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

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1 Medication Guide ® XR (JA N- you-met XR) JANUMET -release) (sitagliptin and metformin hydrochloride extended Tablets this Medication before you start taking JANUMET XR and each time you get a refill. carefully Guide Read does not take the place of talking with your doctor about This information There may be new information. your medical condition any questions about JANUMET XR, ask your doctor or your treatment. If you have or pharmacist. XR? What is the most important information I should know about JA NUMET XR NUMET , including: Serious side effects can happen in people taking JA Metformin, 1. Lactic in JANUMET XR, can cause a rare but serious Acidosis. one of the medicines called condition acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic lactic acidosis is a medical emergency and must be treated in the hospital. taking JANUMET doctor right away if you get any of the following Stop XR and call your 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 kidney s are not working properly should not take XR. JANUMET have liver problem s.   have congestive heart failure that re quires treatment with medicines. drink alcohol very often, or drink a lot of alcohol in short- term “binge” drinking.  amount of body fluids). (lose a large  This can happen if you are sick with a fever, get dehydrated or diarrhea. you sweat a can also happen when vomiting, lot with activity or exercise Dehydration and do not drink enough fluids. have certain x -ray tests with dy es or contrast agents that are injected into y our body .   have surgery .  have a heart attack, severe infection, or stroke. is be severe and lead to death. 2. Pancreatit (inflammation of the pancreas) which may Certain medical problems make y ou more likely to get pancreatitis. Before you start taking JA NUMET XR: Tell y ou have ever had our doctor if y  pancreatitis  stones in y our gallbladder ( gallstones)  a history of alcoholism  high blood trigly ceride levels Stop taking JANUMET XR and call your doctor right away if you have pain in your stomach area (abdomen) and will not go away. The pain may be felt going from your abdomen through to that is severe your back. The pain may happen with or without vom iting. These may be sy mptoms of pancreatitis. Reference ID: 3453495

2 What is JA NUMET XR? JANUMET medicine that contains 2 prescription diabetes medicines,  XR is a prescription ® ) and extended metformin hydrochloride. JANUMET XR can be -release (JANUVIA sitagliptin pe 2 diabetes. used along with diet and exercise to lower blood sugar in adults with ty JANUMET XR is not for people with ty pe 1 diabetes.  JANUMET XR is not for people with diabetic ketoacidosis (increased ketones in your blood or  urine). had pancreatitis (inflammation of the pancreas) in the past, it is not known if you  If you have XR. ou take JANUMET have a higher chance of getting pancreatitis while y It is not known if JANUMET XR is safe and effective when used in children under 18 y ears  of age. NUMET XR? Who should not take JA Do not take JA NUMET XR if:  your kidney s are not working properly .  you are allergic to any of the ingredients in JANUMET XR. See the end of this Medication Guide XR. for a complete list of ingredients in JANUMET include: Symptoms of a serious allergic reaction to JANUMET XR may rash  raised red patches on y our skin (hives)  swelling of the face,  and throat that may cause difficulty in breathing or lips, tongue, swallowing you have diabetic ketoaci  What is JA NUMET XR? ". dosis. See " What should I tell my doctor before taking JA XR? NUMET NUMET Before you take JA XR, tell your doctor if you:  have or have had inflammation of y our pancreas (pancreatitis).  problems. have kidney  have liver problem s.  have hea rt problems, including congestive heart failure.  often, or drink a lot of alcohol in short- term “binge” drinking. drink alcohol very are going to get an injection of dye or contrast agents for an x XR will  -ray procedure; JANUMET for a short time. Talk about when you should stop to be stopped to your doctor need you should JANUMET JANUMET XR again. See “ What is the most XR and when start NUMET XR? important information I should know about JA ”.  have any other medical conditions. pregnant. It is not known if JANUMET XR will harm your unborn  are pregnant or plan to become talk with your doctor about the best way to control your blood baby. If you are pregnant, sugar while y ou are pregnant. Pregnancy Registry: If you take JANUMET XR at any time during your pregnan cy, talk with your doctor about how you can join the JANUMET XR pregnancy registry . The purpose of this registry is to collect about the health of you and your baby. You can enroll in this information by calling 1- registry 800- 986- 8999. are breast -feeding  -feed. It is not known if JANUMET XR will pass into your or plan to breast breast milk. Talk with your doctor about the best way to feed your baby if you are taking JANUMET XR. your doctor about all the medicines Tell take , including prescription and non-prescription you medicines, vitam ins, and herbal supplements. JANUMET XR may affect how well other drugs work and some drugs can affect how well JANUMET XR works. 2 Reference ID: 3453495

3 acist Know Keep a list of your medicines and show it to your doctor and pharm you take. the medicines when y ou get a new m edicine. How should I take JA NUMET XR?  Take JANUMET XR exactly as your doctor tells you. Your doctor will tell you how many XR tablets to take and when y ou should take them. JANUMET Your doctor may change y XR if needed.  our dose of JANUMET other doctor Your XR along with certain may tell you to take diabetes medicines.  JANUMET (hypogly cemia) can happen more often when JANUMET XR is taken with Low blood sugar diabetes other See " What are the possible side effects of certain medicines. ". XR? JANUMET Take JANUMET XR 1 time each  your chance of having an day with a meal to help to lower our evening m eal. upset stomach. It is better to take JANUMET XR with y dissolve, XR tablets whole. Do not break, cut, crush, JANUMET or chew JANUME T XR  Take before swallowing . I f you cannot swallow JANUMET XR tablets whole , tell y our doctor. tablets You that looks like the JANUMET XR tablet in your stool (bowel  may see something our docto r. Do not stop taking movement). If you see tablets in y our stool several times, talk to y our doctor. JANUMET XR without talking to y  XR as long as y our doctor tells y ou. Continue to take JANUMET If you take too much JANUMET XR, call y our doctor or local Poison Control Center right away .  If you miss a dose, take it with foo d as soon as y ou remember. If y ou do not remember until it is  our next dose, skip the missed dose and go back to y time for y our regular schedule. Do not take 2 doses of JANUMET XR at the same time. You may need to stop taking JANUMET XR for a short time. Call your doctor for instructions if  you:  are dehydrated (have lost too much body fluid). Dehydration if you are sick can occur with severe vom iting, diarrhea or fever, or if y ou drink a lot less fluid than normal.  plan to have surgery .  to get an injection of dye or contrast agent for an x- ray procedure. See " What are going important information know about JANUMET XR? " and " What is the most I should XR?”. NUMET should I tell my doctor before taking JA When your body is under some types of stress, such as feve r, trauma (such as a car accident),  , the amount of diabetes medicine that you need may change. Tell your infection or surgery if you have any of these problems and follow y our doctor’s instructions. doctor right away our blood sugar as y  our doctor tells you to. Check y XR.  Stay on your prescribed diet and exercise program while taking JANUMET Talk to your doctor about how to prevent, recognize and manage low blood  sugar (hypogly high blood sugar (hypergly cemia), and problems you have because of your cemia), diabetes.  Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and y our hemoglobin A1C. s are working will do blood tests to check how well your kidney doctor before and during  Your XR. your treatment with JANUMET NUMET XR? What are the possible side effects of JA XR or the individual side have happened in people taking JANUMET effects medicines in Serious JANUMET XR.  See " What is the most important information I should know about JA NUMET XR? ". If you take  blood sugar (hypog lycemia). Low JANUMET XR with another medicine that can cause low blood sugar, such as a sulfony lurea or insulin, your risk of getting low blood sugar is while higher. of your sulfony lurea medicine or insulin may need to be lowered The dose you use JANUMET XR. Signs and sy mptoms of low blood sugar may include: 3 Reference ID: 3453495

4   irritability headache drowsiness hunger   weakness  fast heart beat  dizziness sweating   confusion  feeling jittery  Serious reactions. If you have any symptoms of a serious allergic reacti on, stop taking allergic  our doctor right away . See " Who should not take JA NUMET XR? ". Your XR and call y JANUMET may give you a medicine for your allergic reaction and prescribe a different medicine for doctor your diabetes.  Kidney problems, sometimes requiring dia lysis. XR include: The most common side effects of JANUMET stuffy or runny nose and sore throat  upper respiratory infection  diarrhea   nausea and vomiting  gas, upset stomach, indigestion weakness  headache  medications, sugar (hypogly cemia) when used in combina tion with certain  such as low blood lurea or insulin. a sulfony 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. XR may have other side effects, including: JANUMET  swelling Swelling of the hands and legs can happen if you take or legs. of the hands ® ). Rosiglitazone is another type of (Avandia JANUMET with rosiglitazone XR in combination diabetes medicine. are not all the possible side effects of JANUMET XR. For more information, ask your doctor These or pharmacist. our doctor if y side effect that bothers y ou, is unusual, or does not go away . Tell y ou have any for medical advice about side effects. You may report Call your doctor to FDA at 1- 800- FDA- side effects 1088. NUMET XR? How should I store JA Store JANUMET Store i n a dry place and keep cap tightly closed. XR at 68°F to 77°F (20°C to 25°C). Keep JA NUMET XR and all medicines out of the reach of children. General information about the use of JA NUMET XR. are sometimes Do not for purposes other than those listed in Medication Guides. Medicines prescribed use JANUMET XR for a condition it was not prescribed. Do not give JANUMET XR to other for which have the same sy mptoms y ou have. It may harm them. people, even if they This Medication Guide summariz es the most important information about JANUMET XR. If you would like to know talk with your doctor. You can ask your doctor or pharmacist for additional more information, information about JANUMET XR that is written for health care professionals. For more information go to www.janum etxr.com or call 1 -800- 622- 4477. What are the ingredients in JA NUMET XR? 4 Reference ID: 3453495

5 Active ingredients: sitagliptin and m drochloride extended -release etformin hy Inactive ingredients:  of JANUMET XR Tablets contain : povidone, hypromellose, colloidal silicon dioxide, All doses l fumar ate, propy l gallate, polyethylene glycol, and kaolin. Film coating contains steary sodium droxy hypromellose, hy l cellulose, titanium dioxide, FD&C #2/Indigo Carmine Aluminum Lake propy and carnauba wax. NUMET XR 50 mg/500 mg Tablets also contain: mi crocrystalline cellulose.  In addition the JA  In addition the JA NUMET XR 50 mg/1000 mg Tablets also contain: ye llow iron oxide. What is type 2 diabetes? Type 2 diabetes is a condition your body does not make enough insulin, and the insulin that your in which does body can also make too much sugar. as well as it should. Your body produces When this not work 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. Manufactured by : of Merck Sharp & Dohme Corp., a subsidiary Merck & Co ., Inc. , W hitehouse Station, NJ 08889, USA OR Patheon Inc., W hitby, Ontario, Canada L1 N 5Z5 For patent information: www.merck.com/product/patent/home.html The trademarks depicted herein are owned by their respective companies. Copyright © 2012 Merck Sharp & Dohme Corp., a subsidiary Merck & Co., Inc. of All rights reserved. Revised: 02/2014 usmg -mk0431a -xrt-xxxxr xxx 5 Reference ID: 3453495

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