We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Boehringer Ingelheim Limited

The Crescent Building, , Northwood, Santry, Dublin 9,
Telephone: +353 1 295 9620
Fax: : +353 1 816 3642
Medical Information e-mail: Medinfo@dbl.boehringer-ingelheim.com
Summary of Product Characteristics last updated on medicines.ie: 07/12/2015
SPC Atrovent 500 UDVs, 500 micrograms/2ml Nebuliser Solution

When a pharmaceutical company changes an SPC or PIL, 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 07/12/2015 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   02-Dec-2015
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.

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, 4.5, 4.6, 5.1 and 5.2. Section 10 has also been updated.
Updated on 06/08/2014 and displayed until 07/12/2015
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   28-Jul-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Adverse event reporting statements have been added to the end of section 4.8 (Undesirable effects) as follows:

 

4.8 Undesirable effects

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

 

 

In addition, minor typographical changes have been made to section 4.3 (Interactions) as indicated below:

 

4.5 Interaction with other medicinal products and other forms of interaction

 

There is evidence that the administration of ATROVENT with beta-adrenergic drugs and xanthine preparations may intensify the bronchodilator effect of ATROVENT.

 

The risk of acute glaucoma in patients with a history of narrow-angle glaucoma (see Special Wwarnings and Special Pprecautions for Uuse) may be increased when nebulised ipratropium bromide and beta2-agonists are administered simultaneously.

Section 10 - date of revision of text updated to July 2014

Updated on 11/04/2012 and displayed until 06/08/2014
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Mar-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 1 Name of Medicinal Product

Minor editorial changes have been made to this section.

 

Section 2 Qualitative and Quantitative Composition

Minor editorial changes have been made to this section.

 

Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

A minor editorial change has been made to the section header of this section.

 

Section 4.6 Fertility, Pregnancy and Lactation

A minor editorial change has been made to the section header of this section.

 

Section 5.1 Pharmacodynamic Properties

A new third paragraph regarding preclinical and clinical evidence has been added to this section.

 

The fourth paragraph has had text both added to and deleted from.

 

The fifth paragraph has had text deleted from.

 

A new final paragraph has been added to this section.

 

Section 6.5 Nature and Contents of Containers

Minor editorial changes have been made to this section.

 

Section 10 Date of Revision of the Text

The date has been amended from August 2010 to March 2012.

Updated on 04/10/2010 and displayed until 11/04/2012
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   01-Aug-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



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 11/05/2010 and displayed until 04/10/2010
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 6.3 has been updated to comply with CMPP/QWP/159/96 ‘Note for guidance on maximum shelf-life for sterile products for human use after first opening or following reconstitution’ to include information on the use of the product when diluted.

 

The following statement has been added:

 

'Diluted product:

From a microbiological point of view, unless the method of dilution precludes the risk of microbiological contamination, the product should be used immediately.

                If not used immediately, in-use storage times and conditions are the responsibility of the user.'

Updated on 19/04/2010 and displayed until 11/05/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 4.2 Posology and method of administration

The information relating to the use with a nebuliser has been removed and instead a direct reference has been made to refer to the patient information leaflet for instructions

 

Section 6.3 Shelf life

Information on the shelf life following removal from the foil overwrap (relates to product manufactured at new manufacturing site) has been included.

 

Section 10 has been revised to April 2010

Updated on 05/03/2009 and displayed until 19/04/2010
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   02/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 2: Editorial Change

Section 6.3: Editorial Change

Section 6.1: Editorial Change

Section 6.2: Editorial Change

Section 6.3: Editorial Change

Section 6.4: Editorial Change

Section 6.5: Editorial Change

Section 6.6: Guidance on dilution

Updated on 12/09/2008 and displayed until 05/03/2009
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   11/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Main changes are section 6.3 – shelf life reduced from 3 to 2 years

Updated on 24/05/2007 and displayed until 12/09/2008
Reasons for adding or updating:
  • New SPC for new product

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share

Active Ingredients

 
   ipratropium bromide monohydrate