FAZOL Cream Tube/30g

Micronised isoconazole nitrate........................................................................................................................2 g

For 100 g.

Excipients with known effect: butylhydroxyanisole (E320), benzoic acid.

1°) Candidiasis:

Cutaneous candidiasis encountered in human clinical practice is usually due to Candida albicans. However, in the absence of suggestive clinical symptoms, the mere detection of Candida on the skin cannot in itself constitute an indication.

• Treatment:
  • Intertrigo of the major folds, in particular genito-crural, anal, interdigital buttock, axillary, submammary;
  • Intertrigo of the minor folds: interdigital, interdigital toes, angular cheilitis),
  • Vulvitis, anitis.

In some cases, it is recommended to simultaneously treat the digestive tract.

• Adjunctive treatment of onychia and perionychia.

2°) Dermatophytoses:

• Treatment:
  • Dermatophytoses of glabrous skin,
  • Genital and crural intertrigo,
  • Intertrigo of the toes.
• Adjunctive treatment:
  • Tinea,
  • Trichophyton folliculitis.

An associated systemic antifungal treatment is necessary.

3°) Pityriasis versicolor

Dosage

Regular twice-daily application until complete disappearance of the lesions.

The duration of treatment depends on the condition (on average 2 to 4 weeks).

Method of administration

Apply the cream to the lesions to be treated with the fingertips, by gentle massage until complete penetration.

Hypersensitivity to imidazole derivatives or to any of the excipients mentioned in section Composition.

• Avoid any contact with the eyes.
• Candidiasis: use of an acidic pH soap is not recommended (a pH that promotes the multiplication of Candida).

FAZOL, cream contains butylhydroxyanisole (E320)

Butylhydroxyanisole may cause local skin reactions (for example contact dermatitis) or irritation of the eyes and mucous membranes.

FAZOL, cream contains benzoic acid (E210)

Benzoic acid may cause local irritation and increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks).

The occurrence of systemic effects is unlikely given the low rate of absorption through intact skin. However, on damaged skin, over a large area, and in infants (due to the surface-area-to-weight ratio and the occlusive effect of nappies), attention should be paid to this possibility.

Exceptionally, the following have been observed:

• General allergic manifestations, in particular urticaria and Quincke's oedema.
• Local reactions such as pruritus or burning sensations that subside as soon as treatment is stopped.
• Cases of contact eczema (notably related to the presence of butylhydroxyanisole and benzoic acid).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: www.signalement-sante.gouv.fr

Pharmacotherapeutic class: LOCAL ANTIFUNGAL, ATC code: D01AC05

Mechanism of action

Isoconazole nitrate, an imidazole derivative, has both a broad-spectrum fungicidal action and a bactericidal action against Gram-positive organisms.

Isoconazole nitrate is active against:

• Dermatophytes (Trichophyton, Epidermophyton, Microsporum),
• Yeasts (Candida, Pityrosporum),
• Various fungi (Aspergillus, Nocardia, Streptomyces),
• Gram-positive bacilli and cocci (streptococci, staphylococci).

In vivo At a concentration of 10 micrograms/ml, isoconazole nitrate inhibits the multiplication of most pathogenic species.

The fungicidal activity becomes apparent from a concentration of 50 micrograms/ml.

At a concentration of 500 micrograms/ml, fungicidal activity is very rapid, since the proportion of blastospores killed is 92 percent in two hours and more than 99 percent in twenty-four hours.

The active ingredient is concentrated mainly in the stratum corneum, where it reaches fungicidal concentrations. The stratum corneum constitutes a barrier that prevents absorption of isoconazole. Its penetration through intact skin is so low that it could not be measured.

2 years.

No special precautions for storage.