Magne B6 tablets p / o, No. 100

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

Before taking the drug, the patient should consult a doctor.

Adults are recommended to take 6-8 tablets / day.

Children over 6 years old (body weight over 20 kg) - 4-6 tablets / day.

The daily dose should be divided into 2-3 doses, taken with meals.

The tablets should be taken with a glass of water.

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

Tablet core:

Active ingredients:
magnesium lactate dihydrate * - 470 mg;
pyridoxine hydrochloride - 5 mg;

Excipients: sucrose - 115.6 mg, heavy kaolin - 40.0 mg, acacia gum - 20.0 mg, carboxypolymethylene 934 - 10.0 mg, talc (magnesium hydrosilicate) - 42.7 mg, magnesium stearate - 6, 7 mg.

Tablet shell: acacia gum - 3.615 mg, sucrose - 214.969 mg, titanium dioxide - 1.416 mg, talc (magnesium hydrosilicate) - traces, carnauba wax (powder) - traces.
* - equivalent to the content of magnesium (Mg ++) 48 mg

• Hypersensitivity to the components of the drug;

• severe renal failure (CC <30 ml / min);

• children under 6 years of age;

• fructose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency;

• simultaneous administration of levodopa.

With caution: with a moderate degree of renal failure, because there is a risk of developing hypermagnesemia.

pharmachologic effect

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

The body gets magnesium from food. A lack of magnesium in the body can be observed in violation of the diet (diet), with an increase in the need for magnesium, or with an imbalance in the intake, metabolism and excretion of magnesium (for example, with increased physical and mental stress, stress, during pregnancy, with the use of diuretics).

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

Serum magnesium content:

• from 12 to 17 mg / l (0.5-0.7 mmol / l) - moderate magnesium deficiency;

• below 12 mg / l (0.5 mmol / l) - severe magnesium deficiency.

Pharmacokinetics

Absorption and distribution

Absorption of magnesium from the gastrointestinal tract is no more than 50% of the oral dose. In the body, magnesium is distributed mainly in the intracellular space - about 99%, of which about 2/3 is distributed in bone tissue, 1/3 is in smooth and striated muscle tissue.

Withdrawal

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

Indications

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

Dosage regimen

Before taking the drug, the patient should consult a doctor.

Adults are recommended to take 6-8 tablets / day.

Children over 6 years old (body weight over 20 kg) - 4-6 tablets / day.

The daily dose should be divided into 2-3 doses, taken with meals.

The tablets should be taken with a glass of water.

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

Side effect

According to the WHO, undesirable effects are classified according to their frequency of development as follows: very often (1/10), often (1/100, <1/10), infrequently (1/1000, <1/100), rarely (1 / 10,000, <1/1000), very rare (<1/10,000), frequency unknown (frequency of occurrence of events cannot be determined from available data).

From the immune system: very rarely - allergic reactions, including skin reactions (urticaria, itching).

From the digestive system: the frequency is unknown - diarrhea, abdominal pain.

Contraindications for use

• hypersensitivity to drug components;

• severe renal failure (CC <30 ml / min);

• children under 6 years of age;

• fructose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency;

• simultaneous administration of levodopa.

With caution: with a moderate degree of renal failure, because there is a risk of developing hypermagnesemia.

Application during pregnancy and lactation

Pregnancy

Clinical experience of using the drug in a sufficient number of pregnant women did not reveal any adverse effect on the occurrence of fetal malformations or fetotoxic effects.

Magne B6Ѓ can be used during pregnancy only if necessary and on the recommendation of a doctor.

Breastfeeding period

Magnesium passes into breast milk. Avoid using the drug during breastfeeding.

Application for impaired renal function

The drug is prescribed with caution in case of moderate renal insufficiency. there is a risk of developing hypermagnesemia.

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

Application in children

Contraindication: children under 6 years of age.

special instructions

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

If there is concomitant calcium deficiency, it is recommended that the magnesium deficiency be corrected before taking calcium supplements or calcium supplements.

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

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

Information for patients with diabetes mellitus: coated tablets contain sucrose as an excipient.

Use in pediatrics

The drug in the form of tablets is intended only for adults and children over 6 years of age. For young children (over 1 year old), it is recommended to use the drug in the form of an oral solution.

Influence on the ability to drive vehicles and mechanisms

Does not affect. There are no specific recommendations.

Overdose

With normal kidney function, an overdose of magnesium when taken orally usually does not lead to toxic reactions. However, in the case of renal failure, magnesium poisoning may develop. The severity of symptoms depends on the concentration of magnesium in the blood.

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

Treatment: rehydration, forced diuresis. Renal failure requires hemodialysis or peritoneal dialysis.

Drug interactions

Contraindicated combinations

With levodopa: the activity of levodopa is inhibited by pyridoxine (if the administration of this drug is not combined with the administration of peripheral decarboxylase inhibitors of aromatic L-amino acids). Any amount of pyridoxine should be avoided unless levodopa is taken in combination with aromatic L-amino acid peripheral decarboxylase inhibitors.

Combinations not recommended

The simultaneous use of drugs containing phosphates or calcium salts can impair the absorption of magnesium in the intestine.

Combinations to be taken into account

When prescribing antibiotics of the tetracycline group inside, an interval of at least 3 hours must be observed between the ingestion of tetracycline and Magne B6Ѓ, because magnesium preparations reduce the absorption of tetracyclines.

Storage conditions of the drug Magne B6Ѓ

The drug should be stored out of the reach of children at a temperature not exceeding 30 ? C.