What Glucophage XR is used for and how to use it
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Glucophage XR - Consumer Medicine Information

Manufacture: Bristol-Myers Squibb
Country: United States
Condition: Diabetes, Type 2
Class: Non-sulfonylureas
Form: Tablets
Ingredients: metformin hydrochloride, sodium carboxymethyl, ellulose, hypromellose, microcrystalline cellulose, magnesium stearate

Gglucophage
(metformin hydrochloride) Tablets

and

Gglucophage XR
(metformin hydrochloride) Extended-Release Tablets

What are Gglucophage and Gglucophage XR

Gglucophage and Gglucophage XR are used to treat type 2 diabetes. This is also known as non-insulin-dependent diabetes mellitus. People with type 2 diabetes are not able to make enough insulin or respond normally 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 Gglucophage or Gglucophage XR, try to control your diabetes by exercise and weight loss. While you take your diabetes 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.

Gglucophage and Gglucophage XR have the same active ingredient. However, Gglucophage 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. Gglucophage and Gglucophage 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 Gglucophage 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 Gglucophage or Gglucophage XR. (See "What are the side effects of Gglucophage and Gglucophage XR?")

Who Should Not Take Gglucophage or Gglucophage 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 Gglucophage or Gglucophage 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. Gglucophage and Gglucophage 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 Gglucophage or Gglucophage XR be Used in Children

Gglucophage has been shown to effectively lower glucose levels in children (ages 10-16 years) with type 2 diabetes. Gglucophage has not been studied in children younger than 10 years old. Gglucophage 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 Gglucophage in children, talk with your doctor or other healthcare provider.

Gglucophage XR has not been studied in children.

How Should I take Gglucophage or Gglucophage 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 Gglucophage or Gglucophage XR with meals.

Your doctor may have you take other medicines along with Gglucophage or Gglucophage XR to control your blood sugar. These medicines may include insulin shots. Taking Gglucophage or Gglucophage 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 Gglucophage or Gglucophage 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 normally. There is no evidence that Gglucophage or Gglucophage XR causes harm to the liver or kidneys.

Tell your doctor if you:

  • have an illness that causes severe vomiting, diarrhea 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 Gglucophage or Gglucophage 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 Gglucophage or Gglucophage XR for a short time.
  • start to take other medicines or change how you take a medicine. Gglucophage and Gglucophage XR can affect how well other drugs work, and some drugs can affect how well Gglucophage and Gglucophage XR work. Some medicines may cause high blood sugar.

Gglucophage XR must be swallowed whole and never crushed or chewed. Occasionally, the inactive ingredients of Gglucophage XR may be eliminated as a soft mass in your stool that may look like the original tablet; this is not harmful and will not affect the way Gglucophage XR works to control your diabetes.

What Should I Avoid While Taking Gglucophage or Gglucophage XR

Do not drink a lot of alcoholic drinks while taking Gglucophage or Gglucophage 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 Gglucophage and Gglucophage XR

Lactic Acidosis

In rare cases, Gglucophage and Gglucophage XR can cause a serious side effect called lactic acidosis. This is caused by a buildup of lactic acid in your blood. This buildup can cause serious damage. Lactic acidosis caused by Gglucophage and Gglucophage XR is rare and has occurred mostly in people whose kidneys were not working normally. Lactic acidosis has been reported in about one in 33,000 patients taking Gglucophage 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 normally when you take Gglucophage or Gglucophage XR. Your liver helps remove lactic acid from your blood.

Make sure you tell your doctor before you use Gglucophage or Gglucophage XR if you have kidney or liver problems. You should also stop using Gglucophage or

Gglucophage 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 Gglucophage or Gglucophage 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 Gglucophage and Gglucophage 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 Gglucophage or Gglucophage XR have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time.

Gglucophage and Gglucophage 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 pharmacist for the information about Gglucophage and Gglucophage XR that is written for healthcare professionals. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Gglucophage or Gglucophage XR for a condition for which it was not prescribed. Do not share your medicine with other people.

Distributed by

Bristol-Myers Squibb Company

Princeton, NJ 08543 USA

1125493A9