Sildenafil-SZ granules for oral use 100mg packets, 4pcs

Composition

1 package contains: Active ingredient: sildenafil citrate -140.5 mg (based on sildenafil-100 mg); excipients: sucralose – 48.0 mg; pharmaspers® 416 – 999.5 mg; mint flavor-12.0 mg

Pharmacological action

A treatment for erectile dysfunction is a PDE-5 inhibitor. Sildenafil is a potent selective inhibitor of cyclo-guanosine monophosphate (cGMP) – specific phosphodiesterase type 5 (PDE-5). Restores impaired erectile function under conditions of sexual stimulation of increased blood flow in the vessels of the penis. Mechanism of Action The physiological process underlying penile erection involves the release of nitric oxide (N0) in the cavernous body during sexual stimulation. Nitric oxide activates the enzyme guanylate cyclase, which leads to an increase in the concentration of cGMP and subsequent relaxation of smooth muscle cells of the cavernous body and contributes to its filling with blood. It does not have a direct relaxing effect on the isolated human cavernous body, but it enhances the effect of NO by inhibiting PDE-5, which is responsible for the breakdown of cGMP. When the NO/cGMP system is activated during sexual stimulation, inhibition of PDE5 by sildenafil leads to an increase in cGMP levels in the cavernous body. Sexual stimulation is absolutely necessary for the development of the desired pharmacological action of sildenafil. In vitro studies have shown that sildenafil is selective for PDE-5, which is involved in the development of an erection. Its activity against PDE-5 is superior to that of other known phosphodiesterases. Sildenafil is 10 times less selective for PDE-6, which is involved in retinal phototransmission. At the maximum recommended doses, sildenafil is 80 times less selective for PDE-1 and 700 times less selective for PDE-2,3,4,7,8,9,10 and 11. The activity of sildenafil against PDE-5 is approximately 4000 times higher than its activity against PDE-3 (cycloadenosine monophosphate (cAMP) – specific phosphodiesterase) involved in the regulation of myocardial contractility. Sildenafil causes a slight and transient decrease in blood pressure( BP), which in most cases has no clinical manifestations. The maximum decrease in systolic blood pressure in a horizontal position after taking sildenafil at a dose of 100 mg, on average, is 8.3 mm Hg, and diastolic blood pressure is 5.3 mm Hg. This decrease in blood pressure is due to the vasodilating effect of sildenafil, possibly associated with an increase in the concentration of cGMP in vascular smooth muscle cells. A single dose of sildenafil up to 100 mg is not associated with clinically significant changes in the electrocardiogram (ECG) in healthy volunteers. Sildenafil has no effect on cardiac output and does not alter blood flow through stenosed arteries. In patients with erectile dysfunction and stable angina who regularly took antianginal medications (other than nitrates), the time to angina attack during the exercise test did not significantly differ after taking sildenafil compared to placebo. In some patients,1 hour after taking 100 mg of sildenafil, the Farnsworth-Munsel 100 test revealed transient changes in the ability to distinguish shades of color (blue/green),2 hours after taking sildenafil these changes were absent. Inhibition of PDE-6 is considered to be the suggested mechanism of color perception disorders. Sildenafil has no effect on visual acuity or contrast perception, electroretinogram, intraocular pressure, or pupil diameter. It was noted that in patients with early age-related macular degeneration, sildenafil 100 mg once did not cause clinically significant visual changes assessed by special tests (visual acuity, Amsler grating, traffic light color difference, Humphrey’s perimetry, and photostress). A single 100 mg dose of sildenafil had no effect on sperm motility or morphology in healthy volunteers. Additional information on clinical trials In fixed-dose sildenafil trials, the proportion of men who reported improved erections was 62% (25 mg),74% (50 mg), and 82% (100 mg), compared to 25% in the placebo group. At the same time, the frequency of sildenafil withdrawal was low and comparable to that in the placebo group. In all studies, the proportion of patients who reported improved erections after taking sildenafil was as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly patients (67%), diabetes mellitus (59%), coronary heart disease (CHD) (69%), arterial hypertension (68%), transurethral resection of the prostate (61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%). Analysis of the international index of erectile dysfunction showed that in addition to improving erections, treatment with sildenafil also increased the quality of orgasm, allowed achieving satisfaction from sexual intercourse and overall satisfaction. The safety and efficacy of sildenafil were maintained with prolonged use. Pharmacokineticsabsorption of sildenafil is rapidly absorbed. The maximum concentration in blood plasma (Ctax) when taken on an empty stomach is reached within 30-120 minutes (median 60 minutes). Absolute bioavailability, on average, is about 41% (25-63%). The pharmacokinetics (area under the concentration-time curve (AUC) and Cmax) of sildenafil in the recommended dose range (25-100 mg) are linear. Food intake reduces the rate of absorption of sildenafil, and the time to reach the maximum concentration (TStax) is extended, on average, by 60 minutes, Cstax decreases, on average, by 29%. Distribution The volume of distribution (Vd) of sildenafil at steady state is, on average,105 liters. After a single oral dose of 100 mg of sildenafil, the Cmax is approximately 440 ng / ml (coefficient of variation (CV) 40%). Since sildenafil (and its main circulating N-demethylated metabolite) are 96% bound to plasma proteins, the average plasma concentration of the free fraction of sildenafil is 18 ng / ml (38 nM). In healthy volunteers, less than 0.0002% of the dose (on average,188 ng) is detected in semen 90 minutes after a single dose of 100 mg of sildenafil. Metabolism Sildenafil is mainly metabolized in the liver by microsomal cytochrome P 450 isoenzymes: CYP3A4 (main pathway) and CYP2C9 (secondary pathway). The main circulating active metabolite is formed as a result of N-demethylation of sildenafil. The selectivity of the metabolite to phosphodiesterases is comparable to that of sildenafil, and its activity against PDE-5 in vitro is approximately 50% of that of unchanged sildenafil. The concentration of the metabolite in the blood plasma of healthy volunteers is about 40% of the concentration of sildenafil. The N-demethylated metabolite undergoes further metabolism, its half-life (Jm) is about 4 hours. Elimination The total clearance of sildenafil is 41 l / h, and the final half-life (T 1/2) is 3-5 hours. Sildenafil is mainly excreted as metabolites by the intestines (approximately 80% of the dose) and, to a lesser extent, by the kidneys (approximately 13% of the dose). Pharmacokinetics of selected patient groups Elderly patients In healthy elderly patients (65 years and older), the clearance of sildenafil is reduced, and the concentration of sildenafil and its active N-demethylated metabolite in blood plasma is approximately 90% higher than in young patients (18-45 years). Taking into account the age-related features of binding to plasma proteins, the concentration of free sildenafil in blood plasma increases by about 40%. Renal impairment in patients with mild or moderate renal impairment (creatinine clearance 30-80 ml/min), the pharmacokinetics of sildenafil did not change after a single dose of 50 mg. Mean values of AUC and Cmax of the N-demethylated metabolite increased by 126% and 73%, respectively, compared with healthy patients of the same age. Due to the high inter-individual variability, these differences are statistically insignificant. In severe renal insufficiency (creatinine clearance less than 30 ml/min), sildenafil clearance decreases, which leads to approximately a twofold increase in AUC (100%) and Ctax (88%) compared to those in patients of the same age group without impaired renal function. Impaired liver function In patients with Child-Pugh class A and B cirrhosis, sildenafil clearance decreases, resulting in increased AUC (84%) and Cmax (47%) compared to patients with normal liver function in the same age group. The pharmacokinetics of sildenafil in patients with severe hepatic impairment have not been studied.

Indications

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

Use during pregnancy and lactation

According to the registered indication, sildenafil is not intended for use in women.

Contraindications

Hypersensitivity to sildenafil or any other component of the drug. Simultaneous use with nitric oxide (N0) donors (for example, amyl nitrite) or nitrates in any form, becausesildenafil may enhance the antihypertensive effect of nitrates (mediated by NO/cGMP). Medications for the treatment of erectile dysfunction, including sildenafil, should not be used in men who are not recommended for sexual activity (for example, patients with severe cardiovascular diseases, such as unstable angina or severe heart failure). The safety and efficacy of sildenafil in combination with other medications for the treatment of erectile dysfunction have not been studied. Therefore, simultaneous use is contraindicated (see the section “Special instructions”). Concomitant use with ritonavir is contraindicated. Loss of vision in one eye due to anterior ischemic optical neuropathy of non-arterial origin, regardless of whether it is associated with the use of phosphodiesterase 5 (PDE-5) inhibitors (see the section “Special instructions”). Use is contraindicated in: severe hepatic impairment, arterial hypotension (blood pressure less than 90/50 mm Hg), recent cerebrovascular accident or myocardial infarction, phenylketonuria, hereditary retinal dystrophies (hereditary degenerative diseases of the retina), such as retinitis pigmentosa (some patients have genetic defects in retinal phosphodiesterases), because the safety of Sildenafil-SZ in such patients has not been studied. According to the registered indication, Sildenafil-SZ is not intended for use in children under 18 years of age and women. With caution:arterial hypertension (BP above 170/100 mm Hg), life-threatening arrhythmias, left ventricular outflow tract obstruction (aortic stenosis, hypertrophic obstructive cardiomyopathy (HOCMP)) or multiple systemic atrophy syndrome, anatomical deformity of the penis (angulation, cavernous fibrosis, or Peyronie’s disease), conditions predisposing to priapism (sickle cell anemia, multiple myeloma, or leukemia), concomitant use of alpha-blockers, diseases accompanied by bleeding, or exacerbation of gastric or duodenal ulcers, episodes of anterior non-arteritic ischemic heart disease a history of optic neuropathy.

Side effects

When using sildenafil in clinical trials, the most common adverse reactions were: headache, hot flashes, dyspepsia, visual disturbances, nasal congestion, dizziness, and color perception disorders (chromatopsia). World Health Organization (WHO)classification of the incidence of side effects:very often >1/10 often > >1/100 to >><1/10 often >1/1000 to <1/10 often ><1/100 rare >1/10000 to <1/100 rare ><1/1000 very rarely In each group, undesirable effects are presented in decreasing order of severity. Immune system disorders: rare: hypersensitivity reactions. Nervous system disorders: very common: headache; common: dizziness; uncommon: drowsiness, hypesthesia; rare: cerebrovascular accident, syncope; frequency unknown: transient ischemic attack, convulsions, recurrent convulsions. Visual disturbances:often: visual disturbances, color perception disorders (chromatopsia); infrequently: conjunctival damage, lacrimation disorders, other visual disorders; frequency unknown: anterior ischemic optical neuropathy of non-arterial origin, retinal vascular occlusion, visual field defect. Hearing disorders and labyrinthine disorders: common: vertigo, tinnitus; rare:deafness*. Vascular disorders: often: feeling of “hot flashes”; rarely: increase / decrease in blood pressure. Cardiac disorders:infrequently: palpitations, tachycardia; rarely: myocardial infarction, atrial fibrillation; frequency unknown: ventricular arrhythmia, unstable angina, sudden cardiac death. Respiratory, thoracic and mediastinal disorders:common: nasal congestion; rare: nosebleeds. Gastrointestinal disorders: often: dyspepsia; infrequently: vomiting, nausea, dryness of the oral mucosa. Skin and subcutaneous tissue disorders: Infrequent: skin rash; frequency unknown: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome). Musculoskeletal and connective tissue disorders: Infrequently: myalgia. Renal and urinary tract disorders: infrequently: hematuria. Genital and breast disorders: infrequently: hematospermia, penile bleeding; frequency unknown: priapism, prolonged (prolonged) erection. General disorders and disorders at the injection site: infrequently: chest pain, increased fatigue. Laboratory and instrumental data: infrequently: increased heart rate. *Hearing loss: sudden deafness. Sudden hearing loss or loss was observed in a small number of cases when studying post-marketing use or clinical studies with all PDE-5 inhibitors, including sildenafil.

Interaction

Effect of other drugs on the pharmacokinetics of sildenafilin vitro studies:Sildenafil is mainly metabolized by cytochrome P450 isoenzymes: CYP3A4 (main pathway) and CYP2C9 (non-main pathway). Therefore, inhibitors of these isoenzymes may reduce the clearance of sildenafil. In vivo studies:A population pharmacokinetic analysis of the results of a clinical study revealed a decrease in the clearance of sildenafil with simultaneous use of inhibitors of the CYP3A4 isoenzyme (such as ketoconazole, erythromycin, cimetidine). At the same time, there was no increase in the frequency of adverse events in these patients. Patients taking CYP3A4 inhibitors are recommended to start treatment with sildenafil at a dose of 25 mg. Concomitant use of sildenafil (100 mg once daily) with the HIV protease inhibitor ritonavir (500 mg twice daily) (a potent cytochrome P450 inhibitor) increases the Cmax and AUC of sildenafil in blood plasma by 300% (i. e. 4-fold) and 1000% (i. e. 11 – fold), respectively. After 24 hours, the concentration of sildenafil in the blood plasma was approximately 200 ng / ml (with sildenafil alone-5 ng / ml). Given the results of a pharmacokinetic study, concomitant use of sildenafil with ritonavir is contraindicated. Co-use of the HIV protease inhibitor saquinavir (a CYP3A4 inhibitor) at steady state (1200 mg three times daily) with sildenafil (100 mg once daily) increases the Cmax and AUC of sildenafil by 140% and 210%, respectively. Sildenafil does not affect the pharmacokinetics of saquinavir. Probably, more potent inhibitors of the CYP3A4 isoenzyme (ketoconazole and itraconazole) have a more pronounced effect on the pharmacokinetics of sildenafil. When sildenafil (100 mg once) is co-administered with erythromycin (a specific inhibitor of the CYP3A4 isoenzyme) at steady state (500 mg twice daily for 5 days) The AUC of sildenafil increases by 182%. In healthy volunteers, azithromycin (500 mg daily for 3 days) does not cause changes in pharmacokinetic parameters (AUC, Ctax, TStax, elimination rate or Ti/2 of sildenafil or its main circulating metabolite. Cimetidine (a non-specific inhibitor of the CYP3A4 isoenzyme) (800 mg) in healthy volunteers increases the concentration of sildenafil (50 mg) in blood plasma by 56%. Grapefruit juice, a weak inhibitor of the isoenzyme CYP3A4 in the intestinal wall, can slightly increase the concentration of sildenafil in blood plasma. A single dose of an antacid (magnesium hydroxide and aluminum hydroxide) does not alter the bioavailability of sildenafil. Although interactions with the following drugs have not been specifically studied, population pharmacokinetic analysis did not reveal changes in the pharmacokinetics of sildenafil when co-administered with: CYP2C9 isoenzyme inhibitors (such as tolbutamide, warfarin, phenytoin), CYP2D6 isoenzyme inhibitors (such as: selective serotonin reuptake inhibitors and tricyclic antidepressants), thiazides and thiazide-like drugs. diuretics, loop and potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, calcium antagonists, beta-blockers or inducers of the CYP450 isoenzyme (such as rifampicin and barbiturates). Nicorandil is a hybrid of potassium channel activator and nitrate. Due to the presence of nitrate in the composition of the drug, a serious interaction with sildenafil is possible. Effect of sildenafil on the pharmacokinetics of other drugs Studies in vitro Sildenafil is a weak inhibitor of cytochrome P450 isoenzymes 1 A 2,2 C 9,2 C 19,2D6,2 E 1 and ZA 4 (IC50 > 150 mmol). The cmax of sildenafil after taking the recommended doses is approximately 1 mmol, so it is unlikely that sildenafil affects the clearance of substrates of these isoenzymes. There are no data on the interaction of sildenafil with non-specific phosphodiesterase inhibitors, such as theophylline or dipyridamole. In vivo studies Sildenafil has an effect on the NO/cGMP system, so it enhances the hypotensive effect of nitrates. Concomitant use with NO donors (such as: amyl nitrite) or nitrates in any form is contraindicated. In some patients, concomitant use of sildenafil with alpha-blockers may lead to the development of symptomatic hypotension. Arterial hypotension most often develops within 4 hours after taking sildenafil.Clinical studies have studied the use of sildenafil (25 mg,50 mg, or 100 mg) in combination with the 4 mg or 8 mg alpha-blocker doxazosin in patients with benign prostatic hyperplasia and stable hemodynamics. There was an additional decrease in blood pressure in the horizontal position of the patient, on average, by 7/7,9/5 and 8/4 mm Hg, respectively, and in the vertical position-on average, by 6/6,11/4 and 4/5 mm Hg. In patients with stable hemodynamics while taking doxazosin, when sildenafil was added to therapy, there were rare cases of symptomatic orthostatic hypotension, clinically manifested by dizziness, but without the development of syncope. Interactions of sildenafil (50 mg) with golbutamide (250 mg) or warfarin (40 mg), which are metabolized by the CYP2C9 isoenzyme, were not detected. Sildenafil (50 mg) does not cause additional prolongation of bleeding time when used simultaneously with acetylsalicylic acid (150 mg). Sildenafil (50 mg) did not potentiate the antihypertensive effect of ethanol in healthy volunteers (the average serum ethanol cmax was 80 mg / dl). Undesirable effects of antihypertensive drugs, including diuretics, beta-blockers, and ACE inhibitors. angiotensin II receptor antagonists, vasodilators, centrally acting drugs, adrenergic neuron blockers, slow calcium channel blockers, and alpha-blockers did not differ in patients treated with sildenafil or placebo. In a drug interaction study of the concomitant use of sildenafil (100 mg) with amlodipine in patients with arterial hypertension, an additional decrease in horizontal systolic blood pressure by 8 mm Hg and diastolic blood pressure by 7 mm Hg was noted. The additional decrease in blood pressure is comparable to that with sildenafil alone in healthy volunteers. Sildenafil (100 mg) at steady state did not affect the pharmacokinetic parameters of HIV protease inhibitors: saquinavir and ritonavir, which are substrates of the CYP3A4 isoenzyme.

How to take, course of use and dosage

Inside, if necessary, with a small amount of water. The recommended dose is 50 mg, which is taken if necessary, approximately 1 hour before the intended sexual activity. Depending on the efficacy and tolerability, the dose of Sildenafil-SZ can be increased to 100 mg. The maximum recommended dose is 100 mg. The maximum recommended frequency of use of the drug is 1 time per day. Special patient groups Elderly patients No dose adjustment of Sildenafil-SZ is required. 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 less than 30 ml/min), the dose of Sildenafil – SZ should be reduced to 25 mg. Depending on the effectiveness and tolerability, the dose can be increased to 50 mg and 100 mg. Impaired liver function Since the elimination of sildenafil is impaired in patients with impaired liver function (for example, with cirrhosis of the liver), the dose of the drug should be reduced to 25 mg. Depending on the effectiveness and tolerability, the dose can be increased to 50 mg and 100 mg. Concomitant use with other medicinal products Simultaneous use of ritonavir is contraindicated. When used concomitantly with inhibitors of the CYP3A4 isoenzyme (such as ketoconazole, erythromycin, cimetidine, with the exception of ritonavir), the initial dose of Sildenafil-SZ should not exceed 25 mg. To reduce the likelihood of developing orthostatic hypotension, it is necessary to achieve a stable state of hemodynamics against the background of alpha-blocker therapy before starting sildenafil. The initial dose of Sildenafil-SZ should be reduced to 25 mg.

Overdose

Symptoms: with a single dose of sildenafil in doses up to 800 mg, adverse reactions are similar to those with lower doses of the drug, while the severity and frequency increased. Taking sildenafil at a dose of 200 mg did not lead to an increase in effectiveness, but the frequency of adverse reactions (headache, hot flashes, dizziness, dyspepsia, nasal congestion, visual disturbances) increased. Treatment: symptomatic. Hemodialysis is ineffective because sildenafil is strongly bound to plasma proteins and is not excreted by the kidneys.

Description

A mixture of granules of different sizes of white or almost white color with a mint smell.

Special instructions

Before using drug therapy, it is necessary to evaluate the medical history and conduct a clinical examination in order to diagnose erectile dysfunction and identify its possible causes. Drugs for the treatment of sexual dysfunction, including sildenafil, should be used with caution in patients with anatomical deformities of the penis (such as angulation, cavernous fibrosis or Peyronie’s disease), as well as in patients with conditions predisposing to priapism (such as sickle cell anemia, multiple myeloma or leukemia). Medications for the treatment of erectile dysfunction, including sildenafil, should not be used in men who are not recommended for sexual activity. Sexual activity poses a certain risk in the presence of diseases of the cardiovascular system. Therefore, before starting any therapy for erectile dysfunction, it is necessary to assess the patient’s condition. The use of sildenafil is contraindicated in patients with heart failure, unstable angina, myocardial infarction or stroke in the last 6 months, arterial hypotension (BP Sexual activity is undesirable for patients with life-threatening arrhythmias, arterial hypertension (BP > 170/100 mm Hg). There is no difference in the incidence of myocardial infarction (1.1 per 100 person-years) and the mortality rate from cardiovascular diseases (0.3 per 100 person-years) when using sildenafil compared to patients in the placebo group. Cardiovascular complications Serious cardiovascular events (time-related to sildenafil use) have been reported with post-marketing sildenafil use, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, arterial hypertension and arterial hypotension. Most of the patients had cardiovascular risk factors. Many of the complications developed during or immediately after sexual intercourse, and some developed shortly after using sildenafil without sexual activity. It is impossible to determine the causal relationship with any factors. Reduction of ADSildenafil has a systemic vasodilator effect, leading to a slight and transient decrease in blood pressure. Before using sildenafil, the doctor should carefully assess the risk of possible undesirable vasodilating effects in patients with the corresponding diseases, especially against the background of sexual activity. Increased susceptibility to vasodilators is observed in patients with left ventricular outflow tract obstruction (for example, aortic stenosis, HOCMP) or rarely occurring multiple systemic atrophy syndrome, which is manifested by a severe violation of the autonomous regulation of blood pressure. Concomitant use with alpha-blockers Sildenafil should be used with caution in patients taking alpha-blockers, since the simultaneous use of sildenafil and alpha-blockers may lead to symptomatic hypotension in some susceptible patients. Arterial hypotension most often develops within 4 hours after taking sildenafil. PDE5 inhibitors, including sildenafil, and alpha-blockers are antihypertensive vasodilators. With the simultaneous use of vasodilators, an excessive decrease in blood pressure may develop. Patients with unstable hemodynamics on the background of the use of alpha-blockers are at an increased risk of developing symptomatic arterial hypotension when used simultaneously with PDE-5 inhibitors. To minimize the risk of developing orthostatic hypotension in such patients, sildenafil therapy should be initiated only after hemodynamic stabilization has been achieved while taking alpha-blockers. Consideration should be given to reducing the initial dose of sildenafil to 25 mg. If the patient is already receiving sildenafil, the use of alpha-blockers should begin with a low dose. When used concomitantly with PDE5 inhibitors, a further decrease in blood pressure may be associated with a gradual increase in the dose of alpha-blockers. In addition, the doctor should explain to the patient what actions should be taken in case of orthostatic hypotension (for example, dizziness, pre-fainting, loss of consciousness). If these symptoms occur, the patient should sit down or take a horizontal position. Visual impairment When using all PDE-5 inhibitors, including sildenafil, in rare cases, the development of anterior ischemic optical neuropathy of non-arterial origin was observed, which was accompanied by deterioration or loss of vision. Most of these patients had risk factors such as excavation of the optic nerve head, age over 50 years, diabetes mellitus, hypertension, CHD, hyperlipidemia, and smoking. A causal relationship between the use of PDE5 inhibitors and the development of anterior ischemic optic neuropathy of non-arterial origin has not been established. In case of sudden loss of vision, the patient should receive immediate medical attention and stop using Sildenafil-SZ. A small number of patients with hereditary retinitis pigmentosa have genetically determined retinal phosphodiesterase defects.The safety of sildenafil in patients with retinitis pigmentosa has not been studied, so its use in these patients is contraindicated. Hearing impairment patients with all PDE-5 inhibitors, including sildenafil, have experienced sudden hearing loss or loss. Most of these patients had risk factors for hearing loss or loss. No correlation was found between the use of PDE5 inhibitors and hearing impairment. In case of sudden hearing loss or loss, you should stop using Sildenafil-SZ and immediately consult a doctor. A causal relationship between the use of PDE5 inhibitors and sudden hearing loss has not been established. Bleedingasildenafil potentiates the antiplatelet effect of sodium nitroprusside (a NO donor) in vitro. There is no information available on the safety of sildenafil in patients with acute bleeding or peptic ulcers. Therefore, sildenafil should be used with caution in such patients only after careful assessment of the benefit / risk ratio. Concomitant use with other medications intended for the treatment of erectile dysfunctionthe safety and efficacy of sildenafil in combination with other medications intended for the treatment of erectile dysfunction have not been studied. Therefore, the use of such combinations is contraindicated. Sildenafil-SZ is not intended for use in women.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C.

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Sildenafil

Conditions of release from pharmacies

By prescription

Dosage form

granules