Виагра®

General characteristics. Structure:

International unlicensed name: sildenafit

Dosage form: tablets, film coated

Active agent: sildenafit citrate (25 mg, 50 mg or 100 mg of a sildenafil are equivalent)

Excipients: cellulose microcrystallic, calcium hydrophosphate, croscarmellose sodium,
magnesium stearate; film cover: опадрай blue OY-LS-20921 (contains a gipromelloza, lactose, triacetin, titanium dioxide (E171) and an aluminum varnish on the basis of indigo carmine (E132)) and опадрай transparent YS-2-19114-A (contains a gipromelloza and triacetin)

To a blue film covering it can be added to 30 mkg/g of vanillin and/or biotin; at the same time the maintenance of one or both components in a film covering will make up to 0,75 mkg, 1,5 mkg and 3,0 mkg for dosages of 25 mg, 50 mg and 100 mg, respectively.

Description. Blue tablets, film coated, rhomboid, slightly biconvex, with the cut-off and rounded edges, with an engraving of "Pfizer" on one party and "VGR 25", "VGR 50" or "VGR 100" on other party, respectively.

Pharmacological properties:

Pharmacodynamics. Sildenafil – powerful selection inhibitor циклогуанозинмонофосфат (tsGMF) - specific phosphodiesterase of the 5th type (FDE5).

Action mechanism

Sale of the physiological mechanism of an erection is connected with release of nitrogen oxide (NO) in a cavernous body during sexual stimulation. It, in turn, leads to increase in the tsGMF level, the subsequent relaxation of smooth muscle tissue of cavernous body and increase in inflow of blood.

Sildenafil has no the direct weakening effect on the isolated cavernous body of the person, but strengthens effect of nitrogen oxide (NO) by means of inhibition of FDE5 which is responsible for disintegration of tsGMF.

Sildenafil селективен concerning FDE5 in vitro, its activity concerning FDE5 surpasses activity concerning other known isoenzymes of phosphodiesterase: FDE6 - by 10 times; FDE1 - more than by 80 times; FDE2, FDE4, FDE7-FDE11 - more than by 700 times. Sildenafil by 4000 times more селективен concerning FDE5 in comparison with FDE3 that is essential as FDE3 is one of key enzymes of regulation of contractility of a myocardium.

Indispensable condition of efficiency of a sildenafil is sexual stimulation.

Clinical data

Cardiological researches

Use of a sildenafil in doses to 100 mg did not lead to clinically significant changes of an ECG at healthy volunteers. The maximum decrease in systolic pressure in a prone position after reception of a sildenafil in a dose of 100 mg made 8,3 mm of mercury., and diastolic pressure – 5,3 mm of mercury. More expressed, but also the passing effect on the arterial pressure (AP) was noted at the patients accepting nitrates (see sections of "Contraindication" and "Interaction with Other Medicines").

In a research of hemodynamic effect of a sildenafil in a single dose of 100 mg at 14 patients with the heavy coronary heart disease (CHD) (more than 70% of patients had a stenosis, at least, of one coronary artery), systolic and diastolic pressure at rest decreased by 7% and 6%, respectively, and pulmonary systolic pressure decreased by 9%. Sildenafil did not influence cordial emission and did not break a blood stream in stenosed coronary arteries, and also led to increase (approximately for 13%) adenosine - the induced coronary flow both in stenosed, and in intact coronary arteries.

In a double blind platsebokontroliruyemy research 144 patients with erectile dysfunction and stable stenocardia accepting anti-anginal drugs (except nitrates) carried out physical exercises until when expressiveness of symptoms of stenocardia decreased. Duration of performance of exercise was authentically more (19,9 seconds; 0.9 - 38.9 seconds) at the patients accepting sildenafit in a single dose 100 mg in comparison with the patients receiving placebo.

In a randomized double blind platsebokontroliruyemy research studied effect change of a dose of a sildenafil (to 100 mg) at the men (n = 568) with erectile dysfunction and arterial hypertension accepting more than two anti-hypertensive drugs. Sildenafil improved an erection at 71% of men in comparison with 18% in group of placebo. Frequency of adverse effects was comparable with that in other groups of patients, just as at the persons accepting more than three anti-hypertensive drugs.

Researches of visual disturbances

At some patients in 1 hour after reception of a sildenafil in a dose of 100 mg by Farnsvorta-Munsel's test 100 easy and passing disturbance of ability to distinguish shades of color (blue/green) is revealed. In 2 hours after administration of drug these changes were absent. It is considered that disturbance of color sight is caused by inhibition of FDE6 which participates in the course of transfer of light in an eye retina. Sildenafil did not exert impact on visual acuity, contrast perception, the electroretinogram, intraocular pressure or diameter of a pupil.

In a platsebokontroliruyemy cross research of patients with the proved early age macular degeneration (n = 9) sildenafit 100 mg in a single dose it was transferred well. No clinically significant changes of sight estimated according to special visual tests were revealed (visual acuity, a lattice Amsler, color perception, modeling of passing of color, Hemfri's perimeter and a photostress).

Efficiency

Efficiency and safety of a sildenafil estimated in 21 randomized double blind platsebokontroliruyemy researches lasting up to 6 months at 3000 patients aged from 19 to 87, with erectile dysfunction of various etiology (organic, psychogenic or mixed). Efficiency of drug estimated globally with use of the diary of erections, the international index of erectile function (a validirovanny questionnaire about a state sexual functions) and the partner's poll.

Efficiency sildenafit, defined as ability to reach and support the erection sufficient for satisfactory sexual intercourse, was shown in all the conducted researches and confirmed in long-term researches lasting 1 year. In researches using the fixed dose the ratio of the patients who reported that therapy improved their erection made: 62% (the dose sildenafit 25 mg), 74% (the dose sildenafit 50 mg) and 82% (the dose sildenafit 100 mg) in comparison with 25% in group of placebo. The analysis of the international index of erectile function showed that in addition to improvement of an erection treatment sildenafily also increased quality of an orgasm, allowed to reach satisfaction from sexual intercourse and the general satisfaction.

According to the generalized data, among the patients who reported about improvement of an erection at treatment sildenafily there were 59% of patients with diabetes, 43% of the patients who transferred a radical prostatectomy and 83% of patients with injuries of a spinal cord (against 16%, 15% and 12% in group of placebo, respectively).

Pharmacokinetics. The pharmacokinetics of a sildenafil in the recommended range of doses has linear character.

Absorption
After intake sildenafit quickly it is soaked up. Absolute bioavailability averages about 40% (from 25% to 63%). In vitro sildenafit about 1,7 ng/ml (3,5 nanometers) in concentration suppresses activity of FDE5 of the person for 50%. After a single dose of a sildenafil in a dose of 100 mg average maximum concentration of a free sildenafil in a blood plasma (Cmax) of men makes about 18 ng/ml (38 nanometers). Cmax at reception of a sildenafil inside is on an empty stomach reached on average within 60 min. (from 30 min. to 120 min.). At reception in combination with greasy food the speed of absorption decreases: Cmax decreases on average by 29%, and time of achievement of the maximum concentration (Tmax) increases for 60 min., however extent of absorption authentically does not change (the area under a pharmacokinetic curve concentration time (AUC) decreases by 11%).

Distribution

The volume of distribution of a sildenafil in an equilibrium state averages 105 l.

Communication sildenafit and its main circulating metabolite N-demetilnogo with proteins of a blood plasma makes about 96% and does not depend on the general concentration of drug. Less than 0,0002% of a dose of a sildenafil (on average 188 нг) are revealed in sperm in 90 min. after administration of drug.

Metabolism

Sildenafil is metabolized, mainly, in a liver under the influence of a CYP3A4 cytochrome isoenzyme (the main way) and a CYP2C9 cytochrome isoenzyme (a minor way). The main circulating active metabolite which is formed as a result
N-demethylations of a sildenafil, is exposed to further metabolism. Selectivity of action of this metabolite concerning FDE is comparable to that sildenafit, and its activity concerning FDE5 in vitro makes about 50% of activity of a sildenafil. Concentration of a metabolite in a blood plasma of healthy volunteers made about 40% of concentration of a sildenafil. N-demetilny a metabolite is exposed to further metabolism; the period of its semi-removal (T1/2) makes near the 4th hour.

Removal

The general clearance of a sildenafil makes 41 l/hour, and final T1/2 - 3-5 hour. After intake also as after intravenous administration sildenafit it is removed in the form of metabolites, generally by intestines (about 80% of a peroral dose) and, to a lesser extent, kidneys (about 13% of a peroral dose).

Pharmacokinetics at special groups of patients

Elderly patients

At healthy elderly patients (65 years are more senior) the clearance of a sildenafil is reduced, and concentration of a free sildenafil in a blood plasma is about 40% higher, than at young people (18-45 years). The age does not exert clinically significant impact on the frequency of development of side effects.

Renal failures

At easy (the clearance of creatinine (CC) of 50-80 ml/min.) and moderated (KK of 30-49 ml/min.) degrees of a renal failure the pharmacokinetics of a sildenafil after a single dose inside in a dose of 50 mg does not change. At a heavy renal failure (KK of £30 ml/min.) the clearance of a sildenafil decreases that also Cmax (88%) in comparison with those indicators at normal function of kidneys at patients of the same age group leads to approximately double increase in AUC value (100%).

Abnormal liver functions

At patients with cirrhosis (stages And yes In on classification of Chayld-Pyyu) the clearance of a sildenafil decreases that also Cmax (47%) in comparison with those indicators at normal function of a liver at patients of the same age group leads to increase in AUC value (84%). The pharmacokinetics of a sildenafil at patients with heavy abnormal liver functions (a stage With on classification of Chayld-Pyyu) was not studied.

Indications to use:

Treatment of the disturbances of an erection which are characterized by inability to achievement or preservation of an erection of a penis sufficient for satisfactory sexual intercourse.

Sildenafil is effective only at sexual stimulation.

Route of administration and doses:

Inside.

The recommended dose for most of adult patients makes 50 mg approximately in 1 hour prior to sexual activity. Taking into account efficiency and portability the dose can be increased to 100 mg or is lowered to 25 mg. The maximum recommended dose makes 100 mg. The maximum recommended frequency rate of use - once a day.

Renal failures

At easy and medium-weight degree of a renal failure (KK of 30-80 ml/min.) correction of a dose is not required, at a heavy renal failure (KK <30 ml/min.) – a dose of a sildenafil should lower to 25 mg.


Abnormal liver functions

As removal of a sildenafil is broken at patients with injury of a liver (in particular, at cirrhosis), the dose of the drug Viagra® should be lowered to 25 mg.

Combined use with other medicines

At combined use with ritonaviry the maximum single dose of the drug Viagra® should not exceed 25 mg, and frequency rate of use – 1 time in the 48th hour (see the section "Interaction with Other Medicines").

At combined use with CYP3A4 cytochrome isoenzyme inhibitors (erythromycin, саквинавир, кетоконазол, итраконазол) the initial dose of the drug Viagra® has to make 25 mg (see the section "Interaction with Other Medicines").

To minimize risk of development of postural hypotension in the patients accepting α-adrenoblockers, administration of drug of Viagra® should be begun only after achievement of stabilization of a hemodynamics at these patients. It is also necessary to consider expediency of decrease in an initial dose of a sildenafil (see the sections "Special Instructions" and "Interaction with Other Medicines").

Elderly patients

Correction of a dose of the drug Viagra® is not required.

Features of use:

For diagnosis of disturbances of an erection, definition of their possible reasons and the choice of adequate treatment it is necessary to collect the full medical anamnesis and to conduct careful physical examination. Remedies for erectile dysfunction have to be used with care at patients with anatomic deformation of a penis (an angulation, cavernous fibrosis, Peyroni's disease), or patients with risk factors have development of a priapism (drepanocytic anemia, a multiple myeloma, leukemia) (see the section "With Care").

Men to whom sexual activity is undesirable should not appoint the drugs intended for treatment of disturbances of an erection.

Sexual activity represents a certain risk in the presence of heart diseases therefore before any therapy concerning disturbances of an erection the doctor should direct the patient to inspection of a condition of cardiovascular system. Sexual activity is undesirable at patients with heart failure, unstable stenocardia, the myocardial infarction postponed to the last 6 months or a stroke, zhizneugrozhayushchy arrhythmias, arterial hypertension (the ABP> of 170/100 mm of mercury.) or hypotonia (ABP <90/50 mm of mercury.) (see the section "With Care"). In clinical trials lack of distinctions in the frequency of development of a myocardial infarction (1,1 on 100 people a year) or the frequency of mortality from cardiovascular diseases (0,3 on 100 people a year) at the patients receiving the drug Viagra® in comparison with the patients receiving placebo is shown. Visual disturbances

Cardiovascular complications

During post-marketing use of a sildenafil for treatment of erectile dysfunction it was reported about such undesirable phenomena as heavy cardiovascular complications (including a myocardial infarction, unstable stenocardia, a sudden cardiac death, ventricular arrhythmia, a hemorrhagic stroke, the tranzitorny ischemic attack, hypertensia and hypotension) which had temporary communication using a sildenafil. Most of these patients, but not all from them, had risk factors of cardiovascular complications. Many of the specified undesirable phenomena were observed soon after sexual activity, and some of them were noted after reception of a sildenafil without the subsequent sexual activity. Existence is not possible to establish a feedforward between noted undesirable phenomena and the specified or other factors.



Hypotension

Sildenafil has the systemic vazodilatiruyushchy action leading to passing decrease in the ABP that is not clinically significant phenomenon and does not lead to any effects at most of patients. Nevertheless, before purpose of the drug Viagra® the doctor has to estimate carefully risk of possible undesirable manifestations of vazodilatiruyushchy action at patients with the corresponding diseases, especially against the background of sexual activity. The raised susceptibility to vazodilatator is observed at patients with obstruction of an output path of a left ventricle (an aorta stenosis, a hypertrophic subaortic stenosis), and also with seldom found syndrome of a multiple system atrophy, the shown heavy disturbance of regulation of the ABP from the autonomic nervous system.

As combined use of a sildenafil and α-adrenoblockers can lead to symptomatic hypotension at certain sensitive patients, it is necessary to appoint the drug Viagra® with care the patient accepting α-adrenoblockers ((((((((((see the section "Interaction with Other Medicines"). To minimize risk of development of postural hypotension in the patients accepting α-adrenoblockers, administration of drug of Viagra® should be begun only after achievement of stabilization of indicators of a hemodynamics at these patients. It is also necessary to consider expediency of decrease in an initial dose of the drug Viagra® (see the section "Route of Administration and Doses"). The doctor has to inform patients on what actions should be taken in case of symptoms of postural hypotension.

Visual disturbances

Exceptional cases of development of a lobby of a nearteriitny ischemic neuropathy of an optic nerve were celebrated as sildenafit the reasons of deterioration or loss of sight against the background of use of all FDE5 inhibitors, including. Most of these patients had risk factors, such as excavation (deepening) of an optic disk, the age is more senior than 50 years, a diabetes mellitus, arterial hypertension, coronary heart disease, a lipidemia and smoking. Relationship of cause and effect between reception of FDE5 inhibitors and development of a front nearteriitny ischemic neuropathy of an optic nerve is not revealed. The doctor has to inform the patient on increase in risk of development of a front nearteriitny ischemic neuropathy of an optic nerve if this state at it was already noted. In case of sudden loss of sight patients should provide necessary medical care immediately.

The small number of patients with a hereditary pigmental retinitis has genetically determined disturbances of functions of phosphodiesterases of a retina of an eye. Data on safety of use of the drug Viagra® for patients with a pigmental retinitis are absent therefore sildenafit it is necessary to apply with care (see the section "With Care").

Hearing disorder

In some post-market and clinical trials it is reported about the cases of sudden deterioration or a hearing loss connected using all FDE5 inhibitors, including sildenafit. Most of these patients had risk factors of sudden deterioration or a hearing loss. To relationship of cause and effect between use of FDE5 inhibitors and sudden deterioration in hearing or a hearing loss it is not established. In case of sudden deterioration in hearing or a hearing loss against the background of reception of a sildenafil it is necessary to consult immediately with the doctor.

Bleedings

Sildenafil strengthens antiagregantny effect of Sodium nitroprussidum, the donator of nitrogen oxide, on thrombocytes of the person of in vitro. Data on safety of use of a sildenafil for patients with tendency to bleeding or an aggravation of a peptic ulcer of a stomach and a 12-perstny gut are absent therefore the drug Viagra® at these patients should be used with care (see the section "With Care"). Frequency of nasal bleedings at patients from LG connected with diffusion diseases of connecting fabric was higher (sildenafit 12,9%, placebo of 0%), than at patients with primary pulmonary hypertensia (sildenafit 3,0%, placebo of 2,4%). At the patients receiving sildenafit in combination with the antagonist of vitamin K, the frequency of nasal bleedings was higher (8,8%), than at the patients who were not accepting the antagonist of vitamin K (1,7%).

Use together with other remedies for disturbances of an erection

Safety and efficiency of the drug Viagra® together with other remedies for disturbances of an erection were not studied therefore use of similar combinations is not recommended (see the section "Contraindications").



Influence on ability to drive the car and to control of mechanisms
Against the background of reception of a sildenafil of any negative influence on ability to drive the car or other technical means it was not observed.

However as at reception of a sildenafil decrease in the ABP, development of a chromatopsia, the obscured sight, etc. in by-effects is possible, it is necessary to show consideration for individual effect of drug in the specified situations, especially in an initiation of treatment and at change of the mode of dosing.

Side effects:

Usually side effects of the drug Viagra® poorly or are moderately expressed and have passing character.

In researches using the fixed dose it is shown that the frequency of some undesirable phenomena increases with increase in a dose.

Bodies and systems of bodies By-effects
Sildenafil, % of Placebo, %
The most frequent by-effects (> 1/10)
Nervous system
Headache 10,8
2,8

Cardiovascular system
Vazodilatation (blood "inflows"

to face skin)
10,9
1,4

Frequent by-effects (> 1/100 and <1/10)

Nervous system
Dizziness
2,9
1,0

Organ of sight
Sight change (the obscured sight, sensitivity change

to light)
2,5
0,4


Chromatopsia (easy and passing, mainly change of perception of shades of color)
1,1
0,03

Cardiovascular system
Cardiopalmus
1,0
0,2

Respiratory system
Rhinitis (nose congestion)
2,1
0,3

Alimentary system
Dyspepsia
3,0
0,4


When using the drug Viagra® in the doses exceeding the recommended, undesirable phenomena were similar with noted above, but usually met more often.

Disturbances of the general state: hypersensitivity reactions (including skin rash).

Changes from the central and peripheral nervous system: spasms.

Changes from cardiovascular system: tachycardia, decrease in the ABP, faints, nasal bleeding.

Gastrointestinal disturbances: vomiting.

Changes from an organ of sight: eye pain, reddening of an eye/injection of scleras.

Disturbances from reproductive system: long erection and/or priapism.

Interaction with other medicines:

Influence of other medicines on pharmacokinetics of a sildenafil

Metabolism of a sildenafil happens generally under the influence of CYP3A4 cytochrome isoenzymes (the main way) and CYP2C9 therefore inhibitors of these isoenzymes can reduce clearance of a sildenafil, and inductors, respectively, to increase clearance of a sildenafil. Decrease in clearance of a sildenafil at simultaneous use of inhibitors of an isoenzyme of CYP3A4 cytochrome is noted (кетоконазол, erythromycin, Cimetidinum). Cimetidinum (800 mg), nonspecific inhibitor of an isoenzyme of CYP3A4 cytochrome, at joint reception with sildenafily (50 mg) causes increase in concentration of a sildenafil in plasma for 56%. The single dose of 100 mg of a sildenafil together with erythromycin (on 500 mg/days 2 times a day within 5 days), specific inhibitor of an isoenzyme of CYP3A4 cytochrome, against the background of achievement of constant concentration of erythromycin in blood, leads to increase in AUC of a sildenafil by 182%. At joint reception of a sildenafil (once 100 mg) and the sakvinavira (1200 mg/day 3 times a day), inhibitor of HIV protease and an isoenzyme of CYP3A4 cytochrome, against the background of achievement of constant concentration of a sakvinavir in Cmax blood of a sildenafil increased by 140%, and AUC increased by 210%. Sildenafil does not exert impact on pharmacokinetics of a sakvinavir. Stronger inhibitors of an isoenzyme of CYP3A4 cytochrome, such as кетоконазол and итраконазол, can cause also stronger changes of pharmacokinetics of a sildenafil.

Simultaneous use of a sildenafil (once 100 mg) and a ritonavira (on 500 mg 2 times a day), inhibitor of HIV protease and strong inhibitor of P450 cytochrome, against the background of achievement of constant concentration of a ritonavir in blood leads to increase in Cmax of a sildenafil by 300% (by 4 times), and AUC for 1000% (by 11 times). In 24 hours concentration of a sildenafil in a blood plasma makes about 200 ng/ml (after single use of one sildenafil - 5 ng/ml).

If sildenafit the patients receiving at the same time strong inhibitors of an isoenzyme of CYP3A4 cytochrome accept in the recommended doses, then Cmax of a free sildenafil does not exceed 200 nanometers, and drug is well transferred.

The single dose of an antacid (hydroxide aluminum hydroxide magnesium) does not influence bioavailability of a sildenafil.

CYP2C9 cytochrome isoenzyme inhibitors (Tolbutamidum, warfarin), a CYP2D6 cytochrome isoenzyme (selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and tiazidopodobny diuretics, APF inhibitors and antagonists of calcium, do not exert impact on pharmacokinetics of a sildenafil.

Azithromycin (500 mg/days within 3 days) does not exert impact on AUC, Cmax, Tmax, a constant of speed of removal and T1/2 of a sildenafil or its main circulating metabolite.

Influence of a sildenafil on other medicines

Sildenafil is weak inhibitor of isoenzymes of P450 cytochrome - 1A2, 2S9, 2S19, 2D6, 2E1 and 3A4 (IK50> 150 µmol). At reception of a sildenafil in the recommended doses of its Cmax makes about 1 µmol therefore it is improbable that sildenafit can affect clearance of substrates of these isoenzymes.

Sildenafil strengthens hypotensive effect of nitrates both at prolonged use of the last, and at their appointment according to acute indications. In this regard, use of a sildenafil in combination with nitrates or donators of nitrogen oxide contraindicated.

At a concomitant use of α-adrenoblocker of a doksazozin (((((((((((4 mg and 8 mg) and a sildenafila (25 mg, 50 mg and 100 mg) at patients with a benign hyperplasia of a prostate with a stable hemodynamics average additional decrease in the systolic/diastolic ABP in a dorsal decubitus made 7/7 mm of mercury., 9/5 mm of mercury. and 8/4 mm of mercury., respectively, and in a standing position - 6/6 mm of mercury., 11/4 mm of mercury. and 4/5 mm of mercury., respectively. It is reported about exceptional cases of development in such patients of the symptomatic postural hypotension shown in the form of dizzinesses (without faint). At the certain sensitive patients receiving
α-adrenoblockers, simultaneous use of a sildenafil can lead to symptomatic hypotension.

Signs of considerable interaction with Tolbutamidum (250 mg) or warfarin (40 mg) which are metabolized by a CYP2C9 cytochrome isoenzyme are not revealed.

Sildenafil (100 mg) does not exert impact on pharmacokinetics of inhibitors of HIV protease, the sakvinavir and a ritonavir who is CYP3A4 cytochrome isoenzyme substrates at their constant level in blood.

Sildenafil (50 mg) does not cause additional increase in a bleeding time at reception of acetylsalicylic acid (150 mg).

Sildenafil (50 mg) does not strengthen hypotensive effect of alcohol at healthy volunteers at the maximum concentration of alcohol in blood on average of 0,08% (80 mg/dl).

At patients with an arterial hypertension of signs of interaction of a sildenafil (100 mg) with amlodipiny it is not revealed. Average additional decrease in the ABP in a prone position makes 8 mm of mercury. (systolic) and 7 mm of mercury. (diastolic).

Use of a sildenafil in combination with anti-hypertensive means does not lead to emergence of additional side effects.

Contraindications:

Hypersensitivity to a sildenafil or to any other component of drug.

Use for the patients receiving constantly or with breaks donators of nitrogen oxide organic nitrates or nitrites in any forms as sildenafit strengthens hypotensive effect of nitrates (see the section "Interaction with Other Medicines")

Safety and efficiency of the drug Viagra® at combined use with other remedies for disturbances of an erection were not studied therefore use of similar combinations is not recommended (see the section "Special Instructions")

According to the registered indication the drug Viagra® is not intended for use for children up to 18 years

According to the registered indication the drug Viagra® is not intended for use for women

With care

Anatomic deformation of a penis (angulation, cavernous fibrosis or Peyroni's disease) (see the section "Special Instructions")

The diseases contributing to development of a priapism (a sickemia, a multiple myeloma, a leukosis, a trombotsitemiya) (see the section "Special Instructions")

The diseases which are followed by bleeding

Aggravation of a peptic ulcer

Hereditary pigmental retinitis (see the section "Special Instructions")

The heart failure, unstable stenocardia postponed to the last 6 months a myocardial infarction, a stroke or zhizneugrozhayushchy arrhythmias, arterial hypertension (the ABP> of 170/100 mm of mercury.) or hypotonia (ABP <90/50 mm of mercury.) (see the section "Special Instructions")

Pregnancy and period of a lactation
According to the registered indication drug is not intended for use for women

Overdose:

At a single dose of the drug Viagra® in a dose to 800 mg the undesirable phenomena were comparable to those at administration of drug in lower doses, but met more often.

Symptomatic treatment. The hemodialysis does not accelerate clearance of a sildenafil as the last actively contacts proteins of plasma and is not removed by kidneys.

Storage conditions:

List B. To store in the dry place at a temperature not above 30 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated 25 mg, 50 mg or 100 mg of 1, 2, 4, 8 or 12 tablets in the blister from PVC/polyethylene / аклар / aluminum foil 1, 2 or 3 of the blister in a cardboard pack together with the application instruction.