CONBRIZA 20 mg film coated tablets

  • Name:

    CONBRIZA 20 mg film coated tablets

  • Company:
    info
  • Active Ingredients:

    Bazedoxifene acetate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/12/19

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Summary of Product Characteristics last updated on medicines.ie: 15/4/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
Medicine Name Cabaser 2mg Tablet Active Ingredients Cabergoline
Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 231 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 6 December 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 15 April 2019 PIL

Reasons for updating

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

Updated on 15 April 2019 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 19 February 2019 PIL

Reasons for updating

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

Updated on 13 August 2018 PIL

Reasons for updating

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

Updated on 13 August 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

The SPC has been updated as follows:

Section 7: Marketing Authorisation Holder updated to new MAH, Pfizer EEIG, Belgium.

Section 10: Date of Revision of Text updated to 08/2018

Updated on 13 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 February 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 29 July 2016 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

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 4.5 administrative updates.  Section 4.8 adverse event update for ‘Eye disorders.’

Updated on 29 July 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 27 July 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 12 April 2016 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 26 June 2015 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 18 June 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.2 Posology and method of administration use – update to align with QRD template.

 

Section 4.8 Undesirable effects – Updated with ADR frequency categories in order to align with current CDS (for Oedema peripheral to ‘Very common’ from ‘Common’, Retinal vein thrombosis to ‘Uncommon’ from ‘Rare’, and Rash and Pruritus to ‘Common’ from ‘Not known’).

Section on reporting of adverse events updated in line with new name and contact details for HPRA.

Section 4.9 Overdose - Updated to delete ‘A few’ from ‘A few case of overdose have been reported’.

Updated on 16 June 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 25 March 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

Update to section 4.8

Updated on 24 March 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 17 March 2014 SmPC

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Update to sections:

Section 2, 4.2-4.8, 5.1, 5.2 & 9

Updated on 11 March 2014 PIL

Reasons for updating

  • Change to instructions about missed dose
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to date of revision
  • Improved electronic presentation

Updated on 2 September 2013 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

Section 4.8 Undesirable effects:

Under the appropriate SOC:

Frequency not known:                  Palpitations

Frequency not known:                  Rash, pruritus

Updated on 28 August 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of marketing authorisation holder

Updated on 3 June 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company



Section 6.3 is updated to reflect reduce shelf life from 2 years to 18 months

Updated on 7 June 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

Labelling update, additional of wording to sections.   

Updated on 1 June 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to MA holder contact details
  • Change to improve clarity and readability

Updated on 3 January 2012 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 23 December 2011 PIL

Reasons for updating

  • New PIL for new product