eMC Medicine Guides  
The electronic Medicines Compendium (eMC) contains information about UK licensed medicines.
go to eMC homepage
Search for:  
  Advanced Search

Galen Limited
Seagoe Industrial Estate, Craigavon, Co Armagh, Northern Ireland, BT63 5UA, Ireland
Telephone: +44 (0)28 3833 4974
Fax: +44 (0)28 3835 0206
WWW: http://www.galen.co.uk
Medical Information e-mail: customer.services@galen.co.uk

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: 06/08/2010
SPC Diclomax SR

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 06/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   29-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Sections 6.3, 6.4 and 6.5 - updated to add the approved packaging information relating to Alu-Alu packs.
Updated on 08/01/2010 and displayed until 06/08/2010
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 'Contraindications' 
Section 10 - Date of revision
Updated on 02/11/2009 and displayed until 08/01/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   25-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 'Special warnings and precautions for use' of the SPCs have been updated in line with the guidance documents, issued by the MHRA, on minimum clinical particulars, for non-selective non-steroidal anti-inflammatory drugs for systemic administration.
Updated on 22/07/2009 and displayed until 02/11/2009
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   17-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The changes are to Sections 6.3, 6.4 and 6.5. - To include an additional packaging material with a shelf life of 60 months
Updated on 28/08/2008 and displayed until 22/07/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   22-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

  • In section 4.3 (Contraindications) the following wording has been added 'Diclomax should not be used concomitantly with other NSAIDs including the cyclo-oxygenase-2-specific inhibitors (see section 4.5)
  • In section 4.5 (Interactions with other medicinal products and other forms of interaction the following has been added 'Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of GI bleeding (see section 4.4) and  Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
  • In section 4.8 (Undesirable effects) the following has been added 'Pancreatitis has been reported very rarely' and under 'Cardiovascular and cerebrovascular' the following has been added 'hypertension and cardiac failure have been reported in association with NSAID treatment'.
Updated on 24/06/2008 and displayed until 28/08/2008
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:   05-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 7, (Marketing Authorisation Holder),the Marketing Authorisation Holder has changed from KoGEN to Galen Limited.
In section 10. (Date of Revision of the Text) the date has been changed to 05 June 2008.
Updated on 10/06/2008 and displayed until 24/06/2008
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   10-Jun-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 9: Date changed to 12 January 1995
Secrion 10: Date changed to 10 June 2007
Updated on 10/07/2007 and displayed until 10/06/2008
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  diclofenac sodium