Active substanceBenzothiamine + PyridoxineBenzothiamine + Pyridoxine
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    VALENTA PHARM, PAO     Russia
  • Dosage form: & nbsp

    Film-coated tablets.

    Composition:

    One tablet, film-coated, contains:

    active substances: benfotiamine in terms of 100% substance - 0.1 g; pyridoxine hydrochloride in terms of 100% substance - 0.1 g;

    Excipients: microcrystalline cellulose, potato starch, copovidone, croscarmellose sodium, magnesium stearate;

    shell: Opadry II (series 85): partially hydrolysed polyvinyl alcohol, macrogol-3350, titanium dioxide E 171, talc.

    Description:The tablets covered with a film membrane of white or almost white color, round, biconcave. On a cross-section of white or almost white color.
    Pharmacotherapeutic group:Vitamin
    ATX: & nbsp

    N.07.X.X   Other drugs for the treatment of diseases of the nervous system

    Pharmacodynamics:

    Combined multivitamin preparation containing B vitamins. Benzothiamine - Fat-soluble vitamin analogue B1 (thiamine). In the body it is converted into thiamine pyrophosphate (active form of thiamine) - coenzyme of a number of enzymes of oxidative and non-oxidative decarboxylation of a-keto acids (pyruvic and a-ketoglutaric acids) and the exchange of a-ketosugars.It plays an important role in the carbohydrate metabolism and energy supply of the nervous system, including the brain and spinal cord, regulates the conduct of the nerve impulse, influencing the transmission of excitation.

    Pyridoxine is involved in the metabolism, is a coenzyme of the metabolism of amino acids and proteins, the synthesis of neurotransmitters, is necessary for the normal functioning of the central and peripheral nervous system. Entering the body, it is phosphorylated, converted to pyridoxal-5-phosphate and is included in the enzymes that carry out decarboxylation, transamination and racemization of amino acids, as well as the enzymatic conversion of sulfur-containing and hydroxylated amino acids. Participates in the exchange of tryptophan (participation in the reaction of biosynthesis of serotonin).
    Pharmacokinetics:

    Benfotiamin in unchanged form reaches the proximal parts of the small intestine and is rapidly absorbed in the form of a lipophilic formation Sbenzoylthiamine by passive diffusion. Benzothiamine after biotransformation into thiamine pyrophosphate has a kinetics not differing from the kinetics of water-soluble thiamine.

    Pyridoxine is rapidly absorbed from the gastrointestinal tract.More pyridoxine is absorbed in the jejunum.

    Pyridoxine is metabolized in the liver with the formation of pharmacologically active metabolites (pyridoxalphosphate AND pyridoxamino phosphate). Pyridoxalphosphate with plasma proteins binds to 90%. It penetrates well into all tissues; accumulates mainly in the liver, less - in the muscles and central nervous system. Penetrates through the placenta, is secreted with breast milk. It is excreted by the kidneys, as well as during hemodialysis.

    Indications:

    It is used in the complex therapy of the following neurological diseases:

    - polyneuropathy of various etiologies, including diabetic, alcoholic;

    - intercostal neuralgia; lumboishalgia; radiculopathy; cervico-brachial syndrome; radicular syndrome caused by degenerative changes in the spine;

    - neuritis of the facial nerve, neuralgia of the trigeminal nerve, retrobulbar neuritis.

    Contraindications:

    - increased individual sensitivity to the components of the drug;

    - Decompensated heart failure;

    - children's age till 18 years;

    - period of pregnancy and breastfeeding.

    Carefully:

    Peptic ulcer of the stomach and duodenum (in connection with the possible increase in the acidity of the gastric juice); cardiac ischemia.

    Pregnancy and lactation:

    Not applicable during pregnancy and breastfeeding.

    Dosing and Administration:

    Inside, not liquid, squeezed enough liquid.

    For any of the above indications, 1 tablet is prescribed 1-3 times a day. The recommended duration of treatment is 4 weeks. The maximum daily dose is 3 tablets. Depending on the clinical situation, the doctor's recommendation may increase the duration of treatment under medical supervision. Repeated courses - on the recommendation of a doctor.

    Side effects:

    Allergic reactions (skin itching, hives, shortness of breath, Quincke's edema, anaphylactic shock), increased sweating, tachycardia, acne, nausea, diarrhea, constipation, pain at stomach.

    Overdose:

    Symptoms: it is possible to increase the symptoms of dose-dependent side effects.

    In case of an overdose, consult a doctor.

    Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy.
    Interaction:

    Therapeutic doses of pyridoxine weaken the antiparkinsonian action of levodopa, enhance the action of diuretics.

    Isoniazid, penicillamine, cycloserine and estrogen-containing oral contraceptives weaken the effect of pyridoxine.

    Combines with cardiac glycosides (pyridoxine promotes an increase in the synthesis of contractile proteins in the myocardium), with glutamic acid and potassium and magnesium asparaginate.

    Pyridoxine is pharmaceutically incompatible with thiamine (B1) vitamins and cyanocobalamin (B 12).

    Simultaneous use of pyridoxine with cycloserine, ethionamide, hydralazine, azathioprine, chlorambucil, corticotropin, cyclophosphamide, cyclosporine, mercaptopurine, penicillamine - can cause anemia and neuropathy.

    Special instructions:

    During the reception of the drug is not recommended the use of multivitamin complexes, containing B vitamins.

    Allergic reactions to benfotiamine often occur in women in menopause and in patients with chronic alcoholism.

    Effect on the ability to drive transp. cf. and fur:

    The drug does not affect the performance of potentially hazardous activities,requiring special attention and quick reactions (driving and other vehicles, working with moving mechanisms, dispatcher and operator work, etc.).

    Form release / dosage:

    Film-coated tablets.

    Packaging:

    For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    3 or 6 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

    Storage conditions:

    In dry, dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-008853/10
    Date of registration:30.08.2010
    The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp30.08.2010
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