Bioprexum Plus Adverse Reactions

Summary of safety profile: The administration of perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by indapamide.
Four percent of the patients on treatment with BIOPREXUM Plus 5 mg/1.25 mg experience hypokalaemia (potassium level <3.4 mmol/L).
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: Hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions and maculopapular rashes.
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 (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). (See Tables A and B.)


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Cases of SIADH have been reported with other ACE inhibitors. SIADH can be considered as a very rare but possible complication associated with ACE inhibitor therapy including perindopril.
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.