Warnings
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about Metformin ER tablets?
Serious side effects can happen in people taking Metformin ER tablets, including:
Lactic Acidosis. Metformin, the medicine in Metformin ER tablets, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.
Stop taking Metformin ER tablets and message your healthcare provider right away if you get any of the following symptoms of lactic acidosis:
feel very weak and 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 if you:
have kidney problems. People whose kidneys are not working properly should not take Metformin ER tablets.
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 agents.
have surgery.
have a heart attack, severe infection, or stroke.
are 80 years of age or older and have not had your kidney function tested.
Do not take Metformin ER tablets if you:
have kidney problems
have an abnormal creatinine level (not to exceed 500mg daily)
are allergic to the active ingredient metformin, in Metformin ER, or to any of the inactive ingredients in Metformin ER. Inactive ingredients include: Copovidone K25-31, Povidone, hypromelloses, hypromelloses 2208, magnesium stearate, unspecified carboxymethylcellulose sodium, microcrystalline cellulose.
are going to get an injection of dye or contrast agents for an x-ray procedure or if you are going to have surgery and not able to eat or drink much. In these situations, Metformin ER tablets will need to be stopped for a short time. Talk to your healthcare provider about when you should stop Metformin ER tablets and when you should start Metformin ER tablets again.
What should I tell my healthcare provider before taking Metformin ER tablets?
Before taking Metformin ER tablets, tell your healthcare provider if you:
have type 1 diabetes. Metformin ER tablets should not be used to treat people with type 1 diabetes.
have a history or risk for diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). Metformin ER tablets should not be used for the treatment of diabetic ketoacidosis.
have kidney problems.
have an abnormal creatinine level.
have liver problems.
have heart problems, including congestive heart failure.
are older than 80 years. If you are over 80 years old you should not take Metformin ER tablets unless your kidneys have been checked and they are normal.
drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking.
are taking insulin.
have any other medical conditions.
are pregnant or plan to become pregnant. It is not known if metformin will harm your unborn baby. If you are pregnant, talk with your healthcare provider about the best way to control your blood sugar while you are pregnant.
are breast-feeding or plan to breast-feed. It is not known if metformin passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you take Metformin ER tablets.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Medication disposal
If you no longer need your medication, the best way to dispose of most types of old, unused, unwanted, or expired medicines (both prescription and over the counter) is to drop off the medicine at a drug take back site, location, or program immediately. You can use the DEA DIVERSION CONTROL DIVISION LOOKUP to find your nearest drug disposal site.
If no drug take back sites, locations, or programs are available in your area, and there are no specific disposal instructions (such as flushing) in the medication guide or package insert, you can visit FDA- Disposal of Unused Medicines for more information or follow these simple steps to dispose of most medicines in your trash at home:
Mix medicines (liquid or pills; do not crush tablets or capsules) with an unappealing substance such as dirt, cat litter, or used coffee grounds;
Place the mixture in a container such as a sealed plastic bag;
Throw away the container in your trash at home; and
Delete all personal information on the prescription label of empty medicine bottles or medicine packaging, then trash or recycle the empty bottle or packaging.
This is only a summary of the most important information about Metformin ER
Need more information?
Ask your healthcare provider or pharmacist.
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