BIODERMATIN GRAT 30BUST 20MG

BIODERMATIN

active ingredients

Biodermatin 5 mg Tablets Each tablet contains: Active ingredient: Biotin 5 mg. Excipients with known effects: each tablet contains 0.75 mg sodium. Biodermatin 20 mg Effervescent Granulate Each bag of effervescent granulate contains: Active ingredient: Biotin 20 mg. Excipients with known effects: each bag contains 3.234 g sucrose and 26.83 mg sodium. For the full list of excipients, see paragraph 6.1.

Excellent

Biodermatin 5 mg Tablets: Sodium stearate 10 mg, Rice starch 185 mg. Biodermatin 20 mg Effervescent Granulate: Tartaric acid 73 mg: Sodium bicarbonate 98 mg; Citric acid 12 mg; sucrose 3,234 g; saccharin 3 mg; Orange aroma 50 mg; Polyvinylpyrrolidone 10 mg.

Therapeutic indications

Biotin deficiencies

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1, or to other chemically related substances.

Population

Tablets 5 mg: Biotin deficiency states with skin and outbuildings (seborrheic and desquamative skin affections, alopecia, nail fragility) from 5 to 10 mg/die (1-2 tablets per day) up to 4 weeks. For treatments over 4 weeks, supervision by the doctor is required. Congenital deficit of biotin metabolism: 5-20 mg/die (1-4 tablets) up to 40 mg/die (8 tablets) as chronic treatment, to be supervised by your doctor. Effervescent granulate 20 mg: Congenital deficit of biotin metabolism: 10-20 mg/die (half or bag) up to 40 mg/die (2 sachets) as chronic treatment.

Conservation

Do not store at temperature above 25°C.

Warnings

Interference with clinical laboratory tests: Biotin can interfere with laboratory diagnostic tests based on biotin/streptavidine interaction, producing falsely decreased or falsely increased results, depending on the test used. The risk of interference is greater in children and patients with kidney failure and increases when the dose increases. In the interpretation of the results of laboratory tests, biotin interference should be considered, especially if there is a lack of consistency with clinical presentation (e.g., results of thyroid examinations suggesting Graves disease in asymptomatic patients taking biotin or negative false results of troponin examination in patients with myocardial infarction taking biotin). In cases of suspected interference, alternative diagnostic tests are not sensitive to interference with biotin. It is necessary to consult the laboratory staff when preparing laboratory tests in patients taking biotin. Biodermatin 5 mg tablets contains sodium: This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “without sodium”. Biodermatin 20 mg effervescent granulate contains sucrose: Patients with rare hereditary problems of fructose intolerance, glucosegalactose mal absorption, or isomaltase sucrasis failure, should not take this medicine. This medicine contains 3.234 g sucrose per bag. To consider in people with diabetes mellitus. Biodermatin 20 mg effervescent granulate contains sodium: This medicine contains 26.83 mg sodium per sachet, equivalent to 1,34% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult.

Interactions

Biotin is inactivated by the avidine, contained in the albume of the raw egg.

Effects

Rarely there have been phenomena of intolerance with skin manifestations of erythematose or orthyroid type. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.aifa.gov.it/content/segnalazioni-reazioniavverse.

Overdosing

No reported toxic effects from biotin hyperdosage.

The product can be used during pregnancy and nursing

Source: Farmadati