Nebivolol and Valsartan

Tell your doctor if you are pregnant or plan to become pregnant. Do not take the combination of nebivolol and valsartan if you are pregnant. If you become pregnant while you are taking nebivolol and valsartan, stop taking nebivolol and valsartan and call your doctor immediately. Nebivolol and valsartan may cause death or serious injury to the fetus when taken in the last 6 months of pregnancy.

Nebivolol and valsartan is used in adults alone or in combination with other medications to treat high blood pressure. Nebivolol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure. Valsartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly.

High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

Nebivolol and valsartan comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take nebivolol and valsartan at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take nebivolol and valsartan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Nebivolol and valsartan controls high blood pressure but does not cure it. It may take 2 to 4 weeks before the full benefit of nebivolol and valsartan is seen in blood pressure readings. Continue to take nebivolol and valsartan even if you feel well. Do not stop taking nebivolol and valsartan without talking to your doctor. If you suddenly stop taking nebivolol and valsartan it may cause angina (chest pain), heart attack, or irregular heartbeat. Your doctor will probably decrease your dose gradually over 1 to 2 weeks. Your doctor will watch you carefully and will probably tell you to avoid physical activity during this time.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking nebivolol and valsartan,

• tell your doctor and pharmacist if you are allergic to nebivolol (Bystolic), valsartan (Diovan, in Diovan HCT, in Exforge, others), any other medications, or any of the ingredients in nebivolol and valsartan tablets. Ask your pharmacist for a list of the ingredients.
• Some medications should not be taken with nebivolol and valsartan. Make sure you have discussed any medications you are currently taking or plan to take before starting nebivolol and valsartan with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking nebivolol and valsartan, please get the advice of your doctor or pharmacist.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with nebivolol and valsartan: nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve, Naprosyn, others). Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking nebivolol and valsartan. Do not start this medication while taking nebivolol and valsartan without discussing with your healthcare provider.
• tell your doctor if you have a slow or irregular heart rate, heart failure, or liver disease. Your doctor may tell you not to take nebivolol and valsartan.
• tell your doctor if you have or have ever had asthma or other lung diseases, diabetes, hyperthyroidism (an overactive thyroid gland), problems with blood circulation, pheochromocytoma (a tumor that develops on a gland near the kidneys and may cause high blood pressure and fast heart rate), high levels of potassium in your blood, low blood pressure, or heart or kidney disease. Also tell your doctor if you have ever had a serious allergic reaction to a food or any other substance.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking nebivolol and valsartan.
• tell your doctor if you are breastfeeding. Do not breastfeed during your treatment with nebivolol and valsartan.
• you should know that valsartan may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking nebivolol and valsartan. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause lightheadedness and fainting. Tell your doctor if you have any of these problems or develop them during your treatment.
• you should know that if you have allergic reactions to different substances, your reactions may be worse while you are using nebivolol and valsartan, and your allergic reactions may not respond to the usual doses of injectable epinephrine.

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.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Nebivolol and valsartan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness or lightheadedness
• excessive tiredness
• cold hands and feet

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• chest pain
• fast, slow, or irregular heartbeat
• swelling of the hands, feet, ankles, or lower legs
• rash; hives; swelling of the face, throat, tongue, lips, or eyes
• hoarseness
• difficulty breathing or swallowing
• stomach pain
• shortness of breath
• unexplained weight gain

Nebivolol and valsartan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• dizziness
• fainting
• fast, slow, or irregular heartbeat
• swelling of the hands, feet, ankles, or lower legs
• unusual weight gain
• shakiness
• sweating
• nervousness, irritability, or sudden changes in behavior or mood
• headache
• numbness or tingling around the mouth
• weakness
• pale skin
• sudden hunger
• clumsy or jerky movements
• difficulty breathing or wheezing
• tiredness
• vomiting

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.

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