Prescribing Information
References
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MPR-MY-xxxxxx
Production date: May 2020
Production date: May 2020
Telmisartan (Micardis®) Important Safety Information
The overall incidence of adverse events reported with telmisartan (41.4%) was usually comparable to placebo (43.9%) in controlled clinical trials in patients treated for hypertension. The incidence of adverse events was not dose related and showed no correlation with gender, age or race of the patients. The safety profile of Micardis® in patients treated for cardiovascular risk reduction was consistent with that obtained in hypertensive patients. For further details, please refer to the full prescribing information.
Telmisartan + HCTZ (Micardis Plus®) Important Safety Information
The overall incidence of adverse events reported with Micardis Plus® was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients receiving telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636). There was no dose-relationship to undesirable effects and there was no correlation with gender, age or race of the patients. For further details, please refer to the full prescribing information.
Telmisartan + Amlodipine besilate (Twynsta®) Important Safety Information
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. For further details, please refer to the full prescribing information.
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. For further details, please refer to the full prescribing information.