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Daktacort 2% 1% w/w Cream

Product Information *

  • Company:

    Janssen Sciences Ireland

  • Status:

    No Recent Update

  • Active Ingredients * :

    Hydrocortisone Miconazole nitrate

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
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When a pharmaceutical company changes any document, 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 05 November 2020

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Updated inline with QRD template and/or excipient guideline

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updated SmPC in line with revised excipient guideline.

Updated on 05 November 2020

Reasons for updating

  • Change to section 2 - excipient warnings

Free text change information supplied by the pharmaceutical company

Updated PIL in line with revised excipient guidelines.

Updated on 02 October 2019

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 12 April 2019

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 12 April 2019

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 May 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 04 May 2018

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 03 May 2018

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

1. Addition of the following in section 4.4:

Visual disturbance
 

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

2. Addition Vision, 'blurred (also see section 4.4)' in section 4.8 under System Organ Class 'Eye disorders' with frequency of 'Not Known'.

 

 

Updated on 12 November 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 12 November 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updated wording of section 4.4 to clarify warning of concurrent use of vaginal anti-infective preparations with latex contraceptive agents such as condoms and diaphrapms.

Updated section 4.8 side effect reporting statement to reflect change from IMB to HPRA.

Updated on 12 November 2015

Reasons for updating

  • New PIL for new product

Updated on 12 November 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 23 May 2014

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.1: delete Daktarin cream
4.2: Wording added re duration of treatment, thinning of the skin and paediatrics
4.3: Additional contraindication
4.4: Contact should be avoided with latex products
4.6: Embryotoxic at maternal toxic doses.  Breast-feeding section added.
4.9: Skin irritation with prolonged use. Removal of gastric empyting.
5.1: ATC code added.  Clinical efficacy information added and information on hydrocortisone
6.2: Contact should be avoided with latex products
10: 22 May 2014

Updated on 22 May 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 01 May 2014

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.3: addition of hypersensitivity to other imidazole derivatives
4.6: clarification of wording
4.8: Term 'ADR' changed to 'adverse reaction' and addition of reporting of suspected adverse reactions wording
6.1: spelling correction to disodium edetate
10: 29 April 2014

Updated on 29 April 2014

Reasons for updating

  • Change of contraindications
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 14 January 2013

Reasons for updating

  • Change of contraindications
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 21 June 2011

Reasons for 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

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 15 June 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 08 January 2010

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 19 January 2009

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 19 January 2009

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

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 July 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

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 04 July 2008

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 19 July 2007

Reasons for updating

  • Change of trade or active ingredient name
  • Change of inactive ingredient
  • Change of manufacturer
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to date of revision

Updated on 18 July 2007

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

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 June 2007

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

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 September 2006

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

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 20 September 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 09 August 2004

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 25 May 2004

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 21 July 2003

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)