Biotebal

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BİOTEBAL (BIOTEBAL)

Composition:

Active substance: biotinum;

1 tablet contains 5 mg or 10 mg of biotin;

Excipients: lactose monohydrate, microcrystalline cellulose, povidone K-30, sodium croscarmellose, colloidal anhydrous silicon dioxide, magnesium stearate, purified water.

Pharmaceutical form. Tablets.

Main physicochemical properties:

5 mg: white or almost white, round, biconvex tablets;

10 mg: white or almost white, round, biconvex tablets, engraved with "10" on one side.

Pharmacotherapeutic group. Simple vitamin preparations. Biotin. ATC code A11HA05.

Pharmacological properties.

Pharmacodynamics.

Biotin is an essential substance for cell development and growth. As a coenzyme, it plays an important role in gluconeogenesis, lipogenesis, propionate biotransformation, fatty acid synthesis, and leucine catabolism. Biotin deficiency may occur in case of unbalanced nutrition, prolonged diets, consumption of raw egg white, parenteral nutrition, malabsorption syndrome, after resection of the small intestine, and in patients undergoing hemodialysis. In addition, in biotin-dependent multiple carboxylase deficiency due to genetic defects, the requirement for biotin is increased. Deficiency manifests clinically as skin and appendage disorders. In the body, biotin plays a crucial role in carbohydrate, fat, and protein metabolism and is essential for normal cell growth and development. Once absorbed, biotin acts as a coenzyme for carboxylases, exerts an insulin-like effect, and participates in gluconeogenesis (due to its role in glucokinase synthesis), thereby contributing to blood glucose stabilization and improved nervous system function. Biotin acts synergistically with 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 (collagen) synthesis, thus exerting a beneficial effect on the structure of the skin and its appendages (hair, nails).

Pharmacokinetics.

Absorption of free biotin begins in the upper part of the small intestine. Here, the biotin molecule passes through the intestinal wall unchanged. Absorption occurs primarily via diffusion.

The extent of biotin binding to plasma proteins is approximately 80%.

The concentration of free or weakly bound biotin in blood typically ranges from 200 to 1200 mcg/L. Biotin is excreted in urine (6 to 50 mcg per day) and feces. Biotin is excreted unchanged (about 50%) and as biologically inactive metabolites. The elimination half-life depends on the dose and is approximately 26 hours after an oral dose of 100 mcg per kilogram of body weight. In patients with biotinidase deficiency, the half-life after administration of the same dose is reduced to 10–14 hours.

Biotin enters the human body through food and is also synthesized by intestinal microflora. Dietary biotin is mostly protein-bound and occurs as biocytin (in animal-derived foods), which is rapidly reabsorbed after hydrolysis in the small intestine. In plants, biotin is partially present in free form.

Clinical characteristics.

Indications.

Treatment of conditions caused by biotin deficiency manifested by symptoms such as hair loss, impaired hair and nail growth and their excessive fragility, skin inflammation around the eyes, nose, mouth, and ears, as well as prevention of symptoms caused by biotin deficiency after a physician has excluded other causes.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

When biotin is used concomitantly with anticonvulsant drugs (phenytoin, carbamazepine, phenobarbital, primidone), a decreased plasma concentration of biotin may occur due to increased urinary excretion.

Valproic acid reduces biotinidase activity, impairing mitochondrial functions in the liver.

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

Alcohol reduces biotin levels in plasma.

Steroid hormones may accelerate biotin catabolism in tissues.

Antibiotics may reduce biotin concentration due to disruption of intestinal microflora.

Raw egg protein 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 cause biotin deficiency.

Smoking enhances biotin catabolism, which may lead to deficiency and reduced treatment efficacy.

Special precautions for use.

The duration of the treatment course prescribed by the physician should not be violated. If treatment is intermittent or prematurely discontinued, the effect of the drug may be reduced. Due to the good tolerability of biotin, treatment may be continued for a prolonged period.

Effect on clinical laboratory tests.

Biotin may interfere with clinical laboratory tests based on the biotin-streptavidin interaction, leading to falsely decreased or increased 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 patient biotin intake should be considered, especially if results are inconsistent with the clinical picture (e.g., false-positive thyroid function tests for Graves' disease or false-negative troponin levels in patients with myocardial infarction). Prior consultation with laboratory specialists is recommended when planning clinical laboratory tests in patients taking biotin. If biotin interference cannot be ruled out, alternative tests not dependent on this interaction should be used.

To minimize biotin interference with laboratory test results, the medicinal product should be discontinued at least 3 days before testing, unless the laboratory specifies another timeframe.

Excipients

One 5 mg tablet contains 53.9 mg of lactose monohydrate; one 10 mg tablet contains 107.8 mg of lactose monohydrate. Therefore, the product should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

The medicinal product is considered sodium-free, as it contains less than 1 mmol of sodium (23 mg) per tablet.

Use during pregnancy or breastfeeding.

The amount of biotin in the medicinal product Biotebal exceeds the recommended daily intake for pregnant women. The use of high-dose biotin during pregnancy has not been studied. The product should not be used during pregnancy.

The amount of biotin in the medicinal product Biotebal exceeds the recommended daily intake for breastfeeding women. Biotin is excreted in breast milk, but no adverse effects on breastfeeding have been observed. However, the product should not be used during breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

No effect.

Dosage and Administration.

Biotebal is intended for oral administration in adults. Take before meals with sufficient amount of water (e.g., half a glass).

The daily dose is 5 mg; in cases of pronounced symptoms – 10 mg.

The duration of treatment depends on the nature and course of the disease and usually lasts 4 weeks. Symptomatic improvement is observed approximately after 4 weeks of treatment.

Children.

Due to limited experience of use, the drug is not prescribed to children under 12 years of age.

For children aged 12 years and older, the drug may be used as prescribed by a physician; dosage recommendations are not available due to limited relevant data.

Overdose.

Currently, there are no reports of biotin overdose.

Side effects.

Immune system side effects: very rare (˂ 1/10,000): allergic reactions, including urticaria.

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

Reporting of suspected side effects.

Reporting suspected adverse reactions after drug registration is of great importance. It allows continuous monitoring of the benefit-risk ratio of the drug. Healthcare professionals should report any suspected adverse reactions.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

5 mg tablets:

30 tablets per blister; 1, 2 or 3 blisters per cardboard box.

10 mg tablets:

15 tablets per blister; 2, 4 or 6 blisters per cardboard box.

20 tablets per blister; 6 blisters per cardboard box.

Prescription category.

Over-the-counter.

Manufacturer.

Pharmaceutical Works «POLPHARMA» S.A.

Pharmaceutical Works «POLPHARMA» S.A.

Manufacturer's address and place of business.

19, Pelplinska Str., 83-200 Starogard Gdanski, Poland