Stiolto Respimat - Instructions for Use
|Manufacture:||Boehringer Ingelheim Pharmaceuticals, Inc.|
|Condition:||COPD, Maintenance, COPD|
|Ingredients:||tiotropium bromide, olodaterol, water for injection, benzalkonium chloride, edetate disodium, and hydrochloric acid|
For Oral Inhalation Only
Do not spray STIOLTO RESPIMAT into your eyes
Read these Instructions for Use before you start using STIOLTO RESPIMAT and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
Your STIOLTO RESPIMAT cartridge contains either 60 puffs (equal to 30 doses of medicine) or 28 puffs (equal to 14 doses of medicine) after you prepare your inhaler for the first use. There is enough medicine for 30 days or 14 days when it is used as 2 puffs 1 time each day at the same time of the day.
Before your STIOLTO RESPIMAT inhaler is used for the first time, the STIOLTO RESPIMAT cartridge must be inserted into the STIOLTO RESPIMAT inhaler and then primed. The instructions below show you how to prepare and prime the inhaler for first time use and how to use the inhaler for daily dosing.
Do not turn the clear base before inserting the cartridge.
The STIOLTO RESPIMAT inhaler
Prepare For First Time Use
|Step 1. With the light green cap closed, press the safety catch while pulling off the clear base. See Figure 1.|
Be careful not to touch the piercing element located inside the bottom of the clear base.
|Step 2. Write the discard by date on the label of the STIOLTO RESPIMAT inhaler. The discard by date is 3 months from the date the cartridge is inserted into the inhaler. See Figure 2.|
|Step 3. Take the STIOLTO RESPIMAT cartridge out of the box. Push the narrow end of the cartridge into the inhaler. The base of the cartridge will not sit flush with the inhaler. About 1/8 of an inch will remain visible when the cartridge is correctly inserted. See Figure 3.|
The cartridge can be pushed against a firm surface to ensure that it is correctly inserted. See Figure 3.
Do not remove the cartridge once it has been inserted into the inhaler.
|Step 4. Put the clear base back into place. See Figure 4.|
Do not remove the clear base again.
Your STIOLTO RESPIMAT inhaler should not be taken apart after you have inserted the cartridge and put the clear base back.
Prime For First Time Use
The following steps are needed to fill the dosing system the first time you use it and will not affect the number of doses available. After preparation and initial priming, your STIOLTO RESPIMAT inhaler will be able to deliver the labeled number of doses (30 or 14).
Proper priming of the inhaler is important to make sure the correct amount of medicine is delivered.
|Step 5. Hold the STIOLTO RESPIMAT inhaler upright, with the light green cap closed, to avoid accidental release of the dose. Turn the clear base in the direction of the black arrows on the label until it clicks (half a turn). See Figure 5.|
|Step 6. Flip the light green cap until it snaps fully open. See Figure 6.|
|Step 7. Point the STIOLTO RESPIMAT inhaler toward the ground (away from your face).|
Press the dose release button. See Figure 7. Close the light green cap.
Repeat Steps 5, 6, and 7 until a spray is visible.
Once the spray is visible, you must repeat Steps 5, 6, and 7 three more times to make sure the inhaler is prepared for use.
Your STIOLTO RESPIMAT inhaler is now ready to use.
These steps will not affect the number of doses available. After preparation and initial priming, your STIOLTO RESPIMAT inhaler will be able to deliver the labeled number of doses (30 or 14).
|Step A. Hold the STIOLTO RESPIMAT inhaler upright, with the light green cap closed, so you do not accidentally release a dose of medicine.|
Turn the clear base in the direction of the black arrows on the label until it clicks (half a turn). See Figure A.
|Step B. Flip the light green cap until it snaps fully open.|
Breathe out slowly and fully, and then close your lips around the end of the mouthpiece without covering the air vents. See Figure B.
Point your STIOLTO RESPIMAT inhaler to the back of your throat. While taking in a slow, deep breath through your mouth, press the dose release button and continue to breathe in slowly for as long as you can.
Hold your breath for 10 seconds or for as long as comfortable.
Step C. Repeat Steps A and B so that you get the full dose.
Close the light green cap until you use your STIOLTO RESPIMAT inhaler again.
Helpful Hints for Daily Dosing:
Using the STIOLTO RESPIMAT inhaler requires 3 simple steps. A helpful way to remember the steps for Daily Dosing is to remember TOP:
Turn the clear base
Open the cap and close your lips around the mouthpiece
Press the dose-release button and inhale
These steps should be performed 2 times to receive the proper dose of medicine.
If your STIOLTO RESPIMAT inhaler has not been used for more than 3 days, spray 1 puff toward the ground to prepare the inhaler for use.
If your STIOLTO RESPIMAT inhaler has not been used for more than 21 days, repeat Steps 5, 6, and 7 until a spray is visible. Then repeat Steps 5, 6, and 7 three more times to prepare the inhaler for use.
The STIOLTO RESPIMAT inhaler should be discarded no later than 3 months from the date the cartridge is inserted into the inhaler.
For more information about STIOLTO RESPIMAT or a video demonstration on how to use STIOLTO RESPIMAT, go to www.STIOLTO.com, or scan the code below. You may also call 1-800-542-6257 or (TTY) 1-800-459-9906 for further information about STIOLTO RESPIMAT.
When should I get a new STIOLTO RESPIMAT inhaler
|STIOLTO RESPIMAT is available with 30 or 14 doses of medicine (equal to 60 or 28 puffs). 2 puffs from STIOLTO RESPIMAT equal 1 dose of medicine. The dose indicator shows approximately how many puffs of medication are left. When the pointer enters the red area of the scale, there is enough medicine for 7 days (30 dose product) or 3 days (14 dose product). This is when you need to refill your prescription or ask your doctor if you need another prescription for STIOLTO RESPIMAT Inhalation Spray. Once the dose indicator has reached the end of the scale, all puffs have been used and the RESPIMAT inhaler locks automatically. At this point, the base cannot be turned any further. Throw away the STIOLTO RESPIMAT inhaler 3 months after insertion of cartridge into inhaler, even if all the medicine has not been used, or when the inhaler is locked, whichever comes first.|
Questions and Answers about your STIOLTO RESPIMAT inhaler
|What if...||Reason||What to do|
|I can not turn the base easily?||The STIOLTO RESPIMAT inhaler is already prepared and ready to use.|
The STIOLTO RESPIMAT inhaler is locked and all the medicine has been used.
|The STIOLTO RESPIMAT inhaler can be used as it is.|
Prepare and use a new STIOLTO RESPIMAT inhaler.
|I can not press the dose release button?||The clear base has not been turned.||Turn the clear base until it clicks (half a turn).|
|The clear base springs back after I have turned it and a small amount of moisture is released?||The clear base was not turned far enough.||Prepare the STIOLTO RESPIMAT inhaler for use by turning the clear base until it clicks (half a turn).|
|I can turn the clear base past the point where it clicks?||Either the dose release button has been pressed, or the clear base has been turned too far.||With the light green cap closed, turn the clear base until it clicks (half a turn).|
How should I care for my STIOLTO RESPIMAT inhaler
Clean the mouthpiece, including the metal part inside the mouthpiece, with a damp cloth or tissue only, at least 1 time a week. Any minor discoloration in the mouthpiece does not affect your STIOLTO RESPIMAT inhaler.
If the outside of your STIOLTO RESPIMAT inhaler gets dirty, wipe it with a damp cloth.
How should I store my STIOLTO RESPIMAT inhaler
- Store STIOLTO RESPIMAT at Room Temperature between 68°F to 77°F (20°C to 25°C).
- Do not freeze your STIOLTO RESPIMAT cartridge and inhaler.
Keep your STIOLTO RESPIMAT cartridge and inhaler out of the reach of children.
This Medication Guide and Instructions for Use has been approved by the U.S. Food and Drug Administration.
Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA
SPIRIVA, HandiHaler, STRIVERDI, STIOLTO™ and RESPIMAT are registered trademarks and are used under license from Boehringer Ingelheim International GmbH
Copyright 2015 Boehringer Ingelheim International GmbH.
ALL RIGHTS RESERVED
Revised: June 2015