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IMPORTANT PATIENT SAFETY INFORMATION

What are BENICAR (olmesartan medoxomil) and BENICAR HCT (olmesartan medoxomil-hydrochlorothiazide)?

BENICAR and BENICAR HCT are prescription drugs used for the treatment of high blood pressure. The active ingredient in BENICAR is olmesartan medoxomil. BENICAR HCT contains two different active ingredients in one tablet, namely BENICAR and a thiazide diuretic known as hydrochlorothiazide or HCTZ. HCTZ is also used for the treatment of high blood pressure and works by removing water from your bloodstream.

BENICAR HCT is for patients who need even more blood pressure reductions than are obtained with BENICAR or HCTZ alone, but BENICAR HCT should not be used for initial blood pressure therapy.

BENICAR or BENICAR HCT may be used alone or in combination with other drugs to treat high blood pressure.

BENICAR and BENICAR HCT should not be used during pregnancy.

Additionally, the thiazide component of BENICAR HCT can cross the placental barrier and appear in umbilical cord blood. This increases the risk of fetal or neonatal jaundice, low blood platelet counts, and possibly other adverse reactions that have occurred in adults.

What should I tell my health care provider?

Be sure to tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.

It is particularly important to tell your health care provider if you are currently taking diuretics (water pills), because starting BENICAR therapy in some patients taking diuretics or who may have low salt or fluid levels may increase the possibility of hypotension (low blood pressure) that may require treatment.

Tell your health care provider if you have kidney or liver problems. While no initial dosage adjustments for BENICAR or BENICAR HCT are recommended for patients with moderate to marked kidney or liver problems, nor in those who are elderly, your health care provider may want to monitor you more closely and may consider starting you on a lower dose of BENICAR or BENICAR HCT.

If you are taking any other prescription or nonprescription medicines, including vitamins and herbal supplements, tell your health care provider. This information can help your health care provider avoid possible interactions with BENICAR or BENICAR HCT. If you decide to stop taking BENICAR or BENICAR HCT for any reason, you should notify your health care provider as soon as possible.

In addition to the Safety Information for BENICAR and BENICAR HCT (described above), is there safety information about the hydrochlorothiazide (HCTZ) component in BENICAR HCT?

Because of the HCTZ ingredient in BENICAR HCT, you should not take BENICAR HCT if you have severe kidney disease, are unable to urinate, or are sensitive to other sulfonamide-derived drugs.

Thiazide diuretics (such as HCTZ) should be used with caution if you have impaired liver function or progressive liver disease.

Thiazide diuretics (such as HCTZ) have also been reported to aggravate a condition known as systemic lupus erythematosus.

Hypersensitivity reactions to hydrochlorothiazide (HCTZ) may occur even if you do not have a history of allergy or bronchial asthma, but may be more likely if you have a history of such reactions.

Lithium generally should not be given if you are taking a thiazide diuretic (such as HCTZ), which is one of the active medications in BENICAR HCT.

What are some possible side effects of BENICAR and BENICAR HCT?

The most common side effect with BENICAR is dizziness. In clinical studies, dizziness occurred in more than 1% of patients treated with BENICAR and more frequently than placebo (3% with BENICAR and 1% with placebo). A placebo is an inactive, nondrug substance, such as a sugar pill, that is given in a drug study to compare the effect of a treatment including the drug being studied with the effect of the same treatment without the drug.

In clinical trials, side effects that occurred in more than 2% of patients treated with BENICAR HCT and more frequently than placebo (“sugar pill”) were nausea (3% with BENICAR HCT and 0% with placebo), higher levels of uric acid in the blood (4% with BENICAR HCT and 2% with placebo), dizziness (9% with BENICAR HCT and 2% with placebo), and upper respiratory tract infection (7% with BENICAR HCT and 0% with placebo).

In these studies, treatment with BENICAR or BENICAR HCT was well tolerated and the incidence of adverse events was similar to placebo. Call your health care provider if you experience any unpleasant effects when taking BENICAR or BENICAR HCT.

Please see full product information for BENICAR and BENICAR HCT, including boxed WARNING regarding use in Pregnancy.