Daiichi Sankyo UK Limited

Chiltern Place, Chalfont Park, Gerrards Cross, Buckinghamshire, SL9 0BG, UK
Telephone: +44 (0)1753 482 771
Medical Information Direct Line: +44 (0)1753 482 771
Medical Information e-mail: medinfo@daiichi-sankyo.co.uk
Customer Care direct line: +44 (0)1753 482 771
Medical Information Fax: +44 (0)1753 893 894
Out of Hours Telephone: +44 (0)1748 828 818

Summary of Product Characteristics last updated on the eMC: 18/10/2011
SPC OLMETEC Plus 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 18/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   12-May-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Various changes to the notified sections following a renewal procedure. Please refer to document.

Updated on 06/01/2010 and displayed until 18/10/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   25-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

None provided
Updated on 14/12/2009 and displayed until 06/01/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • 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:   25-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Section 2 (Qualitative and Quantitative Composition): Information on lactose content added
Setion 4.2 (Posology and method of administration):  Revised information - hepatic impairment
Section 4.3 (Contraindications):  Deletion of 'lactation'
Section 4.4 (Special warnings and precautions for use):  Revised information - hepatic imairment; pregnancy
Section 4.6 (Pregnancy and lactation): Revised information in line with PhVWP wording
Section 4,8 (Undesirable effects): Updated in line with post-marketing data; revised format
Section 5.2 (Pharmacokinetic properties):  Statement on hepatic impairment revised
Section 10 (Date of revision of text):  Updated to 25 October 2009 
Updated on 14/11/2006 and displayed until 14/12/2009
Reasons for adding or updating:
  • Company name change or merger
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Section 7 Marketing Authorisation Holder - Updated from Sankyo Pharma UK Ltd to Daiichi Sankyo UK Ltd; Change of Address

Updated on 07/11/2006 and displayed until 14/11/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Pending awaiting re-submission
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.2  Dosage statement regarding the Elderly has been amended.  Renal impairment - additional cross-reference to Section 4.4.
 
Section 4.4  Addition of statement regarding lactose.
 
Section 4.8  Additional information on special populations:  'In elderly patients the frequency of hypotension is slightly increased from rare to uncommon.'
 
Section 5.2  Additional statement regarding the Elderly.
Updated on 26/09/2006 and displayed until 07/11/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

7.  Marketing Authorisation Holder has been changed from Sankyo Pharma UK Ltd to Daiichi Sankyo UK Ltd; new Company Address.
Updated on 06/06/2006 and displayed until 26/09/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 26/04/2006 and displayed until 06/06/2006
Reasons for adding or updating:
  • New SPC for new product

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