Exforge

Exforge is used alone or together with other medicines to treat high blood pressure (hypertension) in adults. Lowering blood pressure may lower your risk of a stroke or heart attack.

Exforge contains a combination of amlodipine and valsartan. Amlodipine is a calcium channel blocker. It works by relaxing the muscles of your heart and blood vessels.

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

Take Exforge exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Exforge is usually taken once per day.

You may take Exforge with or without food.

Your blood pressure will need to be checked often and you may need frequent blood tests. Your treatment may also include diet, exercise, lifestyle changes, and other medications. Follow your doctor's instructions very carefully.

Your blood pressure may get too low during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea.

Tell your doctor if you have a planned surgery.

Keep using this medicine even if you feel well. High blood pressure often has no symptoms.

Store at room temperature away from moisture and heat.

Do not use Exforge 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 Exforge together with any medication that contains aliskiren (such as Amturnide, Tekturna, Valturna, or Tekamlo).

In rare cases, Exforge 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, and dark colored urine.

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

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

You should not use Exforge if you are allergic to amlodipine or valsartan.

If you have diabetes, do not take Exforge together with any medication that contains aliskiren (a blood pressure medicine).

To make sure Exforge is safe for you, tell your doctor if you have ever had:

• heart problems or low blood pressure;
• a heart attack;
• a severe allergic reaction called angioedema to another blood pressure medicine;
• vomiting or having a lot of diarrhea;
• liver disease; or
• kidney disease (or if you are on dialysis).

You may also need to avoid taking Exforge with aliskiren if you have kidney disease.

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

Do not breastfeed.

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

In rare cases, when you first start taking this medicine, your chest pain may get worse 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, or sweating.

Exforge may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• heart problems - swelling, rapid weight gain, feeling short of breath;
• kidney problems - swelling, urinating less, feeling tired or short of breath; or
• high blood potassium - nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common Exforge side effects include:

• swelling in your hands or feet;
• spinning sensation, dizziness; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

Usual Adult Dose of Exforge for Hypertension:

Initial therapy: Amlodipine 5 mg-Valsartan 160 mg orally once a day Add-on/Replacement therapy: Amlodipine 5 to 10 mg-Valsartan 160 to 320 mg orally once a day Comments: -May increase dose after 1 to 2 weeks of therapy. -A patient who experiences dose-limiting adverse reactions on either component alone may be switched to this drug containing a lower dose of that component in combination with the other. If blood pressure remains uncontrolled after 3 to 4 weeks, may titrate up to a maximum of amlodipine 10 mg-valsartan 320 mg orally once a day.

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.

Overdose symptoms may include rapid heartbeats, low blood pressure, redness or warmth in your arms or legs, or fainting.

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

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

Drinking alcohol with this medicine can cause side effects.

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

Amlodipine and valsartan can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your current medicines. Many drugs can interact with amlodipine and valsartan, especially:

• cyclosporine;
• sildenafil;
• rifampin;
• ritonavir; or
• a heart or blood pressure medication, especially a diuretic ('water pill').

This list is not complete and many other drugs may interact with amlodipine and valsartan. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Active ingredient: amlodipine besylate and valsartan Inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. Additionally, the 5/320 mg and 10/320 mg strengths contain iron oxide yellow and sodium starch glycolate. The film coating contains hypromellose, iron oxides, polyethylene glycol, talc, and titanium dioxide.

Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, USA.