(a'' kli din' ee um )

Brand Name(s): Tudorza^® Pressair^®, Duaklir^® Pressair^® (as a combination product containing Aclidinium, Formoterol)

WHY is this medicine prescribed?

Aclidinium is used as a long term treatment to prevent wheezing, shortness of breath, coughing, and chest tightness in patients with chronic obstructive pulmonary disease (COPD, a group of diseases that affect the lungs and airways) such as chronic bronchitis (swelling of the air passages that lead to the lungs) and emphysema (damage to air sacs in the lungs). Aclidinium is in a class of medications called bronchodilators. It works by relaxing and opening the air passages to the lungs to make breathing easier.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Aclidinium comes as a dry powder in an inhalation device to inhale by mouth. It is usually inhaled twice a day, once every 12 hours. Inhale aclidinium at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Inhale aclidinium exactly as directed. Do not inhale more or less of it or inhale it more often than prescribed by your doctor.

Do not use aclidinium to treat a sudden attack of wheezing or shortness of breath. Your doctor will prescribe a rescue medication to treat sudden attacks of symptoms. Keep this rescue medication with you at all times in case you have sudden difficulty breathing.

Your condition may worsen over time during your treatment with aclidinium. Do not take extra doses of aclidinium if this happens. Call your doctor or get emergency medical help if your breathing problems worsen, you need to use your rescue medication to treat sudden attacks more often, or your rescue medication does not relieve your symptoms as well as it did in the past.

Aclidinium can help control your symptoms but does not cure COPD. You may notice some improvement in your symptoms the first day that you use aclidinium, but it may take longer for you to feel the full benefit of the medication. Continue to use aclidinium even if you feel well. Do not stop using aclidinium without talking to your doctor.

Before you use your aclidinium inhalation device for the first time, read the manufacturer's directions for use carefully. Ask your doctor or pharmacist to show you how to use the device and practice using it while he or she watches.

Be careful not to get aclidinium powder in your eyes. If you get the powder in your eyes, you may experience blurred vision and sensitivity to light.

The aclidinium inhalation device does not need to be cleaned. If you want to clean the device, you may wipe the outside of the mouthpiece with a dry tissue or paper towel. Never use water to clean the device because you might damage the medication.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using aclidinium,

• tell your doctor and pharmacist if you are allergic to aclidinium, atropine (Atropen, in Lomotil, in Lonox, in Motofen), any other medications, any of the ingredients in aclidinium inhalation powder, or milk proteins. Ask your pharmacist or check the patient information for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antihistamines; atropine (Atropen, in Lomotil, in Lonox, in Motofen); glycopyrrolate (Lonhala Magnair, Seebri, in Bevespi Aerosphere, in Utibron); ipratropium (Atrovent); medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, and urinary problems; tiotropium (Spiriva); and umeclidinium (Incruse Ellipta, in Anoro Ellipta, in Trelegy Ellipta). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had glaucoma (increased pressure in the eye that may cause vision loss), benign prostatic hypertrophy (BPH; enlargement of a male reproductive gland), a bladder condition, or any other condition that makes it difficult for you to empty your bladder completely.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking aclidinium, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not inhale a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Aclidinium may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• runny nose and other cold symptoms
• cough
• diarrhea

Some side effects can be serious. If you experience any of these symptoms, stop using aclidinium and call your doctor immediately or get emergency medical treatment:

• sudden shortness of breath immediately after inhaling the medication
• eye pain or redness
• blurred vision
• seeing halos or bright colors around lights
• nausea or vomiting
• difficult, painful or frequent urination
• weak urine stream
• rash
• hives
• itching
• swelling of the eyes, face, lips, mouth, tongue, or throat
• difficulty breathing or swallowing

Aclidinium may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Keep the device in the protective pouch and do not open the sealed pouch until you are ready to use the medication. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not store the medication on a surface that vibrates. Dispose of the inhalation device 45 days after you open it, when you see a zero in the dose indicator window, or when the device locks out, whichever comes soonest.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: May 15, 2019.