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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: 21/07/2010
SPC Benylin Four Flu tablets

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 21/07/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   03-Jul-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Revision to section 6.1 inline with minor change to coating process
Updated on 07/06/2010 and displayed until 21/07/2010
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:   25-May-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change: To section 6.5. To remove reference to 3 strips of 8 tablets (the product is actually supplied as 2 strips of 12 tablets) and a further update to section 6.5 from a recently granted variation to remove non-child resistant foil from the licence. Also renewal of the marketing authorisation for an indefinite period.
Updated on 20/08/2009 and displayed until 07/06/2010
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 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 10 date of revision of the text
Date of revision of text on the SPC:   30-Jul-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Reason for change: To update sections 4.1 (Therapeutic indications), 4.2 (Posology and method of administration), 4.3 (Contraindications), 4.4 (Special warnings and precautions for use), 4.5 (Interaction with other medicinal products and other forms of interaction) and 4.8 (Undesirable effects) of the SPC in response to the MHRA’s letter of 18 February 2009, relating to recent advice from the UK Commission on Human Medicines (CHM) regarding appropriate use of OTC Cough and Cold products in children.

 
Updated on 20/04/2009 and displayed until 20/08/2009
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 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
Date of revision of text on the SPC:   23-Mar-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


SPC changes resulting from MHRA review of paediatric cough & colds medicines:

http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON038908
Updated on 03/04/2008 and displayed until 20/04/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   03/2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to MA as a result of integration
Updated on 15/09/2006 and displayed until 03/04/2008
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   08/2005
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 10 Change to date of revision of text
Updated on 21/04/2005 and displayed until 15/09/2006
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/09/2004 and displayed until 21/04/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 16/01/2004 and displayed until 29/09/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 16/09/2002 and displayed until 16/01/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 24/08/2001 and displayed until 16/09/2002
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC