COMPOSITION

Each film-coated tablet contains:

Biotin USP……..5 mg

ADDITIONAL INGREDIENT

Excipients: Cellactose 80, Sodium lauryl sulphate, Crosscarmellose sodium, Magnesium stearate, Colloidal anhydrous silica, Opadry II 85 G 54348 pink*, purified water.

*Constituents of Opadry II 85 G 54348 pink: Polyvinyl alcohol-Part hydrolyzed (USP, FCC, PhEur, JPE), Talc (USP, FCC, PhEur. JP), Titanium dioxide (NF, FCC, PhEur, JECFA, JP), Lecithin (Soya) (NF, JPE, FCC, JSFA), Ponceau 4R aluminium lake, Quinoloine Yellow aluminium lake (JECFA).

THERAPEUTIC INDICATIONS

Complex treatment and prophylaxis of diseases caused by Biotin deficiency in adults and children:

– 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);

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

Weakness).

Biotin deficiency may be in such cases:

– gut organisms disorders (disbacteriosis) because of prolonged treatment by antibiotics;

– in unbalanced nutrition, malnutrition, long diet;

– in usage of unboiled ovalbumin (it prevents Biotin absorption);

– in parenteral nutrition;

– in patients on hemodialysis;

– in absorption processes disorders (malabsorption syndrome, states after enterectomy).

RECOMMENDED DOSE

Adults:

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

In adults 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.

Elderly patients

The same dose range as in younger patients may be used in the elderly.

Children

In malabsorbtion syndrome the recommended dose is 10 mg.

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

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

In case of biotin-dependent enzymes insufficiency caused by genetics (multiple deficiency of carboxylases) the recommended dose is 20 mg per day.

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

Pediatric:

.Infant’s birth to 6 months: 5 mcg

.Infants 7 to 12 months: 6 mcg

.Children 1 to 3 years: 8 mcg

. Children 4 to 8 years: 12 mcg

. Children 9 to 13 years: 20 mcg

. Adolescents 14 to 18 years: 25 mcg

MODE OF ADMINISTRATION

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

UNDESIRABLE EFFECTS

In this section undesirable effects are defined as follows:

Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare

(>1/10,000, <1/1,000); very rare (<1/10,000), including isolated reports.

Because of the potential for side effects and interactions with medications, dietary supplements should be taken only under the supervision of a knowledgeable healthcare provider. That said, biotin has not been associated with side effects (even in high doses) and is considered to be nontoxic.

ADVERSE EFFECT

*”Inform doctors about unexpected reactions after using drugs”.

Interactions:

Although there is no evidence that biotin interacts with any medication, there are some medications that may deplete biotin levels. If you are being treated with any of the following medications, you should not use biotin without first talking to your health care provider.

Antibiotics — Long-term antibiotic use may lower biotin levels by destroying the bacteria in the gut that produces biotin.

Anticonvulsant Medications — Long-term use of anticonvulsant medications can reduce the body’s stores of biotin.

Valproic acid can cause biotinidase deficiency, which may be helped by biotin supplements. Anticonvulsant medications include:

• Carbamazepine (Carbatrol)

• Phenobarbital

• Phenytoin (Dilantin)

• Primidone (Mysoline)

Pregnancy

Pregnant women and nursing mothers should avoid supplemental doses of biotin greater than the adequate intakes (AI) recommended by the Food and Nutrition Board, unless higher doses are prescribed by their physicians. The AIs are 30 micrograms/day for pregnant women and 35 micrograms/day for nursing mothers.

The use of biotin for the treatment of a biotin-responsive medical conditions requires medical supervision Individual doctor’s advice is necessary if the preparation administration is required during pregnancy periods.

• Pregnant females: 30 mcg

Lactation

Individual doctor’s advice is necessary if the preparation administration is required during lactation periods.

• Breastfeeding females: 35 mcg

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Allergic reactions are possible in case of individual intolerance to Biotin.

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

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.

There is no data indicating negative medication influence on psychomotor actions velocity.

OVERDOSE AND TREATMENT

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

CONTRAINDICATIONS

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

PHARMACEUTICAL FORM

Film coated Tablets

PHARMACOTHERAPEUTIC GROUP- Biotin deficiency disorder

ATC CODE: A11HA05.

PHARMACOLOGICAL PROPERTIES:

PHARMACODYNAMIC PROPERTIES:

Mechanism of action:

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.

PHARMACOKINETIC PROPERTIES:

The intestine is exposed to biotin from a few sources: the diet, biotin supplements and biotin synthesized by bacteria in the large intestine. Dietary biotin exists in free and protein-bound forms. Protein-bound biotin is digested by proteases and peptidases to biotin-containing oligopeptides and biocytin (epsilon-N-biotinyl-L-lysine). Biocytin and the biotin-containing oligopeptides are converted to biotin via the enzyme biotinidase. Biotin—both dietary-derived biotin and supplementary biotin—is efficiently absorbed from the small intestine. At doses of biotin derived from food, biotin appears to be transported into enterocytes by a sodium dependent carrier. At higher doses of biotin, absorption appears to occur by passive diffusion. Absorption of the biotin produced by the colonic microflora, appears to occur by a carrier mediated process in the proximal large intestine.

Biotin is transported to the liver via the portal circulation and by the systemic circulation, to the other tissues of the body. Biotin appears to be transported in the serum in both bound and unbound forms. Uptake of biotin by cells appears to occur by both a sodium-dependent carrier process and by passive diffusion. Transport of biotin across the blood-brain barrier appears to occur by a saturable transport mechanism. Placental transport of biotin appears to occur by a passive process. Within cells, the carboxylases (pyruvate carboxylase, acetyl-CoA carboxylase, methycrotonyl-CoA carboxylase, propionyl-CoA carboxylase) are biotinylated via holocarboxylase synthetase. Biotin and apocarboxylases are the substrates. ATP and magnesium also participate in the reaction. Biotin is recycled from the holocarboxylases via the action of proteolytic enzymes and biotinidase. Biotin is catabolized to a number of different metabolites, including bisnorbiotin, biotin sulfoxide, biotin sulfone, bisonorbiotin methylketone and tetranorbiotin-1-sulfoxide. Biotin is excreted in the urine as biotin, bisnorbiotin, biotin sulfoxide, biotin sulfone, bisnorbiotin methyl ketone and tetranobiotin-1- sulfoxide.

STORAGE CONDITIONS

Store below 30º C.

DOSAGE FORMS AND PACKAGING AVAILABLE

Film-coated tablets are packed in Alu/Alu blister pack.

Each blister contains 10 tablets and 3 such blisters are packed in carton.

NAME AND ADDRESS OF MANUFACTURER

Kusum Healthcare Pvt Ltd

Sp 289(A), Riico Industrial Area,

Chopanki, Bhiwadi (Raj.),

India.

DATE OF REVISION OF PACKAGE INSERT

Not Applicable