Cozaar COMP 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets

  • Name:

    Cozaar COMP 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Hydrochlorothiazide, Losartan potassium

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/04/19

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Summary of Product Characteristics last updated on medicines.ie: 26/3/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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Medicine Name Cozaar COMP 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Losartan potassium
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1 - 0 of 84 items.Total: Infinity pages

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 8 April 2019 PIL

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 SmPC

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 9 August 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 3 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 3 November 2017 SmPC

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 2 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 November 2017 PIL

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 SmPC

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

Change to section 6.5: deletion the reference to the white polypropylene, tamper evident screw cap closure

Updated on 30 April 2015 SmPC

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 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions

Updated on 28 July 2014 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 24 February 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 14 February 2014 SmPC

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

Change to Section 9 - Date of renewal of authorisation and Change to Section 10 – date of revision of the text

Updated on 20 December 2013 SmPC

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 SmPC

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

Change to Section 7: Marketing authorisation holder - Change to address of MAH Ireland

Updated on 2 January 2013 SmPC

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

implementation the PhVWP recommended wording for Losartan in combination with HCT

Updated on 4 April 2012 SmPC

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 7 - The Marketing Authorisation Holder has been transferred.
Section 8 - The Marketing Authorisation Numbers have been changed.

Updated on 3 April 2012 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 10 February 2012 SmPC

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 8 February 2012 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to improve clarity and readability

Updated on 25 October 2011 SmPC

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

Update to Sections: 4.5, 4.8, 5.2 & 6.4.

Updated on 21 October 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 16 February 2011 PIL

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 SmPC

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 SmPC

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

 Change to joint SPC covering all presentations
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 PIL

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 9 June 2009 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Change to date of revision

Updated on 5 September 2006 PIL

Reasons for updating

  • New PIL for medicines.ie