Urocap D Capsule

✔️ Urocap-D Capsule is indicated for:

• Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH)
• Reduction of the risk of acute urinary retention in patients with BPH
• Reduction of the need for BPH-related surgical intervention

✔️ Possible Side Effects

The most commonly reported side effects include:

• Erectile dysfunction (impotence)
• Reduced libido
• Ejaculation disorders
• Breast enlargement or tenderness
• Dizziness

Less commonly, patients may experience:

• Orthostatic hypotension
• Breast disorders
• Weakness or fatigue
• Rare cases of high-grade prostate cancer

Seek medical advice if side effects persist or become troublesome.

✔️ Do not use Urocap-D Capsule if you:

• Are allergic to Tamsulosin, Dutasteride, or any ingredient in the formulation
• Have a history of Tamsulosin-induced angioedema
• Have severe liver impairment
• Have a history of orthostatic hypotension
• Are a woman, child, or adolescent
• Have hypersensitivity to soya or peanuts

✔️ Dosage & Administration

Adults (Including Elderly Patients)

• The recommended dose is one capsule once daily.
• Take approximately 30 minutes after the same meal each day.
• Swallow the capsule whole with water.
• Do not chew, crush, or open the capsule.

Patients already receiving separate Tamsulosin and Dutasteride therapy may switch to Urocap-D Capsule for greater convenience, as advised by a physician.

Renal Impairment

• No dosage adjustment is generally required.
• Use with caution in patients with severe renal impairment.

Hepatic Impairment

• Use cautiously in patients with mild to moderate liver disease.
• Contraindicated in patients with severe hepatic impairment

✔️ Urocap-D Capsule is contraindicated in women.

Pregnancy

Dutasteride may interfere with the normal development of a male fetus. Men whose partners are pregnant or may become pregnant should use condoms during sexual intercourse to avoid exposure through semen.

Breastfeeding

It is not known whether Tamsulosin or Dutasteride passes into human breast milk. Therefore, this medicine should not be used during lactation.

Fertility

Dutasteride may affect semen volume, sperm count, and sperm motility, which could potentially reduce male fertility.

✔️ Overdosage

Dutasteride

No specific antidote is available. Supportive and symptomatic treatment should be provided if overdose is suspected.

Tamsulosin

Overdose may cause:

• Severe low blood pressure
• Dizziness
• Vomiting
• Diarrhea

Immediate medical attention is required. Supportive cardiovascular treatment and monitoring should be initiated.

✔️ Drug Interactions

Dutasteride Interactions

Certain medications may increase Dutasteride levels, including:

• Ketoconazole
• Itraconazole
• Ritonavir
• Indinavir
• Nefazodone
• Verapamil
• Diltiazem

Tamsulosin Interactions

Use caution when combined with:

• Other alpha-blockers
• Blood pressure-lowering medicines
• PDE5 inhibitors such as sildenafil, tadalafil, and vardenafil
• Cimetidine
• Warfarin
• Diclofenac

Alcohol and medications that lower blood pressure may increase the risk of dizziness and fainting.

✔️ Precautions and Warnings

Prostate Cancer Monitoring

Before starting treatment, patients should undergo appropriate examinations to rule out prostate cancer. Regular monitoring, including PSA testing, is recommended throughout treatment.

Blood Pressure

This medicine may cause a drop in blood pressure, particularly when standing up suddenly. Patients should:

• Rise slowly from sitting or lying positions
• Sit or lie down immediately if dizziness occurs

Cardiac Considerations

Combination therapy has been associated with a slightly increased incidence of cardiac failure in some studies. Physicians should carefully assess the benefits and risks before prescribing.

Eye Surgery

Patients scheduled for cataract or glaucoma surgery should inform their ophthalmologist if they are taking or have previously taken Tamsulosin, as it may cause Intraoperative Floppy Iris Syndrome (IFIS).

Handling Precautions

Leaking capsules should not be handled by women, children, or adolescents. If contact occurs, wash the affected area immediately with soap and water.

Liver and Kidney Disease

Use cautiously in patients with hepatic impairment or severe renal dysfunction.

Breast Changes

Patients should promptly report any breast lumps, enlargement, tenderness, or nipple discharge to their healthcare provider.

✔️ Storage:

• Store in a cool, dry place.
• Protect from direct light and moisture.
• Keep out of reach of children.