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Atrovent Inhaler CFC-Free

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Pharmacy Only: Prescription

Updated on 02 March 2023

File name

A9e-E-SPC-11 January 2021.pdf

Reasons for updating

  • Document format updated

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

Updated on 15 January 2021

File name

PIL IE 307868-12 01.10.20 PIP007942-012 AMT 101488-cropped.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 15 January 2021

File name

A9e-E-SPC-11 January 2021.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 8 - Marketing authorisation number(s)
  • 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 5.2:

  • Redundant information relating to intravenous administration was deleted
  • Some information within the section was reformatted

Section 4.2:

  • Wording regarding when to replace the inhaler was updated
  • Outdated information regarding how to check the amount of treatment remaining in the inhaler was deleted.

Additional editorial updates were also made to the following sections:

Section 2 - Alcohol (ethanol) was added as an excipient with known effect and the text aligned with the EU QRD template

Section 4.4 - A statement relating to ethanol was added in line with the Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'

Section 4.8 - The section was reformatted to align with the EU QRD template. Outdated adverse event (AE) reporting details were also corrected.

Sections 5.1, 5.2 and 8 - A number of minor editorial corrections were made

Section 10,  Date of Revision, was updated to January 2021 

Updated on 09 April 2019

File name

PIL IE 307868-11 09.11.18 PIP007942-011 AMT 89217 cropped.pdf

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 05 April 2019

File name

A9e-E-SPC-10.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

Change the MA holder (MAH) from Boehringer Ingelheim Ltd, UK to Boehringer Ingelheim International GmbH, Germany.  Editorial updates from previous version.

Updated on 07 March 2019

File name

A9e-E-SPC-9 clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

Sections 7 and 8 of the SmPC have been updated with new Marketing Authorisation Holder (MAH) details following approval of a transfer application to change the MAH from Boehringer Ingelheim Ltd, UK to Boehringer Ingelheim International GmbH, Germany. This change comes as a direct consequence of Brexit to ensure that the MAH for the Irish product remains within the EU following the UK’s departure.

 Section 9 has been updated to include the date of authorisation of the new licence, 01/03/2019. Consequently the details in section 10, date of revision of the text, were deleted.

 

Updated on 10 December 2015

File name

PIL_10993_530.pdf

Reasons for updating

  • New PIL for new product

Updated on 10 December 2015

Reasons for updating

  • New SPC for new product

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

Updated on 10 December 2015

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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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

Section 4.3: updated to clarify the nature of Atrovent and define the circumstances under which it is contraindicated.

Section 4.4: Updated to include a paragraph on paradoxical bronchospasm and remove outdated information relating to the CFC-containing formulation.

Section 4.5: Updated with a statement relating to chronic co-administration of Atrovent.

Section 4.7: Deletion of repetitive text relating to driving or operating machinery.

Section 5.2: Updated with information that ipratropium does not cross the placental barrier and with information regarding the metabolites of Atrovent. A statement relating to the discontinued CFC-containing formulation was also deleted.

In addition editorial updates were made to sections 4.2, 4.4, 4.6, 5.1 and 5.2. Section 10 has also been updated.

Updated on 10 December 2015

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 11 February 2015

Reasons for updating

  • 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 has been updated to include information on adverse event reporting to align with the current European guidelines. Section 10 – date of revision of the text has also been updated to the month of approval.

Updated on 06 February 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 30 November 2010

Reasons for updating

  • Change to side-effects
  • Change to information about driving or using machinery
  • Change of special precautions for disposal
  • Correction of spelling/typing errors

Updated on 04 October 2010

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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

Section 4.2


Revision of the information on procedures for drying the mouthpiece.

 

Section 4.4

Paragraph relating to ‘Immediate hypersensitivity reactions…’ has been moved to the beginning of the section to improve prominence of this important information.

 

Additional statement added relating to ‘pre-existing urinary outflow tract obstruction’

 

Section 4.6

Statement added to advise about the availability of data relating to the effects on human fertility


Section 4.7

Addition of information taking into account the listed side effects which may impair ability to drive and use machines

 

Section 4.8

Summary of safety profile added. List of adverse events mapped according to appropriate MedDRA preferred terms. Frequencies updated according to available data. Addition of side effect ‘stomatitis’ plus ‘dry throat’

 

Section 4.9

Change of ‘accommodation disturbances’ to ‘accommodation disorder’

 

Section 5.1

Mechanism of action corrected. Addition information on local nature of effect of ipratropium and other amendments to take into account available data.

 

Section 5.2

Section revised based on existing references, reworded and restructured according to ADME. Additional information included to provide more comprehensive information.


Section 10

Revision date changed to August 2010

Updated on 04 March 2009

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.5 - Nature and contents of container
  • 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 2: Editorial Change

Section 3: Removal of reference to new propellant

Section 6.5: Addition of information on volume of solution

Section 6.6: Editorial Change

Updated on 30 September 2008

Reasons for updating

  • Change due to user-testing of patient information

Updated on 27 June 2006

Reasons for updating

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

Section 4.8 (undesirable effects): Updated to include information on the frequency of adverse events.  Dizziness and pruritis have been added to the list of undesirable events.

Updated on 23 June 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 09 February 2006

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

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

Updated on 02 September 2004

Reasons for updating

  • New SPC for new product

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