Expiration date: 10/2025

The composition and form of issue:

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

of Trimetazidine dihydrochloride 35 mg

other ingredients: hypromellose (methocel K 4M Premium EP) ISC silicon dioxide colloidal (Aerosil) magnesium stearate 

the shell: hydroxypropyl methylcellulose (hypromellose) talc titanium dioxide macrogol (polyethylene oxide 4000) azorubin dye (acid red 2C for pharmaceutical purposes) 

in a contour cells packing 10 PCs. in cardboard pack of 3 or 6 packs or in plastic bottles to 60 PCs. in cardboard pack 1 bottle.

Description pharmaceutical form:

Tablets, film-coated pink, round, lenticular.

Pharmacokinetics:

Rapidly and almost completely absorbed from the gastrointestinal tract. Bioavailability is 90%. Cmax achieved after 2 h of Cmax after a single oral administration of 35 mg of Trimetazidine is about 55 ng/ml. Easily passes through gistogematicalkie barriers. The plasma protein binding is 16%. T1/2 — 4,5–5 h

Excreted by the kidneys (60% — unchanged).

Description pharmacological action:

Directly affecting cardiomyocytes and neurons in the brain, optimizing 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).

Supports airway diseases, prevents intracytoplasmic ATP depletion and fosfokreatinina. In conditions of acidosis, normalize the functioning of ion channels, prevents accumulation of calcium and sodium in cardiomyocytes, normalizes the intracellular content of potassium ions.

Reduces endocellular acidosis and the phosphate concentration, i.e., corrects the changes caused by 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.

When strokes reduces the frequency of attacks (reduced consumption of nitrate), after 2 week of treatment increases tolerance to physical activity, reduced variations in HELL. Improves hearing and results of vestibular tests in patients, reduces dizziness and tinnitus. When vascular pathology eye restores functional activity retina.

Indications:

• Coronary artery disease: prevention of angina (in combination therapy)
  
• chorioretinal vascular disorders
  
• vertigo of vascular origin
  
• kohleowestibularnae disorders ischemic nature (tinnitus, hearing loss).
  

Contraindications:

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

Side effects:

Allergic reactions (itching). Rare: gastrointestinal — gastralgia, nausea, vomiting other headache, sensation of palpitations.

Drug interactions:

There is no information.

Method of application and dose:

Inside, during a meal. The recommended dosing regimen — 2 table. (70 mg) per day, in 2 doses. The course of treatment for the advice of a doctor.

Special instructions:

The drug is not intended for the relief of angina!

In the case of angina should be reviewed and tailor the treatment (medical therapy or revascularization holding).

The use of the drug does not affect the ability to drive a car and perform work requiring high speed mental and physical reactions.