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MEXIDOL® (Emoxipine) 125 mg, 50 coated tablets
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Description
The instruction for medical use of Maxigra medicine the Trade name of Maksigr Mezhdunarodnoye the unlicensed name Sildenafil Lekarstvennaya the Tablet form, coated 50 mg, 100 mg Structure One tablet contains active agent – sildenafit citrate of 70.24 mg or 140.48 mg (it is equivalent to a sildenafil) 50.00 mg or 100.00 mg respectively, excipients: Mannitolum, krospovidon (type A), povidone (To 25), silicon dioxide colloidal, starch corn, magnesium stearate, sodium lauryl sulfate, structure of a cover: gipromelloza (15 mPas), macrogoal 6000, titan E171 dioxide, talc, E132 indigo carmine. The description of the Tablet of round shape, with a biconvex surface, coated blue color. Pharmacotherapeutic group Drugs for treatment of urological diseases. Other drugs for treatment of urological diseases, including spasmolysants. Drugs for treatment of disturbances of an erection. Sildenafil. ATH G04BE03 code the Pharmacological Sildenafil Pharmacokinetics Absorption properties is quickly soaked up. The maximum concentration in blood plasma after oral administration of drug are on an empty stomach reached within from 30 to 120 minutes. The average absolute bioavailability at oral administration is 41% (range of 2563%). After oral administration of a sildenafil of AUC and Cmax increase in proportion to a dose at reception in the recommended range of doses (25-100 mg). At reception of a sildenafil together with food the speed of absorption decreases, at the same time the average delay of Tmax makes 60 minutes and average decrease in Cmax – 29%. Distribution the Average volume of distribution of a sildenafil in a condition of equilibrium concentration (Vd) makes 105 l that demonstrates its distribution in fabrics. After single oral administration in a dose of 100 mg the average maximum general concentration of a sildenafil in plasma makes about 440 ng/ml. As sildenafit (and its main circulating N-desmetil metabolite) for 96% contacts proteins of plasma, average maximum concentration of a free sildenafil in plasma makes 18 ng/ml (38 nanometers). Linking with proteins does not affect the general concentration of drug. At the healthy volunteers receiving sildenafit (single dose in a dose of 100 mg), in 90 minutes after introduction in semen less than 0.0002% (on average 188 ng) the entered dose were defined. Metabolism Sildenafil is metabolized by mainly microsomal isoenzymes of a liver of CYP3A4 (main way) and CYP2C9 (minor way). The main circulating metabolite is formed of a sildenafil by N-demethylation. This metabolite possesses a selectivity profile concerning phosphodiesterases, similar to that sildenafit, and its activity concerning FDE5 in vitro is about 50% of activity of initial drug. Concentration of this metabolite in plasma makes about 40% of concentration of a sildenafil. Further the metabolite of N-desmetil is metabolized, at the same time its elimination half-life makes about 4 h. Removal the General clearance of a sildenafil makes 41 l/h, at the same time terminal elimination half-life makes 3-5 h. After oral or intravenous administration sildenafit it is removed in the form of metabolites mainly with a stake (about 80% of the dose entered orally) and in smaller quantity with urine (about 13% of the dose entered orally). Drug pharmacokinetics in separate groups of patients Elderly At healthy volunteers of advanced age (65 years are more senior) the decrease in clearance of a sildenafil was noted that led to increase in concentration of a sildenafil and active metabolite of N-desmetila in plasma up to 90% in comparison with healthy volunteers of younger age (18-45 years). Owing to age differences in linking with proteins of plasma, the corresponding increase in concentration of a free sildenafil in plasma was about 40%. Patients with a renal failure At volunteers with a renal failure of light and moderate severity (clearance of creatinine = 30-80 ml/min.) after single oral introduction of a sildenafil in a dose of 50 mg its pharmacokinetic parameters did not change. Average AUC and Cmax values of a metabolite N-desmetila increased up to 126% and 73% respectively in comparison with volunteers of the same age without renal failure. However owing to high interindividual variability these distinctions were not significant. At volunteers with a heavy renal failure (clearance of creatinine & lt, 30 ml/min.) the clearance of a sildenafil decreased that led to increase in average AUC and Cmax values to 100% and 88% respectively in comparison with volunteers of the same age without renal failure. Besides, AUC and Cmax values for a metabolite of N-desmetila were considerably increased to 79% and 200% respectively. Patients with a liver failure At volunteers with easy and moderate degree of cirrhosis (And yes In a class on classification of Chayld-Pyyu) decrease in clearance of a sildenafil was noted that led to increase in AUC values (84%) and Cmax (47%) in comparison with volunteers of the same age without disturbance of hepatic function. Pharmacokinetic parameters of a sildenafil at patients with a heavy abnormal liver function were not studied. The pharmacodynamics Sildenafil is oral drug for treatment of erectile dysfunction. Under natural conditions, for example at sexual stimulation, drug restores the broken erectile function by strengthening of inflow of blood to a penis. The physiological mechanism by means of which there is a penis erection includes release of nitrogen oxide (NO) in a cavernous body during sexual stimulation. Further nitrogen oxide activates enzyme guanylate cyclase that leads to increase in level of the cyclic guanozinmonofosfat (tsGMF) which causes relaxation of unstriated muscles in a cavernous body and promotes blood inflow. Sildenafil is selection inhibitor of tsGMF-specific phosphodiesterase of the 5th type (FDE5) in a cavernous body where FDE5 is responsible for disintegration of tsGMF. Sildenafil possesses peripheral type of action on an erection. Sildenafil has no direct weakening effect on the isolated cavernous human body, but actively enhances the weakening effect NO on cavernous fabric. At activation of a way NO/tsGMF as in case of sexual stimulation, FDE5 inhibition under the influence of a sildenafil leads to increase in the tsGMF level in a cavernous body. Therefore in order that sildenafit had the expected effective pharmacological effect, sexual stimulation is necessary. Sildenafil selektiven concerning FDE5 which participates in process of an erection. Its activity concerning FDE5 exceeds activity concerning other known phosphodiesterases. This activity by 10 times exceeds activity concerning FDE6 which participates in the course of transfer of light in a retina. Sildenafil causes an insignificant and passing lowering of arterial pressure which in most cases is not shown clinically. Average maximum decrease in systolic arterial blood pressure in a dorsal decubitus after oral administration of a sildenafil in a dose of 100 mg was 8.4 mm Hg. Corresponding change of diastolic arterial blood pressure in a dorsal decubitus made 5.5 mm Hg. Such lowering of arterial pressure will be coordinated with the vazodilatiruyushchy action of a sildenafil which is possibly connected with increase in the tsGMF level in unstriated muscles of vessels. Single oral introduction of a sildenafil in a dose up to 100 mg had no clinically significant impact on the ECG parameters. After single dose of a sildenafil in a dose of 100 mg of impact on mobility or morphology of spermatozoa it was not noted. Indications – the erectile dysfunction which is characterized by inability to achievement or preservation of an erection of a penis sufficient for satisfactory sexual intercourse. Maxigra is effective only at sexual stimulation. A route of administration and doses For oral administration. Maxigra can be accepted with food or without. Nevertheless, to start Maxigra’s action more time in case of reception with food can be necessary. The dosing mode Use for adults the Recommended Maxigra’s dose makes 50 mg inside approximately in 1 hour prior to sexual intercourse. Taking into account efficiency and shipping the dose can be increased up to 100 mg or is reduced up to 25 mg. The maximum recommended dose makes 100 mg. It is necessary to swallow a tablet entirely, washing down with a glass of water. The maximum recommended reception frequency – 1 time a day. Special groups of patients Patients of advanced age (≥ 65 years) dose adjustment is not required From patients of advanced age. Patients with a renal failure At easy and moderate degree of a renal failure (clearance of creatinine of 30-80 ml/min.) the dose adjustment is not required. Due to the decrease in clearance of a sildenafil at patients with a heavy renal failure (clearance of creatinine & lt, 30 ml/min.), it is necessary to consider the possibility of use of Maxigra in a dose of 25 mg. Proceeding from efficiency and tolerance of drug if necessary, it is possible to increase its dose step by step to 50 mg and up to 100 mg. Patients with an abnormal liver function Because the clearance of a sildenafil is lowered at patients with an abnormal liver function (for example, cirrhosis), it is necessary to consider the possibility of use of drug in a dose of 25 mg. Proceeding from efficiency and tolerance of drug if necessary, it is possible to increase its dose step by step to 50 mg and up to 100 mg. Patients of children’s and teenage age Sildenafil is not shown for use for children (& lt, 18 years). Use for the patients accepting other medicines except for a ritonavir which is not recommended to be accepted along with sildenafily it is necessary to consider the possibility of use of drug in an initial dose of 25 mg at the patients receiving the accompanying therapy by CYP3A4 inhibitors. For the purpose of reduction of risk of development of postural arterial hypotension in the patients undergoing treatment by alpha adrenoblockers to follows/stabilize a condition of the patients receiving alpha adrenoblockers before beginning treatment sildenafily. Besides, it is necessary to consider the possibility of use of a sildenafil, since a dose of 25 mg. Side effects At use of a sildenafil are registered undesirable effects which were classified by the frequency of their manifestation as follows: very often (≥ 1/10), it is frequent (from ≥ 1/100 to & lt, 1/10), infrequently (from ≥ 1/1000 to & lt, 1/100) and is rare (≥ 1/10,000 and & lt, 1/1000). Very often – a headache Often – dizziness – congestion of a nose – color distortions of sight (chloropsiya, a chromatopsia, blue vision, red vision, a xanthopsia), a visual disturbance, illegibility of sight – hyperaemia, inflows – dyspepsia, nausea Infrequently – rhinitis – hypersensitivity – drowsiness, a hypesthesia – the disturbances connected with dacryagogue (xerophthalmus, dysfunction of a lacrimal gland, the raised dacryagogue), eye pain, photophobia, a photopsia, hyperaemia of vessels of eyes, brightness of visual perception, conjunctivitis – a spatial disorientation (vertigo), sonitus – tachycardia, heart consciousness – arterial hypertension, arterial hypotension – nasal bleeding, congestion of adnexal bosoms of a nose – pain in an upper part of a stomach, a gastroesophageal reflux disease, vomiting, dryness in a mouth – rash – myalgia, extremity pain – a hamaturia – thorax pain, increased fatigue, feeling of heat Is rare – an acute disorder of cerebral circulation, the tranzitorny ischemic attack, a convulsive attack *, a recurrence of a convulsive attack *, a syncope – front nearteriitny ischemic neuropathy of an optic nerve *, occlusion of vessels of a retina *, a retinal apoplexy, an arteriosclerotic retinopathy, a retina disease, glaucoma, defect of a field of vision, a diplopia, decrease in visual acuity, shortsightedness, an asthenopia, vitreous floating opacities, a disease of an iris of the eye, a mydriasis, existence in sight of iridescent circles, eye hypostasis, swelling of an eye, a visual disturbance, conjunctival hyperaemia, irritation of an eye, unusual feeling in an eye, swelled a century, discoloration of a sclera – deafness – a sudden cardiac death *, a myocardial infarction, ventricular arrhythmia *, fibrillation of auricles, unstable stenocardia – feeling of constraint in a throat, nose hypostasis, dryness mucous a nose – an oral hypesthesia – Stephens-Johnson’s syndrome *, a toxic epidermal necrolysis * – bleeding from a penis, a priapism *, a gematospermiya, strengthening of an erection – irritability * the side effects registered only during post-registration observation. The message of data on expected undesirable reactions the Message of data on the expected undesirable reactions revealed after medicine registration is of great importance. It allows to continue monitoring of a ratio of advantage and risk of medicine. Health workers and patients are asked to report about any undesirable reactions to the address specified at the end of this instruction for medical use. Contraindications – hypersensitivity to active agent or to any of excipients – a concomitant use of drugs, being donators of nitrogen oxide (amyle nitrite) or nitrates in any form – a concomitant use with guanylate cyclase stimulators (riotsiguat) – a heavy liver failure – hereditary degenerative diseases of a retina of an eye (for example, a hereditary pigmentary retinitis (the small number of these patients has inherited disorders of functions of phosphodiesterases of a retina)) – loss of sight on one eye owing to front nearteriitny ischemic neuropathy of an optic nerve, regardless of whether this episode was connected with the previous use of FDE-5 inhibitor or not – arterial hypotension (the ABP & lt, 90/50 mm Hg.) – a serious cardiovascular illness (for example, heavy heart failure, unstable stenocardia) – the myocardial infarction postponed to the last 6 months – the stroke which is had in the last 6 months With care: anatomic deformation of a penis (including, an angulation, cavernous fibrosis or Peyroni’s disease) the diseases contributing to development of a priapism (such as it is crescent – cellular anemia (anomaly of red blood cells), a multiple myeloma (marrow cancer) or leukemia (cancer of blood cells)) the problems with blood clotting (hemophilia) of a disease which are followed by bleeding of exacerbation of a peptic ulcer of a stomach or duodenum a concomitant use with drugs of group of alpha adrenoblockers On the registered indication drug it is not intended for use for children and teenagers aged up to 18 years and at women. Medicinal interactions Influence of other medicines on sildenafit the Researches in Vivo At a concomitant use of a sildenafil with CYP3A4 inhibitors (such as ketokonazol, erythromycin and Cimetidinum) decrease in clearance of a sildenafil is observed. However the frequency of the undesirable phenomena at these patients did not increase. If therapy sildenafily is carried out against the background of use of CYP3A4 inhibitors, the initial dose of a sildenafil should be lowered to 25 mg. The concomitant use of HIV inhibitor of protease of the ritonavir which is strong inhibitor of P450 cytochrome in an equilibrium state (two times a day) with sildenafily (in a single dose of 100 mg) leads 500 mg to increase in the maximum concentration (Cmax) in a sildenafil by 300% (4-hkratno) and also to increase in AUC of a sildenafil in blood plasma for 1000% (11-multiply). In 24 hours the levels of a sildenafil in blood plasma are about 200 ng/ml in comparison with about 5 ng/ml after reception only sildenafit. On these data it will be agreed with the significant effects of a ritonavir on a wide range of substrates of P450 cytochrome. Based on the above-stated data, simultaneous use of a sildenafil with ritonaviry is not recommended. Sildenafil does not influence pharmacokinetics of a ritonavir. The maximum dose of a sildenafil under no circumstances should not exceed 25 mg within 48 hours. The concomitant use of HIV inhibitor of protease of the sakvinavir which is CYP3A4 inhibitor in an equilibrium state (three times a day) with sildenafily (in a single dose of 100 mg) leads 1200 mg to increase in Cmax of a sildenafil
and 140% and also to increase in AUC of a sildenafil by 210%. Sildenafil does not influence pharmacokinetics of a sakvinavir. Stronger CYP3A4 inhibitors, such as ketokonazol and itrakonazol, have more significant effect. At single dose of a sildenafil in a dose of 100 mg together with the erythromycin moderated by CYP3A4 inhibitor in an equilibrium state (500 mg two times a day within 5 days), increase in system influence of a sildenafil by 182% is observed (is determined by AUC value). Azithromycin (in a dose of 500 mg a day within 3 days) does not influence indicators of AUC, Cmax, Tmax, a constant of speed of elimination or the subsequent elimination half-life of a sildenafil or its main circulating metabolite. Simultaneous use of Cimetidinum (800 mg) which is inhibitor of P450 cytochrome and nonspecific CYP3A4 inhibitor with sildenafily (in a dose of 50 mg) at healthy volunteers, causes increase in concentration of a sildenafil in blood plasma for 56%. Grapefruit juice is weak CYP3A4 inhibitor – the mediated metabolism in a wall of intestines and can cause moderate increase in level of a sildenafil in blood plasma. Single dose of antiacid means (hydroxide aluminum hydroxide magnesium) does not affect bioavailability of a sildenafil. CYP2C9 inhibitors (tolbutamide, warfarin and Phenytoinum), CYP2D6 inhibitors (selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and tiazidopodobny diuretics, loopback and kaliysberegayushchy diuretics, inhibitors of the angiotensin-converting enzyme (ACE), blockers of calcium channels, blockers of beta and adrenergic receptors and inductors of metabolic activity P450 (rifampicin, barbiturates) do not influence pharmacokinetics of a sildenafil. Simultaneous use of the antagonist of endothelin of a bozentan (the moderate inductor CYP3A4, CYP2C9 and probably CYP2C19) in an equilibrium state (two times a day) with sildenafily in an equilibrium state (80 mg three times a day) leads 125 mg to decrease in AUC and Cmax values for a sildenafil for 62.6% and 55.4% respectively. Thus, believe that simultaneous use with the strong inductors CYP3A4, such as Rifampinum, causes more significant decrease in concentration of a sildenafil in blood plasma. Nikorandil is a hybrid of the activator of potassium channels and nitrate. At the expense of a nitrate component he is potentially capable to enter serious interactions with sildenafily. Influence of a sildenafil on other medicines of the Research in vitro Data on interaction of a sildenafil with nonspecific inhibitors of phosphodiesterases, such as theophylline or Dipiridamolum, no. The researches in Vivo According to the known action of a sildenafil on the alarm way NO/tsGMF, sildenafit leads to strengthening of hypotensive effect of nitrates, namely to a considerable lowering of arterial pressure. Therefore its simultaneous use with donators of nitrogen oxide (amyle nitrite) or nitrates in any form is contraindicated. Riotsiguat In clinical trials riotsiguat strengthened hypotensive effect of FDE-5 inhibitors. Data on favorable clinical effect at use of such combination in the studied population were absent. Simultaneous use of the riotsiguat with FDE-5 inhibitors, including with sildenafily, contraindicated. Simultaneous use of a sildenafil for the patients receiving treatment by alpha adrenoblockers can lead to developing of symptomatic arterial hypotension at some sensitive patients. Most possibly, it can arise within 4 hours after reception of a sildenafil. During three special researches of interaction of medicines, alpha adrenoblocker docsazozin (in a dose of 4 mg and 8 mg) also sildenafit (in a dose of 25 mg, 50 mg or 100 mg) applied at the same time at patients with the benign hyperplasia of a prostate (BHP) which course was stabilized by means of therapy docsazoziny. In these studied groups of patients the average additional lowering of arterial pressure in a dorsal decubitus on 7/7 mm Hg., 9/5 mm Hg was observed. and 8/4 mm Hg., and the average additional lowering of arterial pressure in a standing position made 6/6 mm Hg., 11/4 mm Hg. and 4/5 mm Hg., respectively. At simultaneous use of a sildenafil and docsazozin for the patients stabilized by means of therapy docsazoziny it was reported about exceptional cases of emergence at patients of symptomatic postural arterial hypotension. These messages also included cases of dizziness and a preunconscious state, but not a faint. At simultaneous use of a sildenafil (in a dose of 50 mg) with tolbutamide (in a dose of 250 mg) or warfarin (in a dose of 40 mg), both from which are metabolized by CYP2C9, considerable interactions it is not revealed. Sildenafil (in a dose of 50 mg) does not promote increase in the bleeding time caused by intake of acetylsalicylic acid (in a dose of 150 mg). Sildenafil (in a dose of 50 mg) does not promote strengthening of hypotensive effect of alcohol at healthy volunteers at the average maximum levels of alcohol in blood of 80 mg/dl. Association of the following classes of antihypertensive medicines: diuretics, beta-blockers, APF inhibitors, antagonists of angiotensin II, antihypertensive medicines (vasodilating and the central action), adrenergic neuroblockers, blockers of calcium channels and blockers of alpha adrenoceptors – did not reveal distinctions of a profile of side effects at the patients accepting sildenafit, in comparison with the patients receiving placebo. In special researches of interaction of medicines during which sildenafit (in a dose of 100 mg) it was applied along with amlodipiny at patients with arterial hypertension, additional decrease in systolic arterial blood pressure in a dorsal decubitus was 8 mm Hg. The corresponding additional decrease in diastolic arterial blood pressure in a dorsal decubitus was 7 mm Hg. These additional lowerings of arterial pressure were similar in size to those which were observed when using a sildenafil at healthy volunteers as monotherapy. Sildenafil in an equilibrium state (in a dose of 100 mg) does not influence pharmacokinetics of HIV inhibitors of protease, a sakvinavir and ritonavir, both from which are CYP3A4 substrates. At simultaneous use with bozentany sildenafit in an equilibrium state (80 mg three times a day) causes increase in AUC and Cmax of a bozentan (125 mg two times a day) for 49.8% and 42%, respectively at healthy volunteers is a male. Special instructions For diagnosis of erectile dysfunction and definition of its possible prime causes it is necessary to study a case history and to perform medical examination before consideration of opportunities of pharmacological treatment. Risk factors of cardiovascular diseases Before an initiation of treatment of erectile dysfunction the attending physician should estimate the cardiovascular status of the patients as there is a certain degree of risk of the warm complications connected with sexual activity. Before purpose of a sildenafil the doctors should check carefully the probability of undesirable consequences of vasodilating effect of this drug for a condition of patients with certain basic diseases, especially in their combination to sexual activity. To group of hypersensitivity to vasodilators patients treat with narrowing of output department of a left ventricle (for example, a stenosis of the aortal valve, a hypertrophic subaortic stenosis) and also patients with a rare syndrome of the multiple system atrophy which is shown in the form of heavy extent of disturbance of autonomous control of arterial blood pressure. Maxigra enhances hypotensive effect of nitrates. During the post-registration period, cases of serious cardiovascular complications were registered, including a myocardial infarction, unstable stenocardia, a sudden cardiac death, ventricular arrhythmia, cerebrovascular bleeding, the tranzitorny ischemic attack, arterial hypertension and arterial hypotension during use of a sildenafil. The majority, but not everything, from these patients had the previous risk factors of cardiovascular diseases. Many of these phenomena were registered in time or soon after completion of sexual intercourse and also several phenomena were registered soon after reception of a sildenafil without sexual activity. There is no opportunity to define whether these phenomena were connected directly with reception of a sildenafil, with sexual activity, with the available cardiovascular disease, with a combination of these factors or with other factors. The priapism Medicines for treatment of erectile dysfunction, including sildenafit, it is necessary to apply with care at patients with anatomic deformation of a penis (such as angulation, cavernous fibrosis or Peyroni’s disease) and also at patients with the diseases contributing to development of a priapism (such as sickemia, multiple myeloma or leukemia). During post-registration use of a sildenafil cases of the prolonged erection and a priapism were reported. In case of the erection proceeding more than 4 hours, the patient should ask for urgent medical care. In the absence of urgent treatment the priapism can lead to damage of tissues of penis and irreversible loss of potency. Safety and efficiency of the drug Maxigra together with other FDE5 inhibitors or other drugs for treatment of pulmonary arterial hypertension containing sildenafit use together with other remedies for disturbances of an erection (for example, Revatsio) or by other remedies for disturbances of an erection it was not studied therefore use of similar combinations is not recommended. Influence on sight there Were cases of a disorder of vision in connection with reception of a sildenafil and other FDE-5 inhibitors, namely a rare disease – front nearteriitny ischemic neuropathy of an optic nerve. In case of any defects of visual acuity it is necessary to stop Maxigra’s reception and to see a doctor. The concomitant use with alpha adrenoblockers Is recommended to be used with care sildenafit at the patients taking the drug of group of alpha adrenoblockers as their simultaneous use can lead to symptomatic arterial hypotension at some sensitive patients. Most likely it can be observed within 4 hours after reception of a dose of a sildenafil. For reduction of risk of development of postural arterial hypotension it is necessary to reach a condition of hemodynamic stability of the patients receiving treatment by alpha adrenoblockers before beginning treatment sildenafily. It is necessary to consider the possibility of use of a sildenafil, since a dose of 25 mg. Besides, doctors should instruct patients about actions in case of symptoms of postural hypotension. Influence on blood clotting of the Research in vitro with use of thrombocytes of the person demonstrate that sildenafit enhances anti-aggregation effect of Sodium nitroprussidum. Data on safety of use of a sildenafil for patients with disturbances of blood clotting or an active round ulcer are absent therefore sildenafit it is necessary to apply advantage/risk only after careful assessment of a ratio. Maxigra should not be applied at men with rare hereditary intolerance of a galactose, deficiency of Lappa lactase or a sprue of glucose and a galactose, owing to lactose content in a drug cover. Pregnancy and the period of a lactation Maxigra is not shown for use for women. Appropriate and strictly controlled researches of use of a sildenafil for pregnant women and the nursing women were not conducted. The reproductive Influence of Drug on Mobility of Spermatozoa function or their morphology after single oral administration of a sildenafil in a dose of 100 mg it was revealed not. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Influence of a sildenafil on ability to run vehicles or to work with potentially dangerous mechanisms was not investigated. Before running vehicles or to work with mechanisms the patients should find out as their organism reacts to Maxigra’s reception, in connection with side effects of drug, such as dizziness and disturbance of visual perception. Overdose the Undesirable reactions registered in researches with single dose of drug in a dose up to 800 mg with participation of volunteers were comparable to those which were observed when using lower doses of drug, but the frequency of their emergence and weight of manifestation were higher. Reception of the raised drug Maxigra doses (200 mg) does not lead to increase in efficiency of drug but only to increase in frequency of undesirable reactions (headache, hyperaemia, dizziness, dyspepsia, congestion of a nose and disturbance of visual perception). In case of overdose it is necessary to take standard symptomatic measures. The hemodialysis does not accelerate clearance of a sildenafil as sildenafit actively contacts proteins of blood plasma and is not removed with urine. Form of release and packing of the Tablet, coated 50 mg and 100 mg. On 1 or 4 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil. On 1, 2, 3 or 4 planimetric packs together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions in the dry, protected from light place, at a temperature not above 25 °C. To store out of children’s reach! A period of storage 4 years not to use drug after expiry date. Prescription status According to the prescription the Producer the Pharmaceutical plant JSC Polfarm of st. Pelplinsk 19, 83-200 Starogard Gdanski, Poland the Owner of the registration certificate of JSC Khimfarm, the Republic of Kazakhstan
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