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 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
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 2:
Section 3: Removal of reference to new propellant
Section 6.5: Addition of information on volume of solution
Section 6.6: Editorial Change
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.