Comtess
- Name:
Comtess
- Company:
Orion Pharma (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/10/20


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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Orion Pharma (Ireland) Ltd
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Company Products
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 PIL
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 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 10 May 2018 SPC
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 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 11 January 2017 SPC
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
Updated on 11 January 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 3 February 2016 SPC
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
Updated on 3 February 2016 PIL
Reasons for updating
- Change to date of revision
Updated on 5 February 2015 SPC
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
Updated on 4 February 2015 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 21 December 2013 SPC
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
Updated on 17 December 2013 PIL
Reasons for updating
- Change to date of revision
- Change of distributor details
Updated on 7 February 2013 SPC
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:
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 4 February 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 21 June 2010 SPC
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 4.4 (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 1 October 2009 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 23 May 2007 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 21 May 2007 SPC
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
Updated on 27 April 2005 PIL
Reasons for updating
- Change to date of revision
Updated on 15 April 2005 SPC
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 5 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 8 December 2003 SPC
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 4 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)