Safety and effectiveness of BENICAR HCT in patients with severe renal impairment (CrCl ≤30 mL/min) have not been established. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on BENICAR HCT. Monitor renal function periodically in these patients. Impaired Renal Function: Patients whose renal function may depend in part upon the activity of the renin-angiotensin-aldosterone system (eg, patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion), may be at particular risk of developing acute renal failure on BENICAR HCT. Hypotension in Volume- or Salt-Depleted Patients: In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (eg, those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with BENICAR HCT. See WARNINGS AND PRECAUTIONS: Fetal Toxicityĭo not co-administer aliskiren with BENICAR HCT in patients with diabetes.īENICAR HCT is contraindicated in patients with anuria or hypersensitivity to any component of BENICAR HCT.įetal Toxicity: BENICAR HCT is Pregnancy Category D. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.When pregnancy is detected, discontinue BENICAR HCT as soon as possible.To report side effects, contact Cosette Pharmaceuticals, Inc., at 1-80 or the FDA at 1-80 or Please see Full Prescribing Information for BENICAR. Call your doctor for medical advice about side effects. For more information, talk with your doctor or pharmacist. Not all the possible side effects of BENICAR have been mentioned in the Important Safety Information. Tell your doctor if you have any side effect that bothers you or does not go away. The most common side effect of BENICAR was dizziness. Tell your doctor if you are experiencing these symptoms. Serious side effects may also include severe, chronic diarrhea with considerable weight loss, which may develop months to years after starting BENICAR. If you have heart failure, your doctor should also check your kidney function before prescribing these medicines. Tell your doctor if you get swelling in your feet, ankles, or hands, or have unexplained weight gain. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose. Serious side effects may include injury or death to an unborn baby low blood pressure (hypotension), which may cause you to feel faint or dizzy and kidney problems, which may get worse in people with kidney disease. Know about possible side effects of BENICAR Talk with your doctor before you stop taking BENICAR. Take BENICAR as prescribed by your doctor. Some of your other medicines and BENICAR could affect each other. Lithium for certain types of depression.Pain or arthritis medicines, such as aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs).Potassium supplements or a salt substitute that contains potassium.Other medicines for high blood pressure or a heart problem.If you take BENICAR, tell your doctor if you also take: These medicines may include prescription and nonprescription medicines, vitamins, and herbal supplements: Tell your doctor about all the medicines you take Let your doctor know if you have these, or any other, medical conditions: Also let your doctor know if you have any of the health conditions listed below: Tell your doctor if you are allergic to any of the ingredients in BENICAR (see Full Product Information for a list of the ingredients in BENICAR). Let your doctor know about any health conditions you may have You and your doctor should decide if you will take BENICAR or breast-feed. A medicine in BENICAR can pass into your breast milk. Also tell your doctor if you are breast-feeding or plan to breast-feed. Take medicine that contains aliskiren and you have diabetes or kidney problemsĬhildren that are less than 1 year of age must not receive BENICAR for high blood pressure.Ĭhildren of any age should not take BENICAR.īefore taking BENICAR tell your doctor if you are pregnant or plan to become pregnant.Please see the WARNINGS AND PRECAUTIONS section of the Full Product Information about Fetal Toxicity. If you get pregnant while taking BENICAR, tell your doctor immediately.Talk with your doctor about other ways to lower your blood pressure if you become pregnant. BENICAR can cause harm or death to an unborn baby.WARNING: DO NOT TAKE BENICAR DURING PREGNANCY
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