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 progestogen.
- 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.
When can you start taking Livial?
Wait before taking Livial (see Section 2.1)
- If it is not yet 12 months since your last natural period
Start taking Livial straight away
- If you are changing over from a period free HRT… (see note below)…
- If you have never used HRT before
- If you were prescribed HRT because you have had ahysterectomy…
- If you are being treated for endometriosis (a condition in which parts of the womb lining move around the body)…
Wait for your next period. Start taking Livial as soon as your period ends
- If you are changing over from another type of HRT with which you have periods… (see the note below)…
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.
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.
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.
Each tablet contains 2.5 milligrams of tibolone.
Each tablet also contains the inactive ingredients, potato starch, lactose, ascorbyl palmitate and magnesium stearate.
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
- 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 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)
4.2 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
- painful nipples or breasts feeling uncomfortable
- vaginal infections
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.
Once you have started on Livial, you should see your doctor forregular 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
2.1 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 orangina
- 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 More about Livial)
- If you are pregnant or think you might be pregnant.
- If you are breastfeeding.
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.
If you have started the menopause you should not take Livial until12 months after your last natural period. If you take it sooner than this you may have irregular bleeding.
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
- 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
2.3 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)".
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.
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)
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.
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.
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 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.
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".
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.
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
- 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
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 be24 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.
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.
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.
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