БориВит®

General characteristics. Structure:

Active ingredients: 100 mg of thiamin a hydrochloride, 200 mg of a pyridoxine of a hydrochloride, 0,2 mg of cyanocobalamine in 1 tablet.

Excipients: magnesium stearate, povidone, cellulose microcrystallic, опадрай series 200 (F) (including: the polyvinyl alcohol which is partially hydrolyzed talc, a macrogoal 3350 (polyethyleneglycol), copolymer of methacrylic acid type C, titanium dioxide (E 171), ferrous oxide yellow (E 172), ferrous oxide red (E 172), sodium bicarbonate, E500ii, ferrous oxide black (E 172)).

Pharmacological properties:

Pharmacodynamics. The HP of Borivit® contains a combination of neurotropic substances - a complex of vitamins. The vitamins which are contained in drug, thiamin (Bl) a pyridoxine (B6) and cyanocobalamine (B12) are coenzymes in the reactions of metabolism proceeding in the central and peripheral nervous system.

The same as all vitamins, they represent necessary nutrients which cannot be synthesized by an organism. Use of therapeutic doses vitaminovbl, provides to B6 and B12 necessary requirement of vitamins at their insufficient receipt with food. Therapeutic use of vitamins of group B at diseases of a nervous system is possible for the purpose of the deficit compensation (caused by increase in requirement) and stimulation of natural mechanisms of recovery.

The researches conducted on animals demonstrate the anesthetizing action vitaminav1.

Pharmacokinetics. Components of drug are water-soluble vitamins that excludes a possibility of their cumulation in an organism.

Absorption and distribution. Thiamin and a pyridoxine are absorbed in an upper part of intestines, extent of absorption depends on a dose.

Cyanocobalamine absorption to a large extent is defined by presence of an internal factor at a stomach and an upper part of intestines, further delivery of cyanocobalamine in fabric is carried out by transport protein transcobalamine II.

Metabolism. Thiamin, a pyridoxine and cyanocobalamine are metabolized in a liver.

Removal. Thiamin and a pyridoxine are removed by kidneys (about 8-10% - in not changed look). At overdose removal of thiamin and a pyridoxine through intestines considerably increases.

Cyanocobalamine is removed generally with bile, extent of removal by kidneys is variable - from 6 to 30%.

Indications to use:

The neurologic disturbances caused by a vitamin deficiency of group B which cannot be eliminated by correction of food.

Route of administration and doses:

Appoint inside on 1 tablet 1-3 times a day. After use within 4 weeks, for the purpose of decrease in risk of development of neuropathy, it is necessary to estimate a possibility of decrease in a dosage to 1 tablet in days. Duration of a course is determined by the doctor individually.

Pill should be taken after food, without chewing and washing down with a small amount of liquid.

Features of use:

At emergence of symptoms of peripheral touch neuropathy (paresthesia) it is necessary to reduce a dosage or to stop treatment. Development of neuropathy registered higher than 50 mg at long-term use (from 6 to 12 months) of daily doses of B6 vitamin, and also short-term use (about 2 months) of B6 vitamin in daily doses it is higher than 1 g in day.

Use vitamin of the B12-containing drugs can change a clinical picture and results of laboratory researches of malignant anemia.

Children and elderly patients. Medicine should not be applied at children 18 years owing to existence in structure of high doses of vitamins are younger. For elderly patients of correction of a dose usually it is not required.

Pregnancy. The data on influence of drug on development of an embryo and a fruit and the course of pregnancy received in researches on animals are limited. The potential risk for the person is unknown. Use during pregnancy is contraindicated.

Lactation. Vitaminybl, by B6 and B12 are brought out of an organism with maternal milk. High doses of B6 vitamin can inhibit production of milk. Data on amount of the drug which is emitted with milk at animals are not available. Purpose of drug during breastfeeding is contraindicated.

Influence on ability to manage transport and to work with mechanisms. The HP of Borivit® does not influence ability to manage transport and to work with mechanisms.

Side effects:

Drug is well transferred. Frequency of side effects is distributed in the following order: very often (more than 10% of cases); often (in 1–10% of cases); infrequently (in 0,1–1% of cases); seldom (in 0,01–0,1% of cases); very seldom (less than 0,01% of cases); frequency is unknown (single spontaneous messages).

From immune system: very seldom — hypersensitivity reaction (skin reactions, an itch, urticaria, skin rash, the complicated breath, a Quincke's edema, an acute anaphylaxis).

From a nervous system: single spontaneous messages — peripheral touch neuropathy at prolonged use of drug (more than 6 months); in some cases — a headache.

From a GIT: very seldom — nausea.

From skin and a hypodermic fatty tissue: single spontaneous messages — acne rash, the increased sweating.

From cardiovascular system: single spontaneous messages — tachycardia.

If any of the specified side effects were aggravated or appeared any other side effects which are not specified in the instruction it is necessary to report about it to the doctor.

Interaction with other medicines:

Thiamin completely collapses in the solutions containing sulfites.

Other vitamins are inactivated in the presence of decomposition products of vitamins of group B.

The pyridoxine reduces effect of a levodopa.

Interaction of medicine with Cycloserinum,   D-Penicillaminum, Epinephrinum, Norepinephrinum, sulfonamides which leads to decrease in effect of a pyridoxine is possible.

Thiamin is incompatible with the oxidizing substances, mercury chloride, iodide, a carbonate, acetate, tannin acid, iron-ammonium-citrate, and also phenobarbital, Riboflavinum, benzylpenicillin, a dextrose and metabisulphite.

Copper accelerates thiamin destruction.

Thiamin loses the action at increase in values рН (more than 3).

B12 vitamin is incompatible with salts of heavy metals.

Thiamin is inactivated 5-ftoruratsily as a result of competitive inhibition by the last of thiamin phosphorylation.

At prolonged treatment by furosemide increase in renal excretion of thiamin is possible.

Antacids, alcohol and tea reduce thiamin absorption.

Contraindications:

• Hypersensitivity to any of medicine components.
• Age up to 18 years.
• Do not recommend to apply HP of Borivit® at pregnancy and in the period of a lactation (breastfeeding) due to the lack of the reliable clinical data confirming safety of use of drug during these periods.

Overdose:

B1 vitamin. Overdose symptoms after oral administration were not registered.

B6 vitamin. After intake more than 2 g a day, were noted neuropathies with an ataxy and disorder of sensitivity, cerebral spasms with changes of EEG and seldom or never hypochromia anemia and seborrheal dermatitis.

B12 vitamin. After high doses of parenteral use (in rare instances after oral administration) allergic reactions, eczema of skin and a soft form of an acne.

Treatment: has to be supporting and symptomatic.

Storage conditions:

In the dry, protected from light place, at a temperature not above 25 °C. A period of validity - 2 years. Medicine cannot be used after the termination of a period of validity.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in a blister strip packaging. On the 3rd blister strip packagings together with the instruction on a medical use place in a pack from a cardboard.