viagra ireland price

Viagra ireland price using can contain given one tech skills. Buy kamagra & cialis

active ingredient: sildenafil;

1 tablet contains 70.225 mg of sildenafil citrate, which is equivalent to sildenafil 50 mg;

excipients: ludiflesh (manit (E 421), crossword, polyvinyl acetate, pozdon), sodium crosscarmylose, microcrystalline cellulose, silicon colloidal hydrophobic dioxide, saccharase (E 955), indigocarminium aluminum varnish 30–36% (E 132), sweet taste enhancer, special natural component, lemon flavoring, magnesium stearate.

Dosage form

Tablets dispersed in the oral cavity.

Basic physicochemical properties: blue tablets in the shape of a diamond, with engraving “V50” on the one hand and without engraving on the other .

Pharmacotherapeutic group

Means used in erectile dysfunction. Sildenafil. The code of ATC G04B E03.

Pharmacological properties

Pharmacodynamics.

Mechanism of action. Sildenafil is an oral medication intended for the treatment of erectile dysfunction. During sexual arousal, the drug restores reduced erectile function by increasing blood flow to the penis.

The physiological mechanism that causes an erection involves the release of nitric oxide (no) in the cavernous bodies during sexual arousal. The released nitric oxide activates the enzyme guanylate cyclase, which stimulates an increase in the level of cyclic guanosine monophosphate (cGMP), which, in turn, causes relaxation of the smooth muscles of the cavernous bodies, promoting blood flow.

Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase 5 (PDE5) in the cavernous bodies, where PDE5 is responsible for the breakdown of cGMP. The effect of sildenafil on erection is peripheral. Sildenafil does not have a direct relaxing effect on isolated human cavernous bodies, but it powerfully enhances the relaxing effect of NO on this tissue. When the no/cGMP metabolic pathway is activated during sexual stimulation, sildenafil inhibition of PDE5 causes an increase in cGMP levels in the cavernous bodies. Thus, in order for sildenafil to cause the necessary pharmacological effect, sexual arousal is necessary.

Effect on pharmacodynamics. In vitro studies have shown that sildenafil is selective for pde5, which is actively involved in the erection process. The effect of sildenafil on PDE5 is stronger than on other known phosphodiesterases. This effect is 10 times more powerful than the effect of exposure to PDE6, which is involved in the processes of phototransformation in the retina. When using the maximum recommended doses, the selectivity of sildenafil to PDE5 is 80 times higher than its selectivity to PDE1, 700 times higher than to PDE2, PDEZ, PDE4, PDE7, PDE8, PDE9, PDE10 and PDE11. In particular, the selectivity of sildenafil to PDE5 is 4,000 times higher than its selectivity to PDEZ – camp, a specific phosphodiesterase isoform involved in the regulation of cardiac contractility.

Pharmacokinetics.

Absorption. Sildenafil is rapidly absorbed. The maximum plasma concentration of the drug is reached within 30-120 minutes (with an average of 60 minutes) after its oral administration on an empty stomach. The average absolute bioavailability after oral administration is 41 % (with a range of values from 25 to 63 %). In the recommended dose range (25 to 100 mg), the AUC and Cmaxildenafil values after oral administration increase in proportion to the dose.

When sildenafil is used during meals, the degree of absorption decreases with an average prolongation of Tmax to 60 Minutes and an average decrease in Cmax by 29 %.

Distribution. The average equilibrium volume of distribution (Vd) is 105 liters, which indicates the distribution of the drug in the body’s tissues. After a single oral administration of sildenafil at a dose of 100 mg, the average maximum total plasma concentration of sildenafil is approximately 440 ng/mL (coefficient of variation is 40 %). Since The Binding of sildenafil and its main n-desmethyl metabolite to plasma proteins reaches 96 %, the average maximum plasma concentration of free sildenafil reaches 18 ng/mL (38 nmol). The degree of binding to plasma proteins does not depend on the total concentration of sildenafil.

In healthy volunteers who used sildenafil once at a dose of 100 mg, after 90 minutes, less than 0.0002 % (on average 188 Ng) of the applied dose was detected in the ejaculate.

Biotransformation. Sildenafil is mainly metabolized by microsomal liver isoenzymes CYP3A4 (main pathway) and CYP2C9 (secondary pathway). The main circulating metabolite is formed by N-demethylation of sildenafil. The selectivity of the metabolite against PDE5 is comparable to that of sildenafil, and the activity of the metabolite against PDE5 is approximately 50% of the activity of the parent substance. The plasma concentration of this metabolite is approximately 40% of the concentration of sildenafil in blood plasma. The N-demethylated metabolite undergoes further metabolism, and its Half-Life is approximately 4 hours.

Elimination. The total clearance of sildenafil is 41 l/h, which leads to a Half-Life of 3-5 hours. Both after oral and intravenous administration, sildenafil is excreted as metabolites mainly in the faeces (approximately 80% of the administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose).

Pharmacokinetics in special groups of patients.

Elderly patients. Healthy elderly volunteers (over 65 years of age) showed a decrease in sildenafil clearance, which led to an increase in plasma concentrations of sildenafil and its active N-demethylated metabolite by approximately 90% compared to the corresponding concentrations in healthy young volunteers (18-45 years). Due to age-related differences in binding to plasma proteins, the corresponding increase in the plasma concentration of free sildenafil was approximately 40 %.

Kidney failure. In volunteers with mild to moderate renal impairment (creatinine clearance 30-80 mL/min), the pharmacokinetics of sildenafil remained unchanged after a single oral dose of 50 mg. The mean AUC and Cmax of the N-demethylated metabolite increased by a maximum of 126% and a maximum of 73%, respectively, compared to those in volunteers of the same age without impaired renal function. However, due to the high individual variability, these differences were not statistically significant. In volunteers with severe renal impairment (creatinine clearance below 30 mL/min), sildenafil clearance decreased, which caused an average increase in AUC and Cmax by 100% and 88%, respectively, compared with volunteers of the same age without renal impairment. In addition, the AUC and Cmax values of the N-demethylated metabolite significantly increased by 200% and 79%, respectively.

Liver failure. In volunteers with mild to moderate cirrhosis of the liver (Child – Pugh classes A and B), sildenafil clearance decreased, which led to an increase in AUC (84 %) and Cmax (47 %) compared to the corresponding indicators in volunteers of the same age without impaired liver function. The pharmacokinetics of sildenafil in patients with severe hepatic impairment have not been studied.

Indications

Viagra ® ODT is recommended for men with erectile dysfunction, which is defined as the inability to achieve or maintain the penile erection necessary for successful sexual intercourse.

For the effective action of Viagra® ODT, sexual arousal is required.

Contraindications

Hypersensitivity to the active substance or any of the excipients of the drug.

Concomitant use with nitric oxide donors (such as amyl nitrite) or nitrates in any form is contraindicated, since sildenafil is known to affect the metabolic pathways of nitric oxide/cyclic guanosine monophosphate (cGMP) and potentiates the hypotensive effect of nitrates.

Concomitant use of PDE5 inhibitors (including sildenafil) with guanylate cyclase stimulants such as riociguate is contraindicated, as it may lead to symptomatic hypotension (see the section “interactions with other drugs and other types of interactions”).

Conditions for which sexual activity is not recommended (for example, severe cardiovascular disorders, such as unstable angina or severe heart failure).

Loss of vision in one eye due to non-arterial anterior ischemic neuropathy of the optic nerve, regardless of whether this pathology is associated with previous use of PDE5 inhibitors or not.

The presence of the following diseases: severe liver function disorders, hypotension (blood pressure below 90/50 mm Hg). recent stroke or myocardial infarction, and known hereditary degenerative retinal diseases such as retinitis pigmentosa (a small number of such patients have genetic disorders of retinal phosphodiesterases), since the safety of sildenafil has not been studied in the case of such diseases.

Interactions with other drugs and other types of interactions

Effect of other drugs on sildenafil.

In vitro studies.

Sildenafil metabolism occurs mainly with the participation of the ZA4 isoform (main pathway) and the 2c9 isoform (secondary pathway) of cytochrome P450 (CYP). Therefore, inhibitors of these isoenzymes can reduce the clearance of sildenafil, and inducers of these isoenzymes can increase the clearance of sildenafil.

In vivo studies.

Population pharmacokinetic analysis of clinical trial data showed a decrease in sildenafil clearance when co-administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, cimetidine). Although no increase in the frequency of side effects was observed with concomitant use of sildenafil and CYP3A4 inhibitors, the possibility of using an initial dose of sildenafil 25 mg should be considered.

Concomitant use of the HIV protease inhibitor ritonavir, a very powerful P450 inhibitor, at steady state concentrations (500 mg 1 time per day) and sildenafil (a single dose of 100 mg) resulted in an increase in the CMAX of sildenafil by 300 % (4 times) and an increase in the plasma AUC of sildenafil by 1000 % (11 times). After 24 hours, the plasma level of sildenafil was still approximately 200 ng/ml compared to the level of approximately 5 ng/mL characteristic of sildenafil alone, which is consistent with the significant effect of ritonavir on a wide range of P450 substrates. Sildenafil does not affect the pharmacokinetics of ritonavir. Given these pharmacokinetic data, concomitant use of sildenafil and ritonavir is not recommended (see the section “special instructions for use”); in any case, the maximum dose of sildenafil should never exceed 25 mg within 48 hours.

Concomitant use of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at a dose that provides an equilibrium concentration (1200 mg three times a day), and sildenafil (100 mg once) resulted in an increase in the CMAX of sildenafil by 140% and an increase in systemic exposure (AUC) of sildenafil by 210 %. There was no effect of sildenafil on the pharmacokinetics of saquinavir (see the section “dosage and administration”). More potent CYP3A4 inhibitors, such as ketoconazole and Itraconazole, are expected to have a more pronounced effect.

When using sildenafil (100 mg once) and erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), an increase in systemic exposure to sildenafil was observed by 182 % (AUC). In healthy male volunteers, no effect of azithromycin (500 mg per day for 3 days) on AUC, Cmax, Tmax, elimination rate constant, and subsequent Half-Life of sildenafil or its main circulating metabolite was observed. Cimetidine (cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor) at a dose of 800 mg when co-administered with sildenafil at a dose of 50 mg in healthy volunteers resulted in a 56% increase in the plasma concentration of sildenafil.

Grapefruit juice is a weak inhibitor of CYP3A4 in the intestinal wall and can cause a moderate increase in plasma sildenafil levels.

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

Although studies of specific interaction with all drugs have not been conducted, according to population pharmacokinetic analysis, the pharmacokinetics of sildenafil did not change when it was co-administered with drugs belonging to the group of CYP2C9 inhibitors (tolbutamide, warfarin, phenytoin), the group of CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), the group of thiazide and thiazide-like diuretics, loop and potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, calcium antagonists, beta-adrenergic antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates).

In a study involving healthy male volunteers, concomitant use of the endothelin antagonist bosentan (a moderate inducer of CYP3A4, CYP2C9, and possibly CYP2C19) at steady state (125 mg twice daily) and sildenafil at steady state (80 mg three times daily) resulted in a decrease in the AUC and Cmax of sildenafil by 62.6% and 55.4%, respectively. Therefore, the simultaneous use of such powerful CYP3A4 inducers as rifampin may lead to a more pronounced decrease in the concentration of sildenafil in blood plasma.

Nicorandil is a hybrid of calcium channel activator and nitrate. The nitrate component determines the possibility of its serious interaction with sildenafil.

Effect of sildenafil on other medications.

In vitro studies.

Sildenafil is a weak inhibitor of cytochrome P450 isoforms 1A2, 2c9, 2c19, 2d6, 2e1 and ZA4 (IC50> 150 mmol). Since the peak plasma concentration of sildenafil is approximately 1 mmol, the effect of Viagra® ODT on the clearance of substrates of these isoenzymes is unlikely.

There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline and Dipyridamole.

In vivo studies.

Since sildenafil is known to affect the metabolism of nitric oxide/cyclic guanosine monophosphate (cGMP), it was found that sildenafil potentiates the hypotensive effect of nitrates, so its simultaneous use with nitric oxide donors or with nitrates in any form is contraindicated (see the section “contraindications”).

Riociguat. Preclinical studies have demonstrated an additive systemic effect of lowering blood pressure when PDE5 inhibitors are co-administered with riociguate. Clinical studies have shown that riociguate enhances the hypotensive effect of PDE5 inhibitors. No positive clinical effect was observed in patients who participated in the study when PDE5 inhibitors were co-administered with riociguate. Concomitant use of riociguate with PDE5 inhibitors (including sildenafil) is contraindicated (see the section “contraindications”).

Concomitant use of sildenafil and alpha-adrenergic blockers may lead to the development of symptomatic hypotension in some predisposed patients. This reaction most often occurred within 4 hours after the use of sildenafil (see the section “dosage and administration” and “application features”). In 3 drug interaction studies, the alpha-adrenergic blocker Doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg and 100 mg) were used simultaneously in patients with Benign Prostatic Hyperplasia, whose condition was stabilized with Doxazosin. In these populations, an average additional reduction in blood pressure was observed in the patient’s supine position by 7/7 mmHg. St., 9/5 mm Hg. St. and 8/4 mmHg. and the average decrease in blood pressure in the patient’s standing position by 6/6 mm Hg. St., 11/4 mm Hg. St., 4/5 mm Hg. Art. respectively. When sildenafil and Doxazosin were co-administered, symptomatic orthostatic hypotension was sometimes reported in patients whose condition was stabilized by Doxazosin. These reports reported cases of dizziness and pre-fainting, but no syncope.

No significant interactions were observed with concomitant administration of sildenafil (50 mg) and tolbutamide (250 mg) or warfarin (40 mg) metabolized by CYP2C9.

Sildenafil (50 mg) did not prolong the bleeding time caused by the use of acetylsalicylic acid (150 mg).

Sildenafil (50 mg) did not potentiate the hypotensive effect of alcohol in healthy volunteers with an average maximum blood ethanol level of 80 mg/dL.

In patients treated with sildenafil, there were no differences in the side-effect profile compared to placebo with concomitant use of such classes of antihypertensive drugs as diuretics, beta-adrenergic blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive drugs (vasodilators and central action), adrenergic neuron blockers, calcium channel blockers and alpha-adrenergic blockers. In a special interaction study, concomitant use of sildenafil (100 mg) and amlodipine in patients with arterial hypertension showed an additional decrease in systolic blood pressure in the supine position by 8 mm Hg. the corresponding decrease in diastolic blood pressure was 7 mm Hg. these additional reductions in blood pressure were comparable to those observed with sildenafil alone in healthy volunteers (see Section “pharmacological properties”).

Sildenafil at a dose of 100 mg did not affect the pharmacokinetic parameters of HIV protease inhibitors, saquinavir and ritonavir, which are substrates of CYP3A4.

In healthy male volunteers, steady-state administration of sildenafil (80 mg three times daily) resulted in a 49.8% and 42% increase in bosentan AUC and Cmax (125 mg twice daily), respectively.

Application features

Before starting therapy, the patient’s medical history should be collected and a physical examination should be performed to diagnose erectile dysfunction and determine its possible causes.

Risk factors for cardiovascular diseases. Since sexual activity is accompanied by a certain risk from the heart, before starting any treatment for erectile dysfunction, the doctor should assess the state of the patient’s cardiovascular system. Sildenafil has a vasodilating effect, which is manifested by a slight and short-term decrease in blood pressure (see the section “pharmacodynamics”). Before prescribing sildenafil, the doctor should carefully weigh whether this effect can adversely affect patients with certain underlying diseases, especially in combination with sexual activity. Patients with hypersensitivity to vasodilators include patients with obstruction of the left ventricular excretory tract (for example, aortic stenosis, Hypertrophic Obstructive Cardiomyopathy) and patients with rare multisystem atrophy syndrome, one of the manifestations of which is a severe violation of blood pressure regulation by the autonomic nervous system.

Viagra ® ODT potentiates the hypotensive effect of nitrates (see the section “contraindications”).

In the post-marketing period, severe cardiovascular adverse reactions were reported, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, arterial hypertension and hypotension, which coincided with the use of Viagra® ODT. Most patients, but not all, had Risk Factors for cardiovascular disease. Many of these adverse reactions were observed during or immediately after sexual intercourse, and only a few occurred shortly after using viagra® ODT without sexual activity. Therefore, it is impossible to determine whether the development of such adverse reactions is directly related to risk factors, or their development is due to other factors.

Priapism. Medications for the treatment of erectile 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) and in patients with conditions that contribute to the development of priapism (such as sickle cell anemia, multiple myeloma, or leukemia).

After the drug was released to the market, cases of prolonged erections and priapism were reported. If an erection lasts more than 4 hours, patients should seek immediate medical attention. If left untreated immediately, priapism can lead to penile tissue damage and permanent loss of potency.

Concomitant use with other PDE5 inhibitors or other medications for the treatment of erectile dysfunction. The safety and efficacy of concomitant use of sildenafil with other PDE5 inhibitors or other drugs for the treatment of pulmonary hypertension containing sildenafil (for example, Revacio), or with other drugs for the treatment of erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

Effects on vision. Spontaneous reports of visual defects have been associated with the use of sildenafil and other PDE5 inhibitors (see Section “adverse reactions”). Cases of non-arterial anterior ischemic optic neuropathy, which is a rare condition, have been reported spontaneously and have been reported in an observational study associated with the use of sildenafil and other PDE5 inhibitors (see Section “adverse reactions”). Patients should be warned that in case of sudden visual impairment, the use of Viagra® ODT should be discontinued and immediately consult a doctor (see below). Section “contraindications”).

Concomitant use with ritonavir. Concomitant use of sildenafil and ritonavir is not recommended (see the section “interactions with other drugs and other types of interactions”).

Concomitant use with alpha-adrenergic blockers. Patients who use alpha-adrenergic blockers should use sildenafil with caution, as this combination may lead to symptomatic hypotension in some predisposed patients. Symptomatic hypotension usually occurs within 4 hours of sildenafil administration. In order to minimize the possible development of postural hypotension, the patient’s hemodynamic parameters during therapy with alpha-adrenergic blockers should be stable before starting sildenafil. An initial dose of sildenafil 25 mg should be considered (see “dosage and administration”). In addition, patients should be informed how to proceed in case of symptoms of orthostatic hypotension.

Effect on Bleeding. Human platelet studies have shown that sildenafil potentiates the antiplatelet effects of sodium nitroprusside in vitro. There is no information on the safety of sildenafil in patients with blood clotting disorders or acute peptic ulcer disease. Thus, the use of sildenafil in patients in this group is possible only after careful assessment of the benefit-risk ratio.

Hearing loss. Doctors should advise patients to stop using PDE5 inhibitors, including Viagra® ODT, and seek immediate medical attention in case of sudden hearing loss or loss. These events, which may also be accompanied by tinnitus and dizziness, have been reported to be associated over time with the use of PDE5 inhibitors, including Viagra® ODT. It is impossible to determine whether these phenomena are directly related to the use of PDE5 inhibitors or other factors.

Concomitant use with antihypertensive drugs. Viagra ® ODT has a systemic vasodilating effect and may further reduce blood pressure in patients using antihypertensive drugs. In a separate drug interaction study, an average additional decrease in systolic pressure of 8 mm Hg was observed when amlodipine (5 mg or 10 mg) and Viagra ODT (100 mg) were co-administered orally. St. and diastolic-by 7 mm Hg. Art.

Sexually transmitted diseases. The use of Viagra® ODT does not protect against sexually transmitted diseases. Consideration should be given to informing patients about the necessary precautions to protect against sexually transmitted diseases, including human immunodeficiency virus.

Fertility. After administration of a dose of 100 mg in healthy volunteers, no effect on sperm morphology or motility was observed (see the section “pharmacodynamics”).

Use during pregnancy or lactation.

Viagra ® ODT is not intended for use by women.

Ability to influence the reaction rate when driving vehicles or other mechanisms.

Studies of the effect of the drug on the ability to drive vehicles and work with other mechanisms have not been conducted.

Since cases of dizziness and visual disturbances have been reported in clinical trials of sildenafil, patients need to find out what their individual response to the use of Viagra® ODT is before driving a vehicle or working with other mechanisms.

Dosage and administration

The drug is used orally.

The drug should be applied immediately after the tablet is removed from the blister. The tablet should be placed on the tongue, wait for it to disintegrate, and then swallow. The drug can be taken with or without water.

If it is necessary to use a dose of 100 mg, the second tablet should be taken only after the first tablet has completely disintegrated.

It is recommended to use the drug on an empty stomach, since when using the drug simultaneously with fatty foods, there is a significant delay in absorption compared to using tablets on an empty stomach.

Adults. If necessary, Viagra® ODT should be used 1 hour before sexual activity. The recommended dose is 50 mg. Since simultaneous use of the drug with food delays absorption and slows down the effect of the drug (see the section “pharmacokinetics”), it is recommended to use the drug on an empty stomach.

Depending on the efficacy and tolerability, the dose can be increased to 100 mg. The maximum recommended dose is 100 mg. If necessary, apply a dose of 100 mg, take 2 tablets of 50 mg sequentially.

The maximum recommended frequency of use of the drug is 1 time per day.

If it is necessary to use a dose of 25 mg, it is recommended to use sildenafil, coated tablets of 25 mg.

Elderly patients. There is no need for dose adjustment in elderly patients (≥ 65 years).

Patients with renal insufficiency. For patients with mild to moderate renal insufficiency (creatinine clearance 30-80 mL/min), the recommended dose of the drug is the same as indicated above in the section “adults”.

Since sildenafil clearance is reduced in patients with severe renal insufficiency (creatinine clearance < 30 mL/min), a dose of 25 mg should be considered. Depending on the effectiveness and tolerability of the drug, if necessary, the dose can be gradually increased to 50 mg and up to 100 mg.

Patients with hepatic insufficiency. Since sildenafil clearance is reduced in patients with hepatic insufficiency (e.g. cirrhosis), a dose of 25 mg should be considered. Depending on the effectiveness and tolerability of the drug, if necessary, the dose can be gradually increased to 50 mg and up to 100 mg.

Patients who use other medications. If patients are using CYP3A4 inhibitors at the same time (with the exception of ritonavir, which is not recommended to be used simultaneously with sildenafil, see the sections “features of use”, “interactions with other drugs and other types of interactions”), the possibility of using an initial dose of 25 mg should be considered.

In order to minimize the possible development of postural hypotension in patients using alpha-adrenergic blockers, the condition of such patients should be stabilized before starting sildenafil. The possibility of using an initial dose of 25 mg should also be considered (see the sections “features of Use” and “interactions with other drugs and other types of interactions”).

Children.

The drug is not indicated for use by persons under 18 years of age.

Overdose

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

In case of overdose, if necessary, resort to the usual maintenance measures. Acceleration of sildenafil clearance during hemodialysis is unlikely due to the high degree of Binding of the drug to plasma proteins and the lack of elimination of sildenafil in the urine.

Adverse reactions

The safety profile of Viagra® ODT is based on data obtained in 74 double-blind placebo-controlled clinical trials (9570 patients). 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 post-marketing follow-up 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 more frequently during clinical trials than with placebo are listed below according to the system-organ-class classification and frequency: very common (≥ 1/10), common (≥ 1/100 – < 1/10), infrequent (≥ 1000 – < 1/100), and rare (≥ 1/10000 – < 1/1000). Within each group, the frequency of adverse reactions is listed in descending order of their severity.

Infectious and invasive diseases.

Infrequently: rhinitis.

Disorders of the immune system.

Infrequently hypersensitivity.

Disorders of the nervous system.

Very common: headache.

Often dizziness.

Infrequently: drowsiness, hypesthesia.

Rare: stroke, transient ischemic attack, convulsions*, recurrent seizures*, syncope.

Disorders of the visual organs.

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

Infrequently: lacrimation disorders***, eye pain, photophobia, photopsia, eye hyperemia, visual brightness, conjunctivitis.

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

Disorders of the hearing organs and vestibular apparatus.

Infrequently dizziness, ringing in the ears.

Rare: deafness.

Heart disorders.

Infrequently: tachycardia, increased heart rate.

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

Vascular disorders.

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

Infrequently: hypertension, hypotension.

Disorders of the respiratory system, chest and mediastinal organs.

Common: nasal congestion.

Infrequently: nosebleeds, sinus congestion.

Rare: tightness in the throat, swelling of the nasal mucosa, dryness in the nose.

Disorders of the gastrointestinal tract.

Common: nausea, dyspepsia.

Infrequently: gastroesophageal reflux disease, vomiting, upper abdominal pain, dry mouth.

Rarely hypesthesia of the oral cavity.

Disorders of the skin and subcutaneous tissue.

Infrequently: rash.

Rare: Stevens-Johnson syndrome*, toxic epidermal necrolysis*.

Disorders of the musculoskeletal system and connective tissue.

Infrequently myalgia, pain in the extremities.

Disorders of the urinary system.

Infrequently: hematuria.

Disorders of the reproductive system and mammary glands.

Rare: penile bleeding, priapism*, hematospermia, prolonged erection.

General disorders and reactions at the injection site.

Infrequently: chest pain, increased fatigue, feeling hot.

Rare: irritation.

Survey.

Infrequently: increased heart rate.

* Reported only during the study after the drug was released to the market.

** Color perception disorders: chloropsia, chromatopsia, cyanopsia, erythropsia, xanthopsia.

*** Impaired lacrimation: dry eyes, impaired lacrimation, and increased lacrimation.

The following adverse reactions were observed in < 2% of patients in controlled clinical trials; their causal relationship with the use of Viagra® ODT is unclear. Adverse reactions that were likely associated with the use of the drug were noted. No mild adverse reactions were reported. There were also no adverse reactions, reports of which were too inaccurate to matter.

Common: facial swelling, photosensitivity reactions, shock, asthenia, pain, sudden fall, abdominal pain, sudden injury.

From the cardiovascular system: angina pectoris, AV block, migraine, postural hypotension, myocardial ischemia, cerebral vascular thrombosis, sudden cardiac arrest, impaired ECG results, cardiomyopathy.

Gastrointestinal disorders: glossitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, impaired liver test results, rectal bleeding, gingivitis.

From the blood and lymphatic system: anemia, leukopenia.

Metabolic and nutritional disorders: thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemia, hypernatremia.

Musculoskeletal disorders: arthritis, osteoarthritis, tendon rupture, tenosynovitis, bone pain, myasthenia gravis, synovitis.

Nervous system disorders: ataxia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depression, insomnia, abnormal dreams, decreased reflexes.

Respiratory system disorders: asthma, dyspnoea, laryngitis, pharyngitis, sinusitis, bronchitis, increased salivation, increased cough.

Skin disorders: urticaria, herpes, itching, sweating, skin ulcers, contact dermatitis, exfoliative dermatitis.

Specific sensations: sudden hearing loss or loss, ear pain, eye hemorrhage, cataracts, dry eyes.

Disorders of the urogenital system: cystitis, nocturia, increased frequency of urination, enlarged mammary glands, urinary incontinence, ejaculation disorders, genital edema, anorgasmia.

Application experience after entering the market. The following adverse reactions were detected after the drug entered the market. Since such reactions are reported voluntarily and reports come from a population of unknown size, it is not always possible to reliably estimate their frequency and establish a causal relationship with drug exposure. These adverse reactions were taken into account due to the presence of the following factors: severity, frequency of reports, lack of a clear alternative link, and a combination of all these factors.

Cardiovascular and cerebrovascular phenomena. Serious cardiovascular, cerebrovascular and vascular events, including cerebrovascular bleeding, subarachnoid and intracerebral bleeding, and pulmonary bleeding, have been reported over time with the use of Viagra® ODT. Most patients, but not all, had cardiovascular risk factors. Many of these events have been reported to occur during or immediately after sexual activity, and several events have occurred immediately after using viagra® ODT without sexual activity. Other events occurred within hours or days of Viagra® ODT use and sexual activity. It is not possible to determine whether these phenomena are related to drug use, sexual activity, existing risk factors, or a combination of these factors, or other factors.

Circulatory and lymphatic systems: vaso-occlusive crisis. In a small pre-discontinued study of Revacio (sildenafil) in patients with pulmonary arterial hypertension secondary to sickle cell anemia, the development of vaso-occlusive crises requiring hospitalization was reported more frequently with sildenafil than with placebo. The clinical significance of this information for patients using viagra® ODT for the treatment of erectile dysfunction is unknown.

Nervous system: anxiety, transient global amnesia.

Specific sensations.

Hearing. After the drug entered the market, cases of sudden hearing loss or loss associated with the use of Viagra® ODT have been reported over time. In some cases, the presence of diseases and other factors that may play a role in the development of adverse hearing reactions has been reported. In many cases, there is no information about further medical supervision. It is not possible to determine whether these events are directly related to the use of Viagra® ODT, existing risk factors for hearing loss, a combination of these factors, or other factors.

Vision: temporary vision loss, redness of the eyes, burning in the eyes, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, vitreous detachment.

After the drug entered the market, cases of non-arterial anterior ischemic neuropathy of the optic nerve, which is the cause of vision loss, including permanent vision loss, were rarely reported, which were associated over time with the use of PDE5 inhibitors, including Viagra® ODT. Many patients, but not all, had anatomical or vascular risk factors for developing non-arterial anterior ischemic neuropathy of the optic nerve, including (but not necessarily limited to) the following: low ratio of excavation diameter to optic disc (congestive disc of the optic nerve), age over 50 years, hypertension, coronary artery disease, hyperlipidemia, and smoking. It is not possible to determine whether these events are directly related to the use of PDE5 inhibitors, with existing anatomical or vascular risk factors, with a combination of all these factors, or with other factors.

Reporting suspected adverse reactions. Reporting suspected adverse reactions after drug registration is important. This makes it possible to continuously monitor the ratio of benefits and risks associated with the use of this drug. Doctors should report any suspected adverse reactions in accordance with legal requirements.

Expiration date

3 years old.

Storage conditions

Keep out of reach of children.

Store in the original packaging to protect from moisture.

It does not require special storage conditions.

Packaging

2 or 4 tablets in a blister; 1 blister in a cardboard box.