Sibolone 2.5mg Tablet 15'S
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Introduction About SIBOLONE 2.5MG TABLET
SIBOLONE 2.5MG TABLET contains Tibolone which belongs to the group of medicines called Steroids. SIBOLONE 2.5MG TABLET is used in postmenopausal women to provide relief from symptoms that occur after menopause.
SIBOLONE 2.5MG TABLET is also used in post-menopausal women to manage osteoporosis which occurs after menopause, generally characterized by symptoms such as weak and fragile bones.
SIBOLONE 2.5MG TABLET is not recommended for use in patients allergic to Tibolone. It is also not recommended for use in patients who have/had/suspected of breast/endometrial cancer or thrombosis (blood clot in vein). The medicine is also not indicated for use in patients who suffer from unusual vaginal bleeding, unmanageed endometrial hyperplasia (excessive thickening of the womb lining), lung disease (such as pulmonary embolism), heart disease (such as heart attack/heart block), and/or liver disease (such as benign liver tumor).
Before taking SIBOLONE 2.5MG TABLET, inform your doctor if you have fibroids (non-cancerous growths inside womb), endometriosis (growth of womb lining outside womb)/endometrial hyperplasia (excessive growth of the womb lining), and/or suffer from epilepsy, otosclerosis (disease that affects eardrum and hearing), and/or lung problems (such as asthma).
SIBOLONE 2.5MG TABLET is not recommended for use in pregnant and breast-feeding women since it is intended to be used only in postmenopausal women. The medicine is also not recommended for use in children and adolescents since it is indicated for use only in postmenopausal women. It is advised to be used with caution in elderly women (aged 60 years and above) after consulting the doctor since the medicine may increase the risk of heart disease in elderly patients.
The most common side effects of taking SIBOLONE 2.5MG TABLET are breast pain, stomach/pelvic pain, unusual hair growth, vaginal bleeding/spotting, vaginal problems (such as increased secretions, itching, and/or irritation), thickening of uterus/cervix lining, and/or weight gain. Consult your doctor if any of these symptoms worsens.
Uses Of SIBOLONE 2.5MG TABLET
- Provides relief from symptoms that occur menopause in postmenopausal women
- Prevents osteoporosis in post-menopausal women
How SIBOLONE 2.5MG TABLET Works
SIBOLONE 2.5MG TABLET works by substituting loss of estrogen (female sex hormone responsible for ovulation) production in postmenopausal women which helps in managing the occurrence of menopausal symptoms (such as hot flashes, night sweats, and/or vaginal problems) and bone loss (followed by menopause) thus providing relief from menopausal symptoms in affected women.
How to use SIBOLONE 2.5MG TABLET
Take SIBOLONE 2.5MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
Side Effects Of SIBOLONE 2.5MG TABLET
Common
- breast pain
- stomach/pelvic pain
- unusual hair growth
- vaginal bleeding/spotting
- vaginal problems (such as more secretions, itching, irritation, and/or thrush)
- thickening of lining of uterus or cervix
- weight gain
Uncommon
- signs of fluid retention such as swelling in arms/legs
- stomach upset
- acne
- painful nipples, feeling uncomfortable in breasts
- vaginal infections
Rare
- itchy skin
Stop taking SIBOLONE 2.5MG TABLET and contact your doctor immediately if you experience any of the following side effects:
- suspected of breast cancer/endometrial cancer
- unexplained vaginal bleeding
- signs of endometrial hyperplasia (excessive thickening of the womb lining) such as heavy menstrual bleeding, anemia, bleeding between menstrual periods
- thrombosis (blood clot in a vein) such as deep venous thrombosis
- signs of blood clot such as painful swelling & redness of the legs, sudden chest pain, and/or difficulty in breathing
- signs of liver disease such as yellowing of skin or whites of eyes (jaundice)
- signs of high blood pressure such as headache, tiredness, and/or dizziness
- migraine-like headaches (happening for the first time)
Warning & Precautions
Pregnancy
SIBOLONE 2.5MG TABLET is not recommended for use during pregnancy and in women planning for pregnancy since it is intended to be used only in postmenopausal women. Consult your doctor before taking the medicine and stop the medicine immediately if you become pregnant or think you may be pregnant.
Breastfeeding
SIBOLONE 2.5MG TABLET is not recommended for use in breastfeeding women as it is intended to be used only in postmenopausal women. Consult your doctor before taking SIBOLONE 2.5MG TABLET.
Driving and Using Machines
SIBOLONE 2.5MG TABLET is unlikely to affect your ability to drive/operate machines. Consult your doctor before taking the medicine.
Kidney
SIBOLONE 2.5MG TABLET should be used with caution in patients with kidney problems. Consult your doctor before taking SIBOLONE 2.5MG TABLET.
Liver
SIBOLONE 2.5MG TABLET is not recommended for use in patients with/history of liver disease (such as benign liver tumor) and in patients who have abnormal liver function. Consult your doctor before taking SIBOLONE 2.5MG TABLET.
Allergy
Do not take SIBOLONE 2.5MG TABLET if you are allergic to Tibolone, and/or any other ingredients of this medicine.
Lungs
SIBOLONE 2.5MG TABLET is not recommended for use in patients with lung disease such as pulmonary embolism (blood clot in lungs). It should be used with caution in patient with other lung problems such as asthma. Consult your doctor before taking SIBOLONE 2.5MG TABLET.
Heart Disease
SIBOLONE 2.5MG TABLET is not recommended for use in patients with heart disease such as heart attack/heart block. Consult your doctor before taking the medicine.
Others
SIBOLONE 2.5MG TABLET is not recommended for use if you:
- have/had/suspected of breast cancer
- have/suspected of endometrium cancer
- have unusual vaginal bleeding
- suffer from unmanageed endometrial hyperplasia (excessive thickening of the womb lining)
- have/had thrombosis (blood clot in a vein) such as deep venous thrombosis
- have blood clotting disorder such as protein C/protein S/antithrombin deficiency
- have/recently had blood clots in arteries such as stroke
- suffer from inherited porphyria (rare blood disorder)
Before taking SIBOLONE 2.5MG TABLET, inform your doctor if you:
- have fibroids (non-cancerous growths) inside womb
- suffer from endometriosis (growth of womb lining outside womb) or have a history of endometrial hyperplasia (excessive growth of the womb lining)
- have an increased risk of developing blood clots
- have an increased risk of developing estrogen-sensitive cancer such as mother, sister/ grandmother who has/had breast cancer
- suffer from high blood pressure, diabetes, gallstones, migraine/severe headaches
- suffer from systemic lupus erythematosus (disease of the immune system that affects many organs of the body)
- suffer from epilepsy
- otosclerosis (disease affecting eardrum and hearing)
- are scheduled for any surgery
Use in Pediatrics:
SIBOLONE 2.5MG TABLET is not recommended for use in children and adolescents since it is intended to be used only in postmenopausal women.
Use in Geriatrics:
SIBOLONE 2.5MG TABLET should be used with caution in elderly women (aged 60 years and above) due to increased risk of developing heart disease. Consult your doctor before taking SIBOLONE 2.5MG TABLET.
Interactions
A. Drug-Drug Interactions:
Before applying SIBOLONE 2.5MG TABLET, inform your doctor, if you are applying any of the following medicine:
- medicines used to manage blood clotting (Ex. warfarin)
- medicines used to manage epilepsy (Ex. phenobarbital, phenytoin, carbamazepine)
- medicines used to manage tuberculosis (Ex. rifampicin)
- St John’s Wort (herbal medicine used to manage depression)
Overdosage:
If you or anyone else accidentally takes too much of SIBOLONE 2.5MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are nausea, vomiting, and/or vaginal bleeding.
Synopsis
| Drug | : | Tibolone |
| Pharmacological Category | : | Steroids |
| Therapeutic Indication | : | Provides relief from symptoms after menopause, Prevents osteoporosis (after menopause) |
| Dosage Forms | : | Tablet |
More Information
- Keep SIBOLONE 2.5MG TABLET out of reach of children
- Store SIBOLONE 2.5MG TABLET at room temperature
FAQs About SIBOLONE 2.5MG TABLET
Q. What is SIBOLONE 2.5MG TABLET used for?
A. SIBOLONE 2.5MG TABLET is used in postmenopausal women to provide relief from symptoms that occur after menopause. It is also used in post-menopausal women to manage osteoporosis which occurs after menopause, generally characterized by symptoms such a s weak and fragile bones.
Q. What are the common side effects of taking SIBOLONE 2.5MG TABLET?
A. The most common side effects of taking SIBOLONE 2.5MG TABLET are breast pain, stomach/pelvic pain, unusual hair growth, vaginal bleeding/spotting, vaginal problems (such as increased secretions, itching, and/or irritation), thickening of uterus/cervix lining, and/or weight gain. Consult your doctor if any of these symptoms worsens.
Q. How SIBOLONE 2.5MG TABLET is taken?
A. Take SIBOLONE 2.5MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
Q. What happens if SIBOLONE 2.5MG TABLET is taken more than its required dosage?
A. If you or anyone else accidentally takes too much of SIBOLONE 2.5MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are nausea, vomiting, and/or vaginal bleeding.
Q. How SIBOLONE 2.5MG TABLET works?
A. SIBOLONE 2.5MG TABLET works by substituting loss of estrogen (female sex hormone responsible for ovulation) production in postmenopausal women which helps in managing the occurrence of menopausal symptoms (such as hot flashes, night sweats, and/or vaginal problems) and bone loss (followed by menopause) thus providing relief from menopausal symptoms in affected women.
References
1. KD Tripathi. Estrogens, Progestins and Contraceptives. Essentials of Medical Pharmacology. seventh edition.2013. Page-311.
2. Helenius J Kloosterboer. Tissue-selectivity: the mechanism of action of tibolone. NIH National Library of Medicine. National center for biotechnology information. PubMed.gov. August 2004. [Accessed on 2nd January 2023] https://pubmed.ncbi.nlm.nih.gov/15337246/
3. Strides Pharma UK Ltd. Electronic Medicines Compendium (EMC). [Revised in November 2022] [Accessed on 2nd January 2023] https://www.medicines.org.uk/emc/files/pil.14366.pdf
Author Details
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