Leaflet DUTASTERIDA ACCORD 0.5mg soft capsules

Indicated for: benign prostatic hyperplasia

Route of administration: oral

Substance: dutasteride (enzyme inhibitor)

ATC: G04CB02 (Genito urinary system and sex hormones | Drugs used in benign prostatic hypertrophy | Testosterone-5-alpha reductase inhibitors)

Precautions:
Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Teratogenic / fetal risk
Teratogenic / fetal risk

This medicine may affect fetal development.

Dutasteride is a medication primarily used to treat benign prostatic hyperplasia (BPH), a condition characterized by the non-cancerous enlargement of the prostate, which can cause urinary difficulties. It is a 5-alpha-reductase inhibitor, an enzyme that converts testosterone into dihydrotestosterone (DHT), a hormone responsible for prostate growth. By reducing DHT levels, dutasteride helps shrink the prostate and alleviate urinary symptoms.

The effects of dutasteride are not immediate, and symptom improvement may take several weeks or months of treatment. The medication is taken orally, usually in capsule form, and is indicated for men with moderate to severe BPH symptoms. Additionally, dutasteride can reduce the risk of acute urinary retention and the need for surgical intervention for BPH.

While effective, dutasteride may cause side effects. The most common include decreased libido, erectile dysfunction, abnormal ejaculation, and breast tenderness or enlargement (gynecomastia). In rare cases, allergic reactions or more severe effects may occur. Dutasteride can also affect prostate-specific antigen (PSA) levels, which are used to screen for prostate cancer, requiring careful monitoring.

Dutasteride should be used as directed by a doctor, and patients should inform their doctor of any pre-existing conditions or concurrent medications. It is contraindicated in women and children, and pregnant or breastfeeding women should not handle the capsules, as the active substance can be absorbed through the skin and may affect fetal development.

General data about DUTASTERIDA ACCORD 0.5mg

  • Substance: dutasteride
  • Date of latest medicines list: 01-10-2019
  • Product code: W66193001
  • Concentration: 0.5mg
  • Pharmaceutical form: soft capsules
  • Quantity: 10
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: PHARMADOX HEALTHCARE LTD. - MALTA
  • Holder: ACCORD HEALTHCARE POLSKA SP. Z O.O. - POLONIA
  • Number: 8260/2015/01
  • Shelf life: 2 years

Combinations with other substances