Instructions for Magne-B6 Antistress coated tablets blister pack No. 60
Composition
active ingredients: magnesium, pyridoxine;
1 tablet contains magnesium citrate anhydrous 618.43 mg (corresponding to 100 mg of magnesium) and pyridoxine hydrochloride (vitamin B6) 10 mg;
excipients: anhydrous lactose, macrogol 6000, magnesium stearate;
shell: hypromellose, macrogol 6000, titanium dioxide (E 171), talc.
Dosage form
Film-coated tablets.
Main physicochemical properties: white, oval tablets, film-coated.
Pharmacotherapeutic group
B vitamin complex with minerals. ATX code A11E C.
Pharmacological properties
Pharmacodynamics
Magnesium is a cation that is mainly found inside cells. Magnesium reduces neuronal excitability and neuromuscular transmission, and it is involved in many enzymatic processes.
Magnesium is an important component of body tissues: skeletal bones contain half of the total amount of magnesium in the body.
A serum magnesium concentration of 12 to 17 mg/L (1–1.4 mEq/L, or 0.5–0.7 mmol/L) indicates magnesium deficiency; below 12 mg/L (1 mEq/L, or 0.5 mmol/L) indicates severe magnesium deficiency.
Magnesium deficiency can be: primary, due to metabolic pathology (chronic congenital hypomagnesemia);
secondary, due to:
insufficient intake of magnesium with food (severe malnutrition, chronic alcohol abuse, exclusively parenteral nutrition), impaired absorption of magnesium in the gastrointestinal tract (chronic diarrhea, gastrointestinal fistulas, hypoparathyroidism), excessive loss of magnesium by the kidneys (tubular disorders, severe polyuria, diuretic abuse, chronic pyelonephritis, primary hyperaldosteronism, cisplatin treatment). Pyridoxine, a coenzyme factor, is involved in most metabolic processes.
Pharmacokinetics
Part of magnesium salts is passively absorbed in the intestine. The degree of absorption depends on the solubility of the salt. Absorption of magnesium salts in the digestive tract does not exceed 50%. Magnesium is excreted mainly in the urine.
In the body, pyridoxine is oxidized to pyridoxal or amination to pyridoxamine. Subsequent phosphorylation produces pyridoxal phosphate. This form of pyridoxine is metabolically active.
Indication
Symptomatic treatment of magnesium deficiency in the body.
This medicine contains magnesium.
A combination of several of the following symptoms may indicate a magnesium deficiency in the body:
increased excitability, irritability, anxiety, transient weakness, minor sleep disturbances, signs of anxiety manifested by gastrointestinal spasms or increased heartbeat (in the absence of heart disease), muscle cramps, tingling sensation in the muscles.
Prescribing magnesium may help reduce or eliminate these symptoms.
If after a month of using the drug the symptoms do not decrease, continuing treatment is inappropriate.
Contraindication
Hypersensitivity to any component of the drug. Severe renal failure (creatinine clearance < 30 ml/min). Children under 6 years of age. Phenylketonuria. Hypermagnesemia, vitamin B6 hypervitaminosis, myasthenia gravis. Atrioventricular block, severe arterial hypotension. Simultaneous use with levodopa (see section "Interaction with other medicinal products and other types of interactions"). Diarrhea.
Interaction with other medicinal products and other types of interactions
Contraindicated combinations.
Concomitant use with levodopa should be avoided, as 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.
Combinations that are not recommended.
Drugs containing phosphate or calcium salts, as they prevent the absorption of magnesium from the intestines.
Combinations to consider.
Oral tetracyclines and Magne-B6® Antistress should be taken at least 3 hours apart, as magnesium inhibits the absorption of tetracyclines.
Magnesium preparations weaken the effect of oral anticoagulants and reduce iron absorption.
Diuretics increase the excretion of magnesium in the urine.
The use of hydralazine, isoniazid, penicillamine, and oral contraceptives increases the need for vitamin B6.
Application features
This medicinal product contains lactose. Therefore, it is not recommended for patients with galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary conditions).
Information for diabetics: film-coated tablets may contain sucrose as an excipient.
In moderate renal insufficiency, measures should be taken to prevent the occurrence of hypermagnesemia.
If no improvement is observed after one month of treatment, the drug should be discontinued.
In the case of simultaneous calcium deficiency, it is necessary to first correct the magnesium deficiency, and then the calcium deficiency.
Precautions for use
THIS MEDICINE IS INTENDED FOR USE ONLY BY ADULTS AND CHILDREN 6 YEARS OLD AND OVER.
Patients with moderate renal insufficiency should take precautions to prevent any risks associated with hypermagnesemia.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Use during pregnancy or breastfeeding
Pregnancy. Sufficient data on the clinical use of the drug in pregnant women have not revealed fetotoxic or embryotoxic effects of the drug. Therefore, the use of magnesium during pregnancy is possible only if necessary after consulting a doctor.
Breastfeeding. Each of the active ingredients of the drug separately (both magnesium and vitamin B6) is not contraindicated during this period. Given the limited evidence available today regarding the use of the maximum recommended daily dose of vitamin B6 during breastfeeding, it is recommended to prescribe no more than 20 mg/day of vitamin B6.
Method of administration and doses
The tablets should be swallowed whole with 1 glass of water.
For adult patients: 3-4 tablets per day, in 2 or 3 doses during meals.
For children aged 6 years and over (weighing approximately 20 kg): 10-30 mg/kg body weight per day (0.4-1.2 mmol/kg body weight per day) or 2-4 tablets per day), in 2 or 3 divided doses with meals. The usual duration of treatment is one month.
Children
The drug is used in children aged 6 years and older. Appropriate dosage forms are available for use in children under 6 years of age.
Overdose
Oral overdose of magnesium usually does not cause toxic reactions in normal renal function. However, magnesium intoxication can develop in cases of renal failure.
When using the drug in high doses and for a long period, sensory neuropathy may occur, which may manifest itself in the following symptoms: numbness, impaired position perception, vibrations of the lower extremities, progression of sensory ataxia (impaired coordination).
Symptoms of overdose depend on the level of magnesium in the blood serum. In case of overdose, a drop in blood pressure, nausea, vomiting, depression of the central nervous system, slowed reflexes, ECG abnormalities, respiratory failure, coma, cardiac arrest and respiratory paralysis, anuria may occur.
Treatment of overdose: rehydration, forced diuresis. In case of renal failure, hemodialysis or peritoneal dialysis is necessary.
Adverse reactions
Allergic reactions, diarrhea, nausea, vomiting, abdominal pain, skin reactions, including itching and hives.
Expiration date
2 years.
Storage conditions
Keep out of the reach of children. Store at a temperature not exceeding 30 °C.
Packaging
15 tablets in a blister, 4 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Sanofi Winthrop Industria, France.
Location of the manufacturer and its business address
56 rue de Choisy au Bac, 60205 Compiègne, France.
