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Lundbeck Limited

Lundbeck House, Caldecotte Lake Business Park, Caldecotte, Milton Keynes, MK7 8LG
Telephone: +44 (0)1908 649 966
Fax: +44 (0)1908 647 888
WWW: http://www.lundbeck.co.uk
Medical Information Direct Line: +44 (0)1908 638 972
Medical Information e-mail: ukmedicalinformation@lundbeck.com
Customer Care direct line: +44 (0)1908 638 935

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: 18/04/2013
SPC Sycrest 5mg and 10mg sublingual 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 18/04/2013 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   21-Feb-2013
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Revision of the following text in Section 4.8, with the addition of angiodoema.

"There have been postmarketing reports of serious hypersensitivity reactions in patients treated with asenapine, including anaphylactic/anaphylactoid reactions, angioedema, swollen tongue and swollen throat (pharyngeal oedema). "
Updated on 29/01/2013 and displayed until 18/04/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
Date of revision of text on the SPC:   13-Dec-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.8

Addition of 'salivary hypsecretion' frequency 'unknown' in the table of undesirable effects.
Updated on 19/11/2012 and displayed until 29/01/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Oct-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

In Section 4.8 (undesirable effects), sinus tachycardia has been added to the table under Cardiac conditions, with a frequency of 'uncommon'

In Section 9, Date of revision is: 17 October 2012 
Updated on 07/08/2012 and displayed until 19/11/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Jun-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company




Section 4.8 Undesirable effects

Addition of:

 

Restless legs syndrome, Nausea, Oral mucosal lesions (ulcerations, blistering and

inflammation) (frequency not known).

 

In addition the following sentence has been revised (added text in red).

 

There have been postmarketing reports of serious hypersensitivity reactions in patients treated with asenapine, including anaphylactic/ anaphylactoid reactions, such as swollen tongue and swollen throat (pharyngeal oedema).

Updated on 16/01/2012 and displayed until 07/08/2012
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