What Tibolon Mylan is and what it is used for
Tibolone Mylan 2.5 mg tablets
The active substance is tibolone.
Tibolone Mylan is used as hormone replacement therapy ( HRT ). Tibolone Mylan is used in women whose menstruation has stopped ( menopause ), at least 12 months after their last natural period.
Tibolone Mylan is used to:
Relieve symptoms during and after menopause
When menstruation stops ( menopause ), the woman’s estrogen drops. It can cause problems such as sweating and hot flashes. Tibolone Mylan relieves these symptoms after menopause. Tibolone Mylan should only be used if the symptoms cause problems in daily life.
Prevent osteoporosis
After menopause, some women suffer from osteoporosis. Discuss all possible options with your doctor.
If you have an increased risk of fractures (broken bones) and other medicines are not suitable for you, you can use Tibolon Mylan to prevent osteoporosis after menopause.
The tibolone contained in Tibolon Mylan 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 taking Tibolon Mylan
Medical background and regular check-ups
The use of HRT or Tibolon Mylan involves risks that must be taken into account when deciding to start treatment or continue an ongoing treatment.
Experience is limited for the treatment of women whose menstruation has stopped prematurely (when the ovaries have stopped working or the uterus has been surgically removed). If you belong to that group, the risks of HRT or Tibolon Mylan may be different. Talk to your doctor.
Before starting treatment (or resuming treatment) with HRT or Tibolon Mylan
Your doctor will ask about your own, and your family’s, medical background. Your doctor may want to perform a physical exam. This may include an examination of your breasts and/or a gynecological examination, if necessary.
→ Tell the doctor if you have any medical conditions or illnesses.
Regular checks
When you have started treatment with Tibolon Mylan, you must go for regular medical check-ups, at least once a year. During these checks, you must discuss with the doctor the benefits and risks of continued treatment.
Do regular breast examinations as recommended by your doctor.
Do not take Tibolone Mylan
If any of the following apply to you, you should not take this medicine. Talk to your doctor before taking Tibolon Mylan if you are not sure.
- If you have or have had breast cancer or there is a suspicion that you may have it
- If you have or have had estrogen-dependent cancer, such as cancer of the lining of the womb (endometrium), or if such cancer is suspected.
- If you have unexpected vaginal bleeding.
- If you have endometrial hyperplasia ( severe thickening of the lining of the uterus ) and are not being treated for it.
- If you have or have had blood clots in a vein (venous thromboembolism ), in the legs (deep vein thrombosis ), or the lungs ( pulmonary embolism ).
- If you have a coagulation disorder, a condition with an increased risk of blood clots (lack of protein C, protein S, or antithrombin).
- 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 any liver disease and still have abnormal liver values.
- If you have porphyria, a rare inherited blood disorder.
- If you are allergic to tibolone or any of the other ingredients of this medicine (listed in section 6).
If any of the above affects you the first time you use Tibolon Mylan, stop taking Tibolon Mylan and contact your doctor immediately.
If you have entered menopause, you should not take Tibolon Mylan 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 if you have or have had any of the following problems before starting treatment. They may recur or worsen during treatment with Tibolon Mylan. Should this occur, you should have more frequent check-ups with a doctor:
- muscle knots in the uterus ( myoma )
- growth of the lining of the uterus outside the uterus ( endometriosis ) or previously had a strong thickening of the lining of the uterus ( endometrial hyperplasia )
- if you have an increased risk of blood clots (see below “Blood clots in a vein ( thrombosis )”)
- increased risk of getting estrogen-sensitive cancer (mother, sister, or grandmother who has had breast cancer)
- high blood pressure
- liver disease, such as a benign liver tumor
- diabetes
- gallstone
- migraine or severe headache
- systemic lupus erythematosus ( SLE ) – is an autoimmune disease that attacks many organs in the body
- epilepsy
- asthma
- a disease that affects the eardrum and hearing (otosclerosis)
- a very high level of blood fats ( triglycerides )
- fluid retention due to heart or kidney disease.
You should immediately contact a doctor and stop treatment if any of the following occur:
- Any of the things mentioned in the section ‘Do not take Tibolon Mylan’
- If the skin or whites of the eyes turn yellow (jaundice); it could be symptoms of liver disease
- If your blood pressure rises sharply (symptoms may include headache, tiredness, or dizziness)
- If you get a migraine-like headache for the first time
- If you become pregnant
- If you get symptoms of blood clots, such as
- painful swelling and redness of the legs
- sudden chest pain
- breathing difficulties. For further information, see below “Blood clots in a vein ( thrombosis )”
Please note: Tibolon Mylan is not a contraceptive. If it has been less than 12 months since your last period, or if you are under 50, you may still need to use contraception to avoid pregnancy. Consult your doctor.
HRT and cancer
Strong thickening 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 Tibolon Mylan. The risk of endometrial cancer increases the longer you take the medicine.
Irregular bleeding
Irregular spotting or spotting may occur during the first 3-6 months of taking Tibolon Mylan. But about the bleeding:
- lasts longer than 6 months
- starts after you have taken Tibolon Mylan for 6 months
- continues after you stop taking Tibolon Mylan
you should see a doctor as soon as possible.
Breast cancer
Data show that treatment with tibolone increases the risk of breast cancer. The risk depends on the treatment time. The extra risk depends on how long you use tibolone. In studies with HRT, once treatment is stopped the additional 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 discontinuation of tibolone but a similar pattern cannot be excluded.
Comparison
Women using Tibolon Mylan have a lower risk than those using combined HRT and a comparable risk to estrogen-only HRT.
Check your breasts regularly. Contact a doctor if you notice changes such as
- indentations or pits
- nipple changes
- lumps you can see or feel
Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer. The use of estrogen-only or combined estrogen-progestogen HRT has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, the diagnosis of ovarian cancer will be given to around 2 women out of 2,000 aged 50 to 54 over 5 years. For women who have been taking HRT for 5 years, there will be 3 cases per 2,000 users (ie about 1 extra case).
When using Tibolon Mylan, the increased risk of ovarian cancer was similar to that of other types of HRT.
How HRT affects the heart and blood circulation
Blood clots in a vein ( thrombosis )
The risk of blood clots in the veins is 1.3-3 times higher for women who take HRT than for those who do not, especially during the first year of treatment.
Blood clots can be serious. If a blood clot ends up in the lungs, it can cause chest pain, shortness of breath, fainting, or 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:
- if you are pregnant or have recently given birth
- if you use estrogen
- if you cannot walk or stand for a long time due to a major operation, injury or illness (see also section 3, “If you need an operation”)
- if you are severely overweight ( BMI over 30 kg/m 2 )
- if you have a coagulation disorder that requires long-term treatment with medicines that prevent blood clots
- if a close relative has had a blood clot in a leg, lung, or another organ
- if you have SLE (systemic lupus erythematosus)
- if you have cancer.
The symptoms of blood clots are described in the section “You should immediately contact a doctor and stop the treatment”.
Comparison
For women in their 50s who do not take HRT, over a 5-year period an average of 4-7 in 1,000 are expected to have a blood clot in a vein.
For women in their 50s who have been taking estrogen-progestogen HRT for more than 5 years, 9-12 out of 1,000 users are expected to have a blood clot in a vein (ie 5 extra cases).
For women using Tibolon Mylan, the increased risk of getting a blood clot in a vein is lower than for other types of HRT.
Heart disease (heart attack)
There is no evidence that HRT or Tibolon Mylan prevents heart attacks.
For women over 60 who take HRT with estrogen-progestogen, the risk of developing heart disease is slightly higher than for those who do not take HRT. As the risk of heart disease is strongly age-dependent, the number of extra cases of heart disease due to the use of HRT with estrogen-progestin is deficient in healthy women close to menopause but increases with increasing age. There is no evidence that the risk of heart attack with tibolone differs from the risk of other HRT.
Stroke
Recent research indicates that HRT and tibolone slightly increase the risk of having a stroke. The increased risk is seen above all in women over 60.
Comparison
For women in their 50s, who do not take tibolone, over 5 years, an average of 3 in 1,000 are expected to have a stroke. For women in their 50s taking tibolone, the corresponding figure is 7 in 1,000 (ie 4 extra cases).
For women in their 60s, who do not take tibolone, over 5 years, an average of 11 in 1,000 are expected to have a stroke. For women in their 60s taking tibolone, the corresponding figure is 24 out of 1,000 (ie 13 extra cases).
Other conditions and Tibolone Mylan
HRT use does not prevent memory loss. The risk of memory loss may be slightly higher in women who start using HRT after the age of 65. Consult your doctor.
Tibolone Mylan is not intended as a contraceptive.
Other medicines and Tibolon Mylan
Some medicines can affect the effect of Tibolon Mylan, which can lead to irregular bleeding. This applies to the following:
- anti-clotting drugs (eg warfarin )
- mdrugsfor epilepsy (eg phenobarbital, phenytoin, and carbamazepine)
- medicines for HIV infection (eg nevirapine , efavirenz, ritonavir and nelfinavir)
- anti-tuberculosis medicines (eg rifampicin)
- herbal medicines containing St. John’s wort ( Hypericum perforatum ).
Tibolone Mylan can affect the effectiveness of certain medicines such as midazolam.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to non-prescription drugs and herbal remedies.
Results from blood test analyses
If you need to have a blood test, you should tell the doctor, or whoever is taking the blood test, that you are taking Tibolon Mylan as it may affect the results of some tests.
Pregnancy and breastfeeding
Tibolone Mylan is intended for women whose menstruation has stopped. If you should become pregnant, stop taking Tibolon Mylan and contact your doctor.
Driving ability and use of machinery
Tibolone Mylan 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.
Tibolone Mylan contains lactose
If you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
Talk to your doctor about the risks and benefits of hormone replacement therapy if anything in this section worries you.
How to take Tibolon Mylan
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
How much Tibolon Mylan you should take and how often
The recommended dose is one tablet daily, preferably at the same time each day.
The doctor aims for you to take the lowest dose that gives you symptom relief and for you to use Tibolon Mylan for the shortest possible time. Talk to your doctor if you do not get any relief from your symptoms, or feel that dose one would be too high.
Do not take any progestagen preparation while taking Tibolon Mylan.
How to take Tibolone Mylan
You should take the tablets with some water or other drink, without chewing, at about the same time each day.
What you should consider before starting treatment with Tibolon Mylan:
If the menopause occurred naturally, you should take Tibolon Mylan no earlier than 1 year after your last natural bleeding. If your ovaries have been surgically removed, you can start treatment with Tibolon Mylan immediately.
If you wish to take Tibolon Mylan and have had irregular or unexpected vaginal bleeding, contact your treating physician before starting treatment with Tibolon Mylan. This is to rule out malignant disease.
If you want to switch to Tibolon Mylan from a medicine that contains estrogen or progestagen, contact your doctor.
If you need surgery
If you are going to have surgery, you must inform the operating doctor that you are taking Tibolon Mylan. You may need to stop taking Tibolon Mylan for 4 to 6 weeks before surgery to avoid the risk of blood clots, see section 2, “Blood clots in a vein ( thrombosis ). Ask the doctor when it is appropriate to start taking Tibolon Mylan again.
If you feel that the effect of Tibolon Mylan is too strong or weak, consult your doctor or pharmacist.
If you have taken too much Tibolon Mylan
If you have ingested too much medicine or for example, a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
Poisoning symptoms are not expected to occur even when several tablets are taken at the same time. In case of acute overdose, you may experience nausea, vomiting, and bleeding from the vagina. If necessary, contact your doctor so that these symptoms can be treated.
If you forget to take Tibolon Mylan
If you forget to take a tablet, take it as soon as possible if it has been less than 12 hours since 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 dose.
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 more common in women who take HRT than those who do not:
- Breast cancer
- Severe thickening of the lining of the uterus ( endometrial hyperplasia ) or cancer of the lining of the uterus (endometrial cancer)
- Ovarian cancer ( ovarian cancer )
- Blood clots in veins in legs or lungs (venous thromboembolism )
- Heart disease
- Stroke
- Probable memory loss, if treatment with HRT is started after the age of 65
See section 2 for more information about these side effects.
Tell your doctor or pharmacist if you are worried about any side effects that you think may be due to Tibolon Mylan (see also section 2, You should contact your doctor immediately and stop treatment).
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 Tibolon Mylan:
- 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 Tibolon Mylan).
Other side effects ar
Common (may affect up to 1 in 10 women):
- 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.
- problems in the vagina 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 women):
- swelling of the hands, ankles, or feet – signs of fluid retention
- stomach upset
- acne
- nipple pain or breast discomfort
- infection in the vagina.
Rare (may affect up to 1 in 1,000 women):
- skin itching
Some women taking Tibolon Mylan have also reported:
- depression, dizziness, headache
- joint or muscle pain
- skin problems such as rash or itching
- visual impairment or blurred vision
- changed liver values
- point-shaped bleeding in the skin ( vascular purpura)
There are reports of breast cancer and increased cell growth or endometrial cancer in women using Tibolon Mylan.
→ Tell the doctor if any of the side effects mentioned above do not stop or become troublesome.
The following side effects have been reported for other HRT:
- Gallbladder disease
- Various skin diseases:
- dark skin spots, especially on the face and neck, so-called “pregnancy spots” (chloasma)
- painful red-purple bumps on the skin (erythema nodosum)
- ring-shaped reddened or ulcerated rash (erythema multiforme)
If you experience side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this information.
How to store Tibolon Mylan
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton/blister after Exp. The expiration date is the last day of the specified month.
Do not use this medicine if the blister pack is damaged or missing, even if the outer packaging is intact.
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.
This medicine has no special storage instructions.
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, and ascorbyl palmitate. See section 2, “Tibolon Mylan contains lactose”.
Appearance and package sizes of the medicine
Tibolone Mylan is a white to whitish, flat, and round tablet with a diameter of approximately 6 mm.
Tibolone Mylan is available in calendar packs of 28 tablets, 30 tablets, and 3 x 28 tablets.
Marketing Authorisation Holder
Mylan AB
Box 23033
113 35 Stockholm
Manufacturer
Aristo Pharma GmbH
Wallenroder Str. 8-10
13435 berlin
Germany
and
Mylan Hungary Kft./Ltd.
Mylan utca 1.
2900 Komáron
Hungary