Cozaar 12.5mg, 50mg & 100mg Film-coated Tablets *

  • Company:

    Organon Pharma (Ireland) Limited
  • Status:

    No Recent Update
  • Legal 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

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 26 August 2021

File name

QRD-IE-LFT-Cozaar-MAT-CRT Jul21_1629978125.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_1629978007.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)_1608220843.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_1589383448.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_1554797973.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_1553084585.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

  • 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  (COZAAR 50 mg tablet - tablet description)

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 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

Change to Section 4.8 - Undesirable effects

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

Update to Section 5.1 - The changes add data following the results from the extension phase of Paediatric Protocol 326: Efficacy and safety study in proteinuria with or without hypertension in children 1-17 years.

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)

Free text change information supplied by the pharmaceutical company

None provided