Cyklokapron 500mg Tablets
- Name:
Cyklokapron 500mg 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: 02/04/19

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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 2 April 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 13 February 2019 PIL
Reasons for updating
- New PIL for new product
Updated on 12 February 2019 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 11 August 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 11 August 2016 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 - how to report a side effect
- Change to section 4.9 - Overdose
- 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 4.3: Minor text change
In section 4.4: Addition of information regarding convulsions
In section 4.8: Addition of convulsions (frequency not known) to undesirable effects
In section 4.9: Addition of signs and symptoms to overdose
In section 10: Date of revision has changedUpdated on 11 August 2016 PIL
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 - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.3: Minor text change
In section 4.4: Addition of information regarding convulsions
In section 4.8: Addition of convulsions (frequency not known) to undesirable effects
In section 4.9: Addition of signs and symptoms to overdose
In section 10: Date of revision has changedUpdated on 18 February 2015 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 10: Date of revision has been changed
Updated on 18 February 2015 PIL
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 10: Date of revision has been changed
Updated on 14 November 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- 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 has been changed for children and those with renal insufficiency
In section 4.3: there has been additional contraindications added
In section 4.4: Additional information has been added for precautions and warnings
In section 4.8: Additional information regarding side effects has been added
In section 5.2: the pharmacokinetic properties has been expanded and additional text has been added
In section 10: the date of revision has changed
Updated on 14 November 2013 PIL
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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.2: Posology has been changed for children and those with renal insufficiency
In section 4.3: there has been additional contraindications added
In section 4.4: Additional information has been added for precautions and warnings
In section 4.8: Additional information regarding side effects has been added
In section 5.2: the pharmacokinetic properties has been expanded and additional text has been added
In section 10: the date of revision has changed
Updated on 18 March 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
In section 10: the date of revision has changed to Feb 2011
Updated on 18 March 2011 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 10: the date of revision has changed to Feb 2011
Updated on 25 February 2008 SPC
Reasons for updating
- Change to section 7 - 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 25 February 2008 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Updated on 2 October 2007 PIL
Reasons for updating
- Change to marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Trading style:
Meda Health Sales Ireland Limited
Office 10 , Dunboyne Business Park
Dunboyne
Co Meath
Ireland
Trading as
Meda Pharma
Office 10 , Dunboyne Business Park
Dunboyne
Co Meath
PA 1332/3/1
Updated on 2 October 2007 SPC
Reasons for updating
- 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
Trading style:
Meda Health Sales Ireland Limited
Office 10 , Dunboyne Business Park
Dunboyne
Co Meath
Ireland
Trading as
Meda Pharma
Office 10 , Dunboyne Business Park
Dunboyne
Co Meath
PA 1332/3/1
Updated on 17 August 2005 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 17 August 2005 PIL
Reasons for updating
- New SPC for medicines.ie