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What you should know about KOMBIGLYZE XR

The most important information you should know about KOMBIGLYZE XR is that serious side effects can happen in people taking KOMBIGLYZE XR, including:

Lactic acidosis. Metformin, one of the medicines in KOMBIGLYZE XR, can cause a rare, but serious, condition called lactic acidosis (a build-up of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Call your doctor right away if you have 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 KOMBIGLYZE 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 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

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 KOMBIGLYZE XR for a while if you have any of these things.

Inflammation of the pancreas (pancreatitis) which may be severe and lead to death

Before taking KOMBIGLYZE XR, tell your doctor if you ever had:

  • Inflammation of your pancreas (pancreatitis)
  • Stones in your gallbladder (gallstones)
  • A history of alcoholism
  • High blood triglyceride levels
  • Inflammation of your pancreas (pancreatitis)
  • Stones in your gallbladder (gallstones)
  • A history of alcoholism
  • High blood triglyceride levels

Stop taking KOMBIGLYZE XR and contact 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

Before taking KOMBIGLYZE XR

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
  • An unusually fast increase in weight
  • Swelling or fluid retention, especially in the feet, ankles, or legs
  • Unusual tiredness

These may be symptoms of heart failure.

Tell your doctor if you have any side effects that bother you or do not go away. These are not all of the possible side effects of KOMBIGLYZE XR. For more information, ask your doctor or pharmacist.

Save with a $0 co-pay offer

You may be able to get KOMBIGLYZE XR for as low as $0 a month for as long as your doctor prescribes it.*

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*Subject to eligibility. Restrictions apply. Not available for government-insured patients. Savings subject to monthly limit.

 

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