Nebivolol/Valsartan, Oral

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KEY POINTS

• This medicine is taken by mouth to treat and control high blood pressure. Take it exactly as directed.
• This medicine is not usually given to pregnant women because it can harm the baby.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: beta blocker/angiotensin receptor blocker

Generic and brand names: nebivolol/valsartan, oral; Byvalson

What is this medicine used for?

This medicine is a combination of 2 medicines taken by mouth to treat and control high blood pressure.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetes
• Glaucoma
• Heart failure, angina, or other heart problems
• Imbalances of potassium or sodium in your blood
• Kidney or liver problems
• Low blood pressure
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Peripheral vascular disease
• Pheochromocytoma (a tumor of the adrenal gland)
• Thyroid problems

Tell your healthcare provider if you have diabetes and are taking medicine that contains aliskiren (Tekturna, Tekturna HCT). Also tell your healthcare provider if you are on a low-salt diet.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant while taking this medicine, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Take it regularly every day, even if you start to feel better. You may need to take it for a long time to control your blood pressure. Do NOT stop taking this medicine without your healthcare provider's approval. Stopping abruptly may cause serious side effects. You may have to reduce your dosage gradually.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Take this medicine with a full glass of water.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure about what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: fast or slow heartbeat, weakness, tiredness, dizziness, confusion, lightheadedness, fainting, dry mouth, increased urination, vomiting, trouble breathing, diarrhea.

What should I watch out for?

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

This medicine may cause a sudden drop in blood pressure, especially when you first start taking it. You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help. If you feel dizzy or faint while you are standing, lie down for a while and then get up slowly. If you are dehydrated (due to diarrhea, vomiting, or sweating heavily) or you have lost salt from your system, this medicine may cause low blood pressure (lightheadedness, dizziness, fainting). This is more likely to happen if you are taking a diuretic (water pill). If you feel faint, lie down until the reaction passes. Also, drinking alcohol may make dizziness worse. Do not drink alcohol unless your healthcare provider approves.

You need to check your blood pressure regularly while taking this medicine. You may need to have blood tests to see how this medicine affects you. Keep all appointments.

Talk with your healthcare provider about whether you should follow a special diet. Do not use salt substitutes that contain potassium without your healthcare provider's approval.

If you are dehydrated (due to diarrhea or sweating heavily) or you have lost salt from your system, this medicine may cause low blood pressure (lightheadedness, dizziness, fainting). If you feel faint, lie down until the reaction passes. Talk with your healthcare provider if this happens often.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar and cover up the symptoms of low blood sugar. It may be harder to tell if your blood sugar level is too low or too high. Talk with your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot contact your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (swelling of your tongue, throat, lips, or face; trouble swallowing; hives; itching; tightness or pain in your chest; trouble breathing); severe dizziness or fainting; slow, fast, or irregular heartbeat; chest pain; seizures.

Serious (Report these to your healthcare provider right away.): Severe stomach pain; severe nausea; severe vomiting or diarrhea; rash; extreme thirst or hunger; unusual tiredness or weakness; confusion; cold hands or feet; persistent cough or hoarseness; unexplained fever; joint pain; lower back or side pain; unusual bruising or bleeding; yellowing of your skin or eyes; shortness of breath; swelling in hands or feet, or any unexplained swelling; numbness or tingling in hands or feet; change in how much you urinate; eye pain; vision changes; unusual mood changes.

Other: Mild cough, stuffy nose, sore throat, headache mild diarrhea, mild nausea, mild dizziness, tiredness, change in sexual desire or ability.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Alcohol
• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), and terazosin
• Alzheimer’s disease medicines such as donepezil (Aricept), galantamine (Razadyne), and rivastigmine (Exelon)
• Amifostine (Ethyol)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, lidocaine (Lidoderm, Xylocaine), propafenone (Rythmol), and quinidine
• Antibiotics such as ciprofloxacin (Cipro), isoniazid, rifampin (Rifadin), rifapentine (Priftin), sulfamethoxazole/trimethoprim (Bactrim, Septra), and trimethoprim (Primsol)
• Antidepressants such as amitriptyline, citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), and sertraline (Zoloft)
• Antifungal medicines such as ketoconazole (Nizoral) and terbinafine (Lamisil)
• Antipsychotic medicines such as aripiprazole (Abilify), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), pimozide (Orap), and thioridazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), clobazam (Onfi), fosphenytoin (Cerebyx), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), and simeprevir (Olysio)
• Aspirin and medicines that contain aspirin
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), metoprolol (Lopressor, Toprol), and pindolol
• Birth control pills that contain drospirenone such as drospirenone/estradiol (Angeliq), drospirenone/ethinyl estradiol (Climara, Estrace, Estraderm, Vivelle), and drospirenone/ethinyl estradiol/levomefolate (Beyaz)
• Bupropion (Aplenzin, Forfivo XL, Wellbutrin, Zyban)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nimodipine (Nymalize), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as abiraterone (Zytiga), ceritinib (Zykadia), nilotinib (Tasigna), and panobinostat (Farydak)
• Cimetidine (Tagamet)
• Cinacalcet (Sensipar)
• Clonidine (Catapres, Kapvay)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Darifenacin (Enablex)
• Diabetes medicines such as canagliflozin (Invokana), chlorpropamide, glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, and tolbutamide
• Digoxin (Lanoxin)
• Diphenhydramine (Benadryl)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Duloxetine (Cymbalta, Irenka)
• Eliglustat (Cerdelga)
• Eltrombopag (Promacta)
• Ephedrine
• Epinephrine (Adrenalin, Asthmanefrin, Auvi-Q, EpiPen)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Ergot derivative medicines such as bromocriptine (Cycloset, Parlodel), cabergoline, dihydroergotamine (D.H.E. 45, Migranal), and ergotamine (Ergomar)
• Gemfibrozil (Lopid)
• HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and tipranavir (Aptivus)
• Lithium (Lithobid)
• Lorcaserin (Belviq)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, and quinine
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat or prevent blood clots such as dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), and heparin
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat breathing or lung problems such as albuterol (ProAir, Proventil, Ventolin), arformoterol (Brovana), levalbuterol (Xopenex), pirbuterol (Maxair), salmeterol (Serevent), and theophylline
• Methyldopa
• Mirabegron (Myrbetriq)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), and pentazocine (Talwin)
• Natural remedies such as bayberry, black cohosh, California poppy, dong quai, garlic, ginger, ginseng, goldenseal, hawthorn, kola nut, licorice, St. John's wort, and yohimbe
• Nesiritide (Natrecor)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), hydrocodone/ibuprofen (Vicoprofen), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), and naproxen (Aleve, Anaprox, Naprelan)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Potassium supplements or salt substitutes that contain potassium
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rolapitant (Varubi)
• Stimulants such as dextroamphetamine (Dexedrine), amphetamine/dextroamphetamine (Adderall), and methamphetamine (Desoxyn)
• Tizanidine (Zanaflex)

Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.