 If you have a rare blood problem called “porphyria” which is passed
down in families (inherited)
 If you are allergic (hypersensitive) to tibolone or any of the other
ingredients of Tibolone (listed in section 6 More about Tibolone)

 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 this
medicine, stop taking it at once and consult your doctor immediately.
If you have started the menopause you should not take Tibolone until 12
months after your last natural period. If you take it sooner than this you
may have irregular bleeding.
2.2 When to take special care with Tibolone
Tell your doctor if you have ever had any of the following problems,
before you start the treatment, as these may return or become worse
during treatment with Tibolone. 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 Tibolone and see a doctor immediately
If you notice any of the following when taking HRT or Tibolone:
 any of the conditions mentioned in the "Do not take Tibolone" 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: Tibolone 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 Tibolone. 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 Tibolone. But if the bleeding or
spotting:
 Carries on for more than the first 6 months
 Starts after you have been taking Tibolone for more than 6 months
 Carries on even after you’ve stopped taking Tibolone
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 Tibolone have a lower risk than women using
combined HRT and a comparable risk with oestrogen-only HRT.
Regularly check your breasts. See your doctor if you notice any
changes such as:
 Dimpling or sinking of the skin
 Changes in the nipple
 Any lumps you can see or feel
Make an appointment to see your doctor as soon as possible
Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has
been reported in women taking HRT for at least 5 to 10 years.
Compare
For women aged 50 to 69 who are not taking HRT, on average about 2
women in 1000 will be diagnosed with ovarian cancer over a 5-year
period. For women who have been taking
HRT for 5 years, there will be between 2 and 3 cases per 1000 users
(i.e. up to 1 extra case).
With use of Tibolone, 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 nonusers, 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 Tibolone 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 Tibolone, 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 Tibolone 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
Tibolone is different to the risk of other HRT.
Stroke
Recent research suggests that HRT and Tibolone 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 Tibolone – 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 Tibolone, the figure would be
7 in 1000 (i.e. an extra 4 cases).
Looking at women in their 60s who are not taking Tibolone – on
average, over a 5-year period, 11 in 1000 would be expected to
have a stroke.
For women in their 60s who are taking Tibolone, the figure would be
24 in 1000 (i.e. an extra 13 cases).
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.
2.7 Using other medicines
Some medicines may interfere with the effect of Tibolone. 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).
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines including medicines obtained without a
prescription, herbal medicines or other natural products.
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 Taking Tibolone with Food and Drink
You can eat or drink normally while you are taking Tibolone.
2.10 Pregnancy and Breast-Feeding
Tibolone is for use in postmenopausal women only. If you become
pregnant, stop taking Tibolone and contact your doctor.
2.11 Driving and Using Machines
Tibolone has no known effect on the ability to drive or use machines.
2.12 Tibolone contains Lactose
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before using Tibolone.
If you are worried about anything in this section, talk to your doctor about
the risks and benefits of HRT.
3. Taking Tibolone
3.1 When can you start taking Tibolone?
If it is not yet 12 months since your
Wait before taking
last natural period…
Tibolone
(see Section 2.1)…
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
Start taking Tibolone
you have had a hysterectomy…
straight away
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
Wait for your next
type of HRT with which you have
period. Start taking
periods… (see the note below)…
Tibolone 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 Tibolone
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 Tibolone 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.
The following is a translation of the days of a week on blister
MAN- MON
FRE-FRI
TIRS-TUE
LØR-SAT
ONS-WED
SØN-SUN
TORS-THU
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 Tibolone 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 Tibolone
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
Tibolone. You may need to stop taking Tibolone 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 Tibolone 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, Tibolone may have 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 Tibolone. (see also section 2.3,
‘Stop taking Tibolone 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 Tibolone:
 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 Tibolone)
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 Tibolone 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 Tibolone.
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)
5. How to store Tibolone
 Keep out of the sight and reach of children.
 Do not use after the ‘Expiry’ date on the pack. The expiry date refers to
the last day of that month.
 Do not store above 25°C. Store in the original package.
 Keep container in outer carton. Protect from light. Protect from
moisture.
 If your tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
 Medicines should not be disposed of via wastewater or household
waste. Ask you pharmacist how to dispose of medicine no longer
required. These measures will help to protect the environment.

6. Further information
What Tibolone contains
Each tablet contains 2.5 milligrams tibolone.
Each tablet also contains the inactive ingredients, potato starch, lactose
monohydrate, ascorbyl palmitate and magnesium stearate.
What Tibolone looks like and the contents of the pack
Tibolone are white, round and flat tablets with beveled edges coded ‘MK’
above ‘2’ on one side and ‘ORGANON*’ on the other side.
They come in packs of one or three strips of 28 tablets.
Manufacturer and Product Licence Holder
Manufactured by N.V. Organon, PO Box 20, 5340 BH Oss, The
Netherlands. Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL No: 20636/2515

Leaflet revision and issue date (Ref.) 01.10.13[4]

More about Tibolone
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.
Tibolone 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.
Tibolone can also stop the process of bone loss that occurs in your spine,
hip and wrists after the menopause. Unlike some hormone replacement
therapies, Tibolone does not stimulate the lining of the womb. So
treatment with Tibolone does not cause monthly vaginal bleeding.

Expand view ⇕

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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