Uses of Amlodipine, Valsartan, and Hydrochlorothiazide:

• It is used to treat high blood pressure.

What do I need to tell my doctor BEFORE I take Amlodipine, Valsartan, and Hydrochlorothiazide?

• If you have an allergy to amlodipine, valsartan, hydrochlorothiazide, or any other part of amlodipine, valsartan, and hydrochlorothiazide.
• If you are allergic to amlodipine, valsartan, and hydrochlorothiazide; any part of amlodipine, valsartan, and hydrochlorothiazide; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have a sulfa allergy.
• If you are taking dofetilide.
• If you have any of these health problems: Kidney disease or liver disease.
• If you are not able to pass urine.
• If you are taking a drug that has aliskiren in it and you also have diabetes or kidney problems.
• If you are breast-feeding. Do not breast-feed while you take amlodipine, valsartan, and hydrochlorothiazide.

This is not a list of all drugs or health problems that interact with amlodipine, valsartan, and hydrochlorothiazide.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take amlodipine, valsartan, and hydrochlorothiazide with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Amlodipine, Valsartan, and Hydrochlorothiazide?

• Tell all of your health care providers that you take amlodipine, valsartan, and hydrochlorothiazide. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how amlodipine, valsartan, and hydrochlorothiazide affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Check your blood pressure as you have been told.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take amlodipine, valsartan, and hydrochlorothiazide.
• If you are taking a salt substitute that has potassium in it, a potassium-sparing diuretic, or a potassium product, talk with your doctor.
• If you are on a low-salt or salt-free diet, talk with your doctor.
• It may take a few weeks to see the full effect.
• It is rare, but worse chest pain and heart attack can happen after amlodipine, valsartan, and hydrochlorothiazide is first started or after the dose is raised. The risk may be greater in people who have very bad heart blood vessel disease. Talk with the doctor.
• Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
• If you take cholestyramine or colestipol, talk with your pharmacist about how to take them with amlodipine, valsartan, and hydrochlorothiazide.
• Watch for gout attacks.
• If you have lupus, amlodipine, valsartan, and hydrochlorothiazide can make your lupus active or get worse. Tell your doctor right away if you get any new or worse signs.
• Liver problems have happened with amlodipine, valsartan, and hydrochlorothiazide. Sometimes, liver problems have needed to be treated in the hospital. Talk with the doctor.
• If you are 65 or older, use amlodipine, valsartan, and hydrochlorothiazide with care. You could have more side effects.

How is this medicine (Amlodipine, Valsartan, and Hydrochlorothiazide) best taken?

Use amlodipine, valsartan, and hydrochlorothiazide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking amlodipine, valsartan, and hydrochlorothiazide as you have been told by your doctor or other health care provider, even if you feel well.
• Take amlodipine, valsartan, and hydrochlorothiazide at the same time of day.
• This medicine may cause you to pass urine more often. To keep from having sleep problems, try not to take too close to bedtime.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Muscle spasm.
• Chest pain that is new or worse.
• Restlessness.
• Swelling in the arms or legs.
• Stiff muscles, shakiness, or muscle movements that are not normal.
• Any skin change.
• This medicine can cause certain eye problems. If left untreated, this can lead to lasting eyesight loss. If eye problems happen, signs like change in eyesight or eye pain most often happen within hours to weeks of starting amlodipine, valsartan, and hydrochlorothiazide. Call your doctor right away if you have these signs.

What are some other side effects of Amlodipine, Valsartan, and Hydrochlorothiazide?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, tired, or weak.
• Headache.
• Upset stomach.
• Back pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Amlodipine, Valsartan, and Hydrochlorothiazide?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about amlodipine, valsartan, and hydrochlorothiazide, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.