SIBOLONE TABLET

SIBOLONE TABLET 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. SIBOLONE TABLET 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.

SIBOLONE TABLET 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, SIBOLONE TABLET prevents osteoporosis in postmenopausal women by restoring oestrogen levels in the body and preventing bone loss and fractures.

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

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

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

If you are allergic to SIBOLONE TABLET or any other medicines, please tell your doctor. Avoid taking SIBOLONE TABLET if you are pregnant or breastfeeding and consult a doctor. SIBOLONE TABLET is not recommended for children. If you have premature menopause, inform your doctor before taking SIBOLONE TABLET so that the risks and benefits may be compared. Avoid taking SIBOLONE TABLET 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 SIBOLONE TABLET. You are recommended to avoid alcohol consumption with SIBOLONE TABLET 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 SIBOLONE TABLET and consult a doctor immediately as these might be signs of a blood clot.

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

Drug-Food Interaction: SIBOLONE TABLET 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 SIBOLONE TABLET.

• WARFARIN
• PHENYTOIN
• CARBAMAZEPINE
• PHENOBARBITAL
• RIFAMPICIN

• 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.

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

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.