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Dosage form: & nbspfilm-coated tablets
Composition:

1 tablet contains:

Core tablet: active ingredients:

Magnesium citrate - 618.43 mg, which corresponds to 100 mg of magnesium (Mg++), pyridoxine hydrochloride-10 mg;

auxiliary substances: lactosis

50.57 mg, macrogol-6000 - 120.00 mg, magnesium stearate - 1.00 mg.

Tablet casing:

hypromellose 6 mPa.s - 14.08 mg, macrogol-6000 - 1.17 mg, titanium dioxide (E 171) - 4.75 mg, talc - traces.

Description:Oval biconvex tablets, covered with a film coating of white color. On the fracture, two layers are visible: a white shell and a white mass tablet.
Pharmacotherapeutic group:Magnesium preparation
ATX: & nbsp
  • Vitamins in combination with mineral substances
  • Pharmacodynamics:

    Magnesium is a vital element that 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. 1/3 of the amount of magnesium contained in the body, accumulates in bone tissue. The body gets magnesium along with the food. A deficiency of magnesium in the body can be observed when eating disorders (diet), with increasing demand for magnesium or with an imbalance in intake, metabolism and excretion of magnesium (for example, with increased physical and mental stress, stress, during pregnancy, with diuretics).

    Pyridoxine (vitamin B6) is involved in many metabolic processes, helps improve the absorption of magnesium from the gastrointestinal tract and its penetration into cells.

    Magnesium levels in serum:

    - between 12 and 17 mg / l (1 - 1.4 mEq / L or 0.5 - 0.7 mmol / L): indicate a moderate deficiency of magnesium;

    - below 12 mg / L (1 mEq / L or 0.5 mmol / L): indicate a severe magnesium deficiency.

    Pharmacokinetics:
    Gastrointestinal absorption of magnesium salts occurs in part by a passive mechanism in which salt solubility plays a decisive role. The degree of this absorption does not exceed 50%. Excretion occurs mainly by the kidneys.
    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, palpitations, fatigue, pain and muscle spasms, a tingling sensation in the muscles.

    If after a month of treatment there is no decrease in these symptoms, continued treatment is not advisable.

    Contraindications:

    - Hypersensitivity to any of the components of the drug.

    - Heavy renal insufficiency (clearance creatinine less than 30 ml / min).

    - Phenylketonuria.

    - Age to 6 years (efficiency and safety not established).

    - Hereditary galactosemia, glucose malabsorption syndrome and galactose, or lactase deficiency (due to the presence of lactose in the formulation).

    - Simultaneous reception of levodopa (see "Interactions with other medicinal agents").

    Carefully:
    Moderate renal failure (risk of hypermagnesemia).
    Pregnancy and lactation:

    Pregnancy

    The clinical experience of using the drug in a sufficient number of pregnant women has not revealed any adverse effect on the onset of fetal developmental or fetotoxic effects.

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

    Breastfeeding period

    Taking into account that magnesium penetrates into the mother's milk, it is recommended to stop breastfeeding if necessary.

    Dosing and Administration:

    Tablets should be taken whole, washed down with a glass of water.

    Adults: 3-4 tablets per day, divided into 2-3 receptions, during meals.

    Children over the age of 6 (weighing about 20 kg):

    10-30 mg / kg / day (0.4-1.2 mmol / kg / day), that is, children older than 6 years (weighing about 20 kg) 2-4 tablets per day, divided into 2-3 doses, in food Time.

    Usually the duration of treatment is one month.

    Side effects:

    Immune system disorders:

    Rarely (<0.01%): allergic reactions, including skin reactions;

    Disorders from the gastrointestinal tract:

    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 when ingested 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; depression 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 reception of inhibitors of peripheral decarboxylase of aromatic L-amino acids). Any amount of pyridoxine should be avoided if levodopa It is not accepted in combination with inhibitors of peripheral decarboxylase of aromatic L-amino acids.

    Unrecommended combinations

    - Simultaneous use of drugs containing phosphates or calcium salts may 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® forte, since magnesium preparations reduce the absorption of tetracyclines.

    Special instructions:

    Tablets are intended only for adults and children over 6 years of age.

    With moderate renal failure should take the drug with caution because of the toffee, the development of hypermagnes.

    With a simultaneous deficiency of calcium and magnesium, magnesium deficiency should: replenish before starting calcium supplements or dietary supplements containing calcium.

    When using pyridoxine at 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 and disturbances of proprioceptive sensitivity, tremor of the distal sections limbs and gradually developing sensory ataxia (impaired coordination of movements). These disorders are usually reversible and pass after stopping the intake of vitamin B6.

    Effect on the ability to drive transp. cf. and fur:Does not affect. There are no specific recommendations.
    Form release / dosage:Film-coated tablets.
    Packaging:

    For 15 tablets in a blister of PVC-PE-PVDC / foil aluminum.

    For 4 blisters together with instructions for use in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use the product after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-007053/09
    Date of registration:07.09.2009 / 04.10.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Sanofi-Aventis FranceSanofi-Aventis France France
    Manufacturer: & nbsp
    Information update date: & nbsp22.03.2018
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