This product is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

This product contains 2 medications: aliskiren and hydrochlorothiazide. Aliskiren works by relaxing blood vessels so blood can flow more easily. It belongs to a class of drugs known as direct renin inhibitors. Hydrochlorothiazide causes your body to get rid of extra salt and water by making more urine. It is called a "water pill" or diuretic.

Read the Patient Information Leaflet if available from your pharmacist before you start using this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose. High-fat foods may decrease how well this drug is absorbed by the body, so it is best to avoid taking this medication with a high-fat meal. Also, if you take this drug too close to bedtime, you may need to wake up to urinate. It is best to take this medication at least 4 hours before your bedtime.

Do not take with fruit juices (such as apple, grapefruit, or orange) since they may decrease the absorption of this drug.

If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine, colestipol), take aliskiren/hydrochlorothiazide at least 4 hours before or at least 4 to 6 hours after these medications.

The dosage is based on your medical condition and response to treatment.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Keep taking this medication even if you feel well. Most people with high blood pressure do not feel sick. It may take up to 4 weeks before you get the full benefit of this drug.

Tell your doctor if your condition does not get better or if it gets worse (your blood pressure readings remain high or increase).

Dizziness or lightheadedness may occur as your body adjusts to the medication. Dry cough or diarrhea may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This product may cause dehydration and electrolyte imbalance. Tell your doctor right away if you have any symptoms of dehydration or electrolyte imbalance, including unusual dry mouth/thirst, muscle cramps/weakness, slow/fast/irregular heartbeat, or confusion.

Tell your doctor right away if you have any serious side effects, including:

• fainting
• severe tiredness
• big toe/joint pain
• signs of kidney problems (such as change in the amount of urine)

Get medical help right away if you have any very serious side effects, including:

• decrease in vision
• eye pain

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this product, tell your doctor or pharmacist if you are allergic to aliskiren or hydrochlorothiazide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• diabetes
• kidney disease
• liver disease
• dehydration
• untreated electrolytes imbalance (such as high/low potassium, low magnesium, high calcium)
• gout
• lupus
• skin cancer

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Severe sweating, diarrhea, or vomiting may cause dehydration and cause you to feel lightheaded. Tell your doctor if you have severe diarrhea or vomiting. To prevent dehydration, drink plenty of fluids unless your doctor tells you not to.

If you have diabetes, this product may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This product may affect your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

This medication may make you more sensitive to the sun. It may also increase your risk for skin cancer, especially if you take it for a long time. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned, have skin blisters/redness, or notice new or changed moles/skin lesions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this product, especially dizziness.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using this medication. Aliskiren may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. See also Warning section.

It is unknown if aliskiren passes into breast milk. Hydrochlorothiazide passes into breast milk. Consult your doctor before breastfeeding.

See also How to Use and Precautions sections.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• dofetilide
• lithium
• drugs that may increase the level of potassium in the blood (including sparsentan, ACE inhibitors such as benazepril/lisinopril, ARBs such as candesartan/losartan, birth control pills containing drospirenone)

Other medications can affect the removal of aliskiren from your body, which may affect how aliskiren works. Examples include itraconazole, cyclosporine, quinidine, among others.

Some products have ingredients that could raise your blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe dizziness, fainting.

Do not share this medication with others.

Lifestyle changes that may help this medication work better include exercising, stopping smoking, and eating a low-cholesterol/low-fat diet. Consult your doctor for more details.

Lab and/or medical tests (including kidney function, blood mineral levels such as potassium, skin exams) should be done while you are taking this medication. Keep all medical and lab appointments.

Have your blood pressure checked regularly while taking this medication. Learn how to monitor your own blood pressure at home, and share the results with your doctor.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.