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.
Section 1 Name of Medicinal Product
Minor editorial changes have been made to this section.
Section 2 Qualitative and Quantitative Composition
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
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
Section 10 Date of Revision of the Text
The date has been amended from August 2010 to March 2012.
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
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
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
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
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
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
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
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
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
Section 10
Revision date changed to August 2010
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.'
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
Section 2: Editorial Change
Section 6.3: Editorial Change
Section 6.1: Editorial Change
Section 6.2: Editorial Change
Section 6.4: Editorial Change
Section 6.5: Editorial Change
Section 6.6: Guidance on dilution