Important Safety Information about GLUMETZA®
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 of 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 treatment 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 a stroke
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.
- 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 are the side effects of GLUMETZA?GLUMETZA can cause serious side effects, including:
- See "What is the most important information I should know about GLUMETZA?"
- Low blood sugar (hypoglycemia). If you take GLUMETZA with another medicine that can cause low blood sugar, such as sulfonylureas or insulin, you have a higher risk of having low blood sugar. Tell your doctor if you take other diabetes medicines. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, then call your doctor.
- Symptoms of low blood sugar include:
- Rapid heartbeat
- Change in vision
- Change in mood
Common side effects of GLUMETZA include:
- Upset stomach or stomach pain
Taking GLUMETZA with your evening meal can help lessen the common stomach side effects of metformin that usually happens at the beginning of treatment. If you have unexplained stomach problems, tell your doctor. Stomach problems that start later, during treatment may be a sign of something more serious.
Tell your doctor if these symptoms return, as they may be symptoms of lactic acidosis.
Tell your doctor if you have side effects that bother you or that do not go away.
These are not all of the possible side effects of GLUMETZA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Learn more about how to take GLUMETZA.