Volvit

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VOLLVIT® (WOLVIT®)

Composition:

Active substance: biotin;

1 tablet contains 5 mg of biotin;

Excipients: celactose 80, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silicon dioxide, magnesium stearate, coating Insta Moistshield Aqua II A22R01063*.

* – coating Insta Moistshield Aqua II A22R01063: polyvinyl alcohol, talc, titanium dioxide (E 171), polyethylene glycol, lecithin, erythrosine (E 127), iron oxide (E 172).

Dosage form. Film-coated tablets.

Main physicochemical properties: round, biconvex, film-coated tablets of pink color.

Pharmacotherapeutic group. Simple vitamin preparations. Biotin.

ATC code: A11HA05.

Pharmacological properties.

Pharmacodynamics.

Biotin (vitamin H, vitamin B7) is a water-soluble vitamin of the B group. In the body, biotin plays an important role in the metabolism of carbohydrates, fats, and proteins, and is essential for normal cellular growth and development. After entering the body, biotin acts as a coenzyme for carboxylases, exerts insulin-like effects, and participates in the process of gluconeogenesis (due to its involvement in the synthesis of glucokinase), thereby promoting stabilization of blood glucose levels and improving nervous system function. Biotin acts as a synergist for other B-complex vitamins, folic acid, pantothenic acid, and cyanocobalamin. There is evidence of biotin's involvement in the synthesis of purine nucleotides. Biotin is also a source of sulfur, which participates in protein synthesis—specifically collagen—and thus positively affects the structure of the skin and its appendages (hair, nails).

Biotin deficiency may occur due to unbalanced nutrition, prolonged diets, and consumption of raw egg white; during parenteral nutrition; in malabsorption syndrome or after resection of the small intestine; in biotin-associated multiple carboxylase deficiency; and in patients undergoing hemodialysis.

Pharmacokinetics.

Biotin is rapidly absorbed in the small intestine via passive diffusion, then enters the liver via the portal system and subsequently reaches systemic circulation. The degree of biotin binding to plasma proteins is 80%. The concentration of free or weakly bound biotin in blood typically ranges from 200 to 1200 mcg/L. Biotin crosses the blood-brain and placental barriers. It is metabolized in the body, forming various metabolites. Biotin is excreted in urine (6 to 50 mcg per day) and feces in unchanged form (about 50%), as well as in the form of biologically inert metabolites. The elimination half-life depends on the administered dose and is approximately 26 hours after an intravenous dose of 100 mcg/kg body weight. In patients with biotinidase deficiency, the half-life after the same dose is reduced to 10–14 hours.

Indications.

Treatment of conditions caused by biotin deficiency: skin, nail, and hair disorders.

Treatment of genetically determined enzymopathies associated with biotin (multiple carboxylase deficiency).

Contraindications.

Hypersensitivity to biotin or to any of the other components of the medicinal product.

Interaction with other medicinal products and other types of interactions.

When biotin is used concomitantly with anticonvulsant drugs, plasma biotin concentrations may be reduced due to increased urinary excretion. Valproic acid reduces biotinidase activity, impairing mitochondrial function in the liver.

Raw egg white contains the protein avidin, which binds to biotin; therefore, simultaneous intake should be avoided. Consumption of large amounts of raw eggs over 2–3 weeks may lead to biotin deficiency.

Pantothenic acid, when administered in high doses, competes with biotin; therefore, simultaneous use should be avoided.

Special precautions for use

Do not deviate from the treatment duration prescribed by the physician. If treatment is interrupted or prematurely discontinued, the therapeutic effect may be reduced. Due to the good tolerability of biotin, treatment can be continued for a prolonged period.

Effect on clinical laboratory test results

Biotin may interfere with clinical laboratory tests based on the biotin-streptavidin interaction, leading to falsely low or high results, depending on the type of assay. The risk of such interference is higher in children and patients with impaired renal function, and increases with higher biotin doses. When interpreting test results, potential interference due to biotin intake should be considered, especially if results are inconsistent with the clinical picture (e.g., false-positive thyroid function test results suggestive of Graves' disease or false-negative troponin levels in patients with myocardial infarction). Prior to scheduling clinical laboratory tests in patients taking biotin, consultation with laboratory specialists is recommended. When biotin interference cannot be ruled out, alternative testing methods not affected by this factor should be used.

Use during pregnancy or breastfeeding

There is no experience with the use of this medicinal product during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery

There are no data regarding negative effects of the drug on psychomotor reaction speed.

Dosage and Administration.

Volvit® should be administered orally to adults. Take before meals with a small amount of water.

Disorders of nails, hair, and skin: the recommended dose is 5 mg (1 tablet) daily.

Genetically determined enzyme deficiencies associated with biotin (multiple carboxylase deficiency): administer 2–4 tablets (daily dose up to 20 mg of biotin) in 1–2 divided doses per day.

The duration of treatment depends on the nature and course of the disease, and usually lasts 1 month.

Children.

The drug is not intended for use in children.

Overdose.

There are currently no reports of biotin overdose.

Adverse reactions.

Immune system side effects: allergic reactions are possible, including urticaria, chest pain, shortness of breath, skin rashes.

If any adverse reactions occur, it is recommended to discontinue treatment and consult a physician.

Shelf life. 4 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets per blister pack, 3 blisters per cardboard box.

Availability category. Over-the-counter (without prescription).

Manufacturer.

KUSUM HEALTHCARE PVT LTD.

Manufacturer's address and place of business.

SP-289 (A), RIICO Industrial Area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.

INSTRUCTIONS

for medical use of the medicinal product

VOLVIT ®

(WOLVIT ®)

Composition:

Active ingredient: biotin;

1 tablet contains 5 mg of biotin;

Excipients: celactose 80, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silicon dioxide, magnesium stearate, coating Insta Moistshield Aqua II A22R01063*.

* – coating Insta Moistshield Aqua II A22R01063: polyvinyl alcohol, talc, titanium dioxide (E 171), polyethylene glycol, lecithin, erythrosine (E 127), iron oxide (E 172)

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: round, biconvex, film-coated tablets of pink color.

Pharmacotherapeutic group. Simple vitamin preparations. Biotin.

ATC code: A11HA05.

Pharmacological properties.

Pharmacodynamics.

Biotin (vitamin H, vitamin B7) is a water-soluble vitamin of the B group. In the body, biotin plays an important role in the metabolism of carbohydrates, fats, and proteins, and is essential for normal cellular growth and development. Once in the body, biotin acts as a coenzyme for carboxylases, exerts insulin-like effects, and participates in the process of gluconeogenesis (due to its involvement in the synthesis of glucokinase), thereby promoting stabilization of blood glucose levels and improving nervous system function. Biotin acts as a synergist of other B-group vitamins, folic acid, pantothenic acid, and cyanocobalamin. There is evidence of biotin's involvement in the synthesis of purine nucleotides. Biotin is also a source of sulfur, which participates in protein synthesis—specifically collagen—and thus positively affects the structure of the skin and its appendages (hair, nails).

Biotin deficiency may occur due to unbalanced nutrition, prolonged diets, and consumption of raw egg white; during parenteral nutrition; in malabsorption syndrome, after resection of the small intestine; in biotin-responsive multiple carboxylase deficiency; and in patients undergoing hemodialysis.

Pharmacokinetics.

Biotin is rapidly absorbed in the small intestine via passive diffusion, then enters the liver through the portal system and subsequently reaches systemic circulation. The degree of biotin binding to plasma proteins is 80%. The concentration of free or weakly bound biotin in blood typically ranges from 200 to 1200 mcg/L. Biotin crosses the blood-brain and placental barriers. It is metabolized in the body, forming various metabolites. Biotin is excreted in urine (6 to 50 mcg per day) and feces in unchanged form (about 50%), as well as in the form of biologically inert metabolic products. The elimination half-life depends on the administered dose and is approximately 26 hours after an intravenous dose of 100 mcg per kg of body weight. In patients with biotinidase deficiency, the elimination half-life after the same dose is reduced to 10–14 hours.

Indications.

Treatment of conditions caused by biotin deficiency: skin, nail, and hair disorders.

Treatment of genetically determined enzyme deficiencies associated with biotin (multiple carboxylase deficiency).

Contraindications.

Hypersensitivity to biotin or to any other component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

When biotin is used concomitantly with anticonvulsant drugs, a decreased plasma concentration of biotin may occur due to increased urinary excretion. Valproic acid reduces biotinidase activity, impairing mitochondrial function in the liver.

Raw egg white contains the protein avidin, which binds to biotin; therefore, simultaneous intake should be avoided. Consumption of large quantities of raw eggs over 2–3 weeks may lead to biotin deficiency.

Pantothenic acid, when administered in high doses, competes with biotin; therefore, concomitant use should be avoided.

Special precautions for use

Do not alter the duration of the treatment course prescribed by the physician. If treatment is interrupted or prematurely discontinued, the therapeutic effect may be reduced. Due to the good tolerability of biotin, treatment may be continued for a prolonged period.

Effect on results of clinical laboratory tests

Biotin may interfere with clinical laboratory tests based on the biotin-streptavidin interaction, leading to falsely low or high results, depending on the type of assay. The risk of such interference is higher in children and patients with impaired renal function, and increases with higher biotin doses. When interpreting test results, the potential influence of biotin intake should be considered, especially if results are inconsistent with the clinical picture (e.g., false-positive thyroid function test results suggestive of Graves' disease or false-negative troponin assay results in patients with myocardial infarction). When planning clinical laboratory testing in patients taking biotin, consultation with laboratory specialists is recommended. In cases where biotin interference cannot be ruled out, alternative assays not affected by biotin should be used.

Use during pregnancy or breastfeeding

There is no experience with the use of this medicinal product during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery

There are no data regarding a negative effect of the medicinal product on psychomotor performance.

Method of administration and dosage.

Volvit® should be administered orally to adults. Take before meals with a small amount of water.

Nail, hair, and skin disorders: the recommended dose is 5 mg (1 tablet) daily.

Genetically determined biotin-associated enzymopathies (multiple carboxylase deficiency): 2–4 tablets daily (daily dose up to 20 mg of biotin) in 1–2 divided doses.

Duration of treatment depends on the nature and course of the disease and usually amounts to 1 month.

Children.

The drug is not intended for use in children.

Overdose.

There are currently no reports of biotin overdose.

Side effects.

Immune system side effects: allergic reactions are possible, including urticaria, chest pain, shortness of breath, skin rashes.

If any adverse reactions occur, it is recommended to discontinue treatment and consult a physician.

Shelf life. 4 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets per blister, 3 blisters per cardboard pack.

Availability. Over-the-counter (without prescription).

Manufacturer.

KUSUM HEALTHCARE PVT LTD.

Manufacturer's address and location of business activity.

Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Distt. Dhar, Madhya Pradesh, Pin 454774, India