Xigduo® Xr

Lactic Acidosis. Metformin, one of the medicines in XIGDUO XR, can cause a rare but serious condition called lactic acidosis (a build-up 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 XIGDUO XR and call your healthcare provider right away if you have any of the following symptoms, which could be signs of lactic acidosis:
– you feel cold in your hands or feet
– you have unusual (not normal) muscle pain
– you feel dizzy or lightheaded
– you have trouble breathing
– you have a slow or irregular heartbeat
– you feel unusual sleepiness or sleep longer than usual
– you feel very weak or tired
– you have stomach pains, nausea or vomiting

Most people who have had lactic acidosis with metformin have other things that, combined with the metformin use, led to the lactic acidosis. Tell your healthcare provider if you have any of the following, because you have a higher chance for getting lactic acidosis with XIGDUO XR if you:
– have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye
– have liver problems
– drink alcohol very often or drink a lot of alcohol in the 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 surgery
– have new or worsening symptoms of congestive heart failure such as shortness of breath or increased fluid or swelling of the legs
– have a heart attack, severe infection, or stroke
– are 65 years of age or older

The best way to keep from having a problem with lactic acidosis from metformin is to tell your healthcare provider if you have any of the problems in the list above. Your healthcare provider may decide to stop your XIGDUO XR for a while if you have any of these things.

Diabetic Ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. XIGDUO XR can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery or a procedure that requires not having food for a long time (prolonged fasting). Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood.

Stop taking XIGDUO XR and call your healthcare provider or get medical help right away if you get any of the following. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL:
– nausea
– tiredness
– vomiting
– trouble breathing
– stomach area (abdominal) pain
– ketones in your urine or blood

XIGDUO XR can have other serious side effects. See “What are the possible side effects of XIGDUO X