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 oestrogens, 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 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
migraine or severe headaches
a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
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.
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.
Taking oestrogen, oestrogen-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 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
Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are no obvious signs of the disease.
Effects of HRT on heart or circulation
Heart disease (heart attack)
Livial is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be taking Livial.
Studies with one type of HRT (containing conjugated oestrogen plus the progestogen medroxyprogesterone acetate) have shown that women may be slightly more likely to get heart disease during the first year of taking medication. For other types of HRT including Livial; the risk may be similar, although this is not yet certain.
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.
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.
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)
Oestrogen and oestrogen-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 oestrogens
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”.
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.
Tell your doctor if you become pregnant or are breast-feeding.
Livial is for use in postmenopausal women only. If you are pregnant or breast-feeding or think you may be pregnant, do not take Livial.
Tell your doctor if you react badly to lactose or milk before you start taking Livial.
Livial tablets contain lactose.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you get without a prescription, herbal medicines or other natural products from your pharmacy, supermarket or health food shop.
Some medicines may interfere with the effect of Livial.
This applies to the following medicines:
medicines against blood clotting (such as warfarin)
medicines for epilepsy (such as phenobarbitone, phenytoin and carbamazepine)
medicines for tuberculosis (such as rifampicin)
herbal remedies containing St John’s Wort (hypericum perforatum)
Your doctor may need to adjust the dose of these medicines.
Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Livial.
The following diseases are reported more often in women using HRT compared to women not using HRT:
abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
blood clots in the veins of the legs or lungs (venous thromboembolism)
probable memory loss if HRT is started over the age of 65
Livial helps most women with menopausal symptoms, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Common side effects observed in clinical studies (occurring in 1-10% of the women using Livial) were:
vaginal bleeding or spotting
unnatural hair growth
vaginal symptoms, such as discharge, itching, and irritation
Uncommon side effects (occurring in 0.1-1% of the women using Livial) were:
Other side effects observed with Livial in market use were:
dizziness, headache, migraine, depression
rash or itching
joint pain, muscle pain
changes in liver function
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 vaginal bleeding or spotting occurs or if any of the above mentioned side effects worry you or continue.
Please see “Medical history and regular check-ups” for conditions where Livial should be stopped.
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)
Tell your doctor or pharmacist if you notice any side effects not mentioned in this leaflet.