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Meda Pharmaceuticals

Sky Way House, Parsonage Road, Takeley, Bishop's Stortford, CM22 6PU
Telephone: 0845 460 0000
Fax: 0845 460 0002
Medical Information Direct Line: +44 (0)1748 828 810
Medical Information e-mail: meda@professionalinformation.co.uk
Medical Information Fax: +44 (0)1748 828 801
Out of Hours contact: +44 (0)1748 828 810

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: 24/08/2011
SPC Eccoxolac

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 24/08/2011 and displayed until Current
Reasons for adding or updating:
  • 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 4.6 - 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
Date of revision of text on the SPC:   21-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 and 5.1 of the SPC in line with the NSAIDs text as per the MHRA recommendation.
Updated on 08/08/2007 and displayed until 24/08/2011
Reasons for adding or 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 4.8 - Undesirable Effects
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 Add the following: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
 
Section 4.4 Warning Inclusion of paragraph on lowest effective dose.  Addition of warnings on cardiovascular and cerebrovascular effects.
 
Section 4.8 Add the following: Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
Updated on 19/09/2006 and displayed until 08/08/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   11/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.1 Excipients
 
Section 7 MAH Holder
 
Section 10 Date of revisison of the text
Updated on 09/06/2005 and displayed until 19/09/2006
Reasons for adding or updating:
  • Change to section 1 - trade name
Updated on 07/07/2003 and displayed until 09/06/2005
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  etodolac