Boehringer Ingelheim Spriva HandiHaler Operating instructions

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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Instructions for Use
SPIRIVA®(speh REE vah) HandiHaler®
(tiotropium bromide inhalation powder)
Do not swallow SPIRIVA capsules.
Important Information about using your SPIRIVA HandiHaler
• Do not swallow SPIRIVA capsules.
• SPIRIVA capsules should only be used with the HandiHaler device
and inhaled through your mouth (oral inhalation).
• Do not use your HandiHaler device to take any other medicine.
First read the Patient Information, then read these Instructions for Use before
you start to use SPIRIVA HandiHaler and each time you refill your prescription.
There may be new information.
Becoming familiar with your HandiHaler device
and SPIRIVA capsules:
Your SPIRIVA HandiHaler comes with SPIRIVA capsules in blister packaging and a
HandiHaler device. Use the new HandiHaler device provided with your medicine.
The parts of your HandiHaler device include:
(See Figure A)
1. dust cap (lid)
2. mouthpiece
3. mouthpiece ridge
4. base
5. green piercing button
6. center chamber
7. air intake vents
Each SPIRIVA capsule is packaged in a blister. (See Figure B)
• Each SPIRIVA capsule contains only a small amount
of powder. (See Figure C) This is 1 full dose.
• Do not open the SPIRIVA capsule or it may not
work.
Taking your full daily dose of medicine requires 4 main steps.
Step 1. Opening your HandiHaler device:
After removing your HandiHaler device from the pouch:
• Open the dust cap (lid) by pressing the green
piercing button. (See Figure D)
• Pull the dust cap (lid) upwards away from the
base to expose the mouthpiece. (See Figure E)
• Open the mouthpiece by pulling the mouthpiece ridge
up and away from the base so the center
chamber is showing. (See Figure F)
Step 2. Inserting the SPIRIVA capsule into your HandiHaler device:
Each day, separate only 1 of the blisters from the blister
card by tearing along the perforated line. (See Figure G)
Remove the SPIRIVA capsule from the blister:
• Do not cut the foil or use sharp instruments to take
out the SPIRIVA capsule from the blister.
• Bend 1 of the blister corners with an arrow and
separate the aluminum foil layers.
• Peel back the printed foil until you see the whole
SPIRIVA capsule. (See Figure H)
• If you have opened more than 1 blister to the air,
the extra SPIRIVA capsule should not be used and
should be thrown away.
Place the SPIRIVA capsule in the center chamber of your
HandiHaler device. (See Figure I)
Close the mouthpiece firmly against the gray base
until you hear a click. Leave the dust cap (lid) open.
(See Figure J)
Step 3. Piercing the SPIRIVA capsule:
• Hold your HandiHaler device with the mouthpiece
pointed up. (See Figure K)
• Press the green piercing button once until it is flat
(flush) against the base, then release. This is how
you make holes in the SPIRIVA capsule so that you
get your medicine when you breathe in.
• Do not press the green button more than one time.
• Do not shake your HandiHaler device.
• The piercing of the SPIRIVA capsule may produce
small gelatin pieces. Some of these small pieces
may pass through the screen of your HandiHaler
device into your mouth or throat when you breathe
in your medicine. This is normal. The small pieces
of gelatin should not harm you.
Figure A
OpenBlister Immediately Before Use
ForOral InhalationOnly
DoNot Swallow Capsules.
ForUse With HandiHaler Only.
Peelback
Exp.MMMYY Lot000000X
N(01) 103 0597-0075-47 6
OpenBlister Immediately Before Use
ForOral Inhalation Only
DoNot Swallow Capsules .
ForUseWith HandiHaler Only.
Peelback
Exp.MMM YY Lot 000000X
N(01) 1 03 0597-0075-476
OpenBlisterImmediately Before Use
ForOral Inhalation Only
DoNot Swallow Capsules.
ForUse With HandiHaler Only.
Peelback
Exp.MMM YY Lot000000X
N(01) 1 03 0597-0075-47 6
OpenBlister Immediately Before Use
ForOral Inhalation Only
DoNot Swallow Capsules .
ForUseWith HandiHaler Only.
Peelback
Exp.MMM YY Lot 000000X
N(01) 1 03 0597-0075-476
OpenBlisterImmediately Before Us
ForOral Inhalation Only
DoNot Swallow Capsules.
ForUse With HandiHaler Only.
Peelback
Exp.MMM YY Lot000000X
N(01) 1 03 0597-0075-47 6
iatelyBefore Use
onOnly
NotSwallow Capsules.
WithHandiHaler Only.
Peelback
MMYY Lot 000000X
97-0075-476
OpenBlister Immediately Before Use
ForOral Inhalation Only
DoNot Swallow Cap
ForUse With HandiHaler
Peelback
Exp.MMM YY Lot 000000X
N(01) 1 03 0597-0075-47 6
DoNo
ForU
Peelback
Figure B
TI 01
Amount of
powder in
the SPIRIVA
capsule
Figure C
Figure D
Figure E
Figure F
OpenBlisterImmediately Before Use
ForOral InhalationOnly
DoNot Swallow Capsules.
ForUse With HandiHaler Only.
Peelback
Exp.MMMYY Lot000000X
N(01) 103 0597-0075-476
OpenBlister Immediately Before Use
ForOral Inhalation Only
DoNot Swallow Capsules .
ForUseWith HandiHaler Only.
Peelback
Exp.MMM YYLot 000000X
N(01) 1 03 0597-0075-476
OpenBlisterImmediately Before Use
ForOral Inhalation Only
DoNot Swallow Capsules.
ForUse With HandiHaler Only.
Peelback
Exp.MMM YY Lot000000X
N(01) 1 03 0597-0075-47 6
OpenBlister Immediately Before Use
ForOral Inhalation Only
DoNot Swallow Capsules .
ForUseWith HandiHaler Only.
Peelback
Exp.MMM YY Lot 000000X
N(01) 1 03 0597-0075-47 6
OpenBlisterImmediately Before Us
ForOral Inhalation Only
DoNot Swallow Capsules.
ForUse With HandiHaler Only.
Peelback
Exp.MMM YY Lot000000X
N(01) 1 03 0597-0075-47 6
iatelyBefore Use
onOnly
NotSwallow Capsules.
WithHandiHaler Only.
Peelback
MMYY Lot 000000X
97-0075-476
OpenBlister Immediately Before Use
ForOral Inhalation Only
DoNot Swallow Cap
ForUse With HandiHaler
Peelback
Exp.MMM YY Lot 000000X
N(01) 1 03 0597-0075-47 6
DoNo
ForU
Peelback
Figure G
OpenBlister Immediate
ForOral Inhalati
DoNot Swallo wCa psul
ForUse With HandiHale
Exp. MMM YY Lot 00
N (01) 1 03 0597-
Blister Immediately Before Use
Oral Inhalation Only
allow Capsules.
ith HandiHaler Only.
Peel back
p. MMM YY Lot 000000X
N(
01) 1 03 0597-0075-47 6
en Blister Immediately Befo
For Oral Inhalation O
wallow Capsules.
With HandiHaler Only.
Peel ba
Exp. MMM YY Lot 000000X
N (01) 1 03 0597-0075-47
Figure H
Figure I
Figure J
Figure K

Step 4. Taking your full daily dose (2 inhalations from the same Spiriva®
HandiHaler®(tiotropium bromide inhalation powder) capsule):
Breathe out completely in 1 breath, emptying your
lungs of any air. (See Figure L)
Important: Do not breathe into your HandiHaler device.
With your next breath, take your medicine:
• Hold your head in an upright position while
you are looking straight ahead. (See Figure M)
• Raise your HandiHaler device to your mouth in a
horizontal position. Do not block the air intake vents.
• Close your lips tightly around the mouthpiece.
•Breathe in deeply until your lungs are full. You
should hear or feel the SPIRIVA capsule vibrate
(rattle). (See Figure M)
• Hold your breath for a few seconds and, at the same
time, take your HandiHaler device out of your mouth.
• Breathe normally again.
The rattle tells you that you breathed in correctly. If you
do not hear or feel a rattle, see the section, “If you do not
hear or feel the SPIRIVA capsule rattle as you breathe in
your medicine.”
To get your full daily dose, you must again, breathe
out completely (See Figure N) and for a second time,
breathe in (See Figure O) from the same SPIRIVA
capsule.
Important: Do not press the green piercing button
again.
Remember: To get your full medicine dose each day, you
must breathe in 2 times from the same SPIRIVA capsule.
Make sure you breathe out completely each time before
you breathe in from your HandiHaler device.
Caring for and storing your SPIRIVA HandiHaler:
• After taking your daily dose, open the mouthpiece
and tip out the used SPIRIVA capsule into your
trash can, without touching it.
• Remove any SPIRIVA capsule pieces or SPIRIVA
powder buildup by turning your HandiHaler device
upside down and gently, but firmly, tapping it. (See Figure P)
Then, close the mouthpiece and dustcap for storage.
• Do not store your HandiHaler device and SPIRIVA
capsules (blisters) in a damp moist place. Always
store SPIRIVA capsules in the sealed blisters.
If you do not hear or feel the SPIRIVA capsule rattle as you breathe in your
medicine:
Do not press the green piercing button again.
Hold your HandiHaler device with the mouthpiece pointed
up and tap your HandiHaler device gently on a table. (See
Figure Q)
Check to see that the mouthpiece is completely closed.
Breathe out completely before deeply breathing in again
with the mouthpiece in your mouth. (See Figure O)
If you still do not hear or feel the SPIRIVA capsule rattle
after repeating the above steps:
• Throw away the SPIRIVA capsule.
• Open the base by lifting the green piercing
button and check the center chamber for pieces
of the SPIRIVA capsule. SPIRIVA capsule pieces in
the center chamber can cause a SPIRIVA capsule
not to rattle.
• Turn your HandiHaler device upside down and
gently, but firmly, tap to remove the SPIRIVA
capsule pieces. Call your doctor for instructions.
Cleaning your HandiHaler device:
Clean your HandiHaler device as needed. (See Figure R)
• It takes 24 hours to air dry your HandiHaler
device after you clean it.
• Do not use cleaning agents or detergents.
• Do not place your HandiHaler device in the
dishwasher for cleaning.
Cleaning Steps:
• Open the dust cap and mouthpiece
• Open the base by lifting the green piercing button.
• Look in the center chamber for SPIRIVA capsule
pieces or powder buildup. If seen, tap out.
• Rinse your HandiHaler device with warm water,
pressing the green piercing button a few times so
that the center chamber and the piercing needle
is under the running water. Check that any powder
buildup or SPIRIVA capsule pieces are removed.
• Dry your HandiHaler device well by tipping the
excess water out on a paper towel. Air-dry
afterwards, leaving the dust cap, mouthpiece,
and base open by fully spreading it out so that it
dries completely.
• Do not use a hair dryer to dry your HandiHaler device.
• Do not use your HandiHaler device when it is wet.
If needed, you may clean the outside of the
mouthpiece with a clean damp cloth.
Helpful Hints to help ensure that you are properly taking your full daily
dose of SPIRIVA HandiHaler:
• Press the green piercing button 1 time; Breathe in 2 times; Breathe
out completely before each of the 2inhalations.
• Always use the new HandiHaler device provided with your medicine.
• Keep your HandiHaler device with the mouthpiece pointed up when
pressing the green piercing button.
• Press the green piercing button 1 time to pierce the SPIRIVA capsule.
• Do not breathe out into your HandiHaler device.
• Keep your HandiHaler device in a horizontal position and keep your head
upright, looking straight ahead, when breathing in.
• Check the center chamber of your HandiHaler device for SPIRIVA capsule
pieces or powder build-up. If pieces or powder are seen, tap out before use.
• Clean your HandiHaler as needed and dry thoroughly.
For more information, ask your doctor or pharmacist, or go to www.spiriva.com,
or scan the code below, or call 1-800-542-6257.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Distributed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA
Licensed from:
Boehringer Ingelheim International GmbH
SPIRIVA®and HandiHaler®are registered trademarks and are used under license from
Boehringer Ingelheim International GmbH.
Copyright ©2014 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED
Revised: April 2014
IT1600AED292014 10004551/12 IT5300H 75740-08
SV615902PROF
Figure L
Figure M
Figure N
Figure O
Figure P
Figure Q
Figure R