Read the patient information that comes with GLUMETZA before you start taking this medicine and each time you refill your prescription. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. Ask your doctor or pharmacist if you do not understand some of this information or if you want to know more about this medicine.

What is the most important information I should know about GLUMETZA?

Serious side effects can happen in people taking GLUMETZA, including:

Lactic Acidosis. Metformin hydrochloride, the medicine in GLUMETZA can cause a rare, but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Stop taking GLUMETZA and call your doctor right away if you get any of the following symptoms of lactic acidosis:

feel very weak or tired
have unusual (not normal) muscle pain
have trouble breathing
have unusual sleepiness or sleep longer than usual
have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea
feel cold, especially in your arms and legs
feel dizzy or lightheaded
have a slow or irregular heartbeat
You have a higher chance for getting lactic acidosis with GLUMETZA if you:

have kidney problems. People whose kidneys are not working properly should not take GLUMETZA.
have liver problems
have congestive heart failure that requires treatments with medicines
drink a lot of alcohol (very often or short-term "binge" drinking)
get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
have certain x-ray tests with injectable dyes or contrast agent
have surgery
have a heart attack, severe infection, or stroke
What is GLUMETZA?

GLUMETZA is a prescription medicine that contains metformin hydrochloride used with diet and exercise to help control high blood sugar in adults with type2 diabetes.
GLUMETZA is not for people with type1 diabetes.
GLUMETZA is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
It is not known if GLUMETZA is safe and effective in children younger than 18years old.

Who should not take GLUMETZA?

Do not take GLUMETZA if you:

have kidney problems
are allergic to the metformin hydrochloride in GLUMETZA or any of the ingredients in GLUMETZA. See the end of this leaflet for a list of ingredients in GLUMETZA.
you are going to get an injection of dye or contrast agents for an x-ray procedure, GLUMETZA will need to be stopped for a short time. Talk to your doctor about when you should stop GLUMETZA and when you should start GLUMETZA again. See "What is the most important information I should know about GLUMETZA?"
have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in your blood or urine).
What should I tell my doctor before taking GLUMETZA?

Before you take GLUMETZA, tell your doctor if you:

have type1 diabetes. GLUMETZA should not be used to treat people with type1 diabetes.