SITAGLIPTIN AND METFORMIN HYDROCHLORIDE- sitagliptin and metformin hydrochloride tablet, film coated 
Zydus Pharmaceuticals (USA) Inc.

----------

Medication Guide
Sitagliptin and metformin hydrochloride tablets
(SYE-ta-GLIP-tin and met-FOR-min HYE-droe-KLOR-ide)
tablets, for oral use
Read this Medication Guide carefully before you start taking sitagliptin and metformin hydrochloride tablets 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 sitagliptin and metformin hydrochloride tablets, ask your healthcare provider or pharmacist
What is the most important information I should know about sitagliptin and metformin hydrochloride tablets?
sitagliptin and metformin hydrochloride tablets can cause serious side effects , including:
1. Lactic Acidosis. Metformin, one of the medicines in sitagliptin and metformin hydrochloride tablets, 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 sitagliptin and metformin hydrochloride tablets 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 sitagliptin and metformin hydrochloride tablets 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 sitagliptin and metformin hydrochloride tablets for a while if you have any of these things. Sitagliptin and metformin hydrochloride tablets can have other serious side effects. See "What are the possible side effects of sitagliptin and metformin hydrochloride tablets?"
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 sitagliptin and metformin hydrochloride tablets, 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 sitagliptin and metformin hydrochloride tablets 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 sitagliptin and metformin hydrochloride tablets, 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 sitagliptin and metformin hydrochloride tablets?
       Sitagliptin and metformin hydrochloride tablets 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.
       Sitagliptin and metformin hydrochloride tablets 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 sitagliptin and metformin hydrochloride tablets
       It is not known if sitagliptin and metformin hydrochloride tablets is safe and effective in children .
Who should not take sitagliptin and metformin hydrochloride tablets?
Do not take sitagliptin and metformin hydrochloride tablets if you:
       have severe kidney problems.
       have diabetic ketoacidosis.
       are allergic to any of the ingredients in sitagliptin and metformin hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in sitagliptin and metformin hydrochloride tablets.
Symptoms of a serious allergic reaction to sitagliptin and metformin hydrochloride tablets 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 sitagliptin and metformin hydrochloride tablets?
Before you take sitagliptin and metformin hydrochloride tablets, 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. Sitagliptin and metformin hydrochloride tablets may need to be stopped for a short time. Talk to your healthcare provider about when you should stop sitagliptin and metformin hydrochloride tablets and when you should start sitagliptin and metformin hydrochloride tablets again. See " What is the most important information I should know about sitagliptin and metformin hydrochloride tablets? "
       have low levels of vitamin B12 in your blood.
       are pregnant or plan to become pregnant. It is not known if sitagliptin and metformin hydrochloride tablets 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 sitagliptin and metformin hydrochloride tablets will pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you are taking sitagliptin and metformin hydrochloride tablets.
       are a woman who has not gone through menopause (premenopausal) who does not have periods regularly or at all. sitagliptin and metformin hydrochloride tablets 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 sitagliptin and metformin hydrochloride tablets.
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sitagliptin and metformin hydrochloride tablets may affect the way other medicines work and other medicines may affect how sitagliptin and metformin hydrochloride tablets 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 sitagliptin and metformin hydrochloride tablets?
          Take sitagliptin and metformin hydrochloride tablets 2 times a day by mouth. Your healthcare provider will tell you exactly how many sitagliptin and metformin hydrochloride tablets to take and when you should take them.
          Take sitagliptin and metformin hydrochloride tablets with meals to help to lower your chance of having an upset stomach.
          Do not break or cut sitagliptin and metformin hydrochloride tablets before swallowing. If you cannot swallow sitagliptin and metformin hydrochloride tablets whole, tell your healthcare provider.
          Your healthcare provider may tell you to take sitagliptin and metformin hydrochloride tablets along with certain other diabetes medicines. Low blood sugar (hypoglycemia) can happen more often when sitagliptin and metformin hydrochloride tablets is taken with certain other diabetes medicines. See "What are the possible side effects of sitagliptin and metformin hydrochloride tablets?".
          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 sitagliptin and metformin hydrochloride tablets
          If you take too much sitagliptin and metformin hydrochloride tablets, 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 sitagliptin and metformin hydrochloride tablets?
sitagliptin and metformin hydrochloride tablets may cause serious side effects, including:
  • see "What is the most important information I should know about sitagliptin and metformin hydrochloride tablets?".
  • 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 sitagliptin and metformin hydrochloride tablets 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 sitagliptin and metformin hydrochloride tablets. 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 sitagliptin and metformin hydrochloride tablets and call your healthcare provider right away or get emergency medical help. See " Who should not take sitagliptin and metformin hydrochloride tablets?". 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 sitagliptin and metformin hydrochloride tablets, 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 sitagliptin and metformin hydrochloride tablets, 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 sitagliptin and metformin hydrochloride tablets.
The most common side effects of sitagliptin and metformin hydrochloride tablets 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 sitagliptin and metformin hydrochloride tablets 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.
sitagliptin and metformin hydrochloride tablets may have other side effects, including swelling of the hands or legs . Swelling of the hands and legs can happen if you take sitagliptin and metformin hydrochloride tablets 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 sitagliptin and metformin hydrochloride tablets. 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 sitagliptin and metformin hydrochloride tablets?
  • Store sitagliptin and metformin hydrochloride tablets in the original container at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Keep sitagliptin and metformin hydrochloride tablets in the original container to protect it from moisture.
  • Use sitagliptin and metformin hydrochloride tablets within 3 months of opening the bottle.
 Keep  sitagliptin and metformin hydrochloride tablets and all medicines out of the reach of children.
General information about the safe and effective use of sitagliptin and metformin hydrochloride tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sitagliptin and metformin hydrochloride tablets for a condition for which it was not prescribed. Do not give sitagliptin and metformin hydrochloride tablets 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 sitagliptin and metformin hydrochloride tablets that is written for health professionals.
What are the ingredients in sitagliptin and metformin hydrochloride tablets ?
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
Distributed by: Zydus Pharmaceuticals (USA) Inc., Route 31 North, Pennington, NJ 08534
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: 02/2024
Revised: 3/2024
Document Id: 1ead94f4-7af5-4d75-81ac-85a93490ecb2
Set id: 4d812277-21a8-4de3-b728-e3fdd01305b5
Version: 1
Effective Time: 20240322
Zydus Pharmaceuticals (USA) Inc.