Magnelis B6 forte tab n / 100mg + 10mg of 30 pcs

Description

Composition
Active substance:
Magnesium citrate – * 618.43 mg, pyridoxine hydrochloride – 10.00 mg.
* – the amount equivalent to 100 mg of magnesium (Mg 2+)
Excipients:
ludipress® [lactose monohydrate – 92.20 mg – 96.05 mg Kollidon® 30 – 3.04 mg – 4.05 mg, Kollidon® CL – 3,04 mg – 4,05 mg] – 101.21 mg -6000 macrogol (polyethylene glycol – 6000) – 69.36 mg magnesium stearate – 1.00 mg.
Sheath VIVACOAT® PM-1P-000 [6 cps hypromellose (hydroxypropylmethylcellulose 6 cps) – 10.00 mg Titanium dioxide – 6.00 mg, giproloza (hydroxypropyl) – 1.00 mg talc – 2.00 mg macrogol – 3350 (polyethylene glycol – 3350) – 1.00 mg] – 20.00 mg.
Description:
tablets, film-coated white, oblong, biconvex. On a section of white or nearly white.
Product form:
Tablets, film-coated, 100 mg + 10 mg.
10 tablets in blisters of PVC film or imported PVC / PVDC or PVC / PE / PVDC and aluminum foil printed patent.
3 contour cell packs of 10 tablets together with instructions for use placed in a pile of cardboard.
Contraindications
– hypersensitivity to any component of the drug;
– severe renal impairment (creatinine clearance less than 30 mL / min);
– up to age 12 years (effectiveness and safety have been established);
– hereditary galactosemia, malabsorption syndrome glucose and galactose or lactase deficiency (due to the presence in the composition of the lactose monohydrate formulation);
– simultaneous levodopa (see “Interaction with other drugs”).
Precautions moderate renal failure (risk of gipermagniemii).
Dosage
100 mg + 10 mg
Indications
Established magnesium deficiency, isolated or associated with other deficiency states, accompanied by symptoms such as irritability, minor sleep disturbances, gastrointestinal spasms, heart palpitations, fatigue, pain, and muscle spasms, tingling sensation in the muscles. If after a month of treatment there is no reduction in these symptoms, continued treatment is inappropriate.
Interaction with other drugs
Before the appointment of other drugs should inform the doctor or seek advice about the possibility of receiving “Magnelis® B6 forte, tablets, film-coated.”
contraindicated combinations
Since levodopa: levodopa pyridoxine activity is inhibited (when the drug is not compatible with aromatic L-amino acid decarboxylase inhibitors peripheral reception). Avoid taking any number of pyridoxine when levodopa will not be processed in combination with peripheral decarboxylase inhibitors aromatic L-amino acids.
Not recommended combinations
Simultaneous application of preparations containing phosphate or calcium salts, magnesium may deteriorate the absorption in the intestine.
Combinations to be taken into account
When assigning inwardly tetracyclines observe interval of at least three hours between ingestion of tetracycline and “Magnelis® B6 forte tablets, film-coated” as magnesium drugs reduce the absorption of tetracyclines.
Overdose
symptoms
In normal kidney function magnesium overdose ingestion usually does not cause toxic reactions. However, in the case of renal insufficiency may develop magnesium poisoning.
Overdose symptoms, the severity of which depends on the magnesium concentration in the blood: reduction in blood pressure, nausea, vomiting; central nervous system depression, decreased reflexes; changes in the electrocardiogram; respiratory depression, coma, cardiac arrest and respiratory paralysis, anurichesky syndrome.
Treatment
Rehydration, forced diuresis. In renal failure requires dialysis or peritoneal dialysis.
pharmachologic effect
Pharmacological group:
magnesium preparation.
Pharmacodynamics:
Magnesium is an essential element, which is required for normal functioning of cells involved in most metabolic reactions. In particular, it is involved in the regulation of the transmission of nerve impulses and muscle contraction. 50% of the amount of magnesium contained in the body is stored in bones.
Pyridoxine (vitamin B6) is involved in many metabolic processes, it helps improve magnesium absorption from the gastrointestinal tract and its penetration into cells.
The concentration of magnesium in serum:
– in the range of 12 and 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.
The body gets magnesium from food. Magnesium deficiency in the body may occur at deficiency Incoming or increasing of magnesium needs.
Pharmacokinetics:
Gastro-intestinal absorption of magnesium salts, salts occurs partly by passive mechanism in which the solubility of the salt plays a decisive role. The degree of this absorption does not exceed 50%. Excretion occurs mainly kidneys.
Pregnancy and breast-feeding
Pregnancy
Clinical experience of magnesium citrate and a combination of pyridoxine hydrochloride in a sufficient amount of pregnant women has not revealed any adverse effect on the appearance of fetal malformations or foetotoxic action.
Drug “Magnelis® B6 forte, tablets, film-coated” may be used during pregnancy only if necessary, on doctor’s advice.
Period breastfeeding
Taking into account that magnesium enters the mother’s milk, if necessary, of the drug is recommended to stop breast-feeding.
Conditions of supply of pharmacies
Without recipe.
side effects
The frequency of adverse events classified according to the recommendations of the World Health Organization: very often (> 10%), frequent (> 1% and 0.1% and 0.01% and 0.01%), the unknown frequency (where the available data is not possible to evaluate the incidence of side reactions).
Violations by the immune system:
very rarely (> 0.01%): allergic reactions including skin reactions;
Violations of the gastrointestinal tract:
Unknown frequency (available data to estimate the frequency of occurrence is not possible): diarrhea, abdominal pain, nausea, vomiting, flatulence.
special instructions
Drug “Magnelis® B6 forte, tablets, film-coated” is only for adults and children over 12 years.
The preparation contains lactose monohydrate, therefore, its use is not recommended for patients with hereditary galactosemia, malabsorption syndrome glucose and galactose or lactase deficiency.
At a moderate renal insufficiency should be taken with caution because of the risk of gipermagniemii.
With simultaneous deficiency of calcium and magnesium, a magnesium deficiency must fill before starting reception of calcium preparations or food additives containing calcium.
In the application of pyridoxine in high doses (200 mg daily) for a long time (over several months or in some cases – s) can develop sensory axonal neuropathy that is accompanied by symptoms such as numbness and disruption of proprioceptive sensitivity, tremor distal limbs and gradually developing sensory ataxia (incoordination). These disorders are usually reversible and disappear after the abolition of high doses of vitamin B6.
Effect on the ability to drive mechanisms and
Does not affect. No specific recommendations.
Storage conditions
At temperatures above 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Tablets should be taken whole, washed down with a glass of water.
Adults: 3-4 tablets a day, divided into 2-3 doses, at mealtime.
Children over 12 years: 2-4 tablets per day, divided into 2-3 doses, at mealtime.
Typically, the duration of drug administration is one month.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist