Biolectra magnesium forte

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BIOLECTRA® MAGNESIUM FORTE

Composition:

Active substance: light magnesium oxide;

One effervescent tablet contains 403.0 – 435.2 mg of light magnesium oxide, corresponding to 243 mg (10 mmol) of magnesium ions;

Excipients: anhydrous citric acid, sodium bicarbonate, anhydrous sodium carbonate, potassium bicarbonate, malic acid, mannitol (E 421), rice starch, lemon flavor "MN" (containing mannitol (E 421), sorbitol (E 420)), sodium cyclamate, sodium chloride, sodium saccharin, simethicone.

Pharmaceutical form. Effervescent tablets.

Main physicochemical properties: round, white tablets with a smooth, flawless surface and the imprint "Biolectra" on one side.

Pharmacotherapeutic group.
Mineral supplements. Other mineral supplements. Magnesium preparations. Magnesium oxide.

ATC code A12CC10.

Pharmacological properties.

Pharmacodynamics.

Magnesium is an essential element for the body due to its central role in metabolism. Magnesium is required for numerous energy-dependent processes in the body and participates in the metabolism of proteins, fats, carbohydrates, nucleic acids, and in neuromuscular excitation.

Numerous functions involving energy generation (e.g., oxidative phosphorylation) or energy consumption (e.g., ion transport, muscle contraction) depend on magnesium and may be partially or completely impaired in its deficiency.

Magnesium activates glycolytic enzymes, cellular oxidation enzymes, and enzymes involved in nucleic acid synthesis. It also plays an important role in myocardial contraction processes and acts as a stabilizer of fibrinogen and platelets. It is known that magnesium deficiency is one of the causes of arterial hypertension, vascular spasm, neoplastic diseases, and urolithiasis. In stressful situations, an increased amount of free ionized magnesium is excreted; therefore, additional magnesium intake helps enhance stress resistance. Magnesium plays a key role in neuromuscular excitation, acting as an antagonist to calcium ions.

Total magnesium content in the adult human body is approximately 20–30 g. Of this amount, about 50% is located in bones, 45% within cells, and only 5% of the total amount can be detected in blood serum.

Intracellular magnesium concentration ranges from 10 to 60 mmol/L, while the normal plasma magnesium concentration ranges from 0.7 to 1.1 mmol/L. In plasma, approximately two-thirds of magnesium ions are in ionized (free) form, and about one-third is bound to proteins.

Pharmacokinetics.

When administered orally, magnesium absorption depends on the body's baseline magnesium content. Absorption increases in case of magnesium deficiency and decreases when magnesium stores are saturated. Absorption conditions follow homeostatically regulated resorption kinetics, typical for physiologically active substances.

Under conditions of magnesium balance and normal kidney function, even high magnesium doses do not lead to accumulation exceeding normal levels.

After intestinal absorption, magnesium is primarily excreted via the kidneys. Unabsorbed magnesium is eliminated in feces.

Clinical characteristics.

Indications.

Treatment of magnesium deficiency in the body in cases where it is the cause of disturbances in muscle function (neuromuscular disorders, muscle cramps).

Contraindications.

Hypersensitivity to the active substance or to any of the excipients.

Renal impairment and disturbances in cardiac conduction (high-grade AV block), which may lead to bradycardia. Disorders of mineral and electrolyte metabolism (hypermagnesemia, hyperkalemia).

Severe myasthenia gravis, dehydration, and calcium-magnesium-phosphate-ammonium diathesis.

Interaction with other medicinal products and other forms of interaction.

Since magnesium and other medicinal products may mutually affect absorption in the body, an interval of 2–3 hours between administration of different medicinal products should generally be observed. This particularly applies to fluorides and tetracyclines, for which a strict interval of 2–3 hours must be maintained.

Concomitant use with medicinal products containing aluminium (e.g. antacids) may increase aluminium absorption.

Aminoglycoside antibiotics, cisplatin, and cyclosporine A accelerate magnesium excretion.

Diuretics (such as thiazides and furosemide), epidermal growth factor receptor (EGFR) antagonists (such as cetuximab and erlotinib), proton pump inhibitors (such as omeprazole and pantoprazole), and viral DNA polymerase inhibitors (foscarnet, pentamidine, rapamycin, and amphotericin B) may cause magnesium deficiency. Due to increased magnesium excretion, patients receiving the above-mentioned drugs may require magnesium dose adjustments.

Special precautions for use.

This medicinal product contains 169 mg of sodium (the main component of food preparation/table salt) in each effervescent tablet. This is equivalent to 8.5% of the recommended maximum daily sodium intake for an adult.

This medicinal product contains 3.48 mmol (or 136 mg) of potassium in each effervescent tablet. Caution should be exercised when administering to patients with impaired renal function or those on a potassium-controlled diet.

This medicinal product contains 0.59 mg of sorbitol in each effervescent tablet.

Use during pregnancy or breastfeeding.

There are no risks associated with using the medicinal product during pregnancy or breastfeeding. Use of the medicinal product during breastfeeding is recommended only after consultation with a physician and under medical prescription.

Ability to influence reaction rate while driving or operating machinery. Does not affect.

Dosage and Administration

The dosage of the drug "Biolectra Magnesium Forte" depends on the degree of magnesium deficiency in the body. The average daily dose is 1–2 effervescent tablets (243–486 mg of magnesium ions = 10–20 mmol).

Children aged 6 years and older should take 1 effervescent tablet once daily.

Adolescents and adults should take 1 effervescent tablet 1–2 times daily.

In cases of severe magnesium deficiency, higher doses may be prescribed under medical supervision and with monitoring of electrolyte balance.

The tablet should be dissolved in a glass of water, and the resulting solution should be consumed.

The duration of treatment depends on the underlying causes of magnesium deficiency.

Long-term use of magnesium in high doses should be carried out under medical supervision.

Children

The drug is not recommended for children under 6 years of age.

Overdose

Hypermagnesemia following oral administration of magnesium salts occurs only in patients with renal insufficiency. Magnesium salts are contraindicated in such patients.

Symptoms of intoxication

Elevated magnesium concentrations cause relaxation of skeletal muscles (plasma magnesium concentrations above 5.5 mmol/L). Magnesium concentrations of 10–20 mmol/L prolong cardiac conduction time, and even higher concentrations may lead to cardiac arrest in diastole.

Treatment of intoxication

Intravenous administration of calcium provides immediate antagonism of the described symptoms due to the antagonistic relationship between calcium and magnesium ions.

Side effects.

At higher doses, softening of stools may occur, which is not considered dangerous and disappears after dose reduction. With prolonged use of high doses of the drug, a feeling of fatigue may develop. In such a case, the physician should decide on the appropriateness of continuing magnesium administration based on the clinical picture and laboratory findings.

Shelf life.

3 years.

Storage conditions.

No special storage conditions required.

Packaging.

10 effervescent tablets in a tube. 1 tube in a cardboard box.

4 effervescent tablets in a strip. 5 strips in a cardboard box.

Dispensing category.

Over-the-counter.

Manufacturer.

Hermes Pharma GmbH.

Manufacturer's address and location of business operations.

Hans-Urmiller-Ring 52, 82515 Wolfratshausen, Germany.