| SmPC updated in line with NSAIDs class labelling, at the request of the MHRA.
Section 4.3
Addition of:
‘Hypersensitivity to diclofenac sodium or to any of the excipients.’
‘Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).’
Deletion of:
‘Use with concomitant NSAIDs including cyclooxygenase-2 specific inhibitors (See section 4.5 - Interactions).’
Section 4.4
Addition of:
‘The use of Motifene with concomitant NSAIDs including cyclo-oxygenase‑2 selective inhibitors should be avoided (See section 4.5).’
‘The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5).’
‘Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (See section 4.5).’
‘Dermatological: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens‑Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Motifene should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.’
Section 4.5
Addition of:
‘Other analgesics including cyclo-oxygenase‑2 selective inhibitors: Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects (See section 4.4).’
‘Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4).’
‘Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.’
Section 4.6
Addition of:
‘Lactation: In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breast-feeding. See section 4.4 regarding female fertility.’
Section 4.7
Minor update to wording:
‘Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.’
Section 4.8
Addition of:
‘Pancreatitis has been reported very rarely.’
‘Cardiovascular and cerebrovascular: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.’
‘Isolated cases of bullous eruptions, eczema, erythema multiforme, Stevens-Johnson syndrome and Toxic Epidermal Necrolysis (very rare), Lyell's syndrome, loss of hair.’
|
