Instructions for Use

It is important for patients to understand how to correctly administer SEEBRI capsules using the NEOHALER device. Instruct patients that SEEBRI capsules should only be administered via the NEOHALER device and the NEOHALER device should not be used for administering other medications. Remind patients that the contents of SEEBRI capsules are for oral inhalation only and must not be swallowed.

Instruct patients always to store SEEBRI capsules in sealed blisters and to only remove a SEEBRI capsule immediately before use or it may not be as effective. Instruct patients to discard unused additional SEEBRI capsules that are exposed to air (i.e., not intended for immediate use).

Inform patients to use one inhalation of SEEBRI NEOHALER orally twice-daily (1 capsule in the morning and 1 capsule in the evening) at the same time every day.

Inform patients that if they miss a dose of SEEBRI NEOHALER, they should use their next capsule at the usual time. Instruct patients to not use 2 capsules at one time and to not use more than 2 capsules in a day.

Learn the 3 I’s for helping patients remember the detailed steps for using the SEEBRI NEOHALER.

Help patients remember the 13 detailed steps in the Instructions for Use by learning the 3 I's for using SEEBRI NEOHALER. You can also watch the brief video below. Before patients use the SEEBRI NEOHALER, they should refer to the full Prescribing Information and Patient Information.

insert

Step 1. Pull off cap

Step 2. Open Inhaler

Hold the base of the inhaler firmly and tilt the mouthpiece to open the inhaler.

Step 3. Prepare capsule

Separate 1 of the blisters from the blister card by tearing along the perforation.

Take 1 blister and peel away the protective backing to expose the capsule.

Do not push the capsule through the foil to remove it from the blister.

Step 4. Remove a SEEBRI capsule

Capsules should always be stored in the blister and only removed immediately before use.

With dry hands, remove 1 capsule from the blister.

Do not swallow the SEEBRI capsule.

Step 5. Insert capsule

Place the capsule into the capsule chamber.

Do not place a capsule directly into the mouthpiece.

Step 6. Close the inhaler

Close the inhaler fully. You should hear a 'click' as it fully closes.

inhale

Step 7. Pierce the capsule

Hold the inhaler upright with the mouthpiece pointing up.

Press both piercing buttons together firmly at the same time. You should hear a ‘click’ as the capsule is being pierced.

Do not press the piercing buttons more than 1 time.

Step 8. Release the piercing buttons fully

Step 9. Breathe out

Before placing the mouthpiece in your mouth, breathe out fully.

Do not blow into the mouthpiece.

Step 10. Inhale the medicine

Before breathing in:

Hold the inhaler as shown in the figure for Step 10. Make sure that the piercing buttons are to the left and right of the inhaler (not up and down).
Place the mouthpiece in your mouth and close your lips firmly around the mouthpiece.
Breathe in rapidly but steadily, as deeply as you can. Do not press the piercing buttons.

Note the whirring noise from the inhaler

Step 11. Note

As you breathe in through the inhaler, the capsule spins around in the chamber and you should hear a whirring noise. You may experience a sweet flavor as you inhale the medicine.

If you do not hear a whirring noise, the capsule may be stuck in the capsule chamber. If this occurs, open the inhaler and carefully loosen the capsule by tapping the base of the inhaler. Do not press the piercing buttons to loosen the capsule. (Repeat steps 9 and 10 if necessary).

Step 12. Hold breath

Continue to hold your breath for at least 5 to 10 seconds or as long as comfortably possible while removing the inhaler from your mouth. Then breathe out.

inspect

Remove SEEBRI capsule from the NEOHALER inhaler

Open the inhaler to see if any powder is left in the capsule. If there is powder left in the capsule, close the inhaler and repeat steps 9 to 12. Most people are able to empty the capsule with 1 or 2 inhalations.

Some people may cough soon after inhaling the medicine. If you do, don’t worry, as long as the capsule is empty, you have received 1 full dose.

Step 13. Remove capsule

After you have finished taking your dose of SEEBRI NEOHALER, open the mouthpiece again, remove the empty capsule by tipping it out of the capsule chamber, and throwing it away. Close the inhaler and replace the cap.

Do not leave the used capsules in the NEOHALER inhaler.

For additional information, please see the full Prescribing Information and Patient Information for SEEBRI NEOHALER.

A Video Guide to Using the SEEBRI NEOHALER.

Read or download the full Instructions for Use. Print out a copy to review and keep for reference.

Important Safety Information & Indication

Important Safety Information

SEEBRI NEOHALER is contraindicated in patients with a hypersensitivity to glycopyrrolate or to any of the ingredients.

SEEBRI NEOHALER should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta₂-agonist.

As with other inhaled medicines, SEEBRI NEOHALER can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs following dosing with SEEBRI NEOHALER, it should be treated immediately with an inhaled, short-acting bronchodilator; SEEBRI NEOHALER should be discontinued immediately and alternative therapy instituted.

Immediate hypersensitivity reactions have been reported with SEEBRI NEOHALER. If signs occur, discontinue immediately and institute alternative therapy. SEEBRI NEOHALER should be used with caution in patients with severe hypersensitivity to milk proteins.

SEEBRI NEOHALER should be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema) and of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Patients should be instructed to consult a physician immediately should any of these signs or symptoms develop.

The most common adverse events reported in ≥1% of patients taking SEEBRI NEOHALER, and occurring more frequently than in patients taking placebo, were upper respiratory tract infection (3.4% vs 2.3%), nasopharyngitis (2.1% vs 1.9%), oropharyngeal pain (1.8% vs 1.2%), urinary tract infection (1.4% vs 1.3%), and sinusitis (1.4% vs 0.7%).

SEEBRI capsules must not be swallowed as the intended effects on the lungs will not be obtained. SEEBRI capsules are only for oral inhalation and should only be used with the NEOHALER device.

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.

For additional information, please see full Prescribing Information and Patient Information for SEEBRI NEOHALER.

Indication

SEEBRI^TM NEOHALER^® (glycopyrrolate) is an anticholinergic indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.