Uses of Glycopyrrolate and Formoterol:

• 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 Glycopyrrolate and Formoterol?

• If you are allergic to glycopyrrolate and formoterol; any part of glycopyrrolate and formoterol; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have asthma.
• If you are using another drug like this one. If you are not sure, ask your doctor or pharmacist.
• If you take other drugs called anticholinergics, like ipratropium or oxybutynin. Ask your doctor if you are not sure if any of your drugs are anticholinergic.
• If the patient is a child. Do not give glycopyrrolate and formoterol to a child.
• If you are breast-feeding or plan to breast-feed.

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

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 glycopyrrolate and formoterol 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 Glycopyrrolate and Formoterol?

• Tell all of your health care providers that you take glycopyrrolate and formoterol. This includes your doctors, nurses, pharmacists, and dentists.
• 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.
• If you have high blood sugar (diabetes), glycopyrrolate and formoterol may sometimes raise blood sugar. Talk with your doctor about how to keep your blood sugar under control.
• Do not take more of glycopyrrolate and formoterol 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.
• If glycopyrrolate and formoterol gets in the eyes, rinse with water right away. Call the doctor right away if glycopyrrolate and formoterol gets in the eyes and blurred eyesight, worsened glaucoma, or eye pain happens.
• 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 glycopyrrolate and formoterol with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using glycopyrrolate and formoterol while you are pregnant.

How is this medicine (Glycopyrrolate and Formoterol) best taken?

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

• For breathing in only by an inhaler into the lungs.
• You will need to prime the pump before first use. You may also need to prime the pump if it has not been used for some time. Be sure you know when you need to prime the pump and how to do it. Talk with the doctor or pharmacist if you have questions.
• Shake well before use.
• Only use the device that comes with glycopyrrolate and formoterol. Do not use any other devices.
• Put the cap back on after you are done using your dose.
• Use new inhaler with each refill.
• If you are using more than 1 inhaled drug, ask the doctor which drug to use first.
• Follow how to clean the inhaler as you have been told. Do this at least every 7 days. You will need to prime again after cleaning.
• Keep using glycopyrrolate and formoterol 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 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 high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Chest pain or pressure.
• Fast or abnormal heartbeat.
• Shakiness.
• Very nervous and excitable.
• Change in eyesight, eye pain, or very bad eye irritation.
• Seeing halos or bright colors around lights.
• Red eyes.
• Trouble passing urine, pain when passing urine, passing urine in a weak stream or drips, or passing urine more often.
• 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 glycopyrrolate and formoterol, use a rescue inhaler and get medical help right away.

What are some other side effects of Glycopyrrolate and Formoterol?

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:

• Cough.

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 Glycopyrrolate and Formoterol?

• Store at room temperature.
• This inhaler has a dose counter to keep track of how many doses are left. Throw away the inhaler when you have been told after opening or when the dose counter has a 0 in it, whichever comes first.
• Protect from heat or open flame. Do not puncture or burn even if it seems empty.
• 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 glycopyrrolate and formoterol is refilled. If you have any questions about glycopyrrolate and formoterol, 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.