Vardenorect 20 mg - 8 F.C. Tablets

Phosphodiesterase-5 Enzyme Inhibitor used in the treatment of erectile dysfunction, pulmonary arterial hypertension and Raynaud’s disease.

-May be administered with or without food, approximately 60 minutes prior to sexual activity. -Oral disintegrating tablet should not be removed from blister pack until administered. Using dry hands, place immediately on tongue. Tablet will dissolve within seconds; do not take with liquid. Do not crush, split, or chew.

-May cause dose-related impairment of color discrimination, sudden decrease or loss of hearing, decrease in blood pressure may occur due to vasodilator effects, painful erection >6 hours in duration, vision loss. -Flushing, headache, dizziness, dyspepsia, nausea, back pain , increased creatine phosphokinase, rhinitis, flu-like symptoms, nasal congestion and sinusitis.

-Erectile dysfunction: Elderly ≥65 years: Tablet: Oral: Consider a starting dose of 5 mg administered ~60 minutes prior to sexual activity; taken as one single dose and not taken more than once daily. -Should not be taken by patients undergoing Hemodialysis. -In case of hepatic impairment: Moderate hepatic impairment: Tablet: Initial: 5 mg administered ~60 minutes prior to sexual activity (maximum dose: 10 mg daily); taken as one single dose and not taken more than once daily, oral disintegrating tablet: Use is not recommended. Severe hepatic impairment: Use is not recommended -Use with caution in patients with left ventricular outflow obstruction (aortic stenosis or hypertrophic cardiomyopathy [HCM] with outflow tract obstruction) -Use caution in patients with retinitis pigmentosa. -Use with caution in patients who have conditions which may predispose them to priapism (sickle cell anemia, multiple myeloma, leukemia). -Use with caution in patients with bleeding disorders. -Use is not recommended in patients with hypotension (<90/50 mm Hg); uncontrolled hypertension (>170/100 mm Hg); unstable angina or angina during intercourse; life-threatening arrhythmias, stroke, or myocardial infarction within the last 6 months -Use with caution in patients with active peptic ulcer disease. -Concomitant use with all forms of nitrates is contraindicated. If nitrate administration is medically necessary, it is not known when nitrates can be safely administered following the use of vardenafil; however, when a 20 mg (film-coated tablet) was administered 24 hours prior to a 0.4 mg sublingual dose of nitroglycerin, no changes in blood pressure or heart rate were detected. -High-fat meals decrease maximum serum concentration 18% to 50%. Serum concentrations/toxicity may be increased with grapefruit juice. -Incase of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676.

Store at room temperature.

-Alcohol (Ethyl): May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. -Alpha1-Blockers: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Alpha1-Blockers. -Blood pressure lowering agents: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of blood pressure lowering agents. -Dapoxetine: May enhance the orthostatic hypotensive effect of Phosphodiesterase 5 Inhibitors. -Itraconazole: May increase the serum concentration of Vardenafil.

-Adverse events were not observed in animal studies; however, vardenafil is not indicated for use in pregnant women. -It is not known if vardenafil is present in breast milk. Vardenafil is not indicated for use in lactating women.

EGPI