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Aliskiren/ valsartan

Generic Name: aliskiren/valsartan (AL-is-KYE-ren/val-SAR-tan)
Brand Name: Valturna

Aliskiren/valsartan may cause injury or death to the fetus if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. If you are planning to become pregnant, talk with your doctor about other treatment options.

Aliskiren/ valsartan is used for:

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

Aliskiren/valsartan is a combination of a direct renin inhibitor and an angiotensin II receptor blocker. It works by relaxing the blood vessels, which helps to lower blood pressure.

Do NOT use aliskiren/ valsartan if:

  • you are allergic to any ingredient in aliskiren/valsartan
  • 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/valsartan
  • you are pregnant
  • you have diabetes or moderate to severe kidney problems
  • 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/ valsartan:

Some medical conditions may interact with aliskiren/valsartan. 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 able to become pregnant
  • 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
  • if you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness), including angioedema caused by treatment with another angiotensin receptor blocker (ARB) (eg, losartan) or an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril)
  • if you have a history of heart problems (eg, heart failure), blood vessel problems, blood flow problems, liver problems, kidney problems (eg, renal artery stenosis), gout, or gallbladder problems
  • if you have a history of a stroke or recent heart attack
  • if you are dehydrated or have low blood volume
  • if you have electrolyte problems (eg, high blood potassium levels, low blood sodium levels), are on a low-salt (sodium) diet, or drink alcohol
  • if you are on dialysis or are scheduled to have surgery
  • if you are taking another medicine for high blood pressure or heart problems

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

  • Atorvastatin, certain azole antifungals (eg, itraconazole, ketoconazole), cyclosporine, medicines for heart problems, other medicines for high blood pressure (eg, ACE inhibitors, such as lisinopril), rifamycins (eg, rifampin), or ritonavir because they may increase the risk of aliskiren/valsartan's side effects, including low blood pressure
  • Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood pressure may be increased
  • Potassium-sparing diuretics (eg, spironolactone, triamterene) or potassium supplements because the risk of high blood potassium levels may be increased
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, celecoxib, ibuprofen, indomethacin) because they may decrease aliskiren/valsartan's effectiveness and the risk of kidney problems and high blood potassium levels may be increased
  • Lithium because the risk of its side effects may be increased by aliskiren/valsartan

This may not be a complete list of all interactions that may occur. Ask your health care provider if aliskiren/valsartan 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/ valsartan:

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

  • An extra patient leaflet is available with aliskiren/valsartan. Talk to your pharmacist if you have questions about this information.
  • Take aliskiren/valsartan by mouth with or without food. However, you must take it the same way each time you take it. If you take aliskiren/valsartan on an empty stomach, always take it on an empty stomach. If you take it with food, always take it with food.
  • Take aliskiren/valsartan on a regular schedule to get the most benefit from it. Taking aliskiren/valsartan at the same time each day will help you remember to take it.
  • Continue to take aliskiren/valsartan even if you feel well. Do not miss any doses.
  • If you miss a dose of aliskiren/valsartan, 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/valsartan.

Important safety information:

  • Aliskiren/valsartan may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use aliskiren/valsartan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Aliskiren/valsartan may cause dizziness, light-headedness, 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.
  • Aliskiren/valsartan 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.
  • Aliskiren/valsartan may not work as well in black patients. Discuss any questions or concerns with your doctor.
  • Dehydration, excessive sweating, vomiting, or diarrhea may increase the risk of low blood pressure. Contact your health care provider at once if any of these occur.
  • It may take 2 weeks or more to receive the full benefit of aliskiren/valsartan. Do NOT stop taking aliskiren/valsartan without checking with your doctor.
  • High-fat meals may decrease the amount of aliskiren/valsartan that is absorbed into your body. Discuss any questions or concerns with your doctor. Be sure you take aliskiren/valsartan consistently with regard to meals.
  • Check with your doctor before you use a salt substitute or a product that has potassium in it.
  • Tell your doctor or dentist that you take aliskiren/valsartan before you receive any medical or dental care, emergency care, or surgery.
  • 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.
  • If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
  • Lab tests, including blood pressure, blood electrolyte levels, and kidney function, may be performed while you use aliskiren/valsartan. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Aliskiren/valsartan should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Aliskiren/valsartan may cause birth defects or fetal 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 this medicine is found in breast milk. Do not breast-feed while you are taking aliskiren/valsartan.

Possible side effects of aliskiren/ valsartan:

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; mild flu-like symptoms; runny nose; sore throat; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

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); burning, numbness, or tingling; change in the amount of urine produced; chest pain; fainting; frequent or painful urination; irregular heartbeat; muscle pain, weakness, or cramps; red, swollen, blistered, or peeling skin; shortness of breath; signs of infection (eg, fever, chills, persistent sore throat); sudden, unexplained weight gain; swelling of the hands, ankles, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent stomach pain, yellowing of the eyes or skin); symptoms of low blood pressure (eg, fainting, light-headedness, severe dizziness).

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.

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 light-headedness.

Proper storage of aliskiren/valsartan:

Store aliskiren/valsartan at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep aliskiren/valsartan out of the reach of children and away from pets.

General information:

  • If you have any questions about aliskiren/valsartan, please talk with your doctor, pharmacist, or other health care provider.
  • Aliskiren/valsartan 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 should not be used to decide whether or not to take aliskiren/valsartan or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about aliskiren/valsartan. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to aliskiren/valsartan. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using aliskiren/valsartan.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.