Magnelis B6 forte, 100 mg+10 mg 60 pcs

Pharmacotherapeutic group: magnesium drug.

TAC code: A12CC

Pharmacological properties

Pharmacodynamics

Magnesium is a vital element that is necessary for normal cell function, it participates in most metabolic reactions. In particular it participates in the regulation of nerve impulse transmission and muscle contraction. 50% of the amount of magnesium contained in the body is accumulated in bone tissue.

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

Serum magnesium concentrations:

• in the range 12 and17 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.

The body gets magnesium with food. Magnesium deficiency in the body can occur when there is a deficiency in intake or when the need for magnesium increases.

Pharmacokinetics

The gastrointestinal absorption of magnesium salts occurs in part by a passive mechanism in which salt solubility plays a determining role. The degree of this absorption does not exceed 50%. Excretion occurs mainly by the kidneys.

Indications

Neurosis, Weakness and fatigue, Tachycardia, Myalgia (muscle pain), Magnesium deficiency, Seizures, InsomniaAn established magnesium deficiency, isolated or associated with other deficiency conditions, accompanied by symptoms such as increased irritability, minor sleep disturbances, gastrointestinal cramps, palpitations, increased fatigue, muscle aches and spasms, tingling sensation in muscles. If after one month of treatment there is no reduction of these symptoms, continuation of treatment is not advisable.

Composition

Active ingredients:

Magnesium citrate – 618.43 * mg,

pyridoxine hydrochloride – 10.00 mg.

Auxiliary substances: ludipress^® [lactose monohydrate – 92.20 mg – 96.05 mg, collidone^® 30 – 3.04 mg – 4.05 mg, collidone^® CL – 3.04 mg – 4.05 mg] – 101.21 mg, macrogol -6000 (polyethylene glycol – 6000) – 69.36 mg, magnesium stearate – 1.00 mg.

The coating

VIVACOAT^® PM-1P-000 [hypromellose 6 cPs (hydroxypropyl methylcellulose 6 cPs) – 10.00 mg, titanium dioxide – 6.00 mg, hyprolose (hydroxypropyl cellulose) – 1.00 mg, talc – 2.00 mg, macrogol – 3350 (polyethylene glycol – 3350) – 1.00 mg] – 20.00 mg.

* – amount equivalent to 100 mg of magnesium (Mg ²⁺).

How to take, the dosage

The tablets should be taken whole with a glass of water.

Adults: 3-4 tablets a day, divided into 2-3 doses, with meals.

Children over 12 years of age: 2-4 tablets per day, divided into 2-3 doses, with meals.

The drug usually lasts for one month.

Interaction

Before prescribing other medicinal products, a physician should be informed or consulted about the possibility of taking Magnelis^{® B} Forte, film-coated tablets.

Contraindicated combinations

With levodopa: Levodopa activity is inhibited by pyridoxine (unless this drug is combined with intake of peripheral aromatic L-amino acid decarboxylase inhibitors). Any amount of pyridoxine should be avoided unless levodopa is taken in combination with peripheral aromatic L-amino acid decarboxylase inhibitors.

Unrecommended combinations

Simultaneous use of drugs containing phosphates or calcium salts may impair intestinal absorption of magnesium.

Combinations to consider

If oral tetracyclines are administered, an interval of at least three hours between oral tetracyclines and Magnelis

sup>® B₆ forte, film-coated tablets” because magnesium preparations reduce absorption of tetracyclines.

Special Instructions

The drug “Magnelis^® B₆ forte, film-coated tablets” is intended for adults and children over 12 years old only.

The drug contains lactose monohydrate; therefore its use is not recommended in patients with hereditary galactosemia, glucose and galactose malabsorption syndrome or lactase deficiency.

In patients with moderate renal impairment, the drug should be used with caution because of the risk of hypermagnesemia.

If calcium and magnesium are simultaneously deficient, magnesium deficiencies should be corrected before starting calcium preparations or calcium supplements.

When using pyridoxine in high doses (more than 200 mg daily) for a long time (for several months or in some cases years) sensory axonal neuropathy may develop with symptoms such as numbness and violation of proprioceptive sensitivity, tremor of distal limbs and gradually developing sensory ataxia (movement coordination disorders). These impairments are usually reversible and go away after withdrawal of high doses of vitamin B₆.

Impact on the ability to drive and operate vehicles

There is no effect. There are no special recommendations.

Contraindications

• Hypersensitivity to any of the ingredients of the drug;

• severe renal failure (creatinine clearance less than 30 ml/min);

• age less than 12 years (efficacy and safety not established);

• hereditary galactosemia, glucose and galactose malabsorption syndrome, or lactase deficiency (due to the presence of lactose monohydrate in the drug);

• concurrent use of levodopa (see “Interactions with other medicinal products”).

With caution

Moderate renal impairment (risk of hypermagnesemia).

Overdose

Symptoms

In normal renal function, magnesium overdose when ingested does not usually cause toxic reactions. However, in cases of renal insufficiency, magnesium poisoning may develop.

The symptoms of overdose, the severity of which depends on the concentration of magnesium in the blood:

Lower blood pressure, nausea, vomiting; depression of the central nervous system, reduced reflexes; changes in the electrocardiogram; respiratory depression, coma, cardiac arrest and respiratory paralysis, anuric syndrome.

Treatment

Rehydration, forced diuresis. Hemodialysis or peritoneal dialysis is necessary in renal failure.

Pregnancy use

Pregnancy

Clinical experience with the combination of magnesium citrate and pyridoxine hydrochloride in a sufficient number of pregnant women has not revealed any adverse effect on the occurrence of fetal malformations or fetotoxic effects.

The drug Magnelis^® B₆ forte, film-coated tablets may be used during pregnancy only if necessary, upon physician’s recommendation.

Breast-feeding period

Taking into account that magnesium passes into the mother’s milk, it is recommended to stop breast-feeding if the drug has to be taken.