Nizoral™ Dandruff Shampoo

Ketoconazole 2% w/w.

For excipients, see 6.1.

Pink viscous shampoo.

In the prevention and treatment of the scalp conditions dandruff and seborrhoeic dermatitis.

For topical administration.

Adults, elderly and children:

Wash affected areas and leave for 3 to 5 minutes before rinsing.

Treatment:

Wash the hair every 3 or 4 days for 2 to 4 weeks.

Prophylaxis:

Use once, every 1 to 2 weeks.

Do not use more often than directed.

Known hypersensitivity to ketoconazole or any of the excipients.

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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral Dandruff Shampoo, to prevent any potential rebound effect.

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

None Known.

There are no adequate and well-controlled studies in pregnant or lactating women. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity at doses that are not relevant to the topical administration of ketoconazole. No effects on the breastfed newborn/infant are anticipated. See Pharmacokinetic properties, section 5.2.

Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral Dandruff Shampoo to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Nizoral Dandruff Shampoo on the whole body. There are no known risks associated with the use of Nizoral Dandruff Shampoo in pregnancy or lactation.

None likely.

The safety of Nizoral Dandruff Shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Nizoral Dandruff 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 Nizoral 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

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.

Ketoconazole is a synthetic imidazole dioxolane antimycotic active against yeasts, including Malassezia, and dermatophytes. Its broad spectrum of activity is already well known.

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

Plasma concentrations of ketoconazole were not detectable after topical administration of NIZORAL^® SHAMPOO 2% on the scalp. Plasma levels were detected after topical administration of NIZORAL^® SHAMPOO 2% on the whole body.

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

Sodium lauryl ether sulphate

Disodium monolauryl ether sulphosuccinate

Coconut fatty acid diethanolamide

Laurdimonium hydrolysed animal collagen

Macrogol 120 methyl glucose dioleate

Sodium chloride

Concentrated hydrochloric acid

Imidurea

Sodium hydroxide

Erythrosine sodium (E127)

Purified water

None known.

3 years.

Store below 25°C.

High-density polyethylene bottle containing 60 ml, 100 ml or 120ml Nizoral Dandruff Shampoo.

Not all pack sizes may be marketed.

Not applicable.

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

UK

PL 15513/0311

20/08/2008

15/04/2011