Natrilix SR Adverse Reactions

Summary of safety profile: The most commonly reported adverse reactions are hypokalaemia, hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions and maculopapular rashes.
Tabulated summary of adverse reactions: The following undesirable effects have been observed with indapamide during treatment ranked under the following frequency: Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥1/10,000 to <1/1,000); very rare (≥1/100,000 to <1/10,000), not known (cannot be estimated from the available data). (See table.)


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Description of selected adverse reactions: During phase II and III studies of indapamide 1.5 mg, plasma potassium analysis showed a dose-dependent effect of indapamide: Indapamide 1.5 mg: 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.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.