Posology : מינונים

4.2   Posology and method of administration

Posology
The medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler.

Two puffs from the Respimat inhaler comprise one medicinal dose.

Spiolto Respimat is not indicated to treat asthma.
Spiolto Respimat is not indicated for the treatment of acute deteriorations of COPD.
Adults
The recommended dose is 5 microgram tiotropium and 5 microgram olodaterol given as two puffs from the Respimat inhaler once daily, at the same time of the day.
Spiolto Respimat                                      Approved prescribing information Inhalation solution                                   May 2019

The recommended dose should not be exceeded.

Elderly population
Elderly patients can use Spiolto Respimat at the recommended dose.


Hepatic impairment and Renal impairment
Spiolto Respimat contains tiotropium which is a predominantly renally excreted drug and olodaterol, which is predominantly metabolized in the liver.


Hepatic impairment
Patients with mild and moderate hepatic impairment can use Spiolto Respimat at the recommended dose.

There are no data available for use of olodaterol in patients with severe hepatic impairment.

Renal impairment
Renally impaired patients can use Spiolto Respimat at the recommended dose.
For patients with moderate to severe impairment (creatinine clearance  50 ml/min) see 4.4 and 5.2.

Spiolto Respimat contains olodaterol. There is limited experience with the use of olodaterol in patients with severe renal impairment.


Paediatric population
There is no relevant use of Spiolto Respimat in the paediatric population (under 18 years).


Method of administration
To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler by a physician or other health care professionals.


Spiolto Respimat                                       Approved prescribing information Inhalation solution                                    May 2019

SPIOLTO® RESPIMAT®

Instructions For Use
Introduction
Read these Instructions for Use before you start using Spiolto Respimat.
The patient will need to use this inhaler only ONCE A DAY. Each time used 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 first use’ until a cloud is visible. Then repeat steps 4 to 6 three more times.


How to care for Spiolto Respimat
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 Spiolto Respimat inhaler performance.
If necessary, wipe the outside of Spiolto Respimat inhaler with a damp cloth.


When to get a new Spiolto Respimat



•   Your Spiolto Respimat inhaler contains 60 puffs (30 doses) if used as indicated (two puffs/once daily).
•   The dose indicator shows approximately how much medication is left.
•   When the dose indicator enters the red area of the scale you need to get a new prescription; there is approximately medication for 7 days left (14 puffs).
•   Once the dose indicator reaches the end of the red scale, your Spiolto Respimat locks automatically no more doses can be released. At this point, the clear base cannot be turned any further.


Spiolto Respimat                                            Approved prescribing information Inhalation solution                                         May 2019
•      Spiolto Respimat should be discarded three months after you have prepared it for first use, even if it has not been fully used or used at all.

Prepare for first use
1. Remove clear base
• Keep the cap closed.
•    Press the safety catch while pulling off the clear base with the 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.
•    Do not remove the cartridge once it has been inserted into the inhaler.
3. Replace clear base
• Put the clear base back into place until it clicks.
•    Do not remove the clear base again.



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.
The inhaler is now ready to use and will deliver 60 puffs (30 doses).


Daily use
TURN
• Keep the cap closed.

Spiolto Respimat                                             Approved prescribing information Inhalation solution                                          May 2019 • 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 the lips around the mouthpiece without covering the air vents. Point the Inhaler to the back of the throat.
• While taking a slow, deep breath through the mouth, PRESS the dose-release button and continue to breathe in slowly for as long as comfortable.
• Hold the breath for 10 seconds or for as long as comfortable.
• Repeat TURN, OPEN, PRESS for a total of 2 puffs.
• Close the cap until the inhaler is used again.