Magnemax-health

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

Composition:

Active substances: magnesium lactate dihydrate; magnesium pidolate; pyridoxine hydrochloride;

10 ml of the preparation contain 186 mg of magnesium lactate dihydrate and 936 mg of magnesium pidolate (equivalent to 100 mg of Mg++ or 4.12 mmol), and 10 mg of pyridoxine hydrochloride;

Excipients: sodium metabisulfite (E 223); sodium saccharin; ammonia caramel sulphite (E 150d), containing sulfites expressed as sulfur dioxide (E 220); "Raspberry" flavouring containing ethanol 96%, propylene glycol (E 1520), alpha-tocopherol (E 307), ascorbic acid (E 300), purified water; water for injections.

Pharmaceutical form. Oral solution.

Main physicochemical properties: clear liquid, light brown to brown in colour, with a raspberry odour.

Pharmacotherapeutic group.

Vitamin B complex with minerals. ATC code A11EC.

Pharmacological properties.

Pharmacodynamics.

Magnesium is an intracellular cation that reduces neuronal excitability and inhibits neuromuscular transmission, as well as participates in numerous enzymatic reactions. Magnesium is an essential component of body tissues: skeletal bone contains half of the total amount of magnesium present in the body.

Serum magnesium concentration between 12 and 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 disorders (chronic congenital hypomagnesemia);

Secondary, due to:

• Inadequate dietary intake of magnesium (imbalanced nutrition, chronic alcohol abuse, exclusive parenteral nutrition);
• Impaired magnesium absorption in the gastrointestinal tract (chronic diarrhea, gastrointestinal fistulas, hypoparathyroidism);
• Excessive magnesium loss via renal excretion (tubular disorders, severe polyuria, diuretic abuse, chronic pyelonephritis, primary hyperaldosteronism, cisplatin therapy).

Pharmacokinetics.

Absorption of magnesium salts in the gastrointestinal tract involves, among other mechanisms, a passive mechanism for which the solubility of the salt is a determining factor.

Absorption of magnesium salts in the gastrointestinal tract does not exceed 50%. Magnesium is primarily excreted in the urine.

Clinical characteristics.

Indications.

Treatment of confirmed magnesium deficiency in the body, either isolated or associated with other deficiency states.

Contraindications.

Hypersensitivity to any component of the medicinal product. Severe renal insufficiency with creatinine clearance less than 30 ml/min. 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 the effect of levodopa is inhibited when it is administered without inhibitors of peripheral dopa-decarboxylase. Administration of pyridoxine in any amount is not recommended if levodopa is not co-administered with dopa-decarboxylase inhibitors.

Not recommended combinations.

Do not use with medicinal products containing phosphate or calcium salts, as they inhibit magnesium absorption from the intestine.

Combinations requiring caution.

Use oral tetracyclines with caution, as magnesium reduces the absorption of tetracyclines from the stomach and intestine. When used concomitantly with oral tetracyclines, administration of the product should be delayed by at least 3 hours.

Magnesium preparations weaken the effect of oral anticoagulants and reduce 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

In patients with severe magnesium deficiency, treatment should be initiated with intravenous administration of magnesium preparations in the form of an injection solution. This is also indicated in patients with malabsorption.

In patients with concomitant calcium deficiency, correction of magnesium deficiency should generally be performed before calcium supplementation is initiated.

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., for several months or years). Symptoms include numbness, sensory disturbances, tremor, and progressively worsening sensory ataxia (coordination problems). This effect is usually reversible and resolves after discontinuation of the drug.

This medicinal product contains sodium metabisulfite and sulfur dioxide, which may rarely cause hypersensitivity reactions and bronchospasm.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

Precautions for use

Patients with moderate renal impairment should take precautions to prevent any risks associated with hypermagnesemia.

Use during pregnancy or breastfeeding

Pregnancy. Limited clinical and animal data have not revealed any fetotoxic or embryotoxic effects of the drug. Therefore, magnesium may be used during pregnancy only if necessary and after consultation with a physician.

Breastfeeding period. Each of the active substances of the medicinal product (both magnesium and vitamin B6) is individually not contraindicated during this period. However, due to limited evidence regarding 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 vehicles or operating machinery. The medicinal product has no effect or only a negligible effect on the ability to drive vehicles or operate machinery.

Dosage and Administration

Dissolve the contents of the vials in half a glass of water.

Adults: 3–4 vials per day, divided into 2 or 3 doses taken during meals.

Children and infants with body weight over 10 kg (approximately 1 year of age): 10–30 mg/kg body weight per day (i.e., 0.4–1.2 mmol/kg body weight per day), corresponding to 1–4 vials per day, divided into 2 or 3 doses taken during meals.

Treatment with the medicinal product should be discontinued as soon as magnesium levels in the blood return to normal.

Children.

The medicinal product should be administered to children with body weight over 10 kg (approximately 1 year of age).

Overdose.

Related to magnesium

Magnesium overdose following oral administration usually does not lead to toxic reactions in patients with normal renal function. However, in patients with renal insufficiency, magnesium intoxication may develop.

Toxic effects depend on serum magnesium levels and may manifest as follows: a sharp drop in arterial blood pressure, nausea, vomiting, central nervous system depression, impaired reflex functions, pathological changes on ECG, respiratory depression, coma, cardiac arrest, respiratory paralysis, and anuria.

Treatment: rehydration and forced diuresis. Hemodialysis or peritoneal dialysis is required for patients with renal insufficiency.

Related to pyridoxine

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

Signs and symptoms: parasthesia, dysesthesia, hypoesthesia, sensory deficits, limb pain, involuntary muscle contractions, burning sensations, loss of balance, gait disturbances, tremors in hands and legs, and progressive sensory ataxia (difficulty in motor coordination).

Treatment: neurological symptoms gradually resolve after discontinuation of treatment.

Side effects.

The adverse reactions that may occur during the use of the medicinal product are listed below according to system organ class and frequency: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10 000, < 1/1000); very rare (< 1/10000); 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*, nausea, vomiting, abdominal pain*.

Skin and subcutaneous tissue disorders.

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

* Adverse reactions associated with magnesium.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or 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 the reach and sight of children.

Packaging.

10 ml of the preparation in a vial, hermetically sealed with a rubber stopper and aluminum cap; 5 vials in a blister pack;

2 blister packs in a carton.

Supply category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and location of business activity.

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