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Livial tablets contain the active ingredient tibolone, which is a synthetic steroid medicine used for hormone replacement therapy (HRT). It mimics the activity of the female sex hormones in the body.
Livial contains tibolone, a substance that has favourable effects on different tissues in the body, such as brain, vagina and bone. Livial is used in postmenopausal women at least 12 months since their last natural period.
Livial is used for:
Relief of symptoms occurring after menopause
During the menopause, the amount of estrogen 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 Livial 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 take Livial to prevent osteoporosis after menopause.
Livial is not a contraceptive.
Livial has no effect on alertness and concentration as far as is known.
A doctor's prescription is required to obtain this medicine.
Before you use Livial
When you must not take it
Do not take Livial if:
you are pregnant or think you may be pregnant
you are breastfeeding
you have or have ever had breast cancer, or if you are suspected of having it
you have cancer which is sensitive to estrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it
you have any unexplained vaginal bleeding
you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated
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)
you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
you have or have ever had liver disease and your liver function tests have not returned to normal
you have a rare blood problem called porphyria which is passed down in families (inherited)
you are allergic (hypersensitive) to tibolone or any of the ingredients of Livial listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or troubled breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
If any of the above conditions appear for the first time while taking Livial, stop taking it at once and consult your doctor immediately.
Medical history and regular check-ups
As well as benefits, HRT or Livial has some risks which need to be considered when deciding whether to starting taking it, or whether to carry on taking it.
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 (or restart) HRT or Livial, your doctor will ask you 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.
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.
When to take special care with Livial
Tell your doctor if you have ever had any of the following conditions 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 estrogen-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
Tell your doctor if you notice any change in your condition whilst using Livial.
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)"
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 and studies 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 with the duration of use.
Irregular bleeding
You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of taking Livial.
However, if the irregular bleeding:
carries on for more than the first 6 months
starts after you have been taking Livial for more than 6 months
carries on after you have stopped taking Livial
see your doctor as soon as possible.
Breast cancer
Taking estrogen, estrogen-progesterone combined HRT or Livial for several years slightly increases the risk of breast cancer. The risk increases with the duration of HRT use and returns to normal within about 5 years after stopping HRT.
Women taking Livial have a lower risk than women using combined HRT and a comparable risk with estrogen-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
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 case).
With use of Livial, the increased risk of ovarian cancer is similar to other types of HRT.
Effects of HRT on heart or circulation
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 estrogen-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 estrogen-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.
See a doctor as soon as possible and do not take any more Livial if you get a pain in your chest that spreads to your arm or neck.
This pain could be a sign of heart disease.
Stroke
Recent research suggests that HRT and Livial increases the risk of having a stroke. This increased risk has mainly been observed in elderly postmenopausal women above 60 years of age.
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).
If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take Livial.
See a doctor as soon as possible and do not take any more Livial until your doctor says you can if you get any unexplained migraine-type headaches with or without disturbed vision.
These headaches may be an early warning sign of a stroke.
Blood clots in a vein (Thrombosis)
Estrogen and estrogen-progestogen combined HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the 1st year of taking it. It is unknown if Livial increases the risk in the same way.
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 estrogens
you are unable to walk for a long time because of major surgery, injury or illness (see also "If you need to have surgery")
you are seriously overweight (BMI greater than 30kg per square metre)
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, a disease of your immune system)
you have cancer
If any of these apply to you, talk to your doctor about whether you should use Livial.
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 estrogen-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.
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