2.5 mg tablets
tibolone
What Livial is and what it is used for
Livial is a preparation used for hormonal substitution therapy ( Hormone Replacement Therapy, HRT ). Livial is used for women whose menstruation has stopped ( menopause ), at least 12 months after their last natural menstruation.
Livial is used to:
Relieve symptoms during and after menopause
When menstruation ends ( menopause ), the woman’s estrogen decreases. It can cause problems such as sweating and hot flashes. Livial relieves these symptoms after menopause. Livial should only be used if the problems cause problems in daily life.
Prevent osteoporosis
After menopause, some women suffer from osteoporosis. Discuss all possible options with your doctor.
If you have an increased risk of fractures (bone fractures) and other medicines that are not suitable for you, you can use Livial to prevent osteoporosis after menopause.
What you need to know before taking Livial
Do not use Livial
Medical background and regular check-ups
The use of HRT or Livial involves risks that must be taken into account when deciding to start treatment or continue ongoing treatment.
Experience is limited for the treatment of women whose menstruation has stopped prematurely (when the ovaries have stopped working or the uterus has been removed). If you belong to that group, the risks of HRT or Livial may be different. Talk to your doctor.
Before starting treatment (or resuming treatment) with HRT or Livial, your doctor will ask about your own, and your family’s, medical background. Your doctor may do a general medical and gynecological examination, which also includes the examination of your breasts.
Once you have started treatment, you should go for regular medical check-ups, at least once a year. During these check-ups, you should discuss with your doctor the benefits and risks of continued treatment.
Perform regular examinations of the breasts according to the doctor’s recommendations.
Do not take Livial:
if any of the following apply to you. If you are not sure, talk to your doctor before taking Livial.
Do not take Livial
- if you have or have had breast cancer or there is a suspicion that you may have it.
- if you have estrogen-dependent cancer , such as cancer of the uterine lining (endometrium) or if there is a suspicion of such cancer.
- if you have unexpected genital bleeding that has not been investigated by a doctor.
- if you have endometrial hyperplasia (severe thickening of the uterine lining) and are not being treated for it.
- if you have or have had a blood clot in a vein (venous thromboembolism ), in your legs (deep vein thrombosis ) or in your lungs ( pulmonary embolism ).
- if you have a coagulation disorder , a condition with an increased risk of blood clots (lack of protein C, protein S or antithrombin).
- if you have or have had a disease caused by blood clots in the arteries are as heart attack, stroke (stroke) or angina .
- if you have or have had any liver disease and still have abnormal liver values.
- if you have porphyria , a rare inherited blood disorder.
- if you are allergic to tibolone or any of the other ingredients of this medicine (listed in section 6).
If any of the above affects you the first time you use Livial, stop taking Livial and contact a doctor immediately.
Warnings and cautions
Talk to your doctor if you have or have had any of the following problems before starting treatment. They may recur or worsen during treatment with Livial. Should this occur, have more frequent check-ups with a doctor.
- if you have any disease affecting the lining of the uterus, as well as muscle knots ( fibroids ), endometriosis or have had endometrial hyperplasia (severe thickening of the uterine lining).
- if you have an increased risk of getting a blood clot (see below “Blood clots in a vein ( thrombosis )”)
- if a close relative has had breast cancer or other estrogen-dependent cancer
- high blood pressure
- liver disease eg liver adenoma (benign tumor )
- diabetes
- gallstone disease
- if you get a migraine or severe headache
- if you have systemic lupus erythematosus ( SLE ) – an autoimmune disease that affects many organs in the body
- epilepsy
- asthma
- otosclerosis (ossification of the middle ear leading to hearing loss)
- hypertriglyceridemia (elevated blood lipids)
- fluid retention due to heart or kidney disease.
You should contact your doctor immediately and discontinue treatment if any of the following occur:
- Some of what is mentioned in the section “Do not take Livial”
- If skin or whites of the eyes turn yellow (jaundice); it may be a symptom of liver disease
- If your blood pressure rises sharply (symptoms may include headache, fatigue or dizziness)
- If you are experiencing migraine-like headaches for the first time
- If you become pregnant
- If you get symptoms of a blood clot, such as
- painful swelling and redness of the legs
- sudden chest pain
- breathing difficulties.
For more information, see below “Blood clots in a vein ( thrombosis )”.
Note: Livial is not a contraceptive. If it is less than 12 months since your last period, or if you are under 50, you may still need to use contraception to avoid pregnancy. Consult your doctor.
HRT and cancer
Severe thickening of the uterine lining ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer)
There are reports and studies on an increased risk of uterine cancer in women using Livial. The risk increases with the length of the treatment period.
Irregular bleeding
Irregular spotting or spotting may occur during the first 3-6 months of taking Livial. But about the bleeding:
- lasts longer than 6 months
- begins after taking Livial for 6 months
- continues after you stop taking Livial
you should see a doctor as soon as possible.
Breast cancer
Data show that treatment with tibolone increases the risk of breast cancer. The extra risk depends on how long you use tibolone. Studies of HRT show that when treatment is stopped, the increased risk decreases over time, but it can persist for 10 years or more if you have used HRT for more than 5 years. There are no data on whether there is a residual risk after discontinuation of tibolone, but a similar pattern cannot be ruled out.
Comparison
Women who take Livial have a lower risk than women who use combined HRT and a comparable risk with HRT with estrogen alone.
Check your breasts regularly. Contact a doctor if you notice changes such as:
- indentations or pits
- changes of the nipple
- nodules you can see or feel.
Ovarian cancer
Ovarian cancer is rare – much more rare than breast cancer. Use of HRT with estrogen alone or combined estrogen – progestogens has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. The diagnosis of ovarian cancer will, for example, be made on about 2 women out of 2,000 aged 50 to 54 over 5 years. For women who have taken HRT for 5 years, there will be 3 cases per 2,000 users (ie about 1 extra case).
When using Livial, the increased risk of ovarian cancer is similar to that of other types of HRT.
How HRT affects the heart and blood circulation
Blood clot in a friend ( thrombosis )
The risk of blood clots in the veins is 1.3-3 times higher for women who take HRT than for those who do not, especially during the first year of treatment.
Blood clots can be serious. If a blood clot ends up in the lungs, it can cause chest pain, shortness of breath, collapse or even lead to death.
It is more likely that you get a blood clot in a vein the older you get and if any of the following applies to you. Tell your doctor if any of the following apply to you:
- you use estrogen er
- you have not been able to walk or stand for a long time due to a major operation, injury or illness (see also section 3, “If you need surgery”)
- you are overweight ( BMI over 30 kg / m 2 )
- you have a coagulation disorder that requires long-term treatment with drugs that prevent blood clots
- if a close relative has had a blood clot in the bone, lung or other organ
- you have SLE (systemic lupus erythematosus)
- you have cancer.
The symptoms of a blood clot are described in the section “You should contact a doctor immediately and stop the treatment”.
Comparison
For women in their 50s who do not take HRT, an average of 4-7 out of 1,000 people are expected to have a blood clot in a vein over 5 years.
For women in their 50s who have taken HRT with estrogen-progestogen for more than 5 years, 9-12 out of 1,000 users are expected to get a blood clot in a vein (ie 5 extra cases).
With the use of Livial, the increased risk of blood clots is similar to that of other types of HRT.
Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks.
For women over 60 who take HRT with estrogen-progestogen, the risk of developing heart disease is slightly higher than those who do not take HRT. As the risk of heart disease is strongly age-dependent, the number of extra cases of heart disease due to the use of HRT with estrogen-progestogen is very low in healthy women near menopause but increases with increasing age.
There is no evidence that the risk of myocardial infarction with Livial differs from the risk of other HRT.
Stroke
There is data to suggest that HRT and Livial increase the risk of stroke. This increased risk has mainly been observed in older postmenopausal women over 60 years of age. If you have had a stroke before, discuss with your doctor if the benefits of treatment outweigh a possible increased risk.
Comparison
For women in their 50s who do not take Livial, an average of 3 out of 1,000 people are expected to have a stroke over 5 years.
For women in their 50s who have taken Livial for more than 5 years, 7 out of 1,000 users are expected to have a stroke (ie 4 extra cases).
For women in their 60s who do not take Livial, an average of 11 out of 1,000 people are expected to have a stroke over 5 years. For women in their 60s who have taken Livial, the figure is 24 out of 1,000 users (ie 13 extra cases).
• This relative risk is not dependent on age or the duration of treatment, but as the baseline risk is strongly dependent on age, the overall risk of stroke in women using HRT or tibolone will increase with age (see section 4.4).
• A 2.9-year randomized controlled trial has estimated a 2.2-fold increase in the risk of stroke in women (mean age 68) who used 1.25 mg tibolone (28/2 249) compared with placebo (13 / 2 257). The majority (80%) of these strokes were ischemic.
• The underlying risk of stroke is strongly age-dependent. However, the underlying incidence is estimated over five years to 3 per 1,000 women aged 50-59 years resp. 11 per 1,000 women aged 60-69.
• For women using tibolone for 5 years, the number of additional cases is expected to be approximately 4 per 1,000 users aged 50-59 years and 13 per 1,000 users aged 60-69 years.
Other conditions
Using HRT does not prevent memory loss. The risk of memory loss may be slightly higher in women who start using HRT after the age of 65. Consult your doctor.
Other drugs and Livial
Some medicines can affect the effect of Livial, which can lead to irregular bleeding. The following applies:
- blood-thinning drugs (eg warfarin )
- antiepileptic drugs (eg phenobarbital, phenytoin and carbamazepine)
- drugs against tuberculosis (eg rifampicin)
- drugs against HIV – infection (for example, nevirapine, efavirenz, ritonavir, and nelfinavir)
- herbal medicine containing St. John’s wort ( Hypericum perforatum ).
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal remedies.
Results from blood test analyze
If you need to take a blood sample, tell your doctor, or the person taking the blood sample, that you are taking Livial as it may affect the results of some tests.
Pregnancy and breastfeeding
Livial is intended for women whose menstruation has stopped. If you become pregnant, stop taking Livial and consult a doctor.
Driving and using machines
No effects on the ability to drive and use machines have been observed.
Livial contains lactose monohydrate
Livial tablets contain lactose monohydrates. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Livial
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 1 tablet daily. You should take the tablet at about the same time each day and swallow it with some liquid.
You should take the first tablet on the tablet map on a mark that corresponds to the current day of the week. Then follow the day markings and take one tablet daily until the map is blank.
Your doctor will strive to give you the lowest dose, which will give you relief of symptoms, and to use Livial for the shortest possible time. Talk to your doctor if you do not get any relief from the symptoms, or feel that the dose is too high.
Possible side effects
The following diseases are more common in women who take HRT than those who do not:
- breast cancer
- severe thickening of the uterine lining ( endometrial hyperplasia ) or cancer of the uterine lining (endometrial cancer)
- ovarian cancer ( ovarian cancer )
- blood clots in veins in bones or lungs (venous thromboembolism )
- heart disease
- stroke (stroke)
- probable memory loss, if treatment with HRT is started after the age of 65.
See section 2 for more information on these side effects.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are usually mild to moderate and do not usually mean that women need to stop taking their tablets.
Illegal bleeding (breakthrough bleeding/spotting) may occur during the first months of treatment. You should contact your doctor if the irregular bleeding lasts longer than a few months or if it starts to occur after a period of treatment, or if it continues after the end of treatment, as the cause may need to be investigated further.
Common (≥1 / 100, <1/10): abdominal pain, pelvic pain, weight gain, chest tightness, unnatural hair growth, abdominal problems such as discharge, itching, bleeding, spotting, inflammation, and fungal infection.
Uncommon (≥1 / 1,000, <1/100): fluid retention, gastrointestinal upset, acne, and nipple pain.
Rare (≥1 / 10,000, <1 / 1,000): pruritus
Dizziness, headaches, migraines, depression, skin problems, visual disturbances, joint pain, muscle aches, and altered liver values have also been reported.
There have been reports of breast cancer and an increase in cell growth or cancer of the uterine lining in women using Livial.
The following side effects have been reported for other HRTs:
- gallbladder disease
- various skin diseases:
- dark skin spots, especially on the face and neck, so-called “pregnancy spots” (chloasma)
- painful reddish-purple bumps on the skin (erythema nodosum)
- annular redness or sore rash (erythema multiforme).
If you get any side effects, talk to your doctor. This also applies to any side effects not mentioned in this information.
How to store Livial
Do not store above 25 ° C. Store in the original package. Sensitive to light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is tibolone.
- The other ingredients are potato starch, magnesium stearate, ascorbyl palmitate and lactose monohydrate .
What the medicine looks like and contents of the pack
Livial tablets are white, round, flat, and marked MK 2 on one side and ORGANON * on the other.
Marketing Authorization Holder and Manufacturer
NV Organon
Kloosterstraat 6
5349 AB Oss
Netherlands