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Boehringer Ingelheim Limited
Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
Telephone: +44 (0)1344 424 600
Fax: +44 (0)1344 741 298
WWW: http://www.boehringer-ingelheim.co.uk
Medical Information Direct Line: +44 (0)1344 741 286
Medical Information e-mail: medinfo@bra.boehringer-ingelheim.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 04/08/2011
SPC Atrovent UDVs

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 04/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   01-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 Special Warnings and Precautions for Use

The final paragraph of this section i.e. one regarding other inhalation therapy has been amended.

 

Section 4.8 Undesirable Effects

The Respiratory, Thoracic and Mediastinal Disorders sub-heading of this section has been amended to include a figure (2) in superscript.  The corresponding footnote text has also been amended.

 

Section 5.1 Pharmacodynamic Properties

This entire section has been amended.

 

Section 10 Date of Revision of the Text

The date has been updated to May 2011.
Updated on 03/03/2011 and displayed until 04/08/2011
Reasons for adding or 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 10 date of revision of the text
Date of revision of text on the SPC:   01-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
- minor revision to section 4.4
- revision of section 4.8
- addition of information for section 4.7
- section 10 date of revision changed to February 2011
Updated on 15/09/2009 and displayed until 03/03/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 4.2 - the information previously given under the sub heading 'Administration' has been removed and replaced by an instruction to refer to the patient information leaflet for details on use with a nebuliser

 

Section 6.5 - the details have been revised to remove any reference to secondary packaging.

 

Section 10 – date has been revised to June 2009
Updated on 04/12/2007 and displayed until 15/09/2009
Reasons for adding or updating:
  • 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:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 - shelf life reduced from 36 to 24 months
Updated on 04/07/2007 and displayed until 04/12/2007
Reasons for adding or 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
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.4: Update to include glucose statement
4.8: updated at MHRA request (re-ordered frequencies, vomiting included as a gastrointestinal disorder rather than footnote, tachycardia instead of increased heart rate)
Updated on 27/02/2006 and displayed until 04/07/2007
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 12/03/2004 and displayed until 27/02/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 15/04/2003 and displayed until 12/03/2004
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • 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 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • 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. 6 - Instruction for Use/Handling
Updated on 24/07/2001 and displayed until 15/04/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 24/07/2001 and displayed until 24/07/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 14/06/2000 and displayed until 24/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  ipratropium bromide