MAGRO-B6 [Magnesium lactate dihydrate + Pyridoxine hydrochloride] 470 mg + 5 mg Tablets

instructions for the medical use of the medicinal product

MAGRO-В6

Tradename: Magro-B6, Магро-В6

International non-proprietary name or generic name: магний + витамин В6, magnesium + vitamin B6

Composition per 1 tablet:

active substance: magnesium lactate dihydrate 470 mg (equivalent to magnesium content 48 mg), pyridoxine hydrochloride 5 mg.

excipients: lactose monohydrate, povidone K30, talc, magnesium stearate, colloidal anhydrous silica, sodium starch glycolic acid ester, microcrystalline cellulose, corn starch, hydroxypropyl methylcellulose, purified talc, titanium dioxide, polyethylene glycol, ethanol 96%, purified water.

Dosage form: film-coated tablet, whitish in color, oval in shape with a solid edge.

Pharmacotherapeutic group: Magnesium preparation.

ATX code: A11JB

Pharmacological properties

Pharmacodynamics

Magnesium is a vital element that is found in all tissues of the body and is necessary for the normal functioning of cells and is involved in most metabolic reactions. In particular, it is involved in the regulation of the transmission of nerve impulses and muscle contraction.

The body receives magnesium through food. A lack of magnesium in the body can occur when the diet is disrupted, when the need for magnesium increases, or when there is an imbalance in the intake, metabolism and excretion of magnesium (for example, with increased physical and mental stress, stress, during pregnancy, when using diuretics).

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

Pharmacokinetics

Absorption of magnesium from the gastrointestinal tract is no more than 50% of the dose taken orally. In the body, magnesium is distributed mainly in the intracellular space - about 99%, of which approximately 2/3 is distributed in bone tissue, 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 for use

Established magnesium deficiency, isolated or associated with other deficiency conditions, accompanied by symptoms such as:

• increased irritability;

• minor sleep disturbances;

• gastrointestinal spasms;

• cardiopalmus;

• increased fatigue;

• pain and muscle spasms, tingling sensation in the muscles.

Contraindications

• hypersensitivity to the active substances and any other components of the drug;

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

• children under 6 years of age;

• simultaneous administration of levodopa.

Method of administration and dosage

Taken orally. Swallow the tablets whole, without chewing, with plenty of water.

Adults are recommended to take 6-8 tablets/day. The daily dose should be divided into 2-3 doses.

Children over 6 years old (body weight more than 20 kg) - 4-6 tablets/day. The daily dose should be divided into 2-3 doses.

Treatment should be stopped immediately after normalization of magnesium concentration in the blood.

Use during pregnancy and breastfeeding

It is possible to use the drug during pregnancy only if necessary and on the recommendation of a doctor.

If it is necessary to use it during lactation, the issue of stopping breastfeeding should be decided.

Side effect

Adverse reactions that may occur with the use of the drug Magro-B6 are mentioned below by organ system classes:

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Special instructions and precautions

Before using the drug, consult your doctor.

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

If there is a concomitant calcium deficiency, it is recommended to correct the magnesium deficiency before taking calcium supplements 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.

With caution: moderate renal failure (risk of developing hypermagnesemia).

Interaction with other medicinal products

With the simultaneous use of Magro-B6 and levodopa at a dose of 5 mg or more, the effects of levodopa are reduced. Therefore, in patients taking levodopa, the drug should be prescribed concomitantly with peripheral dopa decarboxylase inhibitors.

The simultaneous use of drugs containing phosphates, calcium salts or iron ions is not recommended, since such drugs reduce the absorption of magnesium in the intestine.

The drug Magro-B6 should be prescribed at least not earlier than 3 hours after taking tetracycline orally (since magnesium drugs reduce the absorption of tetracyclines).

Quinolones should be prescribed at least 2 hours before or 6 hours after taking Magro-B6 in order to avoid impaired absorption of quinolones.

Overdose

Symptoms: decreased blood pressure, nausea, vomiting, central nervous system depression, decreased reflexes, ECG changes, respiratory depression, coma, cardiac arrest and respiratory paralysis, anuric syndrome.

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

Release form

5 blisters of 10 film-coated tablets along with instructions for use in a box.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 30°C.

Keep out of the reach of children!

Shelf life

36 months.

Vacation conditions

Without a prescription.