DUETACT 30 mg-2 mg tablet

Generic name:
Pioglitazone/glimepiride - oral

Pronunciation
(PYE-oh-GLI-ta-zone/glih-MEH-pih-ride)

Brand name(s)
Duetact

Pioglitazone may rarely cause or worsen a certain heart problem (heart failure). Tell your doctor right away if you notice any symptoms of heart failure, including: shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain.

This medication is not recommended for people with certain types of heart failure. Before using this medication, tell your doctor if you have heart failure.

This medication is a combination of 2 drugs, pioglitazone and glimepiride. It is used along with a proper diet and exercise program to control high blood sugar in patients with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

Pioglitazone belongs to a class of drugs known as thiazolidinediones or "glitazones." It works by helping to restore your body's proper response to insulin, thereby lowering your blood sugar.

Talk to your doctor about the risks and benefits of using pioglitazone-containing products.

Glimepiride belongs to a class of drugs known as sulfonylureas. It works by causing the release of your body's natural insulin.

Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily with the first main meal of the day.

The dosage is based on your medical condition and response to treatment.

Colesevelam can decrease the absorption of glimepiride. If you are taking colesevelam, take this product at least 4 hours before taking colesevelam.

Use this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. Monitor your blood sugar on a regular basis, and share the results with your doctor.

It may take up to 2 to 3 months before you get the full benefit of this drug.

When switching from individual diabetes drugs to this combination product, your doctor may ask you to check your blood sugar more often to make sure you do not have a sudden attack of low blood sugar (hypoglycemic reaction) when starting this product. (See also Side Effects section.) Follow your doctor's directions carefully.

See also Warning section.

Headache, dizziness, diarrhea, nausea, muscle pain, sore throat, or tooth problems may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• new/worsening vision problems (such as color or night vision problems)
• bone fracture
• reddish-colored urine
• urgent need to urinate
• pain while urinating
• signs of liver disease (such as loss of appetite, yellowing eyes/skin, dark urine)
• mental/mood changes (such as hallucinations, confusion)
• seizures
• easy bruising/bleeding
• signs of infection (such as sore throat that doesn't go away, fever)

This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms include cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, headache, fainting, tingling of the hands/feet, and hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor about the reaction right away. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include increased thirst/urination. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to pioglitazone or glimepiride; or to other "glitazones" (such as rosiglitazone); or to other sulfonylureas (such as glipizide, tolbutamide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of:

• heart problems (such as heart failure)
• fluid in your lungs
• swelling (edema, fluid retention)
• liver problems
• kidney disease
• thyroid problems
• certain hormonal conditions (adrenal/pituitary insufficiency, syndrome of inappropriate secretion of antidiuretic hormone-SIADH)
• mineral imbalance (hyponatremia)
• anemia
• eye (retina) problems
• bladder cancer

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do anything that needs alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar (hypoglycemia).

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). In these cases, consult your doctor because you may require a change in your treatment plan, medications, or blood sugar testing.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

This medication may increase the risk of bone fracture (such as upper arm, hand, foot, ankle) in female patients. To lower the chance of getting injured, use caution when doing activities such as contact sports.

Older adults maybe at greater risk for low blood sugar while using this drug.

This medication can cause changes in the menstrual cycle (promote ovulation) and increase the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using this medication.

During pregnancy, this medication should be used only when clearly needed. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may substitute insulin for this drug during pregnancy. If this medication is used, it may be switched to insulin at least 2 weeks before the expected delivery date because of the medication's risk of causing low blood sugar in your newborn. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of pioglitazone from your body, which may affect how pioglitazone works. Examples include gemfibrozil, rifamycins including rifampin, among others.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.

Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: shakiness, fast heartbeat, sweating, loss of consciousness.

Do not share this medication with others.

Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.

Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, eating well-balanced meals containing adequate calcium and vitamin D, stopping smoking, and limiting alcohol. Consult your doctor to see if you need to take calcium/vitamin D supplements and discuss lifestyle changes that might benefit you.

Lab and/or medical tests (such as kidney/liver function, fasting blood glucose, hemoglobin A1c, complete blood counts) should be done while you are taking this medication. Keep all medical and lab appointments. Check your blood sugar regularly as directed and share the results with your doctor.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.