Boehringer Ingelheim Spriva HandiHaler - User Manual

How To Use Your HandiHaler
Familiarize yourself with the parts of your HandiHaler device:
It’s important to remember to take SPIRIVA every day and use your SPIRIVA HandiHaler correctly as prescribed by your doctor. This quick overview may help.
For complete information on using the SPIRIVA HandiHaler, please see the Instructions for Use attached to your SPIRIVA HandiHaler prescription.
Important information about using your SPIRIVA HandiHaler:
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Please see accompanying full Prescribing Information, including Patient Information and
Instructions for Use.
1. Dust cap (lid)
2. Mouthpiece
3. Mouthpiece ridge
4. Base
5. Green piercing button
6. Center chamber
7. Air intake vents
Taking your dose of SPIRIVA requires 4 main steps:
1. Open the HandiHaler device. Separate only one of the blisters
from the blister card; then open the blister.
3. Press the green piercing button once until it is flat (flush)
against the base, then release.
2. Insert the SPIRIVA capsule and close the mouthpiece firmly
against the gray base until you hear a click.
4. Breathe out completely. Then, with the HandiHaler in your
mouth, breathe in deeply until your lungs are full. You should
hear or feel the SPIRIVA capsule vibrate (rattle).
Remember, to take your full daily dose, you must inhale twice
from the same SPIRIVA capsule.
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Summary

Familiarize Yourself With Your HandiHaler Device

Parts of the HandiHaler Device

Identifies and labels the key components of the HandiHaler device, including the dust cap, mouthpiece, base, and piercing button.

How to Use Your SPIRIVA HandiHaler

Opening the HandiHaler Device

Details the initial steps for opening the HandiHaler, including separating a blister and opening the dust cap.

Inserting the SPIRIVA Capsule

Explains how to correctly place the SPIRIVA capsule into the HandiHaler's center chamber and close the mouthpiece.

Piercing the SPIRIVA Capsule

Describes the process of pressing the green piercing button to create holes in the capsule for inhalation.

Taking Your Dose

Guides the user on how to inhale deeply from the HandiHaler twice for a full daily dose.

Important Safety Information

Allergy and Breathing Warnings

Advises users to stop taking SPIRIVA and seek medical help if allergic reactions or sudden breathing worsening occurs.

Rescue Inhaler and Vision;Urination Issues

Clarifies SPIRIVA is not a rescue medicine and to consult a doctor for vision changes or urination difficulties.

Pre-existing Conditions and Side Effects

Mentions conditions like glaucoma, enlarged prostate, kidney problems, and common side effects like dry mouth.

Product Indication and Reporting

SPIRIVA HandiHaler Indication

States SPIRIVA HandiHaler is for controlling symptoms of chronic obstructive pulmonary disease (COPD).

Reporting Side Effects

Encourages reporting negative side effects of prescription drugs to the FDA via MedWatch.

Caring for and Cleaning Your HandiHaler

Storage and Maintenance

Provides instructions on storing the device in a dry place and keeping capsules in sealed blisters.

Cleaning Procedures

Details how to clean the HandiHaler with warm water, air-dry for 24 hours, and avoid detergents.

Overview

1. Function Description
2. Usage Features
3. Troubleshooting Inhalation
4. Maintenance Features
5. Storage

The SPIRIVA HandiHaler is a prescription medicine delivery device designed for the oral inhalation of tiotropium bromide powder, a maintenance medicine used once daily to control symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It helps relax airways, keep them open, and reduce the likelihood of flare-ups and worsening COPD symptoms.

Function Description:

The HandiHaler device is specifically engineered to deliver a small amount of tiotropium bromide powder from a capsule into the lungs through oral inhalation. It consists of several key parts: a dust cap (lid), a mouthpiece, a mouthpiece ridge, a base, a green piercing button, a center chamber, and air intake vents. The device works by allowing the user to insert a SPIRIVA capsule into the center chamber, pierce it with the green button, and then inhale the released powder. The design ensures that the medicine is delivered directly to the lungs, where it can be most effective. It is crucial to remember that SPIRIVA capsules should never be swallowed, as their contents are intended solely for inhalation using this device. The HandiHaler is not a rescue medicine and should not be used for treating sudden breathing problems.

Usage Features:

Using the SPIRIVA HandiHaler involves a four-step process to ensure the full daily dose is administered correctly.

1. Opening the Device and Preparing the Capsule:

   • To begin, the user separates a single SPIRIVA blister from the blister card by tearing along the perforated line. It's important not to cut the foil or use sharp instruments. Instead, the user bends a blister corner with an arrow and peels back the printed foil until the entire SPIRIVA capsule is visible. If more than one blister is opened to the air, the extra capsules should be discarded.
   • The HandiHaler device is then opened by pressing the green piercing button to release the dust cap (lid), which is then pulled upwards away from the base to expose the mouthpiece. The mouthpiece is then pulled up and away from the base, revealing the center chamber.
   • The SPIRIVA capsule is carefully placed into the center chamber of the HandiHaler device.
   • Finally, the mouthpiece is closed firmly against the gray base until a click is heard, ensuring the capsule is securely in place. The dust cap (lid) should be left open.

2. Piercing the Capsule:

   • With the mouthpiece pointed up, the user presses the green piercing button once until it is flat (flush) against the base, then releases it. This action creates holes in the SPIRIVA capsule, allowing the medicine to be inhaled. It is critical to press the button only once and not to shake the device. Small gelatin pieces from the capsule may pass through the screen into the mouth or throat during inhalation, which is normal and harmless.

3. Inhaling the Medicine:

   • The user must first breathe out completely, emptying their lungs of any air. It is important not to breathe into the HandiHaler device.
   • Next, the user holds their head in an upright position, looking straight ahead, and raises the HandiHaler device to their mouth in a horizontal position, ensuring the air intake vents are not blocked.
   • The lips are closed tightly around the mouthpiece.
   • The user then breathes in deeply until their lungs are full. During this deep inhalation, a vibrating or rattling sound from the SPIRIVA capsule should be heard or felt, indicating correct inhalation.
   • After inhaling, the user holds their breath for a few seconds while simultaneously removing the HandiHaler device from their mouth.
   • Finally, the user breathes normally again.
   • To ensure the full daily dose is received, the user must repeat the breathing out completely and then breathing in deeply from the same SPIRIVA capsule a second time. The green piercing button should not be pressed again for the second inhalation.

Troubleshooting Inhalation:

If the SPIRIVA capsule rattle is not heard or felt during inhalation, the user should not press the green piercing button again. Instead, they should hold the device with the mouthpiece pointed up and gently tap it on a table. They should also check that the mouthpiece is completely closed and breathe out completely before attempting to inhale deeply again. If the rattle is still absent after these steps, the capsule should be discarded. Additionally, the user can open the base by lifting the green piercing button and check the center chamber for any SPIRIVA capsule pieces, which can prevent rattling. If pieces are found, the device should be turned upside down and gently but firmly tapped to remove them.

Maintenance Features:

The SPIRIVA HandiHaler device requires regular cleaning to maintain its functionality and hygiene.

1. Daily Post-Use Care:

   • After taking the daily dose, the mouthpiece should be opened, and the used SPIRIVA capsule should be tipped out into a trash can without touching it.
   • Any SPIRIVA capsule pieces or powder buildup can be removed by turning the HandiHaler device upside down and gently but firmly tapping it.
   • The mouthpiece and dustcap are then closed for storage.

2. Cleaning the Device:

   • The HandiHaler device should be cleaned as needed. It takes 24 hours for the device to air dry completely after cleaning.
   • Important Cleaning Restrictions: Do not use cleaning agents or detergents. Do not place the HandiHaler device in a dishwasher. Do not use a hair dryer to dry the device. Do not use the HandiHaler device when it is wet.
   • Cleaning Steps:
     • Open the dust cap and mouthpiece.
     • Open the base by lifting the green piercing button.
     • Inspect the center chamber for SPIRIVA capsule pieces or powder buildup; if seen, tap them out.
     • Rinse the HandiHaler device with warm water, pressing the green piercing button a few times to ensure the center chamber and piercing needle are thoroughly rinsed under running water. Verify that any powder buildup or SPIRIVA capsule pieces are removed.
     • Dry the HandiHaler device well by tipping out excess water onto a paper towel.
     • Air-dry the device by leaving the dust cap, mouthpiece, and base open and fully spread out until completely dry.
     • If necessary, the outside of the mouthpiece can be cleaned with a clean damp cloth.

Storage:

The HandiHaler device and SPIRIVA capsules (blisters) should not be stored in a damp or moist place. SPIRIVA capsules should always be stored in their sealed blisters until ready for use.

Boehringer Ingelheim Spriva HandiHaler Specifications