Amlodipine is a calcium channel blocker. Olmesartan is an angiotensin II receptor blocker (sometimes called an ARB).

Amlodipine and olmesartan is a combination medicine used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

Amlodipine and olmesartan may also be used for purposes not listed in this medication guide.

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

If you have diabetes, do not use amlodipine and olmesartan together with any medication that contains aliskiren (a blood pressure medicine).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take this medication with or without food.

Your blood pressure will need to be checked often. Your kidney function may also need to be checked.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, or heavy sweating. Call your doctor if you are sick with vomiting or diarrhea.

If you need surgery, tell the surgeon ahead of time that you are using amlodipine and olmesartan.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Hypertension:

Initial dose: Amlodipine 5 mg-Olmesartan 20 mg orally once a day; may increase dose after 1 to 2 weeks of therapy.

Maximum dose: Amlodipine 10 mg-Olmesartan 40 mg orally once a day

Uses:
-Substitution therapy for patients maintained on the individual components separately or for patients not adequately controlled with one of the components or a component within the same antihypertensive class.
-Initial therapy in patients who are likely to need more than 1 antihypertensive agent to control blood pressure.

You should not use amlodipine and olmesartan if you are allergic to amlodipine or olmesartan.

If you have diabetes, do not use amlodipine and olmesartan together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking amlodipine and olmesartan with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• kidney disease;

• liver disease;

• coronary artery disease;

• angina (chest pain), congestive heart failure;

• high levels of potassium in your blood;

• if you are on a low-salt diet;

• if you are 75 years or older; or

• if you recently had a heart attack.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Olmesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using this medicine.

Amlodipine and olmesartan is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity until you know how amlodipine and olmesartan will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When you first start taking amlodipine and olmesartan, you may have new or worsening chest pain (angina), or you could have a heart attack. Seek emergency medical attention or call your doctor right away if you have symptoms such as: chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Amlodipine and olmesartan may cause serious side effects. Call your doctor at once if you have:

• new or worsening chest pain;

• swelling in your hands or feet, rapid weight gain;

• severe or ongoing diarrhea with weight loss;

• pounding heartbeats or fluttering in your chest;

• a light-headed feeling, like you might pass out; or

• high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects include swelling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

If you also take colesevelam, take it 4 hours after you take amlodipine and olmesartan.

Tell your doctor about all your other medicines, especially:

• cyclosporine;

• lithium;

• simvastatin;

• tacrolimus; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may affect amlodipine and olmesartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.