Active substanceSildenafilSildenafil
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  • Dosage form: & nbsptfilm-covered laths
    Composition:

    Each film-coated tablet contains:

    Dosage of 25 mg

    Active substance: sildenafil citrate 35.12 mg, equivalent to sildenafil 25 mg.

    Excipients: microcrystalline cellulose * - 84.38 mg, calcium hydrophosphate anhydrous - 25.00 mg, croscarmellose sodium - 3.00 mg, magnesium stearate - 2.50 mg, opadrai red (06B 55000) - 4.50 mg,

    Dosage 50 mg

    Active substance: sildenafil citrate - 70.24 mg, equivalent to sildenafil 50 mg.

    Excipients: microcrystalline cellulose * - 168.76 mg, calcium hydrophosphate anhydrous - 50.00 mg, croscarmellose sodium - 6.00 mg, magnesium stearate - 5.0 mg, opadrai red (06B 55000) - 9.00 mg,

    Dosage of 100 mg

    Active substance: sildenafil citrate 140.48 mg, equivalent to sildenafil 100 mg.

    Excipients: microcrystalline cellulose * - 337.52 mg, calcium hydrophosphate anhydrous - 100,00 mg, croscarmellose sodium - 12,00 mg, magnesium stearate - 10.0 mg, opadrai red (06B 55000) - 18.00 mg,

    Composition Odd red (06B 55000): hypromellose 15 cP - 29.50%, hypromellose 6 ср- 29.50%, dye crimson [Ponso 4R] (Е124) - 19,712%, macrogol - 400 - 11,00%, titanium dioxide - 8.846%, iron dye red oxide - 0.824%, indigocarmine - 0.618%).

    * Adjust the amount according to the added amount of sildenafil citrate to maintain the average weight of the tablet.

    Description:

    25 mg: Tablets of triangular shape, with rounded edges, covered with a film shell, red color, with engraving "S21"on one side and smooth on the other.

    50 mg: Tablets of triangular shape, with rounded edges, covered with a film shell, red color, with engraving "S22" on one side and smooth on the other.

    100 mg: Tablets are triangular in shape, with rounded edges, covered with a film shell, red color, engraved with "S23" on one side and smooth on the other.

    Pharmacotherapeutic group:Treatment for erectile dysfunction PDE5-inhibitor
    ATX: & nbsp

    G.04.B.E   Drugs for the treatment of erectile dysfunction

    G.04.B.E.03   Sildenafil

    Pharmacodynamics:

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

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

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

    Sildenafil is selective for PDE5 in vitro, its activity against PDE5 is higher than that of other known isoenzymes of phosphodiesterase: PDE6 - 10 times; FDE1 - more than 80 times; PDE2, PDE4, PDE7-PDE11 - more than 700 times. Sildenafil is 4000 times more selective with respect to PDE5 than with PDE3, which is of paramount importance, since PDE3 is one of the key enzymes in the regulation of myocardial contractility.

    A mandatory condition for the effectiveness of sildenafil is sexual stimulation.

    The use of sildenafil in doses up to 100 mg did not lead to clinically significant changes in the electrocardiogram (ECG) in healthy volunteers.The maximum decrease in systolic pressure in the supine position after taking sildenafil in a dose of 100 mg was 8.3 mm Hg. and diastolic pressure is 5.3 mm Hg. Art. A more pronounced, but also transient, effect on blood pressure (BP) was noted in patients taking nitrates.

    In a study of the hemodynamic effect of sildenafil in a single dose of 100 mg in 14 patients with severe ischemic heart disease (CHD) (more than 70% of patients had stenosis of at least one coronary artery), systolic and diastolic resting pressure decreased by 7 % and 6%. respectively, and the systolic pressure in the pulmonary artery was reduced by 9%. Sildenafil did not affect cardiac output and did not interfere with blood flow in stenotic coronary arteries, and also led to an increase (approximately 13%) of adenosine-induced coronary flow in both stenotic and intact coronary arteries.

    When taking sildenafil endurance to physical exertion in patients with erectile dysfunction and stable angina, taking antianginal drugs (except nitrates) is significantly higher.

    Sildenafil improves erection in men with erectile dysfunction and hypertension, taking more than two antihypertensive drugs. The incidence of adverse effects is comparable to that in the other groups of patients, as well as those taking more than three antihypertensive drugs.

    In some patients, an easy and transient impairment in the ability to distinguish between shades of color (blue / green) is detected 1 hour after taking 100 mg of sildenafil with the Farnsworth-Mansell 100 test. After 2 hours after taking the drug, these changes disappear. It is believed that impaired color vision is caused by inhibition of PDE6, which is involved in the process of transmitting light in the retina of the eye. Sildenafil does not affect visual acuity, perception of contrast, electroretinogram, intraocular pressure or the diameter of the pupil.

    In patients with proven early age macular degeneration (n = 9) sildenafil in a single dose 100 mg was tolerated well, without significant changes in vision. The effectiveness of sildenafil is defined as the ability to achieve and maintain an erection sufficient for a satisfactory sexual intercourse.

    A fixed dose improves an erection in 62% (a dose of sildenafil 25 mg), 74% (a dose of sildenafil 50 mg) and 82% (a dose of sildenafil 100 mg) cases. The analysis of the international index of erectile function shows that in addition to improving the erection in the treatment with sildenafil, the quality of orgasm also increases, satisfaction from sexual intercourse and general satisfaction is achieved.

    According to generalized data, among patients who reported an improvement in erection in the treatment of sildenafil were 59% of patients with diabetes, 43% of patients undergoing radical prostatectomy and 83% of patients with spinal cord injuries.

    Pharmacokinetics:

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

    Suction

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

    Distribution

    The volume of distribution of sildenafil in the equilibrium state averages 105 liters. The connection between sildenafil and its main circulating N-detyl metabolite with plasma proteins is about 96% and does not depend on the total concentration of the drug. Less than 0.0002% of the dose of sildenafil (an average of 188 ng) was found in the sperm 90 minutes after taking the drug.

    Metabolism

    Sildenafil is metabolized mainly in the liver under the action of the cytochrome isoenzyme CYP3A4 (main pathway) and cytochrome isoenzyme CYP2C9 (additional path). The main circulating active metabolite formed as a result of N-detylation of sildenafil, undergoes further metabolism. The selectivity of this metabolite in relation to PDE is comparable to that of sildenafil, and its activity against PDE5 in vitro is about 50% of the activity of sildenafil. The concentration of metabolite in the blood plasma of healthy volunteers is about 40% of the concentration of sildenafil. N-demethyl metabolite undergoes further metabolism; its half-life (T1/2) is about 4 hours.

    Excretion

    The total clearance of sildenafil is 41 l / h, and T1/2 - 3-5 hours. After oral administration also as after intravenous administration sildenafil is excreted as metabolites, mainly by the intestine (about 80% of the oral dose) and. to a lesser extent, by the kidneys (about 13% of the oral dose).

    Pharmacokinetics in specific patient groups

    Elderly patients

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

    Renal impairment

    In mild (creatinine clearance 50 to 80 ml / min) and moderate (KK 30-49 ml / min) degree of renal insufficiency, the pharmacokinetics of sildenafil after single ingestion at a dose of 50 mg does not change. In severe renal failure (QC 30 ml / min), the clearance of sildenafil decreases, which leads to an approximately two-fold increase in the value AUC (100%) and CmOh (88%) in comparison with those for normal kidney function in patients of the same age group.

    Dysfunction of the liver

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

    Indications:

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

    Contraindications:

    Hypersensitivity to sildenafil or to any other component of the drug; use in patients receiving, continuously or intermittently, nitric oxide donators, organic nitrates or nitrites in any dosage form, since sildenafil strengthens the hypotensive effect of nitrates; simultaneous reception of ritonavir: patients,for whom sexual activity is undesirable, including with severe cardiovascular diseases, such as unstable angina, severe heart failure, life-threatening arrhythmia; unstable angina, transferred in the last 6 months of myocardial infarction, stroke, or life-threatening arrhythmia, hypertension (blood pressure> 170/100 mm Hg..) or hypotension (blood pressure <90/50 mmHg..); patients with loss of vision in one eye due anterior ischemic optic neuropathy, non-arteritis, (regardless of whether it was due to PDE5 inhibitor reception or not); hereditary degenerative diseases of the retina, including retinitis pigmentosa (a minority of these patients have a genetic PDE of the retina); severe hepatic impairment; chronic renal failure of severe severity.

    Simultaneous use with cytochrome isoenzyme inhibitors CYP3A4 is contraindicated.

    With the use of sildenafil with other treatments for erectile dysfunction of safety and efficacy data is not available, so the use of such combinations is not recommended.

    Not suitable for use in children under 18 years.

    Not intended for use in women.

    Carefully:

    Anatomic deformation of the penis (curvature of the penis, cavernous fibrosis or Peyronie's disease).

    Diseases predisposing to the development of priapism (sickle cell anemia, multiple myeloma, leukemia, thrombocythemia).

    Diseases accompanied by bleeding.

    Exacerbation of peptic ulcer.

    Hereditary retinitis pigmentosa.

    Heart failure.

    Episodes of the development of anterior non-artery ischemic neuropathy of the optic nerve in the anamnesis.

    A rare syndrome of multiple systemic atrophy, manifested by severe disruption of blood pressure regulation; obstruction of the left ventricular outflow tract, including aortic stenosis; simultaneous administration of α-blockers.

    Pregnancy and lactation:

    According to the registered indication sildenafil not suitable for use in women.

    Dosing and Administration:

    Inside.

    The recommended dose for most adult patients is 50 mg about 1 hour before sexual activity.With regard to efficacy and tolerability, the dose can be increased to 100 mg or reduced to 25 mg. The maximum recommended dose is 100 mg. The maximum recommended frequency of administration is once a day.

    Renal impairment

    At a mild and moderate degree of renal failure (CK 30-80 ml / min) dose adjustment is not required, in severe renal failure (CK <30 ml / min), the dose of sildenafil should be reduced to 25 mg.

    Dysfunction of the liver

    Since the excretion of sildenafil is disrupted in patients with liver damage (in particular, with cirrhosis), the dose of the drug Viathine should be reduced to 25 mg.

    Joint use with other drugs

    When combined with ritonavir, the maximum single dose of the drug Viathine should not exceed 25 mg, and the frequency of reception - 1 time in 48 hours.

    When combined with inhibitors of the cytochrome isoenzyme CYP3A4 (erythromycin, saquinavir, ketoconazole. itraconazole) the initial dose of the drug Viathine should be 25 mg.

    To minimize the risk of postural hypotension in patients taking α-adrenoblockers, taking the drug Viathine It should be started only after achieving stabilization of hemodynamics in these patients. It should also consider the desirability of reducing the initial dose of sildenafil.

    Elderly patients

    For elderly patients, the initial dose is 25 mg. With good tolerability, the dose can be increased to 50 mg or 100 mg.

    Side effects:

    Usually the side effects of the drug Viathine weakly or moderately expressed and of a transient nature. With a fixed dose, the incidence of some adverse events increases with increasing dose.

    The frequency of side effects was divided according to WHO criteria into the following categories: very frequent (≥ 1: 10); Frequent (≥ 1: 100 and <1: 10); infrequent (≥ 1: 1000 and <1: 100); Rare (≥ 1: 10000 and <1: 1000); very rare (<1: 10000).

    From the immune system: rarely - hypersensitivity.

    From the nervous system: very often - headache; often - dizziness; infrequently - drowsiness, hypoesthesia; rarely - a stroke, a faint; frequency unknown - transient ischemic attack, convulsions, including recurrent.

    From the side of the organs of sight: often - a change in vision (blurred vision, change in sensitivity to light),chromatopsy (light and transient, mainly changing the perception of color shades); infrequently - damage to the organ of vision, including damage to the conjunctiva, violation of lacrimation; frequency unknown - anterior ischemic optic neuropathy, retinal vascular occlusion, narrowing of the visual fields.

    From the organs of hearing: infrequently - vertigo, noise in the ears; rarely - deafness.

    From the cardiovascular system: often - vasodilation ("tides" of blood to the skin of the face); infrequently - palpitation, tachycardia, increased heart rate; rarely - increased or decreased blood pressure, myocardial infarction, atrial fibrillation; the frequency is unknown - ventricular arrhythmias, unstable angina, sudden cardiac death.

    On the part of the respiratory system: often - nasal congestion, rhinitis; rarely - epistaxis.

    From the digestive system: often - indigestion; infrequently - vomiting, nausea, dryness of the oral mucosa.

    Allergic reactions: infrequent - skin rash, frequency unknown - Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

    From the side of the musculoskeletal system: infrequently - myalgia.

    On the part of the reproductive system: infrequently - hematospermia and bleeding from the penis, the frequency is unknown - priapism, prolonged erection.

    Other: infrequently - a pain in the chest, fatigue.

    Overdose:

    In single dose of sildenafil at a dose of 800 mg of adverse events were comparable to those when taking the drug at a low dose, but were more common.

    Treatment: symptomatic. Hemodialysis does not accelerate the clearance of sildenafil, since the latter actively binds to plasma proteins and is not excreted by the kidneys.

    Interaction:

    The effect of other drugs on the pharmacokinetics of sildenafil

    The metabolism of sildenafil occurs mainly under the action of cytochrome isoenzymes CYP3A4 (main path) and CYP2C9, therefore inhibitors of these isoenzymes can reduce the clearance of sildenafil, and inductors, respectively, increase the clearance of sildenafil. There was a decrease in clearance of sildenafil with simultaneous use of cytochrome isoenzyme inhibitors CYP3A4 (ketoconazole, erythromycin, cimetidine).

    Cimetidine (800 mg), a nonspecific inhibitor of the cytochrome isoenzyme CYP3A4, with a joint admission with sildenafil (50 mg) causes an increase in the concentration of sildenafil in plasma by 56%.

    A single dose of 100 mg of sildenafil together with erythromycin (250 mg twice a day for 5 days), a specific inhibitor of the cytochrome isoenzyme CYP3A4, on the background of achieving a constant concentration of erythromycin in the blood, leads to an increase AUC sildenafil by 182%. With the joint administration of sildenafil (once 100 mg) and saquinavir (400 mg / day 3 times a day), an HIV protease inhibitor and cytochrome isoenzyme CYP3A4. against the background of achieving a constant concentration of saquinavir in the blood FROMmOh sildenafil increased by 140%, a AUC increased by 210%. Sildenafil does not affect the pharmacokinetics of saquinavir. More potent inhibitors of cytochrome isoenzyme CYP3A4, such as ketoconazole and itraconazole, can cause and stronger changes in the pharmacokinetics of sildenafil.

    Simultaneous use of sildenafil (once 100 mg) and ritonavir (500 mg twice a day), an HIV protease inhibitor and a strong inhibitor of cytochrome P450 on the background of achieving a constant concentration of ritonavir in the blood leads to an increase in CmOh sildenafil by 300% (4 times), a AUC on 1000% (in 11 times). After 24 hours, the concentration of sildenafil in the blood plasma is about 200 ng / ml (after a single application of one sildenafil - 5 ng / ml).

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

    Inhibitors of cytochrome isoenzyme CYP2C9 (tolbutamide, warfarin), cytochrome isoenzyme CYP2D6 (selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and thiazide-like diuretics, ACE inhibitors and calcium antagonists have no effect on the pharmacokinetics of sildenafil. Azithromycin (500 mg per day for 3 days) has no effect on AUC, FROMmOh, TmOh. rate constant and T1/2 sildenafil or its main circulating metabolite.

    Simultaneous use of sildenafil and bosentan, isoenzyme inducer CYP3A4 and CYP2C9, leads to a decrease AUC and CmOh sildenafil by 62.6% and 52.4% respectively.

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

    Effect of sildenafil on other drugs

    Sildenafil is a weak inhibitor of cytochrome P isoenzymes450 - 1A2, 2C9,

    209, 2D6, 2E1 and 3A4 (IC50> 150 μmol). When taking sildenafil in the recommended doses of its CmOh is about 1 μmol, so it is unlikely that sildenafil can affect the clearance of the substrates of these isoenzymes.

    Sildenafil enhances the hypotensive effect of nitrates both with prolonged use of the latter, and when they are prescribed for acute indications. In this regard, the use of sildenafil in combination with nitrates or donators of nitric oxide is contraindicated.

    At simultaneous reception α-adrenoblocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg and 100 mg) in patients with benign prostatic hyperplasia with stable haemodynamics average additional reduction in systolic / diastolic blood pressure in the supine position was 7.7 mmHg. st., 9/5 mm Hg. Art. and 8/4 mm Hg. Art. respectively, while in the standing position it is 6/6 mm Hg. st., 11/4 mm Hg. Art. and 4/5 mm Hg. Art. respectively. We report rare cases of development in these patients of symptomatic postural hypotension, manifested as dizziness (without syncope). Individual sensitive patients receiving α- adrenoblockers, simultaneous use of sildenafil can lead to symptomatic hypotension.

    Simultaneous use of sildenafil and bosentan leads to an increase AUC and CmOh bosentan at 49,8% and 42% respectively.

    Signs of significant interaction with tolbutamide (250 mg) or warfarin (40 mg), which are metabolized by the cytochrome isoenzyme CYP2C9, it is not revealed. Sildenafil (100 mg) does not affect the pharmacokinetics of HIV protease, saquinavir and ritonavir inhibitors. which are substrates of the cytochrome isoenzyme CYP3A4, at their constant level in the blood.

    Sildenafil (50 mg) does not cause an additional increase in bleeding time when taking acetylsalicylic acid (150 mg).

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

    In patients with arterial hypertension, there was no evidence of interaction between sildenafil (100 mg) and amlodipine. The average additional decrease in blood pressure in the prone position is 8 mm Hg. Art. (systolic) and 7 mm Hg. Art. (diastolic). The use of sildenafil in combination with antihypertensive drugs does not lead to additional side effects.

    Special instructions:

    To diagnose erectile dysfunction, determine their possible causes and choose an adequate treatment, you must collect a complete medical history and conduct a thorough physical examination.

    Sexual activity represents a certain risk in the presence of heart disease, so before starting any therapy for erectile dysfunction, the doctor should refer the patient to a cardiovascular system examination. Sexual activity is undesirable in patients with heart failure, unstable angina, suffered in the last 6 months by myocardial infarction or stroke, life-threatening arrhythmias, hypertension (BP> 170/100 mm Hg), or hypotension (BP <90/50 mm Hg. st.). In clinical studies, there was no difference in the incidence of myocardial infarction (1.1 per 100 people per year) or mortality rate from cardiovascular diseases (0.3 per 100 people per year) in patients who received sildenafil compared with patients receiving placebo.

    Drugs intended for the treatment of erectile dysfunction should not be prescribed to men for whom sexual activity is undesirable.

    A drug Viathine has a systemic vasodilating effect, leading to a transient decrease in blood pressure, which is not clinically significant and does not lead to any consequences in most patients.Nevertheless, before the appointment of sildenafil, the doctor should carefully evaluate the risk of possible undesirable manifestations of vasodilating action in patients with the corresponding diseases, especially against the background of sexual activity.

    Increased susceptibility to vasodilators is observed in patients with obstruction of the left ventricular outflow tract (aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as with a rare syndrome of multiple systemic atrophy, manifested severe violation of the regulation of blood pressure from the autonomic nervous system.

    There have been rare cases of development of anterior ischemic optic neuropathy not associated with arteritis, as a cause of worsening or loss of vision against all PDE5 inhibitors, including sildenafil. Most of these patients had risk factors, such as optic nerve head excavation, age over 50 years, diabetes, hypertension, ischemic heart disease (CHD), hyperlipidemia and smoking. The causal relationship between the intake of PDE5 inhibitors and the development of anterior ischemic optic neuropathy not associated with arteritis has not been revealed.

    The physician should inform the patient of the increased risk of developing anterior ischemic optic neuropathy that is not associated with arteritis, if previously this condition has already been noted.

    Since the combined use of sildenafil and α-blockers can lead to symptomatic hypotension in selected sensitive patients, sildenafil should be administered with caution to patients taking α-blockers. To minimize the risk of postural hypotension in patients taking α-adrenoblockers, the use of sildenafil should be started only after hemodynamic stabilization has been achieved in these patients. It should also consider the desirability of reducing the initial dose of sildenafil. The doctor should inform patients about what actions should be taken in case of symptoms of postural hypotension.

    A small number of patients with hereditary pigment retinitis have genetically determined impairments of the functions of the retina phosphodiesterase. Information on the safety of sildenafil in patients with pigment retinitis is absent, therefore sildenafil should be used with caution.

    Sildenafil enhances the anti-aggregation effect of sodium nitroprusside (a donator of nitric oxide) on human platelets in vitro.

    Information on the safety of sildenafil in patients with internal bleeding or active peptic ulcers of the stomach is not available, so it should be used with caution.

    Means for treating erectile dysfunction should be used with caution in patients with anatomical deformation of the penis (curvature of the penis, cavernous fibrosis, Peyronie's disease), or in patients with risk factors for priapism (sickle cell anemia, multiple myeloma, leukemia).

    There have been reports of cases of priapism in the use of sildenafil. If the erection persists for more than 4 hours, seek medical attention. If priapism therapy is not performed in a timely manner, it can lead to damage to the penile tissue and an irreversible loss of potency.

    The safety and effectiveness of the use of sildenafil in conjunction with other treatments for erectile dysfunction have not been studied, so the use of such combinations is not recommended.

    In some post-marketing and clinical trials using all PDE5 inhibitors, including sildenafil, reported a sudden decrease or loss of hearing in patients. However, most of these patients had risk factors for this pathology, and there was no correlation between the use of PDE5 inhibitors and sudden decline or loss of hearing. In case of sudden decrease or loss of hearing, stop sildenafil and immediately consult a doctor.

    Effect on the ability to drive transp. cf. and fur:

    Since admission of sildenafil may reduce blood pressure, the development of chromatopsy, blurred vision and other side effects, you should carefully consider the individual effect of the drug in these situations, especially at the beginning of treatment and changing the dosage regimen. In case of development of adverse reactions from the nervous system and sensory organs, it is recommended that patients refrain from driving the car and controlling the mechanisms, and also take care when engaging in activities requiring concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Film coated tablets, 25 mg, 50 mg and 100 mg.

    Packaging:1 tablet in a blister of aluminum foil and PVC film.

    1 blister with instructions for use in a cardboard bundle.

    1 tablet in a blister of aluminum foil, PVC film and polyamide.

    1 blister with instructions for use in a cardboard bundle.

    1 tablet in a blister of aluminum foil and transparent PVC film, laminated with polyethylene, coated with a film of PVDC.

    1 blister with instructions for use in a cardboard bundle.

    2 tablets in a blister of aluminum foil and PVC film.

    1 blister with instructions for use in a cardboard bundle.

    2 tablets in a blister of aluminum foil, PVC film and polyamide

    1 blister with instructions for use in a cardboard bundle.

    2 tablets in a blister of aluminum foil and transparent PVC film, laminated with polyethylene, coated with PVDC film.

    1 blister with instructions for use in a cardboard bundle.

    4 tablets in a blister of aluminum foil and PVC film.

    1, 2 or 4 blisters with instructions for use in a cardboard bundle.

    4 tablets in a blister of aluminum foil, PVC film and polyamide.

    1, 2 or 4 blisters with instructions for use in a cardboard bundle.

    4 tablets in a blister of aluminum foil and transparent PVC film, laminated with polyethylene, coated with a film of PVDC.

    1, 2 or 4 blisters with instructions for use in a cardboard bundle.

    10 tablets in a blister of aluminum foil and PVC film.

    1 blister with instructions for use in a cardboard bundle.

    10 tablets in a blister of aluminum foil, PVC film and polyamide.

    1 blister with instructions for use in a cardboard bundle.

    10 tablets in a blister of aluminum foil and transparent PVC film, laminated with polyethylene, covered with a film of PVDC.

    1 blister with instructions for use in a cardboard bundle.

    Storage conditions:

    At a temperature of no higher than 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003514
    Date of registration:22.03.2016
    Expiration Date:22.03.2021
    The owner of the registration certificate:San Pharmaceutical Industries Co., Ltd.San Pharmaceutical Industries Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspSAN PHARMACEUTICAL INDUSTRIES LTD. SAN PHARMACEUTICAL INDUSTRIES LTD. India
    Information update date: & nbsp09.01.2017
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