DIOVAN®
(DYE'-o-van)
valsartan Tablets 40 mg, 80 mg, 160 mg, 320 mg

Read the Patient Information that comes with DIOVAN before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition and treatment. If you have any questions about DIOVAN, ask your doctor or pharmacist.

What is the most important information I should know about DIOVAN?

If you get pregnant, stop taking DIOVAN and call your doctor right away. DIOVAN can harm an unborn baby, causing injury and even death. If you plan to become pregnant, talk to your doctor about other treatment options before taking DIOVAN.

What is DIOVAN?

DIOVAN is a prescription medicine called an angiotensin receptor blocker (ARB). It is used in adults to:

• lower high blood pressure (hypertension).
• treat heart failure. In these patients, DIOVAN may lower the need for hospitalization that happens from heart failure.
• improve the chance of living longer after a heart attack (myocardial infarction).

High Blood Pressure (Hypertension). Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. DIOVAN can help your blood vessels relax so your blood pressure is lower.

Heart Failure occurs when the heart is weak and cannot pump enough blood to your lungs and the rest of your body. Just walking or moving can make you short of breath, so you may have to rest a lot.

Heart Attack (Myocardial Infarction): A heart attack is caused by a blocked artery that results in damage to the heart muscle.

Who should not take DIOVAN?

Do not take DIOVAN if you:

• are allergic to any of the ingredients in DIOVAN. The active ingredient is valsartan. See the end of this leaflet for a complete list of ingredients in DIOVAN.

DIOVAN has not been studied in children under 18 years of age.

What should I tell my doctor before taking DIOVAN?

Tell your doctor about all your medical conditions including whether you:

• are pregnant or planning to become pregnant. See “What is the most important information I should know about DIOVAN?”
• are breast-feeding. It is not known if DIOVAN passes into your breast milk. You should choose either to take DIOVAN or breast-feed, but not both.
• have a heart condition
• have liver problems
• have kidney problems

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you are taking:

• other medicines for high blood pressure or a heart problem
• water pills (also called “diuretics”)
• potassium or using a salt substitute

Keep a list of your medicines with you to show to your doctor and pharmacist when a new medicine is prescribed. Talk to your doctor or pharmacist before you start taking any new medicine. Your doctor or pharmacist will know what medicines are safe to take together.

How should I take DIOVAN?

• Take DIOVAN exactly as prescribed by your doctor. Your doctor may change your dose if needed.
• For treatment of high blood pressure, take DIOVAN once a day, at the same time each day.
• For patients with heart failure or who have had a heart attack, take DIOVAN twice a day, at the same time each day. Your doctor may start you on a low dose of DIOVAN and may increase the dose during your treatment.
• DIOVAN can be taken with or without food.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time.
• If you take too much DIOVAN, call your doctor or Poison Control Center, or go to the nearest hospital emergency room.

What are the possible side effects of DIOVAN?

DIOVAN may cause the following serious side effects:

• Low Blood Pressure (Hypotension). Low blood pressure is most likely to happen if you also take water pills, are on a low-salt diet, get dialysis treatments, have heart problems, or get sick with vomiting or diarrhea. Lie down if you feel faint or dizzy. Call your doctor right away.
• Kidney problems. Kidney problems may get worse in people that already have kidney disease. Some people will have changes on blood tests for kidney function and may need a lower dose of DIOVAN. Call your doctor if you get swelling in your feet, ankles, or hands, or unexplained weight gain. If you have heart failure, your doctor should check your kidney function before prescribing DIOVAN.

The most common side effects of DIOVAN used to treat people with high blood pressure include:

• headache
• dizziness
• flu symptoms
• tiredness
• stomach (abdominal) pain

Side effects were generally mild and brief. They generally have not caused patients to stop taking DIOVAN.

The most common side effects of DIOVAN used to treat people with heart failure include:

• dizziness
• low blood pressure
• diarrhea
• joint and back pain
• tiredness
• high blood potassium

Common side effects of DIOVAN used to treat people after a heart attack which caused them to stop taking the drug include:

• low blood pressure
• cough
• rash
• high blood creatinine (decreased kidney function)

Tell your doctor if you get any side effect that bothers you or that won't go away.

These are not all the side effects of DIOVAN. For a complete list, ask your doctor or pharmacist.

How do I store DIOVAN?

• Store DIOVAN tablets at room temperature between 59o to 86oF.
• Keep DIOVAN in a closed container in a dry place.
• Keep DIOVAN and all medicines out of the reach of children.

General information about DIOVAN

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use DIOVAN for a condition for which it was not prescribed. Do not give DIOVAN to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about DIOVAN. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DIOVAN that is written for health professionals.

For more information about DIOVAN, ask your pharmacist or doctor, visit www.DIOVAN.com on the Internet, or call 1-866-404-6361.

What are the ingredients in DIOVAN?

Valsartan is the active ingredient in DIOVAN. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides (yellow, black and/or red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, and titanium dioxide.

REV: NOVEMBER 2006

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