Nebivolol and valsartan is a combination medicine used in adults to treat high blood pressure (hypertension).

Nebivolol and valsartan may also be used for purposes not listed in this medication guide.

Do not use if you are pregnant. Stop using nebivolol and valsartan and tell your doctor right away if you become pregnant.

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 nebivolol and valsartan with or without food.

You should not stop using nebivolol and valsartan suddenly, even if you feel fine. Stopping suddenly may cause you to have chest pain or a heart attack. If you need to stop taking the medicine, follow your doctor's instructions about tapering your dose.

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

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

If you have high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms.

Store tightly closed at room temperature, away from moisture and heat.

Usual Adult Dose for Hypertension:

1 tablet orally daily with or without food

Comments:
-Maximum antihypertensive effects are attained within 2 to 4 weeks.
-Increasing the dose does not result in any meaningful further blood pressure reduction.

You should not use this medicine if you are allergic to nebivolol or valsartan, or if you have:

• a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker);

• severe heart failure (that required you to be in the hospital or take certain medicines);

• very low heartbeats (severe bradycardia); or

• severe liver disease.

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

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

Tell your doctor if you have or have ever had:

• low blood pressure;

• heart problems;

• asthma or lung disease;

• diabetes;

• thyroid disorder;

• blood flow problems to your feet and legs (peripheral vascular disease);

• pheochromocytoma (tumor of the adrenal gland);

• a severe allergic reaction to any blood pressure medication;

• if you are on a low-salt diet;

• if you plan to have surgery with general anesthesia;

• liver disease; or

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

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

Do not breastfeed.

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 heart failure, dizziness, low blood sugar, tiredness, vomiting, slow or fast heartbeats, or fainting.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not use salt substitutes containing potassium without talking to your doctor. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

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.

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

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

• feeling like you might pass out;

• very slow heartbeats;

• low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• 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 side effects of nebivolol and valsartan may include:

• slow heartbeats.

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 current medicines. Many drugs can affect nebivolol and valsartan, especially:

• cyclosporine;

• fluoxetine;

• lithium;

• rifampin;

• ritonavir;

• a diuretic or "water pill";

• other heart or blood pressure medicines; or

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

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

Keep all appointments with your doctor. Your blood pressure should be checked regularly to determine your response to nebivolol and valsartan. Your doctor may ask you to check your pulse (heart rate). Ask your pharmacist or doctor to teach you how to take your pulse. If your pulse is faster or slower than it should be, call your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking nebivolol and valsartan.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.