Spedifen Adverse Reactions



Full Prescribing Info
Adverse Reactions
At gastrointestinal level, nausea, vomiting, dyspepsia, gastric pyrosis, abdominal pain, diarrhea, intestinal microlesions, possible ulcerative activation and hemorrhages can be observed.
Occasionally, headache, confusion, tinnitus and somnolence may appear. Seldom, psychotic reactions and depression, as well as intense headache, nausea, vomiting, fever, neck rigidity and a certain obnubilation were reported. Only rarely, visual disturbances eg, blurred vision, scotoma or altered color perception were observed after ibuprofen administration. These effects however regressed spontaneously.
In terms of hypersensitivity reactions, rash, urticaria and exanthema with or without itching were observed and sometimes, also fever associated with rash, abdominal pain, headache, nausea and vomiting; signs of hepatic dysfunction and anaphylactic phenomena were reported. Only in seldom cases that ibuprofen can induce bronchospasm in predisposed patients.
After prolonged administration at high doses, ibuprofen could induce alterations of the blood corpuscular elements as well as water retention, with the possible onset of swellings and edemas.
In case of onset of adverse events, the treatment must be suspended.
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