Keep out of the reach of children.
Read all of this leaflet carefully before you start taking this medicine.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Active ingredients:
Magnesium lactate dihydrate ................ 470 mg
(Equivalent to magnesium 48 mg)
Vitamin B6 ........................................... 5 mg
Excipients q.s ……………………………… 1 tablet
Film coated tablet.
Product description: An oval, white to off-white, film coated tablet, plain on both sides, intact edges.
Box of 10 blisters x 10 fim coated tablets.
Physiologically, magnesium is a predominantly intracellular cation. It reduces neuronal excitability and neuromuscular transmission, and is involved in many enzymatic reactions.
Approximately 50% of magnesium in the body is found in bones.
Clinically, serum magnesium concentrations: between 12 and 17 mg/L (1 to 1.4 mEq/L or 0.5 to 0.7 mmol/L) indicates a moderate magnesium deficiency. Less than 12 mg/L (1 mEq/L or 0.5 mmol/L) indicates a severe magnesium deficiency.
Magnesium deficiency can be primitive by congenital abnormalities (congenital hypomagnesemia) or secondary by inadequate intake (severe malnutrition, alcoholism, exclusive parenteral nutrition), digestive malabsorption (chronic diarrhea, digestive fistulas, hypoparathyroids), exaggerated renal losses (tubulopathy, diuretic abuse, chronic nephritis, primary hyperaldosteronism, cisplatin therapy).
After oral administration, approximately 1/3 of magnesium is absorbed in the small intestine, even soluble magnesium salts are slowly absorbed from the gastrointestinal tract. Approximately 25 - 30% of magnesium bound to plasma protein (albumin). Magnesium is eliminated mainly by the kidneys, the rate changes among individuals but is directly proportional to serum concentrations and glomerular filtration. The unabsorbed part is excreted in feces.
Vitamin B6 is readily absorbed from the gastrointestinal tract. It may be reduced in individuals with malabsorption syndrome or undergoing gastrectomy. After oral administration, vitamin B6 is mostly reserved in the liver, a smaller mount is in muscle and brain. Vitamin B6 is metabolized in the liver and red blood cells. Biological half-life is about 15 - 20 days. Vitamin B6 is excreted in urine as acid 4 - pyridoxic.
The drug does not affect the ability to drive and operate machinery.
The use of magnesium can be considered during pregnancy if needed.
Magnesium or vitamin B6 taken individually is compatible with breastfeeding. It is recommended that the dose of 20 mg/day of vitamin B6 in breastfeeding women should not be exceeded.
Avoid concomitant administration of magnesium with preparations containing phosphate or calcium salts (since they inhibit the absorption of magnesium in the small intestine).
When tetracycline is co-prescribed, the interval between oral doses should be at least 3 hours. Due to containing pyridoxine, concurrent administration of Magnesi-B6 and levodopa should not be recommended.
Diarrhea, abdominal pain, skin reactions, allergic reactions.
Inform your physician about any undesirable effects occur during the treatment.
Signs and symptoms:
Overdosage of magnesium by the oral route does not generally lead to toxic reactions in normal kidney function. Magnesium poisoning, however, can develop in patients with renal insufficiency.
The toxic effects depend on the blood level of magnesium and the signs are as follows: decreased blood pressure, nausea, vomiting, central nervous system depression, decreased reflexes, ECG abnormalities, onset of respiratory depression, coma, cardiac arrest and respiratory paralysis, anuric syndrome.
Treatment: rehydration, forced diuresis. In patients with renal insufficiency, hemodialysis or peritoneal dialysis is necessary.
Store in dry places, not exceeding 30°C, protect from light.
In case of severe deficiency and malabsorption, treatment should be started by the venous route.
In the case of associated calcium deficiency, it is recommended that the magnesium repletion should be carried out before calcium therapy.
Sensory neuropathy can occur when using high doses of vitamin B6 (> 200 mg/day) over a long period of time (several months or years). This is generally reversible when treatment is discontinued.
This medicine contains lactose. It is not recommended in patients with lactase deficiency, galactose intolerance, or glucose/galactose malabsorption. It is needed to consult your physician before use.
Treatment of magnesium deficiency, isolated or associated.
Hypersensitivity to any components of the drug.
Severe renal impairment with creatinine clearance less than 30 ml/min.
The tablets should be swallowed with a large glass of water.
FOR ADULTS AND CHILDREN AGED MORE THAN 6 YEARS
Adults: 6 to 8 tablets per day to be divided into 2 or 3 doses taken during meals.
Children: 10 to 30 mg/kg/day (0.4 to 1.2 mmol/kg/day) or children aged more than 6 years (weighing 20 kg and more) 4 to 6 tablets per day to be divided into 2 or 3 doses taken during meals.
Treatment will be discontinued upon normalization of magnesemia.
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