Active substance: TIBOLONE

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Package leaflet: Information for the user

2.5 mg

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.

In this leaflet:

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
• 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
• 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.

1. What Livial does

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.

2. Make sure Livial is OK for you

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.

3. Taking Livial
4. Possible side effects
5. How to store Livial
6. Further Information

1. What Livial does
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 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
• 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.
Regular check-ups
Once you have started on Livial, you should see your doctor for regular check-ups (at
least once a year). At these check-ups, discuss with your doctor the benefits and risks of
continuing with Livial.
Go for regular breast screening, as recommended by your doctor.
Be sure to
• go for regular breast screening and cervical smear tests
• regularly check your breasts for any changes such as dimpling of the skin, changes in
the nipple, or any lumps you can see or feel


  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


  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
• 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.


  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.
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:
• 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.
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
With use of Livial, the increased risk of ovarian cancer is similar to other types of HRT.


  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”.
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.
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.

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
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).


  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.


  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.


  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.


  Taking Livial with Food and Drink

You can eat or drink normally while you are taking Livial.
now turn over ➤



  Pregnancy and Breast-Feeding

Livial is for use in postmenopausal women only. If you become pregnant, stop taking Livial
and contact your doctor.


  Driving and Using Machines

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


  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


Wait before taking Livial
(see Section 2.1)…

If you are changing over from a period free
HRT… (see note below)…
Start taking Livial straight

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 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).


  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.
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.


  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.


  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.


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’)

  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

  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)


If you have never used HRT before
If you were prescribed HRT because you have
had a hysterectomy…

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.


can you start taking Livial?

If it is not yet 12 months since your last
natural period…

4. Possible side effects

  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
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”
− painful reddish skin nodules (erythema nodosum)
− rash with target-shaped reddening or sores (erythema multiforme)

5. How to store Livial
Keep your tablets where children cannot see or reach them.
Do not use after the ‘use by’ date on the pack. The expiry date refers to the last day of that
Keep your tablets in the blister strip in the pack, in a dry place, away from the light, below
25°C, but not in the fridge.

6. Further information
What Livial contains
Each tablet contains 2.5 milligrams of tibolone.
Each tablet also contains the inactive ingredients, potato starch, lactose, 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,


Organon (Ireland) Ltd
Drynam Road, Swords,
Co. Dublin, Ireland

This leaflet was revised in July 2013.

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
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.

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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.