Magnelis B6 forte - instructions for use, dose, side effects, contraindications

Active substanceMagnesium citrate + PyridoxineMagnesium citrate + Pyridoxine

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Magwith

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MINSKINTERKAPS, UP Republic of Belarus

Magnelis® B6 forte

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OTISIFARM, OJSC Russia

Dosage form: & nbspfilm coated tablets

Composition:

For one tablet.

Active substances:

Magnesium citrate - 618.43 * mg, pyridoxine hydrochloride - 10,00 mg.

Excipients: ludistress ® [lactose monohydrate - 92.20 mg - 96.05 mg, povidone K-30 (kollidone 30) - 3.04 mg - 4.05 mg, crospovidone (collidone CL) - 3.04 mg - 4.05 mg] - 101.21 mg, macrogol - 6000 (polyethylene glycol - 6000) - 69.36 mg, magnesium stearate - 1.00 mg.

Shell

VIVACOAT® RM-IP-000 [hypromellose 6 cps (hydroxypropylmethylcellulose 6 cps) - 10.00 mg, titanium dioxide - 6.00 mg, giprolose (hydroxypropyl cellulose) - 1.00 mg, talc - 2.00 mg, macrogol - 3350 (polyethylene glycol-3350) - 1.00 mg] - 20.00 mg.

* - an amount equivalent to 100 mg of magnesium (Mg²⁺)

Description:The tablets covered with a film membrane of white color, oblong, biconcave. On the cut is white or almost white.

Pharmacotherapeutic group:Magnesium preparation

ATX: & nbsp

A.11.J.B 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. AT In particular, it is involved in the regulation of the transmission of nerve impulses and in contraction of muscles. 50% of the amount of magnesium contained in the body accumulates in bone tissue. Pyridoxine (vitamin B6) is involved in many metabolic processes, helps improve the absorption of magnesium from the gastrointestinal tract and its penetration into cells.

Concentration of magnesium in serum:

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

- below 12 mg / L (1 mEq / L or 0.5 mmol / L): indicates a severe magnesium deficiency. The body gets magnesium along with the food. The lack of magnesium in the body can be observed with a deficiency in the intake or with an increase in the demand for magnesium.

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 appropriate.

Contraindications:

- Hypersensitivity to any of the components of the drug;

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

- age up to 12 years (efficiency and safety not established);

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

- simultaneous reception of levodopa (see "Interactions with other drugs").

Carefully:

Moderate renal failure (risk of hypermagnesemia).

Pregnancy and lactation:

Pregnancy

The clinical experience of using a combination of magnesium citrate and pyridoxine hydrochloride in a sufficient number of pregnant women has not revealed any adverse effect on the onset of fetal developmental or fetotoxic effects. "Magnelis ® B₆ forte, film-coated tablets "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 12: 2-4 tablets per day, divided into 2-3 receptions, during meals.

Usually the duration of treatment is one month.

Side effects:

The incidence of adverse reactions is classified according to the recommendations of the World Health Organization: very often (≥ 10%), often (≥ 1% and <10%), infrequently (≥ 0.1% and <1%), rarely (≥ 0.01% and <0.1%), very rarely (<0.01%), an unknown frequency (when it is not possible to estimate the incidence of adverse reactions).

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 when ingested usually does not lead to the occurrence of toxic reactions. However, in the case of kidney deficiency may develop magnesium poisoning.

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:

Before prescribing other medicines, you should consult your doctor about the possibility of their simultaneous administration with the drug Magnelis® AT₆ forte, film-coated tablets. "

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 aromatic L-amino acids). Avoid taking any amount of pyridoxine, 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 Magnelis® AT₆, forte, film-coated tablets ", since magnesium preparations reduce the absorption of tetracyclines.

Special instructions:

The preparation "Magnelis® AT₆, forte, film-coated tablets "is intended only for adults and children over 12 years of age.

The drug contains lactose monohydrate, therefore its use is not recommended for patients with hereditary galactosemia, glucose malabsorption syndrome and galactose, or lactase deficiency.

With moderate renal failure, the drug should be taken with caution because of the risk of hypermagnesemia.

With a simultaneous deficiency of calcium and magnesium, magnesium deficiency should be replenished before taking 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 disturbance 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 the vitamin AT₆.

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

Does not affect. There are no specific recommendations.

Form release / dosage:

Tablets, film-coated, 100 mg + 10 mg.

Packaging:

When manufacturing at OJSC "Pharmstandard-Tomskkhimpharm", Russia:

For 10 tablets in a contour mesh package made of a PVC film or imported PVC / PVDC, or PVC / Polyethylene / PVDC and aluminum foil printed lacquer.

By 3, 6, 9 contour cell packs of 10 tablets together with the instruction for use are placed in a pack of cardboard.

at the production of LLC "Nanolek", Russia:

For 10 tablets in a contour mesh box of imported PVC / PVDC film or PVC / Polyethylene / PVDC and aluminum foil printed lacquer.By 3, 6, 9 contour cell packs of 10 tablets together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

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 expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003224

Date of registration:29.09.2015 / 06.12.2017

Expiration Date:29.09.2020

The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-TOMSKHIMFARM, OJSC Russia

NANOLEC, LTD. Russia

Information update date: & nbsp22.03.2018

Illustrated instructions

Instructions

Magnelis® B6 forte (Magnelis® B6 forte)