In the U.S.—

In Canada—

• Antidiabetic agent

Rosiglitazone and metformin (ROS-e-glit-a-zone and met-FOR-min ) combination is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store the excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future. Proper diet is the first step in managing type 2 diabetes but often medicines are needed to help your body. Rosiglitazone helps your body use the insulin better and it reduces the amount of insulin in your body. Metformin reduces the absorption of sugar, reduces the release of stored sugar from the liver, and helps your body's cells use sugar better.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Tablets (U.S.)
• Tablets (Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For rosiglitazone and metformin combination the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to rosiglitazone, metformin or any other ingredients in the medicine. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Rosiglitazone and metformin combination has not been studied in pregnant women or animals. It is easier during pregnancy to control your blood sugar by using injections of insulin rather than by taking oral diabetes medicines. Close control of your blood sugar can reduce the chance of your baby gaining too much weight, having birth defects, or having high blood sugar before birth. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether rosiglitazone or metformin passes into human breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of rosiglitazone and metformin in children with use in other age groups.

Older adults—Some older adults may be more sensitive than younger adults to the effects of these medicines. Older adults are more likely to have age-related problems such as kidney problems. Rosiglitazone and metformin should be used carefully as age increases and older adults may need a lower dose of this medicine.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking rosiglitazone and metformin, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Alcohol—Drinking alcohol may increase the risk of developing lactic acidosis and/or very low blood sugar.

• Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol [e.g., Tenoretic, Tenormin], betaxolol [e.g., Kerlone], Bisoprolol [e.g., Zebeta, Ziac], carteolol [e.g., Cartrol], carvedilol [e.g., Coreg], labetalol [e.g., Normodyne], metoprolol [e.g., Lopressor, Toprol], nadolol [e.g., Corgard, Corzide], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal, Inderide], sotalol [e.g., Betapace, Sorine], timolol [e.g., Blocadren, Timolide])—Beta-adrenergic blocking agents can hide the symptoms of low blood sugar (hypoglycemia). Because of this, a person with diabetes might not recognize that he or she has low blood sugar and might not take immediate steps to treat it.

• Amiloride (e.g., Midamor) or
• Cimetidine (e.g., Tagamet) or
• Digoxin (e.g., Lanoxin) or
• Morphine (e.g., MS Contin) or
• Procainamide (e.g., Procanbid, Pronestyl) or
• Quinidine (e.g., Quinaglute, Quinidex) or
• Quinine (malaria medicine) or
• Ranitidine (e.g., Zantac) or
• Triamterene (e.g., Dyrenium) or
• Trimethoprim (e.g., Proloprim) or
• Vancomycin (e.g., Vancocin)—Using these medicines with rosiglitazone and metformin may cause there to be too much rosiglitazone and metformin in your body. This may increase the chance of low blood sugar or other side effects.

• Furosemide (e.g., Lasix)—Using this medicine with rosiglitazone and metformin may cause there to be too much metformin in your body and a lower dose of rosiglitazone and metformin may be needed.

• Adrenal glands, not properly controlled or
• Alcohol intoxication or
• Caloric intake, deficient (not enough calories) or
• Elderly patients or
• Undernourished condition or
• Underactive pituitary gland, not properly controlled or
• Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking a medication that contains rosiglitazone and metformin.

• Dehydration (not enough water in your body) or
• Heart attack or
• Sepsis (serious illness due to a bacterial infection) or
• Shock—These conditions can cause serious problems; if they happen you should stop taking this medicine as soon as possible

• Diabetic ketoacidosis (ketones in the blood) or
• Lactic acidosis (lactic acid in the blood) or
• Metabolic acidosis (extra acids in the blood)—Patients with any of these conditions should not use this medicine

• Edema—Patients with this condition should use this medicine with caution; use of this medicine can increase the risk of serious side effects in these patients

• Fever or
• Infection or
• Surgery or
• Trauma — These conditions may cause temporary problems with blood sugar control and your healthcare professional may want to treat you temporarily with insulin.

• Heart failure, congestive—Patients with this condition should not use this medicine.

• Jaundice—Patients with this condition should use this medicine with caution; use of this medicine can increase the risk of serious side effects in these patients.

• Kidney disease—Patients with this condition should not use this medicine

• Kidney, heart, or other problems that require medical tests or examinations that use certain medicines called contrast agents, with x-ray exams—Because this medicine contains metformin, your doctor should advise you to stop taking it before you have any medical exams or diagnostic tests that might cause less urine output than usual; you may be advised to start taking the medicine again 48 hours after the exams or tests if your kidney function is tested and found to be normal.

• Liver function, impaired—Patients with impaired liver condition generally should not use this medicine

• Surgery—Use of this medicine should be suspended during surgical procedures (except for minor surgical procedures); you can take your medicine again after your healthcare professional makes sure your kidneys are normal

• Type 1 diabetes—Patients with this condition should not use this medicine

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Rosiglitazone and metformin combination should be taken with meals to help reduce the stomach and intestinal side effects that may occur while you are taking this medicine.

You may notice improvement in your blood glucose control in 1 to 2 weeks but the full effect of blood glucose control may take up to 2 to 3 months. Ask your healthcare professional if you have any questions about this.

Dosing—

The dose of rosiglitazone and metformin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of rosiglitazone and metformin. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For type 2 diabetes:
    • For patients on metformin therapy
      • Adults: Oral, 4 milligrams (mg) rosiglitazone plus the dose of metformin already being taken. Your doctor may gradually increase your dose until your blood sugar is controlled.
      • Children: Use and dose must be determined by your doctor.
    • For patients on rosiglitazone therapy:
      • Oral, 1000 milligrams (mg) of metformin plus the dose of rosiglitazone already being taken. Your doctor may gradually increase your dose until your blood sugar is controlled.
      • Children: Use and dose must be determined by your doctor.
    • For patients previously treated with rosiglitazone and metformin:
      • Adults: Oral, the dose is the same as the dose you are already taking. Your doctor may gradually increase your dose until your blood sugar is controlled.
      • Children: Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check you at regular visits to check your blood sugar control, and to check your kidneys and liver.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines unless they have been discussed with your doctor.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of life-style changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Under certain conditions, too much rosiglitazone and metformin can cause lactic acidosis. Symptoms of lactic acidosis are severe and quick to appear and usually occur when other health problems not related to the medicine are present and are very severe, such as a heart attack or kidney failure. Symptoms of lactic acidosis include abdominal or stomach discomfort; decreased appetite; diarrhea; fast, shallow breathing; general feeling of discomfort; muscle pain or cramping; and unusual sleepiness, tiredness, or weakness.

If symptoms of lactic acidosis occur, you should check your blood sugar and get immediate emergency medical help.

Symptoms of hypoglycemia (low blood sugar) include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

Rosiglitazone and metformin combination can cause low blood sugar. However, it also can occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take rosiglitazone and metformin with another type of diabetes medicine. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, nondiet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it.

Symptoms of hyperglycemia (high blood sugar) include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and volume); ketones in urine; loss of appetite; sleepiness; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

High blood sugar may occur if you do not exercise as much as usual, have a fever or infection, do not take enough or skip a dose of your diabetes medicine, or overeat or do not follow your meal plan.

If symptoms of high blood sugar occur, check your blood sugar level and then call your health care professional for instructions.

Tell your healthcare provider right away if you have any of these symptoms:chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, shortness of breath, swelling of your face, fingers, feet or lower legs, weight gain and wheezing.

It is important to tell your healthcare professional that you are taking this medicine if you are going to have certain medical procedures or surgical procedures.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• More common
  • Pale skin;  troubled breathing with exertion ;  unusual bleeding or bruising;  unusual tiredness or weakness 
  
  

• Less common
  • Anxiety;  blurred vision;  chest pain or discomfort;  chills;  cold sweats;  coma;  confusion;  cool pale skin;  depression;  dilated neck veins;  dizziness;  extreme fatigue;  fast heartbeat;  headache;  increased hunger;  irregular breathing;  irregular heartbeat;  nausea;  nervousness;  nightmares;  seizures;  shakiness;  shortness of breath;  slurred speech;  swelling of face, fingers, feet, or lower legs;  weight gain;  wheezing 
  
  

• Rare
  • Abdominal discomfort;  decreased appetite ;  diarrhea;  fast, shallow breathing;  general feeling of discomfort;  muscle pain or cramping;  sleepiness  
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Body aches or pain;  cough, fever, sneezing, or sore throat;  difficulty in breathing;  ear congestion;  fever;  loss of voice;  nasal congestion;  pain or tenderness around eyes and cheekbones;  stuffy or runny nose;  tightness of chest 
  
  

• Less common
  • Back pain;  cold or flu-like symptoms ;  difficulty in moving;  pain in joints 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.