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Sycrest 5mg and 10mg sublingual tablets

Last Updated on eMC 05-Nov-2014 View document  | Lundbeck Limited Contact details

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 05-Nov-2014 and displayed until Current

Reasons for adding or updating:

  • Removal of black triangle

Date of revision of text on the SPC: 21-Feb-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Black triangle has been removed - everything else (including revision date) remains the same

Updated on 18-Apr-2013 and displayed until 05-Nov-2014

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-Jan-2013 and displayed until 18-Apr-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-Nov-2012 and displayed until 29-Jan-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-Aug-2012 and displayed until 19-Nov-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-Jan-2012 and displayed until 07-Aug-2012

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): YES

Company contact details

Lundbeck Limited

Company image
Address

Lundbeck House, Caldecotte Lake Business Park, Caldecotte, Milton Keynes, MK7 8LG

Fax

+44 (0)1908 647 888

Medical Information e-mail
Telephone

+44 (0)1908 649 966

Medical Information Direct Line

+44 (0)1908 638 972

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?

Active ingredients

asenapine maleate

Legal categories

POM - Prescription Only Medicine

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