JANUMET  XR- sitagliptin phosphate and metformin hydrochloride tablet, film coated, extended release 
Merck Sharp & Dohme Corp.

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Medication Guide
JANUMET® XR (JAN-you-met XR)
(sitagliptin and metformin hydrochloride extended-release)
Tablets

Read this Medication Guide carefully before you start taking JANUMET XR 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 XR, ask your doctor or pharmacist.

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

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

1.
Lactic Acidosis. Metformin, one of the medicines in JANUMET XR, 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 XR 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 XR.
  • 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.

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 XR:

Tell your doctor if you have ever had

Stop taking JANUMET XR 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 XR?

Who should not take JANUMET XR?

Do not take JANUMET XR if:

What should I tell my doctor before taking JANUMET XR?

Before you take JANUMET XR, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JANUMET XR may affect how well other drugs work and some drugs can affect how well JANUMET XR works.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take JANUMET XR?

What are the possible side effects of JANUMET XR?

Serious side effects have happened in people taking JANUMET XR or the individual medicines in JANUMET XR.

The most common side effects of JANUMET XR include:

Taking JANUMET XR with meals can help lessen the common stomach side effects of metformin that usually happen at the beginning of treatment. If you have unusual or sudden stomach problems, talk with your doctor. Stomach problems that start later during treatment may be a sign of something more serious.

JANUMET XR may have other side effects, including:

These are not all the possible side effects of JANUMET XR. For more information, ask your doctor or pharmacist.

Tell your doctor if you have any side effect that bothers you, is unusual, or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store JANUMET XR?

Store JANUMET XR at 68°F to 77°F (20°C to 25°C). Store in a dry place and keep cap tightly closed.

Keep JANUMET XR and all medicines out of the reach of children.

General information about the use of JANUMET XR.

Medicines are sometimes prescribed for purposes other than those listed in Medication Guides. Do not use JANUMET XR for a condition for which it was not prescribed. Do not give JANUMET XR to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about JANUMET XR. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for additional information about JANUMET XR that is written for health care professionals. For more information go to www.janumetxr.com or call 1-800-622-4477.

What are the ingredients in JANUMET XR?

Active ingredients: sitagliptin and metformin hydrochloride extended-release

Inactive ingredients:

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems.

High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary.

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

Revised: 02/2014
 
Merck Sharp & Dohme Corp.