LIVIAL 2.5 мг Таблетка

Содержание инструкции

1. LIVIAL 2,5 mg tablets
   1. What is Livial and what is it used for
   2. What you need to know before taking Livial
   3. How to take Livial
   4. Possible side effects
   5. How to store Livial
   6. Contents of the pack and other information

LIVIAL 2,5 mg tablets

Tibolone

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Livial is and what it is used for
• 2. What you need to know before you take Livial
• 3. How to take Livial
• 4. Possible side effects
• 5. How to store Livial
• 6. Contents of the pack and other information

1. What is Livial and what is it used for

Livial is a Hormone Replacement Therapy (HRT). Livial contains the active ingredient tibolone, which
belongs to a group of medicines with estrogenic activity. Livial is indicated in women, in
postmenopause, i.e. after at least 12 months from their last natural menstruation, in the following
cases:

• Relief of symptoms that appear after menopause During menopause, the amount of hormones (estrogens) produced by the woman's body decreases. The reduction in the amount of hormones can cause symptoms such as a feeling of heat on the face, neck and chest (hot flushes), night sweats, dryness and fragility of the vaginal mucosa and disorders of the genitourinary system. Livial relieves these symptoms after menopause. Livial will only be prescribed by your doctor if the symptoms seriously interfere with your normal daily activities.
• Prevention of osteoporosis After menopause, some women may develop fragile bones with a consequent risk of fractures (osteoporosis). The doctor, after evaluating whether you have an increased risk of fractures due to osteoporosis and if other medicines are not suitable for you, may prescribe Livial to prevent osteoporosis after menopause.

2. What you need to know before taking Livial

Before starting therapy with Livialyour doctor will inform you about the benefits and possible risks following treatment with Livial. Both before and during therapy, your doctor will assess whether Livial is suitable for you. Based on your overall state of health, your doctor will decide the type and frequency of checks to be performed. If you have a close relative (mother, sister, grandmother) who has suffered from diseases caused by blood clots (venous thrombosis) or breast cancer, you may be subject to greater risks. For this reason, inform your doctor about all serious illnesses in your family history, and if you notice any changes in your breasts.
Similarly, inform your doctor if you have premature menopause.

Do not take Livial
If you have any of the following conditions. If you are unsure about any of the points below talk to your doctorbefore taking Livial.

• If you are allergic to tibolone or any of the other ingredients of this medicine (listed in section 6).
• If you have or have had breast cancer, or if it is suspected.
• If you have a cancer that is sensitive to female hormones (estrogens) such as, for example, cancer of the uterine lining (endometrium) or if it is suspected.
• If you have any unusual vaginal bleeding.
• If you have excessive thickening of the uterine lining (endometrial hyperplasia) that is not treated.
• If you have or have had a blood clot in a vein (thrombosis), for example in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
• If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency).
• If you have or have recently had a disease caused by blood clots in the arteries, such as a heart attack (angina, myocardial infarction), a stroke.
• If you have or have had a liver disease and liver function values have not returned to normal.
• If you have a rare blood disorder called “porphyria”, a hereditary (familial) disease.
• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.

If any of the above conditions occur for the first time while you are taking Livial, stop taking it and consult your doctor immediately.

Warnings and precautions
Talk to your doctor or pharmacist before taking Livial.
Tell your doctor if you have had any of the following problems, as they may reappear or worsen during treatment with Livial:

• benign tumors inside the uterus (fibroids)
• growth of uterine lining outside the uterus (endometriosis) or a history of abnormal growth of the uterine lining (endometrial hyperplasia)
• risk factors for developing blood clots (see “Blood clots in a vein (thrombosis)”)
• increased risk of developing a cancer sensitive to estrogens (such as having a mother, sister or grandmother who has had breast cancer)
• high blood pressure (hypertension)
• a liver problem, such as a benign liver tumor
• high blood sugar (diabetes)
• gallstones
• migraine or severe headaches
• an autoimmune disease that affects many organs of the body (systemic lupus erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and impairing hearing (otosclerosis)
• a very high level of fats in the blood (hypertriglyceridemia)
• fluid retention caused by heart or kidney problems. For those who engage in sports: the use of the drug without therapeutic need constitutes doping and may still result in positive doping tests.

Stop taking Livial and consult your doctor immediately in the following situations:

• the conditions mentioned in the “Do not take Livial” section
• yellowing of the skin and the whites of the eyes (jaundice). These may be signs of a liver disease
• a significant increase in blood pressure (symptoms may include headache, fatigue, dizziness)
• migraine (headache) that occurs for the first time
• pregnancy
• signs of blood clotting, such as:
• painful swelling and redness of the legs
• sudden chest pain
• difficulty breathing.

Hormone Replacement Therapy (HRT) may increase the risk of the following clinical conditions:
Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer)
There have been reports and studies on increased growth of cells or cancer of the endometrium in women who used Livial. The risk of endometrial cancer increases with the duration of use.

Irregular bleeding
During the first 3-6 months of treatment with Livial, irregular bleeding or spotting (breakthrough bleeding) may occur.
However, consult your doctor as soon as possible if irregular bleeding:

• continues beyond the first 6 months of treatment with Livial
• occurs more than 6 months after starting treatment with Livial
• continues after stopping treatment with Livial.

Breast cancer
Evidence shows that taking tibolone increases the risk of breast cancer. The additional risk depends on the duration of tibolone use. In studies with HRT, after stopping HRT, the additional risk decreased over time, but this risk may persist for 10 years or more in case of use of HRT for more than 5 years. Regarding tibolone, there are no data available on the persistence of the risk after its discontinuation, but a similar trend cannot be excluded.
Perform a breast self-examination regularly. Consult your doctor immediately if you notice any changes in your breasts, such as:

• formation of dimples or skin depressions
• changes in the nipple
• masses found by sight or touch.

Comparative data
Women taking Livial have a lower risk of developing breast cancer compared to those taking combined HRT (estrogens and progestogens, two types of hormones) and a comparable risk to women taking estrogen-only HRT.

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer. The use of estrogen-only or estrogen-progestogen therapy has been associated with a slight increase in the risk of ovarian cancer.
The risk of ovarian cancer varies depending on age. For example, in women aged 50 to 54 who do not use HRT, about 2 women out of 2,000 will be diagnosed with ovarian cancer within 5 years. For women who are using HRT for 5 years, there will be about 3 cases per 2,000 women treated (ie, about 1 additional case).
With the use of Livial, the increased risk of ovarian cancer is similar to other types of HRT.

Effects of HRT on the heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is approximately 1.3 – 3 times higher in patients using HRT compared to those who do not, especially during the first year of use.
Blood clots can be serious and if one of them reaches the lungs, it can cause chest pain, shortness of breath, fainting or even death.
There is a greater likelihood of developing blood clots with advancing age and if one of the following conditions exists, which you should inform your doctor about:

• you are pregnant or have recently had a baby
• you are using estrogens
• you are unable to walk for a long time because you have undergone major surgery, an accident or an illness (see also section 3, “If you are to undergo surgery”)
• you are severely overweight (BMI (body mass index) > 30 kg/m)
• you have had any blood clotting problem that has required long-term treatment with a medicine used to prevent clots
• a close relative has had clots in the legs, lungs or other organs
• you suffer from systemic lupus erythematosus (SLE), an autoimmune disease
• you have cancer.

To learn how the formation of clots manifests in your body, see the section “Stop taking Livial and consult your doctor immediately”.

Comparative data
For women aged 50 to 59 who do not use HRT, in a period of 5 years, a clot is expected to form in a vein on average in 4-7 cases per 1,000 users.
For women aged 50 to 59 who use estrogen-progesterone HRT, in a period of 5 years, a clot is expected to form in a vein in 9-12 cases per 1,000 users (ie 5 additional cases). With Livial, the increased risk of blood clot formation in a vein is lower than observed with other types of HRT.

Heart disease (heart attack)
It has not been shown that HRT or Livial prevent heart attack (angina, myocardial infarction).
Women over 60 years of age who use estrogen-progesterone HRT have a slightly higher risk of developing heart disease compared to those who do not use HRT. The risk of heart disease depends strongly on age, therefore, the number of cases of heart disease due to the use of estrogen-progesterone HRT is very low in healthy women close to menopause, but will become higher with increasing age.
At the current state of clinical knowledge, the risk of myocardial infarction associated with the use of Livial is comparable to that associated with other types of HRT.

Stroke
Recent research suggests that HRT and Livial increase the risk of having a stroke. The increase in risk has been mainly observed in older postmenopausal women over 60 years of age.

Comparative data
For women aged 50 to 59 who do not take Livial, over a 5-year period, about 3 cases of stroke per 1,000 are expected, and 7 cases per 1,000 for women in the same age group who take Livial (ie 4 additional cases).
For women aged 60 to 69 who do not take Livial, over a 5-year period, about 11 cases of stroke per 1,000 are expected, and 24 cases per 1,000 for women in the same age group who take Livial (ie 13 additional cases).

Other conditions
HRT does not prevent memory loss. There is some evidence of an increased risk of memory loss in women who start using HRT after age 65.

Other medicines and Livial
Some medicines listed below may interfere with the effect of Livial, causing irregular bleeding:

• medicines against excessive blood clotting (such as warfarin)
• medicines for the treatment of epilepsy (such as phenobarbital, phenytoin and carbamazepine)
• medicines for the treatment of tuberculosis (such as rifampicin)
• herbal preparations containing St. John's Wort (Hypericum perforatum).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Livial with food and drink
Livial can be taken normally with food and drink.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine. Livial is only indicated for postmenopausal women.
Livial is not a contraceptive. If less than 12 months have passed since your last menstrual period or if you are under 50 years of age, you may still need to use a contraceptive method to avoid pregnancy. Ask your doctor for advice.

Driving and using machines
Livial has no known effects on the ability to drive and operate machines.

Livial contains lactose
Livial tablets contain lactose. If you have been diagnosed with lactose intolerance by your doctor, consult him before taking this medicine.

3. How to take Livial

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Livial must be taken orally. The recommended dose is one tablet per day. The
tablets of Livial must be swallowed with water or another beverage. Take the tablet every
day at the same time.
On the tablet container (blister) of Livial are reported the days of the week. Start the
treatment by taking the tablet marked with the day of the week. For example, if it were
Monday, take a tablet marked with Monday on the top line of the blister. Follow the
days of the week until the blister is empty. The next day start a new blister. Do not
leave any empty space in the blister.
Livial should not be taken before twelve months have passed since the last spontaneous
menstruation. If Livial is taken before, the possibility of irregular vaginal bleeding may
increase.
The doctor will prescribe the lowest dose to treat your symptoms for the shortest necessary
period. Consult your doctor if you feel that this dose is too strong or too weak.

If you take more Livial than you should
If you have taken an excessive dose of Livial, contact your doctor or pharmacist immediately.
If more tablets are taken at the same time, there is no major cause for
concern. However, you should report this to your doctor immediately. Signs of overdose may
include feeling unwell or vaginal bleeding.

If you forget to take Livial
If you have forgotten to take a tablet, take it as soon as you remember, unless more than
12 hours have passed since taking the last tablet. If more than 12 hours have passed, do not
take the forgotten tablet and take the next tablet at the usual time.
Do not take a double dose to make up for a missed dose.

If you are to undergo surgery
If you are to undergo surgery, inform the anesthesiologist of your current treatment with
Livial. You may need to stop taking Livial approximately 4-6 weeks before the operation to
reduce the risk of blood clot formation (see paragraph 2, “Blood clots in a vein (thrombosis)”). Ask your doctor when you can resume treatment with Livial.

If you stop taking Livial
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of these side effects are mild.
The following conditions are reported more frequently in women using TOS compared to
women who do not use it:

• breast cancer
• abnormal growth of the uterine lining (endometrial hyperplasia) or cancer of the endometrium
• ovarian cancer
• formation of blood clots in the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• probable memory loss if TOS is started after 65 years of age.

For more information on these side effects, see paragraph 2.
Commonside effects, observed in clinical studies (affect up to 1 in 10 women) are:

• vaginal bleeding or spotting
• abdominal or pelvic pain
• weight gain
• breast pain
• abnormal hair growth
• vaginal symptoms such as discharge, itching, irritation, inflammation (vulvovaginitis), candidiasis infection. Uncommonside effects (affect up to 1 in 100 women) are:
• acne
• nipple pain or breast discomfort
• vaginal infections (vaginal mycoses).

Other side effects observed with Livial in therapeutic use have been:

• dizziness, headache, migraine, depression
• skin rash or itching
• vision disorders
• gastro-intestinal disorders
• fluid retention
• joint pain, muscle pain
• alteration of liver function.

Cases of breast cancer and abnormal cell growth or carcinoma of the uterine lining have been reported in women treated with Livial.
Contact your doctor if you experience vaginal bleeding or spotting or if any of the above
side effects become bothersome or persistent.
The following side effects have been reported with other hormone replacement therapies:

• gallbladder disorders
• various skin disorders:
• skin discoloration (skin), especially of the face or neck, a condition known as “chloasma” (melasma)
• painful red skin nodules (erythema nodosum)
• skin rash with redness in a target shape or ulcerations (erythema multiforme).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the Italian Medicines Agency (Agenzia
Italiana del Farmaco), website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Livial

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C. Do not freeze.
Store in the original package.
Do not use this medicine after the expiry date which is reported on the package, after Exp. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Livial contains

• The active ingredient is: Error. Unknown document property name.2.5 mg.
• The other ingredients are: potato starch, lactose, ascorbyl palmitate and magnesium stearate.

Description of the appearance of Livial and contents of the pack
Livial 2.5 mg tablets are white, round and flat and imprinted with “MK2” on one side and
“Organon*” on the other side. They are available in PVC/Aluminum blisters of 30 tablets. Each
blister is packaged in a carton.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Roma

Manufacturer
N.V. Organon, Kloosterstraat 6, 5349 AB, Oss, Netherlands