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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: 07/06/2010
SPC Benylin Day & Night 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 07/06/2010 and displayed until Current
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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:   27-May-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change: Variation to add an alternative name Sudafed Decongestant & Pain Tablets to the Benylin Day & Night Tablets licence.

Chnages to sections 1 (Name of the medicinal product), 4.4 (Special warnings and precautions for use), 4.5 (Interaction with other medicinal products and other forms of interaction) & 4.6 (Pregnancy and lactation) of the SPC.

Updated on 13/05/2009 and displayed until 07/06/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   30-Apr-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Minor change to SPC section 6.5 (Container type)
Updated on 27/01/2009 and displayed until 13/05/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-Jan-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Licence renewal (change to date of renewal and date of revision of text)
Updated on 03/04/2008 and displayed until 27/01/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   03/2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to MA as a result of integration
Updated on 14/11/2007 and displayed until 03/04/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   10/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

To replace the currently registered pack size of 20 tablets (15 day and 5 night tablets) with a pack size of 16 tablets (12 day and 4 night tablets).
Updated on 09/11/2007 and displayed until 14/11/2007
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 10: Change of the date of the revision of the text
Updated on 14/09/2005 and displayed until 09/11/2007
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 14/09/2005 and displayed until 14/09/2005
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 13/09/2005 and displayed until 14/09/2005
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 09/09/2005 and displayed until 13/09/2005
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 08/09/2005 and displayed until 09/09/2005
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 21/04/2005 and displayed until 08/09/2005
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 24/11/2004 and displayed until 21/04/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 29/09/2004 and displayed until 24/11/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 07/01/2003 and displayed until 29/09/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
Updated on 16/09/2002 and displayed until 07/01/2003
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC