Skip to content
SPC Logo

Zydol XL 150mg 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
  • Change to section 10 - Date of revision of the text

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 4.7 - addition 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 150 mg tablets’ updated to ‘ZYDOL XL 150 mg
prolonged release tablets.’

Updated on 14-Jun-2006 and displayed until 31-Jan-2011

Reasons for adding or updating:

  • No reasons supplied

Date of revision of text on the SPC: 01-Dec-2005

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Details of SPC updates:
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-Jul-2005 and displayed until 14-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

Company contact details

Company image
Address

Units 1 and 2 Stokenchurch Business Park, Ibstone Road, Stokenchurch, Buckinghamshire, HP14 3FE, UK

Medical Information e-mail
Medical Information Direct Line

+44 (0)870 351 8960

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?

Active ingredients

tramadol hydrochloride

Legal categories

POM - Prescription Only Medicine

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue