Prodart 0,5 mg Soft gelatin capsules.
PDF Leaflet Revision Date: 24 March 2023
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 months for assessment.
Special Populations
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Contraindicated in women; may affect male fetus development.
Key Drug Interactions
- CYP3A4 inhibitors
- tamsulosin
- warfarin
Contraindications
- Hypersensitivity to dutasteride
- Women
- Children
Common side effects
- Impotence
- Decreased libido
- Ejaculation disorders
- Gynaecomastia
Counselling Points
- Avoid contact with leaking capsules
- Report breast changes
- Use condoms if partner is pregnant
Serious warnings
- Effects on PSA levels
- Risk of breast neoplasia
- Cardiovascular events
Important Disclaimer
The Prodart 0,5 mg Soft gelatin capsules. professional information leaflet below is the property of Austell Pharmaceuticals 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>>
Healthcare Professionals Only
This content is for registered healthcare professionals
Sign in or create a free account to read the full package insert.
Free for HPCSA-registered professionals. Powered by Medinsert.
