Rosiglitazone/Glimepiride, Oral

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KEY POINTS

• This medicine is taken by mouth to treat type 2 diabetes. Take it exactly as directed.
• This medicine may cause or worsen heart failure. It may also increase your risk for a heart attack, stroke, or other heart problems.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause 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.

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What are other names for this medicine?

Type of medicine: antidiabetic

Generic and brand names: rosiglitazone/glimepiride, oral; Avandaryl

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 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
• 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 healthcare provider if you are taking any medicines to treat heart failure, high blood pressure, high cholesterol, or to prevent heart disease or stroke.

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.

Take it with the first meal of the day. Follow carefully the diet and exercise plan your healthcare provider gives you. Diet and exercise affect your dosage. This medicine may start working in 1 to 2 weeks, but it may take 2 to 3 months to have full effect.

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: strong 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 worsen heart failure. It may also increase your risk for a heart attack, stroke, or other heart problems, especially if you also take insulin. Talk with your healthcare provider about this.

Get medical care right away if you start having chest pain or pressure; pain or discomfort in your arms, back, neck, jaw, or stomach; cold sweats; nausea or vomiting; lightheadedness; shortness of breath; any unexplained swelling or sudden weight gain; or unusual tiredness. These may be symptoms of a serious heart problem.

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

Follow the diet and exercise program prescribed for you. 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. 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. You could also take 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.

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

Rarely, this medicine may cause vision problems. You need to have regular eye exams while taking this medicine.

Some people, particularly women, are at higher risk of having bone fractures while taking this medicine. 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.

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

Adults over the age of 65 may be at greater risk for side effects, including low blood sugar (hypoglycemia). Talk with your healthcare provider about this.

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); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Chest pain or pressure; severe nausea or vomiting; severe stomach pain; fast or irregular heartbeat; severe dizziness; unusual tiredness or weakness; loss of appetite; dark urine; light-colored bowel movements; yellowing of your eyes or skin; swelling of hands, legs, or feet, or any unexplained swelling; trouble breathing or shortness of breath, especially when lying down; unusual bruising or bleeding; vision problems; unusually fast weight gain; confusion; shaking; cold sweats; strong hunger; lightheadedness; blistering or peeling skin.

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

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, rifampin (Rifadin), and rifapentine (Priftin)
• Antidepressants such as amitriptyline, fluoxetine (Prozac), fluvoxamine (Luvox), and sertraline (Zoloft)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Monistat, Oravig), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), 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), primidone (Mysoline), and topiramate (Qudexy, Topamax, Trokendi)
• 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, nicardipine (Cardene), nifedipine (Adalat CC, Procardia), 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)
• 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.)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, 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, chlorothiazide (Diuril), chlorthalidone, furosemide (Lasix), hydrochlorothiazide (Microzide), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), stavudine (Zerit), and tipranavir (Aptivus)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings, and hormones such as conjugated estrogens (Premarin), estradiol (Climara, Estrace, Estraderm, Vivelle), medroxyprogesterone (Depo-Provera, Provera), 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, damiana, fenugreek, garcinia, garlic, ginger, ginseng, gotu kola, green tea, gymnema, St. John’s wort, and stinging nettle
• Niacin
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), diflunisal, etodolac, 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), pioglitazone (Actos), 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.

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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.