Medarum^® 20 (Tablets) Instructions for Use

Marketing Authorization Holder

FP Obolenskoe, JSC (Russia)

ATC Code

C01EB15 (Trimetazidine)

Active Substance

Trimetazidine (Rec.INN registered by WHO)

Dosage Form

Medarum® 20

Coated tablets, 20 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Coated tablets red in color, round, biconvex; a cross-section shows two layers.

Excipients: corn starch, mannitol, povidone, magnesium stearate, croscarmellose, microcrystalline cellulose.

Shell composition hypromellose, titanium dioxide, magnesium stearate, acid red, polyethylene glycol.

20 pcs. – blister packs (3) – cardboard packs.

Clinical-Pharmacological Group

Drug improving metabolism of the myocardium and neurosensory organs under ischemic conditions

Pharmacotherapeutic Group

Antihypoxant

Pharmacological Action

A drug that improves the metabolism of the myocardium and neurosensory organs under ischemic conditions. It has antianginal, coronary dilating, antihypoxic, and hypotensive effects. It improves metabolism in cardiomyocytes and brain neurons.

The cytoprotective effect is due to an increase in energy potential, activation of oxidative decarboxylation, and rationalization of oxygen consumption by enhancing aerobic glycolysis and blocking fatty acid oxidation. It maintains myocardial contractility, prevents intracellular depletion of ATP and phosphocreatinine.

Under conditions of acidosis, it normalizes the functioning of membrane ion channels, prevents the accumulation of calcium and sodium in cardiomyocytes, and normalizes the intracellular content of K⁺. It reduces intracellular acidosis and phosphate content caused by myocardial ischemia and reperfusion.

It prevents the damaging effect of free radicals, preserves the integrity of cell membranes, and prevents the activation of neutrophils in the ischemic zone. It increases the duration of the electrical potential, reduces the release of creatine phosphokinase from cells and the severity of ischemic myocardial damage.

In angina, it reduces the frequency of attacks (nitrate consumption decreases). After 2 weeks of treatment, tolerance to physical activity increases, and blood pressure fluctuations decrease.

It improves hearing and the results of vestibular tests in patients with ENT pathology, reduces dizziness and tinnitus.

In vascular pathology of the eye, it restores the functional activity of the retina.

Pharmacokinetics

Absorption

After oral administration, it is rapidly and almost completely absorbed from the gastrointestinal tract. Bioavailability is 90%. C_max in blood plasma is reached after 2 hours and is about 55 mg/ml after a single oral dose of 20 mg of trimetazidine.

Distribution and Elimination

It easily passes through histohematic barriers. Plasma protein binding is 16%.

It is excreted by the kidneys (about 60% unchanged). T_1/2 is 4.5 -5 hours.

Indications

• Coronary artery disease: angina (as part of combination therapy);
• Chorioretinal vascular disorders;
• Dizziness of vascular origin;
• Cochleovestibular disorders of ischemic nature (tinnitus, hearing impairment).

ICD codes

Dosage Regimen

Take one 20 mg tablet twice daily.

Administer the tablets with meals, typically in the morning and evening.

Swallow the tablet whole with water; do not chew or crush.

The duration of therapy is determined by the treating physician based on the underlying condition and clinical response.

For angina pectoris, use as part of a combination antianginal therapy.

Do not exceed the prescribed daily dose of 40 mg (two tablets).

In case of a missed dose, take it as soon as remembered unless it is nearly time for the next dose; do not double the dose.

Regular clinical monitoring is recommended during long-term treatment.

Discontinuation should be supervised by a physician.

Adverse Reactions

From the digestive system rarely – gastralgia, nausea, vomiting.

Allergic reactions skin itching.

Contraindications

• Renal failure (creatinine clearance below 15 ml/min);
• Severe liver dysfunction;
• Pregnancy;
• Lactation period (breastfeeding);
• Age under 18 years (efficacy and safety have not been established);
• Hypersensitivity to trimetazidine.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

The drug is contraindicated in severe liver dysfunction.

Use in Renal Impairment

The drug is contraindicated in renal failure with creatinine clearance below 15 ml/min.

Pediatric Use

The efficacy and safety of the drug in patients under 18 years of age have not been established.

Special Precautions

During treatment with the drug, the daily need for nitrates is significantly reduced in patients with coronary artery disease.

Effect on the ability to drive vehicles and operate machinery

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

Overdose

Currently, no cases of overdose of Medarum^® 20 have been reported.

Drug Interactions

Drug interactions of Medarum^® 20 have not been described.

Storage Conditions

List B. The drug should be stored in a dry place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.