Coveram Adverse Reactions

Summary of safety profile: The most commonly reported adverse reactions with perindopril and amlodipine given separately are: oedema, somnolence, dizziness, headache (especially at the beginning of the treatment), dysgeusia, paraesthesia, visual impairment (including diplopia), tinnitus, vertigo, palpitations, flushing, hypotension (and effects related to hypotension), dyspnoea, cough, abdominal pain, nausea, vomiting, dyspepsia, change of bowel habit, diarrheoa, constipation, prurit, rash, exanthema, joint swelling (ankle swelling), muscle spasms, fatigue, asthenia.
Tabulated list of adverse reactions: The following undesirable effects have been observed during clinical trials and/or post-marketing use with perindopril or amlodipine given separately and ranked under the MedDRA classification by body system and 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 (<1/10,000); not known (cannot be estimated from the available data). (See Tables A and B.)


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Additional information concerning amlodipine: Exceptional cases of extrapyramidal syndrome have been reported with calcium inhibitor treatment.
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.