1 – the name has been updated to Arthrotec 50 or 75 modified-release tablets
2 – update to include amount of lactose
3 – Pharmaceutical form updated to modified-release tablet
4.2 – undesirable effects may be minimised by using the lowest dose for the shortest duration necessary, monitoring to also include cardiac impairment
4.3 – deletion of lactation/breast-feeding, rewording of GI contraindication, addition of severe heart failure, severe renal and hepatic failure, treatment of peri-operative pain in the setting of coronary artery bypass graft surgery
4.4 – warnings: avoid use with concomitant NSAIDs/COX-2s; precautions: undesirable effects may be minimised by using the lowest dose for the shortest duration necessary, Renal/Cardiac/Hepatic section rewritten to provide updated advice on treatment and monitoring of patients with liver/heart/kidney impairments, including Pharmacovigilance Working Party text & CHMP Key elements, Blood system/Gastrointestinal, Skin reactions sections significantly expanded to provide advice on patients at most risk of developing complications, caution required and action to be taken if events occur, standard lactose warning added.
4.5 – update to spelling of ciclosporin, addition of warnings regarding tacrolimus, anti-coagulants, anti-platelet agents, antihypertensives and SSRIs. Expansion of section on renal function and ACE inhibitors.
4.6 – expansion of reason for contraindication, addition of advise to counsel women of childbearing age on the need for adequate contraception and direction to discontinue treatment if pregnancy is suspected
4.8 – addition of post-marketing adverse events: GI bleeding, sometimes fatal, particularly in the elderly, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, ulcerative stomatitis, gastritis, dermatitis exfoliative, erythema multiforme, urticaria, mucocutaneous reactions, changes in mood, thrombocytopenia, dyspnea, blurred vision, abnormal uterine contractions, uterine rupture/perforation, retained placenta, amniotic fluid embolism, incomplete abortion, premature birth, foetal death, uterine haemorrhage, birth defects, chills and fever. Data suggest that diclofenac, particularly at high doses and in long term treatment may be associated with a small increased risk of arterial thrombotic events.
6.1 – excipients split into core and mantle/coat and names updated in line with current regulatory guidance
6.6 – heading updated
9 – layout and dates updated
10 – date of revision updated
4.4 – addition of advice regarding long term treatment with Arthrotec
4.5 – Cases of hypo and hyperglycaemia have been reported when diclofenac was associated with antidiabetic agents, antacids may delay absorption of diclofenac
4.8 – updated with table of clinical trials adverse events and expanded post-marketing adverse events
5.1 – addition of ATC code
5.2 – section expanded to provide information on terminal half life, clearance, volume of distribution and plasma binding of diclofenac, absorption and metabolism of misoprostol
6.4, 6.5, 6.6 – administrative updates
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