Magni-b6®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MAGNE-В6Ò (MAGNE-В6Ò)

Composition:

Active substances: 1 ampoule of 10 ml contains magnesium lactate dihydrate 186 mg and magnesium pidolate 936 mg (corresponding to 100 mg of Mg++, or 4.12 mmol), pyridoxine hydrochloride (vitamin В6) 10 mg;

Excipients: sodium metabisulfite (Е 223), sodium saccharin, caramel with a cherry flavoring, purified water.

Pharmaceutical form. Oral solution.

Main physicochemical characteristics: transparent brown liquid with a caramel odor.

Pharmacotherapeutic group.

Vitamin B complex with minerals.

ATC code А11Е С.

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 about half of the total magnesium content 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 inherited hypomagnesemia);
• secondary, due to:
  • inadequate dietary intake of magnesium (imbalanced nutrition, chronic alcohol abuse, exclusive parenteral nutrition);
  • impaired gastrointestinal absorption of magnesium (chronic diarrhea, gastrointestinal fistulas, hypoparathyroidism);
  • excessive renal magnesium loss (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 process for which the solubility of the salt is a determining factor.

Gastrointestinal absorption of magnesium salts does not exceed 50%. Magnesium is primarily excreted in the urine.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to the active substances or to any of the excipients listed in the section "Composition". Severe renal insufficiency with creatinine clearance below 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 forms of interaction"). Diarrhea.

Interaction with other medicinal products and other forms of interactions.

Levodopa.

This medicinal product is contraindicated in patients receiving levodopa as monotherapy (e.g., without inhibitors of peripheral dopa-decarboxylase (DDC)), since pyridoxine reduces or inhibits the activity of levodopa.

Phosphate or calcium salts.

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

Tetracyclines.

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 Magne-B6® should be postponed by at least 3 hours.

Quinolones.

Quinolones should be taken at least 2 hours before or 6 hours after taking magnesium-containing products to avoid impaired absorption of magnesium.

Combinations to be considered.

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

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 for patients with malabsorption.

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

This medicinal product contains sodium metabisulfite and may cause severe allergic reactions and bronchospasm.

This medicinal product contains 0.1134 mg of ethanol per 2 ampoules of 10 ml solution, equivalent to 0.00567 mg/ml (0.000567% v/v). The amount of ethanol in two 10 ml ampoules of this medicinal product is equivalent to less than 0.01 ml of beer or 0.01 ml of wine.

Since the amount of ethanol in this product is small, it is unlikely to cause any significant effects.

Pyridoxine-related: Sensory neuropathy may occur during prolonged use of pyridoxine and/or chronic intake of high doses of pyridoxine over a prolonged period (see section "Overdose").

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

Breastfeeding period. Each of the active substances of the drug separately (both magnesium and vitamin B6) is not contraindicated during this period. Due to limited evidence 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 speed when driving or operating machinery. Magne-B6®, oral solution, has no effect or negligible effect on the ability to drive or operate machinery.

Dosage and Administration

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

Adults: 3–4 ampoules daily, 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 daily (i.e., 0.4–1.2 mmol/kg body weight daily), corresponding to 1–4 ampoules daily, divided into 2 or 3 doses taken during meals.

Treatment should be discontinued as soon as the magnesium blood level returns to normal.

Children

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

Overdose

Magnesium-related

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:

• Severe hypotension;
• Nausea, vomiting;
• Central nervous system depression, impaired reflex functions;
• Pathological changes on ECG;
• Respiratory depression, coma, cardiac arrest, and respiratory paralysis;
• Anuria.

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

Pyridoxine-related

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

Signs and symptoms

Cases have been reported of paresthesia, dysesthesia, hypoesthesia, sensory deficit, limb pain, involuntary muscle contractions, burning sensations, impaired balance, gait disturbances, hand and leg tremors, and progressive sensory ataxia (difficulty coordinating movements).

Treatment

Neurological symptoms gradually resolve after discontinuation of treatment.

Adverse Reactions

The adverse reactions that may occur during administration of Magne-B6® are listed below by system organ class and frequency: 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 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 suspected adverse reactions

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

Shelf life. 3 years.

Storage conditions

Keep out of reach and sight of children.

Store in the original packaging at a temperature below 25 °C.

Packaging

No. 10: 10 ml in an ampoule, 10 ampoules with two break lines in a cardboard tray, in a cardboard box.

Supply category Over-the-counter (without prescription).

Manufacturer

COOPERATION PHARMACEUTIQUE FRANCAISE

Manufacturer's address

Place Lucien Haute, 77020 MEAULON, France

Marketing Authorization Holder

LLC "Opella Health Ukraine", Ukraine

Address of the Marketing Authorization Holder and/or its representative

Ukraine, 01033, Kyiv, Zhyljanska St., 48-50A