SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Nizoral 2% shampoo

2.    QUALITATIVE AND QUANTITATIVE    COMPOSITION

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

For a full list of excipients, see 6.1

3    PHARMACEUTICAL FORM

Pink viscous shampoo.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as dandruff, seborrhoeic dermatitis and tinea (pityriasis) versicolor.

4.2    Posology and method of administration

For topical administration.

Ketoconazole shampoo 2% is for use in adolescents and adults:

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

Treatment:

Once daily for a maximum of 5 days.

Prophylaxis:

Dandruff and seborrhoeic dermatitis:    Use once every 1-2 weeks.

Once daily for a maximum of 3 days before exposure to sunshine.

4.3. Contra-indications

Known hypersensitivity to ketoconazole or any of the excipients.

4.4 Special warnings and precautions for use

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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral 2% shampoo, to prevent any potential rebound effect.

Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water.

4.5    Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed

4.6    Pregnancy and lactation

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 ketoconazole 2% shampoo to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of ketoconazole 2% shampoo on the whole body. There are no known risks associated with the use of ketoconazole 2% shampoo in pregnancy or lactation.

4.7    Effects on ability to drive and use machines

Not relevant

4.8    Undesirable effects

The safety of ketoconazole 2% shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Ketoconazole 2% 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 Ketoconazole 2% 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)

Not known (cannot be estimated form the available clinical trial data).

	Adverse Drug Reactions
System Organ Class	Frequency Category
	Uncommon		Rare	Not Known
	(>1/1,000 to <1/100)		(>1/10,000 and <1/1,000)
Immune System disorders			Hypersensitvity

Nervous System Disorders		Dysgeusia
Infections and Infestations	Folliculitis
Eye Disorders	Increased lacrimation	Eye irritation
Skin and Subcutaneous Tissue Disorders	Alopecia Dry skin Hair texture abnormal Rash Skin burning sensation	Acne Dermatitis contact Skin disorder Skin exfoliation	Angioedema Urticaria Hair colour changes
General Disorders and Administration Site Conditions	Application site erythema Application site irritation Application site pruritus Application site reaction	Application site hypersensitivity Application site pustules

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:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard.

4.9 Overdose

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.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Imidazole and triazole derivatives ATC Code: D01AC08

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

5.2 Pharmacokinetic properties

Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral 2%shampoo on the scalp. Plasma levels were detected after topical administration of Nizoral 2% shampoo on the whole body.

5.3 Preclinical safety data

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.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sodium lauryl ether sulfate 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 Water purified (Ph. Eur.)

6.2    Incompatibilities

Not applicable

Shelf Life

6.4    Special precautions for storage

Store below 25°C.

6.5    Nature and contents of container

High density polyethylene bottles, containing 120 ml shampoo.

6.6    Special precautions for disposal

No special requirements

7    MARKETING AUTHORISATION HOLDER

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Bucks

HP12 4EG

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 00242/0139

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

10 DATE OF REVISION OF THE TEXT

02/04/2015