Rhythmicor® forte

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT RHYTHMOCOR® FORTE (RHYTHMOCOR FORTE)

Composition:

Active substances:

1 tablet contains

magnesium salt of 2,3,4,5,6-pentahydroxycaproic acid, calculated as 100% substance — 600 mg,

potassium salt of 2,3,4,5,6-pentahydroxycaproic acid, calculated as 100% substance — 120 mg;

Excipients: microcrystalline cellulose, heavy magnesium carbonate, sodium croscarmellose, calcium stearate, sorbitol.

Pharmaceutical form. Tablets.

Main physicochemical properties: white or almost white elongated tablets, with convex upper and lower surfaces and a dividing line.

Pharmacotherapeutic group. Mineral supplements. Magnesium preparations. ATC code A12CC.

Pharmacological properties.

Pharmacodynamics. RITMOKOR**®** FORTE is a combination medicinal product that exhibits metabolic, antioxidant, membrane-stabilizing, and antiarrhythmic effects. The metabolic activity of RITMOKOR**®** FORTE is due to activation of cellular redox enzymes and increased levels of adenosine triphosphate (ATP) and creatine phosphate. These effects of the drug promote optimization of cellular ion pump function. Due to these effects, as well as the content of magnesium and potassium ions, the drug exerts antiarrhythmic action and enhances the clinical efficacy of antiarrhythmic agents.

Pharmacokinetics. After oral administration, maximum blood concentration is reached within 1–1.5 hours. Within 48 hours, 95% of the drug is metabolized; metabolites are excreted by the kidneys.

Clinical characteristics.

Indications.

RHYTHMOCOR® FORTÉ should be used as an adjunctive therapy in diseases and conditions associated with hypomagnesemia and hypokalemia (within comprehensive treatment regimens):

• ischemic heart disease;
• cardiac arrhythmias (atrial and ventricular extrasystolic arrhythmia);
• vegetative-vascular dystonia;
• cardiomyopathies;
• electrolyte imbalance (for correction of magnesium and potassium ion levels);
• fatigue syndrome.

Contraindications.

Hypersensitivity to the components of the drug. Third-degree atrioventricular block. Cardiogenic shock (with systolic blood pressure below 90 mm Hg in adults). Comatose states of unknown etiology. Decompensated forms of diabetes mellitus. Acute and chronic renal impairment of grade II–IV. Addison’s disease. Hyperkalemia and hypermagnesemia.

Interaction with other medicinal products and other types of interactions.

When RHYTHMOCOR® FORTÉ is used concomitantly with antiarrhythmic and antihypertensive agents, mutual enhancement of drug activity may occur. When used simultaneously with potassium-sparing diuretics and angiotensin-converting enzyme inhibitors, serum potassium and magnesium levels should be monitored. When used concomitantly with cardiac glycosides, the risk of their toxic effects on the heart is reduced.

Special precautions.

During treatment with RITMOKOR**®** FORTE, monitoring of serum potassium and magnesium levels is necessary. Particular attention should be paid to patients at high risk of developing hypermagnesemia and hyperkalemia. Hypermagnesemia and hyperkalemia may manifest as paresthesia, decreased tendon reflexes, tremor, and respiratory depression. To reduce hypermagnesemia, calcium preparations should be used.

Continuous ECG monitoring is required during prolonged use. Use with caution in patients with myasthenia gravis and in conditions that may lead to hyperkalemia, such as acute dehydration, extensive tissue damage, particularly in severe burns.

In patients with diabetes mellitus, the possibility of falsely elevated glucose levels should be considered when using the orthotoluidine method due to the presence of gluconic (pentahydroxycaproic) acid in the medicinal product.

1 tablet of RITMOKOR**®** FORTE contains 0.03 bread units.

The product contains sorbitol. If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicinal product.

Use during pregnancy or breastfeeding.
There is no clinical experience available.

Ability to affect reaction speed when driving or operating machinery.
Generally does not affect; however, the possibility of dizziness related to the first-dose effect should be taken into account.

Dosage and Administration

The duration of use and dosage of RITMOKOR® FORTE is determined by a physician in each individual case. Tablets should be taken orally, 10–15 minutes before meals; the dose should be washed down with a small amount of water.

Adults: Take ½–1 tablet 3–4 times daily. In more severe cases, 1½ tablets three times daily may be used. After achieving the therapeutic effect (usually within 5–7 days), the dose should be reduced to ½ tablet three times daily. The duration of treatment is determined individually by the physician.

If a rapid therapeutic effect is required, treatment should begin with the injectable form of RITMOKOR® FORTE.

In cardiac rhythm disorders (atrial and ventricular extrasystolic arrhythmias) caused by hypokalemia and hypomagnesemia, and for prevention of paroxysmal atrial fibrillation regardless of heart rate, concomitant use of RITMOKOR® FORTE with cardiac glycosides reduces the risk of their arrhythmogenic effects.

In chronic fatigue syndrome, take ½ tablet three times daily for 3–6 months.

Children aged 6 to 12 years: ½ tablet three times daily; children aged 12 years and older: same as adults.

Children

This medicinal product in the given pharmaceutical form may be used in children aged 6 years and older.

Overdose

Cases of overdose have not been reported. Since the medicinal product contains magnesium and potassium ions, in the event of overdose, ECG changes typical of hypermagnesemia and hyperkalemia may occur. Hyperkalemia and hypermagnesemia may manifest as paresthesia, diminished tendon reflexes, tremor, and respiratory depression. Symptoms of hyperkalemia include nausea, vomiting, diarrhea, abdominal pain, metallic taste in the mouth, bradycardia, weakness, confusion, and muscle paralysis. Symptoms of hypermagnesemia include facial flushing, thirst, arterial hypotension, neuromuscular transmission disturbances, arrhythmias, seizures, and ECG changes. Calcium preparations should be used to counteract the effects of hyperkalemia.

Side effects.

The medicinal product is well tolerated; adverse reactions develop very rarely.

From the skin and subcutaneous tissue: skin rash, urticaria, itching, skin hyperemia.

From the respiratory system: respiratory depression.

From the musculoskeletal system: paresthesia, hyporeflexia, seizures.

From the cardiovascular system: myocardial conduction disturbances, decreased arterial pressure, atrioventricular block.

From the gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pain, discomfort or burning sensation in the epigastric region, gastrointestinal bleeding, mucosal ulcers of the digestive tract, dry mouth, dyspeptic symptoms (very rare).

From the vestibular apparatus: dizziness (very rare), associated with the first-dose effect.

From the vascular system: sensation of warmth.

From the immune system: allergic reactions, including rash, itching, urticaria, sensation of warmth, skin hyperemia. In case of allergic manifestations, desensitizing therapy is prescribed.

Shelf life. 2 years. The medicinal product should not be used after the expiry date stated on the package.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. 10 tablets in a blister. 3 or 5 blisters per carton.

Dispensing category. Over-the-counter.

Manufacturer.

LLC "Pharmaceutical Company "FARCOС".

Manufacturer's address and place of business.

360, Svyato-Pokrovska Street, town of Hostomel, Irpin, Kyiv region, Ukraine, 08290.

Marketing Authorization Holder.

LLC "Pharmaceutical Company "FARCOС".

Address of the Marketing Authorization Holder.

50A, Zodchykh Street, Kyiv, Ukraine, 03162.