Magnerot^® (Tablets) Instructions for Use

Marketing Authorization Holder

Woerwag Pharma GmbH & Co. KG (Germany)

Manufactured By

Mauermann – Arzneimittel, KG (Germany)

Or

Pik-Pharma Lek, LLC (Russia)

ATC Code

A12CC09 (Magnesium orotate)

Active Substance

Magnesium orotate (Grouping name)

Dosage Form

Magnerot®

Tablets 500 mg: 20, 40, 50, 60, 80 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat, with beveled edges on both sides and a score on one side; the score is intended solely to facilitate breaking the tablet and to ease swallowing, not for dividing into equal doses.

Excipients : colloidal anhydrous silicon dioxide, croscarmellose sodium, microcrystalline cellulose, corn starch, povidone-K30, lactose monohydrate, sodium cyclamate, talc, magnesium stearate.

10 pcs. – blisters (2) – cartons.
10 pcs. – blisters (5) – cartons.
20 pcs. – blisters (1) – cartons.
20 pcs. – blisters (2) – cartons.
20 pcs. – blisters (3) – cartons.
20 pcs. – blisters (4) – cartons.
20 pcs. – blisters (5) – cartons.

Clinical-Pharmacological Group

Magnesium preparation

Pharmacotherapeutic Group

Magnesium preparations

Pharmacological Action

A product containing magnesium. Magnesium is an essential macronutrient. It is necessary for many energy processes and is involved in the metabolism of proteins, fats, carbohydrates, and nucleic acids.

Magnesium is involved in the process of neuromuscular excitation by inhibiting neuromuscular transmission. Magnesium is of particular interest as a natural physiological calcium antagonist. Magnesium controls the normal functioning of myocardial cells and participates in regulating the contractile function of the myocardium. In stressful situations, an increased amount of free ionized magnesium is excreted, which is why an additional amount of magnesium helps to increase resistance to stress.

Magnesium deficiency leads to neuromuscular disorders (motor and sensory hyperexcitability, convulsions, paresthesia), psychological changes (state of depression, confusion, and hallucinations), and cardiovascular diseases (ventricular extrasystole, tachycardia, increased sensitivity to cardiac glycosides). Magnesium deficiency during pregnancy increases the likelihood of toxemia and premature birth.

Orotic acid salts are involved in metabolic processes. Furthermore, orotic acid salts are necessary for fixing magnesium to ATP in the cell and for the manifestation of its action.

Pharmacokinetics

Approximately 35-40% of the administered dose is absorbed. Hypomagnesemia stimulates the absorption of magnesium ions. The presence of orotic acid salts promotes improved magnesium absorption.

Magnesium is excreted by the kidneys; excretion decreases with magnesium deficiency and increases with its excess.

Indications

As part of complex therapy and for the prevention of the following diseases: myocardial infarction, angina pectoris; chronic heart failure; arrhythmias caused by magnesium deficiency; spastic conditions – muscle pain and spasms (including angiospasm); atherosclerosis; arteritis; lipid metabolism disorders.

ICD codes

Dosage Regimen

For initial treatment of magnesium deficiency, take two tablets (1 g) three times daily.

Continue this initial dosage for the first seven days of therapy.

Following the initial week, reduce the dosage to one tablet (500 mg) two to three times daily.

Continue the maintenance therapy for a minimum duration of four to six weeks.

For the specific indication of nocturnal calf muscle cramps, take two to three tablets (1-1.5 g) as a single evening dose.

Administer tablets orally with a sufficient amount of water.

The tablet score is for breaking to ease swallowing only, not for dose division.

Adhere strictly to the prescribed dosage and treatment duration.

Long-term use is permissible if medically indicated.

Adverse Reactions

From the digestive system unstable stools and diarrhea (when taking the drug in high doses), which usually resolve on their own when the dose is reduced.

Other allergic reactions are possible.

Contraindications

Hypersensitivity to magnesium orotate; urolithiasis; impaired renal function; predisposition to the formation of calcium-magnesium-ammonium-phosphate stones; myasthenia gravis; AV-block; liver cirrhosis with ascites; children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Use during pregnancy and lactation is possible according to indications if the expected benefit to the mother outweighs the potential risk to the fetus and child. If magnesium levels are not balanced, it can lead to serious complications, including miscarriage.

Special Precautions

If necessary, it can be used long-term.

Drug Interactions

When taking magnesium-containing drugs simultaneously with iron preparations, sodium fluoride, and tetracyclines, the absorption of the latter may decrease. Therefore, these drugs should be taken at an interval of 2-3 hours.

Oral contraceptives, diuretics, muscle relaxants, glucocorticosteroids, and insulin reduce the effect of magnesium.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.