1.

Lactic Acidosis. Metformin, one of the medicines in JANUMET XR, can cause a rare but serious condition called lactic acidosis (a buildup of an 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 have any of the following symptoms, which could be signs of lactic acidosis:

• you feel cold in your hands or feet
• you feel dizzy or lightheaded
• you have a slow or irregular heartbeat
• you feel very weak or tired
• you have unusual (not normal) muscle pain
• you have trouble breathing
• you feel sleepy or drowsy
• you have stomach pains, nausea or vomiting

Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with JANUMET XR if you:

• have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye
• have liver problems
• 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 surgery
• have a heart attack, severe infection, or stroke
• are 65 years of age or older

The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your JANUMET XR for a while if you have any of these things.

JANUMET XR can have other serious side effects. See "What are the possible side effects of JANUMET XR?"

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:

 

• pancreatitis
• stones in your gallbladder (gallstones)
• a history of alcoholism
• high blood triglyceride levels

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.

3.

Heart failure. Heart failure means that your heart does not pump blood well enough.

• increasing shortness of breath or trouble breathing, especially when you lie down
• swelling or fluid retention, especially in the feet, ankles or legs
• an unusually fast increase in weight
• unusual tiredness

• JANUMET XR is a prescription medicine that contains 2 prescription diabetes medicines, sitagliptin (JANUVIA) and extended-release metformin hydrochloride. JANUMET XR can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
• JANUMET XR is not for people with type 1 diabetes.
• 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 JANUMET XR.
• The safety and effectiveness of JANUMET XR have not been established in pediatric patients.

• have severe kidney problems.
• have diabetic ketoacidosis.
• are allergic to any of the ingredients in JANUMET XR. See the end of this Medication Guide for a complete list of ingredients in JANUMET XR.

Symptoms of a serious allergic reaction to JANUMET XR 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.

• have or have had inflammation of your pancreas (pancreatitis).
• have kidney problems.
• have liver problems.
• have heart failure.
• drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking.
• are going to get an injection of dye or contrast agents for an x-ray procedure. JANUMET XR may need to be stopped for a short time. Talk to your doctor about when you should stop JANUMET XR and when you should start JANUMET XR again. See "What is the most important information I should know about JANUMET XR?".
• have low levels of vitamin B12 in your blood.
• are pregnant or plan to become pregnant. It is not known if JANUMET XR 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.
• are breastfeeding or plan to breastfeed. It is not known if JANUMET XR will pass into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking JANUMET XR.
• are a woman who has not gone through menopause (premenopausal) who does not have periods regularly or at all. JANUMET XR can cause the release of an egg from an ovary in a woman (ovulation). This can increase your chance of getting pregnant. Tell your doctor right away if you become pregnant while taking JANUMET XR.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. JANUMET XR may affect the way other medicines work and other medicines may affect how 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.

• Take JANUMET XR exactly as your doctor tells you. Your doctor will tell you how many JANUMET XR tablets to take and when you should take them.
• Your doctor may change your dose of JANUMET XR if needed.
• Your doctor may tell you to take JANUMET XR along with certain other diabetes medicines. Low blood sugar (hypoglycemia) can happen more often when JANUMET XR is taken with certain other diabetes medicines. See "What are the possible side effects of JANUMET XR?".
• Take JANUMET XR 1 time each day with a meal to help to lower your chance of having an upset stomach. It is better to take JANUMET XR with your evening meal.
• Take JANUMET XR tablets whole. Do not break, cut, crush, or chew JANUMET XR tablets before swallowing. If you cannot swallow JANUMET XR tablets whole, tell your doctor.
• You may see something that looks like the JANUMET XR tablet in your stool (bowel movement). If you see tablets in your stool several times, talk to your doctor. Do not stop taking JANUMET XR without talking to your doctor.
• Continue to take JANUMET XR as long as your doctor tells you.
• If you take too much JANUMET XR, call your doctor or local Poison Control Center right away.
• If you miss a dose, take it with food as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your 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 can occur if you are sick with severe vomiting, diarrhea or fever, or if you drink a lot less fluid than normal.
  • plan to have surgery.
  • are going to get an injection of dye or contrast agent for an x-ray procedure. See "What is the most important information I should know about JANUMET XR?" and "What should I tell my doctor before taking JANUMET XR?".
• When your body is under some types of stress, such as fever, trauma (such as a car accident), infection or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these problems and follow your doctor's instructions.
• Check your blood sugar as your doctor tells you to.
• Stay on your prescribed diet and exercise program while taking JANUMET XR.
• Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of your diabetes.
• Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
• Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with JANUMET XR.

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

• All doses of JANUMET XR Tablets contain: povidone, hypromellose, colloidal silicon dioxide, sodium stearyl fumarate, propyl gallate, polyethylene glycol, and kaolin. Film coating contains hypromellose, hydroxypropyl cellulose, titanium dioxide, FD&C #2/Indigo Carmine Aluminum Lake and carnauba wax.
• In addition the JANUMET XR 50 mg/500 mg Tablets also contain: microcrystalline cellulose.
• In addition the JANUMET XR 50 mg/1000 mg Tablets film coating also contain: yellow iron oxide.