HIGHLIGHT
Cosyrel

Cosyrel Adverse Reactions

Manufacturer:

Servier

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Summary of the safety profile: The most common adverse reactions to bisoprolol include headache, dizziness, worsening of heart failure, hypotension, cold extremities, nausea, vomiting, abdominal pain, diarrhoea, constipation, asthenia and fatigue. The most common adverse reactions reported in clinical trials and observed with perindopril include headache, dizziness, vertigo, paraesthesia, visual disturbance, tinnitus, hypotension, cough, dyspnoea, nausea, vomiting, abdominal pain, diarrhoea, constipation, dysgeusia, dyspepsia, rash, pruritus, muscle cramps and asthenia.
Tabulated list of adverse reactions: The following undesirable effects have been observed during clinical trials and/or post-marketing use with bisoprolol or perindopril 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 (≥ 1/1000 to < 1/100) ; rare (≥ 1/10000 to < 1/1000) ; very rare (< 1/10000) ; not known (cannot be estimated from the available data). (See Table 2a and 2b.)

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