NIZORAL DANDRUFF TREATMENT

For topical administration.

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

Wash affected areas and leave for 3-5 minutes before rinsing. Usually, a palmful of shampoo suffices for one wash.

Treatment:

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

Tinea versicolor:

Once daily for a maximum of 5 days.

Prophylaxis:

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

Tinea versicolor:

Once daily for a maximum of 3 days before exposure to sunshine.

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 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 form the available clinical trial data). System Organ Class Adverse Drug Reactions Frequency Category Uncommon (1/1,000 to <1/100) Rare (≥1/10,000 and <1/1,000) Not Known Immune System disorders Hypersensitvity Nervous System Disorders Dysgeusia Infections and Infestations Folliculitis Eye Disorders Increased lacrimation Eye irritation Skin and Subcutaneous Tissue DisordersAlopecia 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.

Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water. 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 Nizoral Dandruff Treatment 2%w/w Shampoo, to prevent any potential rebound effect.

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

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.

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