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 4.4: - Addition of anxiety as a discontinuation symptom
- Addition of possible paralytic ileus when pregabalin is co-administered with drugs known to reduce lower gastrointestinal tract function to section 4.4 (CDS has it under drug interactions rather than warning/precautions). Section 4.8:
- Addition of anxiety as a discontinuation symptom
The addition of malaise and aggressions as ADRs with unknown frequency to section 4.8 of the SPC.
Section 4.8 undesirable effect
Removal of side effects emanating from clinical trial data from trials for indications for which Lyrica is not indicated.
Section 4.4 - Addition of vision loss and suicidal ideation information
Section 4.8 - Addition of vision loss information
4.4 Addition of information on hypersensitivity reactions, including cases of angioedema and visual changes
4.8 Addition of angioedema & Keratitis as new adverse events and visual field defect
described under eye disorders
5.1 Addition of clinical trial data for visual changes
1) Strengthening of Congestive Heart Failure wording in section 4.4 of the SmPC and addition of urinary retention to section 4.8 of the SmPC
2) Addition of Stevens Johnson Syndrome (SJS) to section 4.8 of the SmPC
Section 4.5 Addition of interaction with CNS depressant medication and effects of ethanol & lorazepam
Section 4.8 Addition of loss of consciousness, mental impairment and headache
Section 4.9 Update of this section with post-marketing information
Section 6.5 Addition of 100 hard capsule PVC/Aluminium blister pack (non-perforated)
Section 8 – Addition of further license numbers