KETOPINE DANDRUFF SHAMPOO, BOOTS ANTI-DANDRUFF KETOCONAZOLE

For topical administration. Do not use shampoo more often than directed. Ketopine Dandruff Shampoo is for use in adults including the elderly and adolescents: Wet hair and scalp thoroughly with water. Apply sufficient shampoo to wash the scalp and hair and lather well.

Gently massage it over the entire scalp and leave for 3-5 minutes before rinsing thoroughly. Use shampoo every 3-4 days for 2-4 weeks. There should be a minimum of 3 days between applications.

Prophylaxis:

Use shampoo once every 1-2 weeks

The safety of Ketopine Shampoo was evaluated in 2980 subjects who participated in 22 clinical trials. Ketopine 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 Ketopine Dandruff 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); 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 Application site erythema Application site Administration Site conditions Application site irritation Application site pruritus Application site reaction 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.

Ketopine Dandruff Shampoo may be irritating to mucous membranes of the eyes and contact with this area should be avoided. If the shampoo does get into the eyes, they should be bathed gently with cold water. Long-term treatment with steroids.

Stopping prolonged treatment with steroids requires the gradual reduction of application of the steroid over a period of 2-3 weeks while simultaneously using ketoconazole. This is to prevent the condition flaring up. If the scalp is not cleared within 4 weeks of treatment a doctor or pharmacist should be consulted.

50 % w/w. Benzyl alcohol may cause allergic reactions and mild local irritation. 4 Special warnings and precautions for use Ketopine Dandruff Shampoo may be irritating to mucous membranes of the eyes and contact with this area should be avoided.

If the shampoo does get into the eyes, they should be bathed gently with cold water. Long-term treatment with steroids. Stopping prolonged treatment with steroids requires the gradual reduction of application of the steroid over a period of 2-3 weeks while simultaneously using ketoconazole.

This is to prevent the condition flaring up. If the scalp is not cleared within 4 weeks of treatment a doctor or pharmacist should be consulted. 50 % w/w. Benzyl alcohol may cause allergic reactions and mild local irritation. 60 % w/w.

Sodium laurilsulfate 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 excipients