Aliskiren (By mouth)

Introduction

Aliskiren (a-lis-KYE-ren)

Used alone or with other medicines to treat high blood pressure. This medicine is a renin inhibitor.

Brand Name(s)

Tekturna

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.
• You may take this medicine with or without food. Try to take this medicine consistently (with or without food). High-fat meals may affect absorption of this medicine.
• 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.
• Take this medicine at the same time each day.
• 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• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.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.

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.
• Confusion, weakness, uneven heartbeat, shortness of breath, or numbness or tingling in your hands, feet, or lips.
• Convulsions (seizures).
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Lightheadedness, dizziness, or fainting.

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

• Back pain.
• Diarrhea, stomach pain, upset stomach, or heartburn.
• Headache.
• Joint pain or stiffness.
• Skin rash.
• 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

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 atorvastatin (Lipitor®), itraconazole (Sporanox®), or any other medicine for a heart problem or high blood pressure (such as irbesartan, Avapro®). Tell your doctor if you are also using cyclosporine (Gengraf®, Neoral®, Sandimmune®) or certain diuretics or "water pills" (such as spironolactone, triamterene, Aldactone®, or Dyrenium®).
• Ask your doctor before you use potassium supplements or salt substitutes that contain potassium.

Warnings While Using This Medicine

• Using this medicine while you are pregnant (especially in your second or third trimester) 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 this medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding, or if you have kidney problems, liver disease, low blood pressure, low blood volume, a history of airway surgery, or a mineral imbalance (such as high amount of potassium or low amount of sodium in the blood).
• Many patients who have high blood pressure will not notice any symptoms of the condition. In fact, many patients feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.
• This medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life.
• This medicine can cause a serious reaction called angioedema. Stop using this medicine and tell your doctor right away if you start to have swelling of your face, lips, tongue, throat, arms, or legs, or if you are having trouble swallowing or breathing.
• This medicine may make you dizzy or lightheaded. Avoid driving, using machines, or doing anything else that could be dangerous if you are dizzy. If you feel dizzy, lie or sit down so you do not faint. The dizziness may be worse if you lose too much water from your body. You can lose water by sweating or by having diarrhea and vomiting. Tell your doctor if this medicine makes you feel lightheaded or dizzy after you have had diarrhea or vomiting.
• If you stop using this medicine, your blood pressure may go up. High blood pressure will not make you feel sick. Even if you feel well, do not stop using this medicine without talking to your doctor.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or 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 tests may be needed to check for unwanted effects.