Pioglitazone/Glimepiride, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat type 2 diabetes. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause or make heart failure worse, or increase your risk for a heart attack, heart failure, or other heart problems. This medicine may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: antidiabetic

Generic and brand names: pioglitazone/glimepiride, oral; Duetact

What is this medicine used for?

This is a combination of two medicines. It is taken by mouth to treat type 2 diabetes and control blood sugar levels. It should not be used to treat type 1 diabetes or diabetic ketoacidosis. Usually you will take this medicine while you follow a diet and exercise program prescribed by your healthcare provider. This medicine may be used alone or with other diabetes medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergy to any medicine
• A stroke or transient ischemic attack (TIA)
• Anemia or G6PD deficiency
• Bladder cancer
• Diabetic ketoacidosis (DKA)
• Edema (fluid buildup)
• Eye problems
• Heart failure, heart attack, or other heart problems
• Kidney or liver problems
• Osteoporosis
• Problems with low levels of sodium in your blood
• Thyroid, pituitary, or adrenal gland problems

Tell your provider if you are also using insulin. You may not be able to use this medicine. Also, tell your healthcare provider if you get sick, injured, or are scheduled to have surgery.

Some women who no longer have periods may be able to become pregnant while taking this medicine. Ask your healthcare provider if this applies to you. Talk with your healthcare provider if you need birth control.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Talk to your healthcare provider about whether you will need to use insulin to control your blood sugar during pregnancy. Do not breast-feed while you are taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine every day exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18 years.

Take this medicine with the first main meal of the day. Follow carefully the diet and exercise plan your healthcare provider gives you. Diet and exercise affect your dosage.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizures, fainting, coma.

What should I watch out for?

This medicine may cause or make heart failure worse, or increase your risk for a heart attack, heart failure, or other heart problems. Talk with your healthcare provider about this.

This medicine may increase your risk for bladder cancer. Talk with your provider about this.

This medicine may cause liver problems. You need blood tests when you start treatment and regularly while you take this medicine. Keep all appointments.

Test your blood sugar on the schedule your provider recommends and keep track of it. See your provider regularly for an A1c test to check the average of your blood sugar over 2 to 3 months. This average is different from your day to day blood sugar. You will need to have blood tests regularly to see if the medicine is working and to check for any signs of side effects that show up only on blood tests. Keep all appointments for these tests.

Low blood sugar (hypoglycemia) can happen if you miss or delay meals, drink too much alcohol, take too much medicine, or exercise more than usual. Symptoms of low blood sugar include shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, and weakness. Treat the condition quickly by eating or drinking something with sugar in it such as candy, juice, or nondiet soda. Taking glucose tablets or gels (available in drug stores) is another quick way to treat hypoglycemia. Be sure to talk about this with your healthcare provider.

Low blood sugar may affect your ability to drive or operate machinery. Do not drive or operate machinery unless you are fully alert and can see clearly.

Rarely, this medicine may cause vision problems. You need to have regular eye exams while taking this medicine. This medicine may increase the risk of fractures in women. You may also need bone scans or X-rays to see if this medicine is affecting your bones. Talk to your healthcare provider about how to keep your bones healthy.

This medicine may make your skin more sensitive to the sun and may make you sunburn more easily. Wear protective clothing and sunscreen lotion when you are exposed to the sun. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

If you develop hives, an itchy rash, or peeling skin, stop taking the medicine and contact your provider right away.

Alcohol may affect the way your body responds to this medicine and to food. Do not drink alcohol unless your healthcare provider approves.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Wear some form of identification stating that you are a diabetic (such as a Medic Alert bracelet). If you become unconscious, the ID tells emergency healthcare providers that you are a diabetic and need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Symptoms of hypoglycemia (shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, weakness); severe nausea; severe vomiting; severe stomach pain; irregular heartbeat; severe dizziness; loss of appetite; dark or bloody urine; pain when urinating; increased urination; light-colored bowel movements; yellowing of your eyes or skin; swelling of legs or ankles, or any unexplained swelling; unexplained or unusually fast weight gain; shortness of breath or trouble breathing (especially when you lie down); unusual bruising or bleeding; unusual tiredness or weakness; vision problems; severe skin redness, blistering, or peeling.

Other: Runny or stuffy nose; cough; mild nausea, vomiting, or headache; joint or muscle pain; back pain; weight gain; diarrhea; sore throat.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Allergy, cold, or cough medicines that contain phenylephrine (Neo-Synephrine, Sudafed PE) or pseudoephedrine (Sudafed)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone) and disopyramide (Norpace)
• Antibiotics such as chloramphenicol, ciprofloxacin (Cipro), isoniazid, levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin, rifabutin (Mycobutin), and rifampin (Rifadin)
• Antidepressants such as amitriptyline, desipramine (Norpramin), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), and sertraline (Zoloft)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Monistat, Oravig), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), perphenazine, prochlorperazine (Compro), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aprepitant (Emend)
• Aspirin and other salicylates
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carteolol, carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol, sotalol (Betapace, Sorine), and timolol
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular) and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as abiraterone (Zytiga), capecitabine (Xeloda), crizotinib (Xalkori), dabrafenib (Tafinlar), dasatinib (Sprycel), enzalutamide (Xtandi), erlotinib (Tarceva), imatinib (Gleevec), lapatinib (Tykerb), nilotinib (Tasigna), paclitaxel (Abraxane, Taxol), pazopanib (Votrient), sorafenib (Nexavar), sunitinib (Sutent), tamoxifen, vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Celecoxib (Celebrex)
• Cholesterol-lowering medicines such as cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), fenofibrate (Antara, Fenoglide, Lipofen, TriCor, Triglide), and gemfibrozil (Lopid) (Take colesevelam at least 4 hours after you take this medicine.)
• Clopidogrel (Plavix)
• Corticosteroids such as cortisone, dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Danazol
• Diuretics (water pills) such as amiloride, bumetanide, chlorthalidone, furosemide (Lasix), hydrochlorothiazide (Microzide), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Hormonal birth control implants, IUDs, patches, pills, shots, vaginal rings, and hormones such as conjugated estrogens (Premarin), estradiol (Climara, Estrace, Estraderm, Vivelle), medroxyprogesterone (Depo-Provera, Provera), and norethindrone (Aygestin, Micronor)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet) and ranitidine (Zantac)
• Natural remedies such as alfalfa, aloe, bilberry, bitter melon, burdock, celery, chromium, damiana, fenugreek, garcinia, garlic, ginger, ginseng, gotu kola, gymnema, St. John's wort, and stinging nettle
• Niacin
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Octreotide (Sandostatin)
• Ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira)
• Other diabetes medicines such as canagliflozin (Invokana), chlorpropamide, dapagliflozin (Farxiga), exenatide (Bydureon, Byetta), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, linagliptin (Tradjenta), metformin (Fortamet, Glucophage, Riomet), nateglinide (Starlix), repaglinide (Prandin), rosiglitazone (Avandia), saxagliptin (Onglyza), sitagliptin (Januvia), and tolbutamide
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pasireotide (Signifor)
• Pegvisomant (Somavert)
• Probenecid
• Procarbazine (Matulane)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Psyllium (Take psyllium 2 hours before or 2 hours after you take this medicine.)
• Quinine
• Somatropin (Genotropin, Humatrope, Nutropin, Serostim)
• Sulfa antibiotics such as sulfadiazine, sulfamethoxazole/trimethoprim (Bactrim, Septra), sulfasalazine (Azulfidine), and trimethoprim (Primsol)
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid USP (Armour Thyroid, Nature-Throid)
• Warfarin (Coumadin)

Do not drink large amounts of alcohol while you are taking this medicine. Talk to your healthcare provider about this.

Many medicines may change how well this medicine controls your blood sugar. Be sure to tell the healthcare provider who prescribed this medicine about any other medicines you are taking, including nonprescription products. Also, tell any other healthcare providers who treat you that you are taking this medicine for diabetes.

Many nonprescription products contain sugar, alcohol, or other ingredients that may interfere with this medicine or increase your blood sugar. Check product labels for warnings for diabetics or ask your healthcare provider or pharmacist for advice.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.