Aliskiren (a-lis-KYE-ren), Valsartan (val-SAR-tan)

Treats high blood pressure. This medicine is a combination of a renin inhibitor and an angiotensin receptor blocker (ARB).

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 at the same time each day, and consistently with or without food.
• Drink more liquids if you exercise, sweat more than usual, or have diarrhea or are vomiting.
• 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.

• Some medicines can affect how aliskiren/valsartan works. Tell your doctor if you are taking any of the following:
  • Atorvastatin, cyclosporine, itraconazole, rifampin, ritonavir
  • Other medicines for high blood pressure (such as benazepril, enalapril, lisinopril, irbesartan, olmesartan, or losartan), a diuretic, or water pill (such as spironolactone, triamterene), or an NSAID pain or arthritis medicine (such as aspirin, celecoxib, ibuprofen, naproxen)
• Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

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, you had a recent heart attack, or you have kidney problems, liver disease, heart failure, high potassium or low sodium, or a history of upper respiratory surgery.
• This medicine could lower your blood pressure too much and cause you to feel dizzy or lightheaded. This is more likely to happen when you begin to use the medicine. It could also happen if you have diarrhea or are vomiting, sweat heavily, or become dehydrated. Stand or sit up slowly if you are dizzy. If you faint, call your doctor right away.
• Do not stop using the medicine without asking your doctor, even if you feel well. This medicine will not cure high blood pressure, but it will help keep it in a normal range. You may have to take blood pressure medicine for the rest of your life.
• 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
• Blistering, peeling, red skin rash
• Blood in your urine, pain in your side or lower back, or sharp back pain just below your ribs
• Change in how much or how often you urinate, or painful urination
• Fast, slow, pounding, or uneven heartbeat
• Lightheadedness, dizziness, fainting, or confusion
• Weakness, shortness of breath, or numbness or tingling in your hands, feet, or lips

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