Read this Medication Guide carefully before you start taking sitagliptin tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about sitagliptin tablets, ask your doctor or pharmacist.

What is the most important information I should know about sitagliptin tablets?

Sitagliptin tablets can cause serious side effects, including:

• 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 tablets, tell your doctor if you have ever had:

• pancreatitis
• high blood triglyceride levels

• stones in your gallbladder (gallstones)
• kidney problems

• a history of alcoholism

Stop taking sitagliptin tablets and call 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. Heart failure means your heart does not pump blood well enough.

  Before you start taking sitagliptin tablets, 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
  • 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 are sitagliptin tablets?

• Sitagliptin tablets are a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
• Sitagliptin tablets are 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 tablets.
• The safety and effectiveness of sitagliptin tablets have not been established in pediatric patients.

Who should not take sitagliptin tablets?

Do not take sitagliptin tablets if:

• you are allergic to any of the ingredients in sitagliptin tablets. See the end of this Medication Guide for a complete list of ingredients in sitagliptin tablets.

Symptoms of a serious allergic reaction to sitagliptin 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 doctor before taking sitagliptin tablets?

Before you take sitagliptin tablets, tell your doctor about all of your medical conditions, including if you:

• have or have had inflammation of your pancreas (pancreatitis).
• have kidney problems.
• have heart failure.
• are pregnant or plan to become pregnant. It is not known if sitagliptin tablets will harm your unborn baby. If you are pregnant, talk with your doctor 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 will pass into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking sitagliptin tablets.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take sitagliptin tablets?

• Take sitagliptin tablets 1 time each day exactly as your doctor tells you.
• You can take sitagliptin tablets with or without food.
• Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with sitagliptin tablets.
• Your doctor may tell you to take sitagliptin tablets along with other diabetes medicines. Low blood sugar can happen more often when sitagliptin tablets are taken with certain other diabetes medicines. See “What are the possible side effects of sitagliptin tablets?”.
• If you miss a dose, take it 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 two doses of sitagliptin tablets at the same time.
• If you take too many sitagliptin tablets, call your doctor or local Poison Control Center right away.
• 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 doctor right away if you have any of these conditions and follow your doctor’s instructions.
• Check your blood sugar as your doctor tells you to.
• Stay on your prescribed diet and exercise program while taking sitagliptin tablets.
• Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of your diabetes.
• Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.

What are the possible side effects of sitagliptin tablets?

Sitagliptin tablets may cause serious side effects, including:

• See "What is the most important information I should know about sitagliptin tablets?".
• Kidney problems, sometimes requiring dialysis.
• Low blood sugar (hypoglycemia). If you take sitagliptin 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 tablets. Signs and symptoms of low blood sugar may include:

• headache
• drowsiness
• irritability

• hunger
• dizziness
• confusion

• sweating
• feeling jittery
• weakness
• fast heart beat

• Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking sitagliptin tablets and call your doctor right away or get emergency medical help. See “Who should not take sitagliptin tablets?”. Your doctor 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 like sitagliptin tablets, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.
• Skin reaction. Some people who take medicines called DPP-4 inhibitors like sitagliptin tablets may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking sitagliptin tablets.

The most common side effects of sitagliptin tablets include upper respiratory infection, stuffy or runny nose and sore throat, and headache.

Sitagliptin tablets may have other side effects, including stomach upset and diarrhea, swelling of the hands or legs, when sitagliptin tablets are used with metformin and rosiglitazone (Avandia). Rosiglitazone is another type of diabetes medicine. Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of sitagliptin tablets. For more information, ask your doctor 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 sitagliptin tablets?

Store sitagliptin tablets at room temperature, between 68°F to 77°F (20°C to 25°C).

Keep sitagliptin tablets and all medicines out of the reach of children.

General information about the safe and effective use of sitagliptin tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sitagliptin tablets for a condition for which it was not prescribed. Do not give sitagliptin tablets 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 sitagliptin tablets. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for information about sitagliptin tablets that is written for health professionals.

What are the ingredients in sitagliptin tablets?

Active ingredient: sitagliptin

Inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, red iron oxide, talc, titanium dioxide, and yellow iron oxide.