Trandolapril is used in adults alone or in combination with other medications to treat high blood pressure and to improve survival after a heart attack.

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

Do not use if you are pregnant. Stop using trandolapril and tell your doctor right away if you become pregnant.

Tell your doctor about all your other medicines. Some drugs should not be used with trandolapril .

Trandolapril comes as a tablet to take by mouth. It is usually taken once or twice a day with or without food. To help you remember to take trandolapril, take it around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take trandolapril exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of trandolapril and gradually increase your dose, not more than once a week.

Trandolapril controls high blood pressure but does not cure it. Continue to take trandolapril even if you feel well. Do not stop taking trandolapril without talking to your doctor.

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 trandolapril with or without food.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking trandolapril. This can lead to very low blood pressure, an electrolyte imbalance, or kidney failure.

Your blood pressure will need to be checked often and you may need frequent blood tests.

Tell your doctor if you have a planned surgery.

If you have high blood pressure, keep using trandolapril even if you feel well. High blood pressure often has no symptoms.

Store tightly closed at room temperature, away from moisture and heat.

You should not use trandolapril if you are allergic to it or to any other ACE (angiotensin converting enzyme) inhibitor such as benazepril, captopril, fosinopril, enalapril, lisinopril, moexipril, perindopril, quinapril, or ramipril.

Do not take trandolapril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

Do not take trandolapril if you have a history of angioedema (severe allergic reaction).

If you have diabetes, do not take trandolapril with any medication that contains aliskiren (a blood pressure medicine).

Tell your doctor if you have ever had:

• heart disease or congestive heart failure;

• stomach pain;

• low blood pressure;

• low white blood cell count;

• if you are on a low-salt diet;

• diabetes;

• liver disease; or

• kidney disease (or if you are on dialysis).

You may also need to avoid taking trandolapril with aliskiren if you have kidney disease.

Stop using this medicine and tell your doctor right away if you become pregnant. Trandolapril can cause injury or death to the unborn baby if you use the medicine during your second or third trimester.

Do not breastfeed.

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

Talk to your doctor before using salt substitutes containing potassium. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Get emergency medical help if you have signs of an allergic reaction: hives, severe stomach pain, difficulty breathing, swelling of your face, lips, tongue, or throat.

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

• a light-headed feeling, like you might pass out;

• chest pain, fast, slow, or uneven heart rate;

• kidney problems--swelling, urinating less, feeling tired or short of breath;

• high blood potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough.

Common side effects of trandolapril may include:

• cough;

• headache, dizziness;

• low blood pressure; 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.

Trandolapril can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis.

Tell your doctor about all your other medicines, especially:

• a diuretic or "water pill" that may increase blood potassium such as spironolactone, triamterene, amiloride;

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;

• insulin or diabetes medications;

• medicine to prevent organ transplant rejection such as temsirolimus, sirolimus, or everolimus; or

• heart or blood pressure medication.

This list is not complete. Other drugs may affect trandolapril, 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 pressure should be checked regularly to determine your response to trandolapril. Your doctor may order certain lab tests to check your body's response to trandolapril.

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.

• Tarka® (containing Trandolapril and Verapamil)