Name: Managra. Release form Coated tablets. Dosage 100 mg. Pack quantity: 2 pcs. Producer Borisov ZMP. MNNsildenafil. FTHERectile dysfunction treatment, PDE-5 inhibitor. Description: Pills are film-coated, blue, round, with a biconvex surface. Composition 1 tablet contains: active substance: sildenafil (in the form of sildenafil citrate) - 50 mg or 100 mg; excipients: calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate, microcrystalline cellulose, Opadry II (including polyvinyl alcohol, partially hydrolyzed; talc; macrogol 3350 (polyethylene glycol); lecithin (soy); titanium dioxide E 171; iron oxide yellow E 172; aluminum varnish based on indigo carmine E 132). Pharmacotherapeutic groupMeans used for erectile dysfunction. Sildenafil. ATX code: G04BE03. Indications for use Sildenafil is indicated for adult men with erectile dysfunction, characterized by an inability to achieve or maintain an erection level necessary for satisfactory intercourse. For the effective action of the drug, sexual stimulation is necessary. Contraindications Hypersensitivity; simultaneous reception of donors of nitric oxide or nitrates in any form. Contraindicated in patients with loss of vision in one eye associated with anterior ischemic optic neuropathy not due to arteritis (NAION), regardless of the association of vision loss with previous use of PDE-5 inhibitors. Taking the drug is contraindicated in the presence of severe liver failure, arterial hypotension (BP<90/50 mmHg), patients with a recent stroke or myocardial infarction, in the presence of hereditary degenerative disorders of the retina, such as retinitis pigmentosa (a small proportion of these patients have genetic disorders of retinal phosphodiesterase). Erectile dysfunction medications, including sildenafil, should not be used by people for whom sexual activity is not recommended (patients with severe cardiovascular disease such as unstable angina or severe heart failure). Method of administration and dosage The recommended dose, taken approximately 1 hour before sexual activity, is 50 mg. Depending on the effectiveness and tolerability of the drug, the dose may be increased to a maximum of 100 mg or reduced to 25 mg. The maximum dose frequency is 1 time per day. Managra 50 mg and 100 mg tablets are not divided into parts. If it is necessary to use a dose of sildenafil 25 mg, it is recommended to use another drug. Use in patients with impaired renal function In patients with severe renal impairment (creatinine clearance <30 ml / min), an initial dose of 25 mg should be used. Use in patients with impaired liver function It is recommended to use an initial dose of 25 mg. Use in patients taking other medicinal products With the exception of ritonavir, whose simultaneous administration with sildenafil is contraindicated, for patients receiving inhibitors of drug metabolism (for example, erythromycin, ketoconazole, cimetidine), an initial dose of sildenafil 25 mg is recommended. Patients should be in a stable condition during treatment with Ξ±-blockers before starting the use of sildenafil. In such cases, it is recommended to start the use of sildenafil with a dose of 25 mg. Use in children Not indicated for children and adolescents (under 18 years of age). Use in Elderly Patients Patients over 65 years of age are recommended to start taking sildenafil with a dose of 25 mg. Side effects If you develop any of the following serious side effects, stop taking sildenafil and seek medical attention immediately: Allergic reaction - occurs infrequently (may affect up to 1 in 100 people). Symptoms: sudden hoarseness, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat. Chest pain - develops infrequently. If this symptom occurs during or after intercourse, take a semi-sitting position and try to relax, do not use nitrates for treatment. Prolonged and sometimes painful erections are rare (may affect up to 1 in 1,000 people). If an erection lasts more than 4 hours, you should immediately consult a doctor. A sharp decrease or loss of vision - rarely develop. Serious skin reactions are rare. Symptoms may include: severe peeling and swelling of the skin, blistering in the mouth, on the genitals and around the eyes, fever. Seizures or seizures are rare. Other side effects: Very common (may affect > 1 in 10 people): headache. Common (may affect < 1 in 10 people): Nausea, facial flushing, hot flashes (sudden feeling of heat in the upper body), indigestion, color perception problems, blurred vision, blurred vision, nasal congestion, and dizziness. Uncommon (may affect < 1 in 100 people): vomiting, skin rash, eye irritation, flushing/redness of the eyes, eye pain, flashes of light in the eyes, blurred vision, photosensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure , low blood pressure, muscle pain, feeling drowsy, decreased tactile sensation, dizziness, ringing in the ears, dry mouth, sinus congestion, inflammation of the nasal mucosa (symptoms include: runny nose, sneezing and nasal congestion), pain in the upper part stomach, gastroesophageal reflux disease (symptoms include heartburn), blood in the urine, pain in the arms or legs, nosebleeds, feeling hot and tired. Rare (may affect < 1 in 1,000 people): syncope, stroke, myocardial infarction, irregular heartbeat, temporary decrease in blood flow in some areas of the brain, tightness in the throat, numbness in the mouth, posterior chamber hemorrhage, double vision, decreased visual acuity, unusual sensation in the eye, swelling of the eye or eyelid, small particles or spots in the field of vision, the appearance of iridescent halos around light sources, pupil dilation, impaired perception of white in the eye, bleeding from the penis, blood in the semen, dry nose , swelling of the nasal mucosa, a feeling of irritation and sudden worsening or loss of hearing. Rare cases of unstable angina (heart disease) and sudden death have been reported. Most of the men who developed these side effects had heart problems even before taking sildenafil. It is not possible to establish a direct relationship between the development of these phenomena and the use of the drug Managra. If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist or nurse. By reporting side effects, you are helping to provide more information about the safety of this medicine. Interaction with other drugs Cimetidine, ketoconazole, erythromycin increase the concentration of sildenafil in the blood and slow down its excretion without increasing the frequency of side effects. When combined with these drugs, the initial dose of sildenafil should not exceed 25 mg. Sildenafil enhances the effect of sodium nitroprusside, the hypotensive effect of nitrates (the combination of sildenafil with nitrates can be fatal). Co-administration of HIV protease inhibitors (ritonavir, saquinavir) with sildenafil leads to an increase in the concentration and absorption of sildenafil. Simultaneous use of sildenafil and ritonavir is not recommended, the dose of sildenafil should not exceed 25 mg within 48 hours. Nicorandil is potentially capable of clinically significant interaction with sildenafil. The effect on the concentration and effect of sildenafil tolbutamide, warfarin, phenytoin, selective serotonin reuptake inhibitors, tricyclic antidepressants, thiazide diuretics and potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, calcium channel blockers, Ξ²-adrenergic antagonists or inducers of liver enzymes (rifampicin, barbiturates) ). With the simultaneous appointment of sildenafil (100 mg) and amlodipine in patients with arterial hypertension, an additional decrease in blood pressure was found. Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid (150 mg). Grapefruit juice inhibits liver and intestinal enzymes that destroy sildenafil and can increase its concentration in the blood. A single dose of antacids (magnesium hydroxide / aluminum hydroxide) does not affect the absorption of sildenafil. Data on the interaction of sildenafil and phosphodiesterase inhibitors such as theophylline or dipyridamole are not available. Simultaneous administration of sildenafil in patients taking Ξ±-blockers may lead to an additional decrease in blood pressure within 4 hours after taking sildenafil. Sildenafil (50 mg) did not potentiate the hypotensive effect of alcohol in healthy individuals who had a mean maximum blood alcohol level of 80 mg/dl. Preclinical studies have shown an additional effect of lowering systemic blood pressure with the simultaneous use of PDE-5 inhibitors and riociguat. In clinical studies, riociguat showed an increase in the hypotensive effect of PDE-5 inhibitors. There is no evidence of a beneficial clinical effect of this combination in population studies. The concomitant use of riociguat and PDE-5 inhibitors, including sildenafil, is contraindicated. Special instructions and warnings To diagnose erectile dysfunction, determine their possible causes and select adequate treatment, it is necessary to collect a complete medical history and conduct a thorough physical examination. Risk Factors for Cardiovascular Disease Sexual activity poses a certain risk in the presence of heart disease, so before starting any therapy for erectile dysfunction, the doctor may consider it necessary to conduct an examination of the patient's cardiovascular system. Sildenafil has a vasodilatory effect, resulting in a slight transient decrease in blood pressure. Before prescribing sildenafil, the physician should carefully assess the risk of possible adverse vasodilatory effects in patients with relevant diseases, especially against the background of sexual activity. Increased susceptibility to vasodilators has been observed in patients with left ventricular outflow obstruction (eg, aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as the rare multiple system atrophy syndrome, manifested by severe dysregulation of blood pressure from the autonomic nervous system. Managra enhances the hypotensive effect of nitrates. During the period of post-registration observation, cases of serious cardiovascular complications (including myocardial infarction, unstable angina pectoris, sudden coronary death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, arterial hypertension and hypotension) were reported, which had a temporal relationship with the use Managra tablets. Most of these patients, but not all of them, had risk factors for cardiovascular events. Many of these adverse events were observed shortly after sexual activity, and some of them were noted after taking sildenafil without subsequent sexual activity. It is not possible to establish the existence of a direct connection between these phenomena and these or other factors. Priapism Drugs for the treatment of erectile dysfunction, incl. sildenafil should be used with caution in patients with an anatomical deformity of the penis (eg, angulation, cavernous fibrosis, or Peyronie's disease) or in patients with diseases predisposing to the development of priapism (such as sickle cell anemia, multiple myeloma, or leukemia). During the post-registration use of sildenafil, there have been reports of the development of prolonged erection and priapism. If the erection lasts more than 4 hours, the patient should seek emergency medical attention. If urgent measures are not taken in priapism, damage to the tissues of the penis and irreversible loss of potency can occur. Co-administration with other PDE-5 inhibitors or other treatments for erectile dysfunction The safety and efficacy of sildenafil when used in combination with other PDE-5 inhibitors or other drugs for the treatment of pulmonary arterial hypertension containing sildenafil, as well as other drugs for the treatment of erectile dysfunction have not been studied , so the use of such combinations is not recommended. Impact on vision Spontaneous reports of cases of visual impairment have been received when taking sildenafil and other PDE-5 inhibitors. Non-arteritic anterior ischemic optic neuropathy (NAION), a rare disease associated with sildenafil and other PDE-5 inhibitors, has been reported in spontaneous reports and observational studies. Patients should be warned that in the event of a sudden visual impairment, stop taking the drug and consult a doctor immediately. Co-administration with ritonavir Co-administration of sildenafil and ritonavir is not recommended. Co-administration with alpha-blockers Since the combined use of sildenafil and alpha-blockers can lead to the development of symptomatic hypotension in some susceptible patients, sildenafil should be administered with caution to patients taking alpha-blockers. The development of this condition is most likely to be observed within 4 hours after taking a dose of sildenafil. In order to minimize the risk of developing orthostatic hypotension, sildenafil therapy should only be started in hemodynamically stable patients using alpha-adrenergic blockers. Consideration should also be given to the use of sildenafil at an initial dose of 25 mg. In addition, physicians should inform patients about what actions to take if symptoms of orthostatic hypotension appear. Effect on blood clotting In vitro studies on human platelets have shown that sildenafil potentiates the antiplatelet effect of sodium nitroprusside. There are no data on the safety of sildenafil in patients with bleeding disorders or acute peptic ulcer, so the use of sildenafil in this group of patients is possible only after a thorough assessment of the benefit / risk ratio. Managra is not intended for use in women. Due to the content of lactose, the drug is not recommended for patients with congenital galactose intolerance, lactase deficiency or malabsorption of glucose-galactose. Due to the sugar content, the medicinal product is not recommended for patients with fructose intolerance or glucose-galactose malabsorption. Pregnancy and lactation Not intended for use by women. Influence on the ability to drive a car and potentially dangerous mechanisms Dizziness and visual disturbances are possible, patients should be careful when driving a car and operating moving mechanisms. Overdose Doses of 200 mg do not lead to an increase in efficacy, but the frequency of adverse reactions increases. Symptoms: headache, hot flashes, dizziness, dyspepsia, nasal congestion, blurred vision. Treatment: standard supportive care. Hemodialysis is not effective because sildenafil is highly bound to plasma proteins and is not excreted in the urine. In case of overdose, consult a doctor. Packing: 2 tablets in a blister pack made of PVC film and aluminum foil. 1 or 2 blister packs, together with a leaflet for use, are placed in a cardboard pack (No. 2 Γ 1, No. 2 Γ 2). 10 tablets in a blister pack made of PVC film and aluminum foil. 1 blister pack together with a leaflet for use is placed in a pack of cardboard (No. 10 Γ 1). Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25 Β° C. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiry date stated on the packaging. Conditions for dispensing from pharmacies By prescription. Buy Managra tablets p/o 50mg No. 2x1
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