Cozaar 12.5mg, 50mg & 100mg 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-LFT-Cozaar-NL-H-1457-IAIN757G Heist SNC-PIL-CRT.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 20 May 2022
File name
COZAAR-tabs-NL-H-1457-001-002-003-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-LFT-Cozaar-NL-H-1457-WS-602-PIL-CRT.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 26 August 2021
File name
QRD-IE-LFT-Cozaar-MAT-CRT Jul21.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 26 August 2021
File name
COZAAR-tabs-NL-H-1457-001-002-003-MAT-SPC-IE-en-CRT.pdf
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 December 2020
File name
QRD-IE-LFT-Cozaar-IA645G (002).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 13 May 2020
File name
Cozaar-tabs-12.5mg-50mg-100mg-PIL (002).pdf.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 09 April 2019
File name
QRD-Cozaar-tabs-WS285-IB040-PL-IE-CRT.pdf
Reasons for updating
- 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
- Correction of spelling/typing errors
Updated on 20 March 2019
File name
COZAAR-tabs-NL-H-1457-001-002-003-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 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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; Correction of spelling/typing errors
Updated on 26 April 2018
File name
Cozaar_Film_Coated_Tablets-IB-040-SPC-IE-en-CRT.docx
Reasons for updating
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 April 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 April 2018
File name
CozaarFilmCoatedTabletsIB040SPCIEenCRT.docx
Reasons for updating
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Correction of spelling/typing errors
Updated on 19 April 2018
File name
Cozaar_Film_Coated_Tablets-IB-040-SPC-IE-en-CRT.docx
Reasons for updating
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 April 2018
File name
ie-pl-cozaartabs (2).pdf
Reasons for updating
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 06 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 June 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
Updated on 01 June 2017
File name
PIL_14521_359.pdf
Reasons for updating
- New PIL for new product
Updated on 01 June 2017
Reasons for updating
- 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 30 April 2015
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.1 - Therapeutic indications
Addition of references
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 18 February 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to dosage and administration
Updated on 05 February 2014
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 - how to report a side effect
- 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, Change to Section 4.3 – Contraindications, Change to Section 4.4 - Special warnings and precautions for use, Change to Section 4.5 - Interactions with other medicinal products and other forms of interaction, Change to Section 4.8 - Undesirable effects, Change to Section 5.1 - Pharmacodynamic properties
Updated on 05 February 2013
Reasons for updating
- Change to side-effects
- Change to MA holder contact details
Updated on 31 January 2013
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
Updated on 19 June 2012
Reasons for updating
- Change to dosage and administration
Updated on 06 June 2012
Reasons for updating
- 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
Updated on 03 May 2011
Reasons for updating
- Change to side-effects
Updated on 11 February 2011
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- 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
Update section 4.1, 4.2, 4.8 & 5.1 of SPC following the HEAAL Study.
Updated on 16 March 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Correct lactose content i.e. change from 12.5mg to 25.25mg
Each COZAAR 12.5 mg tablet contains 25.25 mg lactose monohydrate
Updated on 25 February 2010
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 4.9 - Overdose
- Change to section 9 - Date of renewal of authorisation
- 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
4.9 Overdose
Symptoms of intoxication
Limited data are available with regard to overdose in humans. The most likely manifestation of overdose would be hypotension and tachycardia. Bradycardia could occur from parasympathetic (vagal) stimulation.
Treatment of intoxication
If symptomatic hypotension should occur, supportive treatment should be instituted.Measures are depending on the time of medicinal product intake and kind and severity of symptoms. Stabilisation of the cardiovascular system should be given priority. After oral intake, the administration of a sufficient dose of activated charcoal is indicated. Afterwards, close monitoring of the vital parameters should be performed. Vital parameters should be corrected if necessary.
Neither losartan nor the active metabolite can be removed by haemodialysis.
6.1 List of excipients
microcrystalline cellulose (E460)
lactose monohydrate
pregelatinized maize starch
magnesium stearate (E572)
hyprolose (E463)
hypromellose (E464)
COZAAR 12.5 mg, 50 mg and 100 mg contain potassium in the following amounts: 1.06 mg (0.027 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq) respectively.
COZAAR 12.5 mg tablets also contain carnauba wax (E903), titanium dioxide (E171), indigo carmine (E132) aluminum lake.
6.5 Nature and contents of container
COZAAR 12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 14, 21, 28, 50, 98, 210 or 500 tablets and a unit-dose package of 28 tablets for hospital use. HDPE bottles of 100 tablets.
COZAAR 50 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets
and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 or 300 tablets.
COZAAR 100 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets
and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 tablets.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Cozaar 12.5mg 6th March 2009 /
31 December 2009
Cozaar 50mg 6th June 1995 / 31 December 2009
Cozaar 100mg 16th November 2001 / 31 December 2009
Updated on 14 January 2010
Reasons for updating
- New PIL for medicines.ie
Updated on 07 January 2010
Reasons for updating
- Addition of joint SPC covering all presentations
Legal category:Product subject to medical prescription which may be renewed (B)