Actasvo 0,5 mg Capsules

Actasvo 0,5 mg Capsules

S4
PDF Leaflet Revision Date: 18 June 2025

API: Dutasteride | Company: Activo Health

Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of Benign Prostatic Hyperplasia (BPH).

Dosage (summary)

1 capsule (0.5 mg) orally once daily.

Onset of Action / Duration

Onset: 1-2 weeks, Duration: 6-8 hours

Special Populations

  • Renal impairment
  • Hepatic impairment

Pregnancy & Breastfeeding

Contraindicated in pregnancy; potential risk to male fetus. Unknown if excreted in breast milk.

Key Drug Interactions

  • CYP3A4 inhibitors
  • Tamsulosin
  • Terazosin

Contraindications

  • Hypersensitivity to dutasteride
  • Women and children
  • Severe hepatic impairment

Common side effects

  • Impotence
  • Altered libido
  • Ejaculation disorders
  • Breast disorders

Counselling Points

  • Avoid contact with leaking capsules
  • Report breast changes
  • Use condoms if partner is pregnant

Serious warnings

  • Risk of high-grade prostate cancer
  • Breast neoplasia
  • Cardiovascular adverse events
Important Disclaimer

The Actasvo 0,5 mg Capsules professional information leaflet below is the property of Activo Health 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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