Linagliptin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. linagliptin is not for treating type 1 diabetes.

Linagliptin may also be used for purposes not listed in this medication guide.

linagliptin can cause severe, life-threatening pancreatitis (inflammation of your pancreas). Stop taking linagliptin and call your doctor at once if you have pain in your upper stomach that may spread to your back, with or without vomiting.

Also call your doctor if you have symptoms of heart failure, such as swelling, rapid weight gain, or shortness of breath (even while lying down).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take linagliptin with or without food.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Linagliptin is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Diabetes Type 2:

Recommended dose: 5 mg orally once a day

Comments: When used in combination with insulin or an insulin secretagogue, a lower dose of the insulin secretagogue or insulin may be necessary to reduce the risk of hypoglycemia.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

You should not use linagliptin if:

• you have ever had a severe allergic reaction to linagliptin (breathing problems, swelling, severe skin rash); or

• you have diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you have ever had:

• heart problems;

• kidney disease;

• pancreatitis;

• high triglycerides (a type of fat in the blood);

• gallstones; or

• alcoholism.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

This medicine is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Be sure to follow all diet and exercise recommendations made by your doctor or dietician. It is important to eat a healthy diet, exercise regularly, and lose weight if necessary. This will help to control your diabetes and help linagliptin work more effectively.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction (hives, rash, itching, peeling, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop taking linagliptin and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, with or without vomiting.

Linagliptin may cause serious side effects. Call your doctor at once if you have:

• severe or ongoing pain in your joints;

• a severe autoimmune reaction--itching, blisters, breakdown of the outer layer of skin; or

• symptoms of heart failure--shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common side effects of linagliptin may include:

• runny or stuffy nose, sore throat;

• cough; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may increase or decrease the effects of linagliptin on lowering your blood sugar. Tell your doctor about all your other medicines, especially:

• rifampin (to treat tuberculosis); or

• insulin or other oral diabetes medications.

This list is not complete. Other drugs may affect linagliptin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to linagliptin. Your doctor will also tell you how to check your response to linagliptin by measuring your blood sugar levels at home. Follow these instructions carefully.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Glyxambi® (containing Linagliptin, Empagliflozin)
• Jentadueto® (containing Linagliptin, Metformin)