Binavit Forte tablets p / o, No. 60

In the complex therapy of the following neurological diseases accompanied by a deficiency of B vitamins:

• Polyneuropathy (diabetic, alcoholic);

• Intercostal neuralgia;

• Trigeminal neuralgia;

• Neuritis of the facial nerve;

• Radicular syndrome caused by degenerative changes in the spine;

• Cervical syndrome;

• Shoulder-scapular syndrome;

• Lumbar syndrome;

• Sciatica.

The tablets should be taken after meals, without chewing and with a small amount of liquid.
Assign 1 tablet 1-3 times a day.
The duration of the course is according to the doctor's recommendation.
Treatment with high doses of the drug for more than 4 weeks is not recommended.

1 film-coated tablet contains:
Active ingredients: pyridoxine hydrochloride - 200 mg, thiamine hydrochloride - 100 mg, cyanocobalamin - 0.2 mg.
Excipients: microcrystalline cellulose 102 - 80.00 mg, magnesium stearate - 4.80 mg, povidone-K30 - 15.00 mg;
shell: macrogol 6000 - 9.00 mg, titanium dioxide - 11.25 mg, talc - 30.00 mg, hypromellose - 7.50 mg, methyl methacrylate and ethyl acrylate copolymer [1: 2] dispersion 30% - 2.25 mg.

• Hypersensitivity to the components of the drug.

• Children's age (the effectiveness and safety of the drug have not been studied).

• Severe and acute forms of decompensated chronic heart failure (CHF);

• The period of pregnancy and breastfeeding;

• Childhood.

Trade name:

Binawit forte

International non-proprietary or group name:

Pyridoxine + Thiamine + Cyanocobalamin

Dosage form:

film-coated tablets

Composition

1 film-coated tablet contains:
Active ingredients: pyridoxine hydrochloride - 200 mg, thiamine hydrochloride - 100 mg, cyanocobalamin - 0.2 mg.
Excipients: microcrystalline cellulose 102 - 80.00 mg, magnesium stearate - 4.80 mg, povidone-K30 - 15.00 mg;
shell: macrogol 6000 - 9.00 mg, titanium dioxide - 11.25 mg, talc - 30.00 mg, hypromellose - 7.50 mg, methyl methacrylate and ethyl acrylate copolymer [1: 2] dispersion 30% - 2.25 mg.

Description:

Round biconvex film-coated tablets of white or almost white color. On a cross-section, the core is from white to light pink interspersed with light pink to dark pink.

Pharmacotherapeutic group:

B vitamins

ATX code:

A11DB

Pharmacological properties

Pharmacodynamics
Pharmacological action is determined by the properties of the vitamins that make up the drug. The drug contains vitamins B1 (thiamine), B6 ??(pyridoxine) and B12 (cyanocobalamin), the deficiency of which can lead to neurological disorders, mainly from the peripheral nervous system.
Neurotropic B vitamins have a beneficial effect on inflammatory and degenerative diseases of the nerves and locomotor system, increase blood flow and improve the functioning of the nervous system.
Thiamine is a cofactor of enzymes that carry two-carbon groups in decarboxylation reactions, plays a key role in carbohydrate metabolism, as well as in the Krebs cycle, with subsequent participation in the synthesis of thiamine pyrophosphate (TPP) and adenosine triphosphate (ATP).
Pyridoxine is a transaminase cofactor, is involved in protein metabolism and, in part, in the metabolism of carbohydrates and fats.
The physiological function of both vitamins is to potentiate the action of each other, which manifests itself in a positive effect on the nervous, neuromuscular and cardiovascular systems.
Cyanocobalamin is a cofactor in the transfer reactions of one-carbon groups, is involved in the synthesis of the myelin sheath, stimulates hematopoiesis, reduces pain associated with damage to the peripheral nervous system, and stimulates nucleic acid metabolism through the activation of folic acid.
The drug quickly compensates for the deficiency of these vitamins.

Pharmacokinetics
Thiamine
After oral administration, thiamine undergoes dose-dependent transport, the mechanism of which is of a dual nature: active absorption at concentrations up to 2 µmol / L and passive diffusion at concentrations above 2 µmol / L. Thiamine phosphorylation occurs in the liver. The half-life is about 4 hours.
The human body contains about 30 mg of thiamine. Taking into account the rapid metabolism, it is excreted after 4-10 days.
Pyridoxine
Pyridoxine is absorbed very quickly, mainly in the upper intestine, and is excreted after a maximum of 2-5 hours. Pyridoxine in phosphorylated form (pyridoxal phosphate) binds to plasma proteins by almost 80%. The human body contains about 40-150 mg of pyridoxine. 1.7-3.6 mg per day are excreted by the kidneys.
Cyanocobalamin
Cyanocobalamin is absorbed from the gastrointestinal tract through 2 mechanisms:
- release under the action of gastric juice and rapid binding to intrinsic factor;
- passive diffusion through the intestinal epithelium, regardless of the intrinsic factor.
At doses above 1.5 ?g, the latter mechanism plays a significant role.
In patients with B12-deficiency anemia, reabsorption after oral administration is approximately 1% of 100 ?g or more.
Excess cyanocobalamin is mainly accumulated in the liver.
From the liver, it is excreted with bile into the intestines and is largely reabsorbed during the intestinal-hepatic circulation. The metabolic rate of cyanocobalamin per day is 2.5 ?g.

Indications for use

In the complex therapy of the following neurological diseases accompanied by a deficiency of B vitamins:

• Polyneuropathy (diabetic, alcoholic);

• Intercostal neuralgia;

• Trigeminal neuralgia;

• Neuritis of the facial nerve;

• Radicular syndrome caused by degenerative changes in the spine;

• Cervical syndrome;

• Shoulder-scapular syndrome;

• Lumbar syndrome;

• Sciatica.

Contraindications

• Hypersensitivity to the components of the drug.

• Children's age (the effectiveness and safety of the drug have not been studied).

• Severe and acute forms of decompensated chronic heart failure (CHF);

• The period of pregnancy and breastfeeding;

• Childhood.

Application during pregnancy and during breastfeeding

Use during pregnancy and breastfeeding is contraindicated.

Method of administration and dosage

The tablets should be taken after meals, without chewing and with a small amount of liquid.
Assign 1 tablet 1-3 times a day.
The duration of the course is according to the doctor's recommendation.
Treatment with high doses of the drug for more than 4 weeks is not recommended.

Side effect

The frequency of manifestations of adverse events is given in accordance with the WHO classification: very often (? 1/10); often (? 1/100, <1/10); infrequently (? 1/1000, <1/100); rarely (? 1/10000, <1/1000); very rare (<1/10000), including isolated cases; the frequency is unknown (cannot be estimated from the available data).
From the immune system:
Very rarely: allergic reactions - urticaria, itching.
From the gastrointestinal tract:
Frequency unknown: nausea.
On the part of the cardiovascular system:
Very rare: tachycardia.

Overdose

Clinical symptoms of an overdose of vitamins contained in Binavit forte can only be expected after taking extremely high doses for a very long time.
Vitamin B1:
Thiamin has a wide therapeutic range. Very high doses (> 10 g) have a ganglion blocking effect and inhibit the transmission of nerve impulses, i.e. have a muscle relaxant effect.
Vitamin B6:
Pyridoxine has very low toxicity.
The use of pyridoxine for 2 months or more at a dose of more than 1 g per day can cause neurotoxic effects.
After ingestion of more than 2 g per day, the following effects were noted: neuropathy with ataxia, impaired sensitivity, cerebral convulsions with changes in the ECG, as well as, in some cases, hypochromic anemia and seborrheic dermatitis.
Vitamin B12:
Eczematous skin changes and benign acne have been observed after high dose parenteral administration (and in rare cases after oral administration).
Treatment for overdose consists in washing the gastrointestinal tract, taking activated charcoal, and prescribing symptomatic therapy.

Interaction with other medicinal products

When used simultaneously with levodopa, pyridoxine can reduce the antiparkinsonian effect of levodopa.
Concomitant use of pyridoxine antagonists (eg, isoniazid, hydralazine, penicillamine, or cycloserine) may increase the need for pyridoxine.
Thiamine is inactivated by fluorouracil. Fluorouracil competitively inhibits the phosphorylation of thiamine to thiamine pyrophosphate.
Antacids reduce the absorption of thiamine.
Loop diuretics, such as furosemide, can block tubular resorption, thus increasing thiamine excretion with prolonged use, leading to a decrease in blood thiamine levels.
Ethanol and black tea reduce the absorption of thiamine.
Sulfite-containing beverages (such as wine) increase thiamine degradation.

special instructions

With prolonged use (more than 6-12 months) of vitamin B6 in a daily dose of 50 mg, peripheral sensory neuropathy may occur. Therefore, with long-term therapy, it is recommended to regularly monitor the patient's condition.
If signs of peripheral sensory neuropathy (paresthesia) appear, it is necessary to adjust the dose and, if necessary, stop taking the drug.
When taking vitamin B12, the clinical picture, as well as laboratory parameters for funicular myelosis or pernicious anemia, may lose their specificity.
Vitamin B12 can mask the symptoms of folate deficiency.
While taking the drug Binavit forte, it is not recommended to take multivitamin complexes that include B vitamins.

Influence on the ability to drive vehicles, mechanisms

Binavit forte does not affect the ability to drive vehicles and mechanisms.

Release form

Film-coated tablets.
10 or 20 tablets in a blister strip packaging.
1, 2 or 6 blister packs of 10 tablets each with instructions for use in a carton pack.
1 or 3 blister packs of 20 tablets each with instructions for use in a cardboard box.

Storage conditions

In a dark place at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Shelf life

3 years.
Do not use after the expiration date printed on the package.

Vacation conditions

Dispensed by prescription.

Legal entity in whose name the registration certificate was issued / Organization accepting claims:

CJSC 'Binergiya',
Russia, 143910, Moscow region, Balashikha, st. Krupeshina, 1

Manufacturer and address of the place of production:

LLC NPO 'FarmVILAR',
Russia, 249096, Kaluga region, Maloyaroslavets, st. Kommunisticheskaya, 115