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Grunenthal Ltd
2 Stokenchurch Business Park, Ibstone Road, Stokenchurch, Buckinghamshire, HP14 3FE, UK
Telephone: +44 (0)870 351 8960
Fax: +44 (0)870 351 8961
WWW: http://www.grunenthal.co.uk
Medical Information Direct Line: +44 (0)870 351 8960
Medical Information e-mail: medicalinformationuk@grunenthal.com
Medical Information Fax: +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?
Summary of Product Characteristics last updated on the eMC: 04/01/2013
SPC Zydol XL 200 mg tabs

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 04/01/2013 and displayed until Current
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 31/01/2011 and displayed until 04/01/2013
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 13/06/2006 and displayed until 31/01/2011
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
Date of revision of text on the SPC:   14/12/05
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2: cross reference from excipients
Section 4.2: haemodialysis information
Section 4.5: interactions with MAO inhibitors, morphine derivatives, agonists/antogonists
Section 4.6: animal repro tox data, advice not to use during pregnancy or breast-feeding
Section 4.7: addition of blurred vision and dizziness warning
Section 4.8: Comprehensive update to adverse events, format and details
Section 6.5: reference that not all packs marketed
Section 10: date of revision
Updated on 26/07/2005 and displayed until 13/06/2006
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics