Empagliflozin; Linagliptin; Metformin Extended-Release Tablets

What is this medication?

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN (EM pa gli FLOE zin; lin a GLIP tin; met FOR min) treats type 2 diabetes. It works by decreasing your blood sugar (glucose). It can also be used to lower the risk of heart attack and stroke in people with type 2 diabetes. Changes to diet and exercise are often combined with this medication.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Trijardy XR

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Anemia
• Dehydration
• Diabetic ketoacidosis
• Diet low in salt
• Eating less due to illness, surgery, dieting, or any other reason
• Having surgery
• Heart disease
• Heart failure
• High cholesterol
• History of pancreatitis or pancreas problems
• History of yeast infection of the penis or vagina
• If you often drink alcohol
• Infections in the bladder, kidneys, or urinary tract
• Kidney disease
• Liver disease
• Low blood pressure
• On hemodialysis
• Polycystic ovary syndrome
• Previous swelling of the tongue, face, or lips with difficulty breathing, difficulty swallowing, hoarseness, or tightening of the throat
• Problems urinating
• Serious infection or injury
• Type 1 diabetes
• Uncircumcised male
• Vomiting
• An unusual or allergic reaction to empagliflozin, linagliptin, metformin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Take this medication in the morning with food. Follow the directions on the prescription label. Do not cut, crush, or chew this medication. Take your doses at regular intervals. Do not take your medication more often than directed. Do not stop taking except on your care team's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following medications:

• Certain contrast medications given before X-rays, CT scans, MRI, or other procedures
• Dofetilide
• Gatifloxacin

This medication may also interact with the following medications:

• Acetazolamide
• Alcohol
• Bosentan
• Certain antivirals for HIV or hepatitis
• Certain medications for blood pressure, heart disease, irregular heartbeat
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Cimetidine
• Dichlorphenamide
• Digoxin
• Diuretics
• Estrogen or progestin hormones
• Glycopyrrolate
• Isoniazid
• Lamotrigine
• Lithium
• Memantine
• Methazolamide
• Metoclopramide
• Midodrine
• Niacin
• Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine
• Ranolazine
• Rifabutin
• Rifampin
• St. Johns Wort
• Steroid medications, such as prednisone or cortisone
• Stimulant medications for attention disorders, weight loss, or staying awake
• Thyroid medications
• Topiramate
• Trospium
• Vandetanib
• Zonisamide

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress.

This medication can cause a serious condition in which there is too much acid in the blood. If you develop nausea, vomiting, stomach pain, unusual tiredness, or breathing problems, stop taking this medication and call your care team right away. If possible, use a ketone dipstick to check for ketones in your urine.

A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.

Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.

Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.

Tell your care team if you have high blood sugar. You might need to change the dose of your medication. If you are sick or exercising more than usual, you might need to change the dose of your medication.

Do not skip meals. Ask your care team if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.

This medication may cause ovulation in premenopausal women who do not have regular monthly periods. This may increase your chances of becoming pregnant. You should not take this medication if you become pregnant or think you may be pregnant. Talk with your care team about your birth control options while taking this medication. Contact your care team right away if you think you are pregnant.

If you are going to need surgery, an MRI, CT scan, or other procedure, tell your care team that you are taking this medication. You may need to stop taking this medication before the procedure.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medication and dosage times.

You may see empty tablets in your stool. This is normal.

This medication may cause a decrease in folic acid and vitamin B12. You should make sure that you get enough vitamins while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dehydration—increased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine
• Diabetic ketoacidosis (DKA)—increased thirst or amount of urine, dry mouth, fatigue, fruity odor to breath, trouble breathing, stomach pain, nausea, vomiting
• Genital yeast infection—redness, swelling, pain, or itchiness, odor, thick or lumpy discharge
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• High lactic acid level—muscle pain or cramps, stomach pain, trouble breathing, general discomfort and fatigue
• Infection or redness, swelling, tenderness, or pain in the genitals, or area from the genitals to the back of the rectum
• Low vitamin B12 level—pain, tingling, or numbness in the hands or feet, muscle weakness, dizziness, confusion, trouble concentrating
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Redness, blistering, peeling or loosening of the skin, including inside the mouth
• Severe joint pain
• Urinary tract infection (UTI)—burning when passing urine, passing frequent small amounts of urine, bloody or cloudy urine, pain in the lower back or sides

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Cough
• Diarrhea
• Headache
• Runny or stuffy nose
• Sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Keep container tightly closed. Get rid of any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.