Janssen-Cilag Ltd

50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen-cilag.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550
Summary of Product Characteristics last updated on the eMC: 02/03/2010
SPC Nizoral 2% Shampoo

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 02/03/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   25-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



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

Updated on 13/01/2010 and displayed until 02/03/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   05-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Change to section 6.5 – Nature and Contents of Container

Removal of sachet presentations

Change to section 10 – Date of revision of the text

05 January 2010

Updated on 18/05/2009 and displayed until 13/01/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



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

Updated on 28/01/2009 and displayed until 18/05/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



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

Table 1.  Adverse Drug Reactions Identified During Postmarketing Experience with NIZORAL® SHAMPOO by Frequency Category Estimated from Spontaneous Reporting Rates

  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

Updated on 16/12/2008 and displayed until 28/01/2009
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



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

Updated on 21/10/2008 and displayed until 16/12/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   01-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



X

Change to section 4.3 – Contra-indications

Updated information
Updated on 24/09/2008 and displayed until 21/10/2008
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



X

Change to section 5.2 - Pharmacokinetic properties

Updated information

X

Change to section 10 – Date of revision of the text

September 2008

Updated on 30/06/2008 and displayed until 24/09/2008
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



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

Updated on 16/04/2008 and displayed until 30/06/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 7 – Marketing Authorisation Holder

New Address

Change to section 10 – Date of revision of the text

April 2008

Updated on 18/06/2007 and displayed until 16/04/2008
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

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

Updated on 29/11/2006 and displayed until 18/06/2007
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

 

3.

PHARMACEUTICAL FORM

Change liquid to shampoo

4.1

Therapeutic Indications

Replace pityrosporum with malassezia.

Replace pityriasis with tinea

4.2

Posology and method of administration

Replace pityriasis with tinea

4.4

Special Warnings and Precautions for Use

Add in new paragraph.

4.5

Interaction with other medicinal products and other forms of interaction

Replace paragraph with None Known

4.8

Undesirable effects

Add in 2 sentences

5.1

Pharmacodynamic properties

Replace Pityrosporum with Malassezia

6.4

Special precautions for storage

Store below 25C

6.5

Nature and contents of container

Add not all pack sizes are marketed

8.

MARKETING AUTHORISATION NUMBER(S)

Add 0

10.

DATE OF REVISION OF THE TEXT

Date is Nov 2006

Updated on 23/08/2001 and displayed until 29/11/2006
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
   ketoconazole


© 2010 Datapharm Communications Ltd

Go to www.medicines.org.uk