Viacoram Adverse Reactions

Summary of the safety profile: The safety profile of Viacoram has been evaluated on a 6-month controlled study involving 1,771 patients, 887 of whom received Viacoram, a 6-week controlled study involving 837 patients, 279 of whom received Viacoram, and an 8-week placebo-controlled study involving 1581 patients, 249 of whom received Viacoram.
In these clinical studies, no significant new adverse reactions were observed with the combination compared to the known effects of the individual monocomponents.
The following adverse reactions were found to be the most frequently reported during clinical trials: dizziness, cough and oedema.
The adverse drug reactions previously reported during clinical trials and/or post-marketing experience with one of the individual components of Viacoram (perindopril and amlodipine) have been listed in the following table since they may occur with the fixed-dose combination.
Tabulated list of adverse reactions: The following undesirable effects have been observed during treatment with Viacoram, 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 (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000); not known (cannot be estimated from the available data). (See table.)

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Additional information on the combination perindopril/amlodipine: A randomised, double-blind, placebo-controlled study over 8 weeks demonstrated that peripheral oedema, a recognised side effect of amlodipine, was observed at a lower incidence in patients who received the perindopril 3.5 mg/amlodipine 2.5 mg combination than in those who received amlodipine 5 mg alone (1.6% and 4.9% respectively).
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.