(ertugliflozin and metformin hydrochloride)

tablets, for oral use

 

This Medication Guide has been approved by the U.S. Food and Drug Administration. 12/2017 

 

Read this Medication Guide carefully before you start taking SEGLUROMET and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. 

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

SEGLUROMET may cause serious side effects, including: 

Lactic Acidosis. Metformin, one of the medicines in SEGLUROMET, 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.

Call your doctor 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 feel very weak or tired

you have trouble breathing

you have stomach pains, nausea or vomiting

 you have a slow or irregular heartbeat

you have unusual (not normal) muscle pain

you have unusual sleepiness or sleep longer than usual

you feel dizzy or lightheaded

 

Most people who have had lactic acidosis had other conditions that, in combination with metformin use, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with SEGLUROMET 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 a heart attack, severe infection, or stroke.

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

SEGLUROMET can have other serious side effects. See "What are the possible side effects of SEGLUROMET?" 

What is SEGLUROMET? SEGLUROMET contains 2 prescription medicines called ertugliflozin (STEGLATRO™) and metformin hydrochloride. SEGLUROMET can be used along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes who are already using ertugliflozin and metformin for treatment or who do not have control of their blood sugar on ertugliflozin or metformin alone.

SEGLUROMET is not for people with type 1 diabetes.

SEGLUROMET is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

It is not known if SEGLUROMET is safe and effective in children under 18 years of age.

 

Do not take SEGLUROMET if you: have severe kidney problems or are on dialysis.

have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine).