Active ingredients: Biotin
BIODERMATIN 5 mg Tablets
BIODERMATIN 20 mg Effervescent granules
Why is Biodermatin used? What is it for?
Pharmacotherapeutic group: Vitamin
Therapeutic indications: Biotin deficiency states
Contraindications When Biodermatin should not be used
Hypersensitivity to the components (active ingredient or excipients) or to other related substances from a chemical point of view.
The Biodermatin 20 mg Effervescent granules package contains 3.234 g of sucrose per sachet; its use is therefore contraindicated in individuals with hereditary fructose intolerance, glucose / galactose malabsorption syndrome or isomaltase insufficiency.
Precautions for use What you need to know before taking Biodermatin
Nothing to report
Interactions Which drugs or foods can modify the effect of Biodermatin
Biotin is inactivated by the avidin contained in the white of the raw egg.
Warnings It is important to know that:
Nothing to report
Dose, Method and Time of Administration How to use Biodermatin: Posology
According to medical prescription
Overdose What to do if you have taken an overdose of Biodermatin
No toxic effects from biotin overdose have been reported.
Side Effects What are the side effects of Biodermatin
The product is very well tolerated, in very rare cases there have been phenomena of intolerance with skin manifestations of the erythematous or urticaroid type.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
It is important to communicate to the doctor the appearance of any undesirable effect, even if not described in the package leaflet.
Expiry and Retention
Shelf life: 5 years from the date of manufacture. The validity period is intended for the product in intact packaging, correctly stored.
Warning: do not use the product after the expiry date shown on the package.
Storage: store at a temperature not exceeding 25 ° C.
Keep this medicine out of the reach and sight of children.
Other Information
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
BIODERMATIN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Biodermatin 5 mg Tablets
Each tablet contains:
Active principle
Biotin 5 mg
Biodermatin 20 mg Effervescent granules
Each sachet of effervescent granules contains:
Active principle
Biotin 20 mg
03.0 PHARMACEUTICAL FORM
Tablets
Effervescent granules
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Deficient states of biotin
04.2 Posology and method of administration
According to medical prescription
04.3 Contraindications
Hypersensitivity to the components (active ingredient or excipients) or to other related substances from a chemical point of view.
The Biodermatin 20 mg Effervescent granules package contains 3.234 g of sucrose per sachet; its use is therefore contraindicated in individuals with hereditary fructose intolerance, glucose / galactose malabsorption syndrome or isomaltase insufficiency.
04.4 Special warnings and appropriate precautions for use
Nothing to report
04.5 Interactions with other medicinal products and other forms of interaction
Biotin is inactivated by avidin contained in the white of raw egg.
04.6 Pregnancy and breastfeeding
The product can be used during pregnancy and breastfeeding
04.7 Effects on ability to drive and use machines
No effects on the ability to drive or use machines have been described.
04.8 Undesirable effects
The product is very well tolerated, in very rare cases there have been phenomena of intolerance with skin manifestations of the erythematous or urticaroid type.
04.9 Overdose
No toxic effects from biotin overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Biotin acts as a prosthetic group of carboxylation enzymes essential for lipid, carbohydrate and amino acid metabolism.
In human tissues and higher organisms, Biotin is a cofactor for the enzymatic carboxylation of four substrates: pyruvate carboxylase, acetyl-CoA carboxylase, propionyl-CoA carboxylase and b-methyl-crotonyl-CoA carboxylase.
Biotin is involved in the synthesis of purine and pyrimidine structures and in the desamination of some amino acids, therefore it is essential for all developing cells, including many bacteria.
05.2 Pharmacokinetic properties
The absorption of Biotin occurs in the first third of the small intestine, mainly in the fasting; its deficiency can be induced very quickly in animals treated with antibacterial drugs that reduce intestinal bacterial flora. The elimination of biotin occurs preferentially via the urine as an unchanged molecule, but a small amount is excreted as bis-norbiotin and biotin sulfoxide.
05.3 Preclinical safety data
Biotin is well tolerated even at high doses and for prolonged treatment periods.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Biodermatin 5 mg Tablets
Sodium stearate 10 mg, Rice starch 185 mg
Biodermatin 20 mg Effervescent granules
Tartaric acid 73 mg; Sodium bicarbonate 98 mg; Citric acid 12 mg; Sucrose 3.234 g; Saccharin 3 mg; Orange flavor 50 mg; Polyvinylpyrrolidone 10 mg
06.2 Incompatibility
Biotin is inactivated by avidin contained in the white of raw egg.
06.3 Period of validity
60 months
06.4 Special precautions for storage
Store below 25 ° C
06.5 Nature of the immediate packaging and contents of the package
Biodermatin 5 mg tablets: primary container: blister; secondary container: case; pack of 30 tablets
Biodermatin 20 mg effervescent granules: primary container: sachet; secondary container: case; pack of 30 sachets
06.6 Instructions for use and handling
Nothing to report
07.0 MARKETING AUTHORIZATION HOLDER
ALLIANCE PHARMA S.r.l. - Viale Restelli 5 - 20124 Milan Italy
08.0 MARKETING AUTHORIZATION NUMBER
Biodermatin 5 mg tablets AIC n ° 010130021
Biodermatin 20 mg effervescent granules, 30 sachets AIC n ° 010130060
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Biodermatin 5 mg tablets: March 1985
Biodermatin 20 mg effervescent granules, pack of 30 sachets: March 2000
Date of last renewal: 1 June 2010
10.0 DATE OF REVISION OF THE TEXT
07/2016
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