When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to glimepiride, pioglitazone, or a sulfa drug, or if you have severe heart failure.

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.
• It is best to take this medicine with food or milk. Take this medicine with the first meal of the day.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule, unless your doctor tells you otherwise. Do not double doses.
• 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.

• There are many other drugs that can interact with pioglitazone and glimepiride. Make sure your doctor knows about all other medicines you are using, including the following:
  
  • Clonidine
  • Fluconazole
  • Gemfibrozil
  • Miconazole
  • Reserpine
  • Rifampin
  • Beta-blocker blood pressure medicine
  .
• If you also take colesevelam, take pioglitazone/glimepiride at least 4 hours before you take colesevelam.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart failure, liver disease, kidney disease, heart disease, adrenal or pituitary gland problem, G6PD deficiency, or a history of bladder cancer. Also tell your doctor if you drink alcohol.
• This medicine may cause the following problems:
  
  • Higher risk of heart problems
  • Low blood sugar
  • Edema (retaining fluid)
  • Serious allergic or skin reactions
  • Serious liver problems
  • Macular edema (eye disease)
  • Bone fractures in women
• Women: This medicine may cause you to ovulate if you have not gone through menopause yet. This could happen even if you have a history of irregular periods or problems ovulating. Talk to your doctor about effective birth control.
• 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, trouble seeing, or other vision changes
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Rapid weight gain; swelling in your hands, ankles, or feet; trouble breathing
• Shaking, trembling, sweating, fast or pounding heartbeat, lightheadedness, hunger, confusion

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

• Cough, runny or stuffy nose, or sore throat
• Diarrhea, mild nausea, or vomiting

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