Janssen-Cilag Ltd

Change to section 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%.

Change to section 10 - Date of revision of the text

12 April 2011

Change to section 4.6 - Pregnancy and Lactation

Animal studies have shown reproductive toxicity at doses that are not relevant to the topical administration of ketoconazole.

Change to section 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.

Change to section 10 - Date of revision of the text

10 March 2011

Change to section 1 -Name of the Medicinal product

Nizoral 2% shampoo

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed

Change to section 4.7 - Effects on Ability to Drive and Use Machines

Not relevant

Change to section 5.1 - Pharmacodynamic Properties

Pharmacotherapeutic group: Imidazole and triazole derivatives

ATC Code:  D01AC08

Change to section 6.1 - List of Excipients

Water purified (Ph. Eur)

Change to section 6. 6 - Instructions for use, handling and disposal

No special requirements

Change to section 10 - Date of revision of the text

25 June 2010

Change to section 4.8 - Undesirable Effects

New updated MeDRA table

Change to section 10 - Date of revision of the text

2 June 2010

Change to section 4.4 – Special Warnings and Precautions for Use

Removal of Increased Hair Shedding wording

Change to section 4.9 - Overdose

Statement updated to add symptomatic measures.

Change to section 10 – Date of revision of the text

25 February 2010

Change to section 1 –Name of the medicinal product

Updated to Nizoral 2% Shampoo

Change to section 2 – quantitative and qualitative composition

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

For a full list of excipients, see 6.1

Change to section 10 – Date of revision of the text

22 April 2009

X

Change to section 4.8 – Undesirable effects

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 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 Shampoo.

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

Very common           ³1/10

Common                   ³1/100 and 
                                   < 1/10

Uncommon               ³1/1,000 and
                                    <1/100

Rare                         ³1/10,000,
                                    <1/1,000

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

  Immune System Disorders

                Very rare         Hypersensitivity

Skin and Subcutaneous Tissue Disorder
Very rare         Alopecia (Also see Section 
                      4.4 under Special Warnings 
                      and Special Precautions For
                      Use), Rash, Urticaria, Skin 
                      irritation, Dry skin

General Disorders and Administration Site Conditions

Very rare          Application site reaction

______________________________________

X

Change to section 10 – Date of revision of the text

January 2009

Change to section 4.6 – Pregnancy and Lactation

New information:

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 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

Change to section 10 – Date of revision of the text

December 2008

X

Change to section 4.3 – Contra-indications

Updated information

X

Change to section 5.2 - Pharmacokinetic properties

Updated information

X

Change to section 10 – Date of revision of the text

September 2008

Change to section 9 – Date of Renewal of Authorisation

Changed to 24 June 2008. Added first authorisation 18 April 1988

Change to section 10 – Date of revision of the text

June 2008

Change to section 1 –Name of the medicinal product

Removed TM

Change to section 2 – quantitative and qualitative composition

For excipients, see 6.1

Change to section 3 – pharmaceutical form

Shampoo

Change to section 10 – Date of revision of the text

June 2007