Composition, form of production and packaging
? The tablets covered with a film shell of white color, oval, biconcave; On the fracture are visible two layers: a shell of white color and a white mass tablet.
1 tab.
magnesium citrate 618.43 mg,
which corresponds to the magnesium content (Mg 2+ ) of 100 mg
pyridoxine hydrochloride 10 mg
Excipients: lactose - 50.57 mg, macrogol 6000 - 120 mg, magnesium stearate - 1 mg.
The composition of the membrane: hypromellose 6 mPa.s - 14.08 mg, macrogol 6000 - 1.17 mg, titanium dioxide (E171) - 4.75 mg, talc - traces.
15 pcs. - blisters (2) - packs of cardboard.
15 pcs. - blisters (4) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
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. The lack of magnesium in the body can be observed with a violation of diet (diet) or with increasing demand for magnesium.
Pyridoxine (vitamin B 6 ) is involved in many metabolic processes, improves absorption of magnesium from the digestive tract and its penetration into cells.
The magnesium content in the serum between 12 and 17 mg / L (1-1.4 mEq / L or 0.5-0.7 mmol / L) indicates a moderate magnesium deficiency; below 12 mg / L (1 mEq / L or 0.5 mmol / L) indicates 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%.
It is excreted mainly by the kidneys.
INDICATIONS
- established magnesium deficiency, 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, tingling sensations in the muscles. If after a month of treatment there is no decrease in symptoms of magnesium deficiency, continued treatment is not advisable.
DOSING MODE
Tablets should be taken whole, washed down with a glass of water.
Adults: appoint 3-4 tablets / day, divided into 2-3 receptions, during meals.
Children over the age of 6 years (with a body weight of about 20 kg): prescribed in a dose 10-30 mg / kg / day (0.4-1.2 mmol / kg / day), i.e. 2-4 tablets / day, divided into 2-3 meals, with meals.
The duration of treatment is usually 1 month.
SIDE EFFECT
From the immune system: very rarely (<0.01%) - allergic reactions, including skin reactions.
From the gastrointestinal tract: the frequency is unknown (according to available data to estimate the incidence of it is not possible) - diarrhea, abdominal pain, nausea, vomiting, flatulence.
CONTRAINDICATIONS
- hypersensitivity to any of the components of the drug;
- severe renal failure (CK <30 ml / min);
- phenylketonuria;
- age up 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.
With caution: moderate renal insufficiency (danger of hypermagnesemia development).
PREGNANCY AND LACTATION
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.
Magne B6 В® forte can be used during pregnancy only if necessary, on the recommendation of a doctor.
Taking into account that magnesium penetrates into breast milk, if it is necessary to take the drug during lactation it is recommended to stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in severe renal failure (creatinine clearance less than 30 ml / min). With caution appoint a drug for renal failure of moderate degree (the risk of hypermagnesemia).
APPLICATION FOR CHILDREN
Use in children under 6 years of age: efficacy and safety not established.
SPECIAL INSTRUCTIONS
Tablets are intended only for adults and children over 6 years of age.
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 / 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 distal calves limbs and gradually developing sensory ataxia (impaired coordination of movements). These disorders are usually reversible and pass after stopping the intake of vitamin B 6 .
Impact on the ability to drive vehicles and manage mechanisms
Does not affect. There are no specific recommendations.
OVERDOSE
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. 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. With renal failure, hemodialysis or peritoneal dialysis is necessary.
DRUG 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 is not taken in conjunction with inhibitors of the peripheral decarboxylase of 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 appointing tetracyclines inside, it is necessary to observe an interval of at least 3 hours between ingestion of tetracycline and Magne B6 В® forte, Magnesium preparations reduce the absorption of tetracyclines.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 30 В° C. Shelf life - 2 years.
