Active ingredients: Biotin (D (+) biotin)
DIATHYNIL TABLETS DIATHYNIL VIALS
Why is Diathynil used? What is it for?
Pharmacotherapeutic group
Vitamin of group B essential for the metabolism of carbohydrates, lipids and purines.
Indications
Seborrheic and desquamative skin affections.
Particularly:
In the adult
Seborrheic dermatitis, acne, alopecia of various kinds.
In the child
Localized dermatitis: diaper rash, red skin folds, cradle cap.
Generalized dermatitis: Leiner-Moussous syndrome.
Ailments related to vitamin deficiency: glossitis with digestive problems.
Contraindications When Diathynil should not be used
Individual ascertained hypersensitivity to D (+) biotin.
Precautions for use What you need to know before taking Diathynil
During the therapy it is advisable to exclude raw egg white from the diet, which contains a protein called avidin which combines with D (+) biotin inactivating it.
Interactions Which drugs or foods can modify the effect of Diathynil
None known.
Warnings It is important to know that:
Use in case of pregnancy and lactation
The drug can be used during pregnancy and breastfeeding.
Dose, Method and Time of Administration How to use Diathynil: Posology
Treatment of alopecia and seborrhoea of the scalp
Attack treatment: inject via i.m. or i.v. one or two ampoules of DIATHYNIL, three times a week for six weeks.
Maintenance treatment: three DIATHYNIL tablets a day for two months.
Other indications: orally or parenteral (s.c., i.m., i.v.)
The use in the infant is facilitated by the solubility of the tablets that can be dissolved in the bottle.
Overdose What to do if you have taken too much Diathynil
Manifestations of overdose intoxication are excluded.
Side Effects What are the side effects of Diathynil
The product is very well tolerated; however, very rare cases of intolerance with erythematous or urticarial skin manifestations have been found.
The appearance of undesirable effects not described in the package leaflet must be reported to the attending physician or pharmacist
Expiry and Retention
Warning: do not use the medicine after the expiry date indicated on the package.
The expiry date indicated refers to the intact package, correctly stored.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH OF CHILDREN
Composition
DIATHYNIL TABLETS
Each tablet contains:
Active principle: D (+) biotin 5 mg.
Excipients: lactose, corn starch, talc, stearic acid, magnesium stearate.
DIATHYNIL VIALS
One 1 mL vial contains:
Active principle: D (+) biotin 5 mg.
Excipients: monosodium phosphate dihydrate, monosodium carbonate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, water p.p.i.
Pharmaceutical forms and packaging
DIATHYNIL tablets: 20 tablets of 5 mg.
DIATHYNIL ampoules: 6 ampoules of 5 mg.
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
DIATHYNIL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
DIATHYNIL 5 mg TABLETS
Each tablet contains
Active principle:
D (+) biotin 5 mg.
DIATHYNIL VIALS
A 1ml vial contains
Active principle:
D (+) biotin 5 mg.
03.0 PHARMACEUTICAL FORM
Oral use tablets.
1 ml vials for i.m., i.v. or s.c.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Seborrheic and desquamative skin affections. Particularly:
- in the adult: seborrheic dermatitis, acne, alopecia of various kinds;
- in the child: localized dermatitis:
diaper rash,
redness of the skin folds,
cradle cap.
Generalized dermatitis:
Leiner-Moussous syndrome.
Ailments related to vitamin deficiency:
glossitis with digestive problems.
04.2 Posology and method of administration
- Treatment of alopecia and seborrhoea of the scalp
Attack treatment: inject via i.m. or i.v. one or two ampoules of DIATHYNIL, three times a week for six weeks.
Maintenance treatment: three DIATHYNIL tablets a day for two months.
- Other indications: orally or parenteral (s.c., i.m., i.v.)
The use in the infant is facilitated by the solubility of the tablets that can be dissolved in the bottle.
04.3 Contraindications
Individual ascertained hypersensitivity to D (+) biotin
04.4 Special warnings and appropriate precautions for use
During the therapy it is advisable to exclude raw egg white from the diet, which contains a protein called avidin which combines with D (+) biotin inactivating it.
Keep this medicine out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
None known.
04.6 Pregnancy and lactation
The drug can be used during pregnancy and breastfeeding.
04.7 Effects on ability to drive and use machines
Nobody.
04.8 Undesirable effects
The product is very well tolerated; however, very rare cases of intolerance with erythematous or urticarial skin manifestations have been found.
04.9 Overdose
Manifestations of overdose intoxication are excluded.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
D (+) biotin constitutes the prosthetic group of carboxylation enzymes essential for the metabolism of carbohydrates, lipids and purines.
05.2 "Pharmacokinetic properties
The absorption of D (+) biotin occurs almost entirely in the fasting and in any case in the first third of the small intestine. D (+) biotin is preferentially eliminated in the urine.
05.3 Preclinical safety data
D (+) biotin is well tolerated even at high doses and for prolonged treatment periods. No side effects due to the administration of D (+) biotin have been reported in the literature.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
DIATHYNIL 5 mg TABLETS
lactose, corn starch, talc, stearic acid, magnesium stearate.
DIATHYNIL VIALS
monosodium phosphate dihydrate, monosodium carbonate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, water for injections.
06.2 Incompatibility
No incompatibility phenomena are known to date.
06.3 Period of validity
Tablets: 5 years
Vials: 5 years.
06.4 Special precautions for storage
None.
06.5 Nature of the immediate packaging and contents of the package
DIATHYNIL 5 mg TABLETS:
carton containing 2 PVC / Al blisters of 10 tablets
carton containing 3 PVC / Al blisters of 10 tablets
DIATHYNIL vials:
carton containing 6 injectable vials of 5 mg in 1 ml
06.6 Instructions for use and handling
07.0 MARKETING AUTHORIZATION HOLDER
Avantgarde S.p.A.
Via Pontina km 30,400 - 00040 Pomezia (Rome)
08.0 MARKETING AUTHORIZATION NUMBER
DIATHYNIL 5 mg TABLETS:
box of 20 tablets - AIC n. 028702013; 1992
box of 30 tablets - AIC n. 028702076
DIATHYNIL vials: box of 6 vials - AIC n. 028702025; 1992
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Authorization: 1992
Renewal: 2007
10.0 DATE OF REVISION OF THE TEXT
March 2015
