Product Information:

TAMSOLIN PLUS Capsules are a fixed-dose combination containing:

1. Tamsulosin Hydrochloride 0.4mg – a selective alpha-1A adrenergic receptor antagonist that relaxes smooth muscle in the prostate and bladder neck
2. Dutasteride 0.5mg – a dual 5-alpha reductase inhibitor that blocks the conversion of testosterone to dihydrotestosterone (DHT), leading to gradual reduction in prostate size

This combination is indicated for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate, offering both rapid symptom relief and long-term disease modification.

⚠️ Important Note:

TAMSOLIN PLUS is for use in men only. Women—especially those who are or may become pregnant—must not handle crushed or broken capsules, as dutasteride can cause birth defects in male fetuses.

Uses of (TAMSOLIN PLUS CAPSULES):

1. Relief of lower urinary tract symptoms (LUTS) due to BPH:
2. Weak urine stream
3. Hesitancy
4. Incomplete bladder emptying
5. Frequent/urgent urination
6. Nocturia (nighttime urination)
7. Reduction in risk of acute urinary retention (AUR) and need for BPH-related surgery

Key Benefits of (TAMSOLIN PLUS CAPSULES):

1. Dual-action therapy:
2. Tamsulosin: Provides symptom relief within days
3. Dutasteride: Shrinks prostate over 3–6 months, reducing long-term complications
4. Superior outcomes vs. monotherapy in men with prostate volume >30 mL
5. Once-daily dosing for consistent control
6. Proven to slow disease progression and improve quality of life

How To Use (TAMSOLIN PLUS CAPSULES):

1. Take one capsule once daily, approximately 30 minutes after the same meal each day.
2. Swallow whole with water—do not crush, chew, or open the capsule.
3. Continue therapy long-term—even if symptoms improve—as dutasteride requires sustained use for full benefit.
4. Maximal prostate shrinkage and symptom improvement typically seen after 6 months.

When Not to Use (TAMSOLIN PLUS CAPSULES):

Do not use if you have:

1. Hypersensitivity to tamsulosin, dutasteride, or any excipients
2. Severe hepatic impairment
3. Known or suspected high-grade prostate cancer
4. Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole) without medical supervision

🚫 Contraindicated in women and children.

Side Effects of (TAMSOLIN PLUS CAPSULES):

Common:

1. Retrograde ejaculation (dry orgasm)—due to tamsulosin (~10–20%)
2. Decreased libido, erectile dysfunction—due to dutasteride
3. Dizziness, headache
4. Gynecomastia (breast tenderness/enlargement)—dutasteride-related

Less common:

1. Orthostatic hypotension (less than non-selective alpha-blockers)
2. Runny nose, fatigue

Serious (rare):

1. Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery—inform your ophthalmologist before any eye procedure
2. Depression or mood changes (reported with 5-alpha reductase inhibitors)
3. Allergic reactions (rash, swelling)
4. Discontinue and seek help if vision changes, prolonged erection, or severe mood symptoms occur.

Dosage: (TAMSOLIN PLUS CAPSULES):

1. Adult men: One capsule (tamsulosin 0.4mg + dutasteride 0.5mg) once daily
2. Elderly: No dose adjustment needed
3. Hepatic impairment: Avoid in severe cases; use cautiously in mild/moderate
4. Renal impairment: No adjustment required

Who It’s For (TAMSOLIN PLUS CAPSULES):

Men aged 50+ years with moderate to severe BPH symptoms and enlarged prostate (>30 mL) who are at risk of disease progression and desire both immediate and long-term therapeutic benefits.

Warnings & Precautions:

1. Inform all surgeons—especially ophthalmologists—about use due to IFIS risk
2. Monitor PSA levels: Dutasteride lowers PSA by ~50%—adjust interpretation accordingly
3. Do not donate blood for 6 months after stopping (dutasteride remains in circulation)
4. Use effective contraception if partner is pregnant or may become pregnant

Drug Interactions:

1. Strong CYP3A4 inhibitors (ketoconazole, clarithromycin): May ↑ tamsulosin levels—monitor for dizziness/hypotension
2. Alpha-blockers or antihypertensives: Additive blood pressure-lowering effects
3. Warfarin: Dutasteride may slightly ↑ INR—monitor
4. Always inform your doctor about all medications and supplements.

Additional Information:

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of women and children. Do not use after the expiration date. Available by prescription only in Pakistan.