Product Information:

TARLYCA 15mg Tablets contain Tadalafil 15mg, a phosphodiesterase type 5 (PDE5) inhibitor. However, this strength is not part of the standard global dosing regimen for tadalafil.

⚠️ Critical Clarification:

1. Approved on-demand doses for erectile dysfunction (ED) are 5mg, 10mg, and 20mg.
2. Approved daily doses for ED or benign prostatic hyperplasia (BPH) are 2.5mg and 5mg.
3. Tadalafil 15mg is not a recognized or approved strength by the FDA, EMA, or WHO.

This product likely represents a local formulation error, mislabeling, or non-standard compounding in Pakistan. It may be intended as an intermediate dose between 10mg and 20mg, but its safety and efficacy are not established.

❗ Recommendation: Confirm with your physician or pharmacist whether this should be 10mg or 20mg. Do not use 15mg without explicit medical guidance.

Assuming it contains tadalafil, the following general information applies—with caution:

Uses (If Used Off-Label):

1. Erectile dysfunction (ED) – as an on-demand therapy (though 15mg is non-standard)

Key Considerations:

1. Not approved for daily use, BPH, or pulmonary hypertension at this dose
2. May increase risk of side effects (headache, hypotension, priapism) compared to standard doses
3. No clinical trial data supports 15mg as a safe or effective dose

How To Use (If Prescribed):

1. Take as needed, 30–60 minutes before sexual activity
2. Do not exceed once per day
3. Sexual stimulation is required for effect

When Not to Use:

1. With nitrates (e.g., nitroglycerin)—risk of life-threatening hypotension
2. In patients with severe cardiovascular disease, recent stroke/MI, or uncontrolled arrhythmia
3. With other PDE5 inhibitors (e.g., sildenafil, vardenafil)

Side Effects (Potentially Higher Risk at 15mg):

Common:

1. Headache, flushing, nasal congestion
2. Indigestion, back pain, muscle aches
3. Dizziness

Serious (rare but possible):

1. Priapism (erection >4 hours)—seek emergency care
2. Sudden vision or hearing loss (NAION)
3. Severe hypotension (especially with nitrates)

Dosage Recommendation:

1. Standard on-demand doses: 10mg or 20mg
2. Avoid 15mg unless specifically directed by a specialist familiar with local formulations

Warnings & Precautions:

1. Avoid alcohol—may worsen hypotension
2. Use caution with alpha-blockers or antihypertensives
3. Discontinue if sudden vision/hearing changes occur

Additional Information:

Store below 30°C. Keep out of reach of children. Available by prescription in Pakistan.