Instructions for Magnicum-Antistress film-coated tablets blister pack No. 60
Composition
active ingredients: magnesium, pyridoxine;
1 tablet contains magnesium citrate 618.43 mg, equivalent to magnesium 100 mg, and pyridoxine hydrochloride 10 mg;
excipients: anhydrous lactose, polyethylene glycol (macrogol), magnesium stearate;
shell: Opadry II White film coating mixture: hypromellose (hydroxypropylmethylcellulose); lactose monohydrate; polyethylene glycol (macrogol); titanium dioxide (E 171); triacetin.
Dosage form
Film-coated tablets.
Main physicochemical properties: round tablets with a biconvex surface, film-coated, white to almost white in color.
Pharmacotherapeutic group
Drugs affecting the digestive system and metabolism. Vitamins. B vitamin complexes, including combinations. 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 moderate 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 losses of magnesium through 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 Magnicum-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
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 and disappears after discontinuation of the drug.
Patients with moderate renal insufficiency should take precautions to prevent any risks associated with 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.
There are appropriate dosage forms for use in children under 6 years of age.
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, the use of magnesium during pregnancy is possible only if necessary after consulting a doctor. If necessary, magnesium can be used at any stage of pregnancy. Despite the lack of sufficient data on animal studies, limited clinical trial data are satisfactory.
Breastfeeding period
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.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect or has a negligible effect on the reaction speed when driving vehicles or other mechanisms.
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.
Overdose
Magnesium-related
Oral overdose of magnesium usually does not cause toxic reactions in patients with normal renal function. However, magnesium intoxication may develop in patients with renal insufficiency.
Symptoms: 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, slowing of reflexes, deviations from the norm of ECG indicators, respiratory failure, coma, cardiac arrest and respiratory paralysis, anuria may occur.
Treatment: Rehydration, forced diuresis. In case of renal failure, hemodialysis or peritoneal dialysis is necessary.
Related to pyridoxine
Sensory axonal neuropathy is a major effect that can occur with prolonged and/or long-term use of high doses of pyridoxine (several months or years).
Symptoms: In particular, paraesthesia, dysaesthesia, hypoaesthesia, sensory deficits, pain in the extremities, involuntary muscle contractions, burning sensations, balance disorders, gait disturbances, tremor of the hands and feet and progressive sensory ataxia (difficulty in coordinating movements) have been reported.
Treatment: Neurological symptoms gradually disappear after discontinuation of treatment.
Adverse reactions
Immune system disorders: allergic reactions, hypersensitivity, angioedema.
Gastrointestinal disorders: diarrhea*, abdominal pain*, flatulence, nausea, vomiting.
Skin and subcutaneous tissue disorders: skin reactions including urticaria, pruritus, eczema, erythema.
*Adverse reactions related to magnesium.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua
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; 6 blisters in a pack.
12 tablets in a blister; 4 blisters in a pack.
12 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
