Amlodipine/Valsartan/Hydrochlorothiazide, 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.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause vision problems or other 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: calcium channel blocker/angiotensin receptor blocker (ARB)/diuretic

Generic and brand names: amlodipine/valsartan/hydrochlorothiazide, oral; Exforge HCT

What is this medicine used for?

This medicine is taken by mouth to treat and control high blood pressure. It contains a calcium channel blocker, an angiotensin receptor blocker, and a diuretic.

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
• An autoimmune disease such as lupus, or any other immune system problem
• Asthma
• Diabetes
• Gallstones
• Glaucoma
• Gout
• Heart failure, angina, or other heart problems
• High cholesterol or triglyceride levels in the blood
• Imbalances of calcium, magnesium, potassium, or sodium in your blood
• Kidney or liver problems
• Low blood pressure
• Trouble urinating

Do not take this medicine if you have diabetes and take a medicine that contains aliskiren to reduce blood pressure.

Tell your healthcare provider if you are on a low-sodium diet.

Females of childbearing age: Tell your healthcare provider if you are pregnant, plan to become pregnant, or are breast-feeding. Do not take this medicine after the third month of pregnancy. It can cause severe harm to the baby. 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.

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. Swallow the medicine without crushing, breaking, or chewing it.

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, dizziness, confusion, lightheadedness, fainting, dry mouth, increased urination, vomiting, 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 eye problems that could lead to vision loss. Contact your healthcare provider right away if you have eye pain or a decrease in vision.

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. Also, drinking alcohol may make it 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.

This medicine may make your skin more sensitive to the sun and may cause you to sunburn more easily. While you are taking this medicine, avoid long exposure to the sun. While you are in the sun, wear protective clothing and a sunscreen lotion that is SPF15 or higher until you know how you will react to the sun. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

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 level and change the amount of insulin or other diabetes medicines you may need. Talk to 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 reach 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; 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; muscle cramps; dry mouth; extreme thirst; unusual tiredness or weakness; confusion; black tarry bowel movements; persistent cough or hoarseness; 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.

Other: Cough, stuffy nose, sore throat, headache, flushing, gas, stomach cramps, constipation, diarrhea, nausea, mild dizziness, tiredness, sensitivity to sun, loss of appetite, 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
• 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), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, lidocaine (Lidoderm, Xylocaine), and quinidine
• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), nafcillin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), sulfamethoxazole/trimethoprim (Bactrim, Septra), telithromycin (Ketek), and trimethoprim (Primsol)
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), methscopolamine (Pamine), propantheline, and trihexyphenidyl
• Antidepressants such as amitriptyline, citalopram (Celexa), escitalopram (Lexapro), fluvoxamine (Luvox), nefazodone, and nortriptyline (Pamelor)
• Antifungal medicines such as fluconazole (Diflucan), isavuconazonium (Cresemba), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), chlorpromazine, haloperidol (Haldol), and pimozide (Orap)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), 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 (Ocella, Syeda, Yasmin, Yaz), and drospirenone/ethinyl estradiol/levomefolate (Beyaz)
• Bosentan (Tracleer)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nimodipine (Nymalize), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Calcium supplements
• Cancer medicines such as abiraterone (Zytiga), ceritinib (Zykadia), cyclophosphamide (Cytoxan), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), and mitotane (Lysodren)
• Cholesterol-lowering medicines such as cholestyramine (Prevalite), colestipol (Colestid), lomitapide (Juxtapid), and simvastatin (Zocor)
• Clonidine (Catapres, Kapvay)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as chlorpropamide, glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, and tolbutamide
• Digoxin (Lanoxin)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Everolimus (Afinitor, Zortress)
• Flibanserin (Addyi)
• Gout medicines such as allopurinol (Aloprim, Zyloprim), colchicine (Colcrys), and probenecid
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Lithium (Lithobid)
• Lumacaftor/ivacaftor (Orkambi)
• 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 low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as clopidogrel (Plavix), dalteparin (Fragmin), enoxaparin (Lovenox), and heparin
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Methyldopa
• Mifepristone (Korlym, Mifeprex)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), and pentazocine (Talwin)
• Natural remedies such as dong quai, garlic, ginseng, St. John's wort, and yohimbe
• Nausea medicines such as aprepitant (Emend) and netupitant/palonosetron (Akynzeo)
• 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)
• Potassium supplements or salt substitutes that contain potassium
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine
• Tizanidine (Zanaflex)

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

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

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.