Description

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Overdose

In clinical studies involving volunteers, when using a single dose of sildenafil up to 800 mg, adverse reactions were similar to those observed when using sildenafil at lower doses, but were more common and more severe. The use of sildenafil at a dose of 200 mg did not lead to an increase in effectiveness, but caused an increase in the number of cases of adverse reactions (headache, blood flushes, dizziness, dyspepsia, nasal congestion, visual disturbances).

In case of overdose, if necessary, resort to the usual supportive measures. Acceleration of sildenafil clearance during hemodialysis is unlikely due to the high degree of binding of the drug to plasma proteins and the absence of elimination of sildenafil with urine.

Adverse reactions

The safety profile of Viagra is based on data obtained from 9570 patients in 74 double-blind placebo-controlled clinical trials. The most commonly reported adverse reactions were headache, hot flashes, dyspepsia, nasal congestion, back pain, dizziness, nausea, hot flashes, visual disturbances, cyanopsia and blurred vision. Information on adverse reactions in the framework of post-marketing surveillance was collected over a period of more than 10 years. Since not all adverse reactions were reported to the applicant and not all adverse reactions were included in the safety database, the frequency of such reactions cannot be reliably determined.

All clinically significant adverse reactions that were observed during clinical trials more often than with placebo are listed below in accordance with the classification “System-organ-class” and frequency: very often (≥ 1/10), often (≥ 1/100 – <1/10), infrequently (≥ 1000 – <1/100) and rarely (≥ 1/10000 – <1/1000). Within each frequency group, adverse reactions are listed in order of decreasing severity.

Infectious and invasive diseases.

Infrequently: rhinitis.

From the immune system.

Infrequently: hypersensitivity.

From the nervous system.

Very often: headache.

Often: dizziness.

Infrequently: drowsiness, hypesthesia.

Rarely: stroke, transient ischemic attack, convulsions *, relapses *, syncope.

From the side of the organs of vision.

Often: impaired color perception **, visual disturbances, blurred vision.

Infrequently: disorders lacrimation ***, pain in the eyes, photophobia, photopsia, hyperemia of the eyes, brightness of vision, conjunctivitis.

Rarely: non-arterial anterior ischemic optic neuropathy * retinal vascular occlusion * retinal hemorrhage, arteriosclerotic retinopathy, retinal disorders, glaucoma, visual field defects, diplopia, decreased visual acuity, myopia, asthenopia, floating vitreous opacities, iris disorders, mydriasis, the appearance of glowing circles around the light source (halo) in the field of vision, eye swelling, swelling eye disorders, conjunctival hyperemia, eye irritation, abnormal sensations in the eyes, swelling of the eyelids, discoloration of the sclera.

From the hearing organs and vestibular apparatus.

Infrequently: dizziness, ringing in the ears.

Rare: deafness.

From the side of the heart.

Infrequently: tachycardia, increased heartbeat.

Rare: sudden cardiac death *, myocardial infarction, ventricular arrhythmia *, atrial fibrillation, unstable angina.

From the side of the vessels.

Often: flushes of blood to the face, hot flashes.

Infrequently: hypertension, hypotension.

From the respiratory system, chest organs and mediastinum.

Often: nasal congestion.

Infrequently: nosebleed, nasal congestion of the paranasal sinuses.

Rarely: a feeling of compression in the throat, swelling of the nasal mucosa, dryness in the nose.

From the gastrointestinal tract.

Often: nausea, dyspepsia.

Infrequently: gastroesophageal reflux disease, vomiting, pain in the upper abdomen, dry mouth.

Rarely: hypesthesia of the oral cavity.

From the skin and subcutaneous tissue.

Infrequently: rash.