General: Prolonged use of this medication may increase the risk of adverse renal effects. It is recommended that patient should be under close medical supervision while receiving such combined therapy.
Cross-sensitivity and/or related problems: Patients sensitive to one of the NSAIDs may be sensitive to any of the other NSAIDs also. NSAIDs may cause bronchoconstriction or anaphylaxis in aspirin sensitive asthmatics, especially those with aspirin induced nasal polyps, asthma and other allergic reactions (the "aspirin triad").
Dental: NSAIDs may cause soreness, irritation, or ulceration of oral mucosa. Ibuprofen may rarely cause leukopenia and/or thrombocytopenia, which may result in an increased incidence of microbial infection, delayed healing, and gingival bleeding. If leukopenia or thrombocytopenia occurs, dental work should be deferred until blood counts have returned to normal, and patients should be instructed in proper oral hygiene, including caution in use of regular tooth brushes, dental floss and toothpicks.
Surgical: Caution is recommended in patients who require surgery. Most NSAIDs inhibit platelet aggregation and may prolong bleeding time, which may increase intra- and postoperative bleeding. Recovery of platelet function may occur within one day after discontinuation of ibuprofen. Consideration should be given to discontinuing NSAID treatment for an appropriate length of time prior to elective surgery, depending on the potency and duration of effect of the individual agent on platelet aggregability.
Special Precautions: Mild allergic reaction such as allergic rhinitis, urticaria or skin rash induced by aspirin or other NSAIDs; Anemia; Asthma; Conditions such as compromised cardiac function, congestive heart disease, pre-existing edema, renal function impairment; Conditions predisposing to gastro-intestinal toxicity, such as active alcoholism, inflammatory or ulcerative disease of upper or lower gastrointestinal tract, including Crohn's disease, diverticulitis, peptic ulcer disease, or ulcerative colitis and recent history of tobacco use; Hemophilia or other bleeding problems including coagulation or platelet function disorders; Hepatic cirrhosis or hepatic function impairment; Renal function impairment; Stomatitis; Systemic lupus erythematosus; Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen therapy.
Information for patients: Ibuprofen, like other drugs of its class, is not free of side effects. The side effects of these drugs can cause discomfort and, rarely, there are more serious side effects, such as gastrointestinal bleeding, which may result in hospitalization and even fatal outcomes.
Physicians may wish to discuss with their patients the potential risks (see PRECAUTIONS and ADVERSE REACTIONS) and likely benefits of non-steroidal anti-inflammatory drug treatment, particularly when the drugs are used for less serious conditions where treatment without such agents may represent an acceptable alternative to both the patient and physician.
Use in Children: BRUSTAN tablets are not recommended for use in children under the age of twelve years.
Use in the Elderly: NSAID-induced gastro-intestinal ulceration and/or bleeding may be more likely to cause serious consequences, including fatalities, in geriatric patients than in younger adults. In addition, elderly patients are more likely to have age-related renal function impairment, which may increase the risk of NSAID-induced hepatic and renal toxicity and may also require dosage reduction to prevent accumulation of the medication. Also, careful monitoring of the patient is recommended.