Aclidinium Bromide, Inhalation

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KEY POINTS

• This medicine is inhaled through the mouth to treat breathing problems caused by COPD. Use it exactly as directed.
• Do not use this medicine for sudden breathing problems. Your healthcare provider can prescribe a short-acting inhaled medicine to use when you have a sudden breathing problem.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: bronchodilator; anticholinergic

Generic and brand names: aclidinium bromide, inhalation; Tudorza Pressair

What is this medicine used for?

This is a long-acting medicine that is inhaled through your mouth to treat breathing problems caused by COPD.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to milk proteins
• Glaucoma
• Kidney disease
• Trouble urinating or an enlarged prostate gland

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions in the medicine package for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under age 18.

Use this medicine daily, exactly as your healthcare provider prescribes. Do not use more of it, use it more often, or use it for a longer period than prescribed. Do not stop using this medicine without your healthcare provider's approval.

If you are using other inhaler medicines, talk with your healthcare provider about which medicine to use first.

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. Do not use this medicine more than 2 times in 24 hours. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine is not used to treat acute bronchospasm (sudden wheezing, coughing, and shortness of breath). Your healthcare provider will prescribe a different medicine that you inhale through your mouth for quick relief. Use all medicines as directed by your healthcare provider. This medicine may cause an increase in wheezing or trouble breathing right after taking the medicine. If this happens, stop using this medicine and contact your healthcare provider.

Contact your healthcare provider if your breathing does not improve with use of this medicine or if it gets worse.

If you need to use your quick relief medicine more often than usual or if it does not seem to work as well, contact your healthcare provider.

If this medicine gets in your eyes it can cause pain, large pupils, and blurred vision. If this happens, flush your eyes with water and contact your healthcare provider right away.

This medicine may cause blurred vision. Do not drive or operate machinery unless you can see clearly.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Blurred vision or other vision changes, vision halos, eye pain, increased trouble breathing, irregular or fast heart rate, chest pain, trouble urinating, burning or pain with urinating, nausea or vomiting.

Other: Headache, cough, diarrhea, sore throat, runny or stuffy nose.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), glycopyrrolate (Cuvposa, Robinul), hyoscyamine (HyoMax, Levbid, Levsin), methscopolamine (Pamine), propantheline, and trihexyphenidyl
• Antidepressants such as amitriptyline, amoxapine, clomipramine, desipramine (Norpramin), imipramine (Tofranil), and nortriptyline (Pamelor)
• Antihistamines such as brompheniramine, chlorpheniramine (Chlor-Trimeton), cyproheptadine, diphenhydramine (Benadryl), hydroxyzine (Vistaril), meclizine (Dramamine).
• Antipsychotic medicines such as chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), loxapine, olanzapine (Zyprexa), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine and trifluoperazine
• Bladder control medicines such as darifenacin (Enablex), oxybutynin (Ditropan XL, Oxytrol), solifenacin (VESIcare), and trospium
• Cyclobenzaprine (Amrix)
• Doxepin (Silenor)
• Nausea medicines such as metoclopramide (Metozolv, Reglan), prochlorperazine (Compro), and promethazine
• Other medicines to treat breathing or lung problems such as glycopyrrolate (Seebri), ipratropium (Atrovent), tiotropium (Spiriva), and umeclidinium (Incruse Ellipta)

If you are using other inhaler medicines, talk with your healthcare provider about which medicine to use first.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the inhaler in the pouch until you are ready to use one. Discard the inhaler 45 days after opening the pouch or when the inhaler shows “0”. Protect the inhaler from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.