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MEDICATION GUIDE OSENI (OH-SENN-EE) (ALOGLIPTIN AND PIOGLITAZONE) TABLETS
Read this Medication Guide carefully before you start taking OSENI and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about OSENI, ask your doctor or pharmacist.

What is the most important information I should know about OSENI?

OSENI can cause serious side effects, including:

1.
Heart failure: OSENI can cause heart failure and cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure.
Before you start taking OSENI:

Tell your doctor if you have ever had heart failure or have problems with your kidneys.

Call your doctor right away if you have any of the following symptoms:

shortness of breath or trouble breathing, especially when you lie down
an unusually fast increase in weight
swelling or fluid retention, especially in the feet, ankles, or legs
These may be symptoms of heart failure.

2.
Inflammation of the pancreas (pancreatitis): Alogliptin, one of the medicines in OSENI, may cause pancreatitis, which may be severe. Certain medical conditions make you more likely to get pancreatitis.
Before you start taking OSENI:

Tell your doctor if you have ever had:

pancreatitis
kidney problems
liver problems
Stop taking OSENI and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

What is OSENI?

OSENI contains 2 prescription diabetes medicines, alogliptin (NESINA) and pioglitazone (ACTOS).
OSENI is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.
OSENI is not for people with type 1 diabetes.
OSENI is not for people with diabetic ketoacidosis (increased ketones in blood or urine).
It is not known if OSENI is safe and effective in children under the age of 18. OSENI is not recommended for use in children.

Who should not take OSENI?

Do not take OSENI if you:

have severe heart failure
are allergic to alogliptin (NESINA), pioglitazone (ACTOS) or any ingredient in OSENI or have had a serious allergic (hypersensitivity) reaction to alogliptin or pioglitazone. See the end of this Medication Guide for a complete list of the ingredients in OSENI.
Symptoms of a serious allergic reaction to OSENI may include:

swelling of your face, lips, throat and other areas on your skin
raised, red areas on your skin (hives)
difficulty with swallowing or breathing
skin rash, itching, flaking or peeling
If you have these symptoms, stop taking OSENI and contact your doctor or go to the nearest hospital emergency room right away.

What should I tell my doctor before and during treatment with OSENI?

Before you start taking OSENI, tell your doctor if you:

have heart failure
have a type of diabetic eye disease t