Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ Tablets

What is this medication?

AMLODIPINE; VALSARTAN; HYDROCHLOROTHIAZIDE, HCTZ (am LOE di peen; val SAR tan; hye droe klor oh THYE a zide) is a combination of a calcium channel blocker, a diuretic, and an angiotensin II receptor blocker. It treats high blood pressure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Exforge HCT

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• decreased urine
• diabetes
• heart failure, recent heart attack, or other heart problems
• if you are on a special diet, like a low salt diet
• immune system problems, like lupus
• kidney disease
• liver disease
• an unusual or allergic reaction to amlodipine, valsartan, hydrochlorothiazide, sulfa drugs, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this drug by mouth. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your health care provider tells you to stop.

Talk to your health care provider about the use of this drug in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• alcohol
• barbiturates like phenobarbital
• carbamazepine
• cidofovir
• diuretics like triamterene, spironolactone, or amiloride
• dofetilide
• lithium
• medicines for blood pressure
• medicines for diabetes
• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen
• potassium salts or potassium supplements
• prescription pain medicines
• skeletal muscle relaxants like tubocurarine
• some cholesterol lowering medicines like cholestyramine or colestipol
• steroid medicines like prednisone or cortisone
• tranylcypromine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or health care provider for regular checks on your progress. Check your blood pressure as directed. Ask your doctor or health care provider what your blood pressure should be and when you should contact him or her.

You must not get dehydrated. Ask your doctor or health care provider how much fluid you need to drink a day. Check with him or her if you get an attack of severe diarrhea, nausea and vomiting, or if you sweat a lot. The loss of too much body fluid can make it dangerous for you to take this medicine.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care provider or pharmacist for more information.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine may increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

Avoid salt substitutes unless you are told otherwise by your doctor or health care provider.

Talk to your health care professional about your risk of skin cancer. You may be more at risk for skin cancer if you take this medicine.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Do not treat yourself for coughs, colds, or pain while you are taking this medicine without asking your doctor or health care provider for advice. Some ingredients may increase your blood pressure.

If you are going to have surgery or dialysis, tell your doctor or health care provider that you are taking this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in vision
• chest pain
• confusion
• dark urine
• eye pain
• fast, irregular heartbeat
• feeling faint or lightheaded, falls
• low blood pressure
• muscle cramps
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.
• stomach pain
• swelling of the hands, ankles, or feet
• trouble passing urine or change in the amount of urine
• worsened gout pain
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in sex drive or performance
• cough
• diarrhea
• flushing of face, skin
• headache
• nausea, vomiting
• stomach gas, pain
• weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Keep the container tightly closed. Throw away any unused drug after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.