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Otsuka Pharmaceuticals (UK) Ltd
3 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1EZ, UK
Telephone: +44 (0)20 8756 3100
Fax: +44 (0)20 8848 0529
WWW: http://www.otsuka-europe.com
Medical Information e-mail: otsuka@medinformation.co.uk

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: 03/09/2009
SPC Pletal 50 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 03/09/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   01-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


 

  • Amendment of indication wording (section 4.1 “Therapeutic indications”) + adaptation to QRD template 
  • Amendment of information on treatment duration for non-responder (section 4.2 Posology) 
  • Adaptation of wording on pregnancy and lactation to QRD template (section 4.3 “Contraindications” + 4.6 “Pregnancy and lactation”)
  • Revision of information on CYP-metabolism and interactions (sections 4.3 “Contraindications” + 4.4 “Special warnings” + 4.5 “Interactions” + 5.2 “Pharmacokinetic properties”): removal of contraindication in patients taking inhibitors of CYP3A4 and CYP2C19; information added into sections 4.4 and 4.5
  • Modification of wording regarding concomitant aspirin dosage, anti-platelets and bleeding (sections 4.3 “Contraindications” + 4.4 “Special warnings” + 4.5 “Interactions”): removal of contraindication in patients who have had surgery within previous three months
  • Adaptation of section 4.8 “Undesirable effects” to MedDRA terms
  • Update and revision of sections 5.1 “Pharmacodynamic properties” and 5.3 “Preclinical safety data”: Phase IV study data added to section 5.1
Updated on 18/03/2008 and displayed until 03/09/2009
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   12/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Black Triangle has been removed as it no longer applies
Updated on 05/09/2006 and displayed until 18/03/2008
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 07/07/2006 and displayed until 05/09/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   05/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Update section 4.4 and 4.8
Updated on 20/12/2005 and displayed until 07/07/2006
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations

Active Ingredients/Generics

 
  cilostazol