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The most commonly reported adverse reactions observed are: with perindopril: dizziness, headache, paraesthesia, dysgeusia, visual impairment, vertigo, tinnitus, hypotension, cough, dyspnoea, abdominal pain, constipation, dyspepsia, diarrhoea, nausea, vomiting, pruritus, rash, muscle spasms and asthenia.
With indapamide: hypokalaemia, hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions and maculopapular rashes.
Coversyl Plus 5 mg/1.25 mg: Four percent of the patients on treatment with Coversyl Plus 5mg/1.25mg experience hypokalaemia (potassium level < 3.4 mmol/l).
Coversyl Plus 10 mg/2.5 mg: Six percent of the patients on treatment with Coversyl Plus 10mg/2.5mg experience hypokalaemia (potassium level < 3.4 mmol/l).
Tabulated list of adverse reactions: The following undesirable effects have been observed during clinical trials and/or post-marketing use and ranked under the following frequency: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data). (See table.)
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Click on icon to see table/diagram/imageDescription of selected adverse reactions: During phase II and III studies comparing indapamide 1.5mg and 2.5mg, plasma potassium analysis showed a dose-dependent effect of indapamide: Indapamide 1.5mg: Plasma potassium <3.4 mmol/l was seen in 10% of patients and <3.2 mmol/l in 4% of patients after 4 to 6 weeks treatment. After 12 weeks treatment, the mean fall in plasma potassium was 0.23 mmol/l.
Indapamide 2.5 mg: Plasma potassium <3.4 mmol/l was seen in 25% of patients and <3.2 mmol/l in 10% of patients after 4 to 6 weeks of treatment. After 12 weeks treatment, the mean fall in plasma potassium was 0.41 mmol/l.
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