Diovan HCT can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking Diovan HCT, tell your doctor right away.

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Diovan HCT is indicated for the treatment of hypertension in adults whose blood pressure is not adequately controlled on monotherapy, and as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals.

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Diovan HCT is not for everyone. Do not take Diovan HCT if you are allergic to any of the ingredients of this product, have a history of reduced urine output, have allergic reactions to certain drugs known as sulfonamides, are pregnant, or are breast-feeding.

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Diovan HCT has not been studied in patients under 18 years of age.

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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 HCT?
• Are breast-feeding. Diovan HCT may pass into your breast milk and can harm your baby. You should not take Diovan HCT and breast-feed.
• Have liver problems.
• Have kidney problems.
• Have or had gallstones.
• Have lupus.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medications and Diovan HCT could affect each other, causing serious side effects. Especially tell your doctor if you are taking:

• Other medicines for high blood pressure or a heart problem.
• Water pills (also called "diuretics").
• Potassium supplements or a salt substitute containing potassium.
• Anti-diabetes medicines including insulin.
• Narcotic pain medicines.
• Sleeping pills.
• Lithium, a medicine used in some types of depression (Eskalith^®, Lithobid^®, lithium carbonate, lithium citrate).
• Aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Keep a list of your medicines with you to show 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.

Eskalith and Lithobid are registered trademarks of Noven Pharmaceuticals, Inc.

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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 supplements or a salt substitute containing potassium.
• Anti-diabetes medicines including insulin.
• Narcotic pain medicines.
• Sleeping pills.
• Lithium, a medicine used in some types of depression (Eskalith^®, Lithobid^®, lithium carbonate, lithium citrate).
• Aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Keep a list of your medicines with you to show 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.

Eskalith and Lithobid are registered trademarks of Noven Pharmaceuticals, Inc.

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Diovan HCT can be taken with or without food.

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• As with any medication, Diovan HCT should be taken exactly as directed by your health care professional.
• It's important that you take your Diovan HCT tablet every day or as directed by your health care professional. Usually, Diovan HCT is taken once daily.
• Diovan HCT may be taken with or without food.
• If you forget to take a dose of Diovan HCT, take the missed dose as soon as you remember—unless it is almost time for your next dose. In that case, skip the missed dose. Just take the next dose at your regular time.

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Diovan HCT should be discontinued if you are pregnant, or plan to become pregnant, because it may cause harm or even death to the unborn child.

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No. Continue with therapy as directed by your doctor.

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If you forget to take a dose of Diovan HCT, take the missed dose as soon as you remember—unless it is almost time for your next dose. In that case, skip the missed dose. Just take the next dose at your regular time. As with any medication,
Diovan HCT should be taken exactly as directed by your health care professional.

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Do not cut or crush Diovan HCT tablets unless directed by your health care professional.

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Diovan HCT may cause serious side effects including:

• Harm or death to an unborn baby. See What is the most important information I should know about Diovan HCT?
• Low blood pressure (hypotension). Low blood pressure is most likely to happen if you:
• Take water pills
• Get dialysis treatments
• Have heart problems
• Get sick with vomiting or diarrhea
• Drink alcohol
• Are on a low-salt diet

Lie down if you feel faint or dizzy. Call your doctor right away.

• Worsening liver problems. Liver problems may get worse in people who already have liver problems and take Diovan HCT.
• Allergic reactions. People with and without allergy problems or asthma who take Diovan HCT may get allergic reactions.
• Worsening of lupus. Hydrochlorothiazide, one of the medicines in Diovan HCT, may cause lupus to become active or worse.
• Fluid and electrolyte (salt) problems. Tell your doctor about any of the following signs and symptoms of fluid and electrolyte problems:
• Dry mouth
• Thirst
• Lack of energy (lethargic)
• Weakness
• Drowsiness
• Restlessness
• Confusion
• Seizures
• Muscle pain or cramps
• Muscle fatigue
• Very low urine output
• Fast heartbeat
• Nausea and vomiting
• Kidney problems. Kidney problems may become 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 HCT. 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 HCT.
• Skin rash. Call your doctor right away if you have an unusual skin rash.
• Eye Problems. One of the medicines in Diovan HCT can cause eye problems that may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting Diovan HCT. Tell your doctor right away if you have:
• Decrease in vision
• Eye pain

Other side effects were generally mild and brief. They generally have not caused patients to stop taking Diovan HCT.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

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

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Valsartan and hydrochlorothiazide are the active ingredients in Diovan HCT. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.

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• Store Diovan HCT tablets at room temperature between 59° and 86°F.
• Keep Diovan HCT in a closed container in a dry place.
• Keep Diovan HCT and all medicines out of the reach of children.

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

If you would like more information about Diovan HCT, talk with your health care professional. You can ask your doctor or pharmacist for information about
Diovan HCT that is written for health professionals.

For more information about Diovan HCT (valsartan and hydrochlorothiazide) tablets, ask your pharmacist or doctor, or call 1-866-404-6361.

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