August 06 2020

TIBOLONE

List of brands containing tibolone   

This page contains list of brands of authorized pharmaceutical specialties of the active principle tibolone in the countries listed below:

Australia] [ Brazil] [ Canada] [ France] [ Germany] [ India] [ Italy] [ Japan] [ Mexico] [ Pakistan] [ Puerto Rico] [ Spain] [ Turkey] [ United Kingdom] [ U.S.A]

Given the nature of the pharmaceutical market, some specialties may be unavailable, have been removed from the pharmaceutical market or have changed its name. So that, in no case can take decisions based on the information contained on the page. MEDIZZINE is not responsible for any damage arising from the information provided, which may be incomplete or outdated.

Indications and usage     

At menopause (or after an operation to remove the ovaries or after certain drug treatments), the woman's body stops producing female hormones. From that moment, the patients may experience discomforts such as hot flashes, night sweats and changes in libido and mood.

Tibolone is in a group of drugs for hormonal replacement therapy, which solves most of the menopause symptoms. In case you have more than 60 years, your doctor will assess with you the benefits and risks of this drug.

The active substance tibolone is not a contraceptive and should not be used as such, nor restores fertility.

Medizzine recommends consulting your doctor if you are unsure (or you do not know) why you have been given tibolone.

Besides the active substance tibolone, the other ingredients are potato starch, lactose, ascorbyl palmitate and magnesium stearate

Warning:

The composition of the various presentations may vary from one country to another. We recommend you consult the information provided by your local supplier.

Important information     

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult him before taking.

Before taking the drug     

Do not use tibolone

If you are allergic (hypersensitive) to tibolone or any of the other ingredients of the medicinal product prescribed to you. If you think may be allergic, ask your doctor.

Allergy symptoms may include:

- Asthma attacks with shortness of breath, audible wheezing or rapid breathing.
- More or less sudden swelling of the face, lips, tongue or elsewhere in the body. It is especially critical if it affects the vocal cords.
- Hives, itching, rash
- Anaphylactic shock (loss of consciousness, paleness, sweating, etc.).

Nor you should take this medicine:

- If you have or have had breast or uterine cancer or if you suspect that you may have it
- If you are pregnant or you think may be pregnant
- If you are breastfeeding
- If you have an abnormal vaginal bleeding
- If you have endometrial hyperplasia (abnormal growth of the endometrium, the lining of the uterus) and are not treated
- If you have or have had a venous thrombosis (blood clots in the veins of the leg) or pulmonary embolism (blood clot in the legs veins which can be displaced up to the lungs)
- If you have any disorder that affects the blood clotting
- If you have or have recently had an arterial thrombosis (eg angina pectoris, myocardial infarction, stroke, transient ischemic attack or a retinal artery impairment )
- If you have or have had a serious liver disorder, until it does not return to normal
- If you have porphyria (a disease of blood pigment)

Take special care with tibolone

Before starting tibolone treatment, you should inform your doctor about your personal and family medical history. Your doctor will perform a thorough physical and gynecological examination before beginning treatment and periodically along its duration, especially breast.

Should see your doctor immediately if any of these conditions worse or appear while taking tibolone:

- Gynecological disorders of any kind
- Changes or alterations in the breast
- High levels of fat (triglycerides) in the blood or a family history of this
- Hypertension, particularly if it worsens or does not improve with antihypertensive therapy
- Disorders of the liver or kidney
- Diabetes
- Functional disorders of the gallbladder
- Headaches (migraines) intense and repetitive
- An immune disease called systemic lupus erythematosus
- Epilepsy
- Asthma
- Jaundice (yellowing of the skin and whites of the eyes)
- Pruritus (itching)

Do not exceed recommended doses

During treatment with hormone replacement therapy may occur more frequently some serious diseases such as blood clots (thrombosis) and some types of tumors.

Tumors

Endometrial cancer

There are reports and studies that have registered higher growth of endometrial cells or endometrial cancer (which is the layer of tissue that lines the uterus) in women treated with tibolone. This risk increases with increasing duration of treatment.

If you have bleeding or bloody spotting, usually you should not worry, especially if it is during the first months of treatment.

But if the bleeding or spotting:

- Lasts more than 6 months
- It starts when you are taking tibolone during more than six months
- It continues even if you stopped taking this medication

Consult your doctor, because it may be a sign that it has increased endometrial thickness.

Breast cancer

All women have a small chance of developing breast cancer. Hormone replacement therapy increases this risk, which is greater with increasing duration of treatment.

This risk returns to normal over the next 5 years after stopping treatment. Your doctor will advise you on how you can detect abnormalities in the breast and will perform regular checks throughout the treatment.

Ovarian cancer

Ovarian cancer is very rare but serious. It is difficult to detect, as there are no clear signs of the disease.

It has been observed that, during long-term treatment with estrogen (especially after 10 years of use), there is an increase of having a tumor in the ovaries.

Thrombosis (blood clots) and alterations of the circulation

All women have a small chance of having thrombosis (blood clots). The hormone replacement therapy increases this possibility and this increased risk is higher during the first year of use.

Blood clots can block major blood vessels. If the blood clot originates in the deep veins of the legs, it can break off and block the pulmonary arteries (pulmonary embolism). Blood clots also occur, although much less frequently, in the arteries of the heart (myocardial infarction, angina) in the cerebral arteries (cerebral thrombosis) or eyes (loss of vision or double vision).

Recent studies suggest that hormone replacement therapy and tibolone increase the risk of suffering a stroke. This increased risk has been observed in older postmenopausal women over 60 years old.

Some of the situations listed above imply an increased risk of blood clots, so you should not forget to tell your doctor if you have any of them.

If you identify the occurrence of any of the possible symptoms of a blood clot, notify it right away to your doctor.

These symptoms include:

- Pain and swelling in a leg
- An unusual cough, for example with blood sputum.
- Severe pain in the chest and sometimes in the arm
- Difficulty breathing
- A strong and unusual headache
- Partial or complete loss of vision or double vision
- Difficulty speaking clearly
- Dizziness or fainting
- Seizures
- Weakness or numbness affecting one part of the body
- Difficulty for walking or to hold things

The risk of blood clots may increase if you have to be immobilized for a time because of surgery or by other reasons. Therefore, in these cases, you should consult your doctor since it may be appropriate to interrupt the treatment until full recovery of mobility. If you are going to be subjected to an intervention and known in advance who will be in bed for a while, tell your doctor.

You should assess, together with your doctor, the potential benefits and risks, and how long should last the treatment. This should be checked periodically during the tibolone treatment.

The hormone replacement therapy should not be used to prevent heart disease, nor improves memory and intellectual ability, and might even make it worse if you have more than 65 years.

Remember that your doctor has prescribed this medicine only for you. Never give it to someone else.

If in doubt, consult your doctor.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal products or drugs obtained without a prescription.

Especially, tell your doctor or pharmacist if you are taking:

Other medicines may influence the effects of tibolone or vice versa:

- Drugs for clotting problems, such as warfarin as it may be necessary to adjust the dose of these medicines
- Midazolam (medicine for insomnia)

Tibolone should not be taken together with other medicines for hormone replacement therapy.

Note that this information may also apply to drugs that have been taken before or can be taken after tibolone therapy.

Use with food and beverages

You can eat and drink normally while taking this medicine.

Consult your doctor or pharmacist before taking any medicine.

Special physiological situations

Pregnancy and lactation

always consult your doctor or pharmacist before taking any medicine during pregnancy or lactation.

Do not take tibolone if you are pregnant or you plan to become pregnant.

Do not take tibolone if you are breastfeeding.

Children

Tibolone is not indicated in children

Driving and using machines

There have not been reported adverse effects of tibolone on the ability to drive or operate machinery.

How to use tibolone     

Follow carefully instructions of use of tibolone provided from your doctor. Consult your doctor or pharmacist when in doubt. Follow the instructions of the physician in preference to those given in this website, which may be different. Ask your doctor to explain any aspect that you do not understand, contained in the instruction leaflet that comes with the medicine.

Tibolone should not be taken until two months after the last natural menstruation. If taken before, may be increased the possibility of having an irregular vaginal bleeding.

Taking tibolone for the first time

- If you have not taken any other drug for hormone replacement therapy before, you can start immediately.

If you switch from another preparation for hormone replacement therapy:

There are several types of medicines such as tablets, patches, or gels. With some of them, you may have bleeding between cycles (sequential) and others are taken continuously.

If you were taking a sequential medicine, you should start taking tibolone immediately after the end of bleeding. If you were taking a continuous medicine (no bleeding) you may also start taking it at any time.

Tibolone should be taken orally. Take one tablet every day, which can be swallowed with some water or other drink.

Take the tablets at the same time each day. The blisters (containing each one a tablet) are marked with the corresponding day of the week

Start by taking the tablet marked with the correspondent day of the week. For example, if it's Monday, take the tablet marked Monday on the upper row of the blister. Follow the arrows until the blisters are empty. Start the next strip the next day. Do not leave any day between blisters or boxes.

Relief of menopausal symptoms generally occurs during the first weeks of treatment, and optimal results are obtained if the treatment continues for at least 3 months.

If you think the effect of the medicine is too strong or too weak, consult your doctor.

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

While you take tibolone     

If a doctor prescribes another medicine, tell you are taking tibolone.

Check with your doctor regularly developments of disorder that motivates the use of tibolone. Maybe there is some reason that prevented you properly receive the indicated doses and induce your doctor to erroneous conclusions about treatment.

Do not restart treatment with tibolone at your own risk without first talking to your doctor, nor encourage its use by another person, even if have the same symptoms you have. Nor is it advisable to interrupt or reduce the dose without considering the opinion of your doctor.

If you feel unwell during treatment with tibolone, immediately consult your doctor.

If you take more than you should:

If you have taken more medicine than you should, consult a doctor or pharmacist immediately.

If someone takes too many tablets there is no need for alarm. However, you should talk to your doctor as soon as possible. Signs of overdose may include feeling unwell or ill or have a vaginal bleeding.

If you forget to take tibolone

If you forget to take a tablet, take it as soon as you remember unless it has been more than 12 hours after the last dose. In this case, just leave to take it that day. Do not take a double dose to make up for missed doses.

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

Side Effects of tibolone     

Like all medicines, tibolone can cause side effects although not everybody gets them.

The frequency of side effects is classified into:

Very common: affect 1 out of 1-10 patients
Common: affect 1 out of 10-100 patients
Uncommon: affect 1 out of 100-1.000 patients
Rare: affect 1 out of 1.000-10.000 patients
Very Rare: affect less than 1 in 10,000 patients
Incidence not known: Can not be established the true incidence from the available data

Most of these effects are mild.

Adverse effects observed in clinical trials are:

Common side effects

- Vaginal bleeding or spotting
- Abdominal pain
- Weight gain
- Breast pain
- Unnatural hair growth
- Vaginal discomfort and discharge, itching and irritation.

Uncommon side effects

- Acne

Vaginal bleeding or spotting, abdominal pain and breast pain occur mainly during the first months of treatment and then disappear.

Also have been observed other adverse effects with general use such as:

- Dizziness, headache, migraine, depression
- Rash, itching
- Impaired vision
- Stomach upset
- Fluid retention (swelling of the legs)
- Muscular or joint pain
- Changes in laboratory tests of liver function

Serious adverse reactions:

- Increased risk of thrombosis (blood clots)
- Increased risk of certain tumors

There are reports and studies that have registered higher growth of endometrial cells or endometrial cancer in women treated with tibolone

Tell your doctor if vaginal bleeding or spotting occurs, or if any of the above symptoms is upset or continuous.

This list does not include all adverse reactions associated with the use of tibolone, both well established as those that are under consideration or confirmation. In case you feel unwell, should immediately consult with the doctor who prescribed this medicine.

If you notice any side effects not listed in this website or in the leaflet accompanying the package, ask your doctor or pharmacist.

If any of the side effects gets serious, tell your doctor or pharmacist.

List of brands containing tibolone     

This page contains list of brands of authorized pharmaceutical specialties of the active principle tibolone in the countries listed below:

Australia] [ Brazil] [ Canada] [ France] [ Germany] [ India] [ Italy] [ Japan] [ Mexico] [ Pakistan] [ Puerto Rico] [ Spain] [ Turkey] [ United Kingdom] [ U.S.A]

Given the nature of the pharmaceutical market, some specialties may be unavailable, have been removed from pharmaceutical market or have changed its name. So that, in no case can take decisions based on the information contained in the page. MEDIZZINE is not responsible for any damage arising from the information provided, which may be incomplete or outdated.

Warning:

With exceptions expressly indicated, these lists do not include active principle associations with other drugs or clinical use containers.

Australia:     

LIVIAL 2.5 mg, 10-28 tablets
XYVION 2.5 mg, 28 tablets

Brazil:     

KLIMATER 2.5 mg, 28 tablets
LIBIAM 1.25 mg, 28 tablets
LIBIAM 2.5 mg, 28 tablets
LIVIAL 2.5 mg, 28 tablets
LIVOLON 1.25 mg, 30 tablets
LIVOLON 2.5 mg, 30 tablets
REDUCLIM 1.25 mg, 28 tablets
REDUCLIM 2.5 mg, 28 tablets
TIBIAL 2.5 mg, 28 tablets

Canada:     

N/A

France:     

LIVIAL 2.5 mg, tablets

Germany:     

LIVIELLA 2.5 mg, 28 tablets
LIVIAL 2.5 mg, 28 tablets
TIBOLON ARISTO 2.5 mg, 28 tablets

India:     

LIVIAL 2.5 mg, 28 tablets
MAZTIB 2.5 mg, 14 tablets
SIBOLONE 2.5 mg, 15 tablets
TIBOFEM 2.5 mg, 14 tablets
TIBOMAX 2.5 mg, 10 tablets

Italy:     

LIVIAL 2.5 mg, 30 tablets

Japan:     

N/A

Mexico:     

ANALOBIT 2.5 mg, 30 tablets
BONTIL 2.5 mg, 30 tablets
LISERTIL 2.5 mg, 30 tablets
LIVIAL 2.5 mg, 30 tablets
SINTEMEL 2.5 mg, 30 tablets

Pakistan:     

LIVIAL 2.5 mg, tablets
LOBION-HRT 2.5 mg, tablets
TIBOPAUSE 2.5 mg, tablets

Spain:     

BOLTIN 2.5 mg, 28 tablets

Turkey:     

LIVIAL 2.5 mg, 28 tablets

United Kingdom:     

LIVIAL 2.5 mg, 28 tablets

U.S.A. and Puerto Rico:     

ND

Page updated: December 13, 2010.