Aclidinium; Formoterol Dry Powder Inhaler (DPI)

What is this medication?

ACLIDINIUM; FORMOTEROL (a kli DIN ee um; for MOH te rol) treats chronic obstructive pulmonary disease (COPD). It works by opening the airways of the lungs, making it easier to breathe. It is a combination of an anticholinergic and a bronchodilator. It is often called a controller inhaler. Do not use it to treat a sudden COPD flare-up.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Duaklir

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Asthma
• Diabetes
• Glaucoma
• Heart disease
• High blood pressure
• Irregular heartbeat or rhythm
• Kidney disease
• Liver disease
• Prostate disease
• Seizures
• Thyroid disease
• An unusual or allergic reaction to aclidinium, atropine, milk proteins, formoterol, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is inhaled through the mouth. Take it as directed on the prescription label at the same time every day. Do not use it more often than directed. Keep taking it unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. Special care may be needed

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dofetilide
• Dronedarone
• Other medications that contain long-acting beta-2 agonists (LABAs) like indacaterol, olodaterol, salmeterol, vilanterol
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Antihistamines for allergy, cough, and cold
• Atropine
• Certain medications for bladder problems like oxybutynin, tolterodine
• Certain medications for blood pressure, heart disease, irregular heart beat
• Certain medications for depression, anxiety, or mental health conditions
• Certain medications for Parkinson's disease like benztropine, trihexyphenidyl
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Other medications that contain an anticholinergic like ipratropium, glycopyrrolate, tiotropium, umeclidinium
• Other medications that prolong the QT interval (cause an abnormal heart rhythm)
• Stimulant medications for attention disorders, weight loss, or to stay awake
• Theophylline

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

NEVER use this medication for an acute asthma attack. You should use your short-acting rescue inhaler for an acute attack. If your symptoms get worse or if you need your short-acting inhalers more often, call your care team right away.

This medication can worsen breathing or cause wheezing right after you use it. Be sure you have a short-acting inhaler for acute attacks (wheezing) nearby. If this happens, stop using this medication right away and call your care team.

This medication may increase your risk of serious asthma-related problems. Talk to your care team if you have questions.

Do not treat yourself for coughs, colds, or allergies without asking your care team for advice. Some nonprescription medications can affect this one.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Muscle pain or cramps
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Trouble passing urine
• Wheezing or trouble breathing that is worse after use

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Back pain
• Constipation
• Cough
• Dry mouth
• Headache
• Sore throat
• Tremors or shaking
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep inhaler away from extreme heat, cold or humidity. Get rid of it 2 months after removing it from the foil pouch, when the dose counter reads "0" or after the expiration date, whichever is first.

To get rid of medication that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.