Spiolto Respimat Patient Counseling Information

Handling Instructions: Read these Instructions for Use before you start using Tiotropium bromide + Olodaterol HCl (Spiolto Respimat).
You will need to use this inhaler only ONCE A DAY. Each time you use it take TWO PUFFS.
If not been used for more than 7 days, release one puff towards the ground.
If not been used for more than 21 days, repeat steps 4 to 6 under 'Prepare for use' until a cloud is visible. Then repeat steps 4 to 6 three more times.
How to care for your Tiotropium bromide + Olodaterol HCl (Spiolto Respimat) reusable: Clean the mouthpiece including the metal part inside the mouthpiece with a damp cloth or tissue only, at least once a week. Any minor discoloration in the mouthpiece does not affect your Tiotropium bromide + Olodaterol HCl (Spiolto Respimat) reusable inhaler performance. If necessary, wipe the outside of your reusable inhaler with a damp cloth.
When to replace the inhaler: When you have used an inhaler with 6 cartridges, get a new Tiotropium bromide + Olodaterol HCl (Spiolto Respimat) pack containing an inhaler. Do not use the Respimat re-usable inhaler for more than one year, after having inserted the first cartridge.
Prepare for use: 1. Remove clear base: Keep the cap closed.
Press the safety catch while firmly pulling off the clear base with your other hand.
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. Track cartridge and put clear base back: Mark the check-box on inhaler's label to track the number of cartridges.
Put the clear base back into place until it clicks.
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.
Repeat steps 4-6 until a cloud is visible.
After a cloud is visible, repeat steps 4-6 three more times.
Your inhaler is now ready to use and will deliver 60 puffs (30 doses).
Daily use: 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 your 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 slowly for as long as comfortable.
Repeat Turn, Open, Press for a total of 2 puffs.
Close the cap until you use your inhaler again.
When to replace the Tiotropium bromide + Olodaterol HCl (Spiolto Respimat) cartridge: The dose indicator shows how many puffs remain in the cartridge.
White scale: 60 puffs remaining.
Yellow scale: Less than 10 puffs remaining. Obtain a new cartridge.
Red scale: Your cartridge is used up. Turn the clear base to loosen it. Your inhaler is now in a locked position. Pull off the cartridge from the inhaler. Insert a new cartridge until it clicks (refer to step 2). The new cartridge will stick out more than the very first cartridge (continue with step 3). Remember to put the clear base back to unlock the inhaler.
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.
Are you replacing the cartridge? The new cartridge will stick out more than the very first cartridge. Insert it until it clicks, then replace the clear base.
I cannot press the dose-release button: Did you put the clear base back? If not, put the clear base back to unlock the inhaler. The Respimat reusable only functions with the clear base in place.
Did you turn the clear base? If not, turn the clear base in a continuous movement until it clicks (half a turn).
Does the dose indicator on your cartridge display a white arrow on a red background? Your cartridge is used up. Insert a new cartridge.
It is difficult to remove the cartridge after it is used up: Pull and turn the cartridge at the same time.
I cannot turn or replace 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.
Is the clear base loose and does the dose indicator on your cartridge display a white arrow on a red background? Your cartridge is used up. Insert a new cartridge.
My Respimat reusable has been used up too early: Did you use Respimat reusable as indicated (two puffs/once daily)? Respimat will last 30 days if used at two puffs once daily.
Did you spray in the air often to check whether the Respimat reusable is working? Once you have prepared Respimat reusable, no test-spraying is required if used daily.
Did you take off and put the clear base multiple times back? Do not remove the clear base before the cartridge is used up. Each time you take off the clear base without cartridge exchange, the dose counter records one puff and the remaining doses are reduced.
My Respimat reusable doesn't spray: Did you insert a cartridge? If not, insert a cartridge. Once your Respimat reusable is assembled, do not remove the clear base or the cartridge until the cartridge is used up.
Did you repeat TURN, OPEN, PRESS less than three times after inserting the cartridge? Repeat TURN, OPEN, PRESS three times after inserting the cartridge as shown in the steps 4 to 6 under "Prepare for use" as previously mentioned.
Does the dose indicator on your cartridge display a white arrow on a red background? Your cartridge is used up. Insert a new cartridge.
My Respimat reusable 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). The dose counter will count each incomplete turn and the number of remaining doses is reduced.
Was the cap open when you replaced the cartridge? Close the cap, then replace the cartridge.