COMPOSITION:

Active substance: Biotin.

1 tablet contains Biotin 5 mg or 10 mg.

Excipients:

Celactose 80, Sodium laurylsulfate, Sodium crosscarmellose, Magnesium stearate, Colloidal silicon dioxide anhydrous, Opadry II 85 G 54348 pink: Ponso 4R (Е 124), Titanium dioxide (Е 171), Quinoline yellow (Е 104).

INDICATIONS:

Complex treatment of diseases caused by Biotin deficiency in adults and children older than 12 years old:

– Hair diseases (high hair thinness, hair fragility, hair falling, increased greasiness or dryness of hair, grey hair);

– Skin diseases (dermatitis, seborrhea oleosa, dryness and peeling of skin);

– Nails diseases (fragility, exfoliation, nails growth or structure abnormality);

– Gastro-intestinal tract functional disorders (including malabsorption syndrome);

– Biotinidase deficiency;

– Psycho-emotional disorders (expressed irritation and fatigability, somnolence, apathy, muscle weakness).

DOSAGE:

Tablets of Wolvit® are taken peroral, before meals with a small portion of water.

The recommended dose in the treatment of diseases of nails, hairs and skin, and neurology disorders is 5 mg of Biotin per day.

In malabsorbtion syndrome the recommended dose is 10 mg.

In adults and children with Biotin deficiency symptoms the recommended dose is 5 – 20 mg per day.

In biotinidase deficiency in adults and children the recommended dose is 5 – 10 mg per day.

The drug may be used for a long period, one continuous treatment course is about one month.

ADVERSE REACTIONS:

Allergic reactions are possible in case of individual intolerance to Biotin, which can be exhibited as a chest pain, short breath, urticaria, appearance of skin rash.

Drug interactions:

If Biotin is used with anticonvulsants the concentration of Biotin in plasma can be decreased due to the increase of his excretion with urine. Valproic acid reduces activity of biotinidase by diminishing of the mitochondrial function in the hepar.

The albumen of raw egg contains protein avidin, which co-operates with biotin, therefore it is necessary to avoid their simultaneous use. The use of plenty of raw eggs during 2 – 3 weeks can cause the biotin deficiency.

The Pantothenic acid being used in large doses competes with biotin therefore it is necessary to avoid their simultaneous application.

Pregnancy and lactation:

There is no any data according to medicine application during pregnancy and lactation period.

Children:

Do not administer the drug for children under 12 years old.

PRECAUTIONS:

Do not violate the duration of the treatment course prescribed by physician. In a case of interrupted or prematurely stopped treatment the efficacy of the treatment can be decreased. Because of good Biotin tolerability the treatment can be prolonged for a long time.

Overdose:

By the moment there are no reports of Biotin overdosing even in case of high doses.

Ability to influence reaction velocity while driving or operating any other mechanisms. There is no data indicating negative medication influence on psychomotor actions velocity.

CONTRAINDICATIONS:

Hypersensitivity to Biotin or other drug components. Children less than 12 years old.

PHARMACOLOGICAL PROPERTIES:

Biotin (vitamin H, vitamin B7) is a water-soluble vitamin of B group. In human organism it plays an important role in metabolism of carbohydrate, fatty acids and proteins, and it is essential for normal cells growth and development. In introduction in organism it works as carboxylases coenzyme, causes insulin-mimetic action and takes part in gluconeogenesis (due to involvement into glucokinase syntesis) and in such way promotes stabilizing of sugar contents in blood, improves the function of nervous system. Biotin is a synergist of other B vitamins group, folic acid, pantothenic acid, cyanocobalamin. There is data concerning Biotin role in purine nucleotides synthesis. Biotin is also the source of sulfur that takes part in collagen protein synthesis and in such way it has a positive influence on the structure of skin and its appendages (hair, nails).

Biotin enters the human organism from food and it is also synthesized by human intestine microflora.

In organism Biotin is rapidly absorbed in small intestine by a passive diffusion, and after that it passes through a portal system into liver and then into system circulation. The level of Biotin binding with plasma proteins is approximately 80%. Concentration of free or weakly bound Biotin in blood as a rule is from 200 to 1200 mkg/l. Biotin passes through a hematoencephalic and placental barriers. In organism it is metabolized with different metabolites formation. Biotin is excreted with urine (from 6 to 50 μg per day) and with feces in unchanged form (approximately 50%) and also as biologically inert metabolism products. Half-life period depends on the amount of given dose and it is about 26 hours after inner introduction of 100 μg per kg of body weight.

PHARMACEUTICAL CHARACTERISTICS:

General physico-chemical properties:

Round biconvex film coated tablets of pink colour.

Shelf-life:

2 years.

Storage:

Keep it in dry place, protected from light, at the temperature not more than 25o c.

Keep it out of reach of children Package:

There are 10 tablets in a blister, 3 blisters are in a carton box.

Conditions of supply:

Without prescription.