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

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Medication Guide

JANUMET® (JAN-you-met)
(sitagliptin and 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:

You have a higher chance of getting lactic acidosis if you:

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

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?

Who should not take JANUMET?

Do not take JANUMET if:

What should I tell my doctor before taking JANUMET?

Before you take JANUMET, 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 may affect how well other drugs work and some drugs can affect how well JANUMET 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?

What are the possible side effects of JANUMET?

Serious side effects have happened in people taking JANUMET.

  • headache
  • drowsiness
  • weakness
  • dizziness
  • confusion
  • irritability
  • hunger
  • fast heart beat
  • sweating
  • feeling jittery

The most common side effects of JANUMET include:

Taking JANUMET 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 may have other side effects, including:

These are not all the possible side effects of JANUMET. 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?

Store JANUMET at 68°F to 77°F (20°C to 25°C).

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

General information about the use of JANUMET

Medicines are sometimes prescribed for purposes other than those listed in Medication Guides. Do not use JANUMET for a condition for which it was not prescribed. Do not give JANUMET 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. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for additional information about JANUMET that is written for health care professionals. For more information go to www.JANUMET.com or call 1-800-622-4477.

What are the ingredients in JANUMET?

Active ingredients: sitagliptin and metformin hydrochloride

Inactive ingredients: microcrystalline cellulose, polyvinylpyrrolidone, sodium lauryl sulfate, and sodium stearyl fumarate. The tablet film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and black iron oxide.

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.

Revised: 02/2014
 
Merck Sharp & Dohme Corp.