Benicar and Benicar HCT are prescription drugs used to lower high blood pressure (hypertension). Benicar HCT is not for use as the first medicine to treat your high blood pressure.

The content provided herein is for informational purposes only and does Welfil not constitute or substitute for professional medical advice, diagnosis, or treatment. Talk to your doctor for more information about your specific condition.

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Important Safety Information

WARNING: DO NOT TAKE BENICAR OR BENICAR HCT DURING PREGNANCY
If you become pregnant, stop taking Benicar or Benicar HCT. Call your doctor right away. Benicar and Benicar HCT can cause injury or death to an unborn baby. If you plan to become pregnant, talk with your doctor about other treatments to lower blood pressure. Please see the WARNING section of the full product information about avoiding use in pregnancy.

Before taking Benicar or Benicar HCT, tell your doctor if you are 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.

Do not take Benicar HCT if you:

• Have severe kidney disease
• Have low or no urine output
• Are allergic to other sulfonamide type medicines

Tell your doctor if you are allergic to any of the ingredients in Benicar or Benicar HCT (see the Prescribing Information for a list of the ingredients in Benicar or Benicar HCT). Also, tell your doctor if you have liver or kidney problems or if you have lupus. If you are vomiting, have a lot of diarrhea, or have any other medical conditions, be sure to tell your doctor.

Tell your doctor about all the medicines you take. These medicines may include prescription and nonprescription medicines, vitamins, and herbal supplements. If you are taking Benicar or Benicar HCT, be sure to tell your doctor if you are taking:

• 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)

If you are taking Benicar HCT, also tell your doctor if you are taking:

• Diabetes medicine, including insulin
• Narcotic pain medicine
• Sleeping pills and antiseizure medicines called barbiturates
• Lithium for certain types of depression
• Steroids
• Cholesterol medicines

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. If you choose to stop taking Benicar or Benicar HCT, talk with your doctor first.

Benicar and Benicar HCT may cause serious side effects. These 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 of Benicar or Benicar HCT. 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.

Other serious side effects of Benicar HCT include allergic reactions due to the thiazide diuretic (water pill), 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.

Hydrochlorothiazide (an ingredient 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 a side effect bothers you or does not go away.

Tell your doctor if you have side effects. These are not all the possible side effects of Benicar or Benicar HCT. For more information, talk with your doctor or pharmacist. Call your doctor for medical advice about side effects.

You may report side effects by calling 1-877-437-7763 or the FDA at 1-800-FDA-1088.

Please see full Prescribing Information for Benicar and Benicar HCT, including boxed WARNING regarding avoiding use in Pregnancy.

Benicar HCT Drug Description

BENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide) is a combination of an angiotensin II receptor antagonist (AT₁ subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ).

Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during Libitol absorption from the gastrointestinal tract.

Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3carbonate.

Its empirical formula is C₂₉H₃₀N₆O₆ and its structural formula is:

Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C₇H₈ClN₃O₄S₂ and its structural formula is:

Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution.

BENICAR HCT® is available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropylcellulose, hypromellose, lactose, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, red iron oxide, talc, titanium dioxide and yellow iron oxide.

SIDE EFFECTS:Dizziness or lightheadedness may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, muscle cramps/weakness, slow/fast/irregular heartbeat, unusual decrease in the amount of urine, unusual dry mouth/thirst, decrease in vision, eye pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS:Before taking this medication, tell your doctor or pharmacist if you are allergic to olmesartan or hydrochlorothiazide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: gout, kidney disease, liver disease, lupus.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Severe sweating, diarrhea, or vomiting can increase the risk for lightheadedness or a serious loss of body water (dehydration). Report prolonged diarrhea or vomiting to your doctor. To prevent dehydration, drink plenty of fluids unless your doctor directs you otherwise.

If you have diabetes, this product may affect your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness.

This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)

It is unknown if olmesartan passes into breast milk. Hydrochlorothiazide passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.