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LIVIAL TABLETS 2.5MG

Active substance: TIBOLONE

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Package leaflet: Information for the user

2.1



Some women should not take Livial

Ovarian cancer

Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in
Do not take Livial
women taking HRT for at least 5 to 10 years.
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
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1. What Livial is and what it is used for

• If you have or have ever had breast cancer, or if you are suspected of having it
• If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining
(endometrium), or if you are suspected of having it
• If you have any unexplained vaginal bleeding
• If you have excessive thickening of the womb lining (endometrial hyperplasia) that is not
being treated.
• If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep
venous thrombosis) or the lungs (pulmonary embolism)
• If you have a blood clotting disorder (such as protein C, protein S, or antithrombin
deficiency)
• If you have or recently have had a disease caused by blood clots in the arteries, such as a
heart attack, stroke or angina
• If you have or have ever had a liver disease and your liver function tests have not returned
to normal
• If you have a rare blood problem called “porphyria” which is passed down in families
(inherited)
• If you are allergic (hypersensitive) to tibolone or any of the other ingredients of Livial (listed
in section 6 Contents of the pack and other information)
• If you are pregnant or think you might be pregnant.
• If you are breastfeeding.

2. What you need to know before you take Livial

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

3. How to take Livial

If you have started the menopause you should not take Livial until 12 months after your last
natural period. If you take it sooner than this you may have irregular bleeding.

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.

In this leaflet:

4. Possible side effects
5. How to store Livial

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
Livial 2.5 mg tablet
grandmother who has had breast cancer)
The active substance is: tibolone.
• high blood pressure
• a liver disorder, such as a benign liver tumour
This medicine is a Hormone Replacement Therapy (HRT). It contains tibolone, a
• diabetes
substance that has favourable effects on different tissues in the body, such as brain,
• gallstones
vagina and bone. This medicine is used in postmenopausal women with at least
• migraine or severe headaches
12 months (1 year) since their last natural period.
• a disease of the immune system that affects many organs of the body (systemic lupus
This medicine is used for:
erythematosus, SLE)
• epilepsy
Relief of symptoms occurring after menopause
• asthma
During the menopause, the amount of the oestrogen produced by a woman’s body
• a disease affecting the eardrum and hearing (otosclerosis)
drops. This can cause symptoms such as hot face, neck and chest (“hot flushes”). Livial • a very high level of fat in your blood (triglycerides)
alleviates these symptoms after menopause. You will only be prescribed this medicine
• fluid retention due to cardiac or kidney problems
if your symptoms seriously hinder your daily life.

6. Contents of the pack and other information

1. What Livial is and what it is used for

Prevention of osteoporosis
2.3   Stop taking Livial and see a doctor immediately
After the menopause some women may develop fragile bones (osteoporosis). You should
discuss all available options with your doctor.
If you notice any of the following when taking Livial:
If you are at an increased risk of fractures due to osteoporosis and other medicines are
• any of the conditions mentioned in the “Do not take Livial” section
not suitable for you, you can use Livial to prevent osteoporosis after menopause.
• yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver
There are three different kinds of HRT:
disease
• a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
• Oestrogen-only HRT
• migraine-like headaches which happen for the first time
• Combined HRT, containing two kinds of female hormone, an oestrogen and a
• if you become pregnant
progestogen.
• if you notice signs of a blood clot, such as:
• Livial, which contains a substance called tibolone
− painful swelling and redness of the legs
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. − sudden chest pain
− difficulty in breathing
Its effects and benefits are similar to combined HRT.
For more information, see “Blood clots in a vein (thrombosis)”.
In section 6, ‘Contents of the pack and other information’ you can find more information
Note: Livial is not a contraceptive. If it is less than 12 months since your last menstrual period
about Livial and what it is used for.
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. What you need to know before you take Livial
For information on when you can start taking Livial, (including after a hysterectomy)
see Section 3.1 (overleaf)
Medical History and regular check-ups

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)

The use of HRT or Livial carries risks that need to be considered when deciding whether 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
to start taking it, or whether to carry on taking it. This is especially important if you are
the medicine.
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.

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.

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

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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

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

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For women aged 50 to 69 who are not taking HRT, on average about 2 women in
1000 will be diagnosed with ovarian cancer over a 5-year period. For women who
have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users
(i.e. up to 1 extra case).
With use of Livial, the increased risk of ovarian cancer is similar to other types of HRT.

2.5

  Effect of HRT on heart and circulation

Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 1.3 to 3-times higher in HRT users than in
non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain,
breathlessness, fainting or even death.

You are more likely to get a blood clot in your veins as you get older and if any of the
following applies to you. Inform your doctor if any of these situations apply to you:
• you are pregnant or recently had a baby
• you use oestrogens
• you are unable to walk for a long time because of major surgery, injury or illness
(see also section 3, If you need to have surgery)
• you are seriously overweight (BMI >30 kg/m2)
• you have any blood clotting problem that needs long-term treatment with a medicine
used to prevent blood clots
• if any of your close relatives has ever had a blood clot in the leg, lung or another organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.
For signs of a blood clot, see “Stop taking Livial and see a doctor immediately”.
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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
oestrogen-progestogen HRT is very low in healthy women close to menopause, but will
rise with more advanced age.
There is no evidence to suggest that the risk of myocardial infarction with Livial is
different to the risk of other HRT.

Stroke
Recent research suggests that HRT and Livial slightly increases the risk of having a stroke.
The increased risk is seen mainly in women over 60 years old. Other things that can
increase the risk of stroke include:
• Getting older
• High blood pressure
• Smoking
• Drinking too much alcohol
• An irregular heartbeat
If you are worried about any of these things, talk to your doctor to see if you should take HRT
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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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take this medicine.
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-hormonebinding globulin (SHBG), whereas the levels of corticoid binding globulin (CBG) and
circulating cortisol are unaffected.

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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.

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

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
2.11

  Serious side effects – see a doctor straight away

  Other side effects

  Driving and Using Machines

Common (affect up to 1 in 10 women):
• breast pain
Livial has no known effect on the ability to drive or use machines.
• stomach or pelvic pain
• unusual hair growth
• vaginal bleeding or spotting.
2.12   Livial contains Lactose
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.
If you have been told by your doctor that you have an intolerance to some sugars, contact • vaginal problems such as more secretions, itching, irritation and thrush
your doctor before using Livial.
• thickening of the lining of the womb or the lining of the cervix
If you are worried about anything in this section, talk to your doctor about the risks and
• weight gain.
benefits of HRT.
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
3.1   When can you start taking Livial?
Rare (affects up to 1 in 1000 women):
• itchy skin
If it is not yet 12 months since your last
Wait before taking Livial
Some women taking Livial have also reported:
natural period…
(see Section 2.1)…
• depression, dizziness, headache
If you are changing over from a period free
• joint pain or muscle pain
HRT… (see note below)…
• skin problems such as rash or itching
If you have never used HRT before
• loss of vision or blurred vision
If you were prescribed HRT because you have
• changes in liver tests
Start taking Livial straight away
had a hysterectomy…
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.
If you are being treated for endometriosis
(a condition in which parts of the womb lining
Tell your doctor if any of the above mentioned side effects continues or becomes
move around the body)…
troublesome.
If you are changing over from another type of
Wait for your next period. Start
The following side effects have been reported with other HRTs:
HRT with which you have periods…
taking Livial as soon as your period
• gall bladder disease
(see the note below)…
ends
• various skin disorders:
− discolouration of the skin especially of the face or neck known as “pregnancy patches”
If you are changing over from another type of HRT
(chloasma)
− painful reddish skin nodules (erythema nodosum)
There are several different types of HRT, such as tablets patches and gels. Most contain
− rash with target-shaped reddening or sores (erythema multiforme)
either oestrogen, or oestrogen and progestogen. With some you still have periods, and
with some you don’t (these are called period-free HRT).
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).
3.2   How to take Livial
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
The recommended dose is one tablet every day. Take this dose unless your doctor or
Malta: ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3, Rue
pharmacist told you to do something different.
˙
D’Argens, GZR-1368 Gz
˙ira, Website: www.medicinesauthority.gov.mt,
Press the tablet so that it comes through the foil. Swallow the tablet with some water or e-mail: postlicensing.medicinesauthority@gov.mt
other drink, without chewing. Take Livial at the same time each day.

3. How to take Livial

5. How to store Livial

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 Keep your tablets where children cannot see or reach them.
the next day. Do not leave a break between strips or packs.
Do not use after the ‘use by’ date on the pack. The expiry date refers to the last day of that
month.
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. 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.

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.

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6. Contents of the pack and other 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
Netherlands
This leaflet was revised in October 2014.

More about Livial
The most important natural sex hormones in women are oestrogens and progesterone.
These hormones are produced in the ovaries. They are needed for normal sexual
development and control the menstrual cycle.
The menopause is the time (usually around the age of 50) when the ovaries gradually
stop producing oestrogens. If the ovaries are removed surgically before the
menopause, the decrease in hormone production occurs very quickly. The decrease in
hormone production often leads to symptoms such as hot flushes and night sweats.
The shortage of sex hormones may also cause the lining of the vagina to become thin
and dry. So sexual intercourse may be painful and vaginal infections may occur more
frequently. Some women also experience mood changes, nervousness, depression,
irritability and loss of sexual desire.
Oestrogens are also important for bone formation. Bone is built up during youth, and
peak bone mass is reached between the age of 20 and 30. After that, bone mass
decreases, at first slowly, but later in life more quickly, especially after the menopause.
Gradually, the bones become brittle and may easily break (osteoporosis), especially in
your spine, hip and wrists. Osteoporosis may also cause back pain, loss of height and
a curved back.
Livial contains tibolone, a substance that has beneficial effects on different tissues in the
body, such as the brain, vagina and bone. This results in the relief of symptoms such as hot
flushes and night sweats, and an improvement in the lining of the vagina, mood and sexual
desire. Livial can also stop the process of bone loss that occurs in your spine, hip and
wrists after the menopause. Unlike some hormone replacement therapies, Livial does not
stimulate the lining of the womb. So treatment with Livial does not cause monthly vaginal
bleeding.

To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge: 0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Livial 2.5mg tablets
Reference number: PL 00025/0599
This is a service provided by the Royal National Institute for Blind People.

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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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