Nitro-Dur

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.

Read the Patient Information Leaflet available from your pharmacist. Consult your doctor or pharmacist if you have any questions.

Remove the patch from its pouch, and peel off the protective clear liner as directed. Usually, you will wear the patch on the upper arm or chest. However, you can wear it anywhere on the body below the neck and above the knees or elbows. Apply the patch to a clean, dry, and hairless area. Hair in the area may be clipped, but not shaved. Avoid areas with cuts or irritation. Do not apply the patch immediately after bathing or showering. Wait until your skin is completely dry. However, you may bathe, shower, and swim while wearing the patch. Press the patch firmly in place with the palm of your hand. Wash your hands after applying the patch.

Use this patch as directed by your doctor, usually 1 patch a day, wearing it for 12 to 14 hours. The dosage is based on your medical condition and response to treatment.

To reduce skin irritation, apply each new patch to a different area of skin. After removing the old patch, fold it in half with the sticky sides together, and discard out of reach of children and pets.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Do not suddenly stop using this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

Although unlikely, when this medication is used for a long time, it may not work as well and may require different dosing. Tell your doctor if this medication stops working well (for example, you have worsening chest pain or it occurs more often).

Headache, dizziness, lightheadedness, nausea, and flushing may occur as your body adjusts to this medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Headache is often a sign that this medication is working. Your doctor may recommend treating headaches with an over-the-counter pain reliever (such as acetaminophen, aspirin). If the headaches continue or become severe, tell your doctor promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: fainting, fast/irregular/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as isosorbide mononitrate); or to nitrites; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent head injury, anemia, low blood pressure, dehydration, other heart problems (such as recent heart attack).

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.

Older adults may be more sensitive to the side effects of this medication, especially dizziness and lightheadedness, which could increase the risk of falls.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

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

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: drugs used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), certain drugs to treat migraine headaches (ergot alkaloids such as ergotamine), riociguat, vericiguat.

This medication may interfere with certain lab tests (such as blood cholesterol levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

This medication patch may be harmful if chewed or swallowed. If someone has overdosed, remove the patch if possible. For serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: slow heartbeat, vision changes, severe nausea/vomiting, sweating, cold/clammy skin, bluish fingers/toes/lips.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure monitoring) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Lifestyle changes such as dietary changes, exercise, and stopping smoking may help this drug work better. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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 (See How to Use section).