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.
Update to section 5.1 of the SPC.
Section 5.1
Include data from a recent clinical study in patients with cardiovascular disease.
Section 4.4 - addition of ‘Changes in behaviour or thinking, anxiety, psychosis, mood swings, aggressive behaviour, - addition of post marketing reports on cutaneous reactions, including Stevens-Johnson Syndrome and Erythema Multiforme in patients using varenicline. Section 4.8 The above is added in the post marketing cases of reported side effects.
- addition of post marketing reports on cutaneous reactions, including Stevens-Johnson Syndrome and Erythema Multiforme in patients using varenicline.
Section 4.8
The above is added in the post marketing cases of reported side effects.
Section 4.8: Addition of Aggression and irrational behaviour Section 6.5: Aclar / PVC blisters with aluminium foil backing in a pack containing 140 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Section 8: New EU number - EU/1/06/360/013
4.5 - Text relating to interaction with alcohol has been moved.4.8 - Addition of hypersensitivity reactions.10 - Date of revision updated.
Section 4.4 of the SmPC: regarding a statement on discontinuation of varenicline treatment in the case of serious neuropsychiatric symptoms
6.5 – Change in Pack size
8 – New MA number added for new pack size
4.4 – to include information on depression, suicidal ideation and suicidal attemp
4.8 – to include information on depression, suicidal ideation and suicidal attemp
Section 4.8 – Addition of Myocardial infaction
Section 6.3: extend shelf life from 18 months to 24 months