Faspic

Faspic Adverse Reactions

ibuprofen

Manufacturer:

Zambon

Distributor:

Cathay Drug
Full Prescribing Info
Adverse Reactions
Gastrointestinal Tract: Irritation, anorexia, nausea, vomiting, dyspepsia, gastric pyrosis, abdominal disturbance, Gastrointestinal bleeding and ulcer activation may be experienced with the use of Ibuprofen. Gastrointestinal effects are frequently reported.
Central Nervous System: Headache, confusion, tinnitus and somnolence have a minor incidence with respect to GI effects.
Cases of psychotic and depression were reported.
Isolated case on the use of ibuprofen was followed by the onset of severe headache, nausea, vomiting, fever, rigidity of the neck muscles and sensorium obnubilation (initial signs of meningitis).
Sense Organs: Reversible effects on the eyes eg, toxic amblyopia, blurred vision and color blindness were observed.
Skin and Hypersensitivity Reactions: Various types of rash including urticaria, exanthema and purpura, associated or not with itching, as well as Stevens-Johnson syndrome were reported.
Generalized hypersensitivity reactions are only seldom reported. The symptoms may include fever associated with rash, abdominal pain, headache, nausea and vomiting, signs of hepatic dysfunction together with meningism and anaphylactic phenomena. Systemic lupus erythematosus or other collagen disease represent risk factors for serious forms of generalized hypersensitivity. Seldom does ibuprofen include bronchospasm in predisposed patients.
Hematology: Daily dose exceeding 1 g of ibuprofen may prolong the bleeding time. Alterations of various nature and intensity affecting the blood profile eg, thrombocytopenia, granulocytopenia, agranulocytosis, hemolytic and aplastic anemia were reported. These blood dyscrasias occur particularly after prolonged administration of high doses.
Hepatic Effects: Cases of liver alterations (high serum transaminases) and jaundice were reported. Hepatoxicity can occur in cases of generalized hypersensitivity reactions.
Renal Effects: Cases of sodium and liquid retention or edema are known. Cases of dysuria and acute interstitial nephritis were also reported. Kidney failure of various degree of severity could occur, particularly after prolonged administration of high doses.
Acute kidney failure may occur in case of generalized hypersensitivity reactions. Renal damage (papilla necrosis) were also reported.
Other Effects: Occasionally, stomatitis, menstrual irregularities, increase in serum urate levels were reported. The onset of adverse events during treatment implies the immediate suspension of therapy and the attending physician must be notified and consulted immediately.
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