KETOCONAZOLE

For topical administration.

Adults including the elderly and adolescents:

Wet hair and scalp thoroughly with water. Apply sufficient shampoo to produce enough lather to wash the scalp and hair, gently massage it over the entire scalp and leave for 3-5 minutes before rinsing thoroughly.

Seborrhoeic dermatitis and dandruff:

Use Ketoconazole 2% w/w shampoo twice weekly for 2-4 weeks.

Prophylaxis:

Use Ketoconazole 2% w/w shampoo once every 1-2 weeks Pityriasis versicolor: Use Ketoconazole 2% w/w shampoo once daily for a maximum of 5 days.

Prophylaxis:

As patches of pityriasis versicolor become more apparent on exposure to the sun. Ketoconazole 2% w/w shampoo may be used once daily for a maximum of 3 days in a single treatment course before exposure to sunshine.

The safety of Ketoconazole 2% Shampoo was evaluated in 2980 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 postmarketing experiences.

The displayed frequency categories 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, <1/1,000 Very rare <1/10,000, including isolated reports Not known (cannot estimate from the available clinical trial data). 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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 – 3 weeks, while using Ketoconazole 2% w/w shampoo, to prevent any potential rebound effect.

Ketoconazole 2% w/w shampoo may be irritating to mucous membranes of the eyes and contact with this area should be avoided. If Ketoconazole 2% w/w shampoo does get into the eyes, they should be bathed gently with cold water. 50 % w/w.

Benzyl alcohol may cause allergic reactions and mild local irritation.

Hypersensitivity to ketoconazole or any of the excipients.