Tibilive 2,5 mg Tablet

Tibilive 2,5 mg Tablet

S4
PDF Leaflet Revision Date: 14 May 2025

API: Tibolone | Company: Pharma Dynamics

Clinical Summary

Quick overview from the medicine insert

Indication

Symptomatic treatment of menopause-related hot flushes and prevention of post-menopausal osteoporosis.

Dosage (summary)

1 tablet daily; start at least 12 months after last natural bleed.

Onset of Action / Duration

Onset: weeks, Duration: optimal results after 3 months.

Special Populations

  • Elderly
  • Renal impairment
  • Hepatic impairment

Pregnancy & Breastfeeding

Contraindicated in pregnancy and breastfeeding.

Key Drug Interactions

  • Anticoagulants
  • CYP3A4 inducers
  • St. John's wort

Contraindications

  • Hypersensitivity to tibolone
  • Hormone-dependent tumors
  • History of venous thromboembolism
  • Active liver disease
  • Endometrial hyperplasia

Common side effects

  • Dizziness
  • Headache
  • Vaginal discharge
  • Breast tenderness
  • Weight increase

Counselling Points

  • Report any unusual bleeding
  • Regular breast examinations
  • Avoid in pregnancy and breastfeeding

Serious warnings

  • Increased risk of stroke
  • Increased risk of breast and endometrial cancer
  • Thromboembolic events
Important Disclaimer

The Tibilive 2,5 mg Tablet professional information leaflet below is the property of Pharma Dynamics and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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