IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

TRANDOLAPRIL - ORAL

(tran-DOL-a-pril)

COMMON BRAND NAME(S): Mavik

WARNING: This drug can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication. If you are planning pregnancy, become pregnant, or think you may be pregnant, contact your doctor immediately.

USES: This drug belongs to a group of medications called ACE inhibitors. It is used to treat high blood pressure (hypertension). It works by relaxing blood vessels, causing them to widen. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems.

This medication is also used to improve survival after an acute heart attack and with other drugs (e.g., "water pills"/diuretics, digoxin) to treat congestive heart failure.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to help protect the kidneys from damage due to diabetes.

HOW TO USE: Take this medication by mouth, usually once or twice a day; or as directed by your doctor. You may take this drug with or without food. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day.

Do not take potassium supplements or salt substitutes containing potassium without talking to your doctor or pharmacist first. This medicine can raise your potassium levels, which rarely can cause serious side effects such as muscle weakness or very slow heartbeats. Tell your doctor immediately if these effects occur.

The dosage is based on your medical condition and response to therapy. For the treatment of high blood pressure, it may take 1 week before the full benefit of this drug occurs or several weeks to months when used for congestive heart failure.

It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

SIDE EFFECTS: You may experience dizziness, light-headedness, diarrhea, dry cough or blurred vision as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, decreased sexual ability.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: change in the amount of urine, signs of infection (e.g., fever, chills, persistent sore throat).

This drug may rarely cause serious (possibly fatal) liver problems. If you notice any of the following highly unlikely but very serious side effects, seek immediate medical attention: yellowing eyes or skin, dark urine, stomach/abdominal pain, persistent fatigue, persistent nausea.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking trandolapril, tell your doctor or pharmacist if you are allergic to it; or to other ACE inhibitors (e.g., benazepril, captopril); or if you have any other allergies (including exposure to certain membranes used for blood filtering). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of an allergic reaction which included swelling of the face/lips/tongue/throat (angioedema).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, high blood levels of potassium, severe dehydration (and loss of electrolytes such as sodium), blood vessel disease (e.g., collagen vascular diseases such as lupus, scleroderma).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and light-headedness due to lowering of your blood pressure, get up slowly when rising from a seated or lying position. Serious loss of body fluids can also lower your blood pressure and worsen dizziness. Drink adequate fluids to prevent from becoming dehydrated. If you are on restricted fluid intake, consult your doctor for further instructions. Be careful not to become too overheated during exercise which can lead to excessive sweating. Consult your doctor if you experience severe vomiting or diarrhea.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Caution is advised when using this drug in the elderly because they may be more sensitive its effects, especially dizziness.

This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: drugs that suppress the immune system (e.g., azathioprine), lithium, non-steroidal anti-inflammatory drugs (NSAIDs such as celecoxib, ibuprofen, indomethacin), potassium-sparing "water pills" (diuretics such as amiloride, spironolactone, triamterene), potassium supplements (e.g., potassium chloride) or salt substitutes, gold injections.

A very serious reaction may occur if you are getting injections for bee/wasp sting allergy (desensitization) and are also taking trandolapril. Make sure all your doctors know which medicines you are using.

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: unusually fast or slow heartbeat, severe dizziness, or fainting.

NOTES: Do not share this medication with others. Lifestyle changes such as stress reduction programs, exercise and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

Laboratory and/or medical tests (e.g., kidney function, potassium blood level) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Check your blood pressure regularly while taking this medication, especially when you first start this drug or when your dose is changed. Learn how to monitor your own blood pressure at home, and share the results with your doctor.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the US product at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom.

Store the Canadian product at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture. Do not store in the bathroom.

Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised October 2010 Copyright(c) 2010 First DataBank, Inc.

About Rx Outreach

Rx Outreach is a non-profit pharmacy whose mission is to provide affordable medications to people in need. Each year, we serve over 85,000 people across all fifty states, Puerto Rico, the U.S. Virgin Islands, and Guam. We believe that everyone deserves access to affordable medications. No one should ever have to choose between filling a prescription and feeding their family. That’s why Rx Outreach exists, and why our team is so passionate about the work we do.

Our Medications & Services

Rx Outreach offers more than 600 medication strengths, representing more than 250 different types of medications. There are many online pharmacies that claim to offer cheap drugs. Rx Outreach is different in that we work directly with pharmaceutical manufacturers to ensure we are providing high-quality products at an affordable price. Rx Outreach does not currently offer a Drug Discount Card or prescription coupons, but plans to expand beyond mail order pharmacy services in the future.

Our Pharmacy

The Rx Outreach pharmacy is located in St. Louis, MO and is staffed by more than 60 pharmacists and patient care advocates. We are licensed to dispense medications in all 50 states and U.S. territories. Since we are a mail order pharmacy, we are able to ship medications directly to our patients’ homes. To make it simple and cost-effective for our patients, we usually ship enough medication for 90 or 180 days at a time.