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Cephalon Pharma (Ireland) Ltd
Suite 43, Northwood Court, Northwood Business Campus, Santry, Dublin 9,
Telephone: +353 1 8621600
Fax: +353 1 8621601
Medical Information e-mail: UKMedInfo@cephalon.com
Summary of Product Characteristics last updated on medicines.ie: 21/06/2011
SPC Dilzem XL 120, 180, 240

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 21/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Mar-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 10 - Addition of date for revision of text; omitted from updated document when originally posted to medicines.ie
Updated on 19/04/2011 and displayed until 21/06/2011
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
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   31-Mar-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Amendment to sections 4.4, 4.5, 4.6, 4.7, 4.8 and 4.9 of the Dilzem XL SmPC in order to align it to the Core Safety Profile.

Section 4.4:  addn of information on general anaethesia; increase of plasma concentrations of diltiazem; calcium channel blocking agents and antagonists.

Section 4.5:  Clarification of interactions with other medicinal products & other forms of interactions

Section 4.6:  Clarification on information for pregnant & breast feeding patients.

Section 4.7:  Clarification on ability to drive and use machines

Section 4.8:  Tabulation of all adverse reactions associated

Section 4.9:  Comment on the clinical effects of acute overdose.
Updated on 14/12/2010 and displayed until 19/04/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   19-Nov-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Transfer of Ownership from Cephalon Limited to Cephalon UK Limited with a change in PA number from PA 1260/3/3 - 6 to PA 0827/006/003 - 006.
Updated on 20/04/2010 and displayed until 14/12/2010
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
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   16-Feb-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


1.  Update section 4.4 of the SmPC  with new safety signals ( myasthenia gravis, porphyria)  with consequential update to section 4.8

2.  Update section 4.5 of the SmPC (highlight interaction with clopidogrel)

Updated on 29/04/2009 and displayed until 20/04/2010
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   02/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change to section 7 to update MA Holder address details
Updated on 25/07/2008 and displayed until 29/04/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   02/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 
section 4.5: update the wording to include interaction with other medicinal products and other forms of interaction (Statins, Amiodarone, Inducers of the cytochrome CYP3A4 enzyme).
 
Section 4.8: include the following: 

Gastrointestinal:  gingival hypertrophy.

Dermatologic: Stevens-Johnson syndrome.

Other: muscle pain, thrombocytopenia, prolonged bleeding time, gynaecomastia (very rare).

 
Updated on 26/07/2007 and displayed until 25/07/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 19/07/2007 and displayed until 26/07/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   04/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change to Section 6.1 List of Excipients:  Minor change to the constituents of the printing ink used to mark the capsules

Soya lecithin and Dimethylpolysiloxane, both existing print ink constituents are being replaced with Propylene glycol (E1520).
Updated on 10/01/2007 and displayed until 19/07/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change of MA holder from Zeneus to Cephalon
Updated on 04/01/2006 and displayed until 10/01/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Updated on 04/08/2004 and displayed until 04/01/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Updated on 18/06/2003 and displayed until 04/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Diltiazem Hydrochloride