Rimecor MV (Tablets) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Pharma Start, LLC (Ukraine)

ATC Code

C01EB15 (Trimetazidine)

Active Substance

Trimetazidine (Rec.INN registered by WHO)

Dosage Form

Rimecor MV

Extended-release tablets, film-coated, 35 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Extended-release tablets, film-coated pink, round, biconvex, with two layers visible on the cross-section.

Excipients: mannitol – 13.5 mg, microcrystalline cellulose – 21 mg, glycol montan wax (montan wax) – 39 mg, copolymer of methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate [1:2:0.1] (Eudragit RS PO) – 40 mg, magnesium stearate – 1.5 mg.

Shell composition – 8 mg (FD&C aluminum blue lake No.2 – 0.07%, FD&C aluminum yellow lake No.6 – 0.77%, macrogol (polyethylene glycol) – 20.2%, polyvinyl alcohol – 40%, Ponceau 4R aluminum lake – 0.24%, talc – 14.8%, titanium dioxide – 23.92%).

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.

Extended-release tablets, film-coated pink, round, biconvex, with two layers visible on the cross-section.

Excipients: mannitol – 13.5 mg, microcrystalline cellulose – 21 mg, glycol montan wax (montan wax) – 39 mg, copolymer of methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate [1:2:0.1] (Eudragit RS PO) – 40 mg, magnesium stearate – 1.5 mg.

Shell composition – 8 mg (FD&C aluminum blue lake No.2 – 0.07%, FD&C aluminum yellow lake No.6 – 0.77%, macrogol (polyethylene glycol) – 20.2%, polyvinyl alcohol – 40%, Ponceau 4R aluminum lake – 0.24%, talc – 14.8%, titanium dioxide – 23.92%).

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.

Film-coated tablets pink, round, biconvex, with two layers visible on the cross-section.

Excipients: mannitol – 13.5 mg, microcrystalline cellulose – 21 mg, glycol montan wax (montan wax) – 39 mg, copolymer of methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate [1:2:0.1] (Eudragit RS PO) – 40 mg, magnesium stearate – 1.5 mg.

Shell composition – 8 mg (FD&C aluminum blue lake No.2 – 0.07%, FD&C aluminum yellow lake No.6 – 0.77%, macrogol (polyethylene glycol) – 20.2%, polyvinyl alcohol – 40%, Ponceau 4R aluminum lake – 0.24%, talc – 14.8%, titanium dioxide – 23.92%).

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Antihypoxant

Pharmacological Action

It has an antihypoxic effect. It normalizes the energy metabolism of cells subjected to hypoxia or ischemia. By directly affecting cardiomyocytes and brain neurons, it optimizes their metabolism and function. The cytoprotective effect is due to an increase in energy potential, activation of oxidative decarboxylation, and rationalization of oxygen consumption (enhancement of aerobic glycolysis and slowing of fatty acid oxidation due to selective inhibition of long-chain 3-ketoacyl-CoA thiolase).

Trimetazidine maintains myocardial contractility, prevents a decrease in intracellular adenosine triphosphate (ATP) and creatine phosphate. Under conditions of acidosis, it normalizes the functioning of membrane ion channels, prevents the accumulation of calcium and sodium ions in cardiomyocytes, and normalizes the intracellular concentration of potassium ions.

It reduces intracellular acidosis and the increased 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, 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, reduces the need for nitrate intake, after 2 weeks of treatment increases exercise tolerance, and reduces sharp fluctuations in blood pressure. It reduces dizziness and tinnitus of ischemic etiology. In vascular eye pathology, it restores the functional activity of the retina.

Pharmacokinetics

After oral administration, Trimetazidine is rapidly and almost completely absorbed in the gastrointestinal tract. Food intake does not affect the pharmacokinetic properties of the drug. Bioavailability is 90%. The time to reach maximum plasma concentration is 3-5 hours.

Throughout the day, the plasma concentration remains at a level exceeding 75% of the concentration determined 11 hours after taking one tablet of the drug. The equilibrium plasma concentration is reached approximately 60 hours after the start of treatment. The volume of distribution is 4.8 L/kg, plasma protein binding is 16%. It easily penetrates histohematic barriers.

It is excreted unchanged, mainly by the kidneys (about 60%). The half-life is about 7 hours, in patients over 65 years old – about 12 hours. The renal clearance of trimetazidine directly correlates with creatinine clearance (CrCl), hepatic clearance decreases with age.

Indications

Cardiology:

• Coronary artery disease – prevention of stable angina attacks (as part of combination therapy).

Otolaryngology:

• Treatment of cochleo-vestibular disorders of ischemic origin (such as dizziness, tinnitus, hearing impairment).

Ophthalmology:

• Chorioretinal vascular disorders with an ischemic component.

ICD codes

Dosage Regimen

Administer Rimecor MV orally, with meals, to reduce potential gastrointestinal discomfort.

The standard adult dosage is one 35 mg extended-release tablet twice daily, taken in the morning and in the evening.

Swallow the tablet whole; do not crush, break, or chew it, as this will damage the extended-release properties.

If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with the regular schedule. Do not double the dose to make up for a forgotten tablet.

The duration of treatment is determined by the treating physician based on the indication and patient response.

For angina pectoris, use as part of a combination antianginal therapy. This product is for prophylactic use and is not indicated for aborting an acute angina attack.

In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), monitor renal function periodically during long-term therapy.

Discontinue treatment if symptoms of parkinsonism (such as tremor, rigidity, akinesia) or unstable gait appear. These symptoms are usually reversible upon discontinuation.

Adverse Reactions

Frequency of adverse effects: very common (more than 1/10); common (more than 1/100 and less than 1/10); uncommon (more than 1/1000 and less than 1/100); rare (more than 1/10000 and less than 1/1000); very rare (more than 1/10000), including individual reports.

From the digestive system

Common: abdominal pain, diarrhea, dyspepsia, nausea, vomiting.

From the cardiovascular system

Rare: orthostatic hypotension, flushing. From the central nervous system Common: dizziness, headache, asthenia.

Very rare: extrapyramidal disorders (tremor, rigidity, akinesia), reversible after drug withdrawal.

From the skin

Common: skin rash, itching, urticaria.

Contraindications

• Hypersensitivity to the components of the drug;
• Severe renal failure (creatinine clearance less than 15 ml/min);
• Severe liver dysfunction;
• Pregnancy;
• Lactation period;
• Age under 18 years (efficacy and safety have not been established).

Use in Pregnancy and Lactation

Animal studies have not revealed a teratogenic effect of trimetazidine; however, due to the lack of clinical data on the safety of the drug during pregnancy, the risk of fetal malformations cannot be excluded. The use of the drug during pregnancy is contraindicated.

It is not known whether Trimetazidine is excreted in breast milk. If it is necessary to use Rimecor MV during lactation, breastfeeding should be discontinued.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction.

Use in Renal Impairment

Contraindicated in severe renal failure (creatinine clearance less than 15 ml/min).

Pediatric Use

Contraindicated in children under 18 years of age (efficacy and safety have not been established).

Special Precautions

Rimecor MV is not intended for the relief of angina attacks and is not indicated for the initial course of therapy for unstable angina or myocardial infarction, nor for preparation for hospitalization or in its first days.

In case of an angina attack, treatment should be reviewed and adapted. Due to the lack of relevant clinical data, the use of Rimecor MV is not recommended for patients with renal failure with creatinine clearance less than 15 ml/min, as well as for patients with severe liver dysfunction.

Effect on ability to drive vehicles and mechanisms

Caution is recommended when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Data on overdose cases are limited. In case of overdose, symptomatic therapy should be administered.

Drug Interactions

No information.

Storage Conditions

At a temperature from 15°C (59°F) to 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

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.