Treatment of erectile dysfunction, more commonly known as impotence, in men.

Formula
Each film-coated tablet contains sildenafil citrate equivalent to sildenafil base 50 mg and excipients q.s. (ludipress, kollidon CL, magnesium stearate, film coating excipient).

Dosage form
Film-coated tablets.

Presentation
Box of 1 blister x 3 film-coated tablets.

Indications
Treatment of erectile dysfunction, more commonly known as impotence, in men.

Contra-indications
Hypersensitivity to any component of the drug.
Angina (chest pain) or other heart conditions being treated with nitrates, heart or blood vessel problems that make sexual intercourse inadvisable, heart attack or stroke in the last 6 months.
Severe liver problems, blood pressure is unusually high or low, retinitis pigmentosa.

Precautions
Cardiovascular status of patients must be considered prior to initiating any treatment for erectile dysfunction.
The use of sildenafil offers no protection against sexually transmitted disease.
The treatment of erectile dysfunction should be used with cautions in patients with anatomical deformation of the penis (angulation, cavernosal fibrosis or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism (drepanocytemia (sickle cell anemia), multiple myeloma, or leukemia).
A sudden decrease or loss of vision in one or both eyes was rarely reported in patients treated with PDE5 inhibitors including sildenafil. Though a direct relation between the use of PDE5 inhibitors and the loss of vision has not yet been confirmed, patients should stop taking the medicine and inform their doctors immediately if the symptom occurs.

Side effects
Most common side effects: headache, flushing, stomach-ache, and mild temporary visual changes (color perception changes, light perception changes, and blurred vision), dyspepsia (indigestion), stuffy nose, diarrhea.
The physician should be informed any side effects during the treatment with ADAGRIN.

Drug interactions
Antiulcerants (cimetidine), antifungals (ketoconazole, itraconazole), antibiotics (erythromycin, rifampicin), protease inhibitors (ritonavir), HIV antivirals (saquinavir).
CYP 3A4 inhibitor as cimetidine, erythromycin, ketoconazole, itraconazole; protease inhibitor as ritonavir, saquinavir can increase plasma level of sildenafil.
CYP 3A4 inducer as rifampicin can decrease plasma level of sildenafil.
When driving or operating machinery
If changes in vision, or dizziness occur when taking the drug, driving or operating machinery is not allowed.

Dosage and administration
Usual recommended dose: 50 mg, to be taken about one hour before sexual intercourse.
Doctors’ instructions should be followed.

Shelf-life
36 months.

Storage
Store in a dry and cool place (<30 degree C). Keep out of reach of children.
Prescription only medicine.
Read leaflet carefully before use. For more information, consult your physician.