Viacoram Initio/Viacoram Adverse Reactions

Summary of the safety profile: The safety profile of Viacoram Initio/Viacoram has been evaluated on a 6-month controlled study involving 1,771 patients, 887 of whom received Viacoram Initio/Viacoram, a 6-week controlled study involving 837 patients, 279 of whom received Viacoram Initio/Viacoram, and an 8-week placebo-controlled study involving 1581 patients, 249 of whom received Viacoram Initio/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 edema.
The adverse drug reactions previously reported during clinical trials and/or post-marketing experience with one of the individual components (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 Perindopril arginine + Amlodipine besilate (Viacoram Initio/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 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.
Additional information on the combination perindopril/amlodipine: A randomized, double-blind, placebo-controlled study over 8 weeks demonstrated that peripheral edema, a recognized 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).