Metformin Important Safety Information | WW USA

Important Metformin Safety Information

Most Important Safety Information

Metformin hydrochloride, the medicine in Metformin 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. Discontinue use immediately and notify your healthcare provider if unexplained hyperventilation, myalgias, malaise, unusual somnolence, or other nonspecific symptoms occur. Patients should avoid excessive alcohol intake while taking Metformin.

What is the FDA-approved use of Metformin?

Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Limitations of Use:

• Metformin is not recommended for the treatment of type 1 diabetes or diabetic ketoacidosis.

What should I tell my provider before using Metformin?

Drugs you are taking. It’s important to tell your provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Your entire medical history. In particular, tell your provider if you have a past history of:

• Type 1 diabetes
• Metabolic acidosis, lactic acidosis or diabetic ketoacidosis
• Liver disease or decreased liver function
• Kidney disease or decreased kidney function
• Heart disease or congestive heart failure
• Older than 65 years old
• Taking insulin
• Drink alcohol very often or “binge” drink.

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 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 provider about the best way to feed your baby while you take Metformin.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What drug interactions do I need to be aware of?

While this list is not a complete list, some medications to watch out for include:

• Insulin
• Carbonic Anhydrase Inhibitors
• Alcohol
• Other products for weight loss, including dietary supplements

Metformin tablets may affect the way other medicines work, and other medicines may affect how Metformin tablets work. Please make sure your prescriber is aware of all the medications you are taking.

What are the side effects that I should monitor for when taking Metformin?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These common side effects that can occur with Metformin: 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 healthcare provider 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 Metformin tablets have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time.

Metformin tablets 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.

These are the most serious side effects that can occur with Metformin.

Lactic Acidosis. Metformin, the medicine in Metformin 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 tablets and call 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.
• 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.

You are encouraged to report negative side effects of prescription products:

• Contact FDA MedWatch at 1-800-FDA-1088 or visit fda.gov/medwatch

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.