Medobiotin®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MEDOBIOTIN® (MEDOBIOTIN®)

Composition:

Active substance: biotin;

1 tablet contains 2.5 mg of biotin;

Excipients: long-chain partial glycerides, microcrystalline cellulose, lactose monohydrate, povidone, crospovidone, sodium starch glycolate (type A), magnesium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: white, round, biconvex tablets.

Pharmacotherapeutic group.

Simple vitamin preparations. ATC code A11H A05.

Pharmacological Properties

Pharmacodynamics.

Biotin is an essential substance for cell development and growth. As a coenzyme, it plays an important role in gluconeogenesis, lipogenesis, biotransformation of propionates, fatty acid synthesis, and leucine catabolism. Biotin deficiency may occur due to unbalanced nutrition, prolonged diets, and consumption of raw egg white; in addition, in biotin-dependent multiple carboxylase deficiency, the requirement for biotin is increased due to a genetic defect. Deficiency manifests with skin and skin-derived reactions, and may result in specific neuropsychiatric symptoms and intestinal disturbances during parenteral nutrition, malabsorption syndrome, after resection of the small intestine, and in patients undergoing hemodialysis. Biotin (vitamin H, vitamin B7) is a water-soluble vitamin of the B complex group. In the body, biotin plays a crucial role in carbohydrate, fat, and protein metabolism and is essential for normal cell growth and development. After entering the body, biotin acts as a coenzyme for carboxylases, exerts insulin-like effects, and participates in gluconeogenesis (due to its role in glucokinase synthesis), thereby contributing to blood glucose stabilization and improved nervous system function. Biotin acts as a synergist with 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 involved in protein synthesis—specifically collagen—and thus positively influences the structure of the skin and its derivatives (hair, nails).

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

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 degree of biotin binding to plasma proteins is 80%.

Concentrations of free or weakly bound biotin in blood typically range from 200 to 1200 mcg/L. Biotin is excreted in urine (6 to 50 mcg per day) and feces. Biotin is excreted unchanged (approximately 50%) and as biologically inactive metabolites. The elimination half-life depends on the administered dose and is nearly

26 hours after an oral dose of 100 mcg per kilogram of body weight. In patients with biotinidase deficiency, the elimination half-life after the same dose is reduced to 10–14 hours.

Clinical characteristics.

Indications.

Treatment and prevention of diseases 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 excipients of the medicinal product.

Special precautions.

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.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of biotin with anticonvulsant drugs may reduce biotin plasma concentration due to increased urinary excretion. Valproic acid reduces biotinidase activity, impairing hepatic mitochondrial functions.

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

Special precautions for use.

Effect on results of clinical laboratory tests.

Biotin may interfere with laboratory tests based on biotin/streptavidin interaction, leading to falsely low or falsely high test results, depending on the assay type. The risk of obtaining inaccurate results is higher in children and patients with impaired kidney function, and increases with the use of high doses. The potential influence of biotin should be considered when interpreting laboratory results, especially if such results are inconsistent with clinical presentation (e.g. thyroid function test results mimicking those typical of Graves’ disease in asymptomatic patients taking biotin, or false-negative troponin test results in patients with myocardial infarction receiving biotin). When biotin interference is suspected, alternative testing methods not sensitive to biotin should be used, if possible. Laboratory staff should be consulted prior to ordering tests for patients being treated with biotin.

The product contains lactose; therefore, patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

This medicinal product contains less than 1 mmol (23 mg)/dose of sodium, i.e. essentially "sodium-free".

Use during pregnancy or breastfeeding.

According to general principles, Medobiotin® should be used during pregnancy or breastfeeding only when the expected benefit to the woman outweighs the potential risk to the fetus/infant.

There is currently no information on any adverse effects of using the drug during pregnancy or breastfeeding. Biotin crosses the placenta and is excreted into breast milk. Breast milk usually contains 7–13 mcg of biotin per litre.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Dosage and Administration.

The recommended dose for adults in the treatment of biotin deficiency (nail, hair, and skin disorders) is 1–2 tablets per day.

For the treatment of genetically determined biotin-associated enzymopathies (multiple carboxylase deficiency), 2–4 tablets are prescribed (daily dose – up to 10 mg of biotin). The tablets should be taken before meals, without chewing, with sufficient liquid.

The duration of treatment depends on the nature and course of the disease.

Children.

Due to limited experience of use, the medicinal product is not administered to children under 12 years of age.

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

Overdose.

Currently, there are no reports of biotin overdose.

Side effects.

Immune system: allergic reactions, including urticaria.

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

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging.

10 tablets in a blister; 3 or 6 blisters in a cardboard box.

Dispensing category.

Over-the-counter (without prescription).

Manufacturer.

Anton Hubner GmbH & Co. KG.

Manufacturer's location and address of business activity.

Schlossstrasse 11-17, 79238 Ehrenkirchen, Germany.

or

Manufacturer.

mibe GmbH Arzneimittel.

Manufacturer's location and address of business activity.

Muenchener Strasse 15, Brehna, Sachsen-Anhalt, 06796, Germany.