Instructions for Magnicum enteric-coated tablets, blister pack No. 50
Composition
active ingredients: 1 tablet contains magnesium lactate dihydrate 470 mg, which is equivalent to magnesium 48 mg and pyridoxine hydrochloride 5 mg;
excipients: microcrystalline cellulose, polyvinyl alcohol, colloidal anhydrous silicon dioxide, talc, magnesium stearate;
shell: mixture for enteric film coating Acryl-EZE White (methacrylic acid copolymer, colloidal anhydrous silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide (E 171), triethyl citrate).
Dosage form
Film-coated tablets are enteric-coated.
Main physicochemical properties: oblong tablets with a biconvex surface, coated with a white or almost white film coating.
Pharmacotherapeutic group
B vitamin complex with minerals. ATX code A11E C.
Pharmacological properties
Pharmacodynamics
The therapeutic effects of the drug are the result of the synergistic action of its two active components, the broad participation of which in biochemical reactions of the human and animal body is well known.
Magnesium is an indispensable component of all enzymatic, ATP-dependent reactions; it participates in the metabolism of carbohydrates, proteins, and fats, as well as in redox reactions.
Magnesium activates glycolytic enzymes, cellular oxidation enzymes, nucleic acid synthesis enzymes; it also plays an important role in the processes of myocardial contraction. Magnesium is a stabilizer of platelets and fibrinogen. The pathogenetic role of magnesium deficiency in arterial hypertension, vasospasm, neoplastic diseases and urolithiasis is generally recognized. Magnesium plays a leading role in neuromuscular excitation - in this process it is a calcium antagonist.
Pyridoxine is mainly involved in the metabolism of amino acids, in the form of pyridoxal phosphate it is a part of enzymes that catalyze decarboxylation and reamination, as well as carbohydrates and fats. It promotes the transport of amino acids through the membrane, is necessary for the activation of phosphorylase, the formation of neurotransmitters, gamma-aminobutyric acid, glycine, serotonin. It participates in the metabolism of vitamin B12, folic acid, the synthesis of porphyrins, unsaturated fatty acids. It activates metabolic processes in the myocardium, especially in hypoxia, may have neurotropic, hematopoietic, cardiotropic and hepatotropic properties. The mechanism of interaction between magnesium and vitamin B6 has not yet been precisely established. Symptoms of deficiency, as well as overdose of both components, are similar, however, the symptoms of vitamin B6 deficiency are more pronounced with simultaneous magnesium deficiency, since magnesium is necessary for the activation of pyridoxine-dependent enzymatic systems.
Pharmacokinetics
The simultaneous use of magnesium and pyridoxine increases the rate of magnesium absorption in the intestine, improves its transmembrane passage to cells due to the formation of a vitamin B6-magnesium-amino acid chelate complex, increases the concentration of magnesium in plasma and erythrocytes, and also reduces its excretion in the urine.
Indication
Prevention of complications associated with magnesium and/or vitamin B6 deficiency.
The drug can also be used prophylactically for the following conditions:
chronic physical and mental fatigue, irritability, increased risk of stress, depression, sleep disorders, myalgia, for the prevention of atherosclerosis and myocardial infarction.
Magnicum can also be used for hypomagnesemia due to prolonged smoking and alcohol abuse, prolonged use of laxatives, contraceptives, certain diuretics, or osmotic diuresis in diabetic patients with persistent hyperglycemia.
In the complex treatment of cardiovascular diseases, such as arterial hypertension (AH), congestive heart failure, cardiac arrhythmias, in patients recovering from bone fractures, and in the complex treatment of osteoporosis.
Contraindication
Hypersensitivity to the components of the drug, severe renal failure (creatinine clearance less than 30 ml/min), hypermagnesemia, vitamin B6 hypervitaminosis, AV blockade, myasthenia gravis, Parkinson's disease (treated with levodopa without concomitant use of peripheral levodopa decarboxylase inhibitors), severe arterial hypotension, diarrhea.
Interaction with other medicinal products and other types of interactions
Concomitant use of drugs containing phosphates and calcium salts, excess lipids can significantly reduce the absorption of magnesium in the gastrointestinal tract. Diuretics, cisplatin, cycloserine, mineralocorticoids increase the excretion of magnesium in the urine. Aminoglycoside antibiotics, skeletal muscle relaxants and colistin when used concomitantly with the drug can cause muscle paralysis.
The use of cycloserine, hydralazine, isoniazid, penicillamine, and oral contraceptives increases the need for vitamin B6.
Contraindicated combinations: simultaneous use with levodopa should be avoided, since the effect of levodopa is inhibited when its use is not accompanied by peripheral dopa decarboxylase inhibitors. The use of pyridoxine in any quantities is not indicated if levodopa is not accompanied by dopa decarboxylase inhibitors.
Application features
In case of moderate renal insufficiency, measures should be taken to prevent the occurrence of hypermagnesemia (regularly monitor serum magnesium levels and avoid prolonged use of the drug in high doses). Patients with heart and renal insufficiency should consult a doctor before starting treatment with the drug.
If no improvement is noted after 1 month of treatment, the drug should be discontinued.
In case of concomitant calcium deficiency, magnesium deficiency should be corrected before starting additional calcium intake.
Pyridoxine abuse can lead to sensory neuropathy when taken in high doses (>200 mg/day) over a long period of time (i.e., several months or years). This effect is usually reversible, disappearing after discontinuation of the drug.
In patients with severe magnesium deficiency, the drug should be started by intravenous administration. This is also indicated in patients with malabsorption.
Use during pregnancy or breastfeeding
It is not known whether the use of the drug poses any risk to the fetus, since no relevant studies have been conducted during pregnancy. Therefore, the question of using the drug during pregnancy or breastfeeding is decided individually for each patient only by a doctor, taking into account the benefit to the woman/risk to the fetus (child).
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive vehicles and work with potentially dangerous mechanisms.
Method of administration and doses
Prevention: adults and children over 12 years old – 2 tablets once a day or 1-2 tablets twice a day.
Treatment: only as prescribed by a doctor. The duration of treatment is determined by the doctor.
The tablet should be swallowed whole with a glass of water.
Children
The medicine should be used in children over 12 years of age.
Overdose
Overdose of oral magnesium usually does not lead to toxic reactions in patients with normal renal function. However, patients with renal insufficiency may develop magnesium intoxication. Toxic effects depend on blood magnesium levels.
Symptoms: nausea, vomiting, hypotension, central nervous system depression, muscle weakness, respiratory depression, abnormal ECG changes, coma, cardiac arrest and respiratory paralysis, anuria, pain in the extremities, impaired reflex functions.
Treatment: rehydration, forced diuresis. In case of renal failure, hemodialysis or peritoneal dialysis is necessary. Symptomatic therapy.
Adverse reactions
Very rare - gastrointestinal disorders (abdominal pain, constipation, diarrhea, nausea, vomiting); allergic reactions, including itching, urticaria, skin rash.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 5 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "KYIV VITAMIN FACTORY".
Location of the manufacturer and address of its place of business
04073, Ukraine, Kyiv, Kopylivska St., 38.
Website: www.vitamin.com.ua.
