ZITUVIMET XR- sitagliptin and metformin hydrochloride tablet, film coated, extended release 
Zydus Pharmaceuticals USA Inc.

----------

SPL MEDGUIDE

Medication Guide
ZITUVIMET XR (zye too' vi met XR)
(sitagliptin and metformin hydrochloride extended-release)
tablets, for oral use
Read this Medication Guide carefully before you start taking ZITUVIMET XR and each time you get a refill. There may be new information. This information does not take the place of talking with your health care provider about your medical condition or your treatment. If you have any questions about ZITUVIMET XR, ask your health care provider or pharmacist.
What is the most important information I should know about ZITUVIMET XR?
ZITUVIMET XR can cause serious side effects, including:

Lactic Acidosis. Metformin, one of the medicines in ZITUVIMET XR, 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 XR and call your health care 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 health care provider if you have any of the following, because you have a higher chance for getting lactic acidosis with ZITUVIMET 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 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 health care provider if you have any of the problems in the list above. Your health care provider may decide to stop your ZITUVIMET XR for a while if you have any of these things.
ZITUVIMET XR can have other serious side effects. See " What are the possible side effects of ZITUVIMET XR? "
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 XR, tell your health care 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 XR and call your health care 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.

Heart failure. Heart failure means that your heart does not pump blood well enough.
Before you start taking ZITUVIMET XR, tell your health care provider if you have ever had heart failure or have problems with your kidneys. Contact your health care 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 XR?
  • ZITUVIMET XR is a prescription medicine that contains 2 prescription diabetes medicines, sitagliptin and extended-release metformin hydrochloride. ZITUVIMET XR is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
  • ZITUVIMET XR 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 XR.
  • It is not known if ZITUVIMET XR is safe and effective in children
Who should not take ZITUVIMET XR?
Do not take ZITUVIMET XR if you:
  • have severe kidney problems.
  • have diabetic ketoacidosis.
  • are allergic to any of the ingredients in ZITUVIMET XR. See the end of this Medication Guide for a complete list of ingredients in ZITUVIMET XR.
Symptoms of a serious allergic reaction to ZITUVIMET XR 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 health care provider before taking ZITUVIMET XR?
Before you take ZITUVIMET XR, tell your health care 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 XR may need to be stopped for a short time. Talk to your health care provider about when you should stop ZITUVIMET XR and when you should start ZITUVIMET XR again. See "What is the most important information I should know about ZITUVIMET XR?".
  • have low levels of vitamin B12 in your blood.
  • are pregnant, think you may be pregnant, or plan to become pregnant. It is not known if ZITUVIMET XR will harm your unborn baby. If you are pregnant, talk with your health care 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 XR will pass into your breast milk. Talk with your health care provider about the best way to feed your baby if you are taking ZITUVIMET XR.
  • are a woman who has not gone through menopause (premenopausal) who does not have periods regularly or at all. ZITUVIMET XR can cause the release of an egg from an ovary in a woman (ovulation). This can increase your chance of getting pregnant. Tell your health care provider right away if you become pregnant while taking ZITUVIMET XR.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZITUVIMET XR may affect the way other medicines work and other medicines may affect how ZITUVIMET XR works.
Know the medicines you take. Keep a list of your medicines and show it to your health care provider and pharmacist when you get a new medicine.
How should I take ZITUVIMET XR?
  • Take ZITUVIMET XR 1 time each day by mouth. Your health care provider will tell you exactly how many ZITUVIMET XR tablets to take and when you should take them.
  • Take ZITUVIMET XR with meals to help to lower your chance of having an upset stomach.
Take ZITUVUMET XR tablets whole. Do not break or cut ZITUVIMET XR tablets before swallowing. If you cannot swallow ZITUVIMET XR tablets whole, tell your health care provider.
  • Your health care provider may tell you to take ZITUVIMET XR along with certain other diabetes medicines. Low blood sugar (hypoglycemia) can happen more often when ZITUVIMET XR is taken with certain other diabetes medicines. See "What are the possible side effects of ZITUVIMET XR?"
  • 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 health care provider right away. if you have any of these problems and follow your health care provider's instructions.
  • Your health care provider will do blood tests to check how well your kidneys are working before and during your treatment with ZITUVIMET XR.
  • If you miss a dose, take it with food 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 ZITUVIMET XR at the same time.
  • You may need to stop taking ZITUVIMET XR for a short time. Call your health care provider 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.
  • If you take too much ZITUVIMET XR, call your health care 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 XR?
ZITUVIMET XR may cause serious side effects, including:
  • See "What is the most important information I should know about ZITUVIMET XR?"
  • 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 health care provider may do blood tests to check your vitamin B12 levels.
  • Low blood sugar (hypoglycemia). If you take ZITUVIMET XR 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 XR. Signs and symptoms of low blood sugar may include:
  • headache
  • irritability
  • dizziness
  • sweating
  • weakness
  • drowsiness
  • hunger
  • confusion
  • feeling jittery
  • fast heart beat
  • Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking ZITUVIMET XR and call your health care provider right away or get emergency medical help. See "Who should not take ZITUVIMET XR?". Your health care 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 XR, may develop joint pain that can be severe. Call your health care provider if you have severe joint pain.
  • Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in ZITUVIMET XR, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your health care provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your health care provider may tell you to stop taking ZITUVIMET XR.
The most common side effects of ZITUVIMET XR include:
•    diarrhea
•    upper respiratory infection
•    headache
Taking ZITUVIMET XR 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 health care provider. Stomach problems that start later during treatment may be a sign of something more serious.
ZITUVIMET XR may have other side effects, including swelling of the hands or legs. Swelling of the hands and legs can happen if you take ZITUVIMET XR in combination with rosiglitazone (Avandia). Rosiglitazone is another type of diabetes medicine.
Tell your health care 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 XR. For more information, ask your health care provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ZITUVIMET XR?
  • Store ZITUVIMET XR in the original container at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Keep ZITUVIMET XR in the original container to protect it from moisture
  • Use ZITUVIMET XR within 1 month of opening the bottle.
Keep ZITUVIMET XR and all medicines out of the reach of children.
General information about the safe and effective use of ZITUVIMET XR.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZITUVIMET XR for a condition for which it was not prescribed. Do not give ZITUVIMET XR to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about ZITUVIMET XR. If you would like to know more information, talk with your health care provider. You can ask your health care provider or pharmacist for information about ZITUVIMET XR that is written for health professionals.
What are the ingredients in ZITUVIMET XR?
Active ingredients: sitagliptin and metformin hydrochloride
Inactive ingredients:
  • All doses of ZITUVIMET XR Tablets contain: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, ferric oxide yellow, hypromellose, magnesium stearate, malic acid, microcrystalline cellulose, povidone, pregelatinized starch (maize) and sodium stearyl fumarate. In addition, the film-coating for all doses contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, iron oxide yellow, talc and titanium dioxide.
  • Additionally, ZITUVIMET XR 50 mg/500 mg and 100 mg/1,000 mg tablets film-coating contain the inactive ingredient red iron oxide and 50 mg/1,000 mg and 100 mg/1,000 mg tablets film-coating contain the FD&C yellow#6 Aluminum Lake.
For more information, go to MedicalAffairs@zydususa.com or call 1-877-993-8779.
Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.
The trademarks depicted herein are owned by their respective companies.
Manufactured by:
Zydus Lifesciences Ltd.
Pharmez, Matoda, Ahmedabad, India

Distributed by:
Zydus Pharmaceuticals (USA) Inc.
Route 31 North, Pennington, NJ 08534
Approved.: 07/2024

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 7/2024
Document Id: 98507577-c0c5-453d-a80c-9e106b7f667e
Set id: 2f635b36-e86a-4e53-8eaf-589917b5f342
Version: 1
Effective Time: 20240723
Zydus Pharmaceuticals USA Inc.