Contraindications

– Hypersensitivity to sildenafil or to any component of the drug;

– use in patients who receive continuously or intermittently donators of nitric oxide, organic nitrates or nitrates in any form, since sildenafil enhances the hypotensive effect of nitrates.

It is not recommended to use the drug in conjunction with other drugs for the treatment of erectile dysfunction (the safety and efficacy of combination therapy has not been studied).

According to the registered indication, the drug is not intended for use in children and adolescents aged 18 years and in women.

With caution should use the drug for anatomical deformation of the penis (including during angulation , cavernous fibrosis or Peyronie’s disease); in diseases predisposing to the development of priapism (such as sickle cell anemia, multiple myeloma, leukemia, thrombocytopenia); in cases of bleeding; with the exacerbation of gastric ulcer and duodenal ulcer; hereditary pigment retinitis; heart failure, unstable stenocardia, myocardial infarction, stroke, life-threatening arrhythmias, arterial hypertension (BP more than 170/100 mm Hg) or hypotension (BP less than 90/50 mm Hg) in the last 6 months of myocardial infarction.

Special instructions

To diagnose erectile dysfunction, determine their possible causes, and select an adequate treatment, it is necessary to collect a full medical history and conduct a thorough physical examination. Erectile dysfunction treatment should be used with caution in patients with anatomical deformation of the penis (angulation , cavernous fibrosis, Peyronie’s disease), or in patients with risk factors for priapism (sickle cell anemia, multiple myeloma, leukemia).

Drugs intended to treat erectile dysfunction should not be given to men for whom sexual activity is undesirable.

Sexual activity poses a certain risk in the presence of heart disease, so before starting any therapy for erectile dysfunction, the doctor should refer the patient to an examination of the cardiovascular system. Sexual activity is undesirable in patients with heart failure, unstable angina pectoris, myocardial infarction or stroke, dangerous arrhythmias, arterial hypertension (BP> 170/100 mm Hg) or hypotension (BP <90/50 mm Hg) in the last 6 months . Art). Clinical studies have shown no differences in the incidence of myocardial infarction (1.1 per 100 people per year) or the mortality rate from cardiovascular diseases (0.3 per 100 people per year) in patients who received   sildenafil, compared with patients receiving placebo.

Cardiovascular complications

The post-marketing use of sildenafil for the treatment of erectile dysfunction reported adverse events such as serious cardiovascular complications (including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, unacceptable, unacceptable, heart failure, ventricular arrhythmia, hemorrhagic insult, transient ischemic attack, unacceptive heart attack , heart failure, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, heart failure, and ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, heart failure, and heart failure), which had a temporary connection with the use of sildenafil. Most of these patients, but not all of them, had risk factors for cardiovascular complications. Many of these adverse events were observed shortly after sexual activity, and some of them were observed after taking sildenafil without subsequent sexual activity. It is not possible to establish the existence of a direct connection between the observed adverse events and the specified or other factors.

Hypotension

Sildenafil has a systemic vasodilating effect, leading to a transient decrease in blood pressure, which is not a clinically significant event and does not lead to any consequences in most patients. However, prior to appointment   Sildenafil physician should carefully evaluate the risk of possible undesirable manifestations of vasodilating action in patients with relevant diseases, especially against the background of sexual activity. Increased susceptibility to vasodilators is observed in patients with obstruction of the left ventricular output tract (aortic stenosis, hypertrophic obstructive cardiomyopathy ), as well as with rarely occurring syndrome of multiple systemic atrophy, manifested by severe dysregulation of blood pressure by the autonomic nervous system.

Since the combined use of sildenafil and alpha – blockers can lead to symptomatic hypotension in certain sensitive patients,   Sildenafil should be used with caution in patients taking alpha- blockers. To minimize the risk of postural hypotension in patients taking alpha blockers, taking Sildenafil should be started only after stabilization of hemodynamic parameters in these patients has been achieved. Consideration should also be given to reducing the initial dose. The physician should inform the patient about what action should be taken in case of symptoms of postural hypotension.

Visual impairment

Rare cases of development of anterior non-arteritis ischemic optic neuropathy were noted as a cause of deterioration or loss of vision against the background of the use of all PDE5 inhibitors, including sildenafil . Most of these patients had risk factors such as excavation (deepening) of the optic nerve head, age over 50 years, diabetes mellitus, arterial hypertension , coronary artery disease, hyperlipidemia, and smoking. There is no causal relationship between the intake of PDE5 inhibitors and the development of anterior non-arteritis ischemic optic neuropathy.

The doctor should inform the patient about the increased risk of anterior non-arteritis ischemic optic neuropathy, if this condition has already been noted. In the event of a sudden loss of vision, patients should be given immediate medical attention. A small number of patients with hereditary retinitis pigmentosa have genetically determined abnormalities of retinal phosphodiesterase functions. Application Safety Information   Sildenafil in patients with retinitis pigmentosa is absent, therefore, sildenafil should be used with caution.

Hearing loss

In some post-marketing and clinical studies reported cases of sudden deterioration or hearing loss associated with the use of all PDE5 inhibitors, including sildenafil. Most of these patients had risk factors for sudden deterioration or hearing loss. There is no causal relationship between the use of PDE5 inhibitors and the sudden deterioration of hearing or hearing loss. In the event of a sudden hearing loss or hearing loss with sildenafil intake, you should immediately consult with your doctor.

Bleeding

Sildenafil enhances the antiplatelet effect of sodium nitroprusside , a nitric oxide donator, on human platelets in vitro . There are no data on the safety of sildenafil in patients with a tendency to bleeding or exacerbation of gastric ulcer and duodenal ulcer, therefore   Sildenafil in these patients should be used with caution. The incidence of nasal bleeding in patients with pulmonary hypertension associated with diffuse connective tissue diseases was higher ( Sildenafil 12.9%, placebo 0%) than in patients with primary pulmonary hypertension (Sildenafil 3%, placebo 2.4%). In patients receiving sildenafil in combination with a vitamin K antagonist, the frequency of nosebleeds was higher (8.8%) than in patients not taking a vitamin K antagonist (1.7%).

Use in conjunction with other erectile dysfunction treatments.

Safety and efficacy   Sildenafil together with other means of treating erectile dysfunction has not been studied, so the use of such combinations is not recommended.

Influence on ability to drive motor transport and control mechanisms

On reception Sildenafil no adverse effect on the ability to drive a car or other technical means was observed.However, since the admission of the drug may reduce blood pressure, the development of chromatopsia, blurred vision, should be attentive to the individual action of the drug in these situations, especially at the beginning of treatment and when changing the dosage regimen.

When kidney damage

In case of renal failure of mild and moderate severity (CK 30-80 ml / min) dose adjustment is not required, in case of severe renal failure (CK < 30 ml / min) the dose is reduced to 25 mg.

In violation of the liver

With abnormal liver function, the dose should be reduced to 25 mg.

Use in old age

Elderly patients dose adjustment is not required.

Use in childhood

The drug is not intended for use in children and adolescents aged 18 years.