Alogliptin Benzoate (al-oh-GLIP-tin BEN-zoe-ate), Pioglitazone Hydrochloride (pye-oh-GLI-ta-zone hye-droe-KLOR-ide)

Treats type 2 diabetes.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not split, crush, break, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how alogliptin/pioglitazone works. Tell your doctor if you are using gemfibrozil, rifampin, topiramate, or insulin or other diabetes medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding. If you had problems ovulating or have irregular periods, this medicine may cause you to ovulate, which could lead to pregnancy if you are sexually active. Talk to your doctor about effective birth control while you are using this medicine.
• Tell your doctor if you have kidney disease, liver disease, heart failure, edema (fluid retention or swelling), macular edema (swelling of the back of the eye), bone problems, or a history of alcohol use disorder, bladder cancer, or pancreas problems.
• This medicine may cause the following problems:
  • Heart failure
  • Pancreatitis (swelling of the pancreas)
  • Liver problems
  • Increased risk for broken bones (fracture)
  • Increased risk for bladder cancer if you use this medicine for a long time
  • Low blood sugar, when used with other diabetes medicines
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Blurred vision or other vision changes
• Change in how much or how often you urinate, painful urination, lower back or side pain, blood in your urine
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Large, hard skin blisters
• Rapid weight gain, swelling in your hands, ankles, or feet, trouble breathing, tiredness
• Severe joint pain, muscle pain or cramps
• Shaking, trembling, sweating, fast or pounding heartbeat, faintness, hunger, confusion
• Sudden and severe stomach pain, nausea, vomiting, fever, lightheadedness

If you notice these less serious side effects, talk with your doctor:

• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088