Magnelis^® B6 (Tablets) Instructions for Use

Marketing Authorization Holder

Otisipharm, JSC (Russia)

Manufactured By

Pharmstandard-UfaVITA OJSC (Russia)

Or

Otisipharm Pro, JSC (Russia)

ATC Code

A12CC (Magnesium preparations)

Active Substances

Pyridoxine (Rec.INN registered by WHO)

Magnesium lactate (BP British Pharmacopoeia)

Dosage Form

Magnelis® B6

Film-coated tablets, 48 mg+5 mg: 30, 50, 60, 90, 120 or 180 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white with a greyish tint, round, biconvex; on the cross-section, a rough core of white color with inclusions ranging from white with a creamy tint to light yellow.

Excipients : sucrose (white sugar) – 24.7 mg, kaolin – 41 mg, acacia gum (gum arabic) – 25 mg, Kollidon^® SR (polyvinyl acetate – 80%, povidone (K30) – 19%, sodium lauryl sulfate – 0.8%, silicon dioxide – 0.2%) – 34 mg, magnesium stearate – 6.8 mg, carmellose sodium – 34 mg, talc – 6.8 mg.

Shell composition sucrose (white sugar) – 166.7 mg, kaolin – 54 mg, gelatin – 0.9 mg, acacia gum (gum arabic) – 4 mg, beeswax – 0.4 mg, titanium dioxide – 9 mg, talc – 15 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
120 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Drug replenishing magnesium deficiency in the body

Pharmacotherapeutic Group

Mineral supplements; other mineral supplements; magnesium preparations

Pharmacological Action

A drug that replenishes magnesium deficiency.

Magnesium is a vital element that is present in all body tissues and is necessary for the normal functioning of cells. It is involved in most metabolic reactions, in the regulation of nerve impulse transmission and muscle contraction, and has antispasmodic, antiarrhythmic, and antiplatelet effects.

The body receives magnesium from food. Magnesium deficiency in the body can occur with dietary disturbances (diet) or with an increased need for magnesium (during increased physical and mental stress, stress, pregnancy, use of diuretics).

Pyridoxine (vitamin B₆) participates in many metabolic processes and in the regulation of nervous system metabolism. It improves the absorption of magnesium from the gastrointestinal tract and its penetration into cells.

A serum magnesium level from 12 to 17 mg/L (0.5-0.7 mmol/L) indicates a moderate magnesium deficiency; below 12 mg/L (0.5 mmol/L) indicates a severe magnesium deficiency.

Pharmacokinetics

Absorption

After oral administration, the absorption of magnesium from the gastrointestinal tract is 50%.

Excretion

It is excreted mainly by the kidneys. In the kidneys, after glomerular filtration of 70% of the magnesium present in the plasma, its reabsorption in the renal tubules is 95-97%.

Indications

• Established magnesium deficiency, isolated or associated with other deficiency conditions.

ICD codes

Dosage Regimen

Administer the tablets orally with meals. Swallow the tablets whole with a full glass of water; do not chew.

For adults, the typical therapeutic dosage is 6 to 8 tablets per day. Divide the total daily dose into two or three separate administrations.

For children over 6 years of age and with a body weight exceeding 20 kg, the recommended dosage is 4 to 6 tablets per day. Also administer this daily dose in two or three divided doses.

The duration of treatment is determined by the normalization of serum magnesium levels. Discontinue treatment once laboratory tests confirm that blood magnesium concentration has returned to the normal range.

In patients with moderate renal impairment, exercise caution and consider dosage adjustment due to the risk of hypermagnesemia. The drug is contraindicated in severe renal failure (creatinine clearance less than 30 ml/min).

Adverse Reactions

From the digestive system: abdominal pain, constipation, nausea, vomiting, flatulence.

Allergic reactions: allergic reactions are possible.

Contraindications

• Severe renal failure (creatinine clearance less than 30 ml/min);
• Phenylketonuria;
• Children under 6 years of age;
• Hypersensitivity to the components of the drug.

With caution, the drug should be used in patients with moderate renal failure, because there is a risk of developing hypermagnesemia.

Use in Pregnancy and Lactation

Clinical experience has not revealed fetotoxic or teratogenic effects of the drug.

Magnelis^® B6 can be used during pregnancy only as prescribed by a doctor.

Magnesium penetrates and is excreted in breast milk. The use of the drug during lactation and breastfeeding should be avoided.

Use in Renal Impairment

With caution, the drug should be used in patients with moderate renal failure, because there is a risk of developing hypermagnesemia.

Contraindicated in severe renal failure (creatinine clearance less than 30 ml/min).

Pediatric Use

Contraindication: children under 6 years of age.

Special Precautions

If it is necessary to use the drug in patients with diabetes, it should be borne in mind that the tablets contain sucrose as an excipient.

In case of concomitant calcium deficiency, magnesium deficiency should be corrected before starting calcium supplements.

Overdose

With normal renal function, oral intake of magnesium does not cause toxic reactions. Magnesium poisoning can develop in renal failure. Toxic effects mainly depend on the serum magnesium content.

Symptoms: decrease in blood pressure, nausea, vomiting, slowed reflexes, anuria, respiratory depression, coma, cardiac arrest.

Treatment: rehydration, forced diuresis. In renal failure, hemodialysis or peritoneal dialysis is necessary.

Drug Interactions

With the simultaneous use of drugs containing phosphates or calcium salts, a significant decrease in the absorption of magnesium from the gastrointestinal tract is possible.

Magnesium preparations reduce the absorption of tetracycline, it is recommended to separate the intake of these drugs by a 3-hour interval.

Magnesium reduces the effect of oral thrombolytic agents and reduces the absorption of iron.

Vitamin B₆ inhibits the activity of levodopa.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.