Magnelis^® B6 forte (Tablets) Instructions for Use

Marketing Authorization Holder

Otisipharm Pro, JSC (Russia)

Manufactured By

Pharmstandard-UfaVITA OJSC (Russia)

Or

Otisipharm Pro, JSC (Russia)

ATC Code

A12CC (Magnesium preparations)

Dosage Form

Magnelis® B6 forte

Film-coated tablets, 100 mg+10 mg: 30, 60 or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, oblong, biconvex; the cross-section is white or almost white.

Excipients : lactose/crospovidone/povidone [lactose monohydrate – 92.2 mg-96.05 mg, povidone K30 – 3.04 mg-4.05 mg, crospovidone – 3.04 mg-4.05 mg] – 101.21 mg, macrogol 6000 – 69.36 mg, magnesium stearate – 1 mg.

Shell composition white film coating [hypromellose 6 cPz – 7.8 mg, titanium dioxide (E171) – 6 mg, polydextrose – 3 mg, talc – 2 mg, macrogol 3350 – 1.2 mg] – 20 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
15 pcs. – contour cell packs (6) – cardboard packs.

Clinical-Pharmacological Group

Drug replenishing magnesium deficiency in the body

Pharmacotherapeutic Group

Mineral supplements; other mineral supplements; magnesium preparations

Pharmacological Action

Magnesium is a vital element that is present in all body tissues and is necessary for normal cell function, participating in most metabolic reactions. In particular, it is involved in the regulation of nerve impulse transmission and muscle contraction.

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

Pyridoxine (vitamin B₆) participates in many metabolic processes, 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 moderate magnesium deficiency; below 12 mg/L (0.5 mmol/L) indicates severe magnesium deficiency.

Pharmacokinetics

The absorption of magnesium from the gastrointestinal tract is no more than 50% of the orally administered dose. In the body, magnesium is distributed mainly in the intracellular space – about 99%, of which approximately 2/3 is distributed in bone tissue, and 1/3 is in smooth and striated muscle tissue.

Magnesium is excreted primarily in the urine (at least 1/3 of the administered dose of magnesium).

Indications

Established magnesium deficiency, isolated or associated with other deficiency conditions, accompanied by symptoms such as increased irritability, minor sleep disturbances, gastrointestinal cramps or palpitations, increased fatigue, muscle pain and cramps, tingling sensation.

ICD codes

Dosage Regimen

Take orally with a full glass of water during a meal.

Determine the dose based on the patient’s age. For adults and children over 12 years, the typical dose is 3-4 tablets per day. For children aged 6 to 12 years, the typical dose is 2-4 tablets per day.

Divide the total daily dose into 2-3 separate administrations to improve gastrointestinal tolerance and absorption.

Discontinue treatment immediately after laboratory confirmation of normalized serum magnesium levels.

For severe deficiency or malabsorption syndromes, initiate therapy with intravenous magnesium preparations before switching to oral administration.

Avoid concomitant intake with medications or supplements containing phosphates, calcium salts, or iron ions, as they impair magnesium absorption.

If taking tetracycline antibiotics, maintain an interval of at least 3 hours between doses. For quinolone antibiotics, administer the antibiotic at least 2 hours before or 6 hours after taking this medication.

Use with caution in patients with moderate renal impairment (CrCl 30-60 ml/min) due to the risk of hypermagnesemia. The drug is contraindicated in severe renal failure (CrCl <30 ml/min).

Adverse Reactions

From the immune system frequency unknown – allergic reactions, including skin reactions (urticaria, itching).

From the digestive system frequency unknown – diarrhea, abdominal pain.

Contraindications

Severe renal failure (CrCl <30 ml/min); children under 6 years of age; simultaneous use of levodopa; hypersensitivity to magnesium citrate and pyridoxine.

With caution

Moderate renal failure, because there is a risk of developing hypermagnesemia.

Use in Pregnancy and Lactation

During pregnancy, use is possible only if necessary and on the recommendation of a doctor.

Magnesium is excreted in breast milk. The use of this combination should be avoided during breastfeeding.

Use in Renal Impairment

The drug should be prescribed with caution in moderate renal failure, because there is a risk of developing hypermagnesemia.

The drug is contraindicated in severe renal failure (CrCl less than 30 ml/min).

Pediatric Use

Contraindication: children under 6 years of age.

This combination can be used in children over 6 years of age in dosage forms intended for pediatric use according to age.

Special Precautions

In case of severe magnesium deficiency or malabsorption syndrome, treatment should be started with intravenous administration of magnesium preparations.

In case of concomitant calcium deficiency, it is recommended to correct the magnesium deficiency before starting the use of calcium preparations or dietary supplements containing calcium.

With frequent use of laxatives, alcohol, intense physical and mental stress, the need for magnesium increases, which can lead to the development of magnesium deficiency in the body.

When using pyridoxine in high doses (more than 200 mg/day) for a long time (for several months or in some cases – years), sensory axonal neuropathy may develop, which is accompanied by symptoms such as numbness, impaired proprioceptive sensitivity, tremor of the distal extremities, and gradually developing sensory ataxia (impaired coordination of movements). These disorders are usually reversible and disappear after discontinuation of vitamin B₆.

Drug Interactions

Pyridoxine inhibits the activity of levodopa (if a peripheral decarboxylase inhibitor of aromatic L-amino acids is not used simultaneously). Any amount of pyridoxine should be avoided if levodopa is not taken in combination with peripheral decarboxylase inhibitors of aromatic L-amino acids.

Simultaneous use of preparations containing phosphates, calcium salts or iron ions may impair the absorption of magnesium in the intestine.

When using antibiotics of the tetracycline group, an interval of at least 3 hours should be observed between oral administration of tetracycline and the combination of Magnesium citrate/pyridoxine, because magnesium preparations reduce the absorption of tetracyclines.

Quinolones should be administered at least 2 hours before or 6 hours after taking the combination of Magnesium citrate/pyridoxine to avoid impaired absorption of quinolones.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.