Tibolone

Description

Tibolone is used for the treatment of estrogen deficiency in postmenopausal women. It is also used for the prevention of osteoporosis in postmenopausal women who are at a high risk of features and intolerant for other medicines approved for the prevention of osteoporosis. This medicine is not recommended for use in patients below 18 years of age.

Side effects

Major & minor side effects for Tibolone

  • Abnormal hair growth
  • Lower abdominal pain
  • Vaginal discharge
  • Breast tenderness
  • Genital itching
  • Vaginal bleeding
  • Pelvic pain
  • Weight gain
  • Acne
  • Abdominal discomfort
  • Nipple pain

Uses of Tibolone

What is it prescribed for?

  • Oestrogen deficiency
  • Prevention of osteoporosis
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Concerns

Commonly asked questions

  • Onset of action
    The amount of time required for this medicine to show its action is not clinically established.
  • Duration of effect
    The amount of time for which this medicine remains effective in the body is not clinically established.
  • Safe with alcohol?
    Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
  • Is it habit forming?
    No habit-forming tendencies were reported.
  • Usage in pregnancy?
    This medicine is not recommended for use in pregnant women.
  • Usage while breast-feeding?
    This medicine is not recommended for use in breastfeeding women.

Breast cancer

This medicine is not recommended for use in patients with known, past or suspected breast cancer due to the increased risk of worsening of the patient's condition.

Endometrial cancer

This medicine is not recommended for use in patients with endometrial cancer due to the increased risk of worsening of the patient's condition.

Genital bleeding

This medicine is not recommended for use if you have abnormal genital bleeding which was not diagnosed due to the increased risk of worsening the patient's condition.

Endometrial hyperplasia

This medicine is not recommended for use in patients with endometrial hyperplasia due to the increased risk of worsening the patient's condition.

Venous thromboembolic events

This medicine is not recommended for use in patients with previous or current thromboembolism due to the increased risk of worsening of the patient's condition.

Arterial thromboembolic disease

This medicine is not recommended for use in patients with a known history of arterial thromboembolic diseases such as angina, stroke, myocardial infarction, etc. due to the increased risk of worsening of the patient's condition.

Acute liver disease

This medicine is not recommended for use in patients having an acute liver disease due to the increased risk of worsening of the patient's condition.

Allergy

This medicine is not recommended for use in patients with a known allergy to tibolone or any other inactive ingredients present along with it.
Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women.

Breast-feeding

This medicine is not recommended for use in breastfeeding women.
General warnings

Breast cancer

This medicine should not be used in patients with previous history or current symptoms of breast cancer due to the increased risk of recurrence of the disease, especially in postmenopausal women. Appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition.

Limitations of use

This medicine is recommended for use in postmenopausal women only. It is not intended for contraceptive use.

Kidney Disease

This medicine should be used with caution in patients with kidney diseases due to the increased risk of adverse effects. Regular monitoring of kidney function tests is necessary while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Other medicines

Tibolone may interact with many other medicines and may cause severe adverse effects. Hence, it is advised that you inform the doctor about all your current medicines including any herbs and supplements before beginning treatment with this medicine.

Use in Children

This medicine is not recommended for use in patients below 18 years of age since the safety and efficacy of use are not clinically established.

Missed Dose

Take the missed dose as soon as you remember. If it is almost the time for your next dose, skip the missed dose. Do not double your dose to make up for the missed one.

Overdose

Seek emergency medical treatment or contact the doctor in case of an overdose.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Instructions

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
Interaction with Medicine

Phenobarbital

Phenytoin

Carbamazepine

Rifampicin

Warfarin

Disease interactions

Disease

Information not available.
Food interactions
Information not available.
Lab interactions
Information not available.
Take this medicine with or without food. Do not take in larger amounts than advised/prescribed. Consult the doctor if you experience any undesirable effects. Do not stop taking the medicine before completion of the course/without consulting your doctor.
Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken as instructed by doctor

Does not cause sleepiness

How it works
It works by substituting the deficiency of estrogen in the postmenopausal women and alleviates the undesired effects.
Legal Status

Approved

Unknown

Approved

Unknown

Classification

Category

Anabolic steroid

Schedule

Schedule H

Livial 2.5mg tablets - Summary of Product Characteristics (SmPC) - (eMC) [Internet]. Medicines.org.uk. 2018 [cited 6 October 2018]. Available from:

https://www.medicines.org.uk/emc/product/1597/pilv

TGA eBS - Product and Consumer Medicine Information Licence [Internet]. Ebs.tga.gov.au. 2018 [cited 6 October 2018]. Available from:

https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-06529-3

Tibolone 2.5 mg tablets - Summary of Product Characteristics (SmPC) - (eMC) [Internet]. Medicines.org.uk. 2018 [cited 6 October 2018]. Available from:

https://www.medicines.org.uk/emc/product/4429/smpc

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Information on this page was last updated on 13 Jun 2019

Disclaimer

We’ve made all possible efforts to ensure that the information provided here is accurate, up-to-date and complete, however, it should not be treated as a substitute for professional medical advice, diagnosis or treatment. Practo only provides reference source for common information on medicines and does not guarantee its accuracy or exhaustiveness. The absence of a warning for any drug or combination thereof, should not be assumed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Practo does not assume any responsibility for any aspect of healthcare administered with the aid of information provided above. If you have any doubts about your medication then we strongly recommend that you consult with your doctor, nurse or healthcare provider. See detailed T&C here.