Flowel Plus® 0.4 mg/0.5 mg Capsules (Tamsulosin Hydrochloride + Dutasteride)

Flowel Plus

Category: BPH (UROLOGY)

Product Description

Flowel Plus® combines Tamsulosin Hydrochloride 0.4 mg and Dutasteride 0.5 mg in a once-daily capsule for the comprehensive treatment of Benign Prostatic Hyperplasia (BPH).

Tamsulosin provides rapid relief of urinary symptoms by relaxing smooth muscle in the prostate and bladder neck, while Dutasteride, a dual 5-alpha reductase inhibitor, reduces dihydrotestosterone (DHT) levels, shrinking the enlarged prostate and slowing disease progression. This combination addresses both the symptoms and underlying cause of BPH, reducing the risk of acute urinary retention and the need for BPH-related surgery.

Indications

Flowel Plus® is indicated for:

  • Treatment of moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH)
  • Patients with an enlarged prostate at risk of disease progression
  • Reduction of lower urinary tract symptoms (LUTS)
  • Reduction in the risk of acute urinary retention (AUR)
  • Reduction in the need for BPH-related surgical intervention

Contraindications

Flowel Plus® is contraindicated in patients with:

  • Hypersensitivity to Tamsulosin, Dutasteride, other 5-alpha reductase inhibitors, or any component of the formulation.
  • Women and children (Dutasteride is contraindicated in females and paediatric patients).
  • Pregnancy or women who may become pregnant should not handle leaking capsules because Dutasteride can be absorbed through the skin and may affect the development of a male fetus.
  • Severe hepatic impairment.
  • History of orthostatic hypotension.

Use with caution in patients with renal impairment and in those scheduled for cataract surgery because of the risk of Intraoperative Floppy Iris Syndrome (IFIS).

Dosage and Administration

Adults

  • One capsule (Tamsulosin 0.4 mg/Dutasteride 0.5 mg) once daily.
  • Take approximately 30 minutes after the same meal each day.
  • Swallow the capsule whole. Do not chew or open the capsule.

Elderly Patients

  • No dosage adjustment is generally required.

Duration of Therapy

  • Flowel Plus® is intended for long-term treatment.
  • Patients should be informed that clinical improvement in prostate size may require up to 6 months, although improvement in urinary symptoms may occur earlier.

Key Features

  • Dual-action therapy for comprehensive BPH management
  • Combines rapid symptom relief with long-term disease modification
  • Relieves lower urinary tract symptoms effectively
  • Reduces prostate volume by suppressing DHT production
  • Lowers the risk of acute urinary retention and BPH surgery
  • Once-daily dosing for improved adherence
  • Suitable for men with moderate to severe BPH and enlarged prostates
  • Improves urinary flow, quality of life, and long-term clinical outcomes
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