Alogliptin; Pioglitazone Tablets

What is this medication?

ALOGLIPTIN; PIOGLITAZONE (AL oh GLIP tin; pye oh GLI ta zone) treats type 2 diabetes. It works by decreasing your blood sugar (glucose). 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
• Diabetic ketoacidosis
• Eye disease called macular edema
• Gallstones
• Heart disease
• Heart failure
• High triglycerides
• If you often drink alcohol
• Irregular menstrual cycles
• Kidney disease
• Liver disease
• Pancreatitis
• Polycystic ovary syndrome
• Previous swelling of the tongue, face, or lips with difficulty breathing, difficulty swallowing, hoarseness, or tightening of the throat
• 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
• Breast-feeding

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
• Insulin
• Rifampin
• Sulfonylureas like glimepiride, glipizide, glyburide
• Topiramate

Many medications may cause an increase or decrease in blood sugar, these include:

• Alcohol
• Aspirin and aspirin-like medications
• Chloramphenicol
• Chromium
• Diuretics
• Female hormones, like estrogens or progestins and birth control pills
• Heart medications
• Isoniazid
• Male hormones or anabolic steroids
• Medications for weight loss
• Medications for allergies, asthma, cold, or cough
• Medications for mental problems
• Medications called MAO Inhibitors like Nardil, Parnate, Marplan, Eldepryl
• Niacin
• NSAIDs, medications for pain and inflammation, like ibuprofen or naproxen
• Pentamidine
• Phenytoin
• Probenecid
• Quinolone antibiotics like ciprofloxacin, levofloxacin, ofloxacin
• Some herbal dietary supplements
• Steroid medications like prednisone or cortisone
• Thyroid medication

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. You may need blood work while you are taking this medication.

A test called HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.

Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.

Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. Get medical help at once.

Tell your care team if you have high blood sugar. You might need to change the dose of your medication. If you are sick or exercising more than usual, you may need to change the dose of your medication.

Do not skip meals. Ask your care team if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.

This medication may increase your risk of having certain heart problems. Get medical help right away if you have any chest pain or tightness, pain that radiates to the jaw or down the arm, or shortness of breath. These may be signs of a heart attack or other serious condition.

This medication may cause ovulation in premenopausal women who do not have regular monthly periods. This may increase your chances of becoming pregnant. Talk with your care team about your birth control options. Contact your care team if you think you are pregnant.

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.