Tibicare 2.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tibicare 2.5 mg tablets EFG

Tibolone

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Tibicare 2.5 mg tablets EFG is and what it is used for
2. What you need to know before taking Tibicare 2.5 mg tablets EFG
3. How to take Tibicare 2.5 mg tablets EFG
4. Possible side effects
5. How to store Tibicare 2.5 mg tablets EFG
6. Contents of the pack and other information

1. What Tibicare 2.5 mg tablets EFG is and what it is used for

Tibicare belongs to a group of medicines known as Hormone Replacement Therapy (HRT). It contains tibolone, a substance that has beneficial effects on various tissues such as the brain, vagina and bones.

This medicine is used in postmenopausal women, at least 12 months after their last natural menstrual period.

This medicine is used for: Relief of symptoms occurring after menopause.

During menopause, the amount of oestrogen produced by a woman's body decreases. This may cause symptoms such as sweating and hot flushes affecting the face, neck and chest. Tibicare relieves these postmenopausal symptoms. Tibolone will only be prescribed if the symptoms severely affect your daily life.

There are three different types of HRT:

• Oestrogen-only HRT
• Combined HRT, containing two types of female hormones: an oestrogen and a progestogen
• Medicines containing a substance called tibolone

Tibolone differs from other HRT treatments. Instead of containing oestrogens and progestogens, it contains tibolone. Your body metabolises tibolone into hormones. Its effects and benefits are similar to those of combined HRT.

2. What you need to know before starting to take Tibicare 2.5 mg tablets

Medical history and regular medical check-ups

Hormone replacement therapy (HRT) carries risks that should be considered when deciding whether to start or continue treatment.

Experience with treatment in women with premature menopause (due to ovarian problems or surgical removal of the ovaries) is limited. If you have premature menopause, the risk of using HRT may differ. Please consult your doctor.

Before starting or continuing HRT, your doctor will assess your personal and family medical history and may decide to perform a physical examination, including a breast examination and/or internal pelvic examination, if considered necessary.

Inform your doctor if you have any medical problems or existing conditions.

Regular medical check-ups

Once you have started treatment with tibolone, you should visit your doctor for regular medical check-ups (at least once a year). During these visits, the benefits and risks of continuing tibolone treatment will be evaluated.

Your doctor may recommend that you have regular mammograms.

Make sure that:

• you undergo regular breast and cervical smear checks,
• you regularly examine your breasts for changes such as skin dimpling, changes in the breast, or lumps that you can see or feel.

Do not take Tibicare

• if you have or have had breast cancer or suspect you might have it,
• if you have any type of estrogen-sensitive cancer, such as endometrial cancer, or suspect you might have it,
• if you have vaginal bleeding of unknown cause,
• if you have abnormal growth of the lining of the uterus (endometrial hyperplasia) that has not been treated,
• if you have or have ever had a blood clot (thrombosis) in your legs (deep vein thrombosis) or lungs (pulmonary embolism),
• if you have or have ever had blood clotting disorders (such as protein C, protein S or antithrombin deficiency),
• if you have or have ever had a disease caused by blood clots in the arteries, such as heart attack, stroke, or angina pectoris,
• if you have or have ever had liver disease and liver function has not returned to normal,
• if you have a rare inherited blood disorder called porphyria,
• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

If you are unsure about any of the above conditions, consult your doctor before taking tibolone.

If you experience any of the above conditions for the first time while taking tibolone, stop treatment immediately and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take tibolone.

HRT involves certain risks and benefits that should be considered before deciding to start or continue treatment.

Consult your doctor if you have or have had any of the following conditions, as they may recur or worsen during treatment with tibolone. If so, you may need more frequent medical check-ups:

• Uterine fibroids (myomas)
• Abnormal growth of the lining of the uterus (endometriosis) or history of abnormal growth of the uterine lining (endometrial hyperplasia)
• Increased risk of blood clots (see “Blood clots in a vein (thrombosis)”)
• Increased risk of estrogen-dependent cancer (such as if your mother, sister, or grandmother had breast cancer)
• High blood pressure
• Liver disease, such as benign liver tumour
• Diabetes
• Gallstones
• Migraine or severe headaches
• An autoimmune disease affecting multiple organs (systemic lupus erythematosus (SLE))
• Epilepsy
• Asthma
• A disease affecting the eardrum and hearing (otosclerosis)
• Very high levels of fat in the blood (triglycerides)
• Fluid retention due to heart or kidney problems

Stop taking Tibicare and consult your doctor immediately

If you are undergoing HRT and experience any of the following symptoms:

• any of the conditions listed under “Do not take Tibicare”;
• yellowing of the skin or eyes (jaundice) – these could be signs of liver disease;
• a significant increase in blood pressure (symptoms may include headache, fatigue, dizziness);
• new-onset unexplained migraines or severe headaches;
• if you become pregnant;
• if you notice symptoms suggesting a possible blood clot, such as:
  • swelling and redness in the legs
  • sudden chest pain
  • difficulty breathing

For more information, see “Blood clots in a vein (thrombosis)”.

Note: Tibicare is not a contraceptive. If less than 12 months have passed since your last natural menstrual period or if you are under 50 years of age, you should use a contraceptive method to prevent pregnancy. Consult your doctor for advice.

HRT and cancer

Excessive growth of the lining of the uterus (endometrial hyperplasia) and endometrial cancer (lining of the uterus)

Evidence shows an increased risk of endometrial cell proliferation or endometrial cancer in women taking tibolone. This risk increases with the duration of treatment.

Irregular bleeding

You may experience irregular bleeding or spotting during the first 3 to 6 months of treatment with tibolone. However, if bleeding or spotting:

• lasts beyond the first six months,
• starts after you have been taking tibolone for more than six months,
• continues after you have stopped taking tibolone,

consult your doctor immediately.

Breast cancer

Available data show that the use of tibolone increases the risk of breast cancer. The additional risk depends on how long you take tibolone. In HRT studies, after stopping HRT, the additional risk decreased over time, but the risk may persist for 10 years or more in women who used HRT for more than 5 years. Data on the persistence of risk after stopping tibolone are not available, but a similar pattern cannot be ruled out.

Comparison In women aged 50 to 79 years who are not taking HRT, on average, 9 to 17 cases of breast cancer per 1000 women will be diagnosed over a 5-year period. In women aged 50 to 79 years who are taking combined estrogen-progestogen HRT, there will be 13 to 23 cases per 1000 women over a 5-year period (4 to 6 additional cases). Women taking tibolone have a lower risk than women using combined HRT and a risk similar to women taking estrogen-only HRT.

Examine your breasts regularly. Consult your doctor if you notice any changes such as:

• Dimpling of the skin
• Changes in the nipple
• Any lump that you can see or feel

Additionally, it is recommended to participate in screening programs using mammography. It is important to inform the healthcare professional performing your mammogram that you are undergoing THS treatment, as this medication may increase breast density and may affect the test results. When breast density is increased, mammography may not detect lumps.

Ovarian cancer

Ovarian cancer is rare, much less common than breast cancer. A slight increase in the risk of ovarian cancer has been observed in women receiving estrogen-only or combined estrogen-progestagen THS.

The risk of ovarian cancer varies with age. In women aged 50 to 54 years who do not take THS, an average of 2 out of 2000 women will develop ovarian cancer within 5 years. In women who do not take THS for 5 years, between 3 cases of ovarian cancer will occur per 2000 women (one additional case).

The risk of ovarian cancer with tibolone use is similar to the risk with other types of THS.

Effects of THS on the heart and blood circulation

Blood clots in a vein (thrombosis)

The risk of developing a blood clot in a vein is 1.3 to 3 times higher in women taking THS compared to women who do not, especially during the first year of treatment.

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, difficulty breathing, fainting, and even death.

Your risk of developing a blood clot in a vein increases with age and if you have any of the following conditions. Inform your doctor if you experience any of the following:

• If you are unable to walk for an extended period due to major surgery, injury, or illness (see also section 3, If you need surgery)
• If you have significant overweight (BMI >30 kg/m²)
• If you have blood clotting disorders requiring long-term treatment with medication to prevent clots
• If a close family member has ever had a blood clot in the leg, lung, or another organ
• If you have Systemic Lupus Erythematosus (SLE)
• If you have cancer

To identify symptoms of a blood clot, see “Stop taking Tibicare and contact your doctor immediately.”

Comparison In women aged 50 years who do not take HRT, on average, it is expected that between 4 and 7 out of 1,000 will experience a blood clot in a vein over a 5-year period. In women aged 50 years who take combined oestrogen-progestogen HRT, on average, it is expected that between 9 and 12 out of 1,000 will experience a blood clot in a vein over a 5-year period (5 additional cases). The risk of developing a blood clot with tibolone use is lower than with other types of HRT.

Heart disease (heart attack)

There is no evidence that HRT or tibolone can prevent a heart attack.

Women over 60 years of age who use combined oestrogen-progestagen HRT have a slightly increased likelihood of developing heart disease compared to women who do not use HRT.

There is no evidence suggesting that the risk of myocardial infarction with tibolone differs from the risk with other HRT treatments.

Stroke

The risk of stroke is 1.5 times higher in women using HRT than in those who do not. The risk associated with HRT use increases with age. The number of additional stroke cases due to HRT use rises with the patient's age.

Other factors that may increase the risk of stroke include:

• High blood pressure
• Smoking
• Excessive alcohol consumption
• Irregular heartbeat

If you are concerned about any of these factors, consult your doctor to discuss whether you should take HRT.

Comparison On average, it is expected that 8 out of 1000 women aged 50 who do not take HRT will experience a stroke over a 5-year period. In women aged 50 who take HRT, 11 cases are expected, on average, out of 1000 women over 5 years (3 additional cases).

Other diseases

HRT does not prevent memory loss. Some evidence shows a higher risk of memory loss in women who start HRT after the age of 65. Consult your doctor for further information on this.

Tibicare is not a contraceptive medication.

Oestrogens may cause fluid retention; therefore, caution is advised in patients with heart or kidney disease.

Special monitoring is required for patients with hypertriglyceridaemia, as cases of marked increases in plasma triglycerides have been observed with the use of oestrogens or HRT, which in turn have led to pancreatitis.

Use of Tibicare with other medicines

Some medicines may interfere with the effect of Tibicare, which could cause irregular bleeding. These include medicines used to treat:

• epilepsy (e.g.: lamotrigine, phenobarbital, phenytoin and carbamazepine),
• tuberculosis (such as rifampicin or rifabutin),
• HIV infections (e.g.: nevirapine, efavirenz, ritonavir and nelfinavir),
• blood clots (e.g.: warfarin),
• herbal remedies containing St John's wort (Hypericum perforatum).

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Clinical laboratory tests

If you require a blood test, inform your doctor or laboratory staff that you are taking tibolone, as this medicine may affect the results of certain tests.

Taking Tibicare with food and drink

You may eat and drink normally while taking Tibicare.

Pregnancy, breast-feeding and fertility

Tibicare is indicated only for postmenopausal women. If you become pregnant, stop taking Tibicare and consult your doctor.

Driving and using machines

There is no information indicating that the use of Tibicare affects driving or operating machinery.

Tibicare contains lactose

This medicine contains 43.2 mg of monohydrate lactose per tablet. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Tibicare 2.5 mg tablets EFG

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day.

The tablet should be swallowed whole, without chewing, with a little water.

Take the tablet every day at the same time.

The tablet strips are marked with the days of the week. Start taking the tablet on the corresponding day. For example, if it is Monday, take the tablet marked with "M" at the beginning of the strip. Follow the arrows until the strip is finished. The next day, start the next strip.

Your doctor will try to prescribe the lowest dose to treat your symptoms for the shortest possible time. Consult your doctor if you think your dose is too strong or too weak.

You must not take tibolone until 12 months have passed since your last natural menstrual period.

If your ovaries and uterus have been removed, or you are being treated for endometriosis with gonadotropin-releasing hormone (GnRH) analogues, you may start taking tibolone immediately.

If you have never used HRT before, you may start treatment immediately.

If switching from another type of HRT

There are different types of HRT, such as tablets, patches, and gels. Most contain estrogens or estrogens combined with progestogens. Some cause a withdrawal bleed between cycles (sequential preparations), while others do not (continuous regimens).

If you were taking a sequential preparation, you should start taking tibolone immediately after the withdrawal bleeding ends.

If you were taking a continuous regimen (without bleeding), you may start taking tibolone at any time. You may also start tibolone immediately if you are being treated for endometriosis.

Use in children and adolescents

Tibolone must not be administered to children.

If you take more Tibicare than you should

It is unlikely that you will suffer harm if you take more than one tablet, but symptoms may include nausea, vomiting, or vaginal bleeding.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tibicare

If you forget to take a tablet, take it as soon as you remember, unless more than 12 hours have passed since the scheduled dose. If more than 12 hours have passed, skip that dose. Do not take a double dose to make up for a missed dose.

If you need surgery

If you are due to have surgery, inform your doctor that you are taking Tibicare. You should stop taking Tibicare 4 to 6 weeks before the operation to reduce the risk of blood clots (see Section 2, Blood clots in a vein). Ask your doctor when you can resume taking Tibicare.

If you stop taking Tibicare

Do not stop taking tibolone without first consulting your doctor, even if you feel better. It is important to take the medicine for as long as your doctor has instructed. Otherwise, signs or symptoms of estrogen deficiency may reappear.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

The following adverse effects are observed more frequently in women taking HRT compared to those who do not:

• breast cancer;
• abnormal growth of the lining of the uterus (endometrial hyperplasia or cancer);
• ovarian cancer;
• blood clots in the legs or lungs (venous thromboembolism);
• heart disease;
• stroke;
• possible memory loss if HRT is started after age 65.

For more information about these adverse effects, see section 2.

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Most of these effects are mild.

If you think you may be experiencing a serious adverse effect, consult your doctor immediately.

You may need to stop taking Tibicare:

• If you have increased blood pressure
• If your skin or eyes turn yellow (jaundice)
• If you have a sudden, severe headache of migraine type (see Section 2)
• If you have signs of a blood clot (see Section 2)
• If you develop any of the conditions listed in Section 2 (Do not take Tibicare)

Other adverse effects

Common (affects 1 in 10 women):

• Breast pain
• Stomach or pelvic pain
• Abnormal hair growth
• Vaginal bleeding or spotting

This is normal during the first two months of HRT treatment. If bleeding continues or starts after a period of time on HRT, see section 2 “Irregular bleeding”

• Vaginal discomfort such as discharge, itching, and irritation
• Inflammation of the vulva and vagina (vulvovaginitis)
• Candidiasis
• Thickening of the lining of the uterus or cervix
• Tissue changes in the cervix
• Abnormal cervical discharge
• Weight gain

Uncommon (affects 1 in 100 women):

• Swelling of the hands, ankles, or feet – sign of fluid retention
• Stomach discomfort
• Acne
• Breast tenderness or pain
• Vaginal infections (fungal)
• Fungal infection

Rare (affects 1 in 1,000 women):

• Itching of the skin

Some women taking tibolone have also reported:

• Depression, dizziness, headache
• Joint and muscle pain
• Skin irritation or itching
• Loss of vision or blurred vision
• Changes in liver function laboratory tests

There have been reports of breast cancer and increased growth of endometrial cells or endometrial cancer in women treated with tibolone.

Inform your doctor if any of the above symptoms are bothersome or persistent.

With other HRTs, the following adverse reactions have been reported:

• Gallbladder disease
• Skin disorders:
• Skin discoloration, especially on the face or neck, known as “pregnancy mask” (chloasma)
• Painful red nodules on the skin (erythema nodosum)
• Rash with redness or ulcers (erythema multiforme)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tibicare 2.5 mg tablets EFG

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

This medicine does not require any special storage conditions.

Store in the original packaging to protect it from light and moisture.

Do not use this medicine after the expiry date stated on the blister and on the carton, following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tibicare

• The active substance is tibolone.
• The other components are monohydrate lactose (See section 4. “Tibicare contains lactose”), mannitol, potato starch, ascorbyl palmitate, and magnesium stearate.

Appearance of the product and contents of the pack

Tibicare are white or almost white, round tablets, 6 mm in diameter, bevelled edge and unmarked.

They are available in packs containing 1, 3 or 6 blisters with 28 or 30 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Procare Health Iberia, S.L.

Avda. Miguel Hernandez 21, Bajo

46450 Benifaió (Valencia)

Spain

Manufacturer

Cenexi

17, rue de Pontoise

95520 OSNY

FRANCE

This medicinal product is authorized in the European Economic Area member states under the following names:

Country \t\tMedicinal product name

Germany: \tTibelia 2.5 mg tablets
Belgium: \tTibelia 2.5 mg tablets
Spain: \t\tTibicare 2.5 mg tablets EFG
France: \t\tTibolone CCD 2.5 tablets
Netherlands: \tTibolon Mithra 2.5 mg tablets
Luxembourg: \tTibelia 2.5 mg tablets
United Kingdom: \tTibelia 2.5 mg tablets

Date of the most recent review of this leaflet: December 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)