Gent oral spray doses 12.5mg/dose 32 doses vial, 5ml

Composition

Composition for 1 dose: Active ingredient: sildenafil citrate 17,559 mg (based on sildenafil 12.5 mg). Auxiliary substances: propylene glycol 92,625 mg, alcohol 96% 23,400 mg, macrogol-400 (polyethylene glycol 400) 9,360 mg, purified water 7,513 mg, hydrochloric acid concentrated 2,783 mg, lemon oil 1,310 mg,1,200 mg, Sucralose, saccharin 0,187 mg, menthol racemic 0,047 mg, sodium cyclamate 0,016 mg.

Pharmacological properties

Pharmacotherapeutic group: Erectile dysfunction treatment – PDE 5 inhibitor. ATX Code: G04BE03 Pharmacological properties

Pharmacodynamics

Sildenafil is a selective inhibitor of cyclo-guanosine monophosphate (cGMP)- specific phosphodiesterase type 5 (PDE5).

Mechanism of action

The realization of the physiological mechanism of erection is associated with the release of nitric oxide (NO) in the cavernous body during sexual stimulation. This, in turn, leads to an increase in cGMP levels, subsequent relaxation of the smooth muscle tissue of the cavernous body, and increased blood flow.

Sildenafil does not have a direct relaxing effect on the isolated human cavernous body, but it enhances the effect of nitric oxide (NO) by inhibiting PDE5, which is responsible for the breakdown of cGMP.

Sildenafil is selective for PDE5 in vitro, its activity against PDE5 exceeds that of other known phosphodiesterase isoenzymes: PDE6-by 10 times; PDE1-by more than 80 times; PDE2, PDE4, PDE7-PDE11 – by more than 700 times. Sildenafil is 4000 times more selective for PDE5 compared to PDE5, which is of crucial importance, since PDE5 is one of the key enzymes in the regulation of myocardial contractility. A prerequisite for the effectiveness of sildenafil is sexual stimulation.

Pharmacokinetics

The pharmacokinetics of sildenafil in the recommended dose range are linear.

Suction

After oral use, sildenafil is rapidly absorbed. Absolute bioavailability averages about 40% (from 25% to 63%). In vitro, sildenafil at a concentration of about 1.7 ng/ml (3.5 nM) suppresses human PDE5 activity by 50%. After a single 100 mg dose of silednafil, the average maximum concentration of free sildenafil in the blood plasma (Cmax) of men is about 18 ng / ml (38 nM). Cmax when taking sildenafil orally on an empty stomach is reached on average within 60 minutes (from 30 minutes to 120 minutes). When taken in combination with fatty foods, the absorption rate decreases: Cmax decreases by an average of 29%, and the time to reach the maximum concentration (Tmax) increases by 60 minutes, but the degree of absorption does not change significantly (the area under the pharmacokinetic curve concentration-time (AUC) decreases by 11%).

Distribution

The volume of distribution of sildenafil at steady state averages 105 liters. The association of sildenafil and its main circulating N-demethyl metabolite with plasma proteins is about 96% and does not depend on the total concentration of the drug. Less than 0.0002% of the sildenafil dose (average 188 ng) was detected in semen 90 minutes after taking the drug.

Metabolism

Sildenafil is mainly metabolized in the liver by the cytochrome CYP3A4 isoenzyme (major pathway) and the cytochrome CYP2C9 isoenzyme (minor pathway). The main circulating active metabolite formed as a result of N-demethylation of sildenafil undergoes further metabolism. The selectivity of this metabolite against PDE in vitro is about 50% of the activity of sildenafil. The concentration of the metabolite in the blood plasma of healthy volunteers was about 40% of the concentration of sildenafil. The N-demethyl metabolite undergoes further metabolism; its half-life (T1 / 2) is about 4 hours.

Deduction

The total clearance of sildenafil is 41 l / h, and the final T 1/2 is 3-5 hours. After oral use, as well as after intravenous use, sildenafil is excreted as metabolites, mainly by the intestines (about 80% of the oral dose) and, to a lesser extent, by the kidneys (about 13% of the oral dose).

Pharmacokinetics in special patient groups

Elderly patients

In healthy elderly patients (older than 65 years), the clearance of sildenafil is reduced, and the concentration of free sildenafil in blood plasma is approximately 40% higher than in young (18-45 years). Age does not have a clinically significant effect on the incidence of side effects.

Impaired renal function

In mild (creatinine clearance 50-80 ml/min) and moderate (creatinine clearance 30-49 ml/min) renal insufficiency, the pharmacokinetics of sildenafil after a single oral dose of 50 mg do not change. In severe renal insufficiency (creatinine clearance

Liver function disorders

In patients with cirrhosis of the liver (stages A and B according to the Child-Pugh classification), the clearance of sildenafil decreases, which leads to an increase in AUC (84%) and Cmax (47%) compared to those with normal liver function in patients of the same age group. The pharmacokinetics of sildenafil in patients with severe hepatic impairment (Child-Pugh class C) have not been studied.

Indications

Treatment of erectile dysfunction characterized by the inability to achieve or maintain a penile erection sufficient for satisfactory sexual intercourse. Sildenafil is only effective with sexual stimulation.

Use during pregnancy and lactation

The drug is not intended for use in women.

Contraindications

• Hypersensitivity to sildenafil or any other component of the drug.
• Use in patients receiving continuous or intermittent nitric oxide donors, organic nitrates or nitrites in any form, as sildenafil increases the hypotensive effect of nitrates.
• Concomitant use with guanylate cyclase stimulants, such as riociguat, as this may lead to symptomatic hypotension.
• Concomitant use with other treatments for erectile dysfunction has not been studied, so the use of such combinations is not recommended.
• Severe hepatic insufficiency (Child-Pugh class C). Simultaneous use of ritonavir.
• Severe cardiovascular diseases (severe heart failure, unstable angina, stroke or myocardial infarction in the last six months, life-threatening arrhythmias, hypertension (BP >170/100 mm Hg) or hypotension (BP >
• Patients with episodes of non-arteriitic anterior ischemic optic neuropathy with loss of vision in one eye.
• Hereditary retinitis pigmentosa.
• Female gender.
• Age up to 18 years (efficacy and safety have not been established).

With caution

• Anatomical deformity of the penis (angulation, cavernous fibrosis, or Peyronie’s disease) (see section “Special instructions”).
• Diseases that predispose to the development of priapism (sickle cell anemia, multiple myeloma, leukemia, thrombocythemia) (see the section “Special instructions”).
• Diseases accompanied by bleeding.
• Liver function disorders (Child-Pugh class A and B).
• Exacerbation of peptic ulcer of the stomach and duodenum.
• Severe renal insufficiency (creatinine clearance
• Patients with a history of anterior non-arteritic ischemic optic neuropathy (see section “Special instructions”).
• Simultaneous use of alpha-blockers.

Side effects

The most common side effects were headache and hot flashes. Usually, the side effects of the drug are mild or moderate and transient. When using a fixed dose, the frequency of some adverse events increases with increasing dose. To assess the frequency of adverse events, the following criteria were used (according to the World Health Organization classification): :  very common (≥10%); common (≥1% and <10%); infrequent (≥0.1% and <1%); rare (≥0.01% and <0.1%); very rare (From the immune system: infrequently-hypersensitivity reactions (including skin rash), allergic reactions. From the side of the organ of vision: often-blurred vision, visual impairment, cyanopsia; infrequently – eye pain, photophobia, chromatopsia, redness of the eyes/sclera injections, changes in the brightness of light perception, mydriasis, conjunctivitis, hemorrhage in the eye tissue, cataracts, disruption of the lacrimal apparatus;rarely – swelling of the eyelids and adjacent tissues, dryness in the eyes, the presence of iridescent circles in the field of vision around the light source, increased eye fatigue, vision of objects in yellow (xanthopsia), vision of objects in red (erythropsia), conjunctival hyperemia, irritation of the eye mucosa, unpleasant sensations in the eyes; frequency unknown – non-arteritic anterior ischemic neuropathy of the optic nerve, retinal vein occlusion, visual field defect, diplopia, temporary loss of vision or decreased visual acuity, increased intraocular pressure, retinal edema, retinal vascular diseases, vitreous detachment/vitreous traction.From the side of the organ of hearing and labyrinth disorders: infrequently-sudden decrease or loss of hearing, tinnitus, pain in the ears. From the cardiovascular system: often-hot flashes; infrequently-tachycardia, palpitation, decreased blood pressure, increased heart rate, unstable angina, atrioventricular block, myocardial infarction, cerebral thrombosis, cardiac arrest, heart failure, deviations in electrocardiogram readings, cardiomyopathy; rarely – atrial fibrillation, sudden cardiac death, ventricular arrhythmia. From the blood and lymphatic system: infrequently-anemia, leukopenia. From the side of metabolism and nutrition: infrequently-thirst, edema, gout, uncompensated diabetes mellitus, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemia, hypernatremia. Respiratory, thoracic and mediastinal disorders: often-nasal congestion; infrequently-nosebleeds, rhinitis, asthma, dyspnoea, laryngitis, pharyngitis, sinusitis, bronchitis, increased sputum volume, increased cough; rarely – a feeling of tightness in the throat, dryness of the nasal mucosa, swelling of the nasal mucosa. From the gastrointestinal tract: often – nausea, dyspepsia; infrequently-gastroesophageal reflux disease, vomiting, abdominal pain, dry oral mucosa, glossitis, gingivitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, deviation of “liver” functional tests from the norm, rectal bleeding; rarely – hypesthesia of the oral mucosa. Musculoskeletal and connective tissue disorders: often-back pain; infrequently – myalgia, pain in the extremities, arthritis, osteoarthritis, tendon rupture, tenosynovitis, bone pain, myasthenia gravis, synovitis. From the kidneys and urinary tract: infrequently – cystitis, nocturia, urinary incontinence, hematuria. From the genitals and breast: infrequently-breast enlargement (men), ejaculation disorders, genital edema, anorgasmia, hematospermia, penile tissue damage; rarely-prolonged erection and / or priapism. From the nervous system: very often – headache; often-dizziness; infrequently-drowsiness, migraine, ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depressive symptoms, insomnia, unusual dreams, increased reflexes, hypesthesia; rarely-convulsions, repeated convulsions, fainting. Skin and subcutaneous tissue disorders: infrequently – skin rash, urticaria, herpes simplex, pruritus, increased sweating, skin ulceration, contact dermatitis, exfoliative dermatitis; frequency unknown-Stevens-Johnson syndrome, toxic epidermal necrolysis. Others: infrequently-a feeling of heat, swelling of the face, photosensitivity reaction, shock, asthenia, increased fatigue, pain of various localization, chills, accidental falls, chest pain, accidental injuries; rarely-irritability. Cardiovascular complications During post-marketing use of sildenafil for the treatment of erectile dysfunction, adverse events such as severe cardiovascular complications (including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, hypertension and hypotension) have been reported that were temporarily associated with sildenafil use. 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 a direct relationship between the observed adverse events and these or other factors. Visual impairment In rare cases, post-marketing use of all PDE5 inhibitors, including sildenafil, has been reported with non-arteriitic anterior ischemic optic neuropathy – NSAID), a rare disease and cause of reduced or lost vision. Most of these patients had risk factors, such as a decrease in the ratio of excavation diameters to the optic disc (“congestive disc”), age over 50 years, diabetes mellitus, hypertension, coronary heart disease, hyperlipidemia, and smoking. An observational study evaluated the association of recent use of PDE5 inhibitor drugs with acute onset of NSAID. The results indicate an approximately 2-fold increase in the risk of NSAIDs within 5 half-lives after the use of a PDE5 inhibitor. According to published literature data, the annual incidence of NPINZD is 2.5-11.8 cases per 100,000 men aged ≥50 years in the general population. Patients with sudden vision loss should be advised to discontinue sildenafil therapy and consult their doctor immediately. Individuals who have already had a case of NSAIDs have an increased risk of recurrence of NSAIDs. Therefore, the physician should discuss this risk with such patients, as well as discuss with them the potential risk of adverse effects of PDE5 inhibitors. PDE5 inhibitors, including sildenafil, should be used with caution in these patients and only in situations where the expected benefit outweighs the risk. When using sildenafil in doses higher than recommended, adverse events were similar to those noted above, but usually occurred more frequently. If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Effect of other drugs on the pharmacokinetics of sildenafil

The metabolism of sildenfil occurs mainly under the action of cytochrome isoenzymes CYP3A4 (major pathway) and CYP2C9 (minor pathway), so inhibitors of these isoenzymes can reduce the clearance of sildenafil, and inducers, respectively, increase the clearance of sildenafil. A decrease in the clearance of sildenafil was observed with the simultaneous use of inhibitors of the cytochrome CYP3A4 isoenzyme (ketoconazole, erythromycin, cimetidine).

Cimetidine (800 mg), a non-specific inhibitor of the cytochrome CYP3A4 isoenzyme, when co-administered with sildenafil (50 mg) causes an increase in the concentration of sildenafil in plasma by 56%. A single dose of 100 mg of sildenafil together with erythromycin (500 mg / day 2 times a day for 5 days), a moderate inhibitor of the cytochrome CYP3A4 isoenzyme, against the background of achieving a constant concentration of erythromycin in the blood, leads to an increase in the AUC of sildenafil by 182%. When co-administered with sildenafil (100 mg once) and saquinavir (1200 mg / day 3 times a day), an HIV protease inhibitor and cytochrome CYP3A4 isoenzyme, while achieving a constant concentration of saquinavir in the blood, the Cmax of sildenafil increased by 140%, and the AUC increased by 210%. Sildenafil does not affect the pharmacokinetics of saquinavir. Stronger inhibitors of the cytochrome CYP3A4 isoenzyme, such as ketoconazole and itraconazole, can also cause stronger changes in the pharmacokinetics of sildenafil.

Simultaneous use of sildenafil (100 mg once) and ritonavir (500 mg twice daily), an HIV protease inhibitor and a strong cytochrome P450 inhibitor, while achieving a constant concentration of ritonavir in the blood leads to an increase in the Cmax of sildenafil by 300% (4 times), and AUC by 1000% (11 times). After 24 hours, the concentration of sildenafil in the blood plasma is about 200 ng / ml (after a single application of sildenafil alone-5 ng/ml). This is consistent with the effect of ritonavir on a wide range of cytochrome P 450 substrates. Sildenafil does not affect the pharmacokinetics of ritonavir. Given these data, concomitant use of ritonavir and sildenafil is not recommended. In any case, the maximum dose of sildenafil should never exceed 25 mg within 48 hours.

If sildenafil is taken at the recommended doses in patients receiving simultaneously strong inhibitors of the cytochrome CYP3A4 isoenzyme, the Cmax of free sildenafil does not exceed 200 nM, and the drug is well tolerated.

A single antacid dose (magnesium hydroxide/aluminum hydroxide) does not affect the bioavailability of sildenafil.

In studies involving healthy volunteers, concomitant use of an endothelin receptor antagonist, bosentan (an inducer of the CYP3A4 isoenzyme (moderate), CYP2C9, and possibly CYP2C19) at steady-state concentrations (125 mg 2 times a day) and sildenafil at steady-state concentrations (80 mg 3 times a day) decreased the AUC and Cmax of sildenafil by 62.6% and 52.4%, respectively. Sildenafil increased the AUC and Cmax of bosentan by 49.8% and 42%, respectively. It is suggested that the concomitant use of sildenafil with potent inducers of the CYP3A4 isoenzyme, such as rifampicin, may lead to a greater decrease in the concentration of sildenafil in blood plasma.

Inhibitors of the cytochrome CYP2C9 isoenzyme (tolbutamide, warfarin), cytochrome CYP2D6 isoenzyme (selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and thiazide-like diuretics, ACE inhibitors and calcium antagonists do not affect the pharmacokinetics of sildenafil.

Azithromycin (500 mg / day for 3 days) has no effect on the AUC, Cmax, Tmax, elimination rate constant and T 1/2 of sildenafil or its main circulating metabolite.

Effect of sildenafil on other medications

Sildenafil is a weak inhibitor of cytochrome P450 isoenzymes-1A2,2C9,2C19,2D6,2E1AND ZA4 (inhibitory molar concentration of IC50 >150 mmol). When taking sildenafil at the recommended doses, its Cmax is about 1 micromol, so it is unlikely that sildenafil can affect the clearance of substrates of these isoenzymes. Sildenafil enhances the hypotensive effect of nitrates both with prolonged use of the latter, and when they are prescribed for acute indications. In this regard, the use of sildenafil in combination with nitrates or nitric oxide donors is contraindicated.

When the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg,50 mg and 100 mg) were co – administered in patients with benign prostatic hyperplasia with stable hemodynamics, the average additional reduction in systolic/diastolic blood pressure in the supine position was 7/7 mmHg,9/5 mmHg and 8/4 mmHg, respectively, and in the standing position-6/6 mmHg,11/4 mmHg and 4/5 mmHg, respectively. mmHg, respectively. Rare cases of symptomatic postural hypotension, which manifested itself in the form of dizziness (without fainting), have been reported in such patients. In some sensitive patients receiving alpha-blockers, concomitant use of sildenafil may lead to symptomatic hypotension.

There were no signs of significant interaction with tolbutamide (250 mg) or warfarin (40 mg), which are metabolized by the cytochrome CYP2C9 isoenzyme. Sildenafil (100 mg) does not affect the pharmacokinetics of the HIV protease inhibitor, saquinavir, which is a substrate of the cytochrome CYP3A4 isoenzyme, at its constant level in the blood.

Simultaneous use of sildenafil at steady state (80 mg 3 times a day) leads to an increase in the AUC and Cmax of bosentan (125 mg 2 times a day) by 49.8% and 42%, respectively. Sildenafil (50 mg) does not cause an additional increase in bleeding time when taking acetylsalicylic acid (150 mg).

Sildenafil (50 mg) does not enhance the hypotensive effect of alcohol in healthy volunteers with a maximum blood alcohol concentration of 0.08% (80 mg/dl) on average.

In patients with arterial hypertension, there were no signs of interaction between sildenafil (100 mg) and amlodipine. The average additional reduction in blood pressure in the supine position is 8 mm Hg (systolic) and 7 mm Hg (diastolic).

The use of sildenafil in combination with antihypertensive agents does not lead to additional side effects.

How to take, course of use and dosage

Inside. At the first application or during a break in the use of the drug, you should sharply press the sprayer several times, directing the spray into the air, until a uniform spray cloud is formed. When using the bottle should be held vertically, spray upwards. Bring the bottle close to your mouth and, pressing a short sharp movement on the nebulizer, inject the solution (one dose contains 12.5 mg of sildenafil). Repeat the injection procedure until the recommended dose is reached and drink with water. The solution should not be inhaled. The recommended dose for most adult patients is 50 mg approximately 1 hour before sexual activity. Depending on the efficacy and tolerability, the dose can be increased to 100 mg or reduced to 25 mg. The maximum recommended dose is 100 mg. The maximum recommended frequency of use is once a day. Impaired renal function In mild to moderate renal insufficiency (creatinine clearance 30-80 ml / min), no dose adjustment is required, in severe renal insufficiency (creatinine clearance Impaired liver function Since the elimination of sildenafil is impaired in patients with liver damage, the dose of the drug should be reduced to 25 mg. Couse with other medicinescomplete use with ritonavir is not recommended. In any case, the maximum dose of the drug should under no circumstances exceed 25 mg, and the frequency of use-1 time in 48 hours (see the section “Interaction with other drugs”). When co-administered with inhibitors of the cytochrome CYP3A4 isoenzyme (erythromycin, saquinavir, ketoconazole, itraconazole), the initial dose of the drug should be 25 mg (see the section “Interaction with other drugs”). To minimize the risk of postural hypotension in patients taking alpha-blockers, the drug should be started only after hemodynamic stabilization has been achieved in these patients. Consideration should also be given to reducing the initial dose of sildenafil (see sections “Special instructions” and “Interactions with other medicinal products”). Elderly patients There is no need to adjust the dose for elderly patients.

Overdose

With a single dose of sildenafil up to 800 mg, adverse events were comparable to those with lower doses of the drug, but were more common. Treatment is symptomatic. Hemodialysis does not accelerate the clearance of sildenafil, since the latter actively binds to plasma proteins and is not excreted by the kidneys.

Special instructions

To diagnose erectile dysfunction, determine their possible causes, and choose appropriate treatment, it is necessary to collect a complete medical history and conduct a thorough physical examination. Treatment of erectile dysfunction should be used with caution in patients with anatomical deformity of the penis (angulation, cavernous fibrosis, Peyronie’s disease), or in patients with risk factors for priapism (sickle cell anemia, multiple myeloma, leukemia) (see the section “With caution”).

Cases of prolonged erections and priapism have been reported in the post-marketing period. If your erection persists for more than 4 hours, seek immediate medical attention. If priapism therapy is not carried out in a timely manner, it can lead to damage to penile tissues and irreversible loss of potency.

Drugs intended for the treatment of erectile dysfunction should not be used in 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 for a cardiovascular examination. Sexual activity is undesirable in patients with heart failure, unstable angina, a history of myocardial infarction or stroke in the last 6 months, life-threatening arrhythmias, arterial hypertension (BP >170/100 mm Hg) or hypotension (BP > Taking sildenafil in such patients is contraindicated (see the section “Contraindications”). There is no difference in the rate of myocardial infarction (1.1 per 100 people per year) or the rate of death from cardiovascular diseases (0.3 per 100 people per year) in patients treated with sildenafil compared to patients treated with placebo.

Cardiovascular complications

Adverse events such as severe cardiovascular events (including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, hypertension, and hypotension) that were temporarily associated with the use of sildenafil have been reported during post-marketing use of sildenafil for the treatment of erectile dysfunction. 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 a direct link between the observed adverse events and these or other factors.

Hypotension

Sildenafil has a systemic vasodilating effect, leading to a transient decrease in blood pressure, which is not a clinically significant phenomenon and does not lead to any consequences in most patients. However, before prescribing sildenafil, the doctor should assess the risk of possible undesirable manifestations of vasodilating effects in patients with the corresponding diseases, especially against the background of sexual activity. Increased susceptibility to vasodilators is observed in patients with obstruction of the left ventricular exit tract (aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as with a rare syndrome of multiple systemic atrophy, manifested by a severe violation of blood pressure regulation by the autonomic nervous system.

Caution should be exercised when using sildenafil concomitantly with alpha-blockers due to the risk of developing symptomatic hypotension in some sensitive patients (see the section “Interaction with other drugs”). To minimize the risk of postural hypotension in patients taking alpha-blockers, sildenafil should be started only after the hemodynamic parameters have stabilized. Consideration should also be given to reducing the initial dose of Jent® (see section “Dosage and use”). The doctor should inform the patient about what actions should be taken in case of symptoms of postural hypotension.

Visual disturbances

In the post – marketing period, rare cases of NSAID development have been reported- a rare disease and the cause of reduced or lost vision when using PDE5 inhibitors, including sildenafil.Most of these patients had risk factors such as a reduced ratio of excavation diameters to the optic disc (“congestive disc”), age over 50 years, diabetes mellitus, hypertension, coronary heart disease, hyperlipidemia, and smoking. An observational study evaluated the association of recent use of PDE5 inhibitor drugs with acute onset of NSAID. The results indicate an approximately 2-fold increase in the risk of NSAIDs within 5 half-lives after the use of a PDE5 inhibitor. According to published literature data, the annual incidence of NPINZD is 2.5-11.8 cases per 100,000 men aged ≥50 years in the general population. Patients with sudden vision loss should be advised to discontinue sildenafil therapy and consult their doctor immediately. Individuals who have already had a case of NSAID have an increased risk of recurrence of NSAID. Therefore, the doctor should discuss this risk with these patients, as well as discuss with them the potential for adverse effects of PDE5 inhibitors. PDE5 inhibitors, including sildenafil, should be used with caution in such patients and only in situations where the expected benefit outweighs the risk.

A small number of patients with hereditary retinitis pigmentosa have genetically determined disorders of retinal phosphodiesterase functions. There is no information on the safety of sildenafil in patients with retinitis pigmentosa, so such patients should not use sildenafil (see the section “Contraindications”).

Hearing disorders

Cases of sudden hearing impairment or loss associated with the use of PDE5 inhibitors, including sildenafil, have been reported. Most of these patients had risk factors for sudden deterioration or loss of hearing. No causal relationship has been established between the use of PDE5 inhibitors and sudden hearing impairment or hearing loss. In case of sudden hearing loss or loss of hearing while taking sildenafil, you should immediately consult your doctor.

Bleeding issues

Sildenafil enhances the antiplatelet effect of sodium nitroprusside, a nitric oxide donor, on human platelets in vitro. There are no data on the safety of using sildenafil in patients with a tendency to bleeding or exacerbation of gastric and duodenal ulcers, so sildenafil should be used with caution in these patients (see the section “With caution”). The incidence of nosebleeds 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 3.0%, placebo 2.4%). In patients treated with sildenafil in combination with a vitamin K antagonist, the incidence of nosebleeds was higher (8.8%) than in patients who did not take a vitamin K antagonist (1.7%).

Use simultaneously with other means of treating erectile dysfunction

Concomitant use of Jent® with other PDE5 inhibitors, other drugs for the treatment of pulmonary arterial hypertension containing sildenafil, or other drugs for the treatment of erectile dysfunction disorders is not recommended, as the effectiveness and safety of combined use has not been studied (see the section “Contraindications”).

Influence on the ability to drive vehicles and mechanisms

No adverse effects on the ability to drive vehicles or other mechanisms were observed with the use of sildenafil. However, since taking sildenafil may cause dizziness, a decrease in blood pressure, the development of chromatopsia, blurred vision and other side effects, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions. You should also pay close attention to the individual effect of the drug in these situations, especially at the beginning of treatment and when changing the dosage regimen.

Storage conditions

At a temperature not exceeding 30 °C. Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date indicated on the package.

Active ingredient

Sildenafil

Conditions of release from pharmacies

By prescription

Dosage form

oral spray