Ultibro Breezhaler

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/01/20

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Summary of Product Characteristics last updated on medicines.ie: 14/6/2019

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Novartis Ireland Limited

Novartis Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Aclasta 5 mg solution for infusion Active Ingredients Zoledronic acid monohydrate
Medicine Name Afinitor Tablets Active Ingredients Everolimus
Medicine Name Aimovig Active Ingredients Erenumab
Medicine Name Atriance 5 mg/ml solution for infusion Active Ingredients Nelarabine
Medicine Name Azarga 10mg/ml + 5mg/ml eye drops, suspension Active Ingredients Brinzolamide, Timolol Maleate
Medicine Name Azopt 10mg/ml eye drops suspension Active Ingredients Brinzolamide
Medicine Name Cataflam 50 mg Coated Tablets Active Ingredients Diclofenac Potassium
Medicine Name Certican Tablets Active Ingredients Everolimus
Medicine Name CILOXAN 3 mg/ml ear drops, solution Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Co-Diovan 160 mg/12.5 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 160mg/25mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 320mg/12.5mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 320mg/25mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 80mg/12.5mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Cosentyx 150 mg solution for injection in pre-filled pen Active Ingredients secukinumab
Medicine Name Desferal 500mg Vials Active Ingredients Desferrioxamine Mesylate
Medicine Name Diovan 160 mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 320mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 3mg/ml Oral Solution Active Ingredients Valsartan
Medicine Name Diovan 40 mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 80 mg film-coated tablets Active Ingredients Valsartan
Medicine Name DuoTrav Eye Drops Solution Active Ingredients Timolol Maleate, Travoprost
Medicine Name Entresto 24mg/26mg, 49mg/51mg and 97mg/103mg film-coated tablets Active Ingredients Sacubitril, Valsartan
Medicine Name Estradot Transdermal Patches Active Ingredients Estradiol Hemihydrate
Medicine Name Eucreas 50mg / 850mg and 50mg / 1000mg film-coated tablets Active Ingredients Metformin Hydrochloride, Vildagliptin
1 - 0 of 115 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 9 January 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 11 September 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 14 June 2019 PIL

Reasons for updating

  • Removal of Black Inverted Triangle

Updated on 14 June 2019 SmPC

Reasons for updating

  • Removal of Black Inverted Triangle

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

Updated on 4 April 2019 PIL

Reasons for updating

  • Change to further information section

Updated on 1 April 2019 SmPC

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 30 October 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 26 July 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)

Updated on 8 June 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

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

Updated on 10 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 9 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 5 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 February 2018 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents

Updated on 13 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 13 November 2017 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Section 6.3 - updated to read:

The inhaler in each pack should be disposed of after all capsules in that pack have been used.


Section 6.5 - Added detail on pack containing 90x1 hard capsules + 1 inhaler and deleted 90 multipack (3 packs of 30x1 and 3 inhalers) as this is being replaced.


Section 6.6 - updated to read:
The inhaler in each pack should be disposed of after all capsules in that pack have been used

Updated on 26 January 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 9 December 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Section 4.4 - Clarified wording on paradoxical brochospasm
Section 4.8 - revisions of some frequencies and addition of Dysphonia as new post-marketing ADR.
Section 5.1- addition of FLAME study (A2318) results.

                        Key points:

·         Data on exacerbations versus salmeterol/fluticasone, as well as lung function, SGRQ, and pneumonia are included

·         CHMP challenged the inclusion of data on:

o    Severe exacerbations (outcome: included)

o    Incidence of Pneumonia (outcome: included)

Updated on 19 November 2015 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 28 October 2015 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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 6.5 - addition of new 10-pack and 150 multi-pack
Seciton 8 - addition of new MA numbers for new 10-pack and 150 multi-pack

Updated on 18 March 2015 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 29 January 2015 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

Section 7 - MAH contact details changed from Horsham to Frimley address

Updated on 4 January 2015 SmPC

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

Sections 4.4 and 4.8 - wording on hypersensitivity and angioedema updated.

Updated on 26 February 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 Shelf Life increased freom 18 months to 2 years.

Section 4.8 - Address of where to report suspected adverse events was simplified in line with revision to Annex V.

Updated on 9 December 2013 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 September 2013 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