PATIENT PRESCRIBING INFORMATION (PDF)
DIRECTIONS FOR USE WITH PICTURES (PDF)
HOW TO USE YOUR LUPINHALER DEVICE AND INSERT A CAPSULE (VIDEO)
STEPS FOR FIRST-TIME USERS
HELP WITH YOUR LUPINHALER DEVICE
HOW TO CLEAN YOUR
LUPINHALER DEVICE (VIDEO)
STEPS FOR CLEANING
YOUR LUPINHALER DEVICE
SIMPLE TIPS
IMPORTANT SAFETY INFORMATION

LUPINHALER DEVICE HELP AND SUPPORT

This website will help you learn how to use and take care of your LupinHaler®
device (tiotropium bromide dry powder inhaler).

Important information

  • Do not swallow the tiotropium
    capsules
  • The Lupin tiotropium capsules should
    only be used with the LupinHaler
    device and inhaled through your
    mouth (oral inhalation)
  • Do not take any other medicine
    with your LupinHaler device

Get to know Your LUPINHALER DEVICE
and tiotropium capsules

Let’s get familiar with your LupinHaler and medicine by looking at all the different parts. These terms will come up a lot on this website.


–
–
–

Your LupinHaler

Dry powder inhaler:

This device is designed to deliver contents from a
capsule to the lungs

Dust cap (lid):

This covers the mouthpiece and protects it from dust
or other things getting inside

Mouthpiece:

This part of the dry powder inhaler goes in your mouth
when you are ready to inhale your medicine

Mouthpiece ridge:

This is the raised edge on the side of the mouthpiece

Base:

This is the bottom of the dry powder inhaler

Green piercing button:

This button pierces (makes holes in) a capsule –
this allows you to inhale the medicine through your
mouth. The button can also open the dust cap
and inner part of the base of the dry powder inhaler

Center chamber:

This part of the dry powder inhaler holds the capsule

Air intake vents:

These openings allow your breath to move through the
dry powder inhaler. Dry powder inhalers are activated by
breathing in

Your tiotropium capsules

Packaging:

Each capsule is packaged in a blister

Capsule:

Each capsule contains a dry powder form of tiotropium
bromide and lactose for inhalation (the action of inhaling
or breathing in). The capsules are designed to fit your
LupinHaler. Each capsule contains a small amount of
powder (as seen in the image of the capsule). This is one
full dose of medicine

  • Do not open the capsules, or they may not work
  • Do not swallow the capsules

WATCH AND LEARN HOW TO USE YOUR LUPINHALER DEVICE AND INSERT A TIOTROPIUM CAPSULE

Watch this video to see how to use the LupinHaler and how to insert a tiotropium capsule.

STEPS FOR FIRST-TIME USERS – TAKING YOUR FULL DAILY DOSE

Taking your full daily dose of medicine requires several steps. After removing your LupinHaler device from the pouch…

Step 1 – Open your LupinHaler

A

Open the dust cap by pressing the
green piercing button

B

Pull the dust cap upward, away from the
base to see the mouthpiece

C

Pull the mouthpiece ridge up and away
from the base to see the center chamber

Step 2 – Insert the capsule into your LupinHaler

A

Separate only one of the blisters from the blister package by tearing along the perforated line

B

Do not cut the foil or use sharp tools to take out the capsule

Remove the tiotropium capsule from the blister:

  • Bend one of the blister corners with an arrow and separate the aluminum foil layers
  • Peel back the printed foil until you see the whole capsule
  • Do not cut the foil or use sharp tools to take out the capsule from the blister.
    Sharp tools may damage the capsule

C

Place the capsule in the center chamber of your LupinHaler

D

Close the mouthpiece firmly against the white base until you hear a click.
Leave the dust cap open

Step 3 – Pierce the capsule

A

Hold your LupinHaler with the mouthpiece pointed up

B

Do not shake your LupinHaler

Press the green piercing button once until it is flat (flush) against the base, then release

  • Important information – Do not press the green piercing button more
    than  one time
  • Do not shake your LupinHaler

Step 4 – Take your full daily dose (two breaths in from the same capsule)

A

Breathe out completely in one breath
to empty your lungs of any air

  • Do not breathe into your
    LupinHaler

B

Hold your head in an upright position
while you are looking straight ahead.

Raise your LupinHaler to your mouth in a horizontal position

  • Do not block the air intake vents

C

Close your lips tightly around the mouthpiece. Breathe in deeply until
your lungs are full

  • When you breathe in, you should
    hear or feel the capsule vibrate
    (rattle)
  • The rattle tells you that you
    breathed in correctly

D

Hold your breath for a few seconds and,
at the same time, take your LupinHaler out of your mouth

  • After a few seconds, breathe
    normally again

Repeat Step 4

To get your full daily dose (two breaths in from the same tiotropium capsule),
repeat step 4

  • Do not press the green piercing button again

After you take your full daily dose, it is important to take care of your LupinHaler.

Step 5 – Prepare your LupinHaler for storage

A

Open the mouthpiece and tip out the
used capsule into your trash can,
without touching it

B

Remove any capsule pieces or buildup
by turning your LupinHaler upside
down and tapping it

C

Close the mouthpiece and dust cap
for storage

Remember:

  • Do not swallow the tiotropium capsules
  • To get your full medicine dose each day, you must breathe in two times from the same tiotropium capsule
  • Piercing the tiotropium capsule may produce small pieces of the capsule. When you breathe in your medicine, some of these
    pieces may pass through your LupinHaler into your mouth or throat. This is normal. The small pieces of the capsule should
    not harm you
  • If you open more than one blister when preparing for your daily dose by mistake, throw the extra capsule away. Do not use
    the extra capsule
  • Keep your LupinHaler and capsules away from:
    • damp or moist places
    • extreme hot and cold temperatures

You can Save this Step-by-step guide for using
and taking Care of your lupinhaler Device

DOWNLOAD A STEP-BY-STEP GUIDE WITH PICTURES

HELP
WITH YOUR

LUPINHALER
DEVICE

If you need more help
with your
LupinHaler,
you can find the answers
to
some commonly asked
questions below.

You can also call
1-800-399-2561
from
8:00 AM to
5:00 PM EST,
Monday through
Friday,
to speak with someone
who can
assist you.

What is the LupinHaler?

LupinHaler

What is the LupinHaler?

It is a dry powder inhaler designed to deliver tiotropium bromide to your lungs. Tiotropium is a maintenance prescription medicine used once daily to help control symptoms of chronic obstructive pulmonary disease (COPD). Tiotropium is designed to relax your lungs’ airways and help keep them open for 24 hours. It is not a rescue medicine and should not be used for treating sudden breathing problems.

What if I do not hear or feel the tiotropium capsule rattle as I breathe in the medicine?

What if I do not hear or feel the tiotropium capsule rattle as I breathe in the medicine?

  • Do not press the green piercing button again
  • Hold your LupinHaler with the mouthpiece pointed up and tap your LupinHaler gently  on a table
  • Check to see that the mouthpiece is completely closed. Breathe out completely before  deeply breathing in again with the mouthpiece in your mouth

If you still do not hear or feel the capsule rattle after repeating the above steps…

  • Throw out the capsule
  • Open the base by lifting the green piercing button and check the center chamber for  any remaining capsule pieces. A buildup of capsule pieces can stop the rattle
  • Turn your LupinHaler upside down and tap to remove any capsule pieces
  • Contact your healthcare provider for more instructions

How should I store my LupinHaler and medicine?

How should I store my LupinHaler and medicine?

  • Store your LupinHaler and capsules at room temperature (between 68°F and 77°F)  in a dry place
  • Keep your LupinHaler and capsules away from:
    • damp or moist places, like the bathroom medicine cabinet
    • extreme hot and cold temperatures
  • Always store your capsules in the sealed blisters and only remove them right  before use
  • Throw away any unused capsules that have been open to air
  • Do not store capsules in the LupinHaler

What are the potential serious and common side effects of the medicine?

What are the potential serious and common side effects of the medicine?

Serious side effects include:

  • Sudden narrowing and blockage of the airways into the lungs (bronchospasm). 
    Your breathing suddenly gets worse.
    If you have symptoms of bronchospasm, stop taking tiotropium bromide. Call your
    doctor right away or go to the nearest hospital emergency room.
  • New or worsened increased pressure in the eyes (acute narrow-angle glaucoma).
    Symptoms of acute narrow-angle glaucoma may include:

    • eye pain
    • blurred vision
    • seeing halos (visual halos) or colored images along with red eyes
    • Using only eye drops to treat these symptoms may not work. If you have these
      symptoms, stop taking tiotropium bromide and call your doctor right away.
  • New or worsened urinary retention. Symptoms of blockage in your bladder and/or  enlarged prostate may include:
    • difficulty passing urine
    • painful urination
    • If you have these symptoms of urinary retention, stop taking tiotropium bromide and call your doctor right away.

Common side effects include:

  • infection occurring above the neck (upper respiratory tract infection)
  • dry mouth
  • infected sinuses (sinusitis)
  • sore throat (pharyngitis)
  • chest pain
  • bladder infection (urinary tract infection)
  • indigestion (dyspepsia)
  • a congested or runny nose (rhinitis)

Tiotropium bromide may cause other side effects. Contact your healthcare provider if you have any unusual problems while using this medicine.

Where can I report a side effect or a product complaint?

Where can I report a side effect or a product complaint?

  • You can contact LUPIN to report a side effect or a product complaint at
    drugsafety@lupin.com or call 1-800-399-2561
  • You may also report side effects to the US Food and Drug Administration (FDA)
    at www.fda.gov/medwatch or call 1-800-FDA-1088

What if I forget to take a dose or if I take two doses by mistake?

What if I forget to take a dose or if I take two doses by mistake?

  • If you miss a dose, take it as soon as you remember. Do not use tiotropium bromide more than once every 24 hours
  • If you use more than your prescribed dose of tiotropium bromide, call your health care provider or the poison control center at 1-800-222-1222

WATCH AND LEARN HOW TO CLEAN YOUR LUPINHALER DEVICE

Watch this video to see how to clean the LupinHaler.

STEPS FOR
CLEANING

YOUR
LUPINHALER
DEVICE

You may clean your
LupinHaler as needed.

Cleaning it requires
several steps.

Step 1 – Open your LupinHaler

A

Open the dust cap and mouthpiece

B

Open the inner part of the base by lifting the green piercing button

Step 2 – Look in the center chamber

A

Look in the center chamber for tiotropium capsule pieces or powder buildup. If seen, tap out

Step 3 – Rinse your LupinHaler

A

Rinse your LupinHaler with warm water while you also press the green piercing button a few times

  • Pressing the green piercing button will allow the water to clean the center chamber and the piercing needle
  • Check that any remaining powder buildup or capsule pieces are removed

Step 4 – Dry your LupinHaler

A

Dry your LupinHaler well by tipping the excess water out on a paper towel

B

Leave the dust cap, mouthpiece, and base open by fully spreading the LupinHaler out so that all parts can air dry for 24 hours

Remember:

  • Do not use cleaning agents or detergents
  • Do not place your LupinHaler in the dishwasher for cleaning
  • Do not use a hair dryer to dry your LupinHaler
  • Do not use your LupinHaler when it is wet. If needed, you may clean the outside of the mouthpiece with a clean, damp cloth

For more help

Do you have more questions about cleaning your LupinHaler?
You can call us at 1-800-399-2561 from 8:00 AM to 5:00 PM EST, Monday through Friday, to speak with someone who can assist you.

SIMPLE TIPS FOR THE LUPINHALER DEVICE

Read this chart for some quick tips about using and taking care of your LupinHaler.

DO

  • Do use your Lupin tiotropium capsules with your LupinHaler
  • Do check the center chamber for buildup; if there is any, tap out before use
  • Do press the green piercing button once until it is flat (flush) against the base
  • Do breathe out completely before each of the two inhalations
  • Do close the dust cap after every daily use
  • Do clean your LupinHaler as needed
  • Do let your LupinHaler air dry for 24 hours

DO NOT

  • Do not breathe out into your LupinHaler
  • Do not use your LupinHaler with other types of medicine
  • Do not clean your LupinHaler with anything other than warm water
  • Do not use your LupinHaler if it is wet
  • Do not store your LupinHaler and medicine in extreme hot and cold temperatures

You can save these tips and more helpful information for using and taking care of your LupinHaler

DOWNLOAD TIPS AND MORE INFORMATION

IMPORTANT SAFETY INFORMATION

Approved Use

Tiotropium bromide inhalation powder is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Tiotropium bromide inhalation powder is also indicated to reduce exacerbations in COPD patients.

Important Safety Information

  • Do not use tiotropium bromide inhalation powder if you are allergic to tiotropium, ipratropium or similar drugs, or any ingredient in these medicines.
  • Tiotropium bromide inhalation powder 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.
  • Before using tiotropium bromide inhalation powder, tell your doctor if you have a severe allergy to milk proteins.
  • Tiotropium bromide inhalation powder can cause serious side effects, including:
  • Allergic reaction. Symptoms may include:
    • raised red patches on your skin (hives)
    • itching
    • rash
    • swelling of the lips, tongue, or throat that may cause difficulty in breathing or 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 (acute narrow-angle glaucoma). Symptoms of acute narrow-angle glaucoma may
    • include:
    • New or worsened increased pressure in the eyes (acute narrow-angle glaucoma). Symptoms of acute narrow-angle glaucoma may include:
    • eye pain
    • blurred vision
    • seeing halos (visual halos) or colored images along with red eyes
      Using only eye drops to treat these symptoms may not work.
    • New or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include: difficulty
    • passing urine, painful urination.
    • New or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include: difficulty passing urine, painful urination.

    If you have any of these symptoms, stop taking tiotropium bromide inhalation powder and call your doctor right away.

  • The most common side effects reported with tiotropium bromide inhalation powder in patients with COPD include sore throat, cough, dry mouth, and sinus infection.
  • Other side effects with tiotropium bromide inhalation powder include:
    • upper respiratory tract infection
    • dry mouth
    • sinus infection
    • sore throat
    • non-specific chest pain
    • urinary tract infection
    • indigestion
    • runny nose
    • constipation
    • increased heart rate
    • blurred vision
  • Do not swallow tiotropium bromide inhalation powder capsules.
  • The contents of the capsule should only be inhaled through your mouth using the LupinHaler device.
  • Do not use the LupinHaler device to take any other medicine.
  • Do not let the powder from the tiotropium bromide inhalation powder 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.
  • Tiotropium bromide inhalation powder can cause dizziness and blurred vision. Should you experience these symptoms you should
    use caution when engaging in activities such as driving a car or operating appliances or other machines.
  • These are not all the possible side effects with tiotropium bromide inhalation powder. 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 are encouraged to report the negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Read the “Instructions for Use” for Tiotropium Bromide Inhalation Powder before you use your inhaler. Talk with your doctor if you do not understand the instructions.

For more information about tiotropium bromide inhalation powder, visit our website at www.lupinpharmaceuticals.com, or call Lupin Pharmaceuticals, Inc. at 1-800-399-2561.

Please see the full Prescribing Information, including Instructions for Use, for Tiotropium Bromide Inhalation Powder.

NP-TBI-0001

© 2023 Lupin Pharmaceuticals, Inc.