Glycopyrrolate, Inhalation

________________________________________________________________________

KEY POINTS

• This medicine is inhaled by 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.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: anticholinergic; bronchodilator

Generic and brand names: glycopyrrolate, inhalation; Seebri Neohaler

What is this medicine used for?

This medicine is inhaled by 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?

Before taking this medicine, tell your healthcare provider if you have ever had:

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

Females of childbearing age: Tell 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 take it?

Check the label on the medicine for directions about your specific dose. Use this medicine exactly as prescribed. Do use take more than directed because increasing the dosage increases the risk of side effects. Do not stop using this or any other medicines to control or treat your COPD unless told to do so by your healthcare provider.

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

Do not swallow these capsules. Use the capsules only in the Neohaler. Do not use 2 capsules at one time or use more than 2 capsules per day.

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, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. 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?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, blurred vision, eye pain and redness, decreased urination, large pupils, dizziness, drowsiness.

What should I watch out for?

This medicine must not be the only medicine you use to treat COPD. Do not use this medicine for sudden breathing problems. Your healthcare provider may also prescribe a short-acting inhaled medicine to use when you have a sudden breathing problem. Use all medicines as directed by your healthcare provider. Talk with your healthcare provider if you have any questions.

Contact your healthcare provider if your condition does not improve or if it gets worse. If you have any of these symptoms, call your healthcare provider right away:

• You need to use more puffs than usual of your short-acting inhaler or use it more often.
• You have severe breathing trouble that does not improve, such as persistent wheezing, coughing, or shortness of breath.
• You have a bluish color in your lips or fingernails or cannot speak.
• You have any breathing symptoms that are getting worse.

This medicine may cause blurred vision or dizziness. Do not drive or operate machinery unless you are fully alert and able to see clearly.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking 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) or seizures.

Serious (Report these to your healthcare provider right away.): Severe vision problems, eye redness, or eye pain; seeing halos or bright colors around lights; increased trouble breathing or sudden shortness of breath; trouble urinating or painful urination; severe constipation.

Other: Mild nausea, diarrhea, vomiting, stomach pain, back pain, joint pain, stuffy or runny nose, sore throat, dizziness.

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:

• Alzheimer’s disease medicines such as donepezil (Aricept), galantamine (Razadyne), and rivastigmine (Exelon)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as disopyramide (Norpace), procainamide, and quinidine
• Antibiotics such as clarithromycin (Biaxin) and erythromycin (E.E.S., Ery-Tab, Erythrocin)
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), 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), and meclizine (Dramamine)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Atenolol (Tenormin)
• Bladder control medicines such as darifenacin (Enablex), fesoterodine (Toviaz), mirabegron (Myrbetriq), oxybutynin (Ditropan XL, Oxytrol), solifenacin (VESIcare), tolterodine (Detrol), and trospium
• Cimetidine (Tagamet)
• Cyclobenzaprine (Amrix)
• Decongestants such as oxymetazoline (Afrin, Dristan), phenylephrine (Neo-Synephrine, Sudafed PE), and pseudoephedrine (Sudafed)
• Digoxin (Lanoxin)
• Doxepin (Silenor)
• Hydroxyzine (Vistaril)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Metformin (Fortamet, Glucophage, Riomet)
• Metoclopramide (Metozolv, Reglan)
• Narcotic pain medicines such as codeine, hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), morphine (Kadian, MS Contin), and oxycodone (OxyContin, Roxicodone)
• Nausea medicines such as dronabinol (Marinol), nabilone (Cesamet), prochlorperazine (Compro), and promethazine
• Other medicines to treat breathing or lung problems such as aclidinium (Tudorza), glycopyrrolate (Seebri), ipratropium (Atrovent), tiotropium (Spiriva), and umeclidinium (Incruse Ellipta)
• Parkinson’s disease medicines such as amantadine (Symmetrel) and levodopa/carbidopa (Duopa, Rytary, Sinemet)
• Potassium supplements or salt substitutes that contain potassium
• Pramlintide (Symlin)
• Tricyclic antidepressants such as amitriptyline, desipramine (Norpramin), imipramine (Tofranil), and nortriptyline (Pamelor)

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 the medicine at room temperature. Protect the medicine from heat, high humidity, and bright light. Keep the capsules in the blister pack until you use them. Once the blister pack is opened, use the medicine right away.

---

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.