| 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.
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Heart failure: Heart failure means your heart does not pump blood well enough. 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:
- increasing 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
- unusual tiredness
These may be symptoms of heart failure.
- 2.
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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
- high blood triglyceride levels
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- kidney problems
- stones in your gallbladder (gall stones)
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- liver problems
- a history of alcoholism
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| 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.
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: |
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- swelling of your face, lips, throat and other areas on your skin
- raised, red areas on your skin (hives)
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- difficulty with swallowing or breathing
- skin rash, itching, flaking or peeling
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| 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
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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.
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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.
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are breastfeeding or plan to breastfeed. It is not known if OSENI passes into your breast milk and if it can harm your baby. Talk with your doctor about the best way to control your blood glucose levels while breastfeeding.
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?
- Take OSENI exactly as your doctor tells you to take it.
- Take OSENI 1 time each day with or without food.
- Do not break or cut OSENI tablets before swallowing.
- Your doctor may need to change your dose of OSENI to control your blood glucose. Do not change your dose unless told to do so by your doctor.
- If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of OSENI at the same time.
- If you take too much OSENI, call your doctor or your poison control center right away at 1-800-222-1222.
- If your body is under stress, such as from fever, infection, accident or surgery, the dose of your diabetes medicines may need to be changed. Call your doctor right away.
- Stay on your diet and exercise programs and check your blood sugar as your doctor tells you to.
- Your doctor may do certain blood tests before you start OSENI and during treatment as needed. Your doctor may change your dose of OSENI based on the results of your blood tests due to how well your kidneys are working.
- Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
- Your doctor should check your eyes regularly while you take OSENI.
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What are the possible side effects of OSENI?
OSENI can cause serious side effects, including:
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- swelling of your face, lips, throat and other areas on your skin
- raised, red areas on your skin (hives)
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- difficulty swallowing or breathing
- skin rash, itching, flaking or peeling
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If you have these symptoms, stop taking OSENI and contact your doctor right away or go to the nearest hospital emergency room
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Liver problems. Call your doctor right away or go to the nearest hospital emergency room if you have unexplained symptoms such as:
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- nausea or vomiting
- loss of appetite
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- unusual or unexplained tiredness
- yellowing of your skin or the whites of your eyes
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Broken bones (fractures). Usually in the hand, upper arm or foot in women. Talk to your doctor for advice on how to keep your bones healthy.
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Bladder cancer. There may be an increased chance of having bladder cancer when you take OSENI. You should not take OSENI if you are receiving treatment for bladder cancer. Tell your doctor right away if you have any of the following symptoms of bladder cancer:
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- blood or a red color in your urine
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- an increased need to urinate
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Low blood sugar (hypoglycemia). If you take OSENI with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take OSENI. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, then call your doctor. Signs and symptoms of low blood sugar may include:
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- shaking or feeling jittery
- headache
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- change in vision
- dizziness
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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.
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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.
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Joint pain. Some people who take medicines called DPP-4 inhibitors, one of the medicines in OSENI, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.
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Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in OSENI, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking OSENI.
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. |
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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).
ALP008 R11 |