Nizoral 2% 30g cream

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

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

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS FOR USE

NIZORAL cream is not for ophthalmic use. Given the poor percutaneous absorption of ketoconazole, no systemic side effects are to be expected following the use of the product; Despite this, elderly patients, those with a positive history of liver disease and those already previously treated with griseofulvin should be treated with great caution, interrupting treatment if signs indicative of a liver reaction develop. The use of the medicine, especially if prolonged, can give rise to sensitization phenomena; in this case it is necessary to stop treatment and consult your doctor. During treatment with NIZORAL cream, if administered simultaneously with a topical corticosteroid, to prevent the rebound effect after suspension of prolonged treatment with topical corticosteroids, it is recommended to continue the application of a light amount of corticosteroids in the morning and to apply NIZORAL cream in the evening; subsequently decrease the topical dose of corticosteroids until suspension over a period of approximately 2-3 weeks. It is advisable to apply hygiene measures to avoid sources of infection and reinfection. Important information about some excipients NIZORAL cream contains: § propylene glycol: may cause skin irritation; § cetyl alcohol: can cause local skin reactions (e.g. contact dermatitis).

INTERACTIONS

No interaction studies have been performed.

SIDE EFFECTS

The following table shows side effects, including those above, that have been reported with the use of NIZORAL cream 2%, from clinical trials or post-marketing experiences. The frequency categories found use the following convention: very common (≥ 1/10); common (≥ 1/100 and <1/10); uncommon (≥ 1/1,000 and < 1/100); rare (≥1/10,000 and <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available clinical data). The safety of NIZORAL 2% cream was evaluated in 1079 subjects who participated in 30 clinical studies. NIZORAL 2% cream was applied topically to the skin.

System and Organ Classification | Side effects

Pathologies of the skin and subcutaneous tissue

Municipality | Burning sensation of the skin

Uncommon | Bullous rash, contact dermatitis, rash, skin exfoliation, sticky skin.

Not known | Urticaria

Systemic disorders and conditions relating to the administration site

Municipality | Erythema at the administration site, pruritus at the administration site.

Uncommon | Bleeding at the administration site, discomfort at the administration site, Dryness at the administration site, Inflammation at the administration site, Irritation at the administration site, Paraesthesia at the administration site, Reaction at the administration site.

Immune system disorders

Uncommon | Hypersensitivity

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system at “http://www.aifa.gov.it/content/come-segnalare-una-sospetti-reazione-avversa”.