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

Summary of Product Characteristics last updated on the eMC: 14/10/2009
SPC ZAMADOL 24hr 150 (200/300/400)mg TABLETS

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 14/10/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological Properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Changes to the following sections:
 
1:     addition of 'prolonged release tablets' to the name of the medicinal product
 
2:     lactose monohydrate content added 

4.4:  addition of paragraph relating to lactose

4.5:  interaction of tramadol with ondansetron

4.8:  revised Undesirable Effect table

4.9:  addition of outcome of tramadol overdose

5:     Pharmacotherapeutic group added

6.2:  'Not applicable' added

10:   Date of revision of the SPC text 
Updated on 02/09/2008 and displayed until 14/10/2009
Reasons for adding or updating:
  • Improved Electronic Presentation
Date of revision of text on the SPC:   01-Aug-2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

None provided
Updated on 22/09/2005 and displayed until 02/09/2008
Reasons for adding or updating:
  • New SPC for new product
  • SPC Retired pending re-submission

Active Ingredients/Generics

 
   tramadol hydrochloride