Tibelia

LEAFLET SUPPLIED WITH THE PACKAGING

Leaflet supplied with the packaging: information for the patient

Tibelia, 2.5 mg, tablets

Tybolone

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, tell your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Table of contents of the leaflet

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

1. What is Tibelia and what is it used for

Tibelia is a medicine used in Hormone Replacement Therapy (HRT). The medicine contains tybolone - a substance that has a beneficial effect on various tissues and organs of the body, including the brain, vagina, and bones.
The medicine is used in postmenopausal women, in whom the last natural bleeding occurred at least 12 months ago.
The medicine is used in the following cases:

Relief of symptoms occurring after menopause

During the menopausal period, the amount of estrogen produced by the woman's body decreases.
This can cause symptoms such as hot flashes on the face, neck, and chest. Tibelia alleviates symptoms in postmenopausal women. Tibelia is prescribed only when the symptoms are severe and significantly interfere with daily life.

Prevention of osteoporosis

After menopause, some women may develop osteoporosis (bone thinning). You should discuss all available options with your doctor.
In women who are at increased risk of fractures due to osteoporosis and for whom other medicines are not suitable, Tibelia can be used to prevent postmenopausal osteoporosis.
There are three different types of Hormone Replacement Therapy (HRT):

• estrogen-only HRT;
• combined HRT containing two types of female hormones - estrogen and progestogen;
• Tibelia, which contains a substance called tybolone.

Tibelia is different from other HRTs. Instead of real hormones (such as estrogen and progestogen), it contains tybolone. The body breaks down tybolone into hormones.
The action of the medicine and the benefits it provides are similar to those of combined HRT.

2. Important information before taking Tibelia

Medical history and regular check-ups

In addition to the benefits, HRT also carries risks that need to be considered when deciding to start or continue treatment.
Experience in treating women who have had premature menopause (e.g., due to ovarian failure or surgery) is limited. In the case of premature menopause, the risks associated with HRT may be different. You should discuss this with your doctor.
Before starting HRT, your doctor should take a medical history and ask about any diseases in your family. The doctor may decide to perform a physical examination, including a breast examination and/or gynecological examination (if necessary).
You should inform your doctor about any health problems or diseases.

Regular check-ups

After starting Tibelia, regular check-ups (at least once a year) are necessary.
During these check-ups, you should discuss the benefits and risks of continuing to take Tibelia with your doctor.
You should regularly undergo breast examinations as recommended by your doctor.
You should:

• regularly undergo breast examination and cytological examination;
• regularly check your breasts for changes, such as indentation of the skin, changes in the appearance of the nipple, or visible or palpable thickening.

When not to take Tibelia:

• If you are allergicto tybolone or any of the other ingredients of Tibelia (listed in section 6).
• If you currently have, are suspected of having, or have had breast cancer.
• If you have a malignant estrogen-dependent tumoror are suspected of having one (e.g., endometrial cancer).
• If you have unexplained vaginal bleeding.
• If you have uncontrolled endometrial hyperplasia(an overgrowth of the lining of the uterus).
• 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 currently have or have had arterial thromboembolic diseases(e.g., heart attack, stroke, or angina pectoris).
• If you have liver diseaseand liver function has not returned to normal.
• If you have a rare genetic blood disorder called porphyria.

If you are unsure about any of the above information, you should consult your doctorbefore taking Tibelia.
If any of the above conditions occur for the first time while taking Tibelia, you should stop taking the medicine and consult your doctor immediately.

Warnings and precautions

Before taking tybolone, you should consult your doctor or pharmacist.
In addition to the benefits of HRT, there are risks that need to be considered when deciding to start or continue treatment.
Before starting treatment, you should tell your doctor if you have had any of the diseases listed below, as they may recur or worsen while taking Tibelia. In this case, you should have more frequent check-ups:

• uterine fibroids;
• endometriosis or uncontrolled endometrial hyperplasia in the past;
• increased risk of thrombosis (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 a benign liver tumor;
• diabetes;
• gallstones;
• migraine or severe headaches;
• systemic immune system diseases (e.g., systemic lupus erythematosus (SLE));
• epilepsy;
• asthma;
• otosclerosis (a disease of the middle ear that can cause hearing loss);
• very high levels of fats (triglycerides) in the blood;
• fluid retention in the body due to heart or kidney disease.

When to stop taking Tibelia and consult your doctor immediately

If any of the following diseases occur while taking HRT:

• any of the conditions listed in the "When not to take Tibelia" section;
• jaundice (yellowing of the skin or eyes), which may indicate liver disease;
• high blood pressure (which may cause headaches, fatigue, dizziness);
• migraine-like headaches that occur for the first time;
• pregnancy;
• symptoms of thrombosis, such as:
• painful swelling and redness of the skin of the lower limbs;
• sudden chest pain;
• breathing difficulties. More information - see "Venous thromboembolism".

Note:Tybolone is not a contraceptive. In women under 50 years of age and if the last menstrual bleeding occurred less than 12 months ago, additional contraceptive methods may be necessary. You should consult your doctor for advice.

HRT and malignant tumors

Endometrial hyperplasia (uncontrolled growth of the uterine lining) and endometrial cancer

There are reports and studies on endometrial hyperplasia or endometrial cancer in women taking tybolone. The risk of developing endometrial cancer increases with the duration of treatment.

Irregular bleeding

During the first 3-6 months of taking Tibelia, irregular bleeding or spotting may occur. However, if bleeding:

• continues after the first 6 months,
• occurs after 6 months of taking Tibelia,
• persists even after stopping Tibelia, you should consult your doctor as soon as possible.

Breast cancer

Evidence suggests that taking combined estrogen-progestogen or estrogen-only HRT increases the risk of developing breast cancer. This additional risk depends on the duration of HRT and becomes apparent after several years of treatment, but returns to normal within a few (maximum 5) years after stopping treatment.

Comparison

Among women aged 50-79 years who do not take HRT, approximately 9-17 out of 1000 will develop breast cancer within 5 years. Among women of the same age taking combined estrogen-progestogen HRT for 5 years, the number of cases will be 13-23 out of 1000 (i.e., 4-6 additional cases).
The risk of breast cancer in women taking tybolone is lower than in women taking combined estrogen-progestogen HRT and comparable to the risk in women taking estrogen-only HRT.

Regular breast self-examination should be performed. If any changes are noticed, you should consult your doctor. These changes include:

• indentation of the skin;
• changes in the appearance of the nipple;
• any visible or palpable thickening.

In addition, it is recommended to participate in screening mammography. During screening mammography, you should inform the person performing the X-ray about taking HRT, as this medicine may increase breast density, which affects the mammography result. In the case of increased breast density, mammography may not detect all thickening.

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. Taking estrogen-only or combined estrogen-progestogen HRT has been associated with a slight increase in the risk of developing ovarian cancer.
The risk of developing ovarian cancer depends on age. For example, in women aged 50-54 years who do not take HRT, ovarian cancer will be diagnosed within 5 years in approximately 2 out of 2000 women.
In women taking HRT for 5 years, there will be approximately 3 cases out of 2000 (i.e., approximately 1 additional case).
The increased risk of ovarian cancer in women taking Tibelia is similar to that of other HRTs.

Effect of HRT on the heart and circulation

Venous thromboembolism

The risk of developing venous thromboembolism in women taking HRT is approximately 1.3-3 times higher than in women not taking such treatment, especially in the first year of treatment.
Thrombosis can be life-threatening. If a thrombus moves to the lungs, it can cause chest pain, shortness of breath, fainting, or even death.
The likelihood of forming venous thrombi is higher in older age, as well as in the following factors, which you should tell your doctor about (if they occur):

• immobility (inability to move) for a long time due to major surgery, injury, or illness (in the case of necessary surgery, see also section 3);
• severe obesity (body mass index (BMI) over 30 kg/m2);
• blood clotting disorders requiring long-term anticoagulant treatment;
• history of thrombi in the lower limbs, lungs, or other organs in any family members;
• systemic lupus erythematosus (SLE);
• malignant tumors.

Symptoms of thrombosis - see the "When to stop taking Tibelia and consult your doctor immediately" section.
Comparison
It is estimated that in women aged 50-59 years who do not take HRT, venous thromboembolism will occur in approximately 4-7 out of 1000 women within 5 years.
In women of the same age taking combined estrogen-progestogen HRT for 5 years, the number will be 9-12 out of 1000 women (i.e., 5 additional cases).
The increased risk of venous thromboembolism in women taking tybolone is lower than in women taking other HRTs.

Heart disease (myocardial infarction)

There is no evidence that HRT or tybolone prevents myocardial infarction.
In women over 60 years of age taking combined estrogen-progestogen HRT, there is a slightly increased risk of developing heart disease compared to women not taking HRT.
There is no data to suggest that the risk of myocardial infarction in women taking tybolone differs from the risk associated with other HRTs.

Stroke

The risk of stroke in women taking HRT and tybolone is approximately 1.5 times higher than in women not taking these medicines. The number of additional stroke cases associated with HRT will increase with age.
Other factors that may increase the risk of stroke:

• high blood pressure;
• smoking;
• excessive alcohol consumption;
• heart rhythm disorders. People concerned about any of the above factors should consult their doctor to determine if they should take HRT.

Comparison

It is estimated that in women aged 50-59 years who do not take HRT, stroke will occur in approximately 8 out of 1000 women within 5 years. In women of the same age taking HRT for 5 years, the number will be 11 out of 1000 women (i.e., 3 additional cases).

Other diseases

HRT does not prevent memory loss. Some data suggest a higher risk of memory loss in women starting HRT at an older age (over 65 years). You should consult your doctor for advice.
Tibelia is not intended for use as a contraceptive.
Estrogens may cause fluid retention in the body, so patients with heart or kidney failure should be closely monitored.
Women with pre-existing hypertriglyceridemia should be closely monitored during estrogen replacement therapy or HRT, as rare cases of significant increases in triglyceride levels in the blood have been observed in these patients, leading to pancreatitis.

Tibelia and other medicines

Some medicines may affect the action of Tibelia, which can lead to irregular bleeding. This applies to the following medicines:

• antiepileptic drugs(e.g., phenobarbital, phenytoin, and carbamazepine);
• antitubercular drugs(e.g., rifampicin, rifabutin);
• HIV drugs(e.g., nevirapine, efavirenz, ritonavir, and nelfinavir);
• anticoagulant drugs(e.g., warfarin);
• herbal products containing St. John's Wort(Hypericum perforatum).

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those that are available without a prescription, herbal products, and other natural products.

Laboratory tests

Before undergoing a blood test, you should inform your doctor or laboratory staff that you are taking Tibelia, as it may affect the results of some tests.

Tybolone with food and drink

Consuming food and drink does not affect the taking of Tibelia.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

Tibelia contains lactose

The tablet contains 43.2 mg of lactose monohydrate. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicinal product.

• 3.

How to take Tibelia

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
It is recommended to take one tablet per day.
Tybolone should be swallowed without chewing. Take with water.
The medicine should be taken every day at the same time.
The blisters with tablets are marked with the names of the days of the week. The treatment should be started by taking the tablet marked with the current day of the week. For example, if the first tablet is taken on Monday, take the tablet marked "Mon" in the top row of the package and continue taking the tablets for the following days of the week until the package is empty. The first tablet from the next blister should be taken the next day, without making any breaks between the blisters or packages.
Your doctor will prescribe the lowest effective dose for the shortest possible time. If the dose seems too strong or too weak, you should consult your doctor.
In the case of natural menopause, tybolone should not be taken before at least 12 months have passed since the last menstrual bleeding.
Women who have had their uterus and ovaries removed or are taking gonadotropin-releasing hormone analogs (GnRH), for example, due to endometriosis, can start taking tybolone immediately.
Women who have not taken HRT beforecan start taking tybolone immediately.

Women switching from another type of HRT

There are several different types of HRT, such as tablets, patches, and gels. Most of them contain estrogen or estrogen and progestogen. During the use of some of these medicines, bleeding occurs in women, and during the use of others, it does not.
When switching from another type of HRT that causes bleeding, you should start taking tybolone immediately after the bleeding has stopped.
When switching from HRT that does not cause bleeding, you can start taking tybolone immediately. Women treated for endometriosis can also start taking the medicine immediately.

Use in children and adolescents

Tybolone should not be used in children.

Overdose of Tibelia

In the event of taking several tablets at once, there is no reason to worry, but symptoms of overdose may include nausea, vomiting, or vaginal bleeding.

Missed dose of tybolone

You should take the missed tablet as soon as possible, unless more than 12 hours have passed since the planned time of taking the tablet. If more than 12 hours have passed, you should skip this dose and take the next dose at the usual time.

Do not take a double dose

Surgery

Before scheduled surgery, you should inform your doctor that you are taking Tibelia. To reduce the risk of venous thromboembolism, it may be necessary to stop taking Tibelia 4 to 6 weeks before surgery (see section 2 "Venous thromboembolism"). Your doctor will decide when you can start taking Tibelia again.

Stopping tybolone

You should not stop taking tybolone without consulting your doctor first, as your symptoms may return.
If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Compared to women not taking HRT, the following diseases are more common in women taking HRT:

• breast cancer;
• uncontrolled growth or cancer of the uterine lining (endometrial hyperplasia or endometrial cancer);
• ovarian cancer;
• venous thromboembolism in the lower limbs and lungs (venous thromboembolic disease);
• heart disease;
• stroke;
• possible memory loss in women starting HRT at an older age (over 65 years).

More information about the above side effects - see section 2.
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most side effects are mild.

Serious side effects - requiring immediate contact with a doctor

In the event of symptoms of a serious side effect, you should consult your doctor immediately.

Stopping Tibelia may be necessary in the event of:

• increased blood pressure;
• jaundice (yellowing of the skin or eyes) (jaundice);
• sudden onset of migraine-like headaches(see section 2 above);
• symptoms of thrombosis(see section 2 above);
• any of the problems listed in section 2 (When not to take Tibelia).

Other side effects

Common(occurring in up to 1 in 10 women):

• breast pain;
• abdominal or pelvic pain;
• excessive hair growth;
• vaginal bleeding or spotting. (This symptom is usually not a cause for concern during the first few months of HRT; if bleeding persists or occurs after a longer period of HRT, see section 2 "Irregular bleeding");
• vaginal problems, such as excessive discharge, itching, or irritation;
• vulvovaginitis;
• vaginal candidiasis;
• thickening of the uterine lining (endometrium);
• changes in the cervix;
• abnormal cervical smear;
• weight gain.

Uncommon(occurring in up to 1 in 100 women):

• swelling of the hands, feet, or ankles (a sign of fluid retention in the body);
• stomach problems;
• acne;
• nipple pain or breast discomfort;
• vaginal infections (thrush);
• fungal infections.

Rare(occurring in up to 1 in 1000 women):

• skin itching.

Other side effects reported by women taking Tibelia:

• depression, dizziness, headaches;
• joint or muscle pain;
• skin problems, such as rash or itching;
• visual impairment or blurred vision;
• changes in liver function test results. There are reports of breast cancer and endometrial hyperplasia or endometrial cancer in women taking Tibelia. If any of the above side effects persist or become troublesome, you should inform your doctor.

The following side effects have been reported in women taking other HRTs:

• gallbladder disease;
• various skin diseases;
• skin discoloration, especially on the face or neck (chloasma);
• painful, red lumps on the skin (erythema nodosum);
• a rash involving round redness or blisters (erythema multiforme).

Reporting side effects

If you experience any side effects, you should tell your doctor or pharmacist. This includes any side effects not listed in this leaflet. Side effects can also be reported directly using the national reporting system:
Department of Drug Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to obtain more information on the safety of this medicine.

5. How to store Tibelia

The medicine should be stored out of sight and reach of children.
This medicinal product does not require special temperature storage conditions.
Store in the original package to protect from light and moisture.
Do not take the medicine after the expiry date stated on the blister and carton after the abbreviation "Exp:". The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tibelia contains

• The active substance of the medicine is tybolone.
• The other ingredients are: lactose monohydrate (see section 2 "Tibelia contains lactose"), mannitol, potato starch, ascorbyl palmitate, and magnesium stearate.

What Tibelia looks like and contents of the pack

Tibelia is a white or almost white, round tablet with a diameter of 6 mm, with a flat edge, without any markings. The package contains 1, 3, or 6 blisters of 28 or 30 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

NOVALON S.A
rue Saint-Georges 5
4000 Liege
Belgium

Manufacturer

Cenexi
rue de Pontoise 17
95520 Osny
France

This medicinal product is authorized in the Member States of the EEA under the following names:

Finland
Tibelia 2.5 mg tablets
Greece
Tibelia 2.5 mg tablets
Norway
Tibelia
Poland
Tibelia
Portugal
Tibelia 2.5 mg tablet
Sweden
Tibelia 2.5 mg tablet
Hungary
Tibelia 2.5 mg tablet
Italy
Shyla
United Kingdom
Tibolone-Mithra 2.5 mg tablet

Date of last revision of the leaflet: