Spedifen Special Precautions



Full Prescribing Info
Special Precautions
In patients at risk or who reported gastrointestinal alterations due to the use of NSAIDs, ibuprofen must be administered with due caution and under medical surveillance. Similarly, it must be used with caution in patients with history of bronchospasm following the use of other drugs, as well as in elderly patients and in patients with reduced renal, hepatic and/or cardiac function. For all these subjects, a periodic monitoring of clinical and laboratory parameters is required, especially in case of long-term treatment.
In some cases, water retention after ibuprofen administration was observed; thus, Spedifen must be used with caution in patients with heart failure and hypertension. Ibuprofen, similarly to other NSAIDs, can prolong the bleeding time, thus it must be used with due caution in patients with blood coagulation alterations or undergoing an anticoagulant treatment.
In case of previous treatment with corticosteroids, it is recommended to adjust gradually their dosage if an ibuprofen-combined therapy is to be performed.
Only seldom, aseptic meningitis in patients under treatment with ibuprofen was observed. Although this effect is more probably reported in patients with systemic lupus erythematosus and other collagen diseases, it was also observed in some patients who did not suffer from any chronic disease. This feature must be duly considered in case of drug administration.
Ophthalmologic alterations, though of rare occurrence, were observed (see Adverse Reactions). In this case, it is recommended as precautionary measure to discontinue the treatment and perform an ophthalmologic examination.
Similarly to other NSAIDs, some cases of acute interstitial nephritis with hematuria, dysuria and occasionally, nephrotic syndrome were observed after prolonged treatment with ibuprofen.
Anaphylactic reactions may occur when IV acetylcysteine is directly administered at high doses as well as when very fast rate is used. Treatment of those reactions must be symptomatic. Therefore, Hidonac must be administered as described in Dosage & Administration. Patients suffering from bronchial asthma or with a history of asthma must be closely controlled since bronchospasm may occur during treatment. In such event, the treatment must be immediately suspended. Intravenous administration must be done in a hospital under strict medical surveillance.
Effects on the Ability to Drive or Operate Machinery: Ibuprofen must be used with due caution in patients whose activity requires particular attention and who complained about somnolence, dizziness or depression during treatment with Spedifen.
Use in pregnancy: Although studies performed in animals did not show evidence of teratogenic action, it is recommended to avoid ibuprofen administration during the 1st months of pregnancy, as these studies are not predictive of a certain human response. Similarly, owing to prostaglandin synthesis inhibition and some cases, to fetal cardiovascular effects (closing of Botallo's duct), it is recommended not to administer ibuprofen during the last months of pregnancy, except in cases of strict necessity.
Use in lactation: Being proved the passage of ibuprofen into the mother's milk, its administration is not recommended during the lactation period.
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