Alogliptin; Pioglitazone Tablets

What is this medication?

ALOGLIPTIN; PIOGLITAZONE (AL oh GLIP tin; pye oh GLI ta zone) treats type 2 diabetes. It helps your body use insulin effectively, which decreases your blood sugar (glucose).   It also reduces the amount of sugar released into your blood.  Changes to diet and exercise are often combined with this medication.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Oseni

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bladder cancer
• Eye disease caused by diabetes
• Frequently drink alcohol
• Have or have had gallstones
• Have or have had pancreatitis
• Heart failure
• High cholesterol
• Irregular menstrual cycles
• Kidney disease
• Liver disease
• Swelling of the arms, legs, or feet
• Type 1 diabetes
• An unusual or allergic reaction to alogliptin, pioglitazone, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Gemfibrozil
• Topiramate

Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

Some medications may affect your blood sugar levels or hide the symptoms of low blood sugar (hypoglycemia). Talk with your care team about all the medications you take. They may suggest changes to your dose or checking your blood sugar levels more often.

Medications that may affect your blood sugar levels include:

• Alcohol
• Certain antibiotics, such as ciprofloxacin, levofloxacin, sulfamethoxazole; trimethoprim
• Certain medications for blood pressure or heart disease, such as benazepril, enalapril, lisinopril, losartan, valsartan
• Certain medications for mental health conditions, such as fluoxetine or olanzapine
• Diuretics, such as hydrochlorothiazide (HCTZ)
• Estrogen and progestin hormones
• Other medications for diabetes, such as insulin
• Steroid medications, such as prednisone or cortisone
• Testosterone
• Thyroid hormones

Medications that may mask symptoms of low blood sugar include:

• Beta blockers, such as atenolol, metoprolol, propranolol
• Clonidine
• Guanethidine
• Reserpine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication. Your care team will monitor your HbA1C (A1C). This test shows what your average blood sugar (glucose) level was over the past 2 to 3 months.

Know the symptoms of low blood sugar and know how to treat it. Always carry a source of quick sugar with you. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink if your blood sugar is too low and you are unable to care for yourself. Get medical help at once.

Tell your care team if you have high blood sugar. Your medication dose may change if your body is under stress. Some types of stress that may affect your blood sugar include fever, infection, and surgery.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication. Talk to your care team right away if you have red or dark brown urine, pain or trouble when passing urine, or an increased need to urinate while taking this medication.

This medication may cause you to ovulate, which may increase your chances of becoming pregnant. Talk with your care team about contraception while you are taking this medication. Contact your care team if you think you might be pregnant.

This medication may increase your risk of bone fractures. Tell your care team if you have pain, swelling, or trouble moving a part of your body like you usually can.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in vision such as blurry vision, seeing halos around lights, vision loss
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Red or dark brown urine, pain or trouble when passing urine, passing frequent amounts of urine
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Severe joint pain

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Cough
• Diarrhea
• Headache
• Muscle pain
• Runny or stuffy nose
• Sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture and humidity. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.