OSENI- alogliptin and pioglitazone tablet, film coated 
Takeda Pharmaceuticals America, Inc.

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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?

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:

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:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist before you start a new medicine.

OSENI may affect the way other medicines work, and other medicines may affect how OSENI works. Contact your doctor before you start or stop other types of medicines.

How should I take OSENI?

What are the possible side effects of OSENI?

OSENI can cause serious side effects, including:

  • swelling of your face, lips, throat and other areas on your skin
  • raised, red areas on your skin (hives)
  • difficulty swallowing or breathing
  • skin rash, itching, flaking or peeling

If you have these symptoms, stop taking OSENI and contact your doctor right away.

  • nausea or vomiting
  • loss of appetite
  • stomach pain
  • dark urine
  • unusual or unexplained tiredness
  • yellowing of your skin or the whites of your eyes
  • blood or a red color in your urine
  • an increased need to urinate
  • pain while you urinate
  • shaking or feeling jittery
  • headache
  • sweating
  • change in mood
  • fast heartbeat
  • confusion
  • change in vision
  • dizziness
  • hunger

The most common side effects of OSENI include stuffy or runny nose and sore throat, back pain, cold-like symptoms (upper respiratory tract infection).

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of OSENI. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store OSENI?

Keep OSENI and all medicines out of the reach of children.

General information about the safe and effective use of OSENI

Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not take OSENI for a condition for which it was not prescribed. Do not give OSENI to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about OSENI. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for information about OSENI that is written for health professionals.

For more information, go to www.oseni.com or call 1-877-TAKEDA-7 (1-877-825-3327).

What are the ingredients in OSENI?

Active ingredients: alogliptin and pioglitazone.

Inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, and lactose monohydrate; the tablets are film-coated with hypromellose, polyethylene glycol, titanium dioxide, talc and ferric oxide (yellow and/or red) and are marked with red A1 or gray F1 printing ink.

Distributed by Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. OSENI, NESINA and ACTOS are trademarks of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and are used under license by Takeda Pharmaceuticals America, Inc.
©2013 – 2016 Takeda Pharmaceuticals America, Inc.
ALP008 R7

This Medication Guide has been approved by the U.S. Food and Drug Administration.
12/2016

Revised: 12/2016
Takeda Pharmaceuticals America, Inc.