LIVIAL 2.5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Livial
3. 5 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
4. What is Livial and what is it used for
   1. Relief of symptoms occurring after menopause
   2. Prevention of osteoporosis
5. Important information before taking Livial
   1. When not to take Livial:
   2. Medical history and regular check-ups
   3. Warnings and precautions
   4. When to stop taking Livial and consult your doctor immediately
   5. HRT and malignant tumors
   6. Endometrial hyperplasia and endometrial cancer
   7. Irregular bleeding
   8. Breast cancer
   9. Ovarian cancer
   10. Effect on the heart and blood vessels
   11. Venous thromboembolism
   12. Heart disease (heart attack)
   13. Stroke
   14. Other diseases
   15. Livial with food and drink
   16. Pregnancy and breastfeeding
   17. Driving and using machines
6. How to take Livial
   1. Overdose
   2. Missed dose
   3. Surgery
7. Possible side effects
   1. Reporting side effects
8. How to store Livial
9. Contents of the pack and other information
   1. What Livial contains
   2. What Livial looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet: 07/2021

Package Leaflet: Information for the User

Livial

2.5 mg, tablets

Tibolone

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Livial and what is it used for
• 2. Important information 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

1. What is Livial and what is it used for

Livial is a medicine used in Hormone Replacement Therapy (HRT). Livial contains tibolone, a substance that has a beneficial effect on various tissues and organs in the body, including bones. Livial is used in postmenopausal women, at least 12 months after their last natural menstrual period.

Relief of symptoms occurring after menopause

During the postmenopausal period, the amount of estrogen produced by the body decreases. This can cause symptoms such as hot flashes on the face, neck, and chest. Livial relieves postmenopausal symptoms in women. It is prescribed only when the symptoms are severe enough to disrupt daily life.

Prevention of osteoporosis

After menopause, some women may develop osteoporosis (thinning of the bones). You should discuss all available options with your doctor. In women with an increased risk of fractures due to osteoporosis, and for whom other medicines are not suitable, Livial may be used to prevent postmenopausal osteoporosis.

2. Important information before taking Livial

When not to take Livial:

• if you have any of the following conditions. If you are unsure about any of the following, consult your doctor before taking Livial.

When not to take Livial:

• If you are allergic to tibolone or any of the other ingredients of this medicine (listed in section 6).
• If you currently have, are suspected to have, or have had breast cancer.
• If you have or are suspected to have estrogen-dependent malignant tumors (e.g., cancer of the lining of the uterus - endometrium).
• If you have vaginal bleeding of unknown origin.
• If you have untreated endometrial hyperplasia (a condition where the lining of the uterus grows too much).
• If you currently have or have had venous thromboembolism (e.g., deep vein thrombosis or pulmonary embolism).
• If you have blood clotting disorders (e.g., protein C, protein S, or antithrombin deficiency).
• If you have or have had arterial thromboembolic diseases (e.g., heart attack, stroke, or angina).
• If you have or have had liver disease, and liver function has not returned to normal.
• If you have a rare genetic blood disorder called porphyria.
• 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 taking Livial, stop taking the medicine and consult your doctor immediately.

Medical history and regular check-ups

Besides the benefits, HRT and Livial also carry risks, which need to be considered when deciding whether to start or continue treatment.

Warnings and precautions

Before starting treatment, tell your doctor if you have ever had any of the following conditions, as they may come back or get worse while taking Livial. In this case, you may need to have more frequent check-ups:

• uterine fibroids
• endometriosis or endometrial hyperplasia in the past
• increased risk of venous thromboembolism (see "Venous thromboembolism")
• increased risk of estrogen-dependent tumors (e.g., breast cancer in your mother, sister, or grandmother)
• high blood pressure
• liver disease, such as liver tumors
• diabetes
• gallstones
• migraine or severe headaches
• systemic lupus erythematosus
• epilepsy
• asthma
• otosclerosis (a condition that affects the bones of the middle ear)
• very high levels of triglycerides in the blood
• fluid retention due to heart or kidney disease

Tell your doctor immediately if you notice any changes in your health while taking Livial.

When to stop taking Livial and consult your doctor immediately

If you experience any of the following conditions while taking HRT or Livial:

• any of the conditions listed in "When not to take Livial"
• jaundice (yellowing of the skin or whites of the eyes), which may indicate liver disease
• high blood pressure (which may cause headaches, tiredness, dizziness)
• migraine-like headaches that start for the first time
• pregnancy
• suspected signs of a blood clot, such as:
• painful swelling and redness of the legs
• sudden chest pain
• difficulty breathing

Note: Livial is not a contraceptive. If you are under 50 years old, or if your last menstrual period was less than 12 months ago, you may need to use additional methods of contraception. Consult your doctor for advice.

HRT and malignant tumors

Endometrial hyperplasia and endometrial cancer

There have been reports of endometrial hyperplasia and endometrial cancer in women taking Livial. The risk of endometrial cancer increases with the duration of treatment with Livial.

Irregular bleeding

During the first 3-6 months of taking Livial, you may experience irregular bleeding or spotting.

Breast cancer

Data confirm that taking tibolone increases the risk of breast cancer. The additional risk depends on how long you take tibolone. In studies of HRT, it has been found that after stopping HRT, the additional risk decreases over time, but the risk may persist for 10 years or more if you took HRT for more than 5 years. There are no data on whether the risk persists after stopping tibolone, but it cannot be excluded that a similar effect may occur.

Ovarian cancer

Ovarian cancer is rare, much rarer than breast cancer. Taking HRT that only contains estrogen or a combination of estrogen and progestogen may slightly increase the risk of ovarian cancer.

Effect on the heart and blood vessels

Venous thromboembolism

The risk of venous thromboembolism in women taking HRT is about 1.3-3 times higher than in women not taking HRT, especially in the first year of treatment.

Heart disease (heart attack)

There is no evidence that Livial or HRT prevents heart attacks.

Stroke

Recent studies have shown that taking HRT and Livial increases the risk of stroke.

Other diseases

HRT does not prevent memory loss. Some data suggest that the risk of memory loss may be higher in women who start HRT after the age of 65. Consult your doctor for advice.

Livial with food and drink

Eating and drinking do not affect the taking of Livial.

Pregnancy and breastfeeding

Livial is intended for use in postmenopausal women only. If you become pregnant, stop taking Livial and consult your doctor.

Driving and using machines

According to current data, Livial does not affect alertness and concentration.

3. How to take Livial

Livial is for oral use. Take one tablet daily.

Overdose

If you take more than the prescribed dose of Livial, consult your doctor or pharmacist immediately.

Missed dose

Take the missed tablet as soon as possible, unless it is more than 12 hours since the last tablet. Do not take a double dose to make up for the missed dose.

Surgery

Before a planned operation, tell your doctor that you are taking Livial. To reduce the risk of venous thromboembolism, it may be necessary to stop taking Livial 4-6 weeks before the operation (see section 2 "Venous thromboembolism"). Your doctor will decide when you can start taking Livial again.

4. Possible side effects

Like all medicines, Livial can cause side effects, although not everybody gets them.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.

5. How to store Livial

Keep this medicine out of the sight and reach of children.

6. Contents of the pack and other information

The most important natural sex hormones in women are estrogen and progesterone. They are necessary for normal sexual development and function in women, as well as for controlling the menstrual cycle. Estrogen also plays a role in building bone.

What Livial contains

• The active substance is 2.5 mg tibolone
• The other ingredients are potato starch, magnesium stearate, ascorbyl palmitate, lactose.

What Livial looks like and contents of the pack

Livial 2.5 mg tablets are white, marked with "MK2" on one side and "Organon" on the other.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Polska Sp. z o.o.

Manufacturer

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

Date of last revision of the leaflet: 07/2021