Uses of Sitagliptin and Metformin Tablets:

• It is used to lower blood sugar in patients with high blood sugar (diabetes).

What do I need to tell my doctor BEFORE I take Sitagliptin and Metformin Tablets?

• If you have an allergy to sitagliptin, metformin, or any other part of this medicine (sitagliptin and metformin tablets).
• If you are allergic to this medicine (sitagliptin and metformin tablets); any part of this medicine (sitagliptin and metformin tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Acidic blood problem, kidney disease, liver disease, or type 1 diabetes.
• If you have had a recent heart attack or stroke.
• If you are not able to eat or drink like normal, including before certain procedures or surgery.
• If you are having an exam or test with contrast or have had one within the past 48 hours, talk with your doctor.

This is not a list of all drugs or health problems that interact with this medicine (sitagliptin and metformin tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (sitagliptin and metformin tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Sitagliptin and Metformin Tablets?

• Tell all of your health care providers that you take this medicine (sitagliptin and metformin tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before you drink alcohol.
• Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
• Check your blood sugar as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Low blood sugar can happen. The chance may be raised when this medicine (sitagliptin and metformin tablets) is used with other drugs for diabetes. Signs may be dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do for low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.
• It may be harder to control blood sugar during times of stress such as fever, infection, injury, or surgery. A change in physical activity, exercise, or diet may also affect blood sugar.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Follow the diet and workout plan that your doctor told you about.
• A skin reaction called bullous pemphigoid has happened with drugs like this one. Sometimes, people have had to go to the hospital. Call your doctor right away if you have blisters or if your skin starts to break down.
• Heart failure has happened in people taking drugs like this one. Tell your doctor if you have ever had heart failure or kidney problems. Call your doctor right away if you feel very tired or you have shortness of breath, a big weight gain, or swelling in the arms or legs.
• Kidney problems have happened. Sometimes, these may need to be treated in the hospital or with dialysis.
• If you cannot drink liquids by mouth or if you have upset stomach, throwing up, or diarrhea that does not go away; you need to avoid getting dehydrated. Contact your doctor to find out what to do. Dehydration may lead to new or worse kidney problems.
• If you are 65 or older, use this medicine (sitagliptin and metformin tablets) with care. You could have more side effects.
• There is a chance of pregnancy in women of childbearing age who have not been ovulating. If you want to avoid pregnancy, use birth control while taking this medicine (sitagliptin and metformin tablets).
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Sitagliptin and Metformin Tablets) best taken?

Use this medicine (sitagliptin and metformin tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with meals.
• Do not split or break tablet.
• Keep taking this medicine (sitagliptin and metformin tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Severe and sometimes deadly pancreas problems (pancreatitis) have happened with this medicine (sitagliptin and metformin tablets). This could happen at any time during treatment. Signs of pancreatitis include very bad stomach pain, very bad back pain, or very upset stomach or throwing up. Call your doctor right away if you have any of these signs.
• It is common to have stomach problems like upset stomach, throwing up, or diarrhea when you start taking this medicine (sitagliptin and metformin tablets). If you have stomach problems later during treatment, call your doctor right away. This may be a sign of an acid health problem in the blood (lactic acidosis).
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Drugs like this one may cause joint pain that can be very bad and disabling. Call your doctor right away if you have very bad joint pain or any joint pain that does not go away.

What are some other side effects of Sitagliptin and Metformin Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stomach pain or heartburn.
• Upset stomach or throwing up.
• Diarrhea.
• Gas.
• Feeling tired or weak.
• Headache.
• Signs of a common cold.
• Nose or throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Sitagliptin and Metformin Tablets?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (sitagliptin and metformin tablets) is refilled. If you have any questions about this medicine (sitagliptin and metformin tablets), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.