Name:
Magneland
Description:
White color tablets with a smooth surface, oblong, biconvex, scored on one side. Slight marbling is allowed. The risk on the tablet serves to divide the tablet in order to more conveniently take the drug. The main active ingredient Magnesium aspartate dihydrate + pyridoxine hydrochloride Release form Tablets Packing 10 tablets in a blister pack of aluminum foil and polyvinyl chloride film. 30 tablets in a polymer jar for packaging medicines with a pull-on lid with first opening control. Sealing agent – medical cotton wool. One jar or three or six blister packs, together with a leaflet, are placed in a pack of boxed cardboard. Dosage 450 mg + 5 mg Pharmacodynamics Magnesium is predominantly an intracellular cation, reduces the excitability of neurons and neuromuscular transmission of excitation, takes part in many enzymatic processes. Magnesium is a macronutrient; half of the total magnesium in the body accumulates in bone tissue. Serum magnesium levels: – between 12 and 17 mg/l (1-1.4 mEq/l or 0.5-0.7 mmol/l): indicate a mild magnesium deficiency; – below 12 mg/l (1 mEq/l or 0.5 mmol/l): indicate severe magnesium deficiency. Deficiency can be: – primary, due to a congenital anomaly of metabolism (chronic congenital hypomagnesemia); – secondary, due to: inadequate intake (severe malnutrition, alcoholism, exclusively parenteral nutrition); disorders of gastrointestinal absorption (chronic diarrhea, gastrointestinal fistula, hypoparathyroidism); excessive excretion of magnesium by the kidneys (severe polyuria, diuretic abuse, chronic pyelonephritis, primary hyperaldosteronism, treatment with cisplatin). Pyridoxine (vitamin B6) is involved in many metabolic processes. Pyridoxine deficiency is rare, usually accompanied by a deficiency of other micro- and macronutrients: in alcohol abusers, pregnant women and during lactation, in patients receiving isoniazid treatment. Pyridoxine (vitamin B6) improves the absorption of magnesium from the gastrointestinal tract and its penetration into cells. The inclusion of vitamin B6 in Magneland is primarily intended to provide a favorable absorption profile for magnesium aspartate. Pharmacokinetics Gastrointestinal absorption of magnesium salts occurs in part by a passive mechanism in which salt solubility plays a decisive role. absorption and distribution. Magnesium aspartate dihydrate is a highly soluble compound and is absorbed in the small intestine. This process is facilitated by small amounts of vitamin B6, which is also absorbed in the small intestine. The concentration of magnesium in the blood serum is 0.75 – 1.25 mmol / l (usually 0.8 – 0.9 mmol / l), and about 55% of magnesium is in ionized form, 32% is associated with proteins, and 13% – forms complex bonds with anions. Vitamin B6 accumulates mainly in the liver. With magnesium deficiency, the symptoms of pyridoxine deficiency may be more pronounced. The total content of magnesium in the body of an adult is about 25 g (14 mmol / kg), of which more than 50% is localized in bone tissue, approximately 25% in skeletal muscles, and the remaining 25% is distributed throughout the body (mainly: the nervous system, myocardium, liver, digestive tract, 1% in extracellular fluids). Pyridoxine is absorbed in the small intestine. Metabolized in the liver with the formation of pharmacologically active metabolites (pyridoxal phosphate and pyridoxamino phosphate). Distribution is predominantly in the muscles, liver and central nervous system. Penetrates through the placenta and into mother’s milk. Withdrawal. Basically, magnesium is excreted in the urine and partially reabsorbed in the renal tubules. The magnesium requirement for an adult is about 5 mg/kg body weight per day (i.e. 270-350 mg, or 11-14 mmol Mg2+). In conditions of severe deficiency, as well as during periods of intense physical exertion, rapid growth in children, pregnant and lactating women, the need increases to 7-10 mg / kg of body weight. Pyridoxine is excreted by the kidneys. Indications for use Treatment of confirmed magnesium deficiency in the body – both isolated and associated with other deficiency conditions. A combination of the following symptoms may indicate a magnesium deficiency: nervousness, irritability, mild anxiety, transient fatigue, slight sleep disturbances, signs of anxiety such as gastrointestinal cramps or rapid heart rate (with a healthy heart), muscle cramps, tingling sensation. Magnesium may help relieve these symptoms. Dosage and administration Magneland is taken orally after meals with a small amount of liquid. The tablet may be divided at risk into parts for ease of swallowing. – Adults are advised to take 6-8 tablets per day. – children over 6 years old (body weight over 20 kg) 4-6 tablets per day. The daily dose should be divided into 2-3 doses. Duration of treatment Treatment should be discontinued immediately after normalization of magnesium levels in the blood. If after one month of treatment there is no improvement, continuation of monotherapy with this drug is impractical. In case of missing the next dose of the drug, it is necessary to continue the usual regimen. Do not double the dose to make up for a missed dose. Use during pregnancy and lactation Pregnancy Clinical experience with the use of magnesium preparations in a sufficient number of pregnant women did not reveal any adverse effect on the occurrence of fetal malformations or fetotoxic effects. The drug Magneland can be used during pregnancy only if necessary, on the advice of a doctor. Breast-feeding Magnesium passes into breast milk. The use of the drug during lactation and breastfeeding should be avoided. Precautions The composition of the drug Magneland contains lactose. If you have an intolerance to some sugars, contact your doctor before taking this medicine. The tablets are intended for adults and children over 6 years of age. In moderate renal insufficiency, care should be taken to prevent the risk associated with hypermagnesemia. In the case of concomitant calcium deficiency, it is recommended to eliminate the magnesium deficiency before taking calcium supplements or calcium supplements. With frequent use of laxatives, alcohol, intense physical and mental stress, the need for magnesium increases, which can lead to the development of magnesium deficiency in the body. With prolonged use of the drug Magneland, it is recommended to control the concentration of magnesium in the blood serum. Taking more than the recommended dose of the drug may cause diarrhea. In case of diarrhea, reduce the daily dose or temporarily stop taking the drug. When taking pyridoxine (vitamin B6) in high doses (more than 200 mg per day) for a long time (for several months or in some cases – years), sensory axonal neuropathy may develop, which is accompanied by symptoms such as numbness, impaired proprioceptive sensitivity , tremor of the distal extremities and gradually developing sensory ataxia (impaired coordination of movements). These disorders are usually reversible and disappear after the cessation of vitamin B6. Influence on the ability to drive vehicles and work with mechanisms Magneland does not affect or has a slight effect on the ability to drive vehicles and other activities that require a high concentration of attention and speed of psychomotor reactions. Interaction with other drugs Contraindicated combinations – With levodopa: the activity of levodopa is inhibited by pyridoxine (if this drug is not combined with the use of peripheral dopa decarboxylase inhibitors). Any use of pyridoxine should be avoided unless peripheral dopa decarboxylase inhibitors are prescribed concomitantly with levodopa. Not recommended combinations – Phosphate or calcium salts – these drugs can impair the absorption of magnesium in the intestine. Combinations to be taken into account – Oral tetracyclines should be separated from oral tetracycline and Magneland by an interval of at least three hours, due to a decrease in the absorption of tetracyclines in the gastrointestinal tract in the presence of magnesium. – Magnesium salts, administered together with antibiotics from the group of fluoroquinolones, oral anticoagulants – primarily warfarin derivatives, as well as preparations containing iron compounds, can reduce the absorption of each other in the gastrointestinal tract. The use of cycloserine, hydralazine, isoniazid, penicillamine reduces the content of Vitamin B6 in the body. Diuretics (furosemide, ethacrynic acid) increase the excretion of magnesium in the urine. Long-term use of potassium-sparing diuretics can increase magnesium resorption in the renal tubules and cause hypermagnesemia. Other drugs containing magnesium, such as laxatives and antacids, when used with magnesium preparations, can cause symptoms of magnesium toxicity, especially in people with kidney failure. The drug should be used with caution in conjunction with cardiac glycosides. Contraindications hypersensitivity to any of the components of the drug; severe renal failure (creatinine clearance less than 30 ml/minute); hypermagnesemia, hypervitaminosis of vitamin B6; severe arterial hypotension; atrioventricular block; myasthenia gravis; children’s age up to 6 years; simultaneous administration of levodopa (see section “Interaction with other medicinal products”). With caution in moderate renal failure, as there is a risk of developing hypermagnesemia. Composition 1 tablet contains: active substances: magnesium aspartate dihydrate – 450 mg (corresponding to 34 mg of magnesium ions) and pyridoxine hydrochloride – 5 mg. excipients: lactose monohydrate, crospovidone (type A), hypromellose (substitution type 2910), macrogol 6000. OverdoseSymptoms With normal kidney function, an overdose of magnesium when taken orally does not usually lead to toxic reactions. However, in case of renal insufficiency, magnesium poisoning may develop. Overdose symptoms, the severity of which depends on the concentration of magnesium in the blood: lowering blood pressure; nausea, vomiting, abdominal pain, dehydration; depression of the central nervous system, decreased reflexes, paralysis; changes in the electrocardiogram, bradycardia; respiratory depression, coma, cardiac arrest and respiratory paralysis; anuric syndrome. Treatment Rehydration, forced diuresis. Renal failure requires hemodialysis or peritoneal dialysis. The specific antidote is calcium gluconate. Side effects Like all medicines, Magneland can cause side effects, although not everyone gets them. The following adverse reactions have been registered: rarely (may occur in up to 1 person in 1,000): impaired atrioventricular conduction; very rare (may affect up to 1 in 10,000 people): allergic reactions, including skin reactions; the frequency is unknown (based on the available data, the frequency of occurrence cannot be determined): diarrhea, abdominal pain, nausea, vomiting, flatulence. Reporting adverse reactions If you experience any adverse reactions, it is recommended that you consult your doctor. This recommendation applies to any possible adverse reactions, including those not listed in the package insert. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the drug. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ºС. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiration date indicated on the package. Buy Magneland B6 tablets 450mg/5mg No. 10×6
The code | 146645 |
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Barcode | 4 810 368 014 689 |
Dosage | 450mg/5mg |
Active substance | Magnesium aspartate, pyridoxine hydrochloride |
Manufacturer | Pharmland SP LLC, Belarus |
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