Rx only PATIENT rNFORMATION GLUCOPHAGE® (metformin hydrochloride tablets) and GLUCOPHAGE® XR (metformin hydrochloride extended<release tablets) Read this information carefully before you start taking this medicine and eacli time you refill your prescription. There may be new Information. This Information does not take the place of your doctor's advice. Ask your doctor or pharmacist If you do not understand some of this Infonnation or If you want to know more about this medicine. What are GLUC0PHA6E and GLUCOPHAGE XR? GLUCOPHAGE and GLUCOPHAGE XR are used to treat type 2 diabetes. This Is also known as non-lnsulin-dependent diabetes mellltus. People with type 2 diabetes are not able to make enough insulin or respond nomially to the Insulin their bodies make. When this happens, sugar (glucose) builds up In the blood. This can lead to serious medical problems including kidney damage, amputations, and blindness. Diabetes is also closely linked to heart disease. The main goal of treating diabetes Is to lower your blood sugar to a normal level. High blood sugar can be lowered by diet and exercise, by a number of medicines taken by mouth, and by insulin shots. Before you take GLUCOPHAGE or GLUCOPHAGE XR, try to control your diabetes by exercise and weight loss. While you take your dlatjetes medicine, continue to exercise and follow the diet advised for your diabetes. No matter what your recommended diabetes management plan Is, studies have shown that maintaining good blood sugar control can prevent or delay complications of diabetes, such as blindness. GLUCOPHAGE and GLUCOPHAGE XR have the same active ingredient. However, GLUCOPHAGE XR works longer in your body. Both of these medicines help control your blood sugar In a number of ways. These include helping your body respond better to the Insulin It makes naturally, decreasing the amount of sugar your liver makes, and decreasing the amount of sugar your intestines absorb. GLUCOPHAGE and GLUCOPHAGE XR do not cause your body to make more insulin. Because of this, when taken alone, they rarely cause hypoglycemia (low blood sugar), and usually do not cause weight gain. However, when they are taken with a sulfonylurea or with insulin, hypoglycemia is more likely to occur, as is weight gain. WARNING: A small number of people who have taken GLUCOPHAGE have developed a serious condition called lactic acidosis. Lactic acidosis is caused by a buildup of lactic acid In the blood. This happens more often in people with kidney problems. Most people with kidney problems should not take GLUCOPHAGE or GLUCOPHAGE XR. (See "What are the side effects of GLUCOPHAGE and GLUCOPHAGE XR?") Who should not take GLUCOPHAGE or GLUCOPHAGE XR? Some conditions Increase your chance of getting lactic acidosis, or cause other problems if you take either of these medicines. Most of the conditions listed below can Increase your chance of getting lactic acidosis. Do not take GLUCOPHAGE or GLUCOPHAGE XR if you: • have kidney problems • have liver problems • have heart failure that Is treated with medicines, such as Lanoxin' (digoxin) or Lasix* (furosemide) • drink a lot of alcohol. This means you binge drink for short periods or drink all the time • are seriously dehydrated (have lost a lot of water from your body) •are going to have an x-ray procedure with Injection of dyes (contrast agents) • are going to have surgery • develop a serious condition, such as heart attack, severe infection, or a stroke • are 80 years or older and you have NOT had your kidney function tested Tell your doctor If you are pregnant or plan to become pregnant. GLUCOPHAGE and GLUCOPHAGE XR may not be right for you. Talk with your doctor about your choices. You should also discuss your choices with your doctor if you are nursing a child. Can GLUCOPHAGE or GLUCOPHAGE XR be used In children? GLUCOPHAGE has been shown to effectively lower glucose levels In children (ages 10 to 16 years) with type 2 diabetes. GLUCOPHAGE has not been studied In children younger than 10 years old. GLUCOPHAGE has not been studied In combination with other oral glucose-control medicines or Insulin in children. If you have any questions about the use of GLUCOPHAGE in children, talk with your doctor or other healthcare provider. GLUCOPHAGE XR has not been studied in children. How should I take GLUCOPHAGE or GLUCOPHAGE XR? Your doctor will tell you how much medicine to take and when to take it. You will probably start out with a low dose of the medicine. Your doctor may slowly Increase your dose until your blood sugar is better controlled. You should take GLUCOPHAGE or GLUCOPHAGE XR with meals. Your doctor may have you take other medicines along with GLUCOPHAGE or GLUCOPHAGE XR to control your blood sugar. These medicines may Include insulin shots. Taking GLUCOPHAGE or GLUCOPHAGE XR with Insulin may help you better control your blood sugar while reducing the insulin dose. Continue your exercise and diet program and test your blood sugar regularly while taking GLUCOPHAGE or GLUCOPHAGE XR. Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning nomially. There is no evidence that GLUCOPHAGE or GLUCOPHAGE XR causes harm to the liver or kidneys. Tell your doctor If you • have an Illness that causes severe vomiting, diantiea or fever, or if you drink a much lower amount of liquid than normal. These conditions can lead to severe dehydration (loss of water in your body). You may need to stop taking GLUCOPHAGE or GLUCOPHAGE XR for a short time. • plan to have surgery or an x-ray procedure with Injection of dye (contrast agent). You may need to stop taking GLUCOPHAGE (metformin hydrochloride tablets) or GLUCOPHAGE XR (metformin hydrochloride extended-release tablets) for a short time. • start to take other medicines or change how you take a medicine. GLUCOPHAGE and GLUCOPHAGE XR can affect how well other dnjgs work, and some drugs can affect how well GLUCOPHAGE and GLUCOPHAGE XR work. Some medicines may cause high blood sugar. What should I avoid while taking GLUCOPHAGE or GLUCOPHAGE XR? Do not drink a lot of alcoholic drinks while taking GLUCOPHAGE or GLUCOPHAGE XR. This means you should not binge drink for short periods, and you should not drink a lot of alcohol on a regular basis. Alcohol can increase the chance of getting lactic acidosis. What are the side effects of GLUCOPHAGE and GLUCOPHAGE XR? Lactic Acidosis. In rare eases, GLUCOPHAGE and GLUCOPHAGE XR can cause a serious side effect called lactic acidosis. This is caused by a buildup of lactic acid In your blood. This build-up can cause serious damage. Lactic acidosis caused by GLUCOPHAGE (metformin hydrochloride tablets) and GLUCOPHAGE XR (metformin hydrochloride extended-release tablets) is rare and has occurred mostly In people whose kidneys were not working nomnally. Lactic acidosis has been reported In about one in 33,000 patients taking GLUCOPHAGE over the course of a year. Although rare, if lactic acidosis does occur, it can be fatal in up to half the people who develop it. it is also important for your liver to be working nonnaliy when you take GLUCOPHAGE or GLUCOPHAGE XR. Your liver helps remove lactic acid from your blood. Make sure you tell your doctor before you use GLUCOPHAGE or GLUCOPHAGE XR if you have kidney or liver problems. You should also stop using GLUCOPHAGE or GLUCOPHAGE XR and call your doctor right away If you have signs of lactic acidosis. Lactic acidosis is a medical emergency that must be treated in a hospital. Signs of lactic acidosis are: • feeling very weak, tired, or uncomfortable • unusual muscle pain • trouble breathing • unusual or unexpected stomach discomfort • feeling cold • feeling dizzy or lightheaded • suddenly developing a slow or irregular heartbeat If your medical condition suddenly changes, stop taking GLUCOPHAGE or GLUCOPHAGE XR and call your doctor right away. This may be a sign of lactic acidosis or another serious side effect. Other Side Effects. Common side effects of GLUCOPHAGE and GLUCOPHAGE XR Include diarrhea, nausea, and upset stomach. These side effects generally go away after you take the medicine for a while. Taking your medicine with meals can help reduce these side effects. Tell your doctor if the side effects bother you a lot, last for more than a few weeks, come back after they've gone away, or start later in therapy. You may need a lower dose or need to stop taking the medicine for a short period or for good. About 3 out of every 100 people who take GLUCOPHAGE or GLUCOPHAGE XR have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time. GLUCOPHAGE and GLUCOPHAGE XR rarely cause hypoglycemia (low blood sugar) by themselves. However, hypoglycemia can happen if you do not eat enough, if you drink alcohol, or If you take other medicines to lower blood sugar. General advice about prescription medicines If you have questions or problems, talk with your doctor or other healthcare provider. You can ask your doctor or phamiacist for the infomiation about GLUCOPHAGE and GLUCOPHAGE XR that Is written for health care professionals. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use GLUCOPHAGE or GLUCOPHAGE XR for a condition for which it was not prescribed. Do not share your medicine with other people. GLUCOPHAGE' is a registered trademark of LiPHA s.a. Licensed to Bristol- Myers Squibb Company. ' Bristol-Myers Squibb Company Princeton, Nj 08543 U.S.A. 6060DIM-10 1125493A1 F5-B057B-01-01 Revised January 2001 ''Be part of something wonderfur H ONORING COMMUNITY and school leaders who make an inapact on children's lives both on and off the field is what USA WEEKEND Magazine's Ninth Annual Most Cai'ing Coach Awards, co-sponsored by CBS' Early Show, are all about. We visited with Doii Eber, coach of the Rockland County (N.Y.) Challenger League and one of last year's recipients of a Most Caring Coach Award. "The best part about the kids is that when the season starts they are so happy to play it doesn't matter whether you got an award," says Eber, who coaches 150 disabled kids. "That's irrelevant. It's just the fact that you're there." Eber, of Nanuet, N.Y., had thought playing baseball was something her son Josh, 16, who has Down's syndrome, could never do. But when she found out he could play "in such a wondei-fiil environment," she says, "it was better than a dream come true." The league will soon start its ninth season, and looking back over her eight years of coaching, Eber, 45, says her most striking memory is of a young man with Down's. "He understood the directions and would nod his head, but he really never 18 USA WEEKEND • April 6-8,2001 2000 honoree Dori Eber volunteers for a baseball league for disabled youngsters, including Tara Nowak (vrith herabove)."lt's not just coaching," Eber's nominator vi/rote. "It's caring."
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