RISK OF GI ULCERATIONS, BLEEDING AND PERFORATION WITH NSAID: Serious GI toxicity, such as bleeding, ulceration and perforation can occur at any time, with or without warning symptoms, in patients treated with NSAID therapy. Although minor upper GI problems (e.g., dyspepsia) are common, usually developing early in therapy, prescribers should remain alert for ulceration and bleeding in patients treated with NSAIDs even in the absence of previous GI tract symptoms.
Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Patients with prior history of serious adverse events and other risk factors associated with peptic ulcer disease (e.g., alcoholism, smoking, and corticosteroid therapy) are at increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleeding less well than other individuals and account for most spontaneous reports for fatal GI events.
SODIUM METABISULPHITE: This product contains Sodium Metabisulphite that may cause serious allergic type reactions in certain susceptible patients. Do not use if known to be hypersensitive to bisulphites.
As this preparation contains Benzyl Alcohol, its use should be avoided in children under 2 years of age. Not to be used in neonates.