Sibolone Tab

SIBOLONE TAB by SERUM INSTITUTE OF INDIA DIV I

Sibolone Tablet is a medication used in hormone replacement therapy (HRT) for post-menopausal women. It is manufactured by Serum Institute of India Ltd.

• Composition Each tablet contains Tibolone I.P. 2.5 mg. Tibolone is a synthetic steroid hormone that mimics the activity of natural hormones like estrogen, progesterone, and androgen in different tissues.

• Uses Sibolone Tablet is primarily prescribed for:

  • Managing post-menopausal symptoms such as hot flashes, night sweats, vaginal dryness, painful sexual intercourse, and mood swings.
  • Preventing osteoporosis in post-menopausal women who are at a high risk of fractures and are intolerant of or contraindicated for other medicinal products approved for osteoporosis prevention.
  • Addressing genitourinary symptoms associated with menopause and preventing endometrial atrophy.

• Dosage and Administration The typical dosage is one tablet per day. Sibolone Tablet should be swallowed whole with water, preferably at the same time each day, and can be taken with or without food. The dose and duration of treatment will be determined by a doctor based on the patient's condition and response.

  • For natural menopause, treatment should begin at least 12 months after the last natural menstrual bleed.
  • For surgical menopause, treatment may commence immediately.
  • If a dose is missed, it should be taken as soon as remembered, unless it is more than 12 hours overdue. In such a case, the missed dose should be skipped, and the next dose taken at the regular time.

• Side Effects Common side effects may include:

  • Vaginal bleeding or spotting.
  • Breast tenderness or pain.
  • Headache, dizziness.
  • Nausea and vomiting.
  • Weight gain.
  • Mood changes.
  • Skin rash or itching.
  • Lower abdominal pain, abnormal hair growth, vaginal discharge, pelvic pain, cervical thickening, endometrial hyperplasia, genital itching, and vaginal yeast infection.

  Serious side effects that require immediate medical attention include:

  • Breast lumps.
  • Unusual vaginal bleeding.
  • Severe headaches, dizziness, or faintness.
  • Chest pain, shortness of breath.
  • Painful swelling and redness in the legs (signs of a blood clot).

• Precautions

  • Sibolone Tablet is contraindicated during pregnancy and breastfeeding.
  • It is not recommended for use in children.
  • Avoid taking Sibolone Tablet if there is a history of breast cancer, endometrial cancer, abnormal genital bleeding, severe liver disease, or arterial thromboembolic disease (such as stroke or heart attack).
  • Caution is advised with alcohol consumption, as it may increase the risk of breast cancer.
  • Use with caution in patients with kidney disease, mild to moderate liver impairment, or high levels of blood fat (triglycerides).
  • Inform the doctor about any other medications being taken, as Sibolone Tablet may interact with oral anticoagulants, antiepileptic medicines, and some HIV medications.
  • Do not stop the medication abruptly without consulting a doctor.
  • Inform your doctor if you have premature menopause.

• Storage Store Sibolone Tablet below 30°C (some sources suggest below 25°C) in a cool, dry place, away from direct sunlight and moisture. Keep the tablets in their original packaging and out of reach of children and pets. Do not freeze and do not use the medicine after the expiry date.

What is Sibolone Tablet used for?

Sibolone Tablet is primarily used as a hormone replacement therapy (HRT) for post-menopausal women. It helps manage menopausal symptoms such as hot flashes, night sweats, vaginal dryness, itching, mood swings, and low libido. It is also used to prevent osteoporosis (weak and brittle bones) in post-menopausal women who are at a high risk of fractures.

How does Sibolone Tablet work?

Sibolone Tablet contains Tibolone, which is a synthetic steroid hormone. It works by mimicking the activity of natural hormones like estrogen, progesterone, and androgen in the body. This action helps to restore hormone levels, reduce menopausal symptoms, and prevent bone loss and fractures by maintaining bone density.

What is the usual dosage for Sibolone Tablet?

The usual dosage is one tablet per day. It should be taken as prescribed by your doctor, preferably at the same time each day, and can be taken with or without food. Always follow your doctor's instructions and do not change your dosage without consulting them first.

What are the possible side effects of Sibolone Tablet?

Common side effects may include vaginal bleeding or spotting, breast tenderness or pain, headache, dizziness, nausea, vomiting, weight gain, mood changes, skin rash or itching, lower abdominal pain, abnormal hair growth, vaginal discharge, pelvic pain, and cervical thickening. Serious side effects requiring immediate medical attention include breast lumps, unusual vaginal bleeding, severe headaches, chest pain, shortness of breath, or pains in your legs, as these could be signs of a blood clot.

Is Sibolone Tablet safe during pregnancy or breastfeeding?

No, Sibolone Tablet is contraindicated during pregnancy and is not recommended for use by breastfeeding women. If pregnancy occurs while taking Sibolone, treatment should be stopped immediately.

Can Sibolone Tablet be taken with other medications?

Sibolone Tablet may interact with certain other medications. It can interfere with the effectiveness of oral anticoagulants (like warfarin), antiepileptic medicines (such as phenytoin and carbamazepine), and some HIV medications (including ritonavir, nelfinavir, and darunavir). Always inform your doctor about all medicines you are taking to avoid potential interactions.

What precautions should be taken when using Sibolone Tablet?

Sibolone Tablet should not be taken if you have a history of breast cancer or other estrogen-dependent tumors, undiagnosed genital bleeding, severe liver disease, previous or current arterial or venous thromboembolic disease (like a stroke or blood clot), or known hypersensitivity to Tibolone. Caution is advised for patients with kidney disease, those with premature menopause, or older patients. It is also recommended to avoid alcohol consumption while taking this medicine as it may increase the risk of breast cancer.

What happens if a dose of Sibolone Tablet is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose (typically if it's more than 12 hours overdue), you should skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed one. Missing a dose may increase the likelihood of breakthrough bleeding and spotting.

How should Sibolone Tablet be stored?

Sibolone Tablet should be stored in a cool, dry place, ideally below 25°C or 30°C, and protected from direct sunlight and moisture. Keep the tablets in their original packaging and out of reach of children and pets.