Magnelis

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Mагnеліs (Magnelis)

Composition:

Active substances: magnesium, pyridoxine;

One tablet contains magnesium citrate 618.43 mg (equivalent to 100 mg of magnesium) and pyridoxine hydrochloride (vitamin B6) 10 mg;

Excipients: lactose monohydrate; polyethylene glycol 6000; magnesium stearate.
Coating: hypromellose, polyethylene glycol 6000, titanium dioxide (E 171).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: Oval-shaped, biconvex tablets, film-coated, white or almost white in color.

Pharmacotherapeutic group. Vitamin B complex with minerals.
ATC code: A11EC.

Pharmacological Properties

Pharmacodynamics

Magnesium is a cation predominantly located intracellularly. Magnesium reduces neuronal excitability and neuromuscular transmission and participates in numerous enzymatic processes.

Magnesium is an essential component of body tissues: skeletal bone contains approximately half of the total magnesium content in the body.

A serum magnesium concentration of 12 to 17 mg/L (1–1.4 mEq/L, or 0.5–0.7 mmol/L) indicates moderate magnesium deficiency; levels below 12 mg/L (1 mEq/L, or 0.5 mmol/L) indicate severe magnesium deficiency.

Magnesium deficiency may be:

• Primary, due to metabolic disorders (chronic inherited hypomagnesemia);
• Secondary, due to:
  • inadequate dietary intake of magnesium (severe malnutrition, chronic alcohol abuse, exclusive parenteral nutrition);
  • impaired intestinal absorption of magnesium (chronic diarrhea, gastrointestinal fistulas, hypoparathyroidism);
  • excessive renal magnesium loss (tubular disorders, severe polyuria, diuretic abuse, chronic pyelonephritis, primary hyperaldosteronism, cisplatin therapy).

Pyridoxine, a coenzyme factor, participates in most metabolic processes.

Pharmacokinetics

A portion of magnesium salts is passively absorbed in the intestine. The extent of absorption depends on the solubility of the salt. Gastrointestinal absorption of magnesium salts does not exceed 50%. Magnesium is primarily excreted in the urine.

In the body, pyridoxine undergoes oxidation to pyridoxal or amination to pyridoxamine. Subsequent phosphorylation results in the formation of pyridoxal phosphate, which is the metabolically active form of pyridoxine.

Clinical characteristics.

Indications.

Symptomatic treatment of magnesium deficiency in the body.

This medicinal product contains magnesium.

A combination of the following symptoms may indicate magnesium deficiency:

• increased excitability, irritability, anxiety, transient weakness, mild sleep disturbances;
• signs of anxiety such as gastrointestinal spasms or increased heart rate (in the absence of heart disease);
• muscle cramps, tingling sensations.

Administration of magnesium may help reduce or eliminate these symptoms.

If symptoms do not improve after one month of treatment, continued therapy is not recommended.

Contraindications.

Hypersensitivity to any component of the drug. Severe renal insufficiency (creatinine clearance < 30 ml/min). Children under 6 years of age. Phenylketonuria. Hypermagnesemia, hypervitaminosis of vitamin B6, myasthenia gravis. Atrioventricular block, severe arterial hypotension. Concomitant use with levodopa (see section "Interaction with other medicinal products and other types of interactions"). Diarrhea.

Interaction with other medicinal products and other types of interactions.

Contraindicated combinations.

Concomitant use with levodopa should be avoided, as magnesium may inhibit the action of levodopa when it is administered without inhibitors of peripheral dopa-decarboxylase. Pyridoxine in any dosage is not recommended if levodopa is not administered together with dopa-decarboxylase inhibitors.

Not recommended combinations.

Medicinal products containing phosphate or calcium salts, as they interfere with magnesium absorption from the intestine.

Combinations to be taken into consideration.

Oral tetracyclines and Mагnelіs should be administered at an interval of at least 3 hours, since magnesium inhibits the absorption of tetracyclines.

Magnesium preparations reduce the effect of oral anticoagulants and decrease iron absorption.

Diuretics increase magnesium excretion in urine.

The use of hydralazine, isoniazid, penicillamine, and oral contraceptives increases the requirement for vitamin B6.

Special precautions for use.

This medicinal product contains lactose. Therefore, it is not recommended for patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome (rare hereditary conditions).

Abuse of pyridoxine may lead to development of sensory neuropathy when administered in high doses (> 200 mg/day) over a prolonged period (i.e., several months or years). This effect is usually reversible and resolves after discontinuation of the drug.

Patients with moderate renal insufficiency should take precautionary measures to prevent any risks associated with hypermagnesemia.

If there is no improvement after one month of treatment, the drug should be discontinued.

In cases of concomitant calcium deficiency, magnesium deficiency should be corrected first, followed by calcium deficiency.

Precautionary measures during use

This medicinal product is intended for use only in adults and children aged 6 years and older.

For children under 6 years of age, appropriate pharmaceutical forms are available.

Use during pregnancy or breastfeeding

Pregnancy. Sufficient clinical data on the use of this drug in pregnant women have not revealed any fetotoxic or embryotoxic effects. Magnesium may be used during pregnancy only if necessary and after consultation with a physician. If required, magnesium can be administered at any stage of pregnancy. Despite the lack of sufficient animal study data, the limited clinical data available are considered satisfactory.

Breastfeeding period. Each of the active ingredients of the drug separately (both magnesium and vitamin B6) is not contraindicated during this period. Due to limited evidence available today regarding the use of the maximum recommended daily dose of vitamin B6 during breastfeeding, it is recommended to administer no more than 20 mg/day of vitamin B6.

Ability to influence reaction rate while driving or operating machinery.

Magelis, film-coated tablets, have no effect or only negligible effect on the ability to drive or operate machinery.

Dosage and Administration

Tablets should be swallowed whole with a glass of water.

For adult patients: 3–4 tablets per day in 2 or 3 divided doses taken during meals.

For children aged 6 years and older (with body weight approximately 20 kg or more): 10–30 mg/kg body weight per day (0.4–1.2 mmol/kg body weight per day), or 2–4 tablets per day, in 2 or 3 divided doses taken during meals. The usual duration of treatment is one month.

Children

The drug is indicated for use in children aged 6 years and older. For children under 6 years of age, appropriate dosage forms are available.

Overdose

Magnesium-related

Oral magnesium overdose usually does not cause toxic reactions when renal function is normal. However, in patients with renal insufficiency, magnesium intoxication may develop.

Prolonged use of the drug at high doses may lead to sensory neuropathy, which may manifest as symptoms such as numbness, impaired perception of position and vibration in the lower limbs, and progression of sensory ataxia (coordination disorder).

Symptoms of overdose depend on serum magnesium levels and may include:

• Decreased arterial blood pressure;
• Nausea, vomiting;
• Central nervous system depression, slowed reflexes;
• ECG abnormalities;
• Respiratory depression, coma, cardiac arrest, and respiratory muscle paralysis;
• Anuria.

Treatment of overdose: Rehydration, forced diuresis. In cases of renal insufficiency, hemodialysis or peritoneal dialysis is required.

Pyridoxine-related

Sensory axonal neuropathy is the main adverse effect that may occur during prolonged and/or chronic administration of high doses of pyridoxine (over several months or years).

Signs and symptoms

Paresthesia, dysesthesia, hypoesthesia, sensory deficit, limb pain, involuntary muscle contractions, burning sensations, impaired balance, gait disturbances, hand and foot tremors, and progressive sensory ataxia (difficulty with motor coordination) have been reported.

Treatment

Neurological symptoms gradually resolve after discontinuation of the drug.

Side effects

The side effects that may occur during the use of Magnelis are listed below, classified by system organ class and frequency of occurrence: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000); frequency not known (cannot be estimated from the available data).

Immune system disorders

Frequency not known: allergic reactions, hypersensitivity, angioedema.

Gastrointestinal disorders

Frequency not known: diarrhea*, abdominal pain*, loose stools, nausea, vomiting.

Skin and subcutaneous tissue disorders

Frequency not known: skin reactions, including urticaria, pruritus, eczema, erythema.

*Magnesium-related side effects.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

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

Packaging. No. 60 (15×4): 15 tablets in a blister; 4 blisters in a cardboard box.

Supply category. Over-the-counter.

Manufacturer. ASTRAFARM LLC.

Manufacturer's address and location of its business activity. 6, Kyivska St., city of Vyshneve, Buchanskyi district, Kyiv region, 08132, Ukraine.