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.
In section 5.2 - addition of information on the metabolism of piroxicam In section 10 - revision of date last updated
Section 6.5 - 10mg changed from 56 to 30 capsules pack, 20mg changed from 28 to 30 capsules pack
Section 10 - date of revision of text updated
Section 1 - update to name to include full pharmaceutical form in line with SPC Guidelines
Section 2 - inclusion of lactose monohydrate quantity
Sections 4.1 - 4.6, 4.8, 4.9, 5.1, 5.2 - administrative updates including changing 'FELDENE' to 'Feldene'
Section 6.5 - widened description of container to include outer cardboard carton
Section 6.6 - update to heading in line with SPC guidelines
Section 9 - update to date last renewed
Section 10 - update to date last updated
4.1 – deletion of acute indications, only indicated as second line treatment
4.2 – max daily dose reduced to 20mg, only to be prescribed by physicians with relevant experience, consider need for concomitant PPI, advice on regular treatment review, minimise side effects by giving minimum does for shortest duration necessary
4.3 – contraindications strengthened to include history of gastro-intestinal ulceration, bleeding, perforation or GI conditions that predispose to bleeding, current GI disorders, concomitant use with NSAIDs, including COX-2s, aspirin at analgesic dose, anticoagualnts, history of previous serious allergic drug reaction of any type (esp. serious skin reactions, moderate or sever heart failure
4.4 – extensive changes to strengthen advice about GI complications, serious skin reactions, CV risk, appropriate monitoring, affect on fertility
4.5 – updated information about aspirin & other NSAIDs, anticoagulants, anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs), corticosteroids
4.8 – addition of side effects dyspepsia, exacerbation of colitis and Crohn’s disease and gastritis. Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Data suggest that use of some NSAIDs may be associated with a small increased risk of arterial thrombotic events
6.1 – format update to advert SmPC (not related to variation)