KETOCONAZOLE

Adolescents and Adults:

Ketoconazole 20mg/g Shampoo is for use in adolescents and adults. Shake the bottle well. Wash the hair or affected areas of the skin with Ketoconazole shampoo. Leave in contact for 3-5 minutes before rinsing thoroughly. * Seborrhoeic dermatitis and dandruff: Treatment of: Use Ketoconazole 20mg/g Shampoo twice weekly for 2-4 weeks.

Prophylaxis of:

Use Ketoconazole 20mg/g Shampoo once every 1-2 weeks. * Tinea (Pityriasis) versicolor: Treatment of: Use Ketoconazole 20mg/g Shampoo once daily for a maximum of 5 days.

Prophylaxis of:

As patches of pityriasis versicolor become more apparent on exposure to the sun, Ketoconazole 20mg/g Shampoo may be used once daily for a maximum of 3 days in a single treatment course before exposure to sunshine.

Paediatric population:

The safe and effective use of Ketoconazole 20mg/g Shampoo in infants and children under the age of 12 years has not been established.

The following table displays ADRs that have been reported with the use of Ketoconazole 20mg/g 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). 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.

To prevent a rebound effect after stopping prolonged treatment with topical corticosteroids, it is recommended to continue applying the topical corticosteroid together with Ketoconazole 20mg/g Shampoo and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.

Seborrhoeic dermatitis and dandruff are often associated with increased hair shedding, and this has also been reported, although rarely, with the use of ketoconazole containing shampoos (see Undesirable Effects). Keep out of the eyes.

If the shampoo should get into the eyes, they should be bathed with cold water. This medicine contains 380 mg sodium laureth sulfate in 1 g. Sodium laureth 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.

Hypersensitivity to ketoconazole or any of the other ingredients of the preparation.