Amlodipine/valsartan/hydrochlorothiazide (By mouth)

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.
• Carefully follow your doctor's instructions about any special diet. Be sure to drink plenty of fluids if you exercise, sweat more than usual, or have diarrhea or vomiting.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

Brand Name(s)

Exforge HCT

When This Medicine Should Not Be Used

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby, especially after the first 3 months of pregnancy. Use an effective form of birth control to prevent pregnancy. Tell your doctor right away if you become pregnant.
• Make sure your doctor knows if you are breastfeeding, or if you have had a recent heart attack. Tell your doctor if you have kidney problems, liver disease, diabetes, gallstones, gout, lupus, heart or blood vessel disease, heart failure, high cholesterol, a mineral imbalance (such as high calcium or low potassium, magnesium, or sodium in the blood), or a history of asthma. Tell your doctor if you have had surgery on your nervous system. Tell your doctor if you are dehydrated or recently had severe diarrhea or vomiting. Tell your doctor if you are going to have surgery or are on dialysis.
• This medicine could lower your blood pressure too much and cause you to feel dizzy or lightheaded. If you faint, stop using this medicine until you have talked to your doctor. Stand or sit up slowly if you are dizzy. Low blood pressure is more likely to happen when you begin to use the medicine.
• Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, or a fast heartbeat. Drink more fluids when you exercise or if the weather is hot. Heavy sweating or diarrhea and vomiting can cause dehydration or electrolyte imbalances (loss of sodium, potassium, or magnesium). Check with your doctor if you become sick with severe nausea, vomiting, or diarrhea.
• Check with your doctor right away if you feel chest pain that is worse than usual, trouble breathing, nausea, unusual sweating, faintness, or pain in your arms, jaw, back, or neck. This medicine may worsen the symptoms of an existing heart problem.
• Stop using this medicine and check with your doctor immediately if blurred vision, difficulty reading, eye pain, or any other change in vision occurs. Your doctor may want an eye doctor to check your eyes.
• Even if you feel well, do not stop using this medicine without asking your doctor. This medicine will not cure your high blood pressure, but it will help lower it and keep it down. You may have to take blood pressure medicine for the rest of your life.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood and urine tests may be needed to check for unwanted effects.

Introduction

Amlodipine Besylate (am-LOE-di-peen BES-i-late), Hydrochlorothiazide (hye-droe-klor-oh-THYE-a-zide), Valsartan (val-SAR-tan)

Treats high blood pressure. A lower blood pressure will reduce the risk of stroke and heart attack. This medicine is a combination of 3 medicines: a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic or water pill.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using other medicines for high blood pressure, including a diuretic or water pill such as amiloride, spironolactone, triamterene, Aldactone®, Dyrenium®, or Midamor®.
• Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.
• Make sure your doctor knows if you also use lithium (Eskalith®, Lithobid®), norepinephrine, simvastatin (Zocor®), tubocurarine, pain or arthritis medicine (such as aspirin, celecoxib, ibuprofen, Advil®, Aleve®, Celebrex®, or Motrin®), insulin or an oral diabetes medicine (such as glyburide, metformin, Actos®, Avandia®, Glucophage®, Glucotrol®, or Glucovance®), medicine to lower cholesterol (such as cholestyramine, colesevelam, colestipol, Colestid®, or Questran®), a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®), or medicine to treat seizures (such as carbamazepine, phenobarbital, Carbatrol®, or Tegretol®).
• Alcohol, narcotic pain relievers, or sleeping pills may cause you to feel more lightheaded, dizzy, or faint when used with this medicine. Tell your doctor if you drink alcohol or use pain relievers or sleeping pills.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blood in the urine, lower back pain, side pain, or sharp back pain just below the ribs
• Blurred vision or changes in vision
• Changes in how much or how often you urinate
• Chest pain that spreads to your arms, jaw, back, or neck; trouble breathing; nausea; unusual sweating; faintness
• Confusion, body weakness, and muscle twitching
• Dry mouth, increased thirst, muscle cramps, nausea, or vomiting
• Fever, chills, cough, sore throat, runny or stuffy nose, and body aches
• Increased hunger or thirst
• Lightheadedness, dizziness, or fainting
• Rapid weight gain
• Swelling in your hands, ankles, or feet

If you notice these less serious side effects, talk with your doctor:

• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088