Janumet XR are oral diabetes medicines that help control blood sugar levels.

Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Sitagliptin works by regulating the levels of insulin your body produces after eating.

Janumet XR is a combination medicine that is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Janumet XR is not for treating type 1 diabetes.

Janumet XR may also be used for purposes not listed in this medication guide.

You should not use Janumet XR if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment).

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take Janumet XR with meals.

Swallow the tablet whole and do not crush, chew, or break it.

Some tablets are made with a shell that is not absorbed or melted in the body. Part of this shell may appear in your stool. This is normal and will not make the medicine less effective.

Call your doctor if you see a tablet in your stool several times.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Janumet XR is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Your blood will need to be tested often.

Store at room temperature away from moisture and heat.

You should not use this medicine if you are allergic to metformin or sitagliptin (Januvia), or if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment with insulin).

Tell your doctor if you have ever had:

• kidney disease (your kidney function may need to be checked before and while you are taking this medicine);

• liver disease;

• heart disease;

• pancreatitis;

• high triglycerides (a type of fat in the blood);

• gallstones; or

• alcoholism.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Janumet XR. Be sure your caregivers know ahead of time that you are using this medication.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

This medicine is not approved for use by anyone younger than 18 years old.

Take the medicine (with food) as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have severely low blood sugar (extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizure).

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Stop taking this medicine and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Some people using metformin develop lactic acidosis, which can be fatal. Get emergency medical help if you have even mild symptoms such as:

• unusual muscle pain;

• feeling cold;

• trouble breathing;

• feeling dizzy, light-headed, tired, or very weak;

• stomach pain, vomiting; or

• irregular heart rate.

Call your doctor at once if you have any of these serious side effects:

• severe autoimmune reaction--itching, blisters, breakdown of the outer layer of skin;

• severe or ongoing pain in your joints;

• little or no urinating; or

• symptoms of heart failure--shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common side effects of Janumet XR may include:

• low blood sugar (if you also use insulin or another oral diabetes medication);

• upset stomach, indigestion, gas, diarrhea, nausea, vomiting;

• headache, weakness; or

• cold symptoms such as runny or stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can affect Janumet XR, making Janumet XR less effective or increasing your risk of lactic acidosis. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.