Patient information: uses, side effects, how to take - Spiriva Respimat

Instructions for Use

SPIRIVA^®RESPIMAT^®(speh REE vah - RES peh mat)

(tiotropium bromide inhalation spray), for oral inhalation use

For oral inhalation only

Do not spray SPIRIVA RESPIMAT into your eyes.

Read this Instructions for Use before you start using SPIRIVA RESPIMAT and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or your treatment.

You will need to use this inhaler 1 time each day, at the same time each day. Each time you use it take 2 puffs.

Use SPIRIVA RESPIMAT exactly as prescribed by your doctor. Do not change your dose or how often you use SPIRIVA RESPIMAT without talking with your doctor. Children should use SPIRIVA RESPIMAT with the help of an adult, as instructed by their doctor.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SPIRIVA RESPIMAT may affect the way some medicines work and some other medicines may affect the way SPIRIVA RESPIMAT works. Do not use other inhaled medicines with SPIRIVA RESPIMAT without talking to your doctor.

The SPIRIVA RESPIMAT inhaler has a slow-moving mist that helps you inhale the medicine.

Do not turn the clear base before inserting the cartridge.

Your SPIRIVA RESPIMAT may have either an aqua or a blue cap, depending on the strength prescribed by your doctor. The steps shown below should be followed.

How to store your SPIRIVA RESPIMAT inhaler

Store SPIRIVA RESPIMAT at room temperature between 68°F to 77°F (20°C to 25°C).
Do not freeze your SPIRIVA RESPIMAT cartridge and inhaler.
If SPIRIVA RESPIMAT has not been used for more than 3 days, release 1 puff towards the ground.
If SPIRIVA RESPIMAT has not been used for more than 21 days, repeat steps 4 to 6 under the "Prepare for first use" until a mist is visible. Then repeat steps 4 to 6 three more times.
Keep your SPIRIVA RESPIMAT cartridge, inhaler, and all medicines out of the reach of children.

How to care for your SPIRIVA RESPIMAT inhaler

Clean the mouthpiece, including the metal part inside the mouthpiece, with a damp cloth or tissue only, at least 1 time each week. Any minor discoloration in the mouthpiece does not affect your SPIRIVA RESPIMAT inhaler.

When to get a new SPIRIVA RESPIMAT inhaler

The scale on your inhaler shows the number of puffs in the inhaler. You should use 2 puffs 1 time each day.
The dose indicator shows approximately how many puffs are left in the inhaler.
When the dose indicator enters the red area of the scale you need to refill your prescription as soon as possible.
When the dose indicator reaches the end of the red scale, your SPIRIVA RESPIMAT is empty and automatically locks. At this point, the clear base cannot be turned any further.

Three months after insertion of cartridge, throw away the SPIRIVA RESPIMAT even if it has not been used, or when the inhaler is locked, or when it expires, whichever comes first.

Prepare for first use

1. Remove clear base Keep the cap closed. Press the safety catch while firmly pulling off the clear base with your other hand. Be careful not to touch the piercing element. Write the discard by date on the label (3 months from the date the cartridge is inserted).
2. Insert cartridge Insert the narrow end of the cartridge into the inhaler. Place the inhaler on a firm surface and push down firmly until it clicks into place.
3. Replace clear base Put the clear base back into place until it clicks. Do not remove the clear base or the cartridge after it has been put together.
4. Turn Keep the cap closed. Turn the clear base in the direction of the arrows on the label until it clicks (half a turn).
5. Open Open the cap until it snaps fully open.
6. Press Point the inhaler toward the ground. Press the dose-release button. Close the cap. If you do not see a mist, repeat steps 4 to 6 until a mist is seen. After a mist is seen, repeat steps 4 to 6 three more times. After complete preparation of your inhaler, it will be ready to deliver the number of puffs on the label.

Daily use (T O P)

Turn

Keep the cap closed.
Turn the clear base in the direction of the arrows on the label until it clicks (half a turn).

Open

Open the cap until it snaps fully open.

Press

Breathe out slowly and fully.
Close your lips around the mouthpiece without covering the air vents.
Point the inhaler to the back of your throat.
While taking a slow, deep breath through your mouth, Press the dose-release button and continue to breathe in.
Hold your breath for 10 seconds or for as long as comfortable.
Repeat Turn, Open, Press (TOP) for a total of 2 puffs.
Close the cap until you use your inhaler again.

Answers to Common Questions

It is difficult to insert the cartridge deep enough:

Did you accidentally turn the clear base before inserting the cartridge? Open the cap, press the dose-release button, then insert the cartridge.

Did you insert the cartridge with the wide end first? Insert the cartridge with the narrow end first.

I cannot press the dose-release button:

Did you turn the clear base? If not, turn the clear base in a continuous movement until it clicks (half a turn).

Is the dose indicator on the SPIRIVA RESPIMAT pointing to 0 (zero)? The SPIRIVA RESPIMAT inhaler is locked after the labeled number of puffs have been used. Prepare and use your new SPIRIVA RESPIMAT inhaler.

I cannot turn the clear base:

Did you turn the clear base already? If the clear base has already been turned, follow steps "Open" and "Press" under "Daily use" to get your medicine.

The dose indicator on the SPIRIVA RESPIMAT reaches 0 (zero) too soon:

Did you use SPIRIVA RESPIMAT as indicated (2 puffs 1 time each day)?

Did you turn the clear base before you inserted the cartridge? The dose indicator counts each turn of the clear base regardless whether a cartridge has been inserted or not.

Did you spray in the air often to check whether the SPIRIVA RESPIMAT is working? After you have prepared SPIRIVA RESPIMAT, no test-spraying is required if used daily.

Did you insert the cartridge into a used SPIRIVA RESPIMAT? Always insert a new cartridge into a new SPIRIVA RESPIMAT.

My SPIRIVA RESPIMAT sprays automatically:

Was the cap open when you turned the clear base? Close the cap, then turn the clear base.

Did you press the dose-release button when turning the clear base? Close the cap, so the dose-release button is covered, then turn the clear base.

Did you stop when turning the clear base before it clicked? Turn the clear base in a continuous movement until it clicks (half a turn).

My SPIRIVA RESPIMAT does not spray:

Did you insert a cartridge? If not, insert a cartridge.

Did you repeat Turn, Open, Press (TOP) less than 3 times after inserting the cartridge? Repeat Turn, Open, Press (TOP) 3 times after inserting the cartridge as shown in steps 4 to 6 under "Prepare for first use".

Is the dose indicator on the SPIRIVA RESPIMAT pointing to 0 (zero)? You have used up all your medicine and the inhaler is locked.

For more information about SPIRIVA RESPIMAT, including current prescribing information, a video demonstration or a Quick Start Guide on how to use SPIRIVA RESPIMAT, go to www.spiriva.com, scan the code, 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 RESPIMAT^®are registered trademarks of and are used under license from Boehringer Ingelheim International GmbH

Revised: January 2025

COL10534BA022025

SPL10536D

Spiriva Respimat: Uses, Side Effects and Dosage