Aliskiren/amlodipine/hydrochlorothiazide (By mouth)

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding or if you have kidney problems, liver disease, heart or blood vessel disease, diabetes, glaucoma, gout, high cholesterol levels, low blood pressure, or lupus. Tell your doctor if you have mineral imbalances (high or low calcium, magnesium, potassium, or sodium in the blood) or a history of asthma or allergies.
• This medicine could lower your blood pressure too much and cause you to feel dizzy or lightheaded. Stand or sit up slowly if you are dizzy. This is more likely to happen when you begin to use the medicine. It could also happen if you have diarrhea or vomiting, sweat heavily, or do not drink enough water and become dehydrated. If you faint, call your doctor right away.
• Check with your doctor right away if you have 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.
• 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 keep it in normal range. You may have to take blood pressure medicine for the rest of your life.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

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
• Blistering, peeling, or red skin rash
• Blood in the urine, lower back pain, side pain, or sharp back pain just below the ribs
• Change in how much or how often you urinate
• Changes in vision
• Chest pain that spreads to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, or faintness
• Confusion, body weakness, uneven heartbeat, shortness of breath, or numbness or tingling in your hands, feet, or lips
• Dry mouth, increased thirst, or muscle cramps
• Lightheadedness, dizziness, or fainting
• Rapid weight gain
• Seizures
• Swelling in your face, hands, ankles, or feet

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

• Cough, runny or stuffy nose, or sore throat
• Diarrhea
• Tiredness

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

Introduction

Aliskiren (a-lis-KYE-ren), Amlodipine Besylate (am-LOE-di-peen BES-i-late), Hydrochlorothiazide (hye-droe-klor-oh-THYE-a-zide)

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

Brand Name(s)

Amturnide

When This Medicine Should Not Be Used

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.
• Take this medicine the same way every day. This means take it at the same time and take it consistently with or without food.
• 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.

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.

Drugs and Foods to Avoid

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

• You should not use this medicine (unless your doctor specifically tells you to) if you also receive cyclosporine (Gengraf®, Neoral®, Sandimmune®), itraconazole (Sporanox®), or lithium (Eskalith®, Lithobid®).
• Make sure your doctor knows if you also use other blood pressure medicines (such as enalapril, irbesartan, lisinopril, losartan, olmesartan, valsartan, verapamil, Accupril®, Avapro®, Benicar®, Calan®, Cozaar®, Isoptin®, Lotrel®, or Verelan®) or diuretics or water pills (such as furosemide, spironolactone, triamterene, Aldactone®, Dyrenium®, or Midamor®).
• Tell your doctor if you also use atropine, biperiden (Akineton®), corticotropin (ACTH), cyclophosphamide (Cytoxan®), ketoconazole (Nizoral®), methotrexate (Rheumatrex®), norepinephrine (Levophed®), simvastatin (Zocor®), tubocurarine, medicine to lower cholesterol (such as cholestyramine, colestipol, simvastatin, Cholestyramine Light®, Colestid®, Locholest®, Questran®, Prevalite®, or Zocor®), insulin or an oral diabetes medicine (such as glyburide, Actos®, or Glucotrol®), a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®), or pain or arthritis medicine or NSAID (such as celecoxib, ibuprofen, naproxen, Aleve®, Bextra®, Celebrex®, or Motrin®).
• Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.
• 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.