Ketopine Dandruff Shampoo

Superdrug Anti-Dandruff Shampoo

Numark Anti-Dandruff Shampoo

Boots Anti-Dandruff Ketoconazole 2% w/w Shampoo

Each gram of shampoo contains 20 milligrams of Ketoconazole.

For excipients see 6.1

Shampoo

Pink viscous shampoo.

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

For topical administration.

Do not use shampoo more often than directed.

Adults including the elderly and children:

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.

On rare occasions when using Ketopine Dandruff Shampoo to treat pityriasis capitis (dandruff), an increase in normal hair loss and irritation associated with this condition may occur.

If the scalp is not cleared within 4 weeks of treatment a doctor or pharmacist should be consulted

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.

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

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

None.

As with other shampoos, a local burning sensation, itching, or contact dermatitis (due to irritation or allergy) may occur on exposed areas. Oily and dry hair have been reported rarely with the use of Ketopine Dandruff Shampoo.

In rare instances, mainly in patients with chemically damaged hair or grey hair, a discolouration of the hair has been observed.

In the event of accidental ingestion, only supportive 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 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

Quaternium-15

Polyquaternium-7

Dexpanthenol

Laureth-2

Sodium Hydroxide

Erythrosine (E127)

Perfume

Purified water

Not applicable.

27 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

Pinewood Laboratories Limited

Ballymacarbry

Clonmel

Co. Tipperary

Ireland

PL 04917/0063

10.10.2003 / 26.03.2009

26/03/2009