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Cephalon (UK) Limited
Teva UK Limited, Field House, Station Approach, Harlow, Essex, CM20 2FB
Telephone: +44 (0) 207 5407117
Fax: +44 (0) 207 4507349
WWW: http://www.tevauk.com
Medical Information Direct Line: +44 (0) 207 5407117
Medical Information e-mail: medinfo@tevauk.com

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: 18/03/2011
SPC Univer Capsules 120, 180 and 240mg hard-capsules

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 18/03/2011 and displayed until Current
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   11-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4:  Addition of a warning for use in patients with Lambert-Eaton syndrome and advanced Duchenne muscular dystrophy (disease which impact neuromuscual transmission) alongside pre-existing warning regarding Myasthenia Gravis.


Section 4.5:  Addition of interaction with clarithromycin and amendment of wording relating to use with Atorvastatin.
Updated on 30/07/2010 and displayed until 18/03/2011
Reasons for adding or updating:
  • 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 4.9 - Overdose
Date of revision of text on the SPC:   27-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Alignment of the SmPC with a comparator product as part of the Label evaluation project
Updated on 30/07/2010 and displayed until 30/07/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   12-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


 

  • Addition of the amount of Sucrose in each capsule to section 2, and an update to the wording referring the reader to section 6.1 for a full list of excipients. 
 

 

  •     Addition of the Pharmacotherapeutic group and ATC code to section 5.1
Updated on 14/04/2010 and displayed until 30/07/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Sections 7, 8, 9 and 10 of the SmPC have been updated as follows:

Section 7:  Marketing Authorisation Holder has been changed to Cephalon UK Limited, 1 Albany Place, Hyde Way, Welwyn Garden City, Hertfordshire

Section 8: Marketing Authorisation Number(s) have been changed.   

Section 9: Date of First Authorisation/Renewal of the Authorisation

Section 10:  Date of Revision of Text
Updated on 26/01/2010 and displayed until 14/04/2010
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:   18-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4: Addition of the following sentences at the end of the section:
There have been reports of calcium-channel blockers exacerbating muscle weakness in patients with myasthenia gravis.  Verapamil should be used with caution in such patients.

 

Section 4.8: Addition of :
Muscle weakness has been reported
Updated on 09/01/2009 and displayed until 26/01/2010
Reasons for adding or updating:
  • Individual SPC superseded by joint SPC covering several presentations
Date of revision of text on the SPC:   17-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Individual SPCs covering differnt strenghts now superseded by joint SPC
Updated on 17/10/2008 and displayed until 09/01/2009
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   17-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update MAH address from Oxford to Welwyn Garden City
Updated on 03/10/2007 and displayed until 17/10/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.5 and 4.7 of the Univer SPC (to add an interaction with simvastatin and to update the effects on the ability to drive section (Verapamil has been shown to increase the blood levels of alcohol and slow its elimination. Therefore, the effects of alcohol may be exaggerated)). This variation also included a change to the registered name of the product (section 1) to include the pharmaceutical form (Univer 120mg Prolonged-release Hard Capsules).

 

The key changes are the addition of interactions with simvastatin, erythromycin and ritonavir and the replacement of the interaction with cimetidine with one with ketoconazole.

Updated on 19/06/2007 and displayed until 03/10/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   04/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7 - Marketing Authorisation Holder

 

changed to:

 

Cephalon Limited

The Magdalen Centre

Oxford Science Park

Oxford

Oxfordshire

OX4 4GA

United Kingdom
Updated on 15/03/2006 and displayed until 19/06/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 27/09/2005 and displayed until 15/03/2006
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations

Active Ingredients/Generics

 
  verapamil hydrochloride