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Eklira Genuair 322 micrograms inhalation powder

  • Name:

    Eklira Genuair 322 micrograms inhalation powder

  • Company:
    info
  • Active Ingredients:

    Aclidinium Bromide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/02/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 4/2/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

A. Menarini Pharmaceuticals Ireland Ltd

A

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1 - 0 of 31 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 4 February 2020 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Revisions made to align with the SmPC and minor editorial changes

Updated on 4 February 2020 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

The main changes are as folows:

  • 4.1 Therapeutic Indication - Inclusion of Cross reference to Section 5.1 as a result of the ASCENT study revisions
  • 4.4 Special Warnings and Precautions for Use - Cardiovascular effects. Revisions as a result of the ASCENT study
  • 4.8 Undesirable effects -  Inclusion of data from the ASCENT study 
  • 5.1 Pharmacodynamic effects, Clinical efficacy and safety -  Inclusion of data from the ASCENT study  

Updated on 30 August 2018 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 30 August 2018 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 8 May 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

The Instructions for Use have been moved from section 4.2 to 6,6 and have been updated.

Updated on 4 May 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to further information section

Updated on 22 June 2017 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications

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

Free text change information supplied by the pharmaceutical company

Section 4.3 Contraindications updated to :

Hypersensitivity to aclidinium bromide or to the excipients listed in section 6.1.

The following hypersensitivities are removed: atropine or its derivatives, including ipratropium, oxitropium or tiotropium

Updated on 22 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 16 May 2017 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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)

Free text change information supplied by the pharmaceutical company

Update to the SmPC following licence renewal and update to section 4.3 Contra-indications

 

·         Administrative updates to section 2, 4.2. 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 5.3, 6.4, 6.5

·         4.3 Contraindications
Removal of hypersensitivity to atropine or its derivatives, including ipratropium, oxitropium or tiotropium.

·         4.4 Special warnings and precautions
Warning on asthma removed. 

·         4.6 Pregnancy and lactation

Addition of ‘A risk to newborns/infants cannot be excluded’.

·         9 Date of last renewal added

·         10. Date of revision updated

Updated on 16 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 May 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 6 December 2016 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 6 December 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 4.2    Posology and method of administration: Update in line with current QRD

Change to section 4.8    Undesirable effects: Inclusion of side effect: Anaphylactic reaction (frequency not known)

Change to section 5.2    Pharmacokinetic properties: Update to pharmacokinetic data (absorption, elimination and race sections)

Change to section 5.3    Preclinical safety data: Update to preclinical safety data

Change to section 10     Update to date of revision of text

Updated on 19 May 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 19 May 2015 SmPC

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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 main changes are as follows:
- changes in section 4.7 Effects on ability to drive and use machines
- new side-effects in section 4.8; Dizziness as uncommon, Nausea as common and Stomatitis as uncommon.

Updated on 24 March 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to MA holder contact details

Updated on 24 March 2015 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 following sections are updated:
Section 7 Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Sdertlje

Sweden


Section 10 Date of revision of the text
Updated to 5 March 2015

Updated on 24 February 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.8 Undesirable effects

- Add palpitations as uncommon
- Update side-effect reporting details for the HPRA

Section 10 Date of Revision
Update to 11/2014

Updated on 24 February 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 5 June 2014 PIL

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to appearance of the medicine
  • Change of distributor details
  • Change to name of manufacturer

Updated on 5 June 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • 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

The changes relate to the following sections of the SmPC:

  • Section 4.8 - "hypersensitivity reactions", "angioedema", "rash" and "pruritus" have been included as ADRs
  • Section 6.4 and 6.5 - change to the wording relating to the introduction of a plastic pouch
  • Section 10 - the date of revision is updated.

Updated on 3 April 2014 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 3 April 2014 PIL

Reasons for updating

  • New PIL for new product