TIBOCINA 2.5 MG Таблетки

Содержание инструкции

1. TIBOCINA 2,5 mg tablets
   1. What is Tibocina and what is it used for
   2. Cosa deve sapere prima di prendere Tibocina
   3. How to take Tibocina
   4. Possible side effects
   5. How to store Tibocina
   6. Contents of the pack and other information

TIBOCINA 2,5 mg tablets

Tibolone
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 they have the same symptoms as you, as it may 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 Tibocina is and what it is used for
• 2. What you need to know before you take Tibocina
• 3. How to take Tibocina
• 4. Possible side effects
• 5. How to store Tibocina
• 6. Contents of the pack and other information

1. What is Tibocina and what is it used for

Tibocina
The active ingredient is: tibolone.
Tibocina is a hormone replacement therapy (HRT). It contains the active ingredient tibolone, which has beneficial effects
on different tissues of organs in the body such as bones, brain and vagina. Tibocina is used in
women in postmenopause who have not had their menstrual cycle naturally in the last 12 months.
Tibocina is used for the following indications:

Relief of symptoms that appear after menopause
During menopause, the amount of estrogen produced by a woman’s body is reduced. This can
cause unwanted symptoms such as a feeling of heat on the face, neck and chest (“hot flashes”). Tibocina relieves
these symptoms after menopause. This medicine will only be prescribed to you if your symptoms
severely compromise your daily life.

Prevention of osteoporosis
After menopause, some women may develop brittle bones (osteoporosis). Discuss all treatment options
available with your doctor.
If your doctor has told you that you are at high risk of developing fractures due to a medical condition
called osteoporosis and other medicines are not suitable for you, you can start using Tibocina to
prevent osteoporosis after menopause.
There are three types of hormone replacement therapy:

• HRT based on estrogen alone
• Combined HRT, which contains two types of female hormones, known as estrogen and progestogen.
• Tibocina, which contains the active ingredient called tibolone.

Tibolone works differently from other types of hormone replacement therapies, as this medicine contains the active ingredient tibolone
instead of female hormones (i.e. estrogen and progestogens).
The body modifies tibolone to produce natural hormones. Its beneficial effects are similar to those
of combined HRT.

2. Cosa deve sapere prima di prendere Tibocina

For information on when you can start taking Tibocina (even after a hysterectomy, a surgical procedure to remove the uterus) see paragraph 3.

Medical history and regular check-ups
Hormone replacement therapy or treatment with Tibocina involves some risks, which must be considered when deciding whether to start or continue taking the medicine. This is particularly important if you are over 60 years of age.
Experience in treating women who have entered menopause prematurely (due to ovarian insufficiency or surgery) is limited. If you have entered menopause prematurely, the risks associated with hormone replacement therapy or the use of Tibocina may be different. Consult your doctor.

Before starting (or restarting) hormone replacement therapy or taking Tibocina
Your doctor will talk to you about your medical problems and family medical history. Your doctor may also decide to perform a physical examination. The latter may also include a breast exam and/or a pelvic exam, if necessary.
→ Tell your doctor if you suffer from any medical problems or illnesses.

Regular check-ups
Once you have started treatment with Tibocina, you must go to the doctor for regular check-ups (at least once a year). During these check-ups, discuss with your doctor the benefits and risks of continuing therapy with Tibocina.
Have a mammogram screening regularly, as recommended by your doctor.
Make sure you:

• have regular breast screeningand a Pap test
• Check your breasts regularlyfor any changes, such as skin dimples, changes in the nipple, or lumps that can be seen or felt

Do not take Tibocina:
If any of the conditions described below apply to your case, do not take this medicine. If you have any doubts about any of the points below, consultyour doctorbefore taking this medicine. Do not take this medicine:

• If you have or have ever had breast cancer in the past, or if you suspect you have it
• If you suffer from a form of cancer sensitive to estrogens, such as cancer of the uterine lining (endometrium), or if you suspect you have it
• If you have unexplained vaginal bleeding
• If you have excessive thickening of the uterine lining (endometrial hyperplasia) that has not been treated.
• If you have or have ever had a blood clot in a vein (thrombosis) in the past, for example in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism)
• If you suffer from a blood clotting disorder (such as protein C, protein S or antithrombin deficiency)
• If you suffer from or have recently suffered from a disease caused by blood clots in the arteries, such as heart attack, stroke or angina
• If you suffer from or have ever suffered from a liver disease and liver function test values have not returned to normal
• If you suffer from a rare blood disease called "porphyria", which is hereditary (inherited disease)
• If you are allergic to tibolone or any of the other ingredients of this medicine (listed in paragraph 6)
• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.

If any of the above conditions appear for the first time during treatment with Tibocina, stop taking it immediately and consult your doctor immediately.
If you have just entered menopause, you should not take Tibocina until 12 months have passed since your last natural period. If you start taking the medicine before this time, you may experience irregular bleeding.

Warnings and precautions
Talk to your doctor before taking Tibocina. Tell your doctor if you have ever suffered from any of the following conditions, as these may recur or worsen during treatment with Tibocina. In this case, your doctor will need to perform check-ups more frequently:

• uterine fibroids
• growth of the inner lining of the uterus outside the uterus (endometriosis), or a history of excessive growth of the uterine lining (endometrial hyperplasia)
• increased risk of developing blood clots (see “Blood clots in a vein [thrombosis]”)
• increased risk of developing an estrogen-sensitive tumor (e.g. if your mother, sister or grandmother has had breast cancer)
• high blood pressure
• a liver disease, such as a benign liver tumor
• diabetes
• gallstones
• migraine or severe headaches
• an autoimmune disease affecting multiple organs (Systemic Lupus Erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and impairing hearing (otosclerosis)
• a very high level of fats (triglycerides) in the blood
• fluid retention due to heart or kidney problems

For those who play sports: the use of the drug without a therapeutic need constitutes doping and may still result in positive doping tests.

Stop taking Tibocina and consult your doctor immediately:
if, during hormone replacement therapy or while taking Tibocina, you notice any of the following conditions:

• any of the conditions indicated in the paragraph “Do not take Tibocina”
• yellowing of the skin or whites of the eyes (jaundice). These may be signs of a liver disease
• a marked increase in blood pressure (symptoms may include headache, fatigue, dizziness)
• headaches similar to migraines that occur for the first time
• if you become pregnant
• if you notice signs of a blood clot, such as:
• painful swelling and redness of the legs
• sudden chest pain
• difficulty breathing For more information, see “Blood clots in a vein (thrombosis)”.

Note:Tibocina is not a contraceptive. If less than 12 months have passed since your last menstrual period or you are under 50 years of age, you may still need to use an additional contraceptive measure to prevent pregnancy. Ask your doctor for advice.

Hormone replacement therapy and cancer
Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial carcinoma)
Among women using tibolone, reports have been made of increased cell growth or cancer of the uterine lining. The risk of cancer of the uterine lining increases the longer you take the medicine.

Irregular bleeding
During the first 3-6 months of treatment with Tibocina, you may experience irregular bleeding or spotting (spotting). See your doctor as soon as possible if the bleeding or spotting:

• persists beyond the first 6 months
• starts after you have been taking Tibocina for more than 6 months
• persists even after you have stopped Tibocina →see your doctor as soon as possible.

Breast cancer
Evidence suggests that taking combined estrogen-progestin and possibly even estrogen-only hormone replacement therapy increases the risk of breast cancer. The additional risk depends on how long hormone replacement therapy has been started. The additional risk becomes evident within a few years. However, within a few years (maximum 5) after stopping treatment, it returns to normal.

Comparison
Women taking tibolone have a lower risk than women undergoing combined hormone replacement therapy and a similar risk in the case of estrogen-only hormone replacement therapy.

Check your breasts regularly. See your doctor as soon as possible if you notice any changes, such as:

• skin dimples or indentations
• changes in the nipple
• any lumps that are visible or can be felt →Make an appointment with your doctor as soon as possible.

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer. The use of estrogen-only or combined estrogen-progestin HRT 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 are not undergoing HRT, about 2 women out of 21,000 will be diagnosed with ovarian cancer within 5 years. For women who are undergoing HRT for 5 years, there will be about 3 cases per 2000 women treated (i.e. about 1 additional case).
With the use of Tibocina, the increased risk of ovarian cancer is similar to other types of hormone replacement therapy.

Effects of hormone replacement therapy 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 women undergoing hormone replacement therapy compared to women not undergoing it, especially during the first year of therapy.
Blood clots can be serious and if they move to the lungs, they can cause chest pain, shortness of breath, fainting or even death.
You are more likely to develop a blood clot in the veins as you get older and in the following cases. If any of these situations apply to you, tell your doctor:

• if you are pregnant or have recently given birth
• if you are taking estrogens
• if you cannot walk for a long time, due to major surgery, trauma or illness (see also paragraph 3, “In case of surgery”)
• if you are severely overweight (BMI >30 kg/m )
• if you suffer from any blood clotting disorder requiring long-term treatment with an anticoagulant
• if any of your close family members have ever had blood clots in the legs, lungs or other organs
• if you suffer from systemic lupus erythematosus (SLE)
• if you have cancer. For signs of a blood clot, see the paragraph “Stop taking Tibocina and consult your doctor immediately”.

Comparison
Considering women between 50 and 60 years of age not undergoing hormone replacement therapy, it is expected that on average, over a period of 5 years, 4 to 7 out of 1000 will develop a blood clot in a vein.
For women between 50 and 60 years of age undergoing estrogen-progestin hormone replacement therapy for more than 5 years, the cases will be 9 to 12 out of 1000 (i.e. 5 additional cases).
With the use of Tibocina, the increased risk of developing a blood clot in a vein is lower than with other types of hormone replacement therapy.

Heart disease (heart attack)
There is no evidence that hormone replacement therapy or tibolone prevents heart attack.
Women over 60 years of age undergoing estrogen-progestin hormone replacement therapy are slightly more likely to develop heart disease compared to those not undergoing any hormone replacement therapy.
Although the risk of heart disease depends strongly on age, the number of additional cases of heart disease due to the use of estrogen-progestin HRT is very low in healthy women approaching menopause, but will increase with age.
There is no evidence to suggest that the risk of myocardial infarction due to the use of Tibocina is different from the risk given by other HRT.

Stroke
Recent research suggests that HRT and tibolone slightly increase the risk of having a stroke.
The increase in risk has been seen especially in women over 60 years of age.
Other factors that can increase the risk of stroke include:

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

If you are concerned about any of these factors, see your doctor to see if you should take HRT.

Comparison
Considering women between 50 and 60 years of age who are not taking tibolone, it is expected that on average, over a period of 5 years, 3 women out of 1000 will suffer a stroke. For women between 50 and 60 years of age who are taking tibolone, the figure rises to 7 women out of 1000 (i.e. 4 additional cases).
Considering women between 60 and 70 years of agewho are not taking tibolone, it is expected that on average, over a period of 5 years, 11 women out of 1000will have a stroke.
For women between 60 and 70 years of agewho are taking tibolone, the figure rises to 24 out of 1000(i.e. 13 additional cases).

Other conditions and Tibocina
Hormone replacement therapy does not prevent memory loss. There is some evidence of an increased risk of memory loss in women who start hormone replacement therapy after the age of 65.
Ask your doctor for advice.
Tibocina is not indicated for use as a contraceptive.
Treatment with Tibocina causes a marked dose-dependent reduction in HDL cholesterol (from -
16.7% with a dose of 1.25 mg to -21.8% for the 2.5 mg dose after 2 years).
Triglyceride and lipoprotein(a) levels were also reduced. The reduction in total cholesterol and VLDL-C levels was not dose-dependent. LDL-C levels remained unchanged. The clinical
implication of these findings is not yet known.
Estrogens can cause fluid retention, and therefore patients with heart or kidney failure
should be carefully monitored.
Women with pre-existing hypertriglyceridemia should be carefully monitored during estrogen replacement or hormone replacement therapy, as rare cases of
significant increases in plasma triglycerides and subsequent pancreatitis have been reported with estrogen therapy in this situation.
Treatment with Tibocina causes a much smaller reduction in levels of thyroid-binding globulin
(TBG) and total T4. Total T3 levels are unchanged. Tibocina decreases the level of the globulin that
binds sex hormones (SHBG), while levels of corticosteroid-binding globulin (CBG) and circulating cortisol
remain unchanged.

Other medicines and Tibocina
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Some medicines can interfere with the effect of Tibocina. This could cause irregular bleeding. This applies to the following medicines:

• medicines against blood coagulation(such as warfarin)
• medicines for epilepsy(such as phenobarbital, phenytoin and carbamazepine)
• medicines for HIV infection(such as nevirapine, efavirenz, ritonavir and nelfinavir)
• medicines for tuberculosis(such as rifampicin)
• herbal remedies containing St John's wort( Hypericum perforatum)
• Midazolam (medicine for insomnia)
• Tolbutamide (medicine for diabetes)

Laboratory tests
If you are going to have a blood test, tell your doctor or healthcare staff that you are taking Tibocina,
as this medicine can affect the results of some tests.

Surgery
If you are going to have surgery, make sure you tell your doctor. It may be
necessary to stop taking HRT approximately 4-6 weeks before the surgery, to reduce the
risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

Tibocina with food and drink
During treatment with Tibocina you can eat or drink normally.

Pregnancy and breastfeeding
The use of Tibocina is reserved for postmenopausal women. If you become pregnant, stop
taking Tibocina and consult your doctor.
Do not take Tibocina if you are pregnant, if you think you may be pregnant or if you are breastfeeding.

Driving and using machines
Tibocina has no known effect on the ability to drive vehicles or use machines.

Tibocina contains lactose
If your doctor has told you that you have an intolerance to some sugars, consult him before taking this
medicine.
If you are concerned about any of the points discussed in this section, talk to your doctor about the risks and
benefits of hormone replacement therapy.

3. How to take Tibocina

Always take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, ask your doctor or pharmacist.

When you can start taking Tibocina

If you switch to Tibocina while taking another type of HRT
There are different types of HRT, for example, tablet formulations, patches and gels.
Most of these contain estrogens or an estrogen combined with progesterone. It is common
that with some types of HRT you may still have menstrual cycles while with others you do not and these latter are
called “HRT without menstruation”).
What to consider at the start of treatment with Tibocina
If you have entered menopause naturally, you should not start taking Tibocina until 1
year has passed since your last natural menstrual cycle. If, however, your ovaries have been surgically removed, you can
start taking Tibocina immediately.
If you want to start taking Tibocina and have had irregular or unexpected vaginal bleeding, contact your doctor before starting treatment with Tibocina, so that they can rule out
any malignant disease.
If you want to switch to Tibocina from a medicine containing an estrogen and a progestin, consult
your doctor to find out what you need to consider.

How much Tibocina to take and when
Unless otherwise prescribed by your doctor, the recommended dose is:
one tablet a day, preferably at the same time each day.
The doctor will ensure that you are prescribed the minimum dose to treat your symptoms, for the shortest time
possible. If you think this dosage is too high or too low, consult your doctor.
Do not take a progestin preparation in addition to Tibocina.

How to take Tibocina
Swallow the tablets with a little water or another drink, preferably at the same time each day.

If you are going to have surgery
If you are going to have surgery, tell the surgeon that you are taking Tibocina. You may
need to stop taking Tibocina about 4-6 weeks before the surgery, to
reduce the risk of a blood clot (see paragraph 2, “Blood clots in a vein
(thrombosis)”). Ask your doctor when you can start taking Tibocina again.

If you take more Tibocina than you should
Serious symptoms are unlikely, even if you take more than one tablet at a time. In case of
acute overdose, you may feel unwell (nausea), or feel sick (vomiting) and vaginal bleeding may
occur. If necessary, contact your doctor, so that these symptoms
can be treated.

If you forget to take Tibocina
If you forget to take a tablet at the usual time, take it as soon as possible, unless
more than 12 hours have passed since the missed dose. In this case, skip the missed tablet and
take the next tablet at the usual time. Do not take a double dose to make up for the
forgotten dose.
If you have any questions about using Tibocina, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Most side effects are mild.
The following conditions are reported more often in women undergoing hormone replacement therapy
than in those not undergoing hormone replacement therapy:

• breast cancer
• abnormal growth or tumor of the uterine lining (endometrial hyperplasia or endometrial cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• probable memory loss if hormone replacement therapy is started after the age of 65.

For more information on these side effects, see paragraph 2.

Tell your doctor or pharmacistif you are concerned about any side effects that you think may be due to Tibocina (see also paragraph 2 “Stop taking Tibocina and consult your doctor immediately”).

Serious side effects - consult your doctor immediately
If you think you have signs of a serious side effect, consult your doctor immediately.
You may need to stop taking Tibocina:

• if your blood pressure increases
• if the skin or whites of your eyes turn yellowish (jaundice)
• in case of sudden headaches similar to migraine (see paragraph 2 above)
• if you have signs of a blood clot (see paragraph 2 above)
• if any of the disorders listed in paragraph 2 (“Do not take Tibocina”) occur.

Other side effects
Common(affect up to 1 in 10 women):

• breast pain
• stomach or pelvic pain
• unusual hair growth
• vaginal bleeding or spotting. This generally does not represent a cause for concern in the first few months of hormone replacement therapy. If the bleeding continues, or starts after hormone replacement therapy has been followed for some time, see paragraph 2.
• vaginal problems, such as increased discharge, itching, irritation and thrush
• thickening of the uterine lining or the cervical lining
• weight gain.

Uncommon(affect up to 1 in 100 women):

• swelling of hands, ankles or feet - a sign of fluid retention
• stomach ache
• acne
• nipple pain or breast discomfort
• vaginal infections.

Rare(affect up to 1 in 1000 women):

• itchy skin

Some women taking Tibocina have also reported:

• depression, dizziness, headache
• joint or muscle pain
• skin disorders, such as rashes
• loss of vision or blurred vision
• changes in liver function tests.

In women using Tibocina, cases of breast cancer and increased growth of cells or tumors of the uterine lining have been reported.
→ If any of the side effects described above persists or becomes bothersome, tell your doctor.
The following side effects have been reported with other hormone replacement therapies:

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

If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system
at www.aifa.gov.it/content/segnalazione-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tibocina

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the package/blister after the wording
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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 Tibocina contains
The active ingredient is tibolone.
Each tablet contains 2.5 mg of tibolone.
The other ingredients are:
potato starch, lactose monohydrate, magnesium stearate (vegetable), ascorbyl palmitate.

Description of the appearance of Tibocina and contents of the pack
Tibocina is presented in the form of round, flat tablets, white to off-white in colour, with a diameter
of approximately 6 mm, packaged in PVC/PVDC/Al blisters.
Tibocina is available in packs of 1 x 28 tablets, 1 x 30 tablets and 3 x 28 tablets.

Marketing Authorisation Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturers
Aristo Pharma GmbH, Wallenroder Straβe 8-10, 13435 Berlin, Germany
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Denmark Tibocina
Finland Tibocina 2.5 mg tablets
Italy Tibocina 2.5 mg tablets
Norway Tibocina 2.5 mg tablets
Sweden Tibolinia 2.5 mg tablets