BEOTEBAL biotin against hair loss 10mg x 30 tabl

BEOTEBAL biotin against hair loss 10mg x 30 tabl

1. NAME OF THE MEDICINAL PRODUCT

BEOTEBAL 10 mg tablets

BEOTEBAL 10 mg tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 10 mg of biotin.

Excipient with known effect: lactose monohydrate.

Each tablet contains 107.8 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet

White to off-white, biconvex, round tablets, debossed with “10” on one side, 7.8-8.2 mm in diameter.

4. CLINICAL DATA

4.1 Therapeutic indications

Treatment of biotin deficiency with symptoms such as hair loss, nail and hair growth disorders and excessive brittleness, skin inflammation localized around the eyes, nose, lips and ears, and prevention of its consequences after the doctor has ruled out other causes.

BEOTEBAL is indicated in adults.

4.2 Dosage and administration

Dosage

Adults

From 5 mg to 10 mg daily.

The usual recommended dose is 5 mg per day or, for severe symptoms, 10 mg per day.

The duration of treatment depends on the patient's condition and the course of the disease. Improvement of symptoms is observed after approximately 4 weeks of use.

The product should not be used for more than 6 weeks without medical advice.

A longer duration of use may be recommended by a doctor after assessing the patient's condition.

Pediatric population

BEOTEBAL is not recommended due to insufficient data.

Method of administration

Oral administration.

The tablets should be taken with a sufficient amount of water (e.g. ½ cup).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Impact on clinical laboratory tests

Biotin may interfere with laboratory tests, based on the interaction of biotin and streptavidin, resulting in falsely low or falsely high test results, depending on the sample. The risk of interference is higher in children and patients with renal impairment and increases with higher doses. When interpreting laboratory test results, the possibility of interference by biotin should be considered, especially if there is a discrepancy with the clinical presentation (e.g., thyroid test results mimicking Graves' disease in patients taking biotin without symptoms of the disease or falsely negative troponin test results in patients with myocardial infarction taking biotin). In cases where interference is suspected, alternative tests that are not affected by biotin should be performed, if available. If laboratory tests are ordered in patients taking biotin, the laboratory staff should be consulted.

To minimize the effects of biotin on laboratory test results, the product should be discontinued 3 days prior to scheduled tests, unless otherwise recommended by the laboratory.

Pediatric population

BEOTEBAL is not recommended due to insufficient data.

Special warnings regarding excipients

Lactose

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

4.5 Interaction with other medicinal products and other forms of interaction

Anticonvulsant drugs (phenytoin, carbamazepine, phenobarbital, primidone) lead to a decrease in the concentration of biotin in the blood.

Valproic acid reduces the activity of the enzyme biotinidase.

Preclinical studies have shown that high doses of pantothenic acid and lipoic acid reduce the efficacy of biotin. However, this has not been proven in clinical studies.

Alcohol reduces the concentration of biotin in the blood.

Steroid hormones can accelerate the catabolism of biotin in tissues.

Antibiotics can reduce the concentration or potency of biotin by affecting the intestinal microflora.

Avidin, a major glycoprotein found in egg whites, has the ability to bind to biotin, inactivating it and preventing its absorption. Raw egg whites should not be consumed in cases of biotin deficiency or use of biotin-containing products.

Smoking accelerates the catabolism of biotin, which can lead to biotin deficiency and reduced efficacy of treatment.

Influence on the results of laboratory blood tests

See point 4.4.

4.6 Fertility, pregnancy and lactation

Pregnancy

The amount of biotin contained in BEOTEBAL far exceeds the recommended daily intake for pregnant women. No studies have been conducted on the use of high doses of biotin in pregnant women. The product should not be taken during pregnancy.

Breastfeeding

The amount of biotin contained in BEOTEBAL far exceeds the recommended daily intake for nursing mothers. Biotin is excreted in human milk, but has not been found to have any effect on nursing infants. The product should not be used by nursing women.

Fertility

There are no human data available on the effect of biotin on male and female fertility. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).

4.7 Effects on ability to drive and use machines

BEOTEBAL does not affect the ability to drive or use machines.

4.8 Adverse drug reactions

The adverse reaction profile of biotin is presented based on data from clinical trials and extensive post-marketing experience.

Adverse reactions are ranked under headings of frequency, starting with the most common, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to ≤1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).

Immune system disorders

Very rare: allergic reaction (urticaria).

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after authorisation of a medicinal product is important. This allows for continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions:

Executive Agency for Medicines

8 Damyan Gruev Street

1303 Sofia

tel.: +359 2 8903417

website: www.bda.bg

4.9 Overdose

There are no reports of biotin overdose in humans. Available clinical studies show that high doses, even up to 300 mg daily, for 24 months are well tolerated by patients.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Vitamins. Other vitamins, alone ATC code: A11HA05

BEOTEBAL contains biotin in the form of d-biotin, the only biologically active isomer of biotin (d-biotin isomer). Biotin (vitamin H) is a water-soluble vitamin, part of the B vitamin group. The biotin molecule consists of two connected rings – thiophene and imidazole rings, with a valeric acid side chain attached to them.

Biotin is a prosthetic group of enzymes and is essential for the proper functioning of carboxylase transport enzymes. Biotin is contained in four carboxylases, which play an important role in the metabolism of glucose, lipids and some amino acids and energy transformations.

Although in small amounts, biotin is found in many foods. The foods with the highest biotin content are: liver, yeast, egg yolk and some vegetables (e.g. soybeans, cauliflower, lentils). In addition, biotin is synthesized by bacteria in the human colon, but its absorption in this part of the gastrointestinal tract is low.

Biotin deficiency can occur in people following special diets, during parenteral nutrition, in people consuming large amounts of raw eggs, patients on prolonged hemodialysis, during prolonged treatment with anticonvulsants, during treatment with antibiotics, as well as in people with impaired absorption of this vitamin.

Symptoms of biotin deficiency in humans include fatigue, paresthesia, hair loss, dermatitis in the eyes, nose, lips, ears and groin, conjunctivitis, impaired nail and hair growth and their excessive fragility. It has been found that in case of biotin deficiency, lipid metabolism disorders can occur, such as increased levels of palmitic acid in the liver and cholesterol in the serum. The appearance of skin lesions and hair loss occur as a result of biotin deficiency and are due to disorders in lipid metabolism.

Biotin helps with the keratinization and differentiation of epidermal cells and skin appendages (hair and nails), improving their condition.

5.2 Pharmacokinetic properties

Absorption

Biotin is well and completely absorbed from the gastrointestinal tract. Absorption of free biotin begins in the initial part of the small intestine. Absorption through the intestinal mucosa of exogenous biotin supplied with food is carried out with the help of the sodium-dependent multivitamin transporter (SMVT). At therapeutic doses, this process is not SMVT-dependent and occurs by passive diffusion.

Distribution

The binding ratio of biotin to plasma proteins is 80%.

The level of biotin in the blood is approximately 100-800 µg/l.

Biotransformation and elimination

Biotin is excreted in the urine (6 to 50 micrograms per day) and in the feces. Biotin is excreted unchanged (approximately 50%) and as biologically inactive metabolites. The half-life of biotin is dose-dependent and is approximately 15 hours.

Pharmacokinetic properties in patients with renal and hepatic insufficiency

Several studies have evaluated the pharmacokinetic properties of biotin in patients with renal failure. Plasma biotin concentrations did not differ according to renal disease, serum creatinine level, or duration and frequency of hemodialysis. Furthermore, biotin doses improved oral glucose tolerance test results in hemodialysis patients.

There is no evidence of potential risk in patients with organ dysfunction and potential for drug interactions. In vivo studies have shown that biotin does not affect CYP1A-mediated metabolism of xenobiotics.

There is no evidence of altered pharmacokinetics in patients with liver disease. Since biotin metabolites are inactive, hepatic impairment should not affect safety.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.

High doses of biotin (30 mg/kg/day) have a teratogenic effect in rabbits, while in rats even higher doses are not teratogenic or fetotoxic.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Cellulose, microcrystalline (E 460)

Povidone K 30 (E 1201)

Croscarmellose sodium

Silica, colloidal anhydrous

Magnesium stearate (E 572)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special storage conditions

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

PVC/aluminium blisters in a cardboard box.

The package contains: 10, 20, 30, 60, 90 or 120 tablets.

Not all types of packaging can be placed on the market.

6.6 Special precautions for disposal and handling

There are no special disposal requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Zakłady Farmaceutyczne POLPHARMA SA

street Pelplińska 19, 83-200 Starogard Gdański

Poland

8. MARKETING AUTHORISATION NUMBER(S)

Reg. No.: 20250121

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 27.03.2025