Micardis Plus Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reaction is dizziness. Serious angioedema may occur rarely (≥1/10,000 to <1/1,000).
The overall incidence of adverse reactions reported with Micardis Plus was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636). Dose-relationship of adverse reactions was not established and they showed no correlation with gender, age or race of the patients.
Tabulated list of adverse reactions: Adverse reactions reported in all clinical trials and occurring more frequently (p ≤ 0.05) with telmisartan plus hydrochlorothiazide than with placebo are shown as follows according to system organ class. Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with Micardis Plus.
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 Table 1.)

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Additional information on individual components: Adverse reactions previously reported with one of the individual components may be potential adverse reactions with Micardis Plus, even if not observed in clinical trials with this product.
Telmisartan: Adverse reactions occurred with similar frequency in placebo and telmisartan treated patients.
The overall incidence of adverse events reported with telmisartan (41.4%) was usually comparable to placebo (43.9%) in placebo controlled trials. The following adverse reactions listed as follows have been accumulated from all clinical trials in patients treated with telmisartan for hypertension or in patients 50 years or older at high risk of cardiovascular events. (See Table 2.)

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Hydrochlorothiazide: Hydrochlorothiazide may cause or exacerbate hypovolaemia which could lead to electrolyte imbalance (see Precautions).
Adverse reactions of unknown frequency reported with the use of hydrochlorothiazide alone include: See Table 3.

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Description of selected adverse reactions: Hepatic function abnormal / liver disorder: Most cases of hepatic function abnormal/liver disorder from post-marketing experience with telmisartan occurred in Japanese patients. Japanese patients are more likely to experience these adverse reactions.
Sepsis: In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo. The event may be a chance finding or related to a mechanism currently not known (see Pharmacology: Pharmacodynamics under Actions).
Interstitial lung disease: Cases of interstitial lung disease have been reported from post-marketing experience in temporal association with the intake of telmisartan. However, a causal relationship has not been established.
Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed (see also Precautions; and Pharmacology: Pharmacodynamics under Actions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization 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.