Expiration dates: 01/2022

Structure and Composition:

Sustained-release tablets, film-coated. One tablet contains:

Active substance: Trimetazidine dihydrochloride 35 or 70 mg

excipients: calcium hydrogen phosphate dihydrate - 34.6 mg giproloza (hydroxypropyl) - 6 mg hypromellose (hydroxypropyl) - copovidone 64 mg - 4.2 mg of colloidal silicon dioxide (Aerosil) - 6.4 mg Magnesium stearate - 0.8 mg MCC - 59 mg

shell film: selekoat AQ-01 673 - 7 mg, including hypromellose (hydroxypropyl) - 2,8 mg of macrogol 400 (polyethylene glycol 400) - 0.7 mg Macrogol 6000 (polyethylene glycol 6000) - 0.7 mg of aluminum lacquer-based dye crimson [Ponceau 4R] (E124) - 0.7 mg of titanium dioxide - 2.1 mg

in blisters of 10 or 30 pieces. In the paper cartons 1, 2, 3 or 6 packs Table 10. or 1, 2, 3 or 4 to 30 packaging table.

Description pharmaceutical form:

The tablets covered with a film cover of pink color, round, biconcave. The slight roughness. The cross section - almost white.

Pharmacokinetics:

After oral administration of trimetazidine is rapidly and almost completely absorbed from the gastrointestinal tract. Bioavailability - 90%. Time to Cmax plasma -.. 5 h equilibrium state is reached after 60 hours, Vd is 4.8 L / kg, suggesting diffusion good tissue distribution. Contact with blood plasma proteins - 16%. Easily penetrates the blood-tissue barriers. T1 / 2 is about 7 hours, in patients older than 65 years -. About 12 hours is derived from the body by the kidneys (60% unchanged).

Renal clearance of trimetazidine is directly correlated with Cl creatinine, hepatic clearance is reduced with age.

Description of the pharmacological actions:

Trimetazidine has anti-hypoxic action in stable angina. Directly affecting cardiomyocytes and neurons in the brain, improves their metabolism and function. Cytoprotective effect is due to an increase in energy potential, activation of oxidative decarboxylation and rationalization of consumption of oxygen (increased aerobic glycolysis and fatty acid oxidation blockade). It supports myocardial contractility, prevents a decrease in intracellular ATP and creatine phosphate. The conditions of acidosis normalizes the functioning of membrane ion channels, prevents the accumulation of calcium and sodium in cardiomyocytes, normalizes intracellular concentration of potassium ions. Reduces intracellular acidosis and phosphate, caused by myocardial ischemia and reperfusion. It prevents the damaging action of free radicals, preserves the integrity of cellular membranes, prevents activation of neutrophils in the ischemic area, increases the electric potential decreases the yield of the cells and creatine severity of ischemic myocardial injury.

Trimetazidine reduces the frequency of angina attacks (reduced consumption of nitrates), after 2 weeks of reception increases exercise tolerance, reduced the sharp fluctuations in blood pressure. Reduces dizziness and tinnitus.

In vascular pathology eyes improves the functional activity of the retina eyes.

Testiminy:

• Coronary heart disease: prevention of attacks of stable angina (in combination therapy)
  
• chorioretinal disorders with an ischemic component
  
• vestibular-cochlear disorders ischemic nature, such as dizziness, tinnitus, hearing loss.
  

Contraindications:

• Hypersensitivity to any component of the drug
  
• severe renal failure (Cl creatinine less than 15 ml / min)
  
• marked liver function abnormalities
  
• pregnancy
  
• breastfeeding
  
• age of 18 years (effectiveness and safety have been established).
  

Application of pregnancy and breastfeeding:

The drug is contraindicated in pregnancy because of the lack of clinical data on the safety of its use.

It is not known whether trimetazidine is excreted in breast milk. Therefore, if necessary, use during lactation should stop breastfeeding.

Side effect:

The frequency of side effects reported while taking trimetazidine, refer to the following graduation: very common (& ge 1/10) often (& ge 1/100, <1/10) uncommon (& ge 1/1000, <1/100) rarely (& ge 1 / 10,000, <1/1000), very rare (<1/10000), including: individual messages.

From the digestive system: often - abdominal pain, diarrhea, dyspepsia, nausea, vomiting.

CNS: often - dizziness, headache, asthenia, very rarely - extrapyramidal disorders (tremor, rigidity, akinesia), reversible after discontinuation of the drug.

For the skin: often - skin rash, itching, hives.

From the CCC: rarely - orthostatic hypotension, a rush of blood to the skin.

Drug Interactions:

No information.

Dosage and administration:

Inside, during a meal.

Deprenorm MB take 1 table. Two times a day (morning and evening). The course of treatment - on doctor's advice.

Overdose:

Data on cases of overdose is limited. symptomatic treatment should be carried out in case of an overdose.

Special instructions:

Deprenorm MB is not intended for the relief of angina attacks, the initial course of therapy of stable angina or myocardial infarction.

In the case of angina attack should review and adapt the treatment.

Effects on ability to drive or to perform work requiring higher rate of physical and mental reactions. Use of the drug has no effect on the ability to drive a vehicle and the performance of work requiring high speed of psychomotor reactions.