Important Safety Information and Indication for LONHALA MAGNAIR
Important Safety Information
LONHALATM MAGNAIRTM [lon-HAH-luh MAGG-nair] (glycopyrrolate) Inhalation Solution
This summary does not include all information about LONHALA MAGNAIR and is not meant to take the place of discussions with your health care provider about your treatment. Please read this important information carefully before you start taking LONHALA MAGNAIR. Discuss any questions about LONHALA MAGNAIR with your healthcare provider.
What is LONHALA MAGNAIR?
LONHALA MAGNAIR 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 LONHALA MAGNAIR help the muscles around the airways in your lungs stay relaxed to help control COPD symptoms such as wheezing, coughing, chest tightness, and shortness of breath.
Who should not use LONHALA MAGNAIR?
Do not use LONHALA MAGNAIR if you:
- have sudden symptoms of COPD. LONHALA MAGNAIR 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 LONHALA MAGNAIR (see below). Ask your healthcare provider if you are not sure.
- Active ingredient: glycopyrrolate
- Inactive ingredients: citric acid monohydrate, sodium chloride, sodium hydroxide and water for injection
- LONHALA MAGNAIR should not be used by children. It is not known if LONHALA MAGNAIR is safe and effective for children.
What warnings should I know about LONHALA MAGNAIR?
LONHALA MAGNAIR 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 LONHALA MAGNAIR. 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 LONHALA MAGNAIR immediately.
- serious allergic reactions. Stop using LONHALA MAGNAIR if you get any of the following symptoms:
- swelling of the tongue, lips, and face
- difficulty 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
- nausea or vomiting
- seeing halos or bright colors around lights
- new or worsened problems emptying your bladder (urinary retention). People who use LONHALA MAGNAIR 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 any of these side effects, stop using LONHALA MAGNAIR 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 LONHALA MAGNAIR, 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 LONHALA MAGNAIR. Call your healthcare provider.
What should I tell my healthcare provider before using LONHALA MAGNAIR?
Before using LONHALA MAGNAIR, tell your healthcare provider about all of your medical conditions, including if you:
- have kidney problems.
- have eye problems such as glaucoma. LONHALA MAGNAIR may make glaucoma worse.
- have prostate or bladder problems, or problems passing urine. LONHALA MAGNAIR may make these problems worse.
- are pregnant or plan to become pregnant. It is not known if LONHALA MAGNAIR can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if the medicine in LONHALA MAGNAIR passes into your breast milk or if it can harm your baby.
- are allergic to LONHALA MAGNAIR or any of its ingredients or any other medicines.
Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements. LONHALA MAGNAIR may affect the way other medicines work, and other medicines can affect how LONHALA MAGNAIR works. This may cause serious side effects.
Especially tell your healthcare provider if you take other anticholinergics (including umeclidinium, tiotropium, ipratropium, aclidinium, glycopyrrolate).
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 LONHALA MAGNAIR?
Read the step-by-step instructions for using LONHALA MAGNAIR found in the Prescribing Information and the Manufacturer's Instruction for Use booklet.
- Only use LONHALA vials with the MAGNAIR device.
- Do not use LONHALA MAGNAIR unless your healthcare provider has taught you how to use the device and you understand how to use it correctly.
- Use LONHALA MAGNAIR exactly as your healthcare provider tells you to use it.
- Do not use LONHALA MAGNAIR:
- more often than prescribed.
- at higher dose than prescribed.
- with other anticholinergic medicines.
- Inhale the medicine in 1 LONHALA vial through the MAGNAIR device twice each day (1 vial in the morning and 1 vial in the evening).
- Do not inject or swallow the LONHALA medicine.
- If you miss a dose of LONHALA MAGNAIR, just skip that dose. Take the next dose at your usual time. Do not use 2 vials at 1 time. Do not use more than 2 vials in a day.
- Do not stop using LONHALA MAGNAIR 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.
What are the possible side effects with LONHALA MAGNAIR?
- See "What warnings should I know about LONHALA MAGNAIR?"
Common side effects of LONHALA MAGNAIR include: shortness of breath and urinary tract infections.
These are not all the side effects of LONHALA MAGNAIR. 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.LonhalaMagnair.com to obtain the FDA-approved product labeling.
- Call Sunovion at 1-888-394-7377.
For additional information, please see full Prescribing Information and Patient Information for LONHALA MAGNAIR.
LONHALATM MAGNAIRTM (glycopyrrolate) is a medicine called an anticholinergic. LONHALA MAGNAIR is used long term, twice each day (morning and evening), for maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.