Biotinal B7 (Tablets) Instructions for Use

Marketing Authorization Holder

Polpharma Pharmaceutical Works, Sa (Poland)

ATC Code

A11HA05 (Biotin)

Active Substance

Biotin (Rec.INN registered by WHO)

Dosage Form

Biotinal B7

Tablets 10 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex, with an engraving “10” on one side.

Excipients: lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.

15 pcs. – blisters (2) – cardboard packs.
15 pcs. – blisters (4) – cardboard packs.
15 pcs. – blisters (6) – cardboard packs.

Clinical-Pharmacological Group

B vitamin

Pharmacotherapeutic Group

Vitamins; other vitamin preparations

Pharmacological Action

Biotin (vitamin H) is a water-soluble vitamin belonging to the B vitamins. The biotin molecule consists of two linked rings: a thiophene and an imidazole with a side chain of valeric acid.

Biotin acts as a prosthetic group for enzymes that catalyze carboxylation reactions. This vitamin is part of four carboxylases that play an important role in the metabolism of glucose, lipids, some amino acids, and is also involved in energy metabolism.

Biotin is found in small amounts in many foods. The largest amount of biotin is contained in: liver, yeast, egg yolk, and some vegetables (for example, soybeans, cauliflower, lentils). This substance is also synthesized by bacteria in the human colon, but it is absorbed in insignificant amounts in this part of the gastrointestinal tract.

Biotin deficiency occurs in people on special diets, with parenteral nutrition, consumption of large amounts of raw eggs, long-term hemodialysis, long-term treatment with anticonvulsants, antibiotic treatment, and with problems of absorption of this vitamin.

Biotin deficiency causes symptoms of fatigue, paresthesia, hair loss, dermatitis around the eyes, nose, mouth, ears and groin, conjunctivitis, impaired nail growth and excessive dryness and brittleness of hair. It has been recorded that in case of biotin deficiency, fat metabolism may be impaired in the form of increased concentration of palmitic acid in the liver and serum cholesterol. It is assumed that the cause of skin changes and hair loss due to biotin deficiency is a violation of fat metabolism.

Biotin controls the keratinization and differentiation of epidermal cells and skin appendages such as hair and nails, improving their condition.

Additional intake of biotin helps to increase the number of hairs on the scalp, reduce the number of hairs falling out daily and increase the overall volume and thickness of hair, improve hair shine and nail growth according to patients’ subjective assessment.

Pharmacokinetics

Biotin is well and completely absorbed from the gastrointestinal tract. Absorption of free biotin begins already in the initial part of the small intestine. Exogenous biotin supplied with food is absorbed through the intestinal mucosa using a sodium-dependent multivitamin transporter (SMVT). At therapeutic doses, this process occurs independently of the SMVT transporter by passive diffusion.

The degree of binding of biotin to plasma proteins is 80%. The concentration of biotin in the blood is about 100-800 µg/l. Biotin is excreted in the urine (from 6 to 50 µg/day) and feces. Biotin is excreted unchanged (approximately 50%) and as biologically inactive metabolites. T_1/2 is dose-dependent and is about 15 hours.

Indications

Biotin deficiency, the presence of symptoms such as hair loss, impaired hair and nail growth, including degenerative disorders of hair structure (dryness, brittleness), after excluding other causes.

Diffuse alopecia of non-hormonal etiology, decreased hair density and intense hair loss.

ICD codes

Dosage Regimen

Administer one 10 mg tablet orally, once daily.

Take the tablet with a sufficient amount of water, with or without food.

The maximum recommended treatment duration is 90 days.

Do not exceed the recommended daily dose.

Initial therapeutic effects on hair and nails are typically observed after approximately four weeks of continuous use.

If symptoms persist or recur after one completed treatment course, consult a physician to assess the necessity of a repeated course.

This product is indicated for adults 18 years of age and older only.

Safety and efficacy in pediatric patients under 18 years have not been established.

Discontinue use and seek medical advice if adverse reactions occur.

Inform your healthcare provider and laboratory personnel that you are taking biotin, as it can interfere with certain laboratory test results.

Adverse Reactions

Nervous system disorders uncommon – headache.

Gastrointestinal disorders uncommon – diarrhea, flatulence; very rare – gastrointestinal disorders.

Skin and subcutaneous tissue disorders uncommon – skin itching, of the scalp; very rare – urticaria.

Musculoskeletal and connective tissue disorders uncommon – pain in the lumbar region.

Reproductive system and breast disorders uncommon – breast pain.

General disorders uncommon – increased body temperature.

Contraindications

Hypersensitivity to biotin; other diseases accompanied by hair loss (for example, androgenic alopecia, alopecia areata, cicatricial alopecia); pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

It is believed that hepatic insufficiency does not affect the safety of use.

Use in Renal Impairment

The concentration of biotin in plasma did not depend on the presence of renal failure, serum creatinine level, duration and frequency of hemodialysis.

Pediatric Use

Safety and effectiveness in children under 18 years of age have not been established.

Special Precautions

Biotin may affect the results of laboratory tests based on the biotin-streptavidin interaction, which may lead to erroneously low or high test results (depending on the sample). The risk of influence increases in children and patients with renal failure, as well as at higher doses.

When interpreting the results of laboratory tests, the possible influence of biotin should be taken into account, especially if there is a discrepancy with the clinical picture (for example, thyroid test results indicating Graves’ disease in patients receiving biotin without symptoms of this disease, or false-negative troponin test results in patients with myocardial infarction taking biotin). If such an influence is suspected, other tests that are not sensitive to the effects of biotin should be performed.

If laboratory tests are prescribed for patients receiving biotin, the laboratory staff should be consulted on this matter.

Drug Interactions

Anticonvulsant drugs (phenytoin, carbamazepine, phenobarbital, primidone) cause a decrease in biotin levels in the blood.

Valproic acid reduces biotinidase activity.

Preclinical studies have shown that high doses of pantothenic and lipoic acids reduce the effectiveness of biotin, but clinical studies do not confirm this.

Alcohol reduces biotin levels in the blood.

Steroid hormones may accelerate the catabolism of biotin in tissues.

Antibiotics may reduce the concentration or activity of biotin by disrupting the function of the intestinal microflora.

Avidin, an alkaline glycoprotein found in egg white, has the ability to bind to biotin, inactivate it and prevent its absorption. In case of biotin deficiency or its use, raw chicken egg white should not be consumed.

Cigarette smoking accelerates the catabolism of biotin, which can lead to its deficiency and reduced treatment effectiveness.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.