ncrease in weight
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unusual tiredness
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:
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pancreatitis
•
stones in your gallbladder (gallstones)
•
a history of alcoholism
•
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 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
•
difficulty with swallowing or breathing
•
raised, red areas on your skin (hives)
•
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 that causes swelling of the back of the eye (macular edema)
•
have kidney or liver problems
•
have or have had inflammation of the pancreas (pancreatitis)
•
have or have had cancer of the bladder
•
have other medical conditions
•
are pregnant or plan to become pregnant. It is not known if OSENI can harm your unborn baby. Talk to your doctor about the best way to control your blood sugar while you are pregnant or if you plan to become pregnant.
•
are a premenopausal woman who does not have periods regularly or at all. OSENI may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking OSENI. Tell your doctor right away if you become pregnant while taking OSENI.
•
are breastfeeding or plan to breastfeed. It is not known whether OSENI passes into your breast milk and if it can harm your baby. You should not take OSENI if you breastfeed your baby. Talk with your doctor about the best way to feed your baby if you are taking OSENI.
Tell your doctor about all the medicines you take, including prescription and nonprescription med
