McNeil Healthcare (Ireland) Ltd

Nizoral 20mg/g Cream.

Ketoconazole 2% w/w (each gram of cream contains 20 mg).

Excipients;

propylene glycol, 20%w/w

stearyl alcohol, 7.5%w/w

cetyl alcohol, 2.0%w/w

For a full list of excipients, see 6.1.

Cream.

White odourless cream.

Nizoral cream is indicated for topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, Tinea cruris, Tinea manus and Tinea pedis infections due to Trichophyton, Microsporum and Epidermophyton species.

Nizoral cream is also indicated for the treatment of cutaneous candidosis (including external application in vulvitis),Tinea (pityriasis) versicolor and in the treatment of seborrhoeic dermatitis, a skin condition related to the presence of Malassezia furfur (previously called Pityrosporum ovale).

For cutaneous administration.

Tinea pedis

Nizoral cream should be applied to the affected areas twice daily. The usual duration of treatment for mild infections is 1 week.

For more severe or extensive infections (e.g. involving the sole or sides of the feet) treatment should be continued until a few days after the disappearance of all signs and symptoms; the usual duration of treatment is 4-6 weeks.

For other infections:

Nizoral cream should be applied to the affected areas once or twice daily, depending on the severity of the infection.

The treatment should be continued until a few days after the disappearance of all signs and symptoms. The usual duration of treatment is:

The usual duration of treatment for seborrhoeic dermatitis is 2-4 weeks, where maintenance therapy is applied once or twice weekly.

The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks. General measures with regard to hygiene should be observed to control sources of infection or re-infection.

Nizoral cream is contra-indicated in patients with a known hypersensitivity to ketoconazole or any ingredient of the cream formulation.

Significant absorption is unlikely after topical application to unbroken skin.

Nizoral cream is not for ophthalmic use.

To prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids it is recommended to continue applying a mild topical corticosteroid in the morning and to apply Nizoral cream in the evening, and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.

None known.

There are no adequate and well controlled studies in pregnant or lactating women. To date, no other relevant epidemiological data are available. Data on a limited number of exposed pregnancies indicate no adverse effects of 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 stated.

The safety of ketoconazole cream was evaluated in 1079 subjects who participated in 30 clinical trials. Ketconazole cream was applied topically to the skin. Based on pooled safety data from these clinical trials, the most commonly reported (1% incidence) ADRs were (with % incidence): application site pruritus (2%), skin burning sensation (1.9%), and application site erythema (1%).

Including the above-mentioned adverse drug reactions (ADRs), the following table displays ADRs that have been reported with the use of ketoconazole cream 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)

Not Known (cannot be estimated form the available

Topical Application

Excessive topical application may lead to erythema, oedema and a burning sensation, which will disappear upon discontinuation of the treatment.

Ingestion

In the event of accidental ingestion, supportive and symptomatic measures should be carried out.

Ketoconazole, a synthetic imidazole dioxolane derivative, has a potent antimycotic activity against dermatophytes such as Trichophyton sp., Epidermophyton floccosum and Microsporum sp. and against yeasts, including Malassezia spp. The effect on Malassezia spp. is very pronounced.

Nizoral cream acts rapidly on pruritus which is commonly seen in dermatophyte and yeast infections, as well as skin conditions related to the presence of Malassezia spp. This symptomatic improvement often occurs before the first signs of healing are observed.

Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral Cream in adults In one study in infants with seborrhoeic dermatitis (n = 19), where approximately 40 g of Nizoral Cream was applied daily on 40% of the body surface area, plasma levels of ketoconazole were detected in 5 infants, ranging from 32 to 133 ng/mL.

Preclinical data reveal no special hazard for humans based on conventional studies including primary ocular or dermal irritation, dermal sensitisation and repeat-dose dermal toxicity. Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day; a dose that is 10 times above the maximum human oral dose on a mg/kg basis and more than 6000 times the plasma detection limit which was not reached in animal topical studies conducted by the Market Authorisation Holder.

Propylene glycol

Stearyl alcohol

Cetyl alcohol

Sorbitan stearate

Polysorbate 60

Isopropyl myristate

Sodium sulphite anhydrous (E221)

Polysorbate 80

Purified water

Not applicable

5 years.

Do not store above 25°C.

Lined aluminium tube with polypropylene screw cap containing either 5 g*, 15 g* or 30 g cream.

* not all pack sizes may be marketed

No special requirements.

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

823/52/2

Date of first authorisation: 10 November 1987

Date of last renewal: 10 November 2007

February 2010