LIVIAL TABLETS 2.5MG

Active substance: TIBOLONE

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2.1
Package leaflet: Information for the user

Livialtablets
2.5 mg
®

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:



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)
• If you are allergic (hypersensitive) to tibolone or any of the other ingredients of Livial (listed in
section 6 Further Information )
• 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.

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

Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in
women taking HRT for at least 5 to 10 years.
Compare
For women aged 50 to 69 who are not taking HRT, on average about 2 women in
1000 will be diagnosed with ovarian cancer over a 5-year period. For women who
have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users
(i.e. up to 1 extra case).
With use of Livial, the increased risk of ovarian cancer is similar to other types of HRT.

2.5

  Effect of HRT on heart and circulation

Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 1.3 to 3-times higher in HRT users than in
non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain,
breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older and if any of the
following applies to you. Inform your doctor if any of these situations apply to you:
• you are pregnant or recently had a baby
• you use oestrogens
• you are unable to walk for a long time because of major surgery, injury or illness (see
also section 3, If you need to have surgery)
• you are seriously overweight (BMI >30 kg/m2)
• you have any blood clotting problem that needs long-term treatment with a medicine
used to prevent blood clots
• if any of your close relatives has ever had a blood clot in the leg, lung or another
organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.
For signs of a blood clot, see “Stop taking Livial and see a doctor immediately”.
Compare
Looking at women in their 50s who are not taking HRT, on average, over a 5 year
period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogen-progestogen HRT for over
5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).
With use of Livial, the increased risk of getting a blood clot in a vein is lower than with
other types of HRT.

Heart disease (heart attack)
There is no evidence that HRT or Livial will prevent a heart attack.
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

Prevention of osteoporosis
If you notice any of the following when taking HRT or Livial:
After the menopause some women may develop fragile bones (osteoporosis). You
• any of the conditions mentioned in the “Do not take Livial” section
should discuss all available options with your doctor.
• yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver
If you are at an increased risk of fractures due to osteoporosis and other medicines are
disease
not suitable for you, you can use Livial to prevent osteoporosis after menopause.
• a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
• migraine-like headaches which happen for the first time
There are three different kinds of HRT:
• if you become pregnant
If you are worried about any of these things, talk to your doctor to see if you should
• Oestrogen-only HRT
• if you notice signs of a blood clot, such as:
take HRT
• Combined HRT, containing two kinds of female hormone, an oestrogen and a
− painful swelling and redness of the legs
progestogen.
Compare
− sudden chest pain
• Livial, which contains a substance called tibolone
− difficulty in breathing
Livial is different from other HRT. Instead of actual hormones (such as oestrogen and
Looking at women in their 50s who are not taking Livial – on average, over a 5-year
For more information, see “Blood clots in a vein (thrombosis)”.
progestogen) it contains tibolone. Your body breaks down tibolone to make hormones.
period, 3 in 1000 would be expected to have a stroke.
Its effects and benefits are similar to combined HRT.
Note: Livial is not a contraceptive. If it is less than 12 months since your last menstrual period For women in their 50s who are taking Livial, the figure would be 7 in 1000
(i.e. an extra 4 cases).
or you are under 50 years old, you may still need to use additional contraception to prevent
In section 6, ‘Further information’ you can find more information about Livial and what
Looking at women in their 60s who are not taking Livial – on average, over a 5-year
pregnancy. Speak to your doctor for advice.
it is used for.
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).
2.4   HRT and Cancer

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.

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the
lining of the womb (endometrial cancer)

2.6

  Other conditions

There have been reports of an increased cell growth or cancer of the lining of the womb in
HRT will not prevent memory loss. There is some evidence of a higher risk of memory
women using Livial. The risk of cancer of the lining of the womb increases the longer you take loss in women who start using HRT after the age of 65. Speak to your doctor for advice.
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.

Be sure to
• go for regular breast screening and cervical smear tests
Regularly check your breasts. See your doctor if you notice any changes such as:
• regularly check your breasts for any changes such as dimpling of the skin, changes • Dimpling or sinking of the skin
in the nipple, or any lumps you can see or feel
• Changes in the nipple
• Any lumps you can see or feel

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.

Make an appointment to see your doctor as soon as possible
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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

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 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 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).

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.

  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)

  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:
Press the tablet so that it comes through the foil. Swallow the tablet with some water or • depression, dizziness, headache
• joint pain or muscle pain
other drink, without chewing. Take Livial at the same time each day.
• skin problems such as rash or itching
The strips of tablets are marked with the days of the week. Start by taking a tablet
• loss of vision or blurred vision
marked with the current day. For example, if it is Monday, take a tablet marked Monday • changes in liver tests
on the top row of the strip. Follow the arrows until the strip is empty. Start the next strip There have been reports of breast cancer and of an increased cell growth or cancer of the
the next day. Do not leave a break between strips or packs.
lining of the womb in women using Livial.
Your doctor will aim to prescribe the lowest dose to treat your symptoms for as short
Tell your doctor if any of the above mentioned side effects continues or becomes
as necessary. Speak to your doctor if you think this dose is too strong or not strong
troublesome.
enough.
The following side effects have been reported with other HRTs:
• gall bladder disease
• various skin disorders:
3.3   If you take more Livial than you should
− discolouration of the skin especially of the face or neck known as “pregnancy patches”
(chloasma)
It is unlikely that taking more than one tablet will do you any harm, but you may feel
− painful reddish skin nodules (erythema nodosum)
sick, be sick or have some vaginal bleeding.
− rash with target-shaped reddening or sores (erythema multiforme)

3.4

  If you forget to take Livial

5. How to store 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
Keep your tablets where children cannot see or reach them.
at the usual time. Don’t take a double dose.
Do not use after the ‘use by’ date on the pack. The expiry date refers to the last day of that
month.

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. 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:
Like all medicines, Livial may have side effects, although not everybody gets them. Most side Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
effects are mild.
The manufacturer is:
Tell your doctor or pharmacist if you are worried about any side effects which you think
NV Organon,
may be due to Livial. (see also section 2.3, ‘Stop taking Livial and see a doctor immediately’)
PO Box 20, 5340 BH Oss
Netherlands

4.2

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.

4.1

can you start taking Livial?

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

4. Possible side effects

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.

This leaflet was revised in August 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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