Olmesartan/amlodipine/hydrochlorothiazide (By mouth)

Introduction

Amlodipine (am-LOE-di-peen), Hydrochlorothiazide (hye-droe-klor-oh-THYE-a-zide), Olmesartan Medoxomil (ol-me-SAR-tan me-DOX-oh-mil)

Treats high blood pressure. A lower blood pressure will reduce the risk of stroke and heart attack. This medicine is a combination of three medicines: an angiotensin receptor blocker, a calcium channel blocker, and a thiazide diuretic (water pill).

Brand Name(s)

Tribenzor

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.
• Take this medicine at the same time each day.
• Carefully follow your doctor's instructions about any special diet.Drink plenty of fluids if you exercise, sweat more than usual, or have diarrhea or vomiting.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using a statin or other medicine to lower cholesterol (such as simvastatin (Zocor®), cholestyramine, colesevelam, colestipol, Colestid®, or Questran®), or other medicines for high blood pressure, including a diuretic or water pill such as amiloride, spironolactone, triamterene, Aldactone®, Dyrenium®, or Midamor®. Tell your doctor if you use medicines or supplements that contain potassium, including a salt substitute.
• Make sure your doctor knows if you are also using lithium (Eskalith®, Lithobid®), pain or arthritis medicine (NSAIDs, such as aspirin, celecoxib, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Motrin®), insulin or an oral diabetes medicine (such as glyburide, metformin, Actos®, Avandia®, Glucophage®, Glucotrol®, Glucovance®), a steroid medicine (such as dexamethasone, prednisolone, prednisone, Medrol®), or medicine to treat seizures (such as phenobarbital or Luminal®).
• You may feel more lightheaded, dizzy, or faint if you drink alcohol or take narcotic pain relievers or sleeping pills.

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby, especially after the first 3 months of pregnancy. Use an effective form of birth control to prevent pregnancy. If you think you have become pregnant while using this medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding, or if you have had a recent heart attack. Tell your doctor if you have kidney problems, liver disease, diabetes, gout, lupus, congestive heart failure, heart or blood vessel disease, a mineral imbalance (such as high calcium or low potassium, magnesium, or sodium in the blood), or a history of asthma. Tell your doctor if you are dehydrated or if you have diarrhea or vomiting.
• This medicine will not cure your high blood pressure, but it will help lower it and keep it down. Do not stop using this medicine without asking your doctor, even if you feel well. You may have to take blood pressure medicine for the rest of your life.
• This medicine could lower your blood pressure too much and cause you to feel dizzy or lightheaded. Stand or sit up slowly if you are dizzy. This is more likely to happen when you begin to use the medicine. It could also happen if have diarrhea or vomiting, sweat heavily, or do not drink enough water and become dehydrated.
• Check with your doctor right away if you have chest pain that is worse than usual, trouble breathing, nausea or vomiting, pain in your arm, jaw, back, or neck, feel faint, or you are sweating. This medicine may worsen the symptoms of an existing heart problem.
• Stop using this medicine and check with your doctor immediately if you have vision changes such as blurred vision, difficulty reading, or eye pain, during or after treatment. This could be a sign of a serious eye problem. Your doctor will want an eye doctor to check your eyes.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, eye pain, or changes in vision
• Change in how much or how often you urinate, or painful urination
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, faintness
• Confusion, body weakness, and muscle twitching
• Dry mouth, increased thirst, muscle cramps, nausea, or vomiting
• Fast, slow, uneven, or pounding heartbeat
• Fever, chills, cough, sore throat, runny or stuffy nose, and body aches
• Joint pain or swelling
• Lightheadedness, dizziness, or fainting
• Rapid weight gain
• Swelling in your hands, ankles, or feet

If you notice these less serious side effects, talk with your doctor:

• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

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