JANUVIA - sitagliptin tablet, film coated
Physicians Total Care, Inc.
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Medication Guide
JANUVIA ® (jah-NEW-vee-ah)
(sitagliptin)
Tablets
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
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?
Who should not take JANUVIA?
Do not take JANUVIA if:
What should I tell my doctor before taking JANUVIA?
Before you take JANUVIA, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
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 JANUVIA?
What are the possible side effects of JANUVIA?
Serious side effects have occurred in people taking JANUVIA.
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The most common side effects of JANUVIA include:
JANUVIA may have other side effects, including:
These are not all the possible side effects of JANUVIA. 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 JANUVIA?
Store JANUVIA at 68°F to 77°F (20°C to 25°C).
Keep JANUVIA and all medicines out of the reach of children.
General information about the use of JANUVIA
Medicines are sometimes prescribed for purposes that are not listed in Medication Guides. Do not use JANUVIA for a condition for which it was not prescribed. Do not give JANUVIA 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 JANUVIA. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for additional information about JANUVIA that is written for health professionals. For more information, go to www.JANUVIA.com or call 1-800-622-4477.
What are the ingredients in JANUVIA?
Active ingredient: sitagliptin
Inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate. The tablet film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow 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.
JANUVIA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Avandia® is a registered trademark of GlaxoSmithKline.
Copyright © 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved
Revised February 2010
Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
Manufactured by:
Merck Sharp & Dohme (Italia) S.p.A.
Via Emilia, 21
27100 – Pavia, Italy
9984400
This Medication Guide has been approved by the U.S. Food and Drug Administration.