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About TIBOLONE

TIBOLONE belongs to the class of medicines called synthetic steroids used to treat postmenopausal symptoms and prevent osteoporosis (weak and brittle bones) caused in menopausal women. TIBOLONE is a hormone replacement therapy (HRT). Postmenopause is a condition in which women have not had a period of 12 months or longer. The oestrogen levels decrease in postmenopausal women resulting in symptoms such as hot flushes (hot neck, face and chest). Osteoporosis is a bone disease that weakens and thins bones by decreasing bone density which is common in post-menopausal women.

TIBOLONE contains Tibolone which works by mimicking the activity of natural hormones progesterone, oestrogen and testosterone. Thereby, it reduces menopausal symptoms by restoring hormone levels in the body. Also, TIBOLONE prevents osteoporosis in postmenopausal women by restoring oestrogen levels in the body and preventing bone loss and fractures.

Take TIBOLONE as prescribed by your doctor. You are advised to take TIBOLONE for as long as your doctor has prescribed it for you based on your medical condition. In some cases, you may experience stomach pain, breast pain, vaginal bleeding or spotting, unusual hair growth, weight gain, vaginal itching or irritation. Most of these side effects of TIBOLONE do not require medical attention and gradually resolve over time. However, if the side effects persist or worsen, please consult your doctor.

If you are allergic to TIBOLONE or any other medicines, please tell your doctor. Avoid taking TIBOLONE if you are pregnant or breastfeeding and consult a doctor. TIBOLONE is not recommended for children. You are recommended to avoid alcohol consumption with TIBOLONE as it may increase the risk of breast cancer. If you have premature menopause, inform your doctor before taking TIBOLONE so that the risks and benefits may be compared.

Uses of TIBOLONE

Postmenopausal symptoms and prevent osteoporosis in a postmenopausal woman

Medicinal Benefits

TIBOLONE contains Tibolone, a hormone replacement therapy (HRT) used to treat postmenopausal symptoms and prevent osteoporosis (weak and brittle bones) caused by menopause in women. TIBOLONE mimics the activity of natural hormones progesterone, estrogen, and testosterone. Thereby restoring hormone levels in the body and reducing menopausal symptoms. Also, TIBOLONE prevents osteoporosis in postmenopausal women and prevents bone loss and fractures. The risk of breast cancer and blood clots is less with TIBOLONE than with other HRT.

Directions for Use

Take TIBOLONE with or without food as prescribed by your doctor. Swallow it as a whole with a glass of water. Do not break, crush or chew it.

Storage

Store in a cool and dry place away from sunlight

Side Effects of TIBOLONE

  • Stomach pain
  • Breast pain
  • Vaginal bleeding or spotting
  • Unusual hair growth
  • Weight gain
  • Vaginal itching or irritation

In-Depth Precautions and Warning

Drug Warnings

If you are allergic to TIBOLONE or any other medicines, please tell your doctor. Avoid taking TIBOLONE if you are pregnant or breastfeeding and consult a doctor. TIBOLONE is not recommended for children. If you have premature menopause, inform your doctor before taking TIBOLONE so that the risks and benefits may be compared. Avoid taking TIBOLONE if you have recently had a stroke, heart attack, or angina (chest pain).  If you have very high levels of fat (triglycerides) in blood, inform your doctor before taking TIBOLONE. You are recommended to avoid alcohol consumption with TIBOLONE as it may increase the risk of breast cancer. If you experience sudden chest pain, difficulty in breathing, or painful swelling and redness of your legs, stop taking TIBOLONE and consult a doctor immediately as these might be signs of a blood clot.

Drug Interactions

Drug-Drug Interaction: TIBOLONE may interact with a blood thinner (warfarin), anticonvulsants (phenytoin, carbamazepine, phenobarbital), and antitubercular drugs (rifampicin).

Drug-Food Interaction: TIBOLONE may interact with St. John’s wort (herbal medicine to treat depression).

Drug-Disease Interaction: If you have high blood pressure, gallstones, diabetes, migraine, epilepsy (fits), asthma, fluid retention due to kidney or heart problems, unexplained vaginal bleeding, breast cancer, liver disease, systemic lupus erythematosus (an autoimmune disease), estrogen-sensitive cancer, porphyria, fibroids in the womb, endometrial hyperplasia (excessive thickening of the womb lining), blood clotting disorder or blood clot in the vein, inform your doctor before taking TIBOLONE.

Drug-Drug Interactions Checker List:

  • WARFARIN
  • PHENYTOIN
  • CARBAMAZEPINE
  • PHENOBARBITAL
  • RIFAMPICIN
  • Safety Advice

    • Safety Warning

      Alcohol

      unsafe

      Avoid consumption of alcohol with TIBOLONE as it may increase the risk of breast cancer.

    • Safety Warning

      Pregnancy

      unsafe

      TIBOLONE is a category D pregnancy drug and is not recommended for pregnant women as it may harm the unborn baby. Please consult a doctor if you are pregnant.

    • Safety Warning

      Breast Feeding

      unsafe

      Avoid taking TIBOLONE if you are breastfeeding and consult a doctor.

    • Safety Warning

      Driving

      safe if prescribed

      TIBOLONE usually does not affect your ability to drive or operate machinery.

    • Safety Warning

      Liver

      caution

      Take TIBOLONE with caution, especially if you have a history of Liver diseases/conditions. The dose may be adjusted by your doctor as required.

    • Safety Warning

      Kidney

      caution

      Take TIBOLONE with caution, especially if you have a history of Kidney diseases/conditions. The dose may be adjusted by your doctor as required.

    • Safety Warning

      Children

      unsafe

      TIBOLONE is not recommended for children as it is intended for use in postmenopausal women.

    Habit Forming

    No

    Diet & Lifestyle Advise

    • Include dairy products like milk, yogurt, cheese, or milk-based custard in your diet.
    • Eat daily a serving of broccoli, cabbage, bok choy (Chinese white cabbage), spinach, and other green leafy vegetables.
    • Snack on calcium-rich nuts like Brazil nuts or almonds.
    • Sprinkle sesame seeds over your food, vegetables, and salads. Sesame seeds are high in calcium.
    • Avoid or reduce the intake of caffeine, soft drinks, and alcohol that inhibit calcium absorption.
    • Replace the meat with tofu or tempeh for extra calcium in your food.

    Special Advise

    • Regular breast screening is recommended while taking TIBOLONE.
    • Check your breasts regularly for any changes in the nipple, dimpling of the skin or any lumps. 

    Patients Concern

    Disease/Condition Glossary

    Hormone replacement therapy (HRT): It is a treatment to relieve menopause symptoms. It replaces hormones that are at a lower level as you approach menopause.

    Osteoporosis: It is a bone disease that weakens and thins bones by decreasing bone density. As the density of bones decreases, they weaken and are more likely to break. Post-menopausal women are more likely to develop osteoporosis than men because, at menopause, a woman’s ovaries stop producing estrogen (a female hormone) which is essential to keep bones healthy. Following menopause, bone loss occurs, making bones weak and more likely to break. Also, long-term use of steroids may affect bone strength and cause osteoporosis in both men and women. Signs and symptoms include back pain caused by a fractured or collapsed vertebra, loss of height over time, a stooped posture, and a bone that breaks much more easily than expected.

    FAQs

    How does TIBOLONE work?

    TIBOLONE contains Tibolone that works by mimicking the activity of natural hormones progesterone, oestrogen and testosterone. Thereby, restores hormone levels in the body and reduces menopausal symptoms and prevents osteoporosis (weak and thin bones) in postmenopausal women.

    Does TIBOLONE cause irregular bleeding?

    TIBOLONE may cause irregular bleeding or spotting (drops of blood) during the first 3 to 6 months of taking TIBOLONE. However, if the bleeding or spotting continues for more than 6 months or after discontinuing TIBOLONE, please consult a doctor immediately.

    Should I stop taking TIBOLONE before surgery?

    You may be advised to stop taking TIBOLONE about 4 to 6 weeks before surgery to decrease the risk of a blood clot. Therefore, inform your doctor that you are taking TIBOLONE before undergoing any surgery.

    Does TIBOLONE cause endometrial cancer?

    TIBOLONE may increase the risk of endometrial (lining of the womb) cancer especially if it is taken for a prolonged duration. Also, TIBOLONE may increase cell growth resulting in excessive thickening of the womb lining (endometrial hyperplasia).

    Is TIBOLONE a contraceptive?

    TIBOLONE is not a contraceptive. TIBOLONE is a hormone replacement therapy. Therefore, if you are less than 50 years old or if it is less than 12 months since your last period, you are advised to use additional contraceptive measures to avoid pregnancy. However, discuss with a doctor if you have any concerns regarding this.

    Available Medicines for

    TIBOLONE