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.
4.2 - addition of cardiac impairment & cross reference to section 4.4
4.3 - deletion of lactation or breast feeding, addition of Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery, Patients with severe renal and hepatic failure, expansion of active GI contraindication to include perforation
4.4 - expansion of warnings, especially kidney in line with Arthrotec 75 SmPC; addition of hypertension warning - blood pressure monitoring required; may prolong bleeding time; care required in elderly & patients treated with corticosteroids; addition of hypersensitivity warning; may mask fever or infection; excipient warning - sugars; monitor patients in long term treatment
4.5 - addition of information regarding potential interactions with tacrolimus, antidiabetic agents, anti-hypertensives including diuretics, angiotensin-converting enzyme (ACE) inhibitors and angiotensin II antagonists (AIIA), antacids, quinolone antibiotics, mifepristone, corticosteroids
4.6 - expansion to explain contraindication in pregnancy, misoprostol metabolism and diclofenac excretion in milk, diarrhoea is a recognised side effect of misoprostol and could occur in infants of nursing mothers so Arthrotec shouldn't be administered to nursing mothers.
4.8 - conversion of adverse events to a table of frequencies and addition of the following adverse events in line with the Arthrotec 75 SmPC: hypotension, hypertension, palpitations, chest pain and cardiac failure, dyspnea, blurred vision, abnormal uterine contractions, uterine rupture/perforation, retained placenta, amniotic fluid embolism, incomplete abortion, premature birth, fetal death, uterine haemorrhage, birth defects, chills, fever, vasculitis, pneumonitis, cutaneous reactions (including rash and bullous eruptions with vesiculation and erythroderma), dermatitis exfoliative, mucocutaneous reactions, anaphylactoid systemic reactions, oedema of the face and tongue, hypotension and shock, changes in mood, tiredness, aseptic meningitis, proteinuria, haematuria, acute renal insufficiency, severe fulminant hepatitis, gastritis, exacerbation of colitis and Crohn’s disease.
Section 1: name updated in line with current SPC guidelines to Arthrotec 50 modified-release tablets
Section 2: quantity of lactose monohydrate included
Section 3: pharmaceutical form updated inline with current SPC guidelines to modified-release
Section 4.2: administrative update to cross reference
Section 4.4: administrative update to cross reference and removal of lactose quantity
Section 6.1: update to excipient names: lactose monohydrate, povidone
Section 7: MAH address revised to 9 Riverwalk
Section 9: Date of last Renewal updated
Section 10: Date of partial revision to test updated
Section 1 administrative changes
Section 2 administrative changes
Section 3 administrative changes
Section 4.2 addition of instruction to use lowest dose to minimise side effects
Section 4.3 addition of contraindication: severe heart failure
Section 4.4 additional CV precautions, potential increased risk at high dose & long term treatment, use lowest dose for shortest time possible, avoid use with concomitant NSAIDs, potential for serious skin reactions
Section 4.5 rewording of text regarding use with anticoagulants, revised spelling of ciclosporin
Section 4.8 section on GI effects expanded, liver test terminology updated, oedema, hypertension & cardiac failure reported with NSAID treatment, suggested risk at high dose and in long term use
Section 6.1 administrative changes
Section 6.2 administrative changes
Section 6.3 administrative changes
Section 6.6 change to heading
Section 9 formatting change