Kaltrofen Adverse Reactions



Kalbe Farma
Full Prescribing Info
Adverse Reactions
The most common adverse reactions are dyspepsia, nausea, vomiting, diarrhoea, constipation, headache, dizziness, rash, impairment of renal and hepatic function, abdominal pain, mild confusion, vertigo, edema and insomnia.
Haemorrhagic reaction: Mild thrombocytopenia.
Bronchospasm and anaphylactic reactions are rare.
Use of suppositories is sometimes associated with change in stool consistency mostly of mild softening.
Gel: Skin reaction including pruritus and localized erythema have occurred, particularly during exposure to sunlight or UV light. Patient should avoid sunlight or UV light exposure during treatment with KALTROFEN gel.
The prolonged use of products for topical administration may cause hypersensitivity phenomena.
Although not known for topical use of Ketoprofen, the following adverse events are reported for systemic use: minor adverse events, frequently transient, consist of gastrointestinal effects such as indigestion, dyspepsia, nausea, constipation, diarrhoea, heartburn and various types of abdominal discomfort. Other minor effects such as headache, dizziness, mild confusion, vertigo, drowsiness, oedema, mood change and insomnia may occur less frequently. Major gastrointestinal adverse event such as peptic ulceration, haemorrhage or perforation may rarely occur. Haematological reactions including thrombocytopenia, hepatic or renal damage, dermatological reaction, bronchospasm and anaphylaxis exceedingly rare.
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