Cozaar COMP 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets
*Company:
Organon Pharma (Ireland) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 23 March 2023
File name
QRD-IE-COZAAR-Comp-NL-H-1458-IA-757G-PIL-en-CRT.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 30 June 2022
File name
COZAAR Comp-NL-H-1458-001-003-WS-601-SPC-IE-en-CRT.pdf
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
NL/H/xxxx/WS/601
Updated on 30 June 2022
File name
QRD-IE-COZAAR-Comp-NL-H-1458-WS-601-PIL-en-CRT.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 20 May 2022
File name
COZAAR Comp-NL-H-1458-001-003-WS-602-SPC-IE-en-CRT.pdf
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of wording on interactions of grapefruit juice components with losartan
Updated on 20 May 2022
File name
QRD-IE-COZAAR-Comp-NL-H-1458-WS-602-PIL-en-CRT.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 26 August 2021
File name
COZAAR Comp-NL-H-1458-001-003-MAT-SPC-IE-en-CRT.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 August 2021
File name
QRD-IE-COZAAR-Comp-LFT-MAT CRT.pdf
Reasons for updating
- Change of licence holder
Updated on 17 December 2020
File name
QRD-IE-COZAAR-Comp-LFT-IA-645-G_clean (002).pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 20 November 2020
File name
QRD-IE-COZAAR-Comp-LFT-WS-449-03112020-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 20 November 2020
File name
COZAAR Comp-NL-H-1458-001-003-WS-449-SPC-IE-en-CRT.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- Addition of the section regarding Eye disorders to section 4.4 of the SmPC.
- Addition of the following Adverse reactions to section 4.8 of the SmPC under System organ class “Eye disorders” and Frequency “not known”: “choroidal effusion, acute myopia, acute angle-closure glaucoma”
- Editorial update in section 3 of the SmPC to change “Film coated tablet” to: “Film coated tablets (tablets)”
- Update to HPRA details in section 4.8 of the SmPC
Updated on 08 June 2020
File name
Cozaar Comp_PIL QRD_clean_19-May-2020 (002).pdf.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 08 April 2019
File name
Cozaa Comp-NL-H-1458-001-002-003-WS-327-WS-285-PIL-IE-en-CRT.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 March 2019
File name
Cozaar Comp-NL-H-1458-001-003-WS-327-WS-285-SPC-IE-en-CRT.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 4.8 - Undesirable effects
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
A safety label update to include text regarding concomitant use of other drugs that may increase serum potassium levels to the PRECAUTIONS and DRUG INTERACTIONS sections; update with regards to the relationship between non-melanoma skin cancer; Correction of spelling/typing errors
Updated on 09 August 2018
File name
QRD_COZAAR COMP-PIL-deletion of UK details_CRT (2).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 03 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 November 2017
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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
Change to section 3: the scoreline statement for Cozaar comp 50mg/12,5mg has been amended from: “The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal dose.” to “The score line is not intended for breaking the tablet.”
Updated on 02 November 2017
File name
PIL_11484_945.pdf
Reasons for updating
- New PIL for new product
Updated on 02 November 2017
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 10 July 2017
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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 30 April 2015
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 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
Change to Section 4.2 - Posology and method of administration
Addition of references
Change to Section 4.3 – Contraindications
Addition of information on the contraindication of concomitant use with aliskiren containing products
Change to Section 4.4 - Special warnings and precautions for use
Addition of information on Dual Blockade
Change to Section 4.5 - Interactions with other medicinal products and other forms of interaction
Addition of information on Dual Blockade
Change to Section 5.1 - Pharmacodynamic properties
Addition of Clinical Trail data regarding Dual Blockade
Updated on 30 April 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to drug interactions
Updated on 28 July 2014
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
- Change to 4.8 - Undesirable effects - Approval of IA282G
Updated on 14 July 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to Section 4.8 - Undesirable effects
Update to AE reporting contact information
Addition of dysgeusia, dose-related orthostatic effects and cutaneous lupus erythematosus
Updated on 11 July 2014
Reasons for updating
- Change to side-effects
Updated on 24 February 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 14 February 2014
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 20 December 2013
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to Section 4.3 – Contraindications,
Addition of information about aliskiren
Change to Section 4.4 - Special warnings and precautions for use,
Addition of information about aliskiren and Dual blockade
Change to Section 4.5 - Interactions with other medicinal products and other forms of interaction
Addition of information about aliskiren
Change to Section 4.8 - Undesirable effects
Addition of AE reporting contact information
Updated on 21 March 2013
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 02 January 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 04 April 2012
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 8 - The Marketing Authorisation Numbers have been changed.
Updated on 03 April 2012
Reasons for updating
- Change to marketing authorisation holder
Updated on 10 February 2012
Reasons for updating
- 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 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.5 - data on Dual blockade (e.g. by adding an ACE-inhibitor to an angiotensin II receptor antagonist)
4.6 - additional information on Cozaar-Comp and breast-feeding
6.4 - update to storage conditions for HDPE
6.5 - description of HDPE bottle
Updated on 08 February 2012
Reasons for updating
- Change to information about pregnancy or lactation
- Change to improve clarity and readability
Updated on 25 October 2011
Reasons for updating
- 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 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 21 October 2011
Reasons for updating
- Change to side-effects
Updated on 16 February 2011
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to information about pregnancy or lactation
Updated on 16 November 2010
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Renewal - Changes to Section 9 and 10 (Date of revision/approval of text on SPC)
Updated on 15 April 2010
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to joint SPC covering all presentations
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Sections have changed: 4.6, 5.1, 6.4 & 6.5
Change to Pregnancy and lactation, ATC code, storage conditions and pack size
Updated on 13 April 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to information about pregnancy or lactation
- Change to further information section
- Addition of joint PIL covering all presentations
Updated on 09 June 2009
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
To include information relative to losartan and updates following recommendations from the Pharmacovigilance Working Party. Also change in excipient.
Updated on 21 May 2008
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 January 2008
Reasons for updating
- Change to date of revision
Updated on 05 September 2006
Reasons for updating
- New PIL for medicines.ie