Twynsta Adverse Reactions

Summary of the safety profile: The safety and tolerability of TWYNSTA has been evaluated in five controlled clinical studies with over 3500 patients, over 2500 of whom received telmisartan in combination with amlodipine.
No additional adverse reactions were identified in clinical trials with the combination telmisartan plus amlodipine compared to the adverse reactions of the monocomponents. Peripheral oedema, a recognised dose dependent adverse reaction of the monocomponent amlodipine, was generally observed at a lower incidence in patients who received the telmisartan/amlodipine combination than in those who received amlodipine alone.
Adverse reactions previously reported with one of the monocomponents (telmisartan or amlodipine) may be potential adverse reactions with TWYNSTA as well, even if not observed in clinical trials or during the post-marketing period. Therefore in addition to the reported adverse reactions during the TWYNSTA development programme all adverse reactions reported in patients who received telmisartan or amlodipine monotherapy, have been listed for TWYNSTA.
Tabulated summary of adverse reactions: The following adverse reactions derived from the use of the telmisartan/amlodipine combination or the use of the monocomponents (telmisartan or amlodipine) in clinical trials or from post-marketing experience are shown in the table as follows classified by MedDRA System organ class and MedDRA Preferred terms.
Adverse reactions have been ranked under headings of frequency using the following convention: 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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Tables 5a and 5b.)

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