IMPORTANT PATIENT INFORMATION
SPIRIVA- (speh REE vah) HandiHaler
(tiotropium bromide inhalation pov/der)
Important Information: Do not swallow SPIRIVA capsules. SPIRIVA
capsules should only be used with the HandiHaler device. SPIRIVA
HandiHaler should only be inhaled by mouth (oral inhalation).
Read the information that comes with your SPIRIVA HandiHaler
before you start using it and each time you refill your prescription.
There may be new information. This leaflet does not take the
place of talking with your doctor about your medical condition or
your treatment.
What is SPIRIVA HandiHaler?
SPIRIVA HandiHaler is a prescription medicine that you use one time every day
(a maintenance medicine) to control symptoms of chronic obstructive pulmonary
disease (COPD). SPIRIVA HandiHaler helps make your lungs work better for
24
hours.
SPIRIVA HandiHaler relaxes your airways and helps keep them open. You may start to
feel like it is easier to breathe on the first day, but it may take longer for you to feel the
full effects of the medicine. SPIRIVA HandiHaler works best and may help make it
easier to breathe when you use it every day.
SPIRIVA HandiHaler is not a rescue medicine and should not be used for treating
sudden breathing problems. Your doctor may give you other medicine to use for
sudden breathing problems.
SPIRIVA HandiHaler has not been studied in children.
Who should not take SPIRIVA HandiHaler?
Do not use SPIRIVA HandiHaler if you:
•
are allergic to any of the ingredients in SPIRIVA capsules. See ’What are the
ingredients in Spiriva HandiHaler?’
•
have had an allergic reaction to atropine or any medicines like it, such as
ipratropium (AtrovenQ._ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
What should I tell my doctor before using SPIRIVA HandiHaler?
Before
taking SPIRIVA HandiHaler, tell
your doctor about all
your
medical
conditions, including if you:
•
have kidney problems.
•
have glaucoma. SPIRIVA HandiHaler may make your glaucoma worse.
•
have an enlarged prostate, problems passing urine, or a blockage in your
bladder. SPIRIVA HandiHaler may make these problems worse.
•
are pregnant or plan to become pregnant. It is not known if SPIRIVA
HandiHaler could harm your unborn baby.
• are breast-feeding or plan to breast feed. It is not known if SPIRIVA
HandiHaler passes into breast milk. You and your doctor will decide if
SPIRIVA HandiHaler is right for you while you breast-feed.
Tell your doctor about all the m edicines you take, including prescription and
non-prescription medicines and eye drops, vitamins, and herbal supplements. Some of your
other medicines or supplements may affect the way SPIRIVA HandiHaler works. SPIRIVA
HandiHaler is an anticholinergic medicine. You should not take other anticholinergic
medicines v/hile using SPIRIVA HandiHaler. including ipratropium. Ask your doctor or
pharmacist if you are not sure if one of your medicines is an anticholinergic.
Know the medicines you take. Keep a list of your medicines with you to show your
doctor and pharmacist when you get a new medicine.
How should I take SPIRIVA HandiHaler?
•
Use SPIRIVA HandiHaler exactly as prescribed. Use SPIRIVA HandiHaler
one time every day.
•
Read the “Patient’s Instructions for Use” that comes with your prescription before
you use SPIRIVA HandiHaler. Talk with your doctor if you do not understand the
instructions.
•
Do not sw allow SPIRIVA capsules.
•
Only use SPIRIVA capsules with the HandiHaler device.
•
Do not use the HandiHaler device to take any other medicine.
•
SPIRIVA HandiHaler comes as a powder in a SPIRIVA capsule that fits the
HandiHaler device. Each SPIRIVA capsule, containing only a small amount of
SPIRIVA pov/der, is one full dose of medicine.
•
Separate one blister from the blister card. Then take out one of the SPIRIVA
capsules from the blister package right before you use it.
•
After the capsule is pierced, take a complete dose of SPIRIVA HandiHaler
by breathing in the powder by mouth tv/o times, using the HandiHaler device
(take
2
inhalations from one SPIRIVA capsule). See the "Patient’s Instructions for
Use” that comes with your prescription.
•
Throw away any SPIRIVA capsule that is not used right away after it is taken
out of the blister package. Do not leave the SPIRIVA capsules open to air;
they may not v/ork as well.
•
If you miss a dose, take it as soon as you remember.
Do not use SPIRIVA HandiHaler more than one time every
24
hours.
•
If you use more than your prescribed dose of SPIRIVA HandiHaler, call your
doctor or a poison control center.
What should I avoid while using SPIRIVA HandiHaler?
Do not let the powder from the SPIRIVA capsule get into your eyes. Your vision may get
blurry and the pupil in your eye may get larger (dilate). If this happens, call your doctor.
What are the possible side effects of SPIRIVA HandiHaler?
SPIRIVA can cause serious side effects. If you get any of the following side
effects, stop taking SPIRIVA HandiHaler and get medical help right away.
•
Allergic reaction. Symptoms may include: itching, rash, swelling of the lips,
tongue, or throat (trouble swallowing).
•
Sudden narrowing and blockage of the airways into the lungs
(bronchospasm). Your breathing suddenly gets worse.
•
New or worsened increased pressure in the eyes (glaucoma). Symptoms
of acute narrow-angle glaucoma may include: eye pain, blurred vision, seeing
halos (visual halos) or colored images along with red eyes.
Common side effects with SPIRIVA HandiHaler include:
•
dry mouth
•
constipation
•
upper respiratory infection
•
increased heart rate
•
blurry vision
•
glaucoma (new onset or worsening)
•
trouble passing urine
These are not all the possible side effects with SPIRIVA HandiHaler. Tell your doctor if
you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to
FDA at
1
-
800
-FDA-
1088
.
How do I store SPIRIVA HandiHaler?
•
Do not store SPIRIVA capsules in the HandiHaler device.
•
Store SPIRIVA capsules in the sealed blister package at room temperature
[
68
° -
77
°F (
20
° -
25
°C)).
•
Keep SPIRIVA capsules away from heat and cold (do not freeze).
•
Store SPIRIVA capsules in a dry place. Throw away any unused SPIRIVA
capsules that have been open to air.
Ask your doctor or pharmacist if you have any questions about storing your SPIRIVA capsules.
Keep SPIRIVA HandiHaler, SPIRIVA capsules, and all medicines out of the reach
of children.
General information about SPIRIVA HandiHaler
Medicines are sometimes prescribed for purposes other than those listed in Patient
Information leaflets. Do not use SPIRIVA HandiHaler for a purpose for which it has not
been prescribed. Do not give SPIRIVA HandiHaler to other people even if they have the
same symptoms that you have. It may harm them.
For more information about SPIRIVA HandiHaler, talk with your doctor. You can ask
your doctor or pharmacist for information about SPIRIVA HandiHaler that is written for
health professionals.
For more information about SPIRIVA HandiHaler, you may also call
1
-
800
-
542-6257
or
(TTY)
1
-
800
-
459
-
9906
.
What are the ingredients in SPIRIVA HandiHaler?
Active ingredient: tiotropium
Inactive ingredient: lactose monohydrate
What is COPD (Chronic Obstructive Pulmonary Disease)?
COPD is a serious lung disease that includes chronic bronchitis, emphysema, or both.
Most COPD is caused by smoking. When you have COPD, your airways become
narrow. So, air moves out of your lungs more slowly. This makes it hard to breathe.
D
istributed
by:
Boehringer Ingelheim
Pharmaceuticals, Inc.
R
idgefield. CT
06877
USA
Marketed
by:
Boehringer Ingelheim
Pharmaceuticals, Inc.
R
idgefield. CT
06877
USA
and
Pfizer Inc
New York. NY 10017 USA
Licensed from:
Boehringer Ingelheim
International GmbH
SPIRIVA^ and HandiHaler-are registered
trademarks and are used
under license from
Boehnnger Ingelheim
International GmbH
.
^Copyright
2009
Boehringer Ingelheim
International GmbH
ALL RIGHTS RESERVED
SPIRIVA^ is covered by U
.S. Patent Nos. RE
38
.
912
. RE
39
.
820
.
5
.
478
.
578
,
6
.
777
.
423
.
6
.
908
.
928
,
7
.
070
.
800
. and
7
.
309.707
w
ith
other patents pending. The HandiHaler‘device is covered by U
.S. Design Patent No.
0355.029
w
ith
other patents pending.
IT
1600
TC
1109
10004551/06
65626-06
Revised March
2009
SPU
00815
SV
62778
®
Boehringer
Ingelheim
