Janumet XR

Janumet XR is a combination medicine that helps control blood sugar levels in adults with type 2 diabetes mellitus when used along with diet and exercise (not for type 1 diabetes).

Janumet XR may also be used for other reasons not mentioned in this medication guide.

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.

Janumet XR is usually taken either once or twice a day based on the form of this medicine. Follow your doctor's instructions.

Take Janumet XR with meals. Take the extended-release tablet once daily with your meal.

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

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting, diarrhea, fever, or if you drink liquids less than usual.

Call your doctor if you see the extended-release tablet in your stool several times.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia) such as increased thirst or urination. Ask your doctor before changing your medication dosage.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests including checking your kidney function.

You may be given other medications to help with your condition. Keep taking these medicines for as long as your doctor has prescribed.

Your treatment may also include diet, exercise, weight control, and special medical care.

Store at room temperature away from moisture and heat. Certain brands must be stored in the original container and used within 1 to 3 months.

You should not use Janumet XR if you have severe kidney disease or metabolic acidosis (including diabetic ketoacidosis).

You may develop lactic acidosis, which is a serious condition where lactic acid builds up in your blood. Call your doctor or seek emergency medical help if you experience unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or extreme weakness or tiredness.

You should not use Janumet XR if you are allergic to it, or if you have severe kidney disease or metabolic acidosis (including diabetic ketoacidosis).

Tell your doctor if you have or have ever had:

• heart problems such as heart attack, heart failure, or stroke;
• pancreatitis;
• low levels of vitamin B12 or calcium in your blood;
• high triglycerides (a type of fat in the blood);
• gallstones;
• alcoholism; or
• liver or kidney disease.

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. Make sure that your healthcare provider knows ahead of time that you are using this medication.

It is not known if Janumet XR will harm an unborn baby. Follow your doctor's instructions about using Janumet XR if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

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

Ask a doctor if it is safe to breastfeed while using this medicine.

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

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

Some people using Janumet XR develop lactic acidosis, which can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heartbeats, dizziness, feeling cold, or feeling very weak or tired.

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

• severe or ongoing pain in your joints;
• a severe skin reaction-- itching, blisters, breakdown of the outer layer of skin;
• kidney problems or symptoms of heart failure-- swelling, urinating less, rapid weight gain, feeling tired or short of breath; or
• severely low blood sugar-- extreme weakness, confusion, tremors, sweating, fast heartbeats, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).

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.

Take the medicine as soon as you can, but skip the missed dose if it is close to the time for your next dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Tell your doctor about all your other medicines, especially:

• insulin or oral diabetes medicine including rosiglitazone.

Many drugs can increase your risk of lactic acidosis or affect your blood sugar and may also affect Janumet XR. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use. Not all possible interactions are listed here.