Active substanceMolsidomineMolsidomine Similar drugsTo uncover Dilasidom pills inwards Warsaw Pharmaceutical Plant Polfa, JSC Poland Corvatone® pills inwards Sanofi-Aventis SA Spain Sidnofarm pills inwards Sopharma, AO Bulgaria Dosage form: & nbspPills. Composition:1 tablet contains: active substance: molsidomine 2, 00 mg.Excipients: lactose monohydrate (60.00 mg), mannitol (40.00 mg), wheat starch (26.99 mg), microcrystalline cellulose (21.40 mg), hypromellose (5.00 mg), silicon dioxide colloidal anhydrous (2, 00 mg), magnesium stearate (1.60 mg), peppermint leaves butter (1.00 mg), sunset sunset yellow dye (E 110) (0.01 mg). Description:Round biconvex tablets with a risk, light pink color with a mint smell. Pharmacotherapeutic group:Vasodilating agent. ATX: & nbspC.01.D.X.12 Molsidomine Pharmacodynamics:Molsidomine has venodilating, antiaggregant, analgesic and antianginal action. Venodilating activity is caused by the release after a number of metabolic transformations of nitric oxide (NO), which stimulates soluble guanylate cyclase, in connection with this molsidomine is considered as a "donor" NO. The accumulation of cyclic guanosine monophosphate (cGMP) causes the relaxation of smooth muscle cells of the vascular wall (to a large extent - veins).Decrease in preload, even without affecting the contractility of the myocardium, leads to the restoration of the correlation between the oxygen demand and its intake disturbed in patients with coronary insufficiency. Expands the affected by atherosclerosis, but capable of dilatation, large epicardial coronary arteries, improves peripheral circulation.Increases tolerance to physical activity, reduces manifestations of angiospasm. Suppresses the early phase of platelet aggregation, reduces the synthesis and release of serotonin, thromboxane and other proaggregants.Reduces prednazguzku on the myocardium in patients with chronic heart failure, reduces pressure in the pulmonary artery, reduces the filling of the left ventricle and myocardial wall stress, stroke volume of the heart. The action begins 20 minutes after ingestion, reaches a maximum after 0.5-1 h and persists for 6 hours. Unlike nitrates, the development of tolerance with a decrease in efficacy during prolonged therapy is not characteristic. Pharmacokinetics:After oral administration, it is almost completely absorbed from the gastrointestinal tract. Bioavailability - 60 - 70%.The maximum concentration is achieved (4.4 μg / ml) after 1 hour. When ingested after a meal, absorption, although slowing down, does not decrease (the maximum concentration in the blood plasma is reached 30 to 60 minutes later than when taken on an empty stomach). The minimum effective concentration of molsidomine in blood plasma is 3-5 ng / ml. Virtually does not bind to blood plasma proteins. In the liver, it is metabolized to form a pharmacologically active compound SIN-1 (3-morpholino-sydnonimine), from which a very unstable substance SIN-la (N-morpholino-N-aminosinonitrile) forms NO to form a pharmacologically inactive SIN-1c compound. In the course of metabolism, other metabolites are formed. It is excreted by the kidneys by 90% (in the form of metabolites), 9% by the intestine. The half-life is from 1 to 3.5 hours. It does not cumulate (including in patients with renal insufficiency).In severe hepatic insufficiency (an increase in bromsulfalein test to 20-50%), a slowing of the elimination and an increase in its concentration in the blood plasma was noted. When the renal function is impaired, the concentration of molsidomine in the blood plasma does not change. Indications:Ischemic heart disease (IHD) - prevention of angina attacks.Chronic heart failure (as part of a combination therapy with cardiac glycosides, diuretics). Contraindications:- Hypersensitivity to molsidomin and other components of the drug.- Severe arterial hypotension (systolic blood pressure below 100 mm Hg), collapse, cardiogenic shock.- Simultaneous use of phosphodiesterase 5 inhibitors (PDE 5) (sildenafil, vardenafil, tadalafil) due to the high risk of developing arterial hypotension.- Toxic pulmonary edema.- Decrease in central venous pressure.- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.- Pregnancy and the period of breastfeeding. Carefully:The transferred hemorrhagic stroke, cerebral blood flow disturbances, increased intracranial pressure, recently transferred myocardial infarction to stabilization of hemodynamic parameters, propensity to hypotonic reactions, violations of liver function, glaucoma, elderly age. Pregnancy and lactation:The use of the drug during pregnancy is contraindicated.In pregnancy (especially in the first trimester), application is possible only in case of absolute necessity, when the expected benefit for the mother exceeds the potential risk for the fetus.There is no data on the isolation of molsidomine in breast milk. If the use of the drug SIDNOFARM is necessary during lactation, breastfeeding should be discontinued. Dosing and Administration:Inside, regardless of meal time. The tablets are swallowed whole, without chewing and washing down with a sufficient amount of liquid.Acceptance of the drug begins with small doses - 1/2 tablets 2 times a day. If the therapeutic effect is insufficient, 1 tablet 2 mg 3 times a day is prescribed. Dosage regimen is individual and depends on the type, stage of the disease and the severity of clinical symptoms. The duration of the therapeutic course is strictly individual. The maximum daily dose is 12 mg. Side effects:The incidence of side effects developing when taking the drug is classified according to the directions in MedDRA as follows:very frequent (≥ 10%); frequent (≥1% - <10%); infrequent (≥0.1% - <1%); rare (≥0.01% - <0.1%); very rare (<0.01%), including individual cases; with an unknown frequency (from the existing data no estimate can be made).From the nervous system: frequent - headache (usually minor, disappears in the course of further treatment), rare - dizziness, increased fatigue, slowing the speed of psychomotor and motor reactions (mostly at the beginning of treatment).From the digestive system: rare - nausea, loss of appetite, diarrhea. From the cardiovascular system: very frequent - a marked decrease in blood pressure (BP), in rare cases before the development of collapse, tachycardia, reddening of the facial skin.Other: rare - allergic reactions (skin itch, rash, bronchospasm), with unknown frequency - anaphylactic shock. Overdose:Symptoms: severe headache, dizziness, weakness, nausea, vomiting, decreased blood pressure (darkening in the eyes, dizziness, collapse).Treatment: symptomatic. Interaction:With simultaneous use with peripheral vasodilators, blockers of "slow" calcium channels (BCCC), antihypertensive drugs and ethanol, the antihypertensive effect of the drug increases.With simultaneous use with acetylsalicylic acid, its antiplatelet activity increases.There is a high risk of developing hypotension with simultaneous use with FED 5 inhibitors, such as sildenafil, vardenafil, tadalafil. Joint use of the drug SIDNOFARM with inhibitors of FED 5 is contraindicated.SIDNOFARM can be used concomitantly with other antianginal drugs (eg, add to the two- or three-component therapy with nitrates, BCCI, and beta-adrenoreceptor blockers). Special instructions:Do not use to stop angina attacks!In the acute phase of myocardial infarction, SIDNOFARM can be used only after stabilization of hemodynamic parameters.With a pronounced impaired liver function (an increase in the bromosulfolein test to 20-50%), the concentration of molsidomine in the blood plasma and its half-life increase, which may require correction of the dose of the drug.At the time of treatment should be excluded from drinking alcohol and alcohol-containing beverages.1 tablet of the drug SIDNOFARM contains 0.06 g of lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, lactase deficiency Lapp or glucose-galactose malabsorption should not take this drug.The composition of the drug includes wheat starch in an amount that is safe for use in patients with celiac disease (gluten enteropathy). Effect on the ability to drive transp. cf. and fur:During the period of treatment (especially at the beginning) it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions. Form release / dosage:Tablets 2 mg. Packaging:For 10 tablets in a blister of PVC - a film of green color and aluminum foil.For 3 blisters together with instructions for use in a pack of cardboard. Storage conditions:In dry, dark place at a temperature of no higher than 25 FROM.Keep out of the reach of children! Shelf life:3 years. Do not use after the expiry date printed on the package. Terms of leave from pharmacies:On prescription Registration number:P N008922 Date of registration:13.09.2011 / 16.01.2013 Expiration Date:Unlimited The owner of the registration certificate:Sopharma, AOSopharma, AO Bulgaria Manufacturer: & nbspSOPHARMA, AD Bulgaria Representation: & nbspSOFARMA SA SOFARMA SA Bulgaria Information update date: & nbsp2016-10-18 Illustrated instructions × Illustrated instructions Instructions