Kapake 30mg/500mg Tablets * Pharmacy Only: Prescription
Company:
Galen Pharma Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 21 July 2022
File name
62d938489e0de.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 21 July 2022
File name
62d93587cc867.pdf
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 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 May 2022
File name
628f746c80b54.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 May 2022
File name
02-2_1651760134.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 05 May 2022
File name
02-2_1651760095.pdf
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 September 2019
File name
02-2_1568023003.pdf
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Sections 4.4, 4.5 and 10 of the SPC were updated to incorporate warnings relating to the interaction between benzodiazepines/benzodiazepine like products and opioids and the serious risks associated with their combined use including sedation, respiratory depression, coma and death, in line with CMDh advice.
Updated on 09 September 2019
File name
02-2_1568022888.pdf
Reasons for updating
- Change to Section 1 - what the product is
Free text change information supplied by the pharmaceutical company
The description of pharmacotherapeutic group within Section 1 of the PIL was updated.
Updated on 23 May 2019
File name
02-2_1558600437.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 25 April 2019
File name
03-2_1549886646.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 25 April 2019
File name
02-2_1556202826.pdf
Reasons for updating
- 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 not be renewed (A)
Updated on 13 February 2019
File name
03-2_1550068995.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 February 2019
File name
03-2_1549886646.pdf
Reasons for updating
- Addition of manufacturer
- Change to date of revision
Updated on 19 July 2018
File name
Kapake Tabs.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 19 July 2018
File name
03-2.pdf
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 4.6 - Pregnancy and lactation
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Update the Summary of Product Characteristics (SPC) in line with the current EU product information requirements (QRD template).
- Update the Pharmacotherapeutic group and ATC code within section 5.1 of the SPC to the new code for combinations of codeine and paracetamol
Updated on 18 July 2018
File name
03-2.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 18 July 2018
File name
03-2.pdf
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 4.6 - Pregnancy and lactation
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updates have been made in line with the current EU product information requirements (QRD template).
Updated on 11 August 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 August 2015
File name
PIL_12903_80.pdf
Reasons for updating
- New PIL for new product
Updated on 11 August 2015
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section
4.5 ‘Interaction with other medicinal products’ with regards to
Monoamine Oxidase Inhibitors (MAOIs).
Updated on 11 August 2015
Reasons for updating
- Change to date of revision
Updated on 14 August 2014
Reasons for updating
- SPC retired pending re-submission
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
- Very rare cases of serious skin reactions added.
- Change in name of the Irish Medicines Board to the Health Products Regulatory Agency (HPRA) and wording on reporting suspected adverse reactions to the HPRA.
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects)
- Very rare cases of serious skin reactions added.
- Change in name of the Irish Medicines Board to the Health Products Regulatory Agency (HPRA) and wording on reporting suspected adverse reactions to the HPRA.
Updated on 08 August 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 12 November 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
- PIL retired pending re-submission
- Change to warnings or special precautions for use
Updated on 04 May 2011
Reasons for updating
- Change to date of revision
- Change due to user-testing of patient information
Updated on 21 February 2011
Reasons for updating
- Change to warnings or special precautions for use
Updated on 25 June 2010
Reasons for updating
- New SPC for medicines.ie
- SPC retired pending re-submission
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
None provided
Updated on 20 October 2009
Reasons for updating
- Change to date of revision
Updated on 27 January 2009
Reasons for updating
- Change to date of revision
Updated on 25 July 2008
Reasons for updating
- Improved electronic presentation
Updated on 07 March 2008
Reasons for updating
- New PIL for medicines.ie
Updated on 07 March 2008
Reasons for updating
- Change to information about pregnancy or lactation