Nizoral 2% 30g cream

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.

ACTIVE INGREDIENTS

Each gram of cream contains: § active ingredient: ketoconazole 20 mg; § excipients with known effects: propylene glycol and cetyl alcohol. For the complete list of excipients see section 6.1.

EXCIPIENTS

Propylene glycol; stearyl alcohol, cetyl alcohol, polysorbate 60, isopropyl myristate, anhydrous sodium sulfite BP 80, polysorbate 80, sorbitan monostearate, distilled water

CONTRAINDICATIONS AND SIDE EFFECTS

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

DOSAGE

Adults Skin infections caused by candida, tinea corporis, tinea cruris, tinea manus, tinea pedis and tinea (pityriasis) versicolor: the application of NIZORAL 2% cream once or twice a day on the affected and immediately surrounding area is recommended. The duration of the usual treatment is 2-3 weeks in the case of tinea versicolor, 2-3 weeks in the case of yeasts, 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 to the affected part 1 or 2 times a day. The initial duration of treatment for seborrheic dermatitis is generally 2 to 4 weeks. Maintenance therapy for seborrheic dermatitis can be applied intermittently (once a week). Treatment should at least be continued until a few days after all symptoms have disappeared. The diagnosis should be reconsidered if no improvement in clinical symptoms is noted after 4 weeks of treatment. Usually, the action of the medicine on itching is very rapid. Method of administration Topical use. Apply NIZORAL cream on the affected part and immediately surrounding it, without occlusion. Pediatric population The safety and effectiveness of NIZORAL 2% cream in children (17 years of age and younger) have not been established.

CONSERVATION

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

WARNINGS

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.

Pathologies of the skin and subcutaneous tissue.

Common - Side effects: Burning sensation of the skin.

Uncommon - Side effects: Bullous rash, contact dermatitis, skin rash, skin exfoliation, sticky skin.

Not known - Side effects: Urticaria.

Systemic disorders and conditions relating to the administration site.

Common - Side effects: Erythema at the administration site, pruritus at the administration site.

Uncommon - Side effects: 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 - Side effects: 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”.

OVERDOSE

Overdose during topical application: excessive application of the product topically can give rise to erythema, edema and burning sensation which disappear when treatment is suspended. Overdose during ingestion: in case of accidental ingestion, implement supportive and symptomatic actions.

PREGNANCY AND BREASTFEEDING

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

EFFECTS ON DRIVING ABILITY

NIZORAL cream does not alter the ability to drive and use machinery.