Voltaren/Voltaren SR Warnings

Voltaren EC tablet/suppository: Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs, including diclofenac, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occur in patients receiving Voltaren, the medicinal product should be withdrawn.
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, including Voltaren (see Adverse Reactions). Patients appear to be at highest risk of 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. Voltaren should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur in rare cases with diclofenac without earlier exposure to the drug.
Like other NSAIDs, Voltaren may mask the signs and symptoms of infection due to its pharmacodynamic properties.
Voltaren SR-FC tablet: General warning for the use of systemic non-steroidal anti-inflammatory drugs: Gastrointestinal ulceration, bleeding or perforation may occur at any time during treatment with non-steroidal anti-inflammatory drugs (NSAIDs), whether COX-2 selective or not, even in the absence of warning symptoms or a predisposing history. To minimise this risk, the lowest effective dose should be given for the shortest possible duration of treatment.
Placebo-controlled studies have shown an increased risk of thrombotic cardiovascular and cerebrovascular complications with certain COX-2 selective inhibitors. It is not yet known whether this risk correlates directly with the COX-1/COX-2 selectivity of individual NSAIDs. As no comparable clinical study data are available at present for long-term treatment with the maximum dosage of diclofenac, the possibility of a similarly elevated risk cannot be ruled out. Until such data becomes available, a careful risk-benefit assessment must be carried out prior to using diclofenac in patients with clinically confirmed coronary heart disease, cerebrovascular disorders, peripheral arterial occlusive disease or considerable risk factors (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Due to this risk, too, the lowest effective dose should be given for the shortest possible duration of treatment.
The renal effects of NSAIDs include fluid retention with oedema and/or arterial hypertension. For this reason, diclofenac should be used with caution in patients with cardiac impairment and other conditions that predispose to fluid retention. Caution is also indicated in patients who take concomitant diuretics or ACE inhibitors, or who are at increased risk of hypovolaemia.
The consequences are generally more serious in the elderly. If gastrointestinal bleeding or ulceration occurs in patients undergoing treatment with Voltaren, the medicinal product should be withdrawn.
Cutaneous reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported very rarely in association with the use of NSAIDs, including Voltaren (see Adverse Reactions). Patients appear to be at highest risk at the start of treatment, with the onset of the reaction usually occurring within the first month of treatment. Voltaren should be discontinued at the first sign of rash, mucosal lesions or any other sign of hypersensitivity.
As with other NSAIDs, allergic reactions - including anaphylactic/anaphylactoid reactions - may occur in rare cases, even without prior exposure to diclofenac.
Masking signs of infection: Its pharmacodynamic properties mean that, like other NSAIDs, diclofenac may mask the signs and symptoms of infection.