Kapake 15mg/500mg Tablets
Product Information *
Company:
Galen Pharma Ireland LimitedStatus:
No Recent UpdateActive Ingredients :
*Additional information is available upon request
Legal Category:
Product subject to medical prescription which may not be renewed (A)
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 10 June 2019
File name
02-1_1560163752.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- 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 6 - date of revision
Updated on 10 June 2019
File name
02-1_1560161799.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 5.1 - Pharmacodynamic properties
- 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 25 April 2019
File name
02-1_1556202534.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 25 April 2019
File name
02-1_1556202734.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 11 February 2019
File name
03-1_1549888395.pdf
Reasons for updating
- Change to section 6 - date of revision
- Addition of manufacturer
Updated on 03 September 2018
File name
03-1_1535982660.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 9 of the SmPC was updated to add in the date of last renewal.
Updated on 17 August 2018
File name
Kapake 15mg 500mg Tablets IE SPC_1534514012.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 February 2018
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 27 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 February 2018
File name
PIL_16334_94.pdf
Reasons for updating
- New PIL for new product
Updated on 26 February 2018
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- 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 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 26 October 2015
Reasons for updating
- Change to section 4.3 - Contraindications
- 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
The following sections of the SPC have been updated:
4.3 Contraindications (minor administrative update to incorporate a cross-referral to section 4.5)
4.5 InteractionsUpdated on 23 October 2015
Reasons for updating
- Change of contraindications
- Change to drug interactions
- Change to date of revision
Updated on 28 May 2015
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 26 May 2015
Reasons for updating
- New PIL for medicines.ie