Summary of Important Information for SEEBRI NEOHALER
SEEBRI® NEOHALER® [SEE-bree] (glycopyrrolate) Inhalation Powder, for oral inhalation use
This summary does not include all information about SEEBRI NEOHALER and is not meant to take the place of discussions with your healthcare provider about your treatment. Please read this important information carefully before you start taking SEEBRI NEOHALER. Discuss any questions about SEEBRI NEOHALER with your healthcare provider.
What is SEEBRI NEOHALER?
SEEBRI NEOHALER is a prescription, anticholinergic medicine, used long term and twice each day (morning and evening) to improve symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults with COPD. COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both.
Anticholinergic medicines such as SEEBRI NEOHALER help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, coughing, chest tightness, and shortness of breath.
Who should not use SEEBRI NEOHALER?
Do not use SEEBRI NEOHALER if you:
- have sudden symptoms of COPD. SEEBRI NEOHALER should not be used as rescue therapy. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed.
- are allergic to glycopyrrolate, or any of the ingredients in SEEBRI NEOHALER (see below). Ask your healthcare provider if you are not sure.
- Active ingredient: glycopyrrolate
- Inactive ingredients: lactose monohydrate (contains trace levels of milk protein) and magnesium stearate
- SEEBRI NEOHALER should not be used by children. It is not known if SEEBRI NEOHALER is safe and effective for children.
What warnings should I know about SEEBRI NEOHALER?
SEEBRI NEOHALER can cause serious side effects, including:
- sudden shortness of breath immediately after use. Sudden shortness of breath may be life-threatening. If you have sudden breathing problems immediately after inhaling your medicine, stop using SEEBRI NEOHALER. Call your healthcare provider or go to the nearest hospital emergency room right away.
- life-threatening paradoxical bronchospasm, which means your airway passages may narrow and breathing may become difficult. Stop using SEEBRI NEOHALER immediately.
- serious allergic reactions. Stop using SEEBRI NEOHALER if you get any of the following symptoms:
- swelling of the tongue, lips, and face
- difficulty in breathing or swallowing
- new or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms may include:
- eye pain or discomfort
- red eyes
- blurred vision
- seeing halos or bright colors around lights
- nausea or vomiting
- new or worsened problems emptying your bladder (urinary retention). People who use SEEBRI NEOHALER may develop new or worsened urinary retention. Urinary retention can be caused by a blockage in your bladder, or it can develop in men with a larger than normal prostate. Symptoms may include:
- difficulty urinating
- painful urination
- urinating frequently
- urination in a weak stream or drips
If you have these side effects, stop taking SEEBRI NEOHALER and call your healthcare provider or get emergency medical treatment right away before taking another dose.
Do not exceed the recommended dose. Excessive use of SEEBRI NEOHALER, or use with other anticholinergic medications, can result in undesirable increase in anticholinergic activity.
If your COPD symptoms worsen over time, do not increase your dose of SEEBRI NEOHALER. Call your healthcare provider.
What should I tell my healthcare provider before using SEEBRI NEOHALER?
Before using SEEBRI NEOHALER, tell your healthcare provider about all your medical conditions, including if you:
- have kidney problems.
- have eye problems such as glaucoma. SEEBRI NEOHALER may make glaucoma worse.
- have prostate or bladder problems, or problems passing urine. SEEBRI NEOHALER may make these problems worse.
- are pregnant or plan to become pregnant. It is not known if SEEBRI NEOHALER can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if the medicine in SEEBRI NEOHALER passes into your breast milk or if it can harm your baby.
- are allergic to SEEBRI NEOHALER or any of its ingredients, any other medicines, or food products.
SEEBRI NEOHALER contains lactose (milk sugar) and a small amount of milk proteins. It is possible that allergic reactions may happen in people who have a severe milk protein allergy.
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. SEEBRI NEOHALER may affect the way other medicines work, and other medicines can affect how
SEEBRI NEOHALER works. Using SEEBRI NEOHALER with other medicines may cause serious side effects.
Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I use SEEBRI NEOHALER?
Read the step-by-step instructions for using SEEBRI NEOHALER found in the Prescribing Information.
- Do not use SEEBRI NEOHALER unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
- Use SEEBRI NEOHALER exactly as your healthcare provider tells you to use it.
- Always use the new NEOHALER inhaler that is provided with each new prescription.
- Do not swallow SEEBRI capsules.
- Only use SEEBRI capsules with the NEOHALER inhaler.
- Use 1 SEEBRI capsule inhaled through the NEOHALER inhaler twice each day (1 capsule in the morning and 1 capsule in the evening).
- If you miss a dose of SEEBRI NEOHALER, take it as soon as you remember. Take your next dose at the usual time.
- Do not use 2 capsules at 1 time.
- Do not use more than 2 capsules in a day.
- SEEBRI capsules should always be stored in the blister strip and only removed immediately before use. Peel the backing foil away from the blister to open it, do not push the capsule through the foil.
- Do not stop using SEEBRI NEOHALER or other medicines to control or treat your COPD unless told to do so by your healthcare provider. Your symptoms might get worse. Your healthcare provider will change your medicines as needed.
- Call your healthcare provider or get emergency medical care right away if your breathing problems worsen with SEEBRI NEOHALER, you need to use your rescue medicine more often than usual, or your rescue inhaler medicine does not work as well for you at relieving your symptoms.
- Do not use SEEBRI NEOHALER:
- more often than prescribed.
- at higher dose than prescribed.
- with other anticholinergic medicines.
What are the possible side effects with SEEBRI NEOHALER?
- See "What warnings should I know about SEEBRI NEOHALER?"
Common side effects of SEEBRI NEOHALER include: upper respiratory tract infection, sore throat, and runny nose.
These are not all the possible side effects of SEEBRI NEOHALER. Tell your healthcare provider about any side effect that bothers you or that does not go away. Ask your healthcare provider or pharmacist for more information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is not comprehensive.
How to get more information:
- Talk to your healthcare provider or pharmacist.
- Visit www.SEEBRI.us to obtain the FDA-approved product labeling.
- Call Sunovion at 1-888-394-7377.
*Restrictions and eligibility requirements apply. Eligible patients may pay as little as $10 co-pay, equaling a savings of up to $250 off each SEEBRI NEOHALER prescription fill for up to a 30-day supply. Limited to 12 qualifying prescription fills per calendar year. Valid only for those with commercial insurance. Offer not valid under Medicare, Medicaid, or any other federal or state program. Cash-paying patients will save up to $250 off the cost of their prescription. This program is not health insurance. SEEBRI NEOHALER Savings Terms and Conditions apply.