Spedifen Side Effects





Zuellig Pharma


EP Plus Group
Full Prescribing Info
Side Effects
Effects on the gastro-intestinal tract: The most frequent adverse effects occurring with ibuprofen are gastro-intestinal disturbances: heartburn, anorexia, nausea, vomiting, dyspepsia, gastric pyrosis, abdominal discomfort, diarrhea, ulcer activation and gastro-intestinal bleeding.
Effects on the central nervous system: Chefalea, confusion, tinnitus and somnolence have been reported less frequently than gastro-intestinal effects. Cases of psychotic and depressive reactions were experienced. Individual cases of severe headache, nausea, vomiting, fever, stiffness of neck muscles, sensorial disturbance (earlier sign of meningitis) were experienced.
Effects on sense organs: Reversible ocular reactions were observed: toxic amblyopia, blurred vision and changes in colour vision.
Effects on the skin/hypersensitivity reactions: Skin rashes, including urticaria, exanthema and purpura were reported. Those reactions may be accompanied with pruritus and Stevens Johnson's syndrome.
General reactions of hypersensitivity may be rarely experienced.
Symptoms may be fever with skin rashes, abdominal pain, headache, nausea and vomiting, abnormalities of function tests, meningism and anaphylactic reactions.
Systemic Lupus Erythematosus or other collagenous disease can increase the risk of general hypersensitivity reactions. Rarely Ibuprofen may induce bronchospasm in predisposed patients.
Effects on the blood: Doses higher than 1000 mg/day can prolong the bleeding time. Blood alterations have been reported with differences both in nature and in severity: thrombocytopenia, granulocytopenia, agranulocytosis, haemolitic anaemia and aplastic anaemia. Such blood dyscrasias have been observed particularly after prolonged administration of high doses.
Effects on the liver: Abnormalities of liver function tests (high levels of serum transaminases) and icterus have been reported. See also hypersensitivity reactions.
Effects on the kidneys: Sodium and water retention and oedema have been reported. Cases of dysuria and of acute intestinal nephritis have been experienced. Impaired renal functions may be experienced with different severity, particularly after prolonged administration of high doses. Acute renal failure may occur in case of general hypersensitivity reactions. Cases of renal injury (renal papillary necrosis) have been reported.
Other undesirable effects: Stomatitis, menstrual disorder, increased serum levels of urates has been occasionally experienced.
In case that adverse events occur, treatment must be immediately suspended and the physician must be consulted.
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