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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: 21/06/2010
SPC Comtess

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 21/06/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10-Jun-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In section 4.2 (Posology and method of administration) title Children has changed to Pediatric population
In section 4.4 (Special warnings and precautions for use) insertion of one sentence ' Entacapone therapy should be administered cautiously to patients with ischemic heart disease.'
and
For patients..........weight decrease. Prolonged or peristent diarrhoea, the drug should be discontinued and appropriate medical therapy and investigations considered.
In section 4.6 (Pregnancy and lactation) has changed to Fertility, pregnancy and lactation
In section 4.8 (Undesirable effects) addition of Cardiac disorders** section and below an additional paragraph to cover ** The incidence.........receiving entacapone.
In section 5.3 (Preclinical safety data) the first word has changed from Preclinical data to Non-clinical data.
In section 10  (Date of Revision of the Text) is 10 June 2010
Updated on 21/05/2007 and displayed until 21/06/2010
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:   02/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.4 (Special earnings and precautions for use) - 'For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered.' has been added.
 
Section 4.8 (Undesirable effects) - The following have been added to this section; Colitis.  Skin, hair, beard and nail discolourations.  Hepatitis with mainly cholestatic features.
Updated on 15/04/2005 and displayed until 21/05/2007
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 4.8 - Undesirable effects
Updated on 08/12/2003 and displayed until 15/04/2005
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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 04/06/2003 and displayed until 08/12/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Entacapone