NIZORAL CREAM DERM 30G 2%

NIZORAL 2% CREMA

active ingredients

Each gram of cream contains: § active ingredient: ketoconazole 20 mg; § excipients with known effects: propilenglicole and cetilic alcohol. For the full list of excipients see paragraph 6.1.

Excellent

Propilenglycol; stearilic alcohol, cetilic alcohol, polysorbate 60, isopropil miristato, sodium sulfite anidro BP 80, polysorbate 80, sorbitan monostearate, distilled water

Therapeutic indications

§ Skin infections from Candida and dermatophytes (in corporis, cruris, manus, pedis, versicolor). § Treatment of seborrheic dermatitis. Nizoral 2% cream can be used by adults.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Adults Skin infections by candida, tinea corporis, tinea cruris, tinea manus, tinea pedis and tinea (pitiriasi) versicolor: the application of NIZORAL 2% cream once or twice a day on the affected part and immediately surrounding. The duration of the usual treatment is 2-3 weeks in the case of tinea versicolor, 2-3 weeks in the case of yeast, 2-4 weeks in the case of tinea cruris, 3-4 weeks in the case of tinea corporis, 4-6 weeks in the case of tinea pedis. Seborrheic dermatitis: Nizoral 2% cream should be applied on the affected part 1 or 2 times a day. The initial duration of treatment of seborrheic dermatitis is generally from 2 to 4 weeks. The maintenance therapy for seborrheic dermatitis can be applied intermittently (once a week). Treatment at least must be continued until a few days after the disappearance of all symptoms. Diagnosis should be reconsidered if there are no improvements in clinical symptoms after 4 weeks of treatment. Usually, the action of the medicinal product on itching is very fast. Method of administration Topical use. Apply NIZORAL cream on the affected part and immediately surrounding, without occlusion. Pediatric population Safety and effectiveness of NIZORAL 2% cream in children (aged or under 17 years) have not been established.

Conservation

Store at a temperature not exceeding 25°C. Keep out of reach and view of children.

Warnings

NIZORAL cream is not for ophthalmic use. Given the low percutaneous absorption of ketoconazole, systemic side effects should not be expected as a result of the use of the product; despite this, elderly patients, those with positive anamnesis for liver disease and those previously treated with griseofulvina, will be treated very carefully, interrupting treatment in case indicative signs of a liver reaction develop. The long-term use of the medicinal product may give rise to awareness; in such case it is necessary to stop treatment and consult the attending physician. During treatment with NIZORAL cream, if administered simultaneously to a topical corticosteroid, to prevent rebound effect after suspension of prolonged treatment with topical corticosteroids, it is recommended to continue the application of a slight amount of corticosteroids in the morning and to apply NIZORAL cream in the evening; subsequently decrease until suspension the topical dose of corticosteroids in a period of about 2-3 weeks. It is advisable to apply hygienic measures to avoid sources of infection and reinfection. Important information about some excipients NIZORAL cream contains: § propilenglycole: may cause skin irritation; § cetilic alcohol: can cause local skin reactions (e.g. contact dermatitis).

Interactions

No interaction studies have been carried out.

Effects

The following table shows the side effects, including those mentioned above, which have been reported with the use of NIZORAL 2% cream, from clinical studies or post-marketing experiences. The frequency categories found use the following convention: very common (≥ 1/10); common (≥ 1/100 and Classification for Systems and Organs Undesirable effects Pathologies of skin and subcutaneous tissue Town Feeling of skin burning Not common Bollous eruption, contact dermatitis, skin rash, skin exfoliation, sticky skin. Notable Orticaria Systemic pathologies and conditions for the administration site Town Erythema in the administration, itching in the administration. Not common Sanguination in administration, nuisance in administration, Dryness in administration, Inflammation in administration, Irritation in administration, Parestesia in administration, Reaction in administration. Immune system disorders Not common Hypersensitivity Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address “http://www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa”.

Overdosing

Overdose in the course of topical application: the excessive application of product by topical means can give rise to erythema, edema and burning sensation that disappears with the suspension of treatment. Overdose undergoing ingestion: in the event of accidental ingestion to implement support and symptomatic actions.

No suitable and well-controlled studies are available during pregnancy or nursing. After topical application of NIZORAL cream in non-pregnant women, plasma concentrations of ketoconazole are not detectable. There are no associated risks known with the use of NIZORAL cream during pregnancy and lactation.

Source: Farmadati