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Eli Lilly and Company Limited
Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL
Telephone: +44 (0)1256 315 000
Fax: +44 (0)1256 775 858
WWW: http://www.lilly.co.uk
Medical Information e-mail: ukmedinfo@lilly.com
Medical Information Fax: +44 (0)1256 775 569

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: 02/11/2011
SPC Efient 5mg & 10mg film-coated tablets (Eli Lilly and Company Ltd Daiichi Sankyo UK Limited)

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 02/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   24-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


4.         Clinical particulars

4.4       Special warnings and precautions for use

 

Deleted:

 

Therapeutic experience with prasugrel is limited in Asian patients. Therefore, prasugrel should be used with caution in these patients.

 

 

 

5.         PHARMACOLOGICAL PROPERTIES

 

5.1       Pharmacodynamic properties

 

Added:

 

Results of a pharmacodynamic/pharmacogenomic study in 720 Asian ACS PCI patients demonstrated that higher levels of platelet inhibition are achieved with prasugrel compared to clopidogrel, and that prasugrel 60-mg loading dose/10-mg maintenance dose is an appropriate dose regimen in Asian subjects who weigh at least 60 kg and are less than 75 years of age (see section 4.2).

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

24 October 2011
Updated on 06/05/2011 and displayed until 02/11/2011
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   20-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


4.         Clinical particulars

4.4       Special warnings and precautions for use


Hypersensitivity including angioedema

Hypersensitivity reactions including angioedema have been reported in patients receiving prasugrel, including in patients with a history of hypersensitivity reaction to clopidogrel. Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised (see section 4.8).

 

Thrombotic Thrombocytopaenic Purpura (TTP)

 

Added (bold) Deleted (strikethrough):

 

TTP has been reported with the use of other thienopyridinesprasugrel. TTP is a serious condition and requires prompt treatment. Efient was not associated with TTP in clinical trials supporting registration.

 

Sub heading updated:

 

4.6       Fertility, pregnancy and lactation 

4.8           Undesirable effects

 

Added:

 

a.       Summary of the safety profile

 

b.       Tabulated summary of adverse reactions

 

Added (bold):

 

Table 2 summarises haemorrhagic and non-haemorrhagic adverse reactions in TRITON, or that were spontaneously reported, classified by frequency and system organ class. Frequencies are defined as follows:

 

Added (bold):

 

Table 2: Haemorrhagic and Non-haemorrhagic adverse reactions

System Organ Class

Common

Uncommon

Rare

Not Known

Updated on 05/11/2009 and displayed until 06/05/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


4.         Clinical particulars

 

4.8           Undesirable effects

 

 

CABG-related bleeding

 

Added (bold) Deleted (strikethrough):

 

For patients who received their last dose of thienopyridine within 4 to 7 days prior to CABG, the frequencies decreased to 11.3% (9 of 80 patients) in the prasugrel group and 3.34% (3 of 90 89 patients) in the clopidogrel group. Beyond 7 days after drug discontinuation, the observed rates of CABG-related bleeding were similar between treatment groups (see section 4.4).

 

 

 

5.         PHARMACOLOGICAL PROPERTIES

 

5.1       Pharmacodynamic properties

 

Pharmacodynamics

 

Added (bold) Deleted (strikethrough):

 

Prasugrel-mediated inhibition of platelet aggregation exhibits low between-subject (129%) and within-subject (912%) variability with both 5 µM and 20 µM ADP.

 

 

 

6.         PHARMACEUTICAL PARTICULARS

 

6.5           Nature and contents of container

 

Added (bold):

 

Aluminium foil blisters in cartons of 14, 28, 30, 30 (x1), 56, 84, 90 (x1) and 98 tablets.

Not all pack sizes may be marketed.

 

 

 

8.         MARKETING AUTHORISATION NUMBER(S)

 

Added:

 

EU/1/08/503/015   Efient 5mg - 30 film-coated tablet

 

EU/1/08/503/016   Efient 10mg - 30 film-coated tablet

 

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

21 September 2009
Updated on 30/06/2009 and displayed until 05/11/2009
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-May-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


5.             PHARMACOLOGICAL PROPERTIES

 

5.1          Pharmacodynamic properties

 

Added:

 

Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC22.

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

18 May 2009
Updated on 09/06/2009 and displayed until 30/06/2009
Reasons for adding or updating:
  • Change in co-marketing arrangement
Date of revision of text on the SPC:   25-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


First SPC for new product.

 

 

10.          DATE OF REVISION OF THE TEXT

 

25 February 2009
Updated on 11/03/2009 and displayed until 09/06/2009
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

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

Active Ingredients/Generics

 
  prasugrel hydrochloride