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Dosage form: & nbspfilm-coated tablets
Composition:

1 tablet contains:

active substances: magnesium lactate dihydrate 0, 47 g (470 mg), pyridoxine hydrochloride -0.005 g (5 mg).

Excipients: lactose (milk sugar), microcrystalline cellulose, pregelatinized starch, copovidone (Kollidon BA-64), magnesium stearate.

sheath: Opadrai II (series 85): partially hydrolysed polyvinyl alcohol, macrogol-3350, titanium dioxide E 171, talc.

Description:Tablets covered with a film coat of white color, capsular. At the break, white.
Pharmacotherapeutic group:Magnesium preparation
Pharmacodynamics:

Combined drug that replenishes magnesium deficiency.

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 many metabolic reactions. Magnesium ions reduce the excitability of neurons, play an important physiological role in maintaining the ion balance in muscles (slow down the neuromuscular transmission), participate in many enzymatic reactions.

The lack of magnesium in the body can be observed with a violation of diet (diet) or with increasing demand for magnesium (with increased physical and mental stress, stress, pregnancy, the use of diuretics).

Pyridoxine (vitamin B6) is a coenzyme of the metabolism of amino acids and proteins, is involved in the regulation of the metabolism of the nervous system. Phosphorylated and in the form of pyridoxal phosphate is part of the enzymes that catalyze decarboxylation and reamination. It plays an important role in the metabolism of tryptophan, glutamic acid, cysteine, methionine, and also in the transport of amino acids through the cell membrane. It is necessary for the activation of phosphorylase, for the formation of neurotransmitters, gamma-aminobutyric acid, glycine, serotonin. Participates in the exchange of vitamin B12, folic acid, in the synthesis of porphyrins, in the exchange of unsaturated fatty acids. Improves the absorption of magnesium from the gastrointestinal tract and its penetration into the cells. Magnesium content in serum:

- 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 of magnesium in the gastrointestinal tract is no more than 50% of the ingested dose. In the body, magnesium is distributed mainly in the intracellular space (about 99%), of which about 2/3 is distributed in the bone tissue, and a third is in the smooth and striated muscle tissue. It is excreted mainly by the kidneys.Magnesium present in the urine, on average, is 1/3 of the dose taken.

Pyridoxine is easily absorbed by simple diffusion throughout the small intestine, more is absorbed in the jejunum. Well penetrates into all tissues. The greatest concentrations of vitamin are found in the liver and myocardium. Lower concentrations are found in the muscles and CNS. Metabolized in the liver with the formation of pharmacologically active metabolites (pyridoxalphosphate and pyridoxamino phosphate). Pyridoxalphosphate with plasma proteins binds to 90%. Penetrates through the placenta, is secreted with breast milk. It is excreted by the kidneys. The half-life (T1 / 2) is 15-20 days.

Indications:An established deficiency of magnesium, isolated or associated with other deficient conditions, accompanied by symptoms such as: increased irritability, minor sleep disorders; gastrointestinal spasms or heart palpitations, increased fatigue, pain and muscle spasms, tingling sensations.
Contraindications:Hypersensitivity to the components of the drug, severe renal failure (creatinine clearance less than 30 ml / min), phenylketonuria,children under 6 years of age, lactase deficiency, lactose intolerance, glucose-galactose malabsorption, hypermagnesia.
Carefully:With moderate failure of kidney function (risk of hypermagnesemia).
Pregnancy and lactation:

Pregnancy Period

Magnesium plus B6 can be used during pregnancy only as prescribed by the doctor.

Lactation period

It is not recommended to take the drug during breastfeeding (magnesium and pyridoxine derivatives penetrate into breast milk).

Dosing and Administration:

Before taking the drug, you should consult your doctor.

Adults are recommended to take 6-8 tablets per day; children over 6 years (body weight over 20 kg) - 4-6 tablets per day.

The daily dose should be divided into 2-3 doses, taken with food, washed down with a glass of water.

On average, the duration of treatment is 1 month.

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

Side effects:

Allergic reactions. Disorders from the gastrointestinal tract: abdominal pain, constipation, nausea, vomiting, flatulence.

Perhaps the development of hypermagnes.Early signs and symptoms of hypermagnesemia: bradycardia, diplopia, sudden "tide" of blood to the skin of the face, headache, lowering blood pressure, nausea, dyspnea, blurred speech, vomiting, weakness, with kidney failure - dizziness.

Overdose:

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

Symptoms of overdose: lowering blood pressure, nausea, vomiting, slowing reflexes, changes in the electrocardiogram, respiratory depression, coma, cardiac arrest and paralysis of the heart, anuria.

Treatment: rehydration, forced diuresis. As an antidote for an overdose of magnesium (hypermagnesium) use calcium preparations (as a magnesium antagonist) - calcium chloride or calcium gluconate. With renal failure, hemodialysis or peritoneal dialysis is necessary.

Interaction:

Magnesium plus B6 is preferably not administered simultaneously with preparations of phosphates or sodium compounds, since magnesium absorption in the gastrointestinal tract can be significantly reduced.

Magnesium preparations reduce the absorption of tetracycline, with simultaneous admission it is recommended to make an interval of 3 hours before using Magnesium plus B6.

Magnesium weakens the effect of oral anticoagulants (including coumarin and indanedione derivatives), reduces the absorption of iron.

Vitamin B6 reduces the pharmacological effects of levodopa.

Special instructions:

With concomitant calcium deficiency, magnesium deficiency should be eliminated before the introduction of additional calcium intake.

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

Form release / dosage:Tablets, film-coated, 470 mg + 5 mg.
Packaging:

10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil.

For 5 contour packagings together with the instruction for use are put in a cardboard pack.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date.
Terms of leave from pharmacies:Without recipe
Registration number:LSR-001300/10
Date of registration:24.02.2010
Expiration Date:Unlimited
The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia
Manufacturer: & nbsp
Information update date: & nbsp22.03.2018
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