Zydol XL 200 mg tabs
Last Updated on eMC 11-May-2017 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 11-May-2017 and displayed until Current
Reasons for adding or updating:
- Change to section 5.1 - Pharmacodynamic properties
- 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: 05-May-2017
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 5.1: Pharmacodynamic properties
Information on paediatric population included
Section 5.2: Pharmacokinetic properties
Information on paediatric population included
Section 10: Date of revision of the text
05 May 2017
Updated on 24-Jul-2014 and displayed until 11-May-2017
Reasons for adding or updating:
- Change to section 4.7 - Effects on ability to drive and use machines
Date of revision of text on the SPC: 11-Jul-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
section 4.7addition of drug driving warning in line with MHRA directions
Updated on 28-Feb-2014 and displayed until 24-Jul-2014
Reasons for adding or updating:
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 14-Feb-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 4.8:hypoglycaemia added as adverse event of unknown frequency
Updated on 04-Jan-2013 and displayed until 28-Feb-2014
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC: 30-Nov-2012
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 4.2: Dosing in Geriatric patients and patients with renal insufficiency/hepatic impairment has been revised to provide specific details.
Section 4.5: Interaction by concomitant use of tramadol and serotonergic drugs has been revised to provide further clarity.
Updated on 31-Jan-2011 and displayed until 04-Jan-2013
Reasons for adding or updating:
- Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC: 08-Oct-2010
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 1 -‘ZYDOL XL 200 mg tablets’ updated to ‘ZYDOL XL 200 mg prolonged release tablets.’
Updated on 13-Jun-2006 and displayed until 31-Jan-2011
Reasons for adding or updating:
- Change to section 2 - qualitative and quantitative composition
- Change to section 4.2 - Posology and Method of Administration
- Change to section 4.5 - Interactions with other Medicaments 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 6. 5 - Nature and Contents of Container
- Change to section 10 (date of (partial) revision of the text
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Updated on 26-Jul-2005 and displayed until 13-Jun-2006
Reasons for adding or updating:
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Grunenthal 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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