Lonhala Magnair (Inhalation)

Inhaled glycopyrrolate is used to treat blocked air flow and to prevent worsening of chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema. COPD is a long-term lung disease that leads to bronchospasm (difficulty breathing).

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits. This will help your doctor see if the medicine is working properly and to check for any unwanted effects.

Tell your doctor if you are also using other medicines for your COPD. Your doctor may want you to stop using the other medicine and only use it during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.

This medicine should not be used if you are having a severe COPD attack, or if symptoms of a COPD attack have already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.

Talk to your doctor or get medical care right away if:

• your symptoms do not improve after using this medicine within a few days or if they become worse.
• your short-acting inhaler does not seem to be working as well as usual and you need to use it more often.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing may get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you have a cough, difficulty breathing, shortness of breath, or wheezing after using this medicine.

If you develop a skin rash, hives, swelling of the tongue, lips, or face, or any allergic reaction to this medicine, check with your doctor right away.

Check with your doctor right away if blurred vision, difficulty reading, seeing halos around lights, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to weigh the risks of taking it against the benefits it may provide. For this medicine, you should consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Inhaled glycopyrrolate is not recommended for children. Its safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the usefulness of inhaled glycopyrrolate.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of your other medicines.

• Potassium Citrate

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or the frequency of use for one or both medicines.

• Aclidinium
• Amantadine
• Amifampridine
• Amitriptyline
• Amoxapine
• Atropine
• Belladonna
• Benztropine
• Biperiden
• Brompheniramine
• Buprenorphine
• Bupropion
• Carbinoxamine
• Carisoprodol
• Chlorpheniramine
• Chlorpromazine
• Clemastine
• Clidinium
• Clomipramine
• Clozapine
• Codeine
• Cyclobenzaprine
• Cyclopentolate
• Cyproheptadine
• Darifenacin
• Desipramine
• Dicyclomine
• Dimenhydrinate
• Diphenhydramine
• Donepezil
• Doxepin
• Fesoterodine
• Flavoxate
• Fluphenazine
• Glucagon
• Glycopyrronium Tosylate
• Homatropine
• Hydroxyzine
• Hyoscyamine
• Imipramine
• Ipratropium
• Loxapine
• Meclizine
• Mepenzolate
• Methacholine
• Nortriptyline
• Olanzapine
• Orphenadrine
• Oxitropium Bromide
• Oxybutynin
• Oxycodone
• Paroxetine
• Perphenazine
• Pimozide
• Pipenzolate Bromide
• Pirenzepine
• Prochlorperazine
• Procyclidine
• Promethazine
• Propantheline
• Propiverine
• Protriptyline
• Quetiapine
• Revefenacin
• Scopolamine
• Secretin Human
• Solifenacin
• Stramonium
• Tapentadol
• Terodiline
• Thioridazine
• Thiothixene
• Tiotropium
• Tizanidine
• Tolterodine
• Trifluoperazine
• Trihexyphenidyl
• Trimipramine
• Tropicamide
• Trospium
• Umeclidinium

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk with your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any additional medical problems, especially:

• Allergy to milk proteins—Use with caution. This medicine contains lactose (milk sugar) and milk proteins.

• Bladder problems or
• Enlarged prostate or
• Glaucoma, narrow angle or
• Trouble urinating—Use with caution. This may worsen these conditions.

• Severe COPD attack—Should not be used if you are experiencing a severe COPD attack or if symptoms of a COPD attack have already started. Your doctor may prescribe a different medicine for use in case of an acute COPD attack.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do occur, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• difficult, burning, or painful urination
• difficult or labored breathing
• frequent urge to urinate
• lower back or side pain
• rapid weight gain
• tightness in the chest
• tingling of the hands or feet
• unusual weight gain or loss

Rare

• Fast heartbeat
• fever
• hives, itching, or skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• redness of the skin
• troubled swallowing

Incidence not known

• Blindness
• blurred vision
• decrease in the frequency of urination
• decrease in the urine volume
• decreased vision
• difficulty in passing urine (dribbling)
• eye pain or discomfort, or red eyes
• headache
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nausea
• seeing halos around lights
• tearing
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Body aches or pain
• chills
• cough
• ear congestion
• loss of voice
• pain or tenderness around the eyes and cheekbones
• sneezing
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

Rare

• Diarrhea
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• loss of consciousness
• pain in the arms or legs
• stomachache
• sweating
• trouble sleeping
• unexplained weight loss
• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Lonhala Magnair
• Seebri Neohaler

Available Dosage Forms:

• Solution

Therapeutic Class: Bronchodilator

Pharmacologic Class: Antimuscarinic

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.

Inhaled glycopyrrolate comes with a patient information leaflet and patient instructions. Read the instructions carefully before using this medicine and with each refill. There may be new information. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

Use the Lonhala™ vials only with the Magnair® inhaler device. The liquid in the vials should not be swallowed. It is placed only into the Magnair® inhaler that comes with the package. This device opens the vial and loads the liquid medicine from the capsule into the air chamber. You then inhale the liquid through the mouthpiece. Your caregiver will show you how to use your inhaler.

Use the Seebri™ capsules only with the Neohaler® inhaler device. The medicine capsule should not be swallowed. It is placed only into the Neohaler® inhaler that comes with the package. This device opens the capsule and loads the powder medicine from the capsule into the air chamber. You then inhale the powder through the mouthpiece. Your caregiver will show you how to use your inhaler.

Use this medicine at the same time each day, in the morning and evening.

Do not stop using this medicine or other breathing medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

To use the Lonhala™ Magnair®:

• Follow the patient instructions on how to assemble and disassemble your Magnair® inhaler device. Make sure the aerosol head is attached before placing the medication cap to prevent the medicine from leaking.
• Open the foil pouch and remove the 2 vials.
• Separate the 2 vials and place one back in the pouch for the next treatment.
• Check the liquid in the vial. It should be clear and colorless. Do not use it if it is discolored.
• Insert one vial into the bottom of the Medication cap of the Magnair® until you hear a clicking sound.
• Attach the medication cap to the Handset body and turn the cap in a clockwise direction, until you hear a clicking sound.
• Insert the mouthpiece into your mouth.
• Press the "ON/OFF" button to start your treatment.
• Breathe in and exhale normally through the mouthpiece.
• Your treatment will take about 2 to 3 minutes. You will hear a beeping sound and the controller will automatically shut off after your treatment ends.
• Clean your inhaler device after every use. Throw away the used vial and disassemble the inhaler device before cleaning it. Separate the aerosol head from the other parts. Rinse with warm running water for about 10 seconds. Wash with warm soapy water (water and clear liquid dishwashing soap) for about 10 seconds. Then, rinse again with warm running water for about 10 seconds to remove all of the soap.
• Rinse each side of the aerosol head well with warm running water for about 10 seconds. Hold it by the handle and swish it back and forth in the warm soapy water for about 10 seconds. Then, rinse both sides of the Aerosol head well with warm running water for about 10 seconds on each side.
• Allow the parts to air dry completely. Do not assemble the device until you are ready to use it.
• Do not use the inhaler for this medicine with any other medicine.

To use the Seebri™ Neohaler®:

• Dry your hands before handling this medicine.
• Open a blister card of capsules. Do not remove a capsule until you are ready for a dose. Peel the backing to expose the capsule. Do not push the capsule through the foil to remove it from the blister.
• Remove the cap of the inhaler then hold the base firmly and tilt the mouthpiece to open the inhaler.
• Place the capsule into the capsule chamber in the base of the inhaler. Do not swallow the capsule and do not place a capsule directly into the mouthpiece.
• Close the inhaler fully. You should hear a clicking sound as you close it.
• Hold the mouthpiece of the inhaler upright and press both buttons at the same time. Press the buttons only once. You should hear a click as the capsule is being pierced.
• Breathe out fully. Do not exhale into the mouthpiece.
• Place the mouthpiece in your mouth then close your lips around the mouthpiece.
• Breathe in quickly and deeply.
• Remove the inhaler from your mouth. Hold your breath for at least 50 to 10 seconds, or as long as you can and then exhale.
• Open the inhaler after using it, and remove and discard the empty capsule. Do not leave the used capsule inside the chamber.
• If there is still powder in the capsule, close the inhaler and repeat the inhalation process.
• Close the mouthpiece and then replace the cover.
• Do not wash the inhaler. Keep it dry.
• Use a new inhaler with each refill of your medicine.
• Do not use the inhaler for this medicine with any other medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For maintenance treatment of COPD: For inhalation liquid dosage form (used with Lonhala™ Magnair®): Adults—1 vial by oral inhalation two times a day (1 vial in the morning and 1 vial in the evening). Children—Use is not recommended. For inhalation powder dosage form (used with Seebri™ Neohaler®): Adults—1 capsule by oral inhalation two times a day (1 capsule in the morning and 1 capsule in the evening). Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Lonhala™ Magnair®: If you miss a dose, take your next dose at your usual time. Do not use 2 vials at a time. Do not use more than 2 vials in a day.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

You may store the unused vials in the foil pouch until 7 days.

• Lonhala Magnair vs Seebri Neohaler - How do they differ?