How should I take JANUMET?

Take JANUMET twice daily by mouth with meals

Take JANUMET exactly as your doctor tells you. Your doctor will tell you how many JANUMET tablets to take and when you should take them.

  • Take JANUMET with meals to lower your chance of having an upset stomach.
  • Do not break or cut JANUMET tablets before swallowing. If you cannot swallow JANUMET tablets whole, tell your doctor.
  • Continue to take JANUMET for as long as your doctor tells you.
  • If you take too much JANUMET, call your doctor or local Poison Control Center right away.
  • If you miss a dose, take it 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 at the same time.
  • You may need to stop taking JANUMET 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.
  • 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.
  • 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.

Who should not take JANUMET?

Do not take JANUMET if you:

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

Symptoms of a serious allergic reaction to JANUMET 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.

What should I tell my doctor before taking JANUMET?

Before you take JANUMET, tell your doctor about all of your medical conditions, including if you:

  • 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; JANUMET may need to be stopped for a short time. Talk to your doctor about when you should stop JANUMET and when you should start JANUMET again.
  • have low levels of B12 in your blood.
  • are pregnant or plan to become pregnant. It is not known if JANUMET 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. Pregnancy Registry: If you take JANUMET at any time during your pregnancy, talk with your doctor about how you can join the JANUMET pregnancy registry. The purpose of this registry is to collect information about the health of you and your baby. You can enroll in this registry by calling 1-800-986-8999.
  • are breastfeeding or plan to breastfeed. It is not known if JANUMET will pass into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking JANUMET.
  • are a woman who has not gone through menopause (premenopausal) who does not have periods regularly or at all. JANUMET 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.

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

Pay as little as $5 per prescription*

Eligible, privately insured patients may pay as little as $5 per prescription on each of up to 12 qualifying prescriptions. Maximum savings is $150 per prescription.

*Not valid for patients who are uninsured or patients with Medicare or other Government Program insurance. Other eligibility restrictions apply. Please see Terms and Conditions.


Indication for JANUMET and JANUMET XR

JANUMET tablets contain 2 prescription medicines: sitagliptin (JANUVIA®) and metformin. Once-daily prescription JANUMET XR tablets contain sitagliptin (the medicine in JANUVIA®) and extended-release metformin.

JANUMET or JANUMET XR can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

JANUMET or JANUMET XR should not be used in patients with type 1 diabetes. If you have had pancreatitis (inflammation of the pancreas), it is not known if you have a higher chance of getting it while taking JANUMET or JANUMET XR.

Important Safety Information for JANUMET and JANUMET XR

Metformin, one of the medicines in JANUMET and JANUMET XR, can cause a rare but serious side effect called lactic acidosis (a buildup of lactic acid in the blood), which can cause death. Lactic acidosis is a medical emergency that must be treated in a hospital. Stop taking JANUMET or JANUMET XR and call your doctor right away if you get any of the following symptoms, which could be signs of lactic acidosis: feel cold in your hands or feet; feel dizzy or lightheaded; have a slow or irregular heartbeat; feel very weak or tired; have unusual (not normal) muscle pain; have trouble breathing; feel sleepy or drowsy; 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 of getting lactic acidosis with JANUMET or 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 large amounts of body fluids, which may happen if you are sick with fever, vomiting, or diarrhea; if you sweat a lot with activity or exercise and do not drink enough fluids); have surgery; have a heart attack, severe infection, stroke, or are 65 years of age or older. Your doctor may decide to stop your JANUMET or JANUMET XR for a while if you have any of these things.

Pancreatitis (inflammation of the pancreas) is another serious side effect that can happen in people taking JANUMET or JANUMET XR. Pancreatitis may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis. Before you start taking JANUMET or JANUMET XR, tell your doctor if you’ve ever had pancreatitis. Stop taking JANUMET or 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.

Before you start taking JANUMET or JANUMET XR, tell your doctor if you have ever had heart failure (your heart does not pump blood well enough) or have problems with your kidneys. Contact your doctor right away if you have 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; or unusual tiredness. These may be symptoms of heart failure.

Do not take JANUMET or JANUMET XR if you have severe kidney problems or have diabetic ketoacidosis. Your doctor will do blood tests before and during your treatment to see how well your kidneys are working.

Do not take JANUMET or JANUMET XR if you are allergic to any of the ingredients in JANUMET or JANUMET XR. Allergic reactions, which may be serious, including rash; hives; or swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, can occur. If you have an allergic reaction, stop taking JANUMET or JANUMET XR and call your doctor right away or get emergency medical help.

Tell your doctor if you are going to get an injection of dye or contrast agent for an x-ray procedure; JANUMET or JANUMET XR may need to be stopped for a short time.

Kidney problems, sometimes requiring dialysis, have been reported.

Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 blood levels before. Your doctor may do blood tests to check your vitamin B12 levels.

If you take JANUMET or JANUMET XR with another medicine that can cause low blood sugar (hypoglycemia), such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Signs and symptoms of low blood sugar may include headache, drowsiness, irritability, hunger, dizziness, confusion, sweating, feeling jittery, weakness, and fast heartbeat.

Some people who take medicines called DPP-4 inhibitors, one of the medicines in JANUMET and JANUMET XR, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.

Some people who take medicines called DPP-4 inhibitors, one of the medicines in JANUMET and JANUMET XR, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking JANUMET or JANUMET XR.

Common side effects when taking JANUMET or JANUMET XR include stuffy or runny nose and sore throat, gas, upset stomach, indigestion, headache, upper respiratory tract infection, weakness, diarrhea, low blood sugar (hypoglycemia) when used in combination with certain medicines such as sulfonylurea or insulin, nausea and vomiting.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the accompanying Medication Guide for JANUMET® (sitagliptin and metformin HCl) tablets or JANUMET® XR (sitagliptin and metformin HCl extended-release) tablets, including the information about lactic acidosis, and discuss it with your doctor. The physician Prescribing Information for JANUMET or JANUMET XR also is available.

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