BIFUNAL 1% cream 15 g.

COMPOSITION 
Drug in mg cream: Bifonazol 0,01 g
Excipients: octyldodecanol, cetostearyl alcohol; cetyl wax, sorbitan; polysorbate, benzyl alcohol, prechistena.voda
 
PHARMACEUTICAL FORM AND CONTENTS
Bifimal® cream 15 g in aluminum tube, 1 tube per carton Bifunal cream 30 g in aluminum tube 1 tube in a cardboard box
 
NAME AND ADDRESS OF THE MARKETING AUTHORISATION
"Balkanpharma Razgrad" AD Blvd. "April Uprising" N 68 7200 Razgrad, Bulgaria
 
ACTION
Bifunal is an antifungal product belonging to: Group. imidazoles - synthetic compounds izprlzvani successfully to treat the surface and / or organic mycoses. In contrast to other similar products, it is retained longer in the skin at the active antifungal concentrations and has twice longer active. In contrast with other topical medications, clinical effect of the treatment with Bifunal can be achieved by once daily administration.
 
INDICATIONS
Acute and chronic tinea hairy and hairless skin areas:
• fungal infections of the skin, in the spaces between the fingers and superficial mycoses by the applicant;
• pityriasis verzikolor;
• Skin mycoses caused by fungi;
• eritrazma;
Diseases of the skin, which secondarily infected by the same fungus - interdigitating mycoses, mycoses of the skin or folds in the skin, superficial candidiasis of the skin.
 
NECESSARY INFORMATION prelate USE
 
CONTRAINDICATIONS
Hypersensitivity to imidazole antifungal products and excipients in the formulation.
 
SPECIAL PRECAUTIONS FOR USE
Do not use bandages in use of the product, due to the risk of flushing and development of yeast.
Avoid contact with eyes Bifunal!
Please note that in the treatment of large areas of skin and / or damaged surfaces, it is possible, in intrusion .organizma, and effects on many organ systems.
 
DRUG INTERACTIONS AND OTHER
No evidence of interactions with concomitantly-Bifunal with other medicinal products.
 
SPECIAL WARNINGS FOR USE in specific patient groups
 
Bifunal cream is not recommended during the first three months timeliness, although not showing damaging effect in animals. The product is not on the breasts during lactation.
 
EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
Bifunal not affect the ability to drive and use machines.
 
DETAILS OF OTHER SUBSTANCES
Do not use in infants and should not be applied to mucous membranes due to the presence of benzyl alcohol in the composition of the excipients.
 
INFORMATION FOR PROPER USE DOSAGE
Bifunal cream is applied once daily, preferably at bedtime. On previously cleaned and dried ill area of skin spread a thin layer of product (1 cm of cream area the size of a palm) and gently rubbed. When applying the cream needs to be extended to about mm of healthy areas. To achieve a lasting effect of treatment needed long enough application - at least 1-2 weeks after the symptoms disappear.
The duration of treatment is estimated at a total of: 3 weeks - Tinea pedum, Tinea pedis interdigitalis; 2-3 weeks - Tinea corporis, Tinea inguinalis, Tinea manuum; 2-4 weeks - Surface candidiasis, two weeks - Pityriasis versicolor, Erythrasma.
 
ACTION OVERDOSE
Following topical application of skin cream Bifunal penetration is low and does not elicit symptoms from different organs and systems. There is no danger of overdosing.
 
SIDE EFFECTS:
Bifunal cream has very good local, tolerance. Only in very rare cases may occur temporary skin reactions such as mild redness, burning, irritation and flaking. Can be observed contact dermatitis, which resolved after discontinuation of therapy. In case of wounds, treatment should be discontinued. These reactions can result from shvarchuvstvitelnost against aids.
 
STORAGE
Dry and protected from direct sunlight at temperatures below 25 ° C
SHELF LIFE
Three (3) years