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McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
Medical Information Direct Line: 01344 864042
Medical Information e-mail: medinfo@its.jnj.com

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: 07/12/2010
SPC Daktarin Aktiv Spray Powder

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 07/12/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Nov-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


To update section 6.6 (Special precautions for disposal) of the SPC, in order to bring it in line with the Council Directive 75/324/EEC for aerosol dispensers
Updated on 01/07/2010 and displayed until 07/12/2010
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Jun-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Nature of change – 6.1  list of excipients, denatured alcohol has been replaced with ethanol
Updated on 17/02/2009 and displayed until 01/07/2010
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:   01-Aug-2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Transfer of licence from Janssen-Cilag Ltd to McNeil Products Ltd
Updated on 19/03/2008 and displayed until 17/02/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 2 – quantitative and qualitative composition

Miconazole nitrate Ph.Eur 0.16% w/w

(Each gram of powder contains 1.6 mg of miconazole nitrate)

 

For excipients, see Section 6.1

Change to section 3 – pharmaceutical form

Cutaneous spray powder

Spray leaving a white powdery residue

 

 

Change to section 6.4 – Special Precautions for Storage

Keep out of reach and sight of children.

Caution Flammable

Pressurised container

Protect from light  

Do not expose to temperatures exceeding 50ºC

 

Change to section 6.5 – Nature and Contents of Container

 

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

Do not pierce or burn, even when empty.

Do not spray on/near a naked flame or incandescent material.

Do not spray near, or place on, polished or painted surfaces.

 

Change to section 10 – Date of revision of the text

 

 13 March 2008

 

Updated on 24/01/2007 and displayed until 19/03/2008
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

REASON(S) FOR SUBMISSION

 

Change

eMC - Summary of Change Details Per Section

 

Change to section 1 – Name of the medicinal product

Daktarin Aktiv Powder (previously Daktarin Dual Action Powder).

Change to section 4.4 – Special Warnings and Precautions for Use

addition of wording re sensitivity

Change to section 4.6 – Pregnancy and Lactation

new sub-heading to paragraph on pregnancy and addition of paragraph re lactation

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

minor wording change only

Change to section 4.8 – Undesirable effects

post marketing data added and information expanded

Change to section 4.9 - Overdose

description of symptoms added

Change to section 5.1 - Pharmacodynamic properties

Pharmacotherapeutic classification and ATC code added

Change to section 5.2 - Pharmacokinetic properties

wording changed to present three distinct subparagraphs: ‘Absorption’, ‘Distribution’ and ‘Metabolism and Excretion’

Change to section 5.3 - Preclinical Safety Data

Reference to Preclinical data added

Change to section 10 – Date of revision of the text

12 January 2007
Updated on 26/08/2004 and displayed until 24/01/2007
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
Updated on 30/04/2004 and displayed until 26/08/2004
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 5.3 - Preclinical Safety Data
  • 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 (partial) revision of the text
Updated on 05/02/2003 and displayed until 30/04/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 20/09/2001 and displayed until 05/02/2003
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 22/08/2001 and displayed until 20/09/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 30/04/2001 and displayed until 22/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  miconazole nitrate