KETOCONAZOLE

Adults and Adolescents aged over 12:

For use in adults and children over 12 years. Shake the bottle well. Wash the hair or affected areas of the skin with the Shampoo. Leave in contact for 3-5 minutes before rinsing thoroughly.

Treatment of:

Use twice weekly for 2-4 weeks.

Prophylaxis of:

Use once every 1-2 weeks. Do not use more than directed. Paediatric population Safe and effective use in infants and children under the age of 12 years has not been established. Method of administration For topical administration.

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); and not known (cannot be estimated from the available clinical trial data).

Table 1:

Adverse Drug Reactions Adverse Drug Reactions Frequency Category System 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 Application site hypersensitivity Application site 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 2% shampoo and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.

Dandruff is 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.

If the scalp has not cleared within 4 weeks, a doctor or pharmacist should be consulted. 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.

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