SILPAH Oral Suspension

Dosage and Administration

• Dosage should be as prescribed by the physician.
• Shake the bottle well before use.
• Measure the dose using a calibrated measuring cup or spoon.
• Can be taken with or without food; however, high-fat meals may delay onset of action.

⚠️ Do not exceed the prescribed dose.

1. Erectile Dysfunction (ED) – Adults

• Typical starting dose: 50 mg taken as needed, ~1 hour before sexual activity.
• Since SILPAH oral suspension is 10 mg/5 mL, this would be 25 mL for a 50 mg dose.
• Maximum recommended dose: 100 mg per day.
• Dose can be adjusted up or down based on efficacy and tolerability.
• Do not take more than once daily.

2. Pulmonary Arterial Hypertension (PAH) – Adults

• Typical dose: 20 mg three times daily (TID).
• With 10 mg/5 mL suspension, 10 mL per dose.
• Maximum recommended dose: 80 mg/day, divided doses.
• Dose adjustments may be needed in renal or hepatic impairment.

3. Pediatric Use

• Only under strict medical supervision.
• Doses vary depending on weight and indication (e.g., PAH in children).

Missed Dose

• Take the missed dose as soon as remembered.
• If it is almost time for the next dose, skip the missed dose.
• Do not double the dose.

Overdose

• Symptoms may include headache, dizziness, flushing, low blood pressure, prolonged erection, or vision changes.
• In case of overdose, seek immediate medical attention.

Sildenafil is a phosphodiesterase type-5 (PDE-5) inhibitor.
It works by increasing cyclic guanosine monophosphate (cGMP) levels, leading to relaxation of smooth muscles and increased blood flow in specific tissues.

1. Erectile Dysfunction (ED) in Adult Men
   • Treatment of inability to achieve or maintain an erection sufficient for satisfactory sexual performance.
2. Pulmonary Arterial Hypertension (PAH)
   • To improve exercise capacity and delay clinical worsening in patients with PAH (WHO Group I).
3. Other Indications
   • As determined by a physician for conditions requiring PDE-5 inhibition, where clinically appropriate.

• Hypersensitivity to sildenafil or any component of the formulation
• Concomitant use with nitrates or nitric oxide donors which can cause severe hypotension.
• Severe cardiovascular disorders where sexual activity is inadvisable (e.g., unstable angina, recent myocardial infarction, severe heart failure).
• Severe hepatic impairment
• History of non-arteritic anterior ischemic optic neuropathy (NAION)
• Patients who have experienced priapism or conditions predisposing to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).

• Use with caution in patients with:
  • Cardiovascular disease
  • Hypotension or hypertension
  • Renal or hepatic impairment
• Sudden vision or hearing loss requires immediate medical attention.
• Avoid alcohol consumption during treatment.
• Priapism: Prolonged erection (>4 hours) requires urgent medical attention to prevent permanent damage.
• Inform your doctor about all medications you are taking, especially antihypertensives, alpha-blockers, CYP3A4 inhibitors, and other PDE-5 inhibitors.
• Safety in pregnant or breastfeeding women has not been established; use only if clearly indicated by a physician

Important:

• Use only under medical supervision.
• Not indicated for use in women or children except when prescribed for specific conditions by a physician.

Common:

• Headache
• Flushing
• Nasal congestion
• Dizziness
• Dyspepsia

Uncommon/Rare:

• Visual disturbances
• Hypotension
• Palpitations
• Prolonged erection

Serious:

• Priapism (erection lasting >4 hours)
• Sudden loss of vision or hearing

• Mild effects are usually transient.
• Persistent or severe reactions require medical consultation.
• Discontinue and seek immediate care in case of allergic reactions or prolonged erection.

• Store below 25°C
• Protect from light
• Do not freeze
• Keep out of reach of children

• Rx Only / Prescription Drug
• To be sold by retail on the prescription of a Registered Medical Practitioner only
• This leaflet is for informational purposes and does not replace medical advice.
• Keep medicines out of reach of children.