NIZORAL

Ketoconazole cream is for use in adults.

Tinea pedis:

Nizoral 2% cream should be applied to the affected areas twice daily. The usual duration of treatment for mild infections is 1 week. For more severe or extensive infections (eg involving the sole or sides of the feet) treatment should be continued until a few days after all signs and symptoms have disappeared in order to prevent relapse.

Seborrheic dermatitis:

Nizoral 2% cream should be applied to the affected areas once or twice daily. The usual initial duration of treatment in seborrheic dermatitis is 2 to 4 weeks. The treatment should be continued until a few days after the disappearance of all signs and symptoms.

The usual duration of treatment is: tinea versicolor 2– 3 weeks, tinea corporis 3–4 weeks. The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks. General measures in regard to hygiene should be observed to control sources of infection or reinfection.

Seborrhoeic dermatitis is a chronic condition and relapse is highly likely.

Method of administration:

Cutaneous administration. Paediatrics There are limited data on the use of ketoconazole 2% cream in paediatric patients.

The safety of ketoconazole cream was evaluated in 1079 subjects who participated in 30 clinical trials. Ketoconazole cream was applied topically to the skin. 9%), and application site erythema (1%). Including the above-mentioned adverse reactions, the following table displays adverse reactions that have been reported with the use of ketoconazole cream from either clinical trial or postmarketing experiences.

The displayed frequency categories use the following convention:

Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not Known (cannot be estimated from the available clinical trial data). Adverse Reactions Frequency Category System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Not Known Adverse Reactions Frequency Category System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Not Known Immune System Disorders Hypersensitivity Skin and Subcutaneous Tissue Disorders Skin burning sensation Bullous eruption Dermatitis contact Rash Skin exfoliation Sticky skin Urticaria General Disorders and Administration Site Conditions Application site erythema Application site pruritus Application site bleeding Application site discomfort Application site dryness Application site inflammation Application site irritation Application site paresthesia Application site reaction 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. uk or search for MHRA Yellow Card in the Google Play or Apple App Store.

Nizoral 2% cream is not for ophthalmic use. If coadministered with a topical corticosteroid, to prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids it is recommended to continue applying a mild topical corticosteroid in the morning and to apply Nizoral 2% cream in the evening, and to subsequently and gradually withdraw the topical corticosteroid therapy over a period of 2-3 weeks.

Nizoral cream contains 6000 mg propylene glycol in each 30 g tube, which is equivalent to 200 mg/g. g. contact dermatitis).

Nizoral 2% cream is contraindicated in patients with a known hypersensitivity to any of the ingredients or to ketoconazole itself.