Frequently asked questions about JANUMET
What is JANUMET?
JANUMET 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.
The safety and effectiveness of JANUMET have not been established in pediatric patients.
For more information, see What is JANUMET?.
How does JANUMET work?
- Helps your pancreas make more insulin
- Helps your body more effectively use the insulin that it makes
- Helps decrease the amount of sugar that your liver makes
What are the possible side effects of JANUMET?
JANUMET can cause serious side effects. See Possible Side Effects of JANUMET to learn more.
What is the most important information I should know about JANUMET?
JANUMET can cause serious side effects, including:
- Lactic Acidosis. Metformin, one of the medicines in JANUMET, 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 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 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 for a while if you have any of these things.
- 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, 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 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.
- Heart failure. Heart failure means that your heart does not pump blood well enough.
Before you start taking JANUMET, tell your doctor if you have ever had heart failure or have problems with your kidneys.
Contact your doctor right away if you have any of the following symptoms:
- 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
These may be symptoms of heart failure.
What are the possible side effects of JANUMET?
JANUMET may cause serious side effects, including:
- See above section: “What is the most important information I should know about JANUMET?”
- Kidney problems, sometimes requiring dialysis.
- 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.
- Low blood sugar (hypoglycemia). If you take JANUMET with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you use JANUMET. Signs and symptoms of low blood sugar may include:
- headache
- drowsiness
- irritability
- hunger
- dizziness
- confusion
- sweating
- feeling jittery
- weakness
- fast heartbeat
- Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking JANUMET and call your doctor right away or get emergency medical help. See above section: “Who should not take JANUMET?”. Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
- Joint pain. Some people who take medicines called DPP-4 inhibitors, one of the medicines in JANUMET, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.
- Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in JANUMET, 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.
The most common side effects of JANUMET include:
- stuffy or runny nose and sore throat
- gas, upset stomach, indigestion
- headache
- upper respiratory infection
- weakness
- diarrhea
- low blood sugar (hypoglycemia) when used in combination with certain medicines, such as a sulfonylurea or insulin
- nausea and vomiting
Taking JANUMET 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.
JANUMET may have other side effects, including swelling of the hands or legs. Swelling of the hands and legs can happen if you take JANUMET in combination with rosiglitazone (Avandia). Rosiglitazone is another type of diabetes medicine.
Tell your doctor if you have any side effect that bothers you, or does not go away.
These are not all the possible side effects of JANUMET. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Will I gain weight from taking JANUMET?
Is there a difference in how you take JANUMET & JANUMET XR?
Does JANUMET cause low blood sugar (hypoglycemia)?
If you take JANUMET 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 medicine or insulin may need to be lowered while you use JANUMET.
Signs and symptoms of low blood sugar may include:
- headache
- drowsiness
- irritability
- hunger
- dizziness
- confusion
- sweating
- feeling jittery
- weakness
- fast heartbeat
Learn more about the Possible Side Effects of JANUMET.
Can I take JANUMET if I’m already taking metformin?
Sitagliptin was studied for 24 weeks in adults with type 2 diabetes whose A1C was not controlled with metformin, along with diet and exercise. In the study, patients already taking metformin added either placebo or sitagliptin 100 mg. Adding sitagliptin helped people to:
- Significantly lower A1C levels
- People who added sitagliptin saw an additional drop in their A1C number:
- Sitagliptin lowered A1C an average of 0.7%, from 8% at start
- Placebo lowered A1C an average of 0%, from 8% at start
- Reach A1C goal
- In the same study, more than twice as many people who added sitagliptin lowered their A1C to less than 7% compared to those who added placebo.
- Percent of people in the study who reached an A1C goal of less than 7%:
- 47% who took sitagliptin
- 18% who took placebo
How should I take JANUMET?
- 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.