Details

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Manufacturer
LABORATORIOS LEON FARMA S.A(SPAIN)

Registraction Number
MAL24066026AZ

Content:

• Active Ingredients:
  • Dutasteride: 0.5 mg
  • Tamsulosin Hydrochloride: 0.4 mg (equivalent to 0.367 mg Tamsulosin)

 Indications:

• Benign Prostatic Hyperplasia (BPH): Used to treat moderate to severe symptoms of BPH, which is an enlarged prostate. It helps reduce the risk of acute urinary retention and the need for surgery.

Instructions:

• Dosage: The recommended dose is one capsule daily (0.5 mg / 0.4 mg). It should be taken 30 minutes after a meal and never on an empty stomach.
• Administration: Swallow the capsule whole with water. Do not chew or open the capsule, as contact with the contents may cause irritation.
• Precautions:
  • Elderly Patients: No age-related dose adjustment is required.
  • Renal Impairment: Use with caution, especially in patients with severe renal impairment.
  • Hepatic Impairment: Use with caution, especially in patients with severe hepatic impairment.
  • Pregnancy: Women should not handle crushed or broken capsules if they are pregnant or could become pregnant.
  • Children and Adolescents: Not indicated for patients 21 years old.