Natrilix SR Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reactions are hypersensitivity reactions (mainly dermatological) in patients predisposed to allergic or asthmatic reactions or to maculopapular rashes.
During clinical trials, hypokalaemia (plasma potassium <3.4 mmol/l) was observed in 10% of patients and plasma potassium <3.2 mmol/l in 4% of patients after 4 to 6 weeks of treatment. After 12 weeks of treatment, the mean fall in plasma potassium was 0.23 mmol/l.
The biological and clinical adverse reactions are for the most part dose-dependent.
Tabulated list of adverse reactions: The following adverse reactions have been reported during treatment and are categorised according to the following frequencies: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Very rare (<1/10,000), Not known (cannot be estimated from the available data). (See table.)

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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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.