phosphodiesterase 5 enzyme inhibitor

Impotence therapy agent (systemic).

Erectile dysfunction (treatment)

Tadalafil is not indicated for use in females.

Geriatrics: Greater sensitivity to medications in some older individuals should be considered.

Contraindications

Except under special circumstances, this medication should not be used when the following medical problem exists:

Angina occurring during sexual intercourse, Heart failure within last 6 months ,Hereditary degenerative retinal disorders, including retinitis pigmentosa ,Hypotension, Myocardial infarction, within 90 days , Stroke , within last 6 months, Uncontrolled arrhythmias, Uncontrolled hypertension, Unstable angina, Degenerative retinal disorders known hereditary including Retinitis pigmentosa, Hepatic impairment, sever (Child - Pugh Class C).

Hypersensitivity to tadalafil or any component of the tablet, Renal insufficiency, severe or end-stage.

Risk-benefit should be considered when the following medical problem exists:

Age 50> years or Coronary artery disease or Diabetes or Hyperlipidemia or Hypertension or Low cup to disc ration (crowded disc) or Smoking.

Cardiovascular status, current and underlying, Left ventricular outflow obstruction, such as:Aortic stenosis, or Idiopathic hypertrophic subaortic stenosis, Leukemia, Multiple myeloma, Sickle cell anemia.

Anatomical deformation of the penis, such as: Angulation, or Cavernosal fibrosis, or Peyronie's disease. Hepatic impairment, mild to moderate, NAION is one eye previous, Renal Insufficiency moderate or severe, Bleeding disorders, Active peptic ulceration significant.

Drug interactions

Potent CYP3A4 inhibitors, such as: Protease inhibitors including, Ritonavir, Saquinavir, Ketoconazole,  Cytochrome P450 3A4 (CYP3A4) inhibitors others such as: Erythromycin, or Grapefruit juice, or Itraconazole.

Erectile dysfunction treatment, use of combinations is not recommended.

Nitrates, tadalafil was shown to potentiate the hypotensive effects of nitrates.

CYP3A4 inducer, such as: Carbamazepine,or  Phenytoin, or Phenobarbital, or Rifampin, Antacids, Alcohol, Alpha-adrenergic blockers, Antihypertensive agents, other, such as: Amlodipine, or Metoprolol, or Bendrofluazide, or Enalapril .

Angiotensin II receptor blockers.

Erectile dysfunction –

Oral 10mg taken prior to sexual activity, no more than once a day. If necessary,  the dose may be increased up to 20 mg once a day or decreased to 5 mg once a day based on individual efficacy and tolerability.

Tadalafil is not indicated for use in Pediatrics patients.

Those indicationg need for medical attention:

Incidence less frequent (less than 2%):

Angina pectoris, chest pain, dyspnea, hypertension, hypotension, myocardial infarction, palpitations, postural hypotension, syncope, tachycardia.

Incidence rare: Priapism

Incidence not determined - Observed during clinical practice: estimates of frequency cannot be determined, Exfoliative dermatitis, hypersensitivity  reactions, non - arteritic anterior ischemic optic neuropathy(NAION),retinal vein occlusion, Stevens - Johnson syndrome, stroke, sudden cardiac death, urticaria, visual field defect.

Those indicating need for medical attention only if they continue or are bothersome

Incidence more frequent: Back pain, Dyspepsia, Headache.

Incidence less frequent: Arthralgia, asthenia, blurred vision, conjunctivitis, diarrhea, dizziness, dry mouth, dysphagia, erection increased, esophagitis, eye pain, face edema, fatigue, flushing, gastritis, gastroesophageal reflux, hypesthesia, insomnia, lacrimation increased, loose stools, myalgia, nasal congestion, nausea, neck pain, pain, pain in limbs, paresthesia, pharyngitis, pruritis, rash, somnolence, spontaneous penile erection, sweating, swelling of eyelids, upper abdominal pain, vertigo, vomiting

Incidence rare: Changes in color vision.

Store below 30°C (86°F). Protect from light and keep the medicine in the box.

Boxes of 4, F.C tablets tadalafil 20mg.