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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.co.uk
WWW: http://www.janssen-medinfo.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

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 22/09/2010
SPC Daktarin Oral Gel

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 22/09/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   15-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
removal of P indication.

Removal of refernece to P posology
Updated on 01/09/2010 and displayed until 22/09/2010
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:   25-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 4.8 - Addition of ADRs and clinical trial data. ADRs are presented in a single table.
Change to section 10 - 25 August 2010.
Updated on 25/02/2010 and displayed until 01/09/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Feb-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*

Introduction of a new 30g pack

Change to section 10 – Date of revision of the text

18th February 2010
Updated on 22/10/2008 and displayed until 25/02/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   24-Sep-2008
Legal Category:   POM, P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 6.3 – Shelf Life

Reduced from 60 months to 36 months

Change to section 10 – Date of revision of the text

24th September 2008
Updated on 03/07/2008 and displayed until 22/10/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • 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:   30-Jun-2008
Legal Category:   POM, P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 7 – Marketing Authorisation Holder

New address:

 

50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Change to section 8 – Marketing Authorisation Numbers

 

Change to section 9 – Date of Renewal of Authorisation

 

Change to section 10 – Date of revision of the text

Changed form 28th March 2008 to 30th June 2008
Updated on 07/04/2008 and displayed until 03/07/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2008
Legal Category:   P/POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 4.2 – Posology and |Method of Administration

Increase in age of first use from infants (28 days) to Infants age 4 months

 

Further information on dividing dose into smaller portions

 

Addtion of statement:

 

The lower age limit should be increased by 1-2 months for infants who are pre-term, or infants exhibiting slow neuromuscular development.

 

Change to section 4.3 – Contra-indications

Contraindication in children less than 4 months

 

More detailed information of contra-indicated co-medication.

 

Change to section 4.4 – Special Warnings and Precautions for Use

Addition of information which gives further clarification of special precautions with oral hypoglycaemics and warning on risk of obstruction of throat in young children.

 

Also addition f the statement:

 

The lower age limit should be increased by 1-2 months for infants who are pre-term, or infants exhibiting slow neuromuscular development

 

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

-      More detailed information on possible drug interaction.

Change to section 4.8 – Undesirable effects

Addition of frequency of reporting rates spontaneous reports of spontaneous adverse events icludong immune system disorders. Gastro-intestinal system disorder and heoatobiliary disorders.

Change to section 4.9 - Overdose

Addition of  In the event of accidental ingestion of large quantities of Daktarin an appropriate method of gastic emptying may be used, if considered necessary (See Section 4.5 Interactions with Other Medicinal Products and Other Forms of Interaction.)

Change to section 10 – Date of revision of the text

 28th March 2008

 
Updated on 08/06/2006 and displayed until 07/04/2008
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   25/05/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 2:

Notice to see excipients in section 6.1 added

Section 3:

Pharmaceutical form added.

Section 5.1

ATC code added. Section wording re-ordered. Reference to specific gram positive bacterial species.

Section 5.2

Section extended to describe known Pharmacokinetic properties under the separate heading of absorption, distribution, metabolism and excretion.

Section 5.3

The orginal wording stating 'no additonal information to that contained elsewhere in the SPC have been replaced with 'Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity and toxicity to reproduction.'
Updated on 27/08/2004 and displayed until 08/06/2006
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 18/08/2004 and displayed until 27/08/2004
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/08/2001 and displayed until 18/08/2004
Reasons for adding or updating:
  • Transferred from eMC version 1

Active Ingredients/Generics

 
  miconazole