Byvalson is a combination medicine used to treat high blood pressure (hypertension) in adults. Lowering blood pressure may lower your risk of a stroke or heart attack.

Byvalson is sometimes given together with other blood pressure medications.

Byvalson contains a combination of nebivolol and valsartan. Nebivolol is a beta-blocker that affects the heart and circulation (blood flow through arteries and veins).

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

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

If you have diabetes, do not use Byvalson together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

Take Byvalson 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.

You may take Byvalson with or without food.

You should not stop using this medicine 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 Byvalson. 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 Byvalson 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 Byvalson with any medication that contains aliskiren (a blood pressure medicine).

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

To make sure Byvalson is safe for you, tell your doctor if you 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 Byvalson 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.

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 to Byvalson: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Byvalson 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 Byvalson side effects 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 Byvalson, 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 interact with nebivolol and valsartan. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.