Trimektal MR, pills 35mg, 60pcs

Composition

1 modified release film-coated tablet contains:

Active ingredient:

trimetazidine dihydrochloride-0.035 g;

excipients:

collidone SR [polyvinyl acetate 80%, povidone 19%, sodium lauryl sulfate 0.8%, silicon dioxide 0.2%],

calcium hydrophosphate dihydrate,

silicon dioxide colloidal (aerosil),

magnesium stearate;

film coating:

hypromellose (hydroxypropylmethylcellulose),

talc,

titanium dioxide,

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

Pharmacological action

Trimectal eliminates the phenomena of hypoxia. The Active ingredient molecule affects myocardial cells, as well as brain neurons. The substance contributes to the normalization of metabolic processes in cellular structures, improves their functions. Trimetazidine protects cells by moving cells to a new energy level, activating the processes of oxidative decarboxylation.

The drug optimizes the oxygen consumption of cells by enhancing glycolysis reactions that take place with the participation of oxygen molecules, with a parallel blockade of oxidative reactions that take place with the participation of fatty acids. Trimectal supports the optimal level of contractility of the heart muscle, stops the fall in the intracellular concentration of ATP, phosphocreatine molecules.

In acidosis, the drug has a positive effect on the function of channels that transmit ions. Trimectal prevents intracellular accumulation of calcium and sodium ions in the structures of the heart, optimizes the amount of potassium ions. This eliminates acidosis inside the cell, normalizes the content of phosphate ions, which are heated due to the influence of ischemia and reperfusion processes. When taking the drug, the prevention of damage to structures and molecules by free radical groups is observed. This ensures that the membranes remain intact.

Trimectal stops the activation of neutrophil cells in tissues that have been exposed to ischemia. The active molecule extends the Tranzit time of the electric potential, inhibits the release of creatine phosphokinase molecules from cellular structures, and reduces the severity of damage to cardiac tissues after ischemic influence.

With regular intake of Trimectal capsules, there is a decrease in the frequency of angina attacks. Against the background of taking trimetazidine, nitrate doses are corrected with a decrease in their dosages. Patients have increased tolerance to physical activity. blood pressure jumps are eliminated, the symptoms of the existing pathology go away.

Indications

Trimectal is prescribed for: coronary heart disease for the purpose of prevention to prevent the development of angina attacks; cochleovestibular disorders associated with tissue ischemia, which are manifested by dizziness, pathological changes in hearing, tinnitus; chorioretinal vascular disorders.

Use during pregnancy and lactation

There are no data on the use of trimetazidine in pregnant women. As a precautionary measure, it is not recommended to use Trimectal MV during pregnancy.

There are no data on the excretion of trimetazidine or its metabolites in breast milk. The risk to the newborn/child cannot be excluded. Trimectal MV should not be used during breastfeeding.

Contraindications

• hypersensitivity to any component of Trimectal MV;
• severe renal insufficiency (creatinine clearance less than 30 ml / min);
• Parkinson’s disease, Parkinsonism symptoms, tremor, restless legs syndrome and other related motor disorders;
• age up to 18 years (efficacy and safety have not been established).

With caution: severe hepatic insufficiency; moderate renal insufficiency (creatinine clearance 30-60 ml / min); elderly patients (over 75 years).

Side effects

Adverse reactions defined as adverse events that are at least potentially relevant to trimetazidine treatment are listed in the following gradation: very common (more than 1/10); common (more than 1/100, less than 1/10); uncommon (more than 1/1000, less than 1/100); rare (more than 1/10000, less than 1/1000); very rare (less than 1/10000); frequency unknown (frequency cannot be calculated from available data).

From the digestive system: often-abdominal pain, diarrhea, dyspepsia, nausea, vomiting; frequency unknown-constipation.

Common disorders: often-asthenia.

From the central nervous system: often — dizziness, headache; frequency unknown – symptoms of Parkinsonism (tremor, akinesia, increased tone), instability in the Romberg position and unsteady gait, restless legs syndrome, other associated motor disorders, usually reversible after discontinuation of therapy; sleep disorders (insomnia, drowsiness).

From the skin and subcutaneous fat: often-skin rash, pruritus, urticaria; frequency unknown-acute generalized exanthematous pustulosis, angioedema.

From the cardiovascular system: rarely-palpitation, extrasystole, tachycardia, marked decrease in blood pressure, orthostatic hypotension, which may be accompanied by general weakness, dizziness or loss of balance, especially when taking antihypertensive drugs, flushes of blood to the skin of the face.

From the circulatory and lymphatic system: frequency unknown-agranulocytosis, thrombocytopenia, thrombocytopenic purpura.

Liver and biliary tract disorders: frequency unknown-hepatitis.

How to take, course of use and dosage

Inside, during meals,1 tablet 2 times a day (morning and evening).

The course of treatment is based on the doctor’s recommendation.

Special patient groups

Impaired renal function and elderly patients.

When used in patients with moderate renal impairment (creatinine clearance 30-60 ml/min) and elderly patients, it is necessary to reduce the frequency of taking the drug to 1 time per day (in the morning, during breakfast).

Overdose

There is only limited information about trimetazidine overdose.

In case of overdose, symptomatic therapy should be performed.

Special instructions

Trimectal® MV is not intended for the relief of angina attacks and is not indicated for the initial course of treatment of unstable angina or myocardial infarction at the prehospital stage or in the first days of hospitalization. If an angina attack develops, treatment should be reviewed and adapted (drug therapy or revascularization).

Trimetazidine can cause or worsen the symptoms of parkinsonism (tremor, akinesia, increased tone), so patients, especially the elderly, should be regularly monitored. In cases of doubt, patients should be referred to a neurologist for appropriate evaluation. If motor disorders such as Parkinsonism symptoms, restless legs syndrome, tremors, Romberg’s unsteadiness, and unsteady gait occur, trimetazidine should be permanently discontinued. Such cases are rare, and symptoms usually resolve after discontinuation of therapy: in most patients — within 4 months after discontinuation of the drug. If symptoms of parkinsonism persist for more than 4 months after discontinuation of the drug, you should consult a neurologist.

There may be cases of falls associated with instability in the Romberg position and unsteadiness of gait or a marked decrease in blood pressure, especially in patients taking antihypertensive drugs.

Caution should be exercised when prescribing Trimectal MV to patients who may have increased exposure to it: in moderate renal insufficiency; in elderly patients over 75 years of age.

Due to the dosage form of Trimectal MV, modified release film-coated tablets, the tablet may not dissolve in the intestine and be excreted in the feces, which does not affect the therapeutic effectiveness of the drug.

Influence on the ability to drive vehicles and work with mechanisms. Given the possibility of developing adverse reactions from the central nervous system when taking trimetazidine, caution should be exercised when driving vehicles and other technical devices that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Modified release film-coated tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Trimetazidine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Angina, Vascular diseases of the eyes