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 2 addition of excipients, 4.6 sentence on fertility added, 4.8 addition of circulatory collapse and reformatting 6.3 amendments to shelf life.
Section 4.
2 of the spc has been updated to include an additional sentence: "there is limited clinical experience with dynastat treatment beyond three days."
SmPC: Changes to section 4.
9 of the SPC
Section 4.4 (highlighted text = new text)
Serious skin reactions, including erythema multiforme, exfoliative dermatitis and Stevens-Johnson syndrome (some of them fatal) have been reported through post marketing surveillance in patients receiving parecoxib. Additionally, fatal reports of toxic epidermal necrolysis, have been reported through postmarketing surveillance in patients receiving valdecoxib (the active metabolite of parecoxib) and cannot be ruled out for parecoxib (see section 4.8).
Section 4.2 Posology and method of administration
addition of concomitant Use with Opioid Analgesics
- paragraph on renal impairment amended to provide clarity
Section 4.5 Interaction with other medicinal products and other forms of interaction
- Deletion of co-administration with Morphine
- Addition of use with parecoxib
Section 5.1 Pharmacodynamic properties
- Addition of Opioid sparing effects
9 – Date of Renewal
10 – Date last updated
2 – addition of amount of sodium when reconstituted (moved from section 6.1)
4.2 – rewording of statement on lack of experience in children and adolescents
4.3 – hypersensitivity statement updated
4.4 – addition of paragraph on association of COX-2 inhibitors with increased risk of 4.4 – cardiovascular and thrombotic adverse events in long term use
4.4 – update to section on serious skin reactions
4.5 – interaction studies have only been performed in adults
4.6 – update to include statement on suspected to cause serious birth defects when administered during the last trimester of pregnancy
4.8 – addition of myocardial infarction and Stevens-Johnson syndrome as rare post-marketing reactions
6.4 – section reworded in line with current guidelines
In addition the details of the non-marketed 20mg presentations have been added to the advert SmPC. This affects sections 1, 2, 6.5, 6.6 and 8.