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Zentiva
One Onslow Street, Guildford, Surrey, GU1 4YS
Telephone: +44 (0) 1483505515
Fax: +44 (0) 1483 554831
Medical Information Direct Line: +44 (0) 1483 554101
Medical Information e-mail: UK-medicalinformation@sanofi-aventis.com
Medical Information Fax: +44 (0) 1483 554831

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: 08/11/2011
SPC Topiramate 100 mg film-coated 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 08/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   19-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.2 & 5.2: Sentences sentences related to hard capsules issued from the Topiramate referral. Typographical error - one "sentence" has been removed

4.8: Table 1: "Psychiatric disorders - no ADR hallucination auditory included" is changed to "Psychiatric disorders - an ADR hallucination auditory is added to comply with the Topiramate referral".

6.3: Shelf-life: 2 years has been changed to 2 years for 25mg strength with blister and vials and 50mg, 100mg & 200mg strengths with vial as primary packaging. 3 years for Topiramate 50mg, 100mg and 200mg strengths with blister as primary packaging approved through the variation no. DE/H/1031/002-004/IB/005.
Updated on 10/08/2010 and displayed until 08/11/2011
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   23-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Correction of shelf life from 2 to 3 years
Updated on 20/04/2010 and displayed until 10/08/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   07-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 - change of shelf life of blister packs to 2 years
Updated on 05/11/2009 and displayed until 20/04/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  topiramate