Side Effects

Runny/stuffy nose may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.

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.

Rarely, this medication may cause sudden severe worsening of breathing problems right after you use it. If this occurs, use your quick-relief inhaler and get medical help right away.

Tell your doctor right away if you have any serious side effects, including: difficulty urinating, painful urination.

Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision).

A very serious allergic reaction to this product 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 www.fda.gov/medwatch.

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

Uses

Revefenacin is a long-term medication used to treat an ongoing lung disease, Chronic Obstructive Pulmonary Disease (COPD). It must be used regularly to reduce and prevent symptoms such as shortness of breath, cough, and wheezing. This medication belongs to a class of drugs known as anticholinergics. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily.Revefenacin does not work right away and should not be used to relieve sudden breathing problems. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler as prescribed.

How to use Revefenacin Solution For Nebulization

Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using revefenacin and each time you get a refill. This medication is used with a special machine called a nebulizer that changes the solution to a fine mist that you inhale. Learn how to prepare, use, and care for the nebulizer properly. If you have any questions, ask your doctor, pharmacist, or respiratory therapist.

This product should be clear and colorless. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Inhale this medication into your lungs using the nebulizer as directed by your doctor, usually once daily. Do not mix with other medicines in the nebulizer. Avoid getting this medication into your eyes. It may cause eye pain/irritation, temporary blurred vision, and other vision changes. Each treatment usually takes about 8 minutes. Use this medication only with the nebulizer. Do not swallow or inject the solution. Clean the nebulizer after every use according to the manufacturer’s directions.

If you are using other inhaled medications at the same time, wait at least one minute between the use of each medication.

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 increase your dose or use this medication more often than directed.

Learn which of your inhalers/medications you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

Tell your doctor if your symptoms do not get better or if they get worse.

Precautions

Before using revefenacin, tell your doctor or pharmacist if you are allergic to it; 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: personal or family history of glaucoma (angle-closure type), problems with urinating (such as due to blockage/enlarged prostate), liver problems.

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

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

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

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: nausea, vomiting, dizziness, lightheadedness.

Do not share this medication with others.

If you smoke, quitting is the most important step you can take to treat COPD. Talk with your doctor or pharmacist about programs and products that can help you quit.

Because the flu virus can worsen breathing problems, ask your doctor or pharmacist if you should have a flu shot every year.

Lab/medical tests (such as lung function) should be done while you are using this medication. Keep all medical and lab appointments.

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. 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. Consult your pharmacist or local waste disposal company.

Interactions

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.