Aliskiren Hemifumarate, Hydrochlorothiazide Oral tablet

What is this medicine?

ALISKIREN; HYDROCHLOROTHIAZIDE (a lis KYE ren; hye droe klor oh THYE a zide) is a combination of a renin inhibitor and a diuretic. It is used to treat high blood pressure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• dehydration
• diabetes
• gout
• kidney disease or kidney stones
• liver disease
• pancreatitis
• small amount of urine or difficulty passing urine
• an unusual or allergic reaction to aliskiren, hydrochlorothiazide, HCTZ, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on your prescription label. You may take this medicine with or without food, but try to take it the same way every time. Take your doses at regular intervals. Do not take more medicine than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• alcohol
• atorvastatin
• barbiturates
• cholestyramine
• colestipol
• digoxin
• dofetilide
• furosemide
• irbesartan
• lithium
• medicines for blood pressure
• medicines for diabetes
• medicines for fungal infections like ketoconazole
• medicines that relax muscles for surgery
• narcotic medicines for pain
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• potassium supplements
• steroid medicines like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Check your blood pressure as directed. Ask your doctor what your blood pressure should be and when you should contact him or her.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

You may need to be on a special diet while taking this medicine. Ask your doctor.

Check with your doctor or health care professional if you get an attack of severe diarrhea, nausea and vomiting, or if you sweat a lot. The loss of too much body fluid can make it dangerous for you to take this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine may affect your blood sugar level. If you have diabetes, check with your doctor or health care professional before changing the dose of your diabetic medicine.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or hives, swelling of the hands, feet, face, lips, throat, or tongue
• breathing problems
• fast, irregular heartbeat
• feeling faint or lightheaded, falls
• fever or sore throat
• gout pain
• low blood pressure
• muscle pain or cramps
• pain, tingling, numbness in the hands or feet
• pain or difficulty passing urine
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• seizures
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• cough
• diarrhea
• dizziness
• dry mouth
• flu-like symptoms
• headache
• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.