Hydrochlorothiazide is a thiazide diuretic (water pill). Aliskiren is an anti-hypertensive (blood pressure lowering) medicine.

Hydrochlorothiazide and aliskiren is a combination medicine used to treat high blood pressure (hypertension).

Hydrochlorothiazide and aliskiren may also be used for purposes not listed in this medication guide.

You should not use hydrochlorothiazide and aliskiren if you are unable to urinate, or if you are allergic to sulfa drugs.

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

If you have diabetes, do not use hydrochlorothiazide and aliskiren together with certain heart or blood pressure medicines (such as Accupril, Benicar, Capoten, Cozaar, Diovan, Lotensin, Mavik, Prinivil, Vasotec, any many others).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take hydrochlorothiazide and aliskiren with or without food, but take it the same way every time. Avoid taking this medicine with a high-fat meal, which can make it harder for your body to absorb aliskiren.

You may have very low blood pressure while taking hydrochlorothiazide and aliskiren. Call your doctor if you are sick with vomiting or diarrhea, or if you feel light-headed.

It may take up to 4 weeks before your blood pressure improves. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Your blood pressure will need to be checked often.

Your doctor may also check your skin because hydrochlorothiazide can increase your risk of developing non-melanoma skin cancer. Ask your doctor about skin symptoms to watch for.

If you need surgery or medical tests, tell the surgeon ahead of time that you are using hydrochlorothiazide and aliskiren. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Usual Adult Dose for Hypertension:

Initial dose: 150 mg-12.5 mg or 150 mg-25 mg once daily

Maximum dose: Aliskiren-hydrochlorothiazide 300/25 mg orally daily

Comments:
-The combination product may be substituted for patients receiving aliskiren and hydrochlorothiazide from separate tablets.
-Tablets should be taken the same way each day, either with or without a meal. (High-fat meals decrease absorption of aliskiren substantially).

You should not use this medicine if you are allergic to aliskiren or hydrochlorothiazide, or if:

• you are unable to urinate; or

• you are allergic to sulfa drugs.

If you have diabetes, you should not use hydrochlorothiazide and aliskiren together with certain heart or blood pressure medicines, such as:

• azilsartan (Edarbi, Edarbyclor), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), olmesartan (Azar, Benicar), valsartan (Diovan, Exforge, Tribenzor), telmisartan (Micardis); or

• benazepril (Lotensin), captopril (Capoten, Capozide), enalapril (Vasotec, Vasoretic), fosinopril (Monopril), lisinopril (Prinivil, Zestoretic, Zestril), moexipril (Uniretic, Univasc), perindopril (Aceon), quinapril (Accupril, Accuretic), ramipril (Altace), or trandolapril (Mavik, Tarka).

You may also need to avoid taking these medicines with hydrochlorothiazide and aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• kidney disease;

• liver disease;

• low or high levels of potassium in your blood;

• asthma or allergies;

• systemic lupus erythematosus (SLE);

• glaucoma;

• gout;

• diabetes; or

• an allergy to penicillin.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Hydrochlorothiazide and aliskiren can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using this medicine.

Hydrochlorothiazide and aliskiren is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of hydrochlorothiazide and aliskiren.

Get emergency medical help if you have signs of an allergic reaction (hives, vomiting, severe stomach pain, dizziness, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Hydrochlorothiazide and aliskiren may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• little or no urination;

• eye pain, vision problems;

• high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;

• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;

• low sodium level --headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or

• lupus-like symptoms--muscle or joint pain, fever, and a rash or patchy skin color that worsens in sunlight.

Common side effects of hydrochlorothiazide and aliskiren may include:

• dizziness, tired feeling;

• high potassium;

• cough;

• joint pain;

• diarrhea; or

• flu symptoms (fever, chills, body aches).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you take cholestyramine or colestipol, take your hydrochlorothiazide and aliskiren dose 4 hours before or 4 hours after you take the other medicine.

Tell your doctor about all your other medicines, especially:

• cyclosporine;

• lithium;

• any heart or blood pressure medicines;

• a diuretic or "water pill";

• insulin or oral diabetes medicine;

• a potassium supplement such as K-Dur, Klor-Con;

• salt substitutes that contain potassium;

• antifungal medicine--itraconazole, ketoconazole;

• cholesterol medication--atorvastatin, cholestyramine, colestipol, simvastatin, Lipitor, Vytorin, Zocor; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may affect hydrochlorothiazide and aliskiren, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.