Aliskiren/
Amlodipine

Aliskiren/Amlodipine is used for:

Treating high blood pressure. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Aliskiren/Amlodipine is a renin inhibitor and calcium channel blocker combination. It works by relaxing the blood vessels.

Do NOT use Aliskiren/Amlodipine if:

• you are allergic to any ingredient in Aliskiren/Amlodipine
• you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness) caused by treatment with Aliskiren/Amlodipine
• you are pregnant
• you are taking cyclosporine or itraconazole

Contact your doctor or health care provider right away if any of these apply to you.

Before using Aliskiren/Amlodipine:

Some medical conditions may interact with Aliskiren/Amlodipine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are a woman of childbearing age
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances (including other blood pressure medicines)
• if you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness), especially when taking an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril) or an angiotensin receptor blocker (ARB) (eg, losartan)
• if you are dehydrated, have low blood volume, have high blood potassium levels or low blood sodium levels, or are on a low-salt (sodium) diet
• if you have a history of gout, gallbladder or liver problems, kidney problems (eg, renal artery stenosis), low blood pressure, blood vessel problems, or heart problems (eg, heart failure, angina, narrowing of heart blood vessels)
• if you have diabetes, especially if you are also taking an ACE inhibitor (eg, lisinopril) or an ARB (eg, losartan)
• if you are on dialysis or will be having surgery
• if you are taking another medicine for blood pressure or heart problems

Some MEDICINES MAY INTERACT with Aliskiren/Amlodipine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Diuretics (eg, furosemide, hydrochlorothiazide) or sildenafil because the risk of low blood pressure may be increased
• ACE inhibitors (eg, lisinopril, ARBs (eg, losartan), potassium-sparing diuretics (eg, triamterene), or potassium supplements because the risk of high blood potassium levels may be increased
• Atorvastatin, certain azole antifungals (eg, itraconazole, ketoconazole), conivaptan, cyclosporine, or HIV protease inhibitors (eg, ritonavir) because they may increase the risk of Aliskiren/Amlodipine's side effects, including low blood pressure
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, indomethacin, celecoxib) because they may decrease Aliskiren/Amlodipine's effectiveness and the risk of kidney problems may be increased
• Simvastatin because the risk of its side effects may be increased by Aliskiren/Amlodipine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aliskiren/Amlodipine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aliskiren/Amlodipine:

Use Aliskiren/Amlodipine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Aliskiren/Amlodipine. Talk to your pharmacist if you have questions about this information.
• Take Aliskiren/Amlodipine by mouth with or without food. However, you must take it the same way each time you take it. If you take Aliskiren/Amlodipine on an empty stomach, always take it on an empty stomach. If you take it with food, always take it with food.
• Be sure to drink enough liquids while you are taking Aliskiren/Amlodipine. If you do not, you may become dehydrated, which may increase your risk of low blood pressure. Discuss any questions or concerns with your doctor.
• Take Aliskiren/Amlodipine on a regular schedule to get the most benefit from it. Taking Aliskiren/Amlodipine at the same time each day will help you remember to take it.
• Continue to take Aliskiren/Amlodipine even if you feel well. Do not miss any doses.
• If you miss a dose of Aliskiren/Amlodipine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aliskiren/Amlodipine.

Important safety information:

• Aliskiren/Amlodipine may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Aliskiren/Amlodipine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Aliskiren/Amlodipine may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• It may take up to 4 weeks to get the full benefit from Aliskiren/Amlodipine. Do NOT take more than the recommended dose, change your dose, or stop using Aliskiren/Amlodipine without checking with your doctor.
• High-fat meals may decrease the amount of Aliskiren/Amlodipine that is absorbed into your body. Discuss any questions or concerns with your doctor. Be sure you take Aliskiren/Amlodipine consistently with regard to meals.
• Aliskiren/Amlodipine may cause a serious side effect called angioedema. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.
• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
• Check with your doctor before you use a salt substitute or a product that has potassium in it.
• If vomiting, diarrhea, or excessive sweating occur, you will need to take care not to become dehydrated. This could increase your risk of low blood pressure. Contact your doctor for instructions.
• Tell your doctor or dentist that you take Aliskiren/Amlodipine before you receive any medical or dental care, emergency care, or surgery.
• Talk with your doctor or pharmacist about all of your blood pressure medicines and how to use them. Do not start, stop, or change the dose of any blood pressure medicine unless your doctor tells you to.
• Lab tests, including blood pressure, kidney function, and blood electrolyte levels, may be performed while you use Aliskiren/Amlodipine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Aliskiren/Amlodipine with caution in the ELDERLY; they may be more sensitive to its effects.
• Aliskiren/Amlodipine should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Aliskiren/Amlodipine may cause birth defects or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Aliskiren/Amlodipine is found in breast milk. Do not breast-feed while taking Aliskiren/Amlodipine.

Possible side effects of Aliskiren/Amlodipine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness.

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); change in the amount of urine produced; chest pain (new or worsening); fainting; fast or irregular heartbeat; muscle pain or weakness; numbness of an arm or leg; red, swollen, blistered, or peeling skin; severe or persistent dizziness or lightheadedness; shortness of breath; sudden, severe headache or vomiting; sudden, unexplained weight gain; sudden vision changes; swelling of the feet, ankles, or hands; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Aliskiren/Amlodipine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; fast or slow heartbeat; severe dizziness or lightheadedness.

Store Aliskiren/Amlodipine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aliskiren/Amlodipine out of the reach of children and away from pets.

General information:

• If you have any questions about Aliskiren/Amlodipine, please talk with your doctor, pharmacist, or other health care provider.
• Aliskiren/Amlodipine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Aliskiren/Amlodipine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.