Uses of Formoterol Inhalation Solution:

• It is used to treat COPD (chronic obstructive pulmonary disease).
• This medicine is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Formoterol Inhalation Solution?

• If you have an allergy to formoterol or any other part of formoterol inhalation solution.
• If you are allergic to formoterol inhalation solution; any part of formoterol inhalation solution; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have a fast or abnormal heartbeat.
• If you are using another drug like this one. If you are not sure, ask your doctor or pharmacist.
• If you have asthma.
• If the patient is a child. This medicine is not approved for use in children.

This is not a list of all drugs or health problems that interact with formoterol inhalation solution.

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 formoterol inhalation solution 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 Formoterol Inhalation Solution?

• Tell all of your health care providers that you take formoterol inhalation solution. This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), formoterol inhalation solution may sometimes raise blood sugar. Talk with your doctor about how to keep your blood sugar under control.
• Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
• Do not take more of formoterol inhalation solution or use it more often than you have been told. Deaths have happened when too much of this type of drug has been taken. Talk with your doctor.
• Drugs like this one may raise the chance of asthma-related deaths in people with asthma who do not also use an inhaled steroid. It appears that this effect does not apply to people with COPD. If you have questions, talk with the doctor.
• This medicine is not approved to treat asthma. Talk with your doctor.
• If you are 65 or older, use formoterol inhalation solution with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Formoterol Inhalation Solution) best taken?

Use formoterol inhalation solution as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For breathing in only as a liquid (solution) by a special machine (nebulizer) into the lungs.
• Only use the type of nebulizer that you have been told to use. If you are not sure what type of nebulizer to use, talk with the doctor.
• Each container is for one use only. Use right after opening. Throw away any part of the opened container after the dose is given.
• Do not mix other drugs in nebulizer.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Keep using formoterol inhalation solution as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: 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 high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Signs of too much acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
• Chest pain or pressure.
• Fast or abnormal heartbeat.
• This medicine can cause very bad breathing problems right after you take a dose. Sometimes, this may be life-threatening. If you have trouble breathing, breathing that is worse, wheezing, or coughing after using formoterol inhalation solution, use a rescue inhaler and get medical help right away.

What are some other side effects of Formoterol Inhalation Solution?

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:

• Headache.
• Upset stomach or throwing up.
• Diarrhea.
• Feeling nervous and excitable.
• Shakiness.
• Dry mouth.
• Dizziness.
• Feeling tired or weak.
• Trouble sleeping.

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 the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Formoterol Inhalation Solution?

• Store in a refrigerator. Do not freeze.
• If needed, you may store at room temperature for up to 3 months. If stored at room temperature and not used within 3 months, throw this drug away.
• Store unused containers in foil pouch until use.
• Protect from heat and light.
• 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.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time formoterol inhalation solution is refilled. If you have any questions about formoterol inhalation solution, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.