Duodart 0.5Mg/0.4Mg 30Capsules

Duodart 0.5Mg/0.4Mg 30Capsules

Description:

Duodart 0.5 mg/0.4 mg 30 capsules is a prescription oral medicine used for the long-term treatment of benign prostatic hyperplasia (BPH) in adult men. It combines two active ingredients, dutasteride and tamsulosin, to both shrink an enlarged prostate and relax the muscles in the prostate and bladder neck. This dual action helps improve urine flow, relieve urinary symptoms such as weak stream and frequent urination, and reduce the risk of acute urinary retention and the need for prostate surgery. Duodart belongs to the classes of 5-alpha-reductase inhibitors and alpha-adrenergic blockers and is intended for continuous daily use under medical supervision.

Indications:

• Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) in adult men with enlarged prostate.
• Relief of lower urinary tract symptoms (LUTS) associated with BPH, such as weak urinary stream, difficulty starting urination, dribbling, sensation of incomplete bladder emptying, and interrupted flow.
• Reduction in urinary frequency and urgency, including nocturia (frequent urination at night) caused by BPH.
• Prevention of acute urinary retention (sudden inability to pass urine) related to prostate enlargement.
• Reduction in the risk of BPH-related prostate surgery (e.g., TURP or prostatectomy).

Active Ingredients / Key Components:

• Dutasteride – 0.5 mg per capsule (5-alpha-reductase inhibitor that reduces dihydrotestosterone [DHT] levels and shrinks enlarged prostate tissue).
• Tamsulosin hydrochloride – 0.4 mg per capsule (alpha-1 adrenergic receptor blocker that relaxes smooth muscle in the prostate and bladder neck to improve urine flow).
• Other excipients: Full list of inactive ingredients is not available in the provided information. Please refer to the official package leaflet for complete excipient details.

Dosage & Administration / How to Use:

• Usual adult dose: One Duodart capsule (0.5 mg dutasteride / 0.4 mg tamsulosin) once daily, or as directed by your physician.
• Administration: Swallow the capsule whole with a glass of water. Do not chew, crush, or open the capsule, as this may affect the release and absorption of the medicine.
• Timing: Take Duodart approximately half an hour after the same meal each day, preferably after breakfast, to maintain consistent absorption and reduce the risk of side effects such as dizziness.
• Duration of use: Duodart is intended for long-term treatment. Symptom improvement may take several weeks to months. Do not stop taking the medicine without consulting your doctor, even if you feel better.
• Missed dose: If you forget a dose, take it as soon as you remember on the same day. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed one.
• Use only in adult men: This medicine is not indicated for women or children.

Clinical Benefits:

• Provides dual-action BPH management by both shrinking the enlarged prostate (dutasteride) and relaxing smooth muscle in the prostate and bladder neck (tamsulosin).
• Improves urine flow and reduces urinary obstruction, helping men pass urine more easily and with a stronger stream.
• Relieves bothersome lower urinary tract symptoms such as frequency, urgency, nocturia, hesitancy, and incomplete emptying.
• Lowers the risk of acute urinary retention and decreases the likelihood of needing surgical intervention for BPH.

Warnings & Contraindications:

• Contraindicated in patients with known hypersensitivity or allergy to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, or any of the excipients.
• Contraindicated in women, children, and adolescents. Duodart is for adult men only.
• Do not use in patients with severe liver impairment. Use with caution in those with mild to moderate hepatic impairment and only under medical supervision.
• Use with caution in patients with severe kidney impairment or those on antihypertensive medications, as tamsulosin may cause a drop in blood pressure and dizziness.
• May cause dizziness, lightheadedness, or fainting, especially when standing up quickly (orthostatic hypotension). Avoid driving or operating machinery until you know how the medicine affects you.
• Dutasteride can reduce prostate-specific antigen (PSA) levels. Inform your doctor that you are taking Duodart before any PSA testing or prostate cancer screening.
• Capsules should not be handled by women who are pregnant or may become pregnant, especially if the capsule is leaking, as dutasteride can be absorbed through the skin and may harm a male fetus. If contact occurs, wash the area immediately with soap and water.
• Inform your doctor about all other medicines you are taking, especially other alpha-blockers, strong CYP3A4 inhibitors (such as ketoconazole, ritonavir), or medicines for blood pressure, as interactions may occur.
• Consult your doctor before use if you have liver disease, kidney disease, low blood pressure, history of fainting, or planned eye surgery for cataract or glaucoma (tamsulosin may be associated with intraoperative floppy iris syndrome).
• Not intended to diagnose, treat, cure, or prevent any disease without a physician’s prescription and supervision.
• Keep out of reach of children.

Side Effects:

• Common side effects may include decreased libido (reduced sex drive), erectile dysfunction, ejaculation disorders (such as decreased semen volume or retrograde ejaculation), breast tenderness or enlargement in men, dizziness, and headache.
• Other possible side effects: orthostatic hypotension (drop in blood pressure when standing), palpitations, nasal congestion, gastrointestinal discomfort, rash, or itching.
• Serious but less common side effects: allergic reactions (swelling of the face, lips, tongue, or throat; difficulty breathing), severe skin reactions, or prolonged, painful erection (priapism). Seek immediate medical attention if these occur.
• Long-term use of dutasteride may be associated with changes in PSA levels; your doctor will monitor this regularly.
• If you experience persistent breast lumps, pain, or nipple discharge, inform your doctor promptly.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Keep container tightly closed. Keep out of reach of children. Do not use after the expiry date stated on the pack. Do not store above the temperature specified in the official leaflet (exact temperature range is not available in the provided information; refer to the package insert).

Specifications:

• Serving size: 1 capsule (containing 0.5 mg dutasteride and 0.4 mg tamsulosin).
• Count: 30 capsules per pack.
• Form: Oral capsule.
• Intended use: Prescription medicine for adult men with benign prostatic hyperplasia.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.