Expiration date: 04/2025

The composition and form of issue:

Tablets with modified release, film-coated. 1 tablet contains:

of Trimetazidine dihydrochloride 35 mg

excipients: kollidon SR (polyvinyl acetate — 80%, povidone — 19%, sodium lauryl sulfate and 0.8%, silicon dioxide 0,2%), calcium hydrogen phosphate, dihydrate silica colloidal anhydrous (Aerosil), magnesium stearate 

film shell: hypromellose (hydroxypropyl methylcellulose) talc titanium dioxide macrogol 4000 (polyethylene oxide 4000 or polyethylene glycol 4000) or shell film 390009ZA09 Advantia Prime white: hypromellose, talc, titanium dioxide, macrogol 4000 

in a contour acheikova packing 10 PCs. in cardboard pack of 3 or 6 packages or contour acheikova packing 20 PCs per cartons 2, 3, 5 or 6 packages or contour acheikova packing 30 PCs. in cardboard pack 1, 2, or 4 packs or in cans polymer 60 pieces in the paper cartons 1 Bank.

Description pharmaceutical form:

Tablets, film-coated, almost white or white with a yellowish sheen color, round, lenticular.

Pharmacokinetics:

After taking the drug inside Trimetazidine rapidly and almost completely absorbed in the digestive tract. Bioavailability is 90%.

Tmax in plasma is 3 h.

Stable state is achieved after 60 h Vd — 4.8 l/kg, which implies good diffusion distribution in the tissues.

Linking blood plasma proteins — 16%.

Trimetazidine is excreted mainly by the kidneys (60% — unchanged). T1/2 about 7 h, in patients over 65 years — about 12 hours

The renal clearance of Trimetazidine is directly correlated with creatinine clearance hepatic clearance decreases with age.

Easily permeates through gistogematicalkie barriers.

Description pharmacological action:

Provides antihypoxia action.

Directly affecting cardiomyocytes and neurons of the brain, the drug optimizes their metabolism and function. Cytoprotective effect due to higher energy potential, activated oxidative decarboxylation and the rationalization of oxygen consumption (increased aerobic glikoliza and blockade oxidation of fatty acids).

Trimetazidine maintains myocardial contractility, prevents a decrease in intracellular ATP and phosphocreatine. In conditions of acidosis, normalize the functioning of ion channels membranes, prevents the accumulation of calcium ions and sodium in cardiomyocytes, normalizes the intracellular content of potassium ions.

Reduces endocellular acidosis and the raised content of phosphates due to myocardial ischemia and reperfusion. Prevents the damaging action of free radicals, preserves the integrity of cell membranes, prevents the activation of neutrophils in the zone of ischemia, increases the duration of the electric potential, reduces the release of creatine kinase from the cells and the severity of ischemic myocardial damage.

Trimetazidine reduces the frequency of angina attacks, reduces the need for intake of nitrates, after 2 week of treatment increases tolerance to physical load, reducing the sharp fluctuations in HELL. Reduces dizziness and tinnitus. When vascular pathology eye improves the functional activity of the retina.

Indications:

• coronary heart disease, prevention of angina attacks (in the complex therapy)
  
• kohleowestibularnae disorders ischemic nature: dizziness, tinnitus, impaired hearing
  
• chorioretinal vascular disorders with ischemic component.
  

Contraindications:

• hypersensitivity to any component of the drug
  
• chronic renal failure (creatinine Cl <15 ml/min)
  
• marked disorders of liver function
  
• pregnancy
  
• lactation
  
• the age of 18 years (efficacy and safety not established).
  

Application of pregnancy and breast-feeding:

The drug is contraindicated in pregnancy due to the lack of clinical data on the safety of its use. It is unknown whether Trimetazidine penetrates in breast milk. Therefore, if necessary, the appointment of the drug during lactation should stop breastfeeding.

In experimental studies have not found teratogenic effects of Trimetazidine.

Side effects:

Allergic reactions (skin itching), rare — dyspeptic symptoms (nausea, vomiting, gastralgia). Rarely, headache, sensation of palpitations.

Drug interactions:

In clinical studies of Trimetazidine is shown that it increases anti-ischemic activity of other anti-anginal drugs. Other interactions were observed.

Method of application and dose:

Inside, during meal, 1 table. 2 times a day (morning and evening).

The course of treatment on the advice of the doctor.

Overdose:

Currently, the cases of drug overdose were reported.

Special instructions:

Do not use for relief of angina attacks. Not indicated for initial therapy of unstable angina or myocardial infarction.

In the case of angina should be reviewed and adapted treatment.

Effects on ability to drive or to perform work requiring high speed physical and mental reactions. Trimetal MV does not affect the ability to drive and perform work requiring high speed of psychomotor reactions.