Trimetazide (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmaceutical Works Polfa in Pabianice, Joint-Stock Company (Poland)

Contact Information

PABIANICE PHARMACEUTICAL WORKS POLFA JSC (Poland)

ATC Code

C01EB15 (Trimetazidine)

Active Substance

Trimetazidine (Rec.INN registered by WHO)

Dosage Form

Trimetazide

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: microcrystalline cellulose, croscarmellose, povidone, magnesium stearate.

Shell composition: methylhydroxypropylcellulose E5, methylhydroxypropylcellulose E15, hydroxypropylcellulose, polyethylene glycol, carmine red lake, carmine red.

20 pcs. – blisters (3) – cardboard packs.
30 pcs. – blisters (2) – cardboard packs.
60 pcs. – orange glass bottles (1) – 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 organs under ischemic conditions. It has antianginal, coronary dilating, antihypoxic, and hypotensive effects.

It directly improves the metabolism of 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 inhibiting fatty acid oxidation.

It maintains normal myocardial contractility, prevents intracellular depletion of ATP and phosphocreatinine. Under conditions of acidosis, it normalizes the state of membrane ion channels, prevents the accumulation of calcium and sodium in cardiomyocytes, and normalizes the intracellular content of potassium ions.

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, prevents neutrophil activation in the ischemic zone, reduces the release of CPK from cells and the severity of ischemic myocardial damage.

In angina pectoris, it reduces the frequency of attacks (nitrate consumption decreases). After 2 weeks of treatment, tolerance to physical activity increases, and blood pressure fluctuations decrease. Against the background of the drug use, hearing and the results of vestibular tests improve, dizziness and tinnitus decrease. In vascular eye pathology, the functional state of the retina improves.

Pharmacokinetics

Absorption

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

Distribution

Easily penetrates histohematic barriers. Plasma protein binding is 16%.

Elimination

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

Indications

• Coronary artery disease, angina pectoris (as part of complex therapy);
• Chorioretinal vascular disorders with an ischemic component;
• Dizziness of vascular origin;
• Treatment of cochleo-vestibular disorders of ischemic origin (tinnitus, hearing impairment).

ICD codes

Dosage Regimen

Administer Trimetazide orally with meals to reduce potential gastrointestinal discomfort.

The standard adult dosage is 20 mg three times daily, equating to a total daily dose of 60 mg.

Alternatively, for patient convenience, a regimen of one 20 mg tablet in the morning and two tablets in the evening may be used, maintaining the 60 mg daily total.

Adhere strictly to the twice or three times daily divided dosing schedule to ensure consistent plasma levels.

The treatment duration is determined individually based on the underlying condition and therapeutic response.

For angina pectoris, continue therapy as long-term management. In cochleo-vestibular disorders, assess efficacy after several weeks.

Do not chew or crush the tablets; swallow whole with a glass of water.

This product is contraindicated in patients with severe renal impairment (creatinine clearance less than 15 ml/min) and severe hepatic impairment.

Do not use in children or adolescents under 18 years of age.

Adverse Reactions

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

Allergic reactions skin itching.

Other headache, sensation of strong heartbeat.

Contraindications

• Renal failure (creatinine clearance <15 ml/min);
• Severe liver function disorders;
• Children and adolescents under 18 years of age (efficacy and safety have not been established);
• Pregnancy;
• Lactation (breastfeeding);
• Hypersensitivity to the drug.

Use in Pregnancy and Lactation

Trimetazide is contraindicated for use during pregnancy and lactation.

Use in Hepatic Impairment

Contraindicated in severe liver function disorders.

Use in Renal Impairment

Contraindicated in renal failure (creatinine clearance <15 ml/min).

Pediatric Use

Contraindication: children and adolescents under 18 years of age (efficacy and safety have not been established).

Special Precautions

Against the background of the drug use in patients with coronary artery disease, the daily need for nitrates is significantly reduced.

Influence on the ability to drive vehicles and mechanisms

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

Overdose

Currently, no cases of Trimetazide overdose have been reported.

Drug Interactions

Drug interaction of Trimetazide has not been described.

Storage Conditions

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

Shelf Life

The shelf life is 3 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.