Aliskiren Hemifumarate Oral tablet

What is this medicine?

ALISKIREN (a lis KYE ren) is a renin inhibitor. This medicine 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

• kidney disease

• an unusual or allergic reaction to aliskiren, 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 this medicine except on the advice of your doctor or health care professional.

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?

• atorvastatin

• furosemide

• irbesartan

• ketoconazole

• other medicines for high blood pressure

• potassium supplements

• salt substitutes with potassium

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 or health care professional for regular checks on your progress. Check your blood pressure as directed. Ask your doctor or health care professional what your blood pressure should be and when you should contact him or her.

If you have diabetes and are taking a medicine called an angiotensin-receptor-blocker (ARB) or angiotensin-converting-enzyme-inhibitor (ACE inhibitor), do not take this medicine. Talk to your doctor or health care professional for more information.

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.

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

• pain or difficulty passing urine

• pain, tingling, numbness in the hands or feet

• seizures

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

• headache

• stomach upset

• tired

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.