ZITUVIMET- sitagliptin and metformin hydrochloride tablet, film coated 
Zydus Lifesciences Limited

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Medication Guide
ZITUVIMET(zye too' vi met)
(sitagliptin and metformin hydrochloride)
tablets, for oral use
Read this Medication Guide carefully before you start taking ZITUVIMET and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions about ZITUVIMET, ask your healthcare provider or pharmacist
What is the most important information I should know about ZITUVIMET?
ZITUVIMET can cause serious side effects , including:
1. Lactic Acidosis. Metformin, one of the medicines in ZITUVIMET, 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 ZITUVIMET and call your healthcare provider 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 healthcare provider if you have any of the following, because you have a higher chance for getting lactic acidosis with ZITUVIMET 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 healthcare provider if you have any of the problems in the list above. Your healthcare provider may decide to stop your ZITUVIMET for a while if you have any of these things. ZITUVIMET can have other serious side effects. See "What are the possible side effects of ZITUVIMET?"
2. Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.
Before you start taking ZITUVIMET, tell your healthcare provider if you have ever had:
          pancreatitis
          stones in your gallbladder (gallstones)
          high blood triglyceride levels
          a history of alcoholism
          kidney problems
Stop taking ZITUVIMET and call your healthcare provider 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.
3. Heart failure. Heart failure means that your heart does not pump blood well enough.
Before you start taking ZITUVIMET, tell your healthcare provider if you have ever had heart failure or have problems with your kidneys. Contact your healthcare provider 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 is ZITUVIMET?
       ZITUVIMET is a prescription medicine that contains 2 prescription diabetes medicines, sitagliptin and metformin that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
       ZITUVIMET 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 ZITUVIMET
       It is not known if ZITUVIMET is safe and effective in children .
Who should not take ZITUVIMET?
Do not take ZITUVIMET if you:
       have severe kidney problems.
       have diabetic ketoacidosis.
       are allergic to any of the ingredients in ZITUVIMET. See the end of this Medication Guide for a complete list of ingredients in ZITUVIMET.
Symptoms of a serious allergic reaction to ZITUVIMET  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 healthcare provider before taking ZITUVIMET?
Before you take ZITUVIMET, tell your healthcare provider 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 procedure. ZITUVIMET may need to be stopped for a short time. Talk to your healthcare provider about when you should stop ZITUVIMET and when you should start ZITUVIMET again. See " What is the most important information I should know about ZITUVIMET? "
       have low levels of vitamin B12 in your blood.
       are pregnant or plan to become pregnant. It is not known if ZITUVIMET will harm your unborn baby. If you are pregnant, talk with your healthcare provider about the best way to control your blood sugar while you are pregnant.
       are breastfeeding or plan to breastfeed. It is not known if ZITUVIMET will pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you are taking ZITUVIMET.
       are a woman who has not gone through menopause (premenopausal) who does not have periods regularly or at all. ZITUVIMET can cause the release of an egg from an ovary in a woman (ovulation). This can increase your chance of getting pregnant. Tell your healthcare provider right away if you become pregnant while taking ZITUVIMET.
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZITUVIMET may affect the way other medicines work and other medicines may affect how ZITUVIMET works.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take ZITUVIMET?
          Take ZITUVIMET 2 times a day by mouth. Your healthcare provider will tell you exactly how many ZITUVIMET tablets to take and when you should take them.
          Take ZITUVIMET with meals to help to lower your chance of having an upset stomach.
          Do not break or cut ZITUVIMET tablets before swallowing. If you cannot swallow ZITUVIMET tablets whole, tell your healthcare provider.
          Your healthcare provider may tell you to take ZITUVIMET along with certain other diabetes medicines. Low blood sugar (hypoglycemia) can happen more often when ZITUVIMET is taken with certain other diabetes medicines. See "What are the possible side effects of ZITUVIMET?".
          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 healthcare provider right away if you have any of these problems and follow your healthcare provider's instructions.
          Your healthcare provider will do blood tests to check how well your kidneys are working before and during your treatment with ZITUVIMET
          If you take too much ZITUVIMET, call your healthcare provider or Poison Help Line at 1-800-222-1222 or go to the nearest hospital emergency room right away. 
What are the possible side effects of ZITUVIMET?
ZITUVIMET may cause serious side effects, including:
  • see "What is the most important information I should know about ZITUVIMET?".
  • 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 healthcare provider may do blood tests to check your vitamin B12 levels.
  • low blood sugar (hypoglycemia). If you take ZITUVIMET 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 ZITUVIMET. Signs and symptoms of low blood sugar may include:
o  headache
 o  drowsiness
 o  irritability
o  hunger
 o  dizziness
 o  confusion
o  sweating
 o  feeling jittery
 o  weakness
o  fast heart beat
  • Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking ZITUVIMET and call your healthcare provider right away or get emergency medical help. See " Who should not take ZITUVIMET?". Your healthcare provider 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 ZITUVIMET, may develop joint pain that can be severe. Call your healthcare provider if you have severe joint pain.
  • Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in ZITUVIMET, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking ZITUVIMET.
The most common side effects of ZITUVIMET include:
  • stuffy or runny nose and sore throat
  • upper respiratory infection
  • low blood sugar (hypoglycemia) when used in combination with certain medicines, such as a sulfonylurea or insulin
  • gas, upset stomach, indigestion
  • weakness
  • nausea and vomiting
  • headache
  • diarrhea
Taking ZITUVIMET 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 healthcare provider. Stomach problems that start later during treatment may be a sign of something more serious.
ZITUVIMET may have other side effects, including swelling of the hands or legs . Swelling of the hands and legs can happen if you take ZITUVIMET in combination with rosiglitazone (Avandia). Rosiglitazone is another type of diabetes medicine.
Tell your healthcare provider if you have any side effect that bothers you, or does not go away.
These are not all the possible side effects of ZITUVIMET. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ZITUVIMET?
  • Store ZITUVIMET in the original container at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Keep ZITUVIMET in the original container to protect it from moisture.
  • Use ZITUVIMET within 3 months of opening the bottle.
 Keep  ZITUVIMET and all medicines out of the reach of children.
General information about the safe and effective use of ZITUVIMET.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZITUVIMET for a condition for which it was not prescribed. Do not give ZITUVIMET to other people, even if they have the same symptoms you have. It may harm them.
. You can ask your healthcare provider or pharmacist for information about ZITUVIMET that is written for health professionals.
What are the ingredients in ZITUVIMET?
Active ingredients: sitagliptin and metformin hydrochloride
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, low substituted hydroxypropylcellulose, magnesium stearate, malic acid, microcrystalline cellulose, povidone, and sodium stearyl fumarate.
In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The film coating of 50 mg/1,000 mg also contains: FD&C yellow #6 aluminum lake, iron oxide red, and iron oxide yellow.
Manufactured by: Zydus Lifesciences Ltd., Pharmez, Matoda, Ahmedabad, India
The trademarks depicted herein are owned by their respective companies.
For more information, call 1-877-993-8779, email medicalaffairs@zydusua.com, or go to www.zyususa.com/medguides/
This Medication Guide has been approved by the U.S. Food and Drug Administration.   
Revised: 11/2023
Revised: 3/2024
Document Id: a5dfb977-069b-4ac3-a3b2-b8b6dcc999e8
Set id: 0098dec4-f0e5-45d5-8aa4-5d0faf9ab142
Version: 2
Effective Time: 20240322
Zydus Lifesciences Limited