Trytis® (Empagliflozin, linagliptin, and metformin)

Dosage form:

• Empagliflozin 10 mg, linagliptin 5 mg, and metformin 1,000 mg
• Empagliflozin 25 mg, linagliptin 5 mg, and metformin 1,000 mg
• Empagliflozin 5 mg, linagliptin 2.5 mg, and metformin 1,000 mg
• Empagliflozin 12.5 mg, linagliptin 2.5 mg, and metformin 1,000 mg

What is Trytis (Empagliflozin, linagliptin, and metformin) used for?

• It is used to lower blood sugar in people with type 2 diabetes.
• It is used to lower the chance of death from heart disease in certain people.

What do I need to tell my doctor BEFORE I take this drug?

• If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have type 1 diabetes. Do not use this drug to treat type 1 diabetes.
• If you have any of these health problems: Acidic blood problem, kidney disease, or liver disease.
• 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.
• If you are taking rifampin.
• If you are pregnant or may be pregnant. Do not take this drug if you are in the second or third trimester of pregnancy.
• If you are breast-feeding. Do not breast-feed while you take this drug.

This is not a list of all drugs or health problems that interact with this drug.

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 drug 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 this drug?

• Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
• Talk with your doctor before you drink alcohol.
• Long-term treatment with metformin may lead to low vitamin B-12 levels. If you have ever had low vitamin B-12 levels, talk with your doctor.
• A severe and sometimes deadly pancreas problem (pancreatitis) has happened with other drugs like this one.
• Too much acid in the blood or urine (ketoacidosis) has happened with this drug. This may need to be treated in the hospital and can be deadly. This can happen even when blood sugar is normal. Patients with some health problems, including diabetes or pancreas problems, have a higher risk of ketoacidosis. Check your ketones as you have been told by the doctor. Talk with the doctor.
• Severe urinary tract infections (UTIs) have happened with this drug. Sometimes, this needed to be treated in a hospital.
• Kidney problems have happened. Sometimes, these may need to be treated in the hospital or with dialysis.
• A rare but very bad infection has happened with drugs like this one. This infection may be deadly. Get medical help right away if your genitals or the area between your genitals and rectum becomes tender, red, or swollen, and you have a fever or do not feel well.
• 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.
• This drug may raise the risk of lower limb amputations. Toe and foot amputations have happened most often. Talk to your doctor about how to take care of your feet. Tell your doctor if you have ever had an amputation, blood vessel disease, nerve disease, or a foot ulcer caused by diabetes. Call your doctor right away if you have new pain or tenderness, sores or ulcers, or infections in your legs or feet.
• If you are 65 or older, use this drug with care. You could have more side effects.
• There is a chance of pregnancy in people of childbearing age who have not been ovulating. If you want to avoid pregnancy, use birth control while taking this drug.
• This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.

Trytis (empagliflozin, linagliptin, and metformin) side effects:

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 fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or passing out, increased thirst, seizures, feeling very tired or weak, decreased appetite, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or severe upset stomach or throwing up.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• The metformin in the medicine Trytis® may cause lactic acidosis, a rare but serious condition. If you have any lactic acidosis symptoms, such as nausea, vomiting, exhaustion, breathing difficulties, or stomach discomfort, stop taking the drug immediately and seek emergency medical assistance from your doctor.
• 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.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Vaginal yeast infection. Report itching or discharge.
• Yeast infection of the penis. Report pain, swelling, rash, or discharge.
• 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.
• Blood test results may change, including changes in cholesterol and lipid levels, an increase in red blood cell count, and a decrease in creatinine clearance.
• Low blood sugar can happen. The chance may be raised when this drug 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.

What are some other side effects of this drug?

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:

• Signs of a common cold.
• Nose or throat irritation.
• Diarrhea or constipation.

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 your national health agency.

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 the next dose and you have already eaten, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

How do I store and/or throw out this drug?

• Store at room temperature 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.