Duaklir Pressair contains a combination of aclidinium and formoterol and is supplied as a breath activated multi-dose dry powder inhaler.

Duaklir Pressair is a prescription medicine used to prevent airflow obstruction and reduce flare-ups in adults with COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema.

Duaklir Pressair is for use only in people with COPD and should not be used to treat asthma.

You should not use Duaklir Pressair if you are allergic to aclidinium or formoterol, or if you have a severe allergy to milk proteins.

Duaklir Pressair is for use only in people with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.

Duaklir Pressair is not a rescue medicine. It will not work fast enough to treat an bronchospasm attack.

Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.

Before taking this medicine

You should not use Duaklir Pressair if you are allergic to aclidinium or formoterol, or if you have a severe allergy to milk proteins.

To make sure Duaklir Pressair is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure;

• a seizure;

• glaucoma;

• diabetes;

• a thyroid disorder; or

• an enlarged prostate or urination problems.

Tell your doctor if you are pregnant or breastfeeding.

Duaklir Pressair is not approved for use by anyone younger than 18 years old.

Use Duaklir Pressair exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides.

Duaklir Pressair is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Store at room temperature away from moisture, heat, and light. Do not store this medicine on a vibrating surface. Keep the inhaler device in the sealed bag until ready to start using it.

Throw the inhaler away 2 months after opening the sealed bag, or when the dose indicator shows a zero, or if your inhaler is empty and locks out (whichever comes first).

You should not stop using Duaklir Pressair suddenly. Stopping suddenly may make your condition worse.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance:

1 inhalation twice daily (morning and evening)
Maximum dose: 2 inhalations per day

You should not use Duaklir Pressair if you are allergic to aclidinium or formoterol, or if you have a severe allergy to milk proteins.

To make sure Duaklir Pressair is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure;

• a seizure;

• glaucoma;

• diabetes;

• a thyroid disorder; or

• an enlarged prostate or urination problems.

Tell your doctor if you are pregnant or breastfeeding.

Duaklir Pressair is not approved for use by anyone younger than 18 years old.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time. Do not use more than 1 inhalation 2 times in a 24-hour period.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include include blurred vision, dry mouth, nausea, muscle spasms, tremors, headache, and fast or pounding heartbeats.

Do not use a second inhaled bronchodilator that contains formoterol, arformoterol, indacaterol, olodaterol, salmeterol, or formoterol.

Get emergency medical help if you have signs of an allergic reaction to Duaklir Pressair: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;

• worsening breathing problems;

• tremors, nervousness, chest pain, fast or pounding heartbeats;

• severe headache, pounding in your neck or ears;

• painful or difficult urination, or urinating more often;

• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;

• high blood sugar - increased thirst or urination, hunger, dry mouth, fruity breath odor; or

• low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling.

Common Duaklir Pressair side effects may include:

• headache;

• back pain; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• atropine;

• antifungal, or antiviral medicine;

• monoamine oxidase inhibitors, tricyclic antidepressants, drugs that prolong QT interval;

• beta-blockers;

• medicine to treat depression, anxiety, mood disorders, or mental illness;

• cold or allergy medicine (Benadryl and others);

• medicine to treat Parkinson's disease;

• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;

• medicine to treat overactive bladder; or

• another bronchodilator medication.

This list is not complete. Other drugs may interact with aclidinium and formoterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.