• Relief from menopausal symptoms such as hot flushes, vaginal dryness, itching, low mood, and fatigue

• Prevention of osteoporosis in postmenopausal women, especially those at high risk of bone fractures

Tibolone, the active ingredient in Sibolone, acts like three hormones: estrogen, progesterone, and androgen and helps balance hormonal levels in postmenopausal women. This action reduces troublesome symptoms caused by the drop in natural estrogen levels and protects bones from weakening by maintaining bone density.

Some medicines may interact with Tibolone and affect how Sibolone works. Always inform your doctor if you are taking:

• Darunavir

• Lenalidomide

• Fulvestrant

• Raloxifene

• Mycophenolate mofetil

These interactions may increase your risk of blood clots or reduce the effectiveness of either medication.

• Store below 25°C in a cool, dry place, away from direct sunlight and moisture.

• Keep the tablets in their original packaging until it’s time to use them.

• Do not freeze.

• Keep out of reach of children and pets.

• Do not use the medicine after the expiry date mentioned on the pack.

• Dispose of unused or expired tablets responsibly, as per your pharmacist’s guidance.

Take one tablet daily, with or without food, preferably at the same time every day. Swallow the tablet whole with a glass of water. Do not chew or crush it. Do not stop taking it suddenly without your doctor’s advice, as it may affect treatment outcomes.

Like all medicines, Sibolone may cause some side effects. Most are mild and go away as your body adjusts. However, some may need medical attention.

Common side effects:

• Lower abdominal pain

• Breast tenderness

• Vaginal discharge or bleeding

• Genital itching

• Weight gain

• Abnormal hair growth

• Pelvic pain

• Endometrial hyperplasia (thickening of uterine lining)

• Cervical changes (e.g., cervical dysplasia, abnormal smear)

• Vaginal yeast infection

Serious symptoms needing immediate medical attention:

• Unusual vaginal bleeding

• Breast lumps

• Severe headaches or migraines

• Dizziness or fainting

• Chest pain or shortness of breath

• Swelling or pain in the legs (possible blood clot)

• Take Sibolone at the same time each day to help you remember and maintain consistent hormone levels.

• It is not a contraceptive. Use additional birth control if needed.

• It may cause irregular bleeding or spotting, report persistent symptoms to your doctor.

• Stop using the medicine and seek help if you develop severe headaches, swelling in one leg, or breathing difficulty.

• Regularly check your breasts for lumps and keep up with screening tests.

• Not suitable for women with a history of blood clots, liver problems, or breast cancer.

1. KD Tripathi, Essentials of Medical Pharmacology, Estrogens, Progestins and Contraceptives, 7th Edition, 2013, 306-311.
2. Mercury Pharmaceuticals Limited., Electronic Medicines Compendium (EMC), [Revised on September 2020] [Accessed on 20th Sept 2023] https://www.medicines.org.uk/emc/files/pil.4429.pdf
3. Steven R Cummings et al; The effects of tibolone in older postmenopausal women; published on Aug 2014; [Accessed on 20th Sept 2023]; https://pubmed.ncbi.nlm.nih.gov/18703472/