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AVANDAMET

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• Do not keep outdated medicine or medicine no longer needed.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.

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