nformed of the potential need to adjust dose based on changes in renal function tests over time.
SPL UNCLASSIFIED SECTION
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MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
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uspi-mk0431-t-1701r018
MEDICATION GUIDE
Medication Guide
JANUVIA® (jah-NEW-vee-ah)
(sitagliptin)
Tablets
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 01/2017
Read this Medication Guide carefully before you start taking JANUVIA 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 JANUVIA, ask your doctor or pharmacist.
What is the most important information I should know about JANUVIA?
Serious side effects can happen in people taking JANUVIA, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.
Before you start taking JANUVIA:
Tell your doctor if you have ever had
pancreatitis
high blood triglyceride levels
stones in your gallbladder (gallstones)
kidney problems
a history of alcoholism
Stop taking JANUVIA 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 JANUVIA?
JANUVIA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
JANUVIA is not for people with type 1 diabetes.
JANUVIA is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
If you have had pancreatitis (inflammation of the pancreas) in the past, it is not known if you have a higher chance of getting pancreatitis while you take JANUVIA.
It is not known if JANUVIA is safe and effective when used in children under 18 years of age.
Who should not take JANUVIA?
Do not take JANUVIA if:
you are allergic to any of the ingredients in JANUVIA. See the end of this Medication Guide for a complete list of ingredients in JANUVIA.
Symptoms of a serious allergic reaction to JANUVIA may include rash, raised red patches on your skin (hives), or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
What should I tell my doctor before taking JANUVIA?
Before you take JANUVIA, tell your doctor if you:
have or have had inflammation of your pancreas (pancreatitis).
have kidney problems.
have any other medical conditions.
are pregnant or plan to become pregnant. It is not known if JANUVIA will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
Pregnancy Registry: If you take JANUVIA at any time during your pregnancy, talk with your doctor about how you can join the JANUVIA pregnancy registry. The purpose of this registry is to collect information about the health of you and your baby. You can enroll in this registry by calling 1-800-986-8999.
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