Nebivolol and valsartan

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

Nebivolol and valsartan may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. 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 lead to 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 experience 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, continue 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.

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

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.

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

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

• a 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;
• symptoms of a heart attack—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 the FDA at 1-800-FDA-1088.

Usual Adult Dose for Hypertension:

1 tablet orally daily with or without foodComments:-Maximum antihypertensive effects are attained within 2 to 4 weeks.-Increasing the dose does not result in any meaningful further blood pressure reduction.

Take the medicine as soon as you remember, but skip the missed dose if it's almost time for your next dose. Do not take two doses at once.

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.

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.

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.