sweating

fast heartbeat

change in vision

hunger
 headache

change in mood

confusion

dizziness
Diabetic eye disease with swelling in the back of the eye (macular edema). Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly.
•
Release of an egg from an ovary in a woman (ovulation) leading to pregnancy. Ovulation may happen when premenopausal women who do not have regular monthly periods take OSENI. This can increase your chance of getting pregnant.
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?

•
Store OSENI at room temperature between 68°F to 77°F (20°C to 25°C).
•
Keep container tightly closed and protect from moisture and humidity.
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 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.

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

Distributed by:

Takeda Pharmaceuticals America, Inc.

Deerfield, IL 60015

Revised: June 2013

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 Takeda Pharmaceuticals America, Inc.

ALP008 R3

PRINCIPAL DISPLAY PANEL -- 12.5 mg/15 mg

NDC 64764-121 -03

Oseni

(alogliptin and pioglitazone) tablets

12.5 mg/15 mg

Rx Only

Dispense with Medication Guide
Takeda logo

30 Tablets

 
(click image for full-size original) PRINCIPAL DISPLAY PANEL -- 12.5 mg/30 mg

NDC 64764-123 -03

Oseni

(alogliptin and pioglitazone) tablets

12.5 mg/30 mg

Rx Only

Dispense with Medication Guide
Taked