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Winthrop Pharmaceuticals UK Ltd
One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 554 831
E-mail: UK-medicalinformation@sanofi-aventis.com
Medical Information Direct Line: +44 (0)1483 554 101
Medical Information Fax: +44 (0)1483 554 831

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: 17/05/2011
SPC Flagyl 1g Suppositories

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 17/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   11-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


section 4.8 (undeisrable effect)

addition of aseptic meningitis and optic neuropathy/neuritis

 
Updated on 25/03/2011 and displayed until 17/05/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   16-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - brought in line with CCDS
- addition of info about use in patients with active or chronic severe peripheral or central nervous system disease due to the risk of neurological aggravation, as well side effects to look out for.
- warning about darkening of urine
- Cefuroxime info added and mutagenic potential.
Updated on 09/02/2011 and displayed until 25/03/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   31-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 - Updated in line with company core data sheet:

Immune system disorders: fever added
Psychiatric disorders: depressed mood added
Eye disorders: clarification of duration of side effect
Gastrointestinal disorder: clarification of GI disturbances
Skin and subcut tissue disorders: flushing added
Updated on 24/09/2008 and displayed until 09/02/2011
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations
  • 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 4.3 - Contraindications
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   03-Jan-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Completely updated version of SmPC reflecting changes to sections 4.3, 4.5 and 4.8 as well as change in MAH and update of format to QRD template.
Updated on 12/09/2005 and displayed until 24/09/2008
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 25/02/2003 and displayed until 12/09/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 29/08/2001 and displayed until 25/02/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 29/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  metronidazole