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If you experience any unpleasant effects from your medication, call your
doctor right away. Never stop taking your medication unless instructed
by your doctor as it could be dangerous.
If you have liver or kidney problems, tell your doctor. No initial dosing
adjustment is necessary for patients with mild-to-moderate renal impairment;
however, you may have difficulty taking MICARDIS or need to have
your medication adjusted.
MICARDIS should be used with caution in any patient who has a disorder of the liver or gallbladder, because these conditions can be expected to cause reduced clearance of drugs from the body.
If you take any other prescription or nonprescription medications, tell
your doctor. This helps your doctor avoid drugs that might have a negative
reaction with MICARDIS. If you are already taking diuretics, you should inform your doctor, because of the possibility of hypotension (low blood pressure).
DO NOT take MICARDIS if you are pregnant, because of possible effects on your unborn child. If you think you may be pregnant, tell your doctor.
Selected important cautionary information
In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted (e.g., those receiving high doses of diuretics), symptomatic hypotension may occur after initiation of MICARDIS or MICARDIS HCT therapy. This condition should be corrected prior to administration of MICARDIS or MICARDIS HCT, and treatment should start under close medical supervision.
Patients with biliary obstructive disorders or hepatic insufficiency should have treatment started under close medical supervision.
The most common adverse events occurring with MICARDIS Tablets monotherapy at a rate of ≥1% and greater than placebo, respectively, were: upper respiratory tract infection (URTI) (7%, 6%), back pain (3%, 1%), sinusitis (3%, 2%), diarrhea (3%, 2%), and pharyngitis (1%, 0%). The most common adverse events occurring in ≥2% of patients taking MICARDIS HCT vs placebo, respectively, were: dizziness (5%, 1%), diarrhea (3%, 0%), fatigue (3%, 1%), nausea (2%, 0%), influenza-like symptoms (2%, 1%), sinusitis (4%, 3%), and URTI (8%, 7%).
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USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, MICARDIS and MICARDIS HCT Tablets should be discontinued as soon as possible (see WARNINGS, Fetal/Neonatal Morbidity and Mortality).
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