What Tibocina is and what it is used for
Tibocina
The active substance is tibolone.
Tibocina is used as hormone replacement therapy ( HRT ). The medicine contains the active substance tibolone, which has beneficial effects on various types of organ tissue, e.g. the skeleton, the brain, and the vagina. Tibocina is used in women who have passed menopause and have not had a natural menstrual cycle in the last 12 months.
Tibocina is used for:
Relief of symptoms that occur after menopause
During menopause, the level of estrogen produced by the woman’s body decreases. This can cause unwanted symptoms such as a feeling of warmth in the face, neck, and chest (“hot flushes”). Tibocina relieves these symptoms after menopause. Tibocina is only prescribed to you if your symptoms interfere with your daily life to a great extent.
Prevention of osteoporosis
After menopause, some women suffer from osteoporosis. Discuss all available options with your doctor.
If your doctor has told you that you are at increased risk of fracture due to a medical condition called osteoporosis and other medicines are not suitable for you, you can start taking Tibocina to prevent osteoporosis after menopause.
There are three types of hormone replacement therapy:
- Hormone replacement therapy with only estrogen
- Combined hormone replacement therapy that contains two types of the female hormone, estrogen, and progestin
- Tibocin contains the active substance tibolone.
Tibocina works differently than the other types of hormone replacement therapy because this medicine contains the active substance tibolone instead of actual hormones (eg estrogen and progestin ). The body breaks down tibolone to produce natural hormones. The beneficial effects are similar to the effects of combined hormone replacement therapy.
The tibolone contained in Tibocina may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Tibocina
In section 3 there is information about when you can start taking Tibocina (eg after hysterectomy).
Medical history and regular check-ups
The use of hormone replacement therapy or Tibocina involves risks that must be taken into account when deciding whether to start or continue treatment. This is especially important if you are over 60 years of age.
Experience in the treatment of women with a premature menopause (because the ovaries stopped working or because of surgery) is limited. If you have entered menopause early, there may be other risks with using hormone replacement therapy or Tibocina. Talk to your doctor.
Before starting (or restarting) hormone replacement therapy or Tibocina
The doctor will talk to you about your medical problems and any related diseases in the family. The doctor may want to do a physical exam. If necessary, this may include an examination of the breasts and/or a gynecological examination.
→ Tell the doctor if you have any medical conditions or illnesses.
Regular checks
Once you have started taking Tibocina, you should have regular check-ups with your doctor (at least once a year). At the check-ups, you and the doctor can discuss the benefits and risks of continuing to take Tibocina.
Go for a breast check (mammography) at regular intervals according to the doctor’s recommendation.
It is important that you:
- undergo regular breast checks and pap smears from the cervix
- Check your breasts regularly to notice changes such as dimpling of the skin, changes in the nipples, or lumps that you see or feel.
Do not take Tibocina
Do not take Tibocina if any of the following apply to you. If you are not sure about any of the points below, talk to your doctor before taking this medicine. Do not take this medicine:
- if you have or have had breast cancer or are suspected of having breast cancer.
- if you have estrogen-dependent cancer, e.g. cancer of the lining of the womb (endometrium), or there is suspicion of such cancer.
- if you have unexplained vaginal bleeding.
- if you have an untreated heavy growth of the lining of the uterus ( endometrial hyperplasia ).
- if you have or have had a blood clot in a vein ( thrombosis ), e.g. in the legs (deep vein thrombosis ) or the lungs ( pulmonary embolism ).
- if you have a blood clotting disorder (eg protein C, protein S or antithrombin deficiency).
- if you have or have recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke, or angina pectoris.
- if you have or have had liver disease and your liver values have not returned to normal.
- if you have the rare blood disorder porphyria which is hereditary.
- if you are allergic to tibolone or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or think you may be pregnant.
- if you are breastfeeding.
If any of the above occurs for the first time while taking Tibocina, stop taking the tablets immediately and contact the doctor.
If you have entered menopause, you should not take Tibocina until 12 months have passed since your last natural period. If you take it earlier than that, you may have irregular bleeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tibocina. Tell your doctor if you have ever had any of the following problems before starting treatment, as these may return or worsen while taking Tibocina. In this case, you should visit your doctor more often for check-ups:
- benign tissue lump in the uterus ( myoma )
- endometrium growing outside the uterus ( endometriosis ) or if you have ever had a strong growth of the endometrium ( endometrial hyperplasia )
- increased risk of blood clots (see “Blood clots in a vein ( thrombosis )”)
- increased risk of estrogen-dependent cancer (e.g. if your mother, sister, grandmother, or grandmother had breast cancer)
- high blood pressure
- liver disease, e.g. a benign liver tumor
- diabetes
- gallstone
- migraine or severe headache
- an autoimmune disease that affects many of the body’s organs (systemic lupus erythematosus, SLE )
- epilepsy
- asthma
- a disease that affects the eardrum and hearing (otosclerosis)
- very high blood fats ( triglycerides )
- fluid retention due to heart or kidney problems.
Stop taking Tibocina and see a doctor immediately
if you notice any of the following while taking hormone replacement therapy or Tibocina:
- any of the conditions mentioned in the section “Do not take Tibocina”
- yellowing of the skin or the whites of the eyes (jaundice) – may be a sign of liver disease
- greatly increased blood pressure (symptoms can be headache, fatigue, dizziness)
- migraine-like headache that occurs for the first time
- if you become pregnant
- if you notice anything that may indicate a blood clot, such as:
- painful swelling and redness of the legs
- sudden chest pain
- breathing difficulties.
- For more information, see “Blood clots in a vein ( thrombosis )”.
Note! Tibocina is not a contraceptive. If it’s been less than 12 months since your last period or you’re under 50, you may still need to use contraception to avoid pregnancy. Consult your doctor.
Hormone replacement therapy and cancer
Heavy growth of the lining of the uterus ( endometrial hyperplasia ) and cancer of the lining of the uterus (endometrial cancer)
There are reports of increased cell growth or endometrial cancer in women using tibolone. The risk of endometrial cancer increases the longer you take medicine.
Irregular bleeding
You may have irregular bleeding or spotting (spotting) during the first 3-6 months of Tibocina. Contact your doctor as soon as possible if the bleeding:
- lasts longer than the first 6 months
- starts after you have been taking Tibocina longer than 6 months
- continue even if you have stopped taking Tibocina.
→ See a doctor as soon as possible.
Breast cancer
Data show that treatment with tibolone increases the risk of breast cancer. The extra risk depends on how long you use tibolone. Studies of HRT show that when treatment is stopped, the increased risk decreases over time, but it may persist for 10 years or more if you have been using HRT for more than 5 years. There are no data on whether there is a residual risk after stopping treatment with tibolone, but a similar pattern cannot be excluded.
Compare
Women using tibolone have a lower risk of breast cancer than women using combined hormone replacement therapy and a comparable risk to women using estrogen alone.
Check your breasts regularly. Contact your doctor as soon as possible if you notice changes such as
- dimples or depressions in the skin
- nipple changes
- knots that you can see or feel→ Book a doctor’s appointment as soon as possible.
Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer. The use of estrogen -only or combined estrogen-progestin hormone replacement therapy has been associated with a slightly increased risk of ovarian cancer. The risk of ovarian cancer varies with age. For example, about 2 out of 2,000 women aged 50 to 54 who do not take hormone replacement therapy over 5 years will be diagnosed with ovarian cancer. For women who have been on hormone replacement therapy for 5 years, there will be about 3 cases per 2,000 users (ie about one extra case).
When using tibolone, the increased risk of ovarian cancer was similar to that of other types of hormone replacement therapy.
The effect of hormone replacement on the heart and blood circulation
Blood clots in a vein ( thrombosis )
The risk of blood clots in the veins is about 1.3 to 3 times higher among women who use hormone replacement than among non-users, especially during the first year of treatment.
Blood clots can be serious and if they travel to the lungs they can cause chest pain, shortness of breath, fainting, and even death.
The risk of a blood clot in a vein increases with age and if any of the following applies to you. Tell your doctor if any of the following apply to you:
- you are pregnant or have recently given birth
- you use estrogen
- you cannot walk for a longer period due to a major operation, injury or illness (see also section 3, “If you have to have an operation”)
- you are severely overweight ( BMI > 30 kg/m 2 )
- you have blood clotting problems that require long-term treatment with a medicine that prevents blood clots
- a close relative has had a blood clot in the leg, lung, or any other organ
- you have systemic lupus erythematosus ( SLE )
- you have cancer.
More about signs of blood clots can be found in the section “Stop taking Tibocina and see a doctor immediately”.
Compare
Among women in their 50s who do not use hormone replacement, an average of 4-7 in 1,000 can be expected to develop a blood clot in a vein over five years.
Among women in their 50s who have used estrogen and progestin hormone replacement for more than 5 years, 9–12 cases occur in 1,000 users (ie 5 additional cases).
When using Tibocina, the increased risk of a blood clot in a vein is lower than with other types of hormone replacement treatments.
Heart disease (heart attack)
There is no evidence that hormone replacement therapy or tibolone would prevent a heart attack.
Women over the age of 60 who use hormone replacement with estrogen-progestagen have a slightly greater risk of heart disease than those who do not use any hormone replacement. The risk of heart disease is strongly dependent on age. The number of extra cases of heart disease due to the use of estrogen-progestin hormone replacement is very low among healthy women near menopause but increases with age.
There are no research data to suggest differences in the risk of myocardial infarction between tibolone and other hormone replacement therapies.
Stroke
New research suggests that hormone replacement therapy and tibolone slightly increase the risk of stroke. The increased risk is mainly seen in women over 60. Other factors that can increase the risk of stroke are:
- Aging
- High blood pressure
- Smoking
- Heavy alcohol consumption
- Irregular pulse.
If you are worried about any of this, talk to your doctor to find out if you can take hormone replacement therapy.
Compare
Among women in their 50s not taking tibolone, an average of 3 in 1,000 can be expected to have a stroke over five years. Among women in their 50s taking tibolone, the figure is 7 in 1,000 (ie 4 additional cases).
Among women in their 60s not taking tibolone, an average of 11 in 1,000 can be expected to have a stroke over five years.
Among women in their 60s taking tibolone, the figure is 24 in 1,000 (ie 13 additional cases).
Other conditions and Tibocina
Hormone replacement therapy does not prevent memory loss. There is some evidence of a higher risk of memory impairment in women who start hormone replacement after age 65. Consult your doctor.
Tibocina is not intended for use as a contraceptive.
Treatment with Tibocina leads to a significant dose-dependent reduction in HDL cholesterol (from -16.7 % with a 1.25 mg dose to -21.8% with a 2.5 mg dose after 2 years). Total triglyceride and lipoprotein (a) levels also decreased. The reduction in total cholesterol and VLDL cholesterol was not dose-dependent. The levels of LDL cholesterol were unchanged. The clinical significance of these results is not yet known.
Estrogen can cause fluid retention and therefore patients with heart or kidney failure should be followed up closely.
Women with known hypertriglyceridemia (high levels of triglycerides in the blood) should be closely monitored during estrogen or hormone replacement therapy, as large increases in plasma triglyceride levels have been reported rarely to cause pancreatitis with estrogen therapy in this condition.
Treatment with Tibocina leads to a very small decrease in thyroxine-binding globulin and total T4 (the thyroid hormone thyroxine ). Total T3 (thyroid hormone triiodothyronine) levels are unchanged. Tibocina reduces the levels of sex hormone-binding globulin, while the levels of corticosteroid-binding globulin and cortisone in the bloodstream are unchanged.
Other medicines and Tibocina
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines can affect or be affected by Tibocina. It can lead to irregular bleeding. This applies to the following medicines:
- anti-clotting medicines (eg warfarin )
- medicines for epilepsy (eg phenobarbital, phenytoin, and carbamazepine)
- medicines for HIV infection (eg nevirapine , efavirenz, ritonavir and nelfinavir)
- anti-tuberculosis medicines (eg rifampicin)
- herbal remedies containing St. John’s wort ( Hypericum perforatum )
- midazolam (hypnotic)
- tolbutamide (diabetes medicine).
Laboratory tests
If you need to give a blood test, tell the doctor or laboratory staff that you are taking Tibocina because this medicine can affect the results of some tests.
Operations
If you are going to undergo an operation, your doctor must know about it. You may need to stop taking hormone replacement therapy about 4-6 weeks before surgery to reduce the risk of blood clots. The doctor will tell you when you can start taking hormone replacement therapy again.
Tibocina with food and drink
You can eat and drink as usual while taking Tibocina.
Pregnancy and breastfeeding
Tibocina is only intended for postmenopausal women. If you become pregnant, stop taking Tibocina and contact your doctor.
Do not take Tibocina if you are pregnant or think you may be pregnant or are breastfeeding.
Driving ability and use of machinery
Tibocina has no known effect on the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tibocina contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
Talk to your doctor about the risks and benefits of hormone replacement therapy if anything in this section worries you.
How to take Tibocina
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
When you can start taking Tibocina
| If it has been less than 12 months since your last natural menstrual cycle | Wait before you start taking Tibocina. (See Do not take Tibocina in section 2.) |
| If you switch from hormone replacement therapy without periods (see information below about this) | Start taking Tibocina right away. |
| If you have never used hormone replacement therapy before | |
| If you have been prescribed hormone replacement therapy because your uterus has been removed | |
| If you are being treated for endometriosis (growth of the lining of the uterus outside the uterus) | |
| If you switch from another type of hormone replacement therapy with periods (see information below about this) | Wait for the next menstrual cycle. Start taking Tibocina as soon as your period stops. |
If you switch from another type of hormone replacement therapy
There are many different types of hormone replacement therapy, e.g. tablets, patches, and gels. Most contain estrogen or a combination of estrogen and progestin. With some types of hormone replacement therapy, it is common for you to still have menstrual bleeding. With other types, you don’t bleed and these are called hormone replacement therapy without periods.
What you need to consider when starting Tibocina
If you have entered natural menopause, you should start Tibocina no earlier than 1 year after the last natural menstrual bleeding. If your ovaries have been removed, you can start Tibocina straight away.
If you want to start Tibocina and have had irregular or unexpected vaginal bleeding, you must contact the doctor treating you before starting Tibocina, so that malignant diseases can be ruled out.
If you want to switch to Tibocina from another medicine containing estrogen and progestagen, ask your doctor what you need to consider.
How much Tibocina to take and how often
Unless the doctor has prescribed otherwise, the recommended dose is:
One tablet daily. Ideally, it should be taken at the same time every day.
The doctor will prescribe the lowest possible dose to treat your symptoms for the shortest possible time. Talk to your doctor if you think dose one is too strong or not strong enough.
Do not take any progestagen preparation while taking Tibocina.
How to take Tibocina
Swallow the tablets with a little water or other drink, preferably at the same time every day.
If you have to have surgery
If you are going to have surgery, you must tell the surgeon that you are taking Tibocina. You may need to stop Tibocina 4-6 weeks before surgery to reduce the risk of blood clots (see section 2 “Blood clots in a vein”). Ask your doctor when you can start taking Tibocina again.
If you have taken too much Tibocina
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
It is unlikely that you would have severe symptoms even if you took more than one tablet at a time. In case of acute overdose, you may experience nausea or vomiting and slight bleeding from the vagina. If necessary, contact your doctor so that these symptoms can be treated.
If you forget to take Tibocina
If you have forgotten to take a tablet at the usual time, take it as soon as possible unless 12 hours have passed since the time you should have taken it. If more than 12 hours have passed, skip the tablet and take the next tablet at the usual time. Do not take a double dose to make up for a missed tablet.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild.
The following diseases are reported more often in women using hormone replacement therapy than in women not using hormone replacement therapy:
- breast cancer
- strong growth of or cancer in the lining of the uterus ( endometrial hyperplasia or endometrial cancer)
- ovarian cancer
- blood clots in the veins of the legs or lungs (venous thromboembolism )
- heart disease
- stroke
- probably impaired memory if the treatment is started after the age of 65.
More information about these side effects can be found in section 2.
Tell your doctor or pharmacist if you are worried about any side effects that you think may be due to Tibocina, see also section 2 “Stop taking Tibocina and see a doctor immediately”.
Serious side effects – seek medical attention immediately
If you think you have signs of a serious side effect, see a doctor immediately.
You may need to stop taking Tibocina:
- if your blood pressure rises
- if your skin or the whites of your eyes turn yellow (jaundice)
- if you suddenly get a migraine-like headache (see section 2 above)
- if you get signs of a blood clot (see section 2 above)
- if you get any of the problems listed in section 2 (“Do not take Tibocina”).
Other side effects ar
Common (may affect up to 1 in 10 users):
- pains in the chest
- pain in the stomach or pelvis
- abnormal hair growth
- bleeding from the vagina or spotting.
- This is usually nothing to worry about during the first few months of hormone replacement therapy. If the bleeding continues or if it starts after you have been taking hormone replacement therapy for a while, read section 2.
- genital problems such as increased discharge, itching, irritation, and fungal infection
- thickened lining of the uterus or cervix
- weight gain.
Uncommon (may affect up to 1 in 100 users):
- swollen hands, ankles, or feet – a sign of fluid retention
- upset stomach
- acne
- pain in the nipples or discomfort in the breasts
- vaginal infections.
Rare (may affect up to 1 in 1,000 users):
- skin itching.
Some women taking Tibocina have also reported:
- depression, dizziness, headache
- joint or muscle pain
- skin problems such as rashes
- visual impairment or blurred vision
- changed liver values.
There are reports of breast cancer and increased cell growth or endometrial cancer in women using Tibocina.
→ Tell the doctor if any of the side effects mentioned above do not stop or become troublesome.
The following side effects have been reported with other hormone replacement treatments:
- gallbladder disease
- various skin diseases:
- pigment change in the skin, especially on the face and neck, also called pregnancy spots (chloasma)
- painful red nodules in the skin (erythema nodosum or rosacea)
- skin rash with plaque-like redness or sores (erythema multiforme).
How to store Tibocina
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the blister and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is tibolone. Each tablet contains 2.5 mg of tibolone.
Other ingredients are potato starch, lactose monohydrate, magnesium stearate (vegetable), and ascorbyl palmitate.
Appearance and package sizes of the medicine
Tibocina is white to whitish, round and flat tablets with a diameter of approximately 6 mm, packaged in PVC/PVDC/Al blisters.
Tibocina is available in packs of 1 x 28, 1 x 30 and 3 x 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Aristo Pharma GmbH, Wallenroder Strasse 8-10, 13435 Berlin, Germany
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany