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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral Dandruff Shampoo, to prevent any potential rebound effect.

Seborrhoeic dermatitis and dandruff have been associated with increased hair shedding and this has also been reported, although rarely, with the use of Nizoral Dandruff Shampoo.

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

None Known.

To date, no other relevant epidemiological data are available. 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 following oral administration of ketoconazole. (see Preclinical safety data, section 5.3). No effects on the breastfed newborn/infant are anticipated. See Pharmacokinetic properties, section 5.2.

None likely.

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 Nizoral Dandruff Shampoo.

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

Additional adverse drug reactions reported in postmarketing reports with Nizoral Dandruff Shampoo are included in Table 1. The frequencies are based on spontaneous reporting rates, according to the following convention:

Very common 1/10

Common 1/100 and < 1/10

Uncommon 1/1,000 and <1/100

Rare 1/10,000 and <1/1,000

Very rare <1/10,000, including isolated reports

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.

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.

Not applicable.

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

05/01/2010