Boots Anti-Dandruff Ketoconazole 2% w/w Shampoo

Ketopine Dandruff Shampoo is indicated for the prevention and treatment of dandruff.

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

Hypersensitivity to ketoconazole or any of the excipients

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.

This medicine contains 5.00 mg benzyl alcohol in each g which is equivalent to 0.50 % w/w. Benzyl alcohol may cause allergic reactions and mild local irritation.

Not known

Ketoconazole is not detected in plasma after chronic shampooing or topical application.

Ketopine Dandruff Shampoo is not contraindicated for pregnancy or lactation, but caution should be exercised.

None.

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

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

In the event of accidental ingestion, supportive and symptomatic measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.

Pharmacotherapeutic (ATC) Classification: D01A C08

Ketoconazole is a synthetic imidazole-dioxalane derivative. It is a broad spectrum antifungal agent which inhibits the growth of common dermatophytes and yeasts by altering the permeability of the cell membrane:

Dermatophytes: Trichophyton rubrum, T. mentagrophytes, T.tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum.

Yeasts: Candida albicans, C tropicalis, Pityrosporum ovale (Malassezia ovale) and Pityrosporum orbiculare (M. furfur).

Ketoconazole also has a direct anti-inflammatory action independent from its antifungal activity which may contribute to symptom relief in dandruff and seborrhoeic dermatitis.

Ketoconazole was not detected in plasma in 39 patients who shampooed 4-10 times per week for 6 months or in patients who shampooed 2-3 times per week for 3-26 months. Twelve hours after a single shampoo, hair samples taken from six patients showed that high amounts of ketoconazole were present on the hair, only about 5% had penetrated into the hair keratin. There were no detectable plasma levels after chronic shampooing twice weekly for two months with ketoconazole.

There is no relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

Sodium Laureth Sulfate Paste 70 %

Disodium Laureth Sulfosuccinate Liquid 40%

Sodium Chloride

Citric Acid Monohydrate

Benzyl Alcohol

Tetrasodium EDTA

Imidazolidinyl Urea (Imidurea)Polyquaternium-7

Dexpanthenol

Laureth-2

Sodium Hydroxide

Erythrosine (E127)

Purified water

Not applicable.

36 months

Do not store above 25 °C.

Store in original container.

Keep container tightly closed.

White High-density polyethylene (HDPE) multi dose bottles with Polypropylene flip top closures.

Pack sizes: 60 ml, 100 ml

All pack sizes may not be marketed.

Not applicable.

No Data Held