Winofen Special Precautions

Cardiovascular Thrombotic Events: Observational studies have indicated that non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events, principally myocardial infarction, which may increase with dose or duration of use. Patients with cardiovascular disease or cardiovascular risk of an adverse cardiovascular event in patients taking NSAID, especially in those with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration. There is no consistent evidence that the concurrent use of aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAID use.
Hypertension: NSAIDs may lead to the onset of new hypertension or worsen pre-existing hypertension and patients taking anti-hypertensive with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing NSAIDS to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and at regular intervals thereafter.
Heart Failure: Fluid retention and oedema have been observed in some patients taking NSAIDs, caution is advised in patients with fluid retention or heart failure.
Gastrointestinal Events: All NSAIDs can cause gastrointestinal discomfort and rarely serious, potentially fatal gastrointestinal effects such as ulcers, bleeding and perforation which may increase with dose or duration of use, but can occur at any time without warning. Caution is advised in patients with risk factors for gastrointestinal events e.g. the elderly, those with a history of serious gastrointestinal events, smoking and alcoholism. When gastrointestinal bleeding or ulcerations occur in patients receiving NSAIDs, the drug should be withdrawn immediately. Doctors should warn the patient about signs and symptoms of serious gastrointestinal toxicity. The concurrent use of aspirin and NSAIDs also increases the risk of serious gastrointestinal adverse events.
Severe Skin Reactions: NSAIDs may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), which can be fatal and occur without warning. These serious adverse events are idiosyncratic and are independent of dose or duration of use. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of skin rash or any other sign of hypersensitivity.
Caution should be taken when giving to patients with asthma or have ever suffered from asthma particularly those with aspirin-sensitive asthma.
If the existing symptoms persist for more than 3 days, consult a doctor.
Patients with impaired liver or kidney functions should take the medication with caution.
Ibuprofen should be administered with caution to patients with cardiac impairment.
Caution should be taken when giving to patients with a history of gastrointestinal bleeding or peptic ulcerations.