Magnemax-health

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MAGNEMAX-ZDOROVYE (MAGNEMAX-ZDOROVYE)

Composition:

Active substances: 1 tablet contains anhydrous magnesium citrate 618.43 mg, equivalent to 100 mg of magnesium, pyridoxine hydrochloride 10 mg;

Excipients: lactose monohydrate; polyethylene glycol 6000; magnesium stearate; talc; dry mixture "Opadry white" containing titanium dioxide (E 171), hypromellose, triacetin (E 1518).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: oval, film-coated tablets, white or almost white, with a break line on one side.

Pharmacotherapeutic group. Vitamin B complex with minerals.

ATC code A11E C.

Pharmacological properties.

Pharmacodynamics.

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

Magnesium is an essential component of body tissues: skeletal bone contains about half of the total magnesium present 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; below 12 mg/L (1 mEq/L, or 0.5 mmol/L) indicates severe magnesium deficiency.

Magnesium deficiency may be:

• primary, due to metabolic pathology (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 losses (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. Absorption of magnesium salts in the gastrointestinal tract 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. This form of pyridoxine is metabolically active.

Clinical Characteristics

Indications.

Symptomatic treatment of magnesium deficiency in the body.

This medicinal product contains magnesium.

The presence of a combination of several of the following symptoms may indicate magnesium deficiency:

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

Administration of magnesium may help reduce or eliminate these symptoms.

If symptoms do not improve after one month of using the medicinal product, continued treatment is not recommended.

Contraindications.

Hypersensitivity to any component of the medicinal product. 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 levodopa's effect is inhibited when administered without concomitant use of peripheral dopa-decarboxylase inhibitors. Pyridoxine use in any dosage is not recommended if levodopa administration is not accompanied by dopa-decarboxylase inhibitors.

Combinations not recommended.

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

Combinations requiring caution.

Oral tetracycline preparations must be taken at an interval of at least 3 hours, as magnesium inhibits tetracycline absorption.

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.

For patients with severe magnesium deficiency, treatment should begin with intravenous administration of magnesium.

Abuse of pyridoxine may lead to the 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 precautions to prevent hypermagnesemia.

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

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

This medicinal product contains lactose. If the patient has known intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

Precautions for use

THIS MEDICINAL PRODUCT IS INTENDED FOR USE IN ADULTS AND CHILDREN AGED 6 YEARS AND OLDER ONLY. For children under 6 years of age, the medicinal product MagneMax-Zdorov'ya, oral solution, should be used.

Use during pregnancy or breastfeeding.

Pregnancy.

Analysis of sufficient clinical data on the use of the drug in pregnant women has not revealed any fetotoxic or embryotoxic effects. Despite the limited amount of animal study data, the available clinical evidence is considered satisfactory.

Magnesium may be used at any stage of pregnancy, if needed.

Breastfeeding.

Each of the active ingredients of the medicinal product—magnesium and vitamin B6—alone is not contraindicated during this period. Considering the limited available evidence on the use of the maximum recommended daily dose of vitamin B6 during breastfeeding, it is recommended not to exceed 20 mg/day of vitamin B6.

Ability to influence reaction rate when driving or operating machinery.

No effect.

Dosage and Administration

The tablets should be swallowed whole with one glass of water.

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

For children aged 6 years and older (with body weight approximately 20 kg): 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 with meals. The usual duration of treatment is one month.

Administration of the medicinal product should be discontinued as soon as the magnesium level in blood returns to normal.

Children. The medicinal product may be used in children aged 6 years and older.

Overdose.

Magnesium-related.

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

Symptoms. Sensory neuropathy may occur with prolonged use of high doses of the drug, manifesting as numbness, impaired position and vibration sense in the lower limbs, and progression of sensory ataxia (coordination disorder).

Symptoms of overdose depend on serum magnesium levels. Overdose may lead to hypotension, nausea, vomiting, central nervous system depression, diminished reflexes, ECG abnormalities, respiratory depression, coma, cardiac arrest, respiratory muscle paralysis, and anuria.

Treatment. Rehydration and forced diuresis. Hemodialysis or peritoneal dialysis is required in cases of renal failure.

Pyridoxine-related.

Sensory axonal neuropathy is the main adverse effect associated with prolonged and/or chronic use of high-dose pyridoxine (over several months or years).

Symptoms. Parasthesia, dysesthesia, hypoesthesia, sensory deficits, limb pain, muscle twitching, 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 pyridoxine.

Side effects.

The adverse reactions that may occur during the use of the medicinal product are listed below by organ systems and by frequency of occurrence: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10 000, < 1/1000); very rare (< 1/10 000); frequency not known (cannot be estimated from the available data).

Immune system disorders.

Frequency not known: allergic reactions, hypersensitivity, angioneurotic edema.

Gastrointestinal disorders.

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

Skin and subcutaneous tissue disorders.

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

* Adverse reactions associated with magnesium.

Reporting of suspected adverse reactions.

It is important to report suspected adverse reactions after the medicinal product has been authorized, as this allows continued monitoring of the benefit/risks balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national pharmacovigilance system.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. 10 tablets in a blister, 3 or 6 blisters in a cardboard box.

Supply category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and location of business activity.

22, Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.