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Orion Pharma (Ireland) Ltd
c/o Allphar Services Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin,
Telephone: +353 1 428 7777
Fax: +353 1 428 7776
Summary of Product Characteristics last updated on medicines.ie: 25/08/2010
SPC Eldepryl 5mg Tablets

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 25/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 4.2 - Posology and method of administration
  • 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:   02-Aug-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Dosage information has been re-worded to clearly state dosage is 5-10mg daily, alone or in combination with levodopa/DDCI

Inpulse control warning moved to section 4.4

Fluvoxamine added to interactions section

Update and review of undesirable effects section

Section 5.2 - clarification of enzymes used in metabolism of selegiline

Section 5.1 - updated to better describe pharmacodynamic properties of selegiline
Updated on 25/06/2010 and displayed until 25/08/2010
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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-May-2008
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In section 4.5 (Interactions with Other Medicinal products and Other Forms of Interaction) inclusion of 'Tramadol is also a potential interacting medicament.
In section 4.8 (Undesirable Effects) additional paragraph - Hypersexuality has been very rarely reported in association with selegiline use, either as monotherapy or in combination with other dopaminergic antiparkinsonian medication
In section 5.1 (Pharmacodynamic Properties) Pharmacotherapeutic group: Monoamine oxidase B inhibitors, ATC code: N04BD01
In section 5.2 (Pharmacokinetic Properties) Maximal concentration times have been changed and a new paragraph has been inserted plus additional information included in the last paragraph.
In section 10 (Date of Revision of the Text) has been changed to May 2008
Updated on 31/07/2006 and displayed until 25/06/2010
Reasons for adding or updating:
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   06/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Typographical errors in the text have been corrected.  The marketing authorisation number has been amended, as has the date of partial revision of the text.
Updated on 05/08/2004 and displayed until 31/07/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Updated on 10/12/2003 and displayed until 05/08/2004
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Updated on 06/08/2003 and displayed until 10/12/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Selegiline Hydrochloride