Aliskiren (a-lis-KYE-ren), Amlodipine Besylate (am-LOE-di-peen BES-i-late)

Treats high blood pressure. This medicine contains a calcium channel blocker (CCB).

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine the same way and at the same time every day. Take it routinely with or without food. Do not take with a high-fat meal.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

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

• Do not use this medicine if you have diabetes and also take another blood pressure medicine (ACE inhibitor or ARB). Do not use this medicine together with cyclosporine or itraconazole.
• Some foods and medicines can affect how aliskiren works. Tell your doctor if you are also using any of the following:
  • Diuretic (water pill, such as furosemide)
  • NSAID pain or arthritis medicine (such as aspirin, diclofenac, ibuprofen, naproxen, celecoxib)
  • Ketoconazole
  • Simvastatin
  • Medicine to treat HIV/AIDS (such as indinavir, ritonavir).
  • Potassium in any medicine, supplement, or salt substitute

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding or if you have kidney problems, liver disease, heart or blood vessel disease (including heart failure or a history of a heart attack), diabetes, or low blood pressure.
• This medicine may cause the following problems:
  • Higher risk of heart attack or increased angina (severe chest pain)
  • Kidney problems
• This medicine could lower your blood pressure too much when you first use it or if you are dehydrated. Stand or sit up slowly if you feel lightheaded or dizzy.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, or faintness
• Confusion, weakness, uneven heartbeat, trouble breathing, or numbness or tingling in your hands, feet, or lips
• Decrease in how much or how often you urinate
• Lightheadedness, dizziness, or fainting
• Rapid weight gain, swelling in your hands, ankles, or feet

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