Palexia SR prolonged release tablets
Last Updated on eMC 08-Aug-2016 View document | Grunenthal Ltd Contact details
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 08-Aug-2016 and displayed until Current
Reasons for adding or updating:
- Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC: 05-May-2016
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
In section 5.1 (pharmacodynamic properties), update made in light of new clinical data.Updated on 15-Oct-2014 and displayed until 08-Aug-2016
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 4.8 - Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 31-Jul-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 4.2:'Elderly patients' replaced by 'Older people'
Section 4.8
Added 'and from post-marketing environment' to 'The table below lists adverse drug reactions that were identified from clinical trials performed with PALEXIA and from post-marketing environment'
Added - Rare adverse reaction of angioedema, anaphylaxis and anaphylactic shock
Added wording on reporting of suspected adverse reactions
Section 5.2:
'Elderly' replaced by 'older'
Updated on 13-Nov-2013 and displayed until 15-Oct-2014
Reasons for adding or updating:
- New individual SPC (was previously included in joint SPC)
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Combined SmPCGrunenthal Ltd
Units 1 and 2 Stokenchurch Business Park, Ibstone Road, Stokenchurch, Buckinghamshire, HP14 3FE, UK
+44 (0)870 351 8960
+44 (0)1494 486298
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?
Active ingredients
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