Magnicum-antistress®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MАGNICUM-ANTISTRESS (MAGNICUM-ANTISTRESS)

Composition:

Active substances: magnesium, pyridoxine;

One tablet contains magnesium citrate 618.43 mg, equivalent to 100 mg of magnesium, and pyridoxine hydrochloride 10 mg;

Excipients: anhydrous lactose, polyethylene glycol (macrogol), magnesium stearate;

Coating: Opadry II White film-coating mixture: hypromellose (hydroxypropylmethylcellulose); lactose monohydrate; polyethylene glycol (macrogol); titanium dioxide (E 171); triacetin.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex tablets with a film coating, white to almost white in color.

Pharmacotherapeutic group. Agents affecting the digestive system and metabolism. Vitamins. Vitamin B complex preparations, including combinations. 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 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; 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 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 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.

A combination of several of the symptoms listed below may indicate magnesium deficiency in the body:

• 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 advisable.

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 inhibitors of peripheral dopa-decarboxylase. Pyridoxine in any dosage is not recommended if levodopa is not administered together with dopa-decarboxylase inhibitors.

Combinations not recommended.

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

Combinations to be taken into account.

Oral tetracyclines and Magnicum-Antistress® should 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.

Use of hydralazine, isoniazid, penicillamine, and oral contraceptives increases the need 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 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 impairment should take precautionary measures to prevent any risks associated with hypermagnesemia.

If there is no improvement in the patient's condition 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 for use

THIS MEDICINAL PRODUCT IS INDICATED FOR USE IN ADULTS AND CHILDREN AGED 6 YEARS AND OLDER ONLY.

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 the 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 available clinical data are considered satisfactory.

Breastfeeding period

Each of the active ingredients of the drug (both magnesium and vitamin B6) is not contraindicated during this period. Given the limited evidence currently available 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 while driving or operating machinery. The medicinal product has no effect or only a negligible effect on the ability to drive or operate machinery.

Dosage and Administration

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 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 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, in patients with renal insufficiency, magnesium intoxication may develop.

Symptoms. When the drug is used in high doses over a prolonged period, sensory neuropathy may occur, manifesting as numbness, impaired perception of position and vibration in the lower extremities, and progression of sensory ataxia (coordination disorder).

Symptoms of overdose depend on serum magnesium levels. Overdose may be associated with decreased arterial blood pressure, nausea, vomiting, central nervous system depression, diminished reflexes, ECG abnormalities, respiratory depression, coma, cardiac arrest, respiratory paralysis, and anuria.

Treatment. 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 use of high doses of pyridoxine (over several months or years).

Symptoms. In particular, paresthesia, dysesthesia, hypoesthesia, sensory deficits, limb pain, muscle twitching, burning sensations, impaired balance, gait disturbances, tremors in hands and feet, and progressive sensory ataxia (difficulty in coordinating movements) have been reported.

Treatment. Neurological symptoms gradually resolve after discontinuation of treatment.

Adverse reactions.

Immune system disorders: allergic reactions, hypersensitivity, angioneurotic edema.

Gastrointestinal disorders: diarrhea*, abdominal pain*, loose stools, nausea, vomiting.

Skin and subcutaneous tissue disorders: skin reactions, including urticaria, pruritus, eczema, erythema.

*Adverse reactions associated with magnesium.

Reporting suspected adverse reactions after drug registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the automated pharmacovigilance information system at: https://aisf.dec.gov.ua

Shelf life. 3 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; 6 blisters per carton.

12 tablets in a blister; 4 blisters per carton.

12 tablets in a blister; 5 blisters per carton.

Supply category. Over-the-counter.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's address and location of operations.

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua