KETOCONAZOLE

For topical administration.

Ketoconazole shampoo 2 % is for use in adolescents and adults:

Wash affected areas and leave for 3-5 minutes before rinsing.

Treatment:

Dandruff and seborrhoeic dermatitis : Wash hair twice weekly for 2-4 weeks.

Tinea versicolor :

Once daily for 1-5 days.

Prophylaxis:

Dandruff and seborrhoeic dermatitis : Use once every 1-2 weeks.

The safety of ketoconazole 2% shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Ketoconazole 2% shampoo was administered topically to the scalp and/or skin. Based on pooled safety data from these clinical trials, there were no ADRs reported with an incidence ≥1%.

The following table displays ADRs that have been reported with the use of Ketoconazole 2% Shampoo from either clinical trial or post marketing 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 form the available clinical trial data). Adverse Drug Reactions Frequency CategorySystem Organ Class Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 and <1/1,000) Not Known Immune System disorders - Hypersensitivity - Nervous System Disorders - Dysgeusia - Infections and Infestations Folliculitis - - Eye Disorders Increased lacrimation Eye irritation - Skin and Subcutaneous Tissue Disorders Alopecia Dry skin Hair texture abnormal Rash Skin burning sensation Acne Dermatitis contact Skin disorder Skin exfoliation Angioedema Urticaria Hair colour changes General Disorders and Administration Site Conditions Application site erythema Application site irritation Application site pruritus Application site reaction Application site hypersensitivity Application site pustules - 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/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Ketoconazole 2% shampoo, to prevent any potential rebound effect.

Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water.

Excipient warnings:

This medicine contains 24% w/w sodium lauryl ether sulfate in each application. Sodium lauryl ether sulfate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.

Known hypersensitivity to ketoconazole or any of the excipients.