Colofac 135mg Tablets
- Name:
Colofac 135mg Tablets
- Company:
Mylan IRE Healthcare Limited
- 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: 30/06/17


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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
Mylan IRE Healthcare Limited

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 5 July 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 5 July 2017 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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
7. MARKETING AUTHORISATION HOLDER
Mylan IRE Healthcare Limited
Unit 35/36
Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland
BGP Products Ireland Limited
4051 Kingswood Drive,
Citywest Business Campus,
Dublin 24
8. MARKETING AUTHORISATION NUMBER
PA 2010/7/1 2007/2/1
10. DATE OF REVISION OF THE TEXT
June 2017
Updated on 30 June 2017 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 30 June 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 10 October 2016 PIL
Reasons for updating
- Change to date of revision
- Change of distributor details
Updated on 13 August 2015 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 20 April 2015 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Sections 5.1 and 5.3 have been updated to reflect the current scientific knowledge as well as editorial changes to sections 2, 4.3, 4.5, 4.6, 4.8 (addition of SAE reporting), 4.9.
Updated on 16 April 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 8 April 2015 PIL
Reasons for updating
- Change of licence holder
- Change to date of revision
- Change to marketing authorisation holder
Updated on 7 April 2015 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
- Change to marketing authorisation holder
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 2 October 2014 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 29 September 2014 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 22 April 2013 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 18 April 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to further information section
- Change to dosage and administration
- Change due to user-testing of patient information
Updated on 17 February 2011 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 16 February 2011 PIL
Reasons for updating
- Change to marketing authorisation holder
- Change to name of manufacturer
Updated on 23 January 2009 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 5 December 2008 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 9 - Date of renewal of authorisation
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 4 December 2008 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 28 June 2006 PIL
Reasons for updating
- Change of manufacturer
Updated on 28 March 2006 PIL
Reasons for updating
- Change of active ingredient
- Change to warnings or special precautions for use
Updated on 28 March 2006 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 20 July 2005 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 18 October 2004 PIL
Reasons for updating
- New PIL for new product