Comtess *

  • Company:

    Orion Pharma (Ireland) Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, 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 13 October 2020

File name

Comtess Package Leaflet IE approved Sep20_1602600079.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

The manufacturer information has been updated on the leaflet.

Updated on 12 August 2019

File name

Comtess Package leaflet Jul 2019 IE_1565608814.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 10 May 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 11 January 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 11 January 2017

File name

PIL_7825_818.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 January 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The text has been updated to include the warning of soya lecithin, as the coating of the tablets contains soya lecithin in the product information.

Updated on 11 January 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 03 February 2016

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Date of revision of text updated (due to update in PIL contact details), no further changes.

Updated on 03 February 2016

Reasons for updating

  • Change to date of revision

Updated on 05 February 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SmPC template has been updated to include a statement about the local 'Reporting of suspected adverse reactions'

Updated on 04 February 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 21 December 2013

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

No changes to SmPC text, the Package Leaflet has been updated.

Updated on 17 December 2013

Reasons for updating

  • Change to date of revision
  • Change of distributor details

Updated on 07 February 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The following text has been added (to replace the previous text that referred to pathological gambling, increased libido etc):

Section 4.4:
Patients should be regularly monitored for the development of impulse control disorders. Patients
and carers should be made aware that behavioural symptoms of impulse control disorders including
pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge
eating and compulsive eating can occur in patients treated with dopamine agonists and/or other
dopaminergic treatments such as Comtess in association with levodopa. Review of treatment is
recommended if such symptoms develop.

Section 4.8:
Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive
spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine
agonists and/or other dopaminergic treatments such as Comtess in association with levodopa

Updated on 04 February 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 21 June 2010

Reasons for 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

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 01 October 2009

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 23 May 2007

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 21 May 2007

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

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 27 April 2005

Reasons for updating

  • Change to date of revision

Updated on 15 April 2005

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 08 December 2003

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 04 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)