Gofex Special Precautions

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see Dosage & Administration and Gastrointestinal Risk and Cardiovascular Risk under Warnings).
GI Effects: The use of ibuprofen with Concomitant NSAIDs, including COX-2 selective inhibitors should be avoided.
Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation, which may be fatal (see Dosage & Administration).
Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs, at any time during treatment, with or without warning symptoms or previous history of serious GI events. 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 hemorrhage or perforation (see Contraindications), 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 Interactions).
Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. 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 acetyl salicylic acid (see Interactions). When GI bleeding or ulceration occurs, the treatment should be withdrawn. NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated (see Side Effects).
Cardiovascular and cerebrovascular effects: Appropriate monitoring and advice are required for patients with a history of hypertension and or mild to moderate congestive heart failure. Fluid retention, hypertension and oedema have been reported in association with NSAIDs therapy.
Clinical studies suggest that use of ibuprofen, particularly at a high dose (2,400 mg/day) may be associated with a small increased risk of arterial thrombotic event (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤1,200 mg/day) is associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2,400 mg/day) should be avoided.
Careful consideration should also be exercised before initiating long term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, and smoking), particularly if high doses of ibuprofen (2,400 mg/day) are required.
Severe skin reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Steven-Johnson's syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see Side Effects). 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. Ibuprofen-containing products should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Masking of symptoms of underlying infections: Ibuprofen can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When Ibuprofen is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.
Other effects: Caution is required in patients with coagulation disorders and liver, cardiac or kidney insufficiency. Caution should be used when initiating treatment with ibuprofen in patients with considerable dehydration.
Risks of long-term habitual use of analgesic are headache and analgesic nephropathy.
Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.
Caution is required in patients with systemic lupus erythematosus or other collagen diseases. There is some evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.
Patients who experience visual disturbances during ibuprofen therapy should discontinue the treatment and have an ophthalmologic examination. NSAIDs may produce an increase of liver function test results.
Effect on ability of driving and operating machine: Dizziness and headache have been reported which may affect the patient's ability to drive or to operate machinery. Single administration or short term use of ibuprofen does not usually warrant the adoption of any special precautions. Therefore, GOFEN has minor influence on these abilities.