Medication Guide

JANUMET® (JAN-you-met)
(sitagliptin/metformin hydrochloride)

Tablets

Read this Medication Guide carefully before you start taking JANUMET 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. If you have any questions about JANUMET, ask your doctor or pharmacist.

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

Serious side effects can happen in people taking JANUMET, including:

1. Lactic Acidosis. Metformin, one of the medicines in JANUMET, can cause a rare but serious condition 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 the hospital.

Stop taking JANUMET and call your doctor right away if you get any of the following symptoms, which could be signs of lactic acidosis.

You:

feel very weak or tired.
have unusual (not normal) muscle pain.
have trouble breathing.
have unusual sleepiness or sleep longer than usual.
have sudden 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 JANUMET.
have liver problems.
have congestive heart failure that requires treatment with medicines.
drink alcohol very often, or drink a lot of alcohol in 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 dyes or contrast agents that are injected into your body.
have surgery.
have a heart attack, severe infection, or stroke.
are 80 years of age or older and have not had your kidneys tested.
2. Pancreatitis (inflammation of the pancreas) which may be severe and lead to death.

Certain medical problems make you more likely to get pancreatitis.

Before you start taking JANUMET:

Tell your doctor if you have ever had

pancreatitis
stones in your gallbladder (gallstones)
a history of alcoholism
high blood triglyceride levels
Stop taking JANUMET and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

What is JANUMET?

JANUMET is a prescription medicine that contains two prescription diabetes medicines, sitagliptin (JANUVIA®) and metformin. JANUMET can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
JANUMET is not for people with type 1 diabetes.
JANUMET is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
If you have h