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Updated 10/07


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.