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Janssen-Cilag Ltd

50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG , UK
Telephone: +44 1494 567 567
Fax: +44 1494 567 568
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +353 1 800 709 122
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +353 1 620 2300
Medical Information Facsimile: +44 (0) 1494 567 445
Summary of Product Characteristics last updated on medicines.ie: 21/06/2011
SPC Daktacort 2% 1% Cream

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

Updated on 21/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   09-Jun-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.4
Addition of hypersenstivityt warning, advice not to come into contact with eye, warning to avoid long-term treatment. Advice that synthetic materila may be damaged if they come into contact with th cream.
Section 4.6 reference to animal studies.
Section 4.8: update to AADR table.
Section 5.2: additional statement regardin absorption in infants.
Section 5.3: Additioh of pre-clinical safety data, originall 'non stated'
Updated on 19/01/2009 and displayed until 21/06/2011
Reasons for adding or updating:
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

4.5

Interaction with other medicinal products and other forms of interaction

Addition of possible interaction with oral hypoglycaemics and phenytoin. Addition of the statement that miconazole can decrease the rate of metabolism of hydrocortisone.

4.8

Undesirable effects

Addition of postmarketing spontaneous report table.

5.2

Pharmacokinetic properties

Addition of Absorption, Distribution and Metabolisn and elimination data

10.

DATE OF REVISION OF THE TEXT

 

Changed to  28th October 2008

Updated on 04/07/2008 and displayed until 19/01/2009
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:   06/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

7.

MARKETING AUTHORISATION HOLDER

Changred from Saunderton address to 50-100 Holmers Farm Way, High Wycombe, Buks, HP12 4EG, UK

 

10.

DATE OF REVISION OF THE TEXT

 

Changed to 30th June 2008

 

Updated on 18/07/2007 and displayed until 04/07/2008
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 1 – trade name

NAME OF THE MEDICINAL PRODUCT

Daktacort™  2% / 1% w/w Cream.

 

Change to section 2 – quantitative and qualitative composition

Miconazole nitrate 2% w/w and hydrocortisone 1% w/w.

 

Contains 0.2% w/w benzoic acid (E210) and 0.0052% butylated hydroxyanisole (E320).

 

For full list of excipients, see section 6.1

Change to section 3 – pharmaceutical form

White, homogeneous, odourless cream.

 

Change to section 4.4 – Special Warnings and Precautions for Use

Continuous treatment for longer than three weeks should be avoided in infants because of the possibility of adrenocortical suppression. Adrenal suppression can occur even without the use of occlusive dressings.

 

Daktacort cream contains benzoic acid, which is mildly irritant to the skin, eyes and mucous membranes. Daktacort cream also contains butylated hydroxanisole, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

 

Change to section 6 – Pharmaceutical Particulars

 

Change to section 6.1 – List of Excipients

Disodium edentate .

 

Change to section 6.2 - Incompatibilities

 Not applicable..

 

Change to section 6.3 – Shelf Life

 

Change to section 6.4 – Special Precautions for Storage

Store in a refrigerator ( 2-8°C).

Change to section 6.5 – Nature and Contents of Container

 

Change to section 6.6 –  Instructions for use, handling and disposal

No special requirements.

 

Change to section 7 – Marketing Authorisation Holder

 

Change to section 8 – MA number

 

Change to section 9 – Date of Renewal of Authorisation

16 December 1996 / 16 December 2006

 

Updated on 14/06/2007 and displayed until 18/07/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 4.2 – Posology and Method of Administration

For topical administration changed to For cutaneous administration

 

Change to section 4.4 – Special Warnings and Precautions for Use

Addition of:

As with any topical corticosteroid, care is advised with infants and children when Daktacort is to be applied to extensive surface areas or under occlusive dressings including baby napkins. Similarly application to the face should be avoided.

 

Continuous treatment for longer than three weeks should be avoided in infants because of the possibility of adrenocortical suppression.  Adrenal suppression can occur even without the use of occlusive dressings.

 

Change to section 4.6 – Pregnancy and Lactation

The product should not be used during pregnancy unless considered essential by the physician.

 

Addition of;

Caution is also recommended during lactation.  Treatment of large surfaces and the application under occlusive dressing should be avoided during that time.

 

Change to section 10 – Date of revision of the text

June 2007

Updated on 04/09/2006 and displayed until 14/06/2007
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   08/2005
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

1.

NAME OF THE MEDICINAL PRODUCT

Daktacort™ Cream. – Name no longer upper case

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Miconazole nitrate 2% w/w and hydrocortisone 1% w/w.

 

For excipients, see section 6.1.

 

For excipients, see section 6.1. – has been added

 

 

3.

PHARMACEUTICAL FORM

Cream.

 

The cream is white and homogeneous.

 

The cream is white and homogeneous. – has been added

4.5

Interaction with other medicinal products and other forms of interaction

None stated

Changed from Not applicable

6.1

List of excipients

Macrogol ester

Oleoyl macroglycerides Ph. Eur.

Liquid paraffin

Benzoic acid (E210)

Sodium edentate Ph.Eur.

Butylated hydroxyanisole (E320)

Purified water

6.4

Special precautions for storage

Store at 2-8°C. ‘in a refrigerator’ removed

 

7.

MARKETING AUTHORISATION HOLDER

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire

HP14 4HJ

UK

 

 

UK added

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

16 December 1996 / 16 December 2001

 

 

10.

DATE OF REVISION OF THE TEXT

 

August 2005

 

 

Updated on 09/08/2004 and displayed until 04/09/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 25/05/2004 and displayed until 09/08/2004
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5 - Pharmacological properties
  • Change to section 10 - Date of revision of the text
Updated on 21/07/2003 and displayed until 25/05/2004
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 05/06/2003 and displayed until 21/07/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Hydrocortisone
   Miconazole nitrate