Magne B6 - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspcoated tablets, oral solution

Composition:

Film-coated tablets

Tablet core: active ingredients: magnesium lactate dihydrate * - 470 mg; pyridoxine hydrochloride - 5 mg;

Excipients: sucrose - 115.6 mg, kaolin heavy - 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 casing: Acacia gum - 3,615 mg, sucrose - 214.969 mg, titanium dioxide - 1.416 mg, talc (magnesium hydrosilicate) - traces, carnauba wax (powder) - traces.

* - equivalent to magnesium content (Mg⁺⁺) 48 mg

Solution for oral administration

Active substances:

magnesium lactate dihydrate ** - 186 mg;

magnesium pidolate ** - 936 mg;

pyridoxine hydrochloride 10 mg;

Excipients: sodium disulfite - 15 mg, sodium saccharinate - 15 mg, flavoring cherry-caramel - 0.3 ml, water purified to 10 ml.

** - equivalent to the total magnesium content (Mg⁺⁺) 100 mg

Description:

Film-coated tablets, oval biconvex tablets, covered with a white shell, with a smooth shiny surface.

Solution for oral administration, transparent liquid of brown color with the smell of caramel.

Pharmacotherapeutic group:Magnesium preparation

ATX: & nbsp

Vitamins in combination with mineral substances

Pharmacodynamics:

Magnesium is a vital element,which is found in all tissues of the body and is necessary for the normal functioning of cells, is involved 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 along with the food. 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 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 the cells.

Magnesium content in serum.

- from 12 to 17 mg / l (0.5 to 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. 99% of the magnesium in the body is inside the cells. Approximately 2/3 of intracellular magnesium is distributed in the bone tissue, and another 1/3 is in the smooth and striated muscle tissue. Magnesium is excreted mainly in the urine.With urine, at least 1/3 of the dose of magnesium taken is excreted.

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 insufficiency (creatinine clearance less than 30 ml / minute).

- Phenylketonuria.

- Children under 6 years (for the drug in the form of tablets) and up to 1 year (for the solution).

- Fructose intolerance, glucose-galactose malabsorption syndrome, isaromatase sugarase deficiency (only for the drug in the form of tablets because of the presence of sucrose in the composition).

- Simultaneous reception of levodopa (see section "Interaction with other medicinal products").

Carefully:

With a moderate degree of kidney failure, since there is a risk of hypermagnesemia.

Pregnancy and lactation:

Pregnancy

Clinical experience of using the drug in a sufficient number of pregnant women did not revealany adverse effect on the occurrence of malformations of the fetus or fetotoxic action.

The drug Magne B6 ® can be used during pregnancy only if necessary, on the recommendation of a doctor.

Breastfeeding period

Magnesium penetrates into breast milk. Avoid the use of the drug during lactation and lactation.

Dosing and Administration:

Before taking the drug, you should consult your doctor.

Film-coated tablets

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

Children older than 6 years (body weight over 20 kg) 4-6 tablets per day.

Solution for oral administration

Adults are recommended to take 3-4 ampoules per day.

Children older than 1 year (body weight more than 10 kg) daily dose is 10-30 mg magnesium / kg body weight (0.4-1.2 mmol magnesium / kg) or 1-4 ampoules.

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

Tablets should be washed down with a glass of water.

A solution of ampoules before taking is dissolved in a glass of water.

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

Attention

Self-tearing ampoules with Magne B6® do not require the use of a nail file.To open the ampoule, take it by the tip, having covered it with a piece of cloth, and break it off sharply first from one pointed end, and then from the other, first directing the open first end of the ampoule at an angle into a glass with water, so that the broken second The tip of the ampoule was not over the glass. After breaking off the second tip of the ampoule, its contents freely poured into the glass.

Side effects:

Immune system disorders

Very rarely (<0.01%): allergic reactions, including skin reactions.

Disorders from the gastrointestinal tract

An unknown frequency (according to available data to estimate the frequency of occurrence is not possible): diarrhea, abdominal pain, nausea, vomiting, flatulence.

Overdose:

Symptoms

With normal kidney function, an overdose of magnesium with its intake usually does not lead to the occurrence of toxic reactions. However, in the case of kidney failure, the development of magnesium poisoning is possible.

Symptoms of overdose, the severity of which depends on the concentration of magnesium in the blood: lowering blood pressure; nausea, vomiting; oppression of the central nervous system,decreased reflexes; changes on the electrocardiogram; respiratory depression, coma, cardiac arrest and respiratory paralysis; anuric syndrome.

Treatment

Rehydration, forced diuresis. With renal failure, hemodialysis or peritoneal dialysis is necessary.

Interaction:Contraindicated combinations

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

Unrecommended combinations

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

Combinations that should be taken into account

- When administering tetracyclines inside, it is necessary to observe an interval of at least three hours between ingestion of tetracycline and Magne B6®, since magnesium preparations reduce the absorption of tetracyclines.

Special instructions:

Information for patients with diabetes: coated tablets, contain sucrose as an auxiliary.

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

In case of concomitant calcium deficiency, it is recommended to eliminate the magnesium deficiency before taking calcium supplements or calcium supplements.

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.

Ampules contain sulfite, which can cause or intensify manifestations of allergic reactions, including anaphylactic reactions, especially in patients at risk.

When using pyridoxine in high doses (more than 200 mg per day) for a long time (for several months or in some cases - years), sensory axonal neuropathy can develop, which is accompanied by symptoms such as numbness, disturbances of proprioceptive sensitivity,tremor of the distal parts of the limbs and gradually developing sensory ataxia (impaired coordination of movements). These disorders are usually reversible and pass after stopping the intake of vitamin B6.

The drug in the form of tablets is intended only for adults and children over 6 years of age. For children of younger age (over 1 year), the drug is recommended in the form of a solution for oral administration.

Effect on the ability to drive transp. cf. and fur:

Does not affect. There are no specific recommendations.

Form release / dosage:The tablets covered with a cover.
Solution for oral administration.

Packaging:

Film-coated tablets

For 10 tablets in a blister of PVC / aluminum foil. For 5 blisters together with instructions for use are placed in a cardboard box.

Solution for oral administration

For 10 ml of the drug in dark glass ampoules (hydrolytic class III EF), sealed on both sides, with a fault line and applying two marking rings to each side. For 10 ampoules in a packing insert made of cardboard, together with instructions for use, are placed in a cardboard box.

Storage conditions:

Film-coated tablets: in a dry, dark place at a temperature of no higher than 25 ° C.

Solution for oral administration: in a dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

Film-coated tablets: 2 years.

Solution for oral administration: 3 years.

The drug should not be used after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N013203 / 01, П N013203 / 02

Date of registration:13.03.2007

The owner of the registration certificate:Sanofi Winthrop IndustrySanofi Winthrop Industry France

Manufacturer: & nbsp

SANOFI WINTHROP INDUSTRIE France

Cooperation pharmaceutique francaise France

Representation: & nbspSanofi Aventis GroupSanofi Aventis Group

Information update date: & nbsp08.06.2016

Illustrated instructions

Instructions

Magne B6® (Magne B6®)