Prospect: information for the user

Tibicare 2.5 mg tablets EFG

Tibolona

Read this prospect carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in the prospect. See section 4.

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

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

3.How to take Tibicare 2.5 mg tablets EFG

4.Possible adverse effects

5.Storage of Tibicare 2.5 mg tablets EFG

6.Contents of the package and additional information

Tibicare belongs to the group of medications forHormonal Replacement Therapy (HRT). It contains tibolona, a substance that has favorable effects on different tissues, such as brain, vagina, and bones

This medication is used in postmenopausal women after at least 12 months since their last natural period.

This medication is used for:Relief of symptoms that occur after menopause.

During menopause, the amount of estrogens produced in womendecreases. This can cause symptoms such as sweating and hot flashes on the face, neck, and chest. Tibicare relieves these symptoms after menopause. Tibolona will only be prescribed if symptoms severely alter your daily life.

There are three different types of HRT:

• HRT with estrogens only
• Combined HRT, containing two types of female hormones, an estrogen and a progestogen.
• Medications that contain a substance called tibolona

Tibolona is different from other HRT. Instead of hormones such as estrogens and progestagens, it contains tibolona. Your body uses tibolona to produce hormones. Its effects and benefits are similar to combined HRT.

Medical History and Periodic Medical Reviews

Hormone Replacement Therapy (HRT) with Tibolona carries risks that should be considered when deciding whether to start or continue taking it.

The treatment experience in women with premature menopause (due to ovarian problems or surgery) is limited.If you have premature menopause, the risk of using HRT may be different. Consult your doctor.

Before starting or continuing HRT treatment with Tibolona, your doctor will evaluate your personal and family history and may decide to perform a medical examination, including a breast examination and/or internal examination if necessary.

Inform your doctor if you have any medical problems or any disease.

Periodic Medical Reviews

Once you start treatment with Tibolona, you should visit your doctor for periodic medical reviews (at least once a year). In these reviews, the benefits and risks of continuing treatment with Tibolona will be evaluated.

Your doctor may recommend that you have regular mammograms.

Make sure:

• You have regular breast and cervical screening.
• You regularly check your breasts to determine changes in skin texture, 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 may have it,
• If you have any type of estrogen-sensitive cancer, such as endometrial cancer or suspect you may have it,
• If you have unexplained vaginal bleeding,
• If you have or have had abnormal growth of the layer that covers the uterus (endometrial hyperplasia) that has not been treated,
• If you have or have had a blood clot (thrombosis) in your legs (deep vein thrombosis) or lungs (pulmonary embolism)
• If you have or have had any bleeding disorders (such as protein C, protein S, or antithrombin deficiency).
• If you have or have had any arterial disease, such as heart attack, stroke, or angina pectoris,
• If you have or have 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 ingredient or any of the other components of this medication (including those listed in section 6)

If you are unsure about any of the effects mentioned above, consult your doctor before taking Tibolona.

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Tibolona.

HRT has some risks and benefits that should be considered before deciding whether to start or continue taking it.

Consult your doctor if you have or have had any of the following problems before starting treatment, as they may worsen or recur during treatment with Tibolona. If so, you should have more frequent medical check-ups:

• Fibroids in the uterus
• Abnormal growth of the layer that covers the uterus (endometriosis) or a history of abnormal growth of the layer that covers the uterus (endometrial hyperplasia).
• High risk of blood clots (see "Blood Clots in a Vein (Thrombosis)")
• High risk of developing estrogen-dependent cancer (such as your mother, sister, or grandmother having breast cancer).
• High blood pressure
• Liver disease, such as a benign liver tumor
• Diabetes
• Galstones
• Migraines or severe headaches
• A disease of the immune system that affects multiple organs in the body (systemic lupus erythematosus (SLE))
• Epilepsy
• Asthma
• A disease that affects 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 taking HRT and experience any of the following symptoms, such as:

• Any of the conditions mentioned in the section "Do Not Take Tibicare";
• Yellowing of the skin and eyes (jaundice). This may be a sign of liver disease;
• Significant increase in blood pressure (symptoms may include headache, fatigue, dizziness).
• Unexplained migraines or severe headaches;
• If you become pregnant;
• If you notice symptoms of possible blood clots, 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 you have had less than 12 months since your last natural menstrual period or are less than 50 years old, you should use some form of contraception to prevent pregnancy. Consult your doctor for more information.

HRT and Cancer

Abnormal Growth of the Layer that Covers the Uterus (Endometrial Hyperplasia) and Endometrial Cancer

There is evidence of an increased risk of abnormal growth of the layer that covers the uterus or endometrial cancer in women taking Tibolona. 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 Tibolona.But if the bleeding or spotting:

• Lasts more than six months
• Starts after taking Tibolona for more than six months.
• Continues even after stopping Tibolona

Consult Your Doctor Immediately.

Breast Cancer

The available data show that the use of Tibolona increases the risk of breast cancer. The additional risk depends on the duration of use. In studies with HRT, after stopping HRT, the additional risk decreased over time, but the risk may persist for 10 years or more in women who have used HRT for more than 5 years. There is no data on the persistence of risk after stopping Tibolona, but it cannot be ruled out that a similar pattern may occur.

Check Your Breasts Regularly. Consult Your Doctor If You Notice Any Changes Such As:

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

Additionally, it is recommended to participate in early detection programs through mammography. It is essential to inform the healthcare professional performing the mammography test that you are taking HRT, as this medication may increase the density of your breasts and affect the test results. When breast density is increased, mammography may not detect lumps.

Ovarian Cancer

Ovarian cancer is rare and much less common than breast cancer. There has been a slight increase in the risk of ovarian cancer in women taking HRT with estrogen only or combined with estrogen-progestogen.

The risk of ovarian cancer varies with age. In women aged 50 to 54 who are not taking HRT, on average, 2 of every 2000 women will develop ovarian cancer over a 5-year period. In women who are not taking HRT over a 5-year period, 1 of every 2000 women will develop ovarian cancer (1 additional case).

The risk of ovarian cancer using Tibolona is similar to the risk with other types of HRT.

Effects of HRT on the Heart and 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 HRT patients than in women who are not taking it, especially during the first year of treatment.

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

You are more likely to have a higher risk of blood clots in veins as you get older and if you have any of the following conditions. Inform your doctor:

• If you have not been able to walk for a prolonged period due to surgery, an injury, or illness (see also section 3, If You Need Surgery)
• If you have a significant overweight (BMI > 30 kg/m2)
• If you have bleeding disorders that require long-term treatment with a medication to prevent blood clots
• If any of your close relatives have had a blood clot in their leg, lung, or other organ
• If you have Systemic Lupus Erythematosus (SLE)
• If you have cancer

To identify the symptoms of a blood clot, see "Stop Taking Tibicare and Consult Your Doctor Immediately".

Heart Disease

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

There is a slight increased risk of heart disease in women over 60 who use HRT with estrogen-progestogen compared to those who do not use HRT.

There is no evidence to suggest that the risk of myocardial infarction with Tibolona is different from the risk with other HRT.

Stroke

The risk of stroke is 1.5 times higher in HRT patients than in women who are not taking it. The risk of stroke due to HRT increases with age. The number of additional cases of stroke due to HRT increases with the age of the patient.

Other situations 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 situations, consult your doctor about whether you should take HRT.

Other Diseases

HRT does not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start HRT after the age of 65. Consult your doctor for more information.

Tibicare is not a contraceptive.

Estrogens can cause fluid retention, so you should be careful with patients with heart or kidney disease.

Patients with hypertriglyceridemia should be monitored closely, as estrogen use or HRT has been associated with cases of elevated triglyceride levels in plasma that have caused pancreatitis.

Use of Tibicare with Other Medications

Some medications may interfere with the effect of Tibicare, causing irregular bleeding. These medications include those used to treat:

• Epilepsy (e.g., phenobarbital, phenytoin, and carbamazepine),
• Tuberculosis (such as rifampicin or rifabutin)
• VIH 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 taken recently, or may need to take any other medication, including those purchased without a prescription.

Clinical Trials

If you need a blood test, inform your doctor or laboratory staff that you are taking Tibolona, as this medication may affect the results of some tests.

Taking Tibicare with Food and Drinks

You can eat or drink normally while taking Tibicare.

Pregnancy, Breastfeeding, and Fertility

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

Driving and Using Machines

There is no information to indicate that the use of Tibicare affects driving or using machines.

Tibicare Contains Lactose

This medication contains 43.2 mg of lactose monohydrate per tablet. If your doctor has told you that you have a lactose intolerance, consult them before taking this medication.

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

The recommended dose is one tablet per day.

Swallow the tablet whole, without chewing, with a little water.

Take the tablet every day at the same hour.

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

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

Do not take tibolone until 12 months after your last natural period.

If your ovaries and uterus have been removed or you are undergoing treatment for endometriosis with gonadotropin-releasing hormone analogs (GnRH), you can start taking tibolone immediately.

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

If you are switching from another type of HRT

There are different types of HRT, such as tablets, patches, and gels. Most contain estrogens or estrogens with progestogens.With some, there is bleeding between cycles (sequential preparations) and with others there is not (continuous use).

If you were taking a sequential type preparation, you shouldstart taking tibolone immediately after the bleeding ends.

If you were taking a continuous regimen preparation (no bleeding) you can start taking tibolone at any time. You can also start taking tibolone immediately if you are undergoing treatment for endometriosis.

Use in children and adolescents

Tibolone should not be administered to children

If you take more Tibicare than you should

It is unlikely that you will suffer any harm, but symptoms may include nausea, vomiting, or vaginal bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

Ifyou forgot 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 it was due. If more than 12 hours have passed, do not take that dose.
Do not take a double dose to compensate for the missed doses.

If you need surgery

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

If you stop taking Tibicare

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

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

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

• breast cancer;
• abnormal thickening of the layer covering the uterus (endometrial hyperplasia or cancer);
• ovarian cancer;
• blood clots in the veins of the legs or lungs (venous thromboembolism);
• heart disease;
• stroke;
• probable memory loss if THS is initiated after the age of 65.

For more information on these adverse effects, see Section 2.

Like all medications, this medication may have adverse effects, although not all people will experience them. The majority of these effects are mild.

If you believe you may be experiencing a severe adverse effect, consult your doctor immediately.

You may need to stop taking Tibicare:

• if you have high blood pressure
• if your skin or eyes turn yellow (jaundice)
• if you experience a sudden, severe headache (see Section 2)
• if you have signs of a blood clot (see Section 2)
• if you have any of the situations listed in Section 2 (Do not take Tibicare)

Other adverse effects

Frequent(affect 1 in 10 women):

• breast pain
• stomach or pelvic pain
• abnormal hair growth
• vaginal bleeding or spotting

This is normal in the first two months of receiving treatment with THS. If bleeding continues, or if it starts after initiating treatment with THS, see Section 2 “Irregular bleeding”

• vaginal discomfort such as discharge, itching, and irritation.
• inflammation of the vulva and vagina (vulvovaginitis)
• candidiasis
• thickening of the layer covering the uterus or cervix
• tissue changes in the cervix
• abnormal cervical discharge
• weight gain

Rare(affect 1 in 100 women):

• inflammation of hands, ankles, or feet – sign of fluid retention
• stomach discomfort
• acne
• sensitivity or pain in the breasts
• vaginal infections (mycosis)
• fungal infection

Very rare(affect 1 in 1,000 women):

• skin itching

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 test results

There have been reports of breast cancer and an 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 THS, the following adverse reactions have been reported:

• gallbladder disease
• skin disorders:
• skin discoloration, especially on the face or neck, known as “pregnancy mask” (melasma)
• painful, red nodules on the skin (erythema nodosum)
• eruption with redness or ulcers (erythema multiforme).

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special conditions for conservation.

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

Do not usethis medicationafter the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGREcollection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tibicare

• The active principle is tibolone.
• The other components are lactose monohydrate (see section 4. "Tibicare contains lactose"), mannitol, potato starch, ascorbyl palmitate, and magnesium stearate.

Appearance of the product and content of the container

Tibicare are white or off-white, round, 6 mm in diameter, beveled edge, and unmarked tablets.

They are presented in containers with 1, 3, or 6 blisters containing 28 or 30 tablets.

Only some container sizes may be commercially available.

Marketing authorization holder

Procare Health Iberia, S.L.

Avda. Miguel Hernandez 21, Bajo

46450 Benifaió (Valencia)

Spain

Responsible for manufacturing

Cenexi

17, rue de Pontoise

95520 OSNY

FRANCE

This medicine is authorized in the member states of the European Economic Area with the following names:

Pai's      Name of the medicinal product

Germany:      Tibelia 2.5 mg Tabletten

Belgium:      Tibelia 2.5 mg comprimés

Spain:      Tibicare 2.5 mg comprimidos EFG

France:      Tibolone CCD 2.5 comprimés

Netherlands:      Tibolon Mithra 2.5 mg tabletten

Luxembourg:      Tibelia 2.5 mg comprimés

United Kingdom:      Tibelia 2.5 mg tablets

Last review date of this leaflet: September 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)