Amlodipine is a calcium channel blocker that relaxes (widens) blood vessels and improves blood flow.

Telmisartan is an angiotensin II receptor antagonist that keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

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

Do not use this medicine if you are pregnant, and tell your doctor right away if you become pregnant. This medicine can harm an unborn baby.

If you have diabetes, do not use amlodipine and telmisartan 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 medicine with or without food, at the same time each day.

You may have very low blood pressure while taking this medicine. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

Your blood pressure will need to be checked often. You may also need frequent blood tests.

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 medicine for the rest of your life.

Store at room temperature away from moisture and heat. Keep each tablet in the blister pack until you are ready to take one.

Usual Adult Dose for Hypertension:

Amlodipine 5 to 10 mg-Telmisartan 40 to 80 mg orally once a day

Maximum dose: Amlodipine 10 mg-Telmisartan 80 mg orally once a day

Comments:
-Correct volume and salt depletion before initiating therapy.
-Dose titration with the individual components is recommended before switching to this drug; treatment may be initiated with this drug if it is unlikely that blood pressure would be controlled with monotherapy; the usual starting dose for treatment initiation is amlodipine 5 mg-telmisartan 40 mg once a day.
-Patients who experience any dose limiting adverse reactions with amlodipine 10 mg monotherapy may be switched to amlodipine 5 mg-telmisartan 40 mg once a day to reduce the amlodipine dose without reducing the overall expected antihypertensive response.
-Start with a low initial amlodipine dose in patients 65 years or older; initial therapy with this drug is not recommended in patients 75 years or older.
-May increase dose after 2 weeks.

You should not use amlodipine and telmisartan if you are allergic to amlodipine (Norvasc) or telmisartan (Micardis).

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

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

Tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);

• liver disease;

• heart disease;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or

• if you are on a low-salt diet.

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

You should not breast-feed while you are using this medicine.

This medicine 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 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.

In rare cases, amlodipine and telmisartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.

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

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

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• new or worsened chest pain;

• pounding heartbeats or fluttering in your chest;

• tremors, muscle stiffness or twitching; or

• high potassium--nausea, slow or unusual heart rate, weakness, loss of movement.

Common side effects of amlodipine and telmisartan may include:

• swelling in your hands or feet;

• fast or pounding heartbeats;

• dizziness, drowsiness;

• flushing (warmth, redness, or tingly feeling);

• back pain; or

• nausea, diarrhea, stomach pain.

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.

Tell your doctor about all your other medicines, especially:

• digoxin;

• a diuretic or "water pill";

• lithium;

• simvastatin (Zocor, Vytorin);

• medicine to prevent organ transplant rejection--cyclosporine, tacrolimus;

• an ACE inhibitor--benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril; 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 telmisartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.