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BENICAR® and BENICAR HCT® have been proven to help lower blood pressure.

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Understanding high blood pressure.

High blood pressure is a common condition that affects about 1 in 3 adults in the US. Remember, the first step to effectively treating high blood pressure is to understand what it is.

What is high blood pressure?

As your heart pumps blood to the different parts of your body, the blood pushes against the walls of your blood vessels and arteries. The force that it exerts is what doctors call blood pressure.

The more blood your heart pumps, and the narrower your arteries, the greater your blood pressure will be. When it becomes higher than the level recommended for good health, it is called high blood pressure or hypertension. BENICAR and BENICAR HCT have been proven to help lower blood pressure. Talk to your doctor to see if one of them may be right for you.

Often has no symptoms, but serious risks.

High blood pressure is vital to treat because it can dramatically raise your risk of cardiovascular events, like heart attack and stroke. But often, it has no warning symptoms. According to the American Heart Association's Heart Disease and Stroke Statistical Update based on 2007-2010, 78 million American adults have hypertension and almost 1 in 5 of them are unaware they have it.

What causes high blood pressure?

High blood pressure often has no direct cause. But certain risk factors may increase your risk of developing it. Some, such as age, gender, race, and family history, cannot be controlled. Fortunately, you can help control many of the others.

Risk factors you CAN control.

  1. 1 Overweight—Losing even 5 pounds can help you lower your blood pressure.
  2. 2 Lack of physical activity—Regular physical activity can help you lower your blood pressure and keep your weight under control.
  3. 3 Tobacco use—Smoking or chewing tobacco can raise blood pressure. If you smoke, quit.
  4. 4 A high salt (sodium) diet—A diet low in sodium of less than 2,400 milligrams (mg) per day has been shown to help lower blood pressure.
  1. 5 Alcohol use—Too much may raise your blood pressure.
  2. 6 Stress—Stress can raise blood pressure temporarily and may lead to overeating, and tobacco or alcohol use. There are techniques to help reduce it.
  3. 7 Certain conditions—High cholesterol, diabetes, kidney disease, and sleep apnea may increase your risk of high blood pressure. Talk to your doctor if you have these.
  4. 8 Some medications—Decongestants, birth control pills, and certain pain relievers and prescription drugs can raise blood pressure. Talk to your doctor before taking them.

Controlling your blood pressure.

A key to controlling high blood pressure is working with your doctor. Ask your doctor if BENICAR or BENICAR HCT is right for you.

Selected Important Safety Information:

Do not take BENICAR or BENICAR HCT during pregnancy. Before taking BENICAR or BENICAR HCT, tell your doctor if you are pregnant or plan to become pregnant.

BENICAR and BENICAR HCT may cause kidney problems, which may get worse in people with kidney disease. Talk to your doctor if you have kidney problems.

Because of the thiazide diuretic (water pill), an ingredient in BENICAR HCT, a serious side effect of BENICAR HCT may include changes in body salts (such as sodium and potassium) and fluids.

Some of your other medicines and Benicar and Benicar HCT could affect each other. This may cause serious side effects. Tell your doctor about all the medicines you take.

If you are taking BENICAR HCT, do not drink alcohol. Your blood pressure may become too low if you drink alcohol.

BENICAR and BENICAR HCT may cause serious side effects, such as low blood pressure (hypotension), which may cause you to feel faint or dizzy.

The most common side effect of BENICAR and BENICAR HCT was dizziness. Other side effects of BENICAR HCT included upper respiratory tract infection, more uric acid in the blood, and nausea.

    Do not take BENICAR or BENICAR HCT if you:

  • Take a medicine that contains aliskiren and you have diabetes or kidney problems

    Do not take BENICAR HCT if you:

  • Have less urine than normal or if you cannot urinate
  • Are allergic to other sulfonamide type medicines
  • Have severe kidney disease
For important safety information, please see below.

INDICATIONS

BENICAR and BENICAR HCT are prescription medicines used to lower high blood pressure (hypertension). They may be used alone or with other medicines used to treat high blood pressure. BENICAR HCT is not for use as the first medicine to treat high blood pressure.

Important Safety Information for BENICAR® and BENICAR HCT®

WARNING: DO NOT TAKE BENICAR or BENICAR HCT DURING PREGNANCY

  • BENICAR and BENICAR HCT can cause harm or death to an unborn baby
  • Talk with your doctor about other ways to lower your blood pressure if you become pregnant
  • If you get pregnant while taking BENICAR or BENICAR HCT, tell your doctor immediately

Please see the WARNINGS AND PRECAUTIONS section of the Full Product Information about Fetal Toxicity.

Do not take BENICAR or BENICAR HCT if you:

  • Take medicine that contains aliskiren and you have diabetes or kidney problems

Do not take BENICAR HCT if you:

  • Have less urine than normal or if you cannot urinate
  • Are allergic to other sulfonamide type medicines
  • Have severe kidney disease

Children that are less than 1 year of age must not receive BENICAR for high blood pressure.

Before taking BENICAR or BENICAR HCT tell your doctor if you are pregnant or plan to become pregnant. Also tell your doctor if you are breast-feeding or plan to breast-feed. A medicine in BENICAR HCT can pass into your breast milk. This may harm your baby. You and your doctor should decide if you will take BENICAR or BENICAR HCT or breast-feed. You should not do both.

Let your doctor know about any health conditions you may have
Tell your doctor if you are allergic to any of the ingredients in BENICAR or BENICAR HCT (see Full Product Information for a list of the ingredients in BENICAR or BENICAR HCT as applicable). Also let your doctor know if you have any of the health conditions listed below:

Before you take these medicines: Let your doctor know if you have these, or any other, medical conditions:
BENICAR
  • Kidney problems
  • A lot of diarrhea or are vomiting
BENICAR HCT
  • Kidney or liver problems
  • Lupus
  • A lot of diarrhea or are vomiting
  • History of allergy or bronchial asthma

Tell your doctor about all the medicines you take
Some of your other medicines and BENICAR or BENICAR HCT could affect each other. This may cause serious side effects.

These medicines may include prescription and nonprescription medicines, vitamins, and herbal supplements:

If you take BENICAR, tell your doctor if you also take:


  • Water pills (diuretics)
  • Other medicines for high blood pressure or a heart problem
  • Potassium supplements or a salt substitute that contains potassium
  • Pain or arthritis medicines, such as aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Welchol® (colesevelam hydrochloride)
  • Lithium for certain types of depression

If you take BENICAR HCT , tell your doctor if you also take:


  • Water pills (diuretics)
  • Other medicines for high blood pressure or a heart problem
  • Potassium supplements or a salt substitute that contains potassium
  • Pain or arthritis medicines, such as aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Welchol® (colesevelam hydrochloride)
  • Diabetes medicine, including insulin
  • Narcotic pain medicine
  • Sleeping pills and antiseizure medicines called barbiturates
  • Lithium for certain types of depression
  • Steroids
  • Cholesterol-lowering medicines

About alcohol and other drug interactions
If you are taking BENICAR HCT, do not drink alcohol. Your blood pressure may become too low if you drink alcohol.

Some of your other medicines and BENICAR or BENICAR HCT could affect each other. This may cause serious side effects. Take BENICAR or BENICAR HCT as prescribed by your doctor. Talk with your doctor before you stop taking BENICAR or BENICAR HCT.

Know about possible side effects of BENICAR and BENICAR HCT
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. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose. Tell your doctor if you get swelling in your feet, ankles, or hands, or have unexplained weight gain. These may be signs of kidney problems. If you have heart failure, your doctor should also check your kidney function before prescribing these medicines. 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 or BENICAR HCT. Tell your doctor if you are experiencing these symptoms.

Additional side effects of BENICAR and BENICAR HCT
Because of the thiazide diuretic (water pill), an ingredient in BENICAR HCT, other serious side effects may include allergic reactions and changes in body salts (such as sodium and potassium) and fluids. Tell your doctor if you have these signs and symptoms: dry mouth, thirst, weakness, tiredness or sleepiness, restlessness, confusion, seizures, muscle pains or cramps, muscle tiredness, dizziness or fainting, having little or no urine output, fast heartbeat, or nausea and vomiting.

The thiazide diuretic in BENICAR HCT can also cause eye problems, which may lead to vision loss. Symptoms can happen within hours to weeks of starting BENICAR HCT. Tell your doctor if you have a decrease in vision or eye pain.

The most common side effect of BENICAR and BENICAR HCT was dizziness. Other side effects of BENICAR HCT included upper respiratory tract infections, more uric acid in the blood, and nausea.

Tell your doctor if you have any side effect that bothers you or does not go away. Not all the possible side effects of BENICAR or BENICAR HCT have been mentioned in the Important Safety Information. For more information, talk with your doctor or pharmacist. Call your doctor for medical advice about side effects.

To report side effects, contact Daiichi Sankyo, Inc., at 1-877-437-7763 or the FDA at 1-800-332-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information for BENICAR and BENICAR HCT, including Boxed WARNING regarding Fetal Toxicity.

The photos depict models, not actual patients or healthcare professionals.