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_Levelina Crema

Levelina crema

Bifonazole.

Topical antimycotic with a wide spectrum of actions.

1 application per day.

    Tube with 30 g of cream.

    Financed by the S.N.S.

    N.C. 693838.6

Unless advised otherwise by a doctor: Levelina (Bifonazol) is applied once a day, preferably before going to bed, spreading a small amount of cream on the affected area. Generally it is sufficient to apply a few drops for an area the size of your hand. To hygienically support the treatment it is advisable to carefully wash and dry the affected area.

To obtain lasting results treatment with LEVELINA (Bifonazol) should not be interrupted after the symptoms have disappeared, but should be continued for a determined period of time:

Interdigital mycosis of the foot and athlete’s foot: 3 weeks

Mycosis of the body, hands and cutaneous complaints (ringworm etc.): 2-3 weeks

Pitiriasis versicolor and Erythrasma: 2 weeks

Superficial cutaneous candiadiasis: 2-4 weeks

LEVELINA CREMA
Bifonazol
Cutaneous use

COMPOSITION

Per 100g
Bifonazol (D.C.I) 1g.
Excipients: polyethylenglycol 400, polyoxyethylene stereate 40,  cetilstearyl alcohol, mineral oil, white Vaseline, carbomer 934P, sodium hydroxide, Disodium EDTA, methylparaben, propylparaben, and deionized water, c.s.

PHARMACEUTICAL FORM AND CONTENT OF PACKET:
LEVELINA CREMA, cream 30g tube.

ACTION

LEVELINA (Bifonazol) is a broad spectrum antimycotic which deals with dermatophytes, yeasts, mold and other fungal infections such Malessezzia furfus; it is also effective against Corynebacterium minutissimum. Action against dermatophytes (e.g. Trichophyton spp.) is fundamentally fungicidal in vitro, and in yeasts it is strongly fungistatic.

NAME OF PERSON OR ENTITY AUTHORIZED FOR COMMERCIALIZATION AND PRODUCTION OF THIS PRODUCT:
Laboratorios ERN, S.A. Pedro IV, 499-08020 Barcelona, España

INDICATIONS

Skin mycosis caused by dermatophytes, yeasts, molds, and other fungi, such as Malessezia furfur and Corynebacterium minutissimum.
These could be, for example; Mycosis of the feet and hands (e.g. athlete´s foot, ringworm of the hands) Mycosis of the body and cutaneous complaints (e.g. ringworm), Pitiriasis versicolor, Erythrasma, candida balanitis.

COUNTERINDICATIONS

Hypersensibility to bifonazol.

PRECAUTIONS

In known hypersensitivity to cetylstearyl alcohol, one of the cream’s excipients, it is advisable to use one of Levelina’s other forms, to avoid possible allergic reaction.

INCOMPATIBILITIES

None have been described.

DOSAGE

Unless advised otherwise by a doctor: Levelina (Bifonazol) is applied once a day, preferably before going to bed, spreading a small amount of cream on the affected area. Generally it is sufficient to apply a few drops for an area the size of your hand. To hygienically support the treatment it is advisable to carefully wash and dry the affected area. To obtain lasting results treatment with LEVELINA (Bifonazol) should not be interrupted after the symptoms have disappeared, but should be continued for a determined period of time:

Interdigital mycosis of the foot and athlete’s foot: 3 weeks
Mycosis of the body, hands and cutaneous complaints (ringworm etc.): 2-3 weeks
Pitiriasis versicolor and Erythrasma: 2 weeks
Superficial cutaneous candiadiasis: 2-4 weeks

OVERDOSE AND ITS TREATMENT

Given the concentration of the active principle and the form of administration, intoxication is not possible even in the case of accidental ingestion.
In the event of overdose or accidental ingestion consult El Servicio de Información Toxocológica. Tel 91 562 04 20.

ADVERSE REACTIONS

In rare cases light cutaneous reactions may appear. Any adverse reaction which is not described in the medication guide should be reported to your doctor.

EXPIRY
This medicine should not be used after the expiry date indicated on the packaging

PRESCRIPTION ONLY

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

TITULAR AUTHORIZED FOR COMMERCIALIZATION
Laboratorios ERN, S.A. Pedro IV, 499-08020 Barcelona, España

RESPONSIBLE FOR MANUFACTURING
Laboratorios ERN, S.A. Polígono Industrial Can Salvatella, c/ Gorcs i Lladó, 188 Barberá de Vallés. Barcelona. España
Laboratorios ERN, S.A. c/ Perú, 228 - 08020 Barcelona. España

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