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 (see 4.2).
Two puffs from the Respimat inhaler comprise one medicinal dose.

Boehringer Ingelheim Israel                                                                 Page 1 of 21 Spiriva Respimat                                       Prescribing information Solution for inhalation                                July 2019
The recommended dose for adults is 5 microgram tiotropium given as two puffs from the Respimat inhaler once daily, at the same time of the day.

The recommended dose should not be exceeded.

In the treatment of asthma the full benefit will be apparent after several doses of the medicinal product. In adult patients with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (≥ 800 μg budesonide/day or equivalent) and at least one controller.


Special populations
Geriatric patients can use tiotropium bromide at the recommended dose.
Renally impaired patients can use tiotropium bromide at the recommended dose. For patients with moderate to severe impairment (creatinine clearance ≤ 50 ml/min, see 4.4 and 5.2).

Hepatically impaired patients can use tiotropium bromide at the recommended dose (see 5.2).

Paediatric population
Asthma
The recommended dose for patients 6 to 17 years of age is 5 microgram tiotropium given as two puffs from the Respimat inhaler once daily, at the same time of the day.

In adolescents (12 - 17 years) with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (> 800 - 1600 µg budesonide/day or equivalent) and one controller or in addition to inhaled corticosteroids (400 - 800 µg budesonide/day or equivalent) with two controllers.

For children (6 - 11 years) with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (> 400 µg budesonide/day or equivalent) and one controller or in addition to inhaled corticosteroids (200 - 400 µg budesonide/day or equivalent) with two controllers.

The safety and efficacy of Spiriva Respimat in children aged 6 - 17 years with moderate asthma has not been established.The safety and efficacy of Spiriva Respimat in children below 6 years of age has not been established. Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.

COPD
There is no relevant use of Spiriva Respimat in children and adolescents below 18 years 
Cystic fibrosis
The efficacy and safety of Spiriva Respimat has not been established (see sections 4.4 and 5.1).

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 professionals.


Instructions for Use
Introduction

Read these Instructions for Use before you start using Spiriva Respimat. Children should use Spiriva Respimat with an adult’s assistance.


Spiriva Respimat                                       Prescribing information Solution for inhalation                                July 2019
The patient will need to use this inhaler only ONCE A DAY. Each time used take TWO PUFFS.



CAP
MOUTHPIECE                                      ‫פיה‬

AIR VENT                          ‫פתחי אוורור‬
DOSE-RELEASE BUTTON                              ‫לחצן לשחרור מנה‬ 


SAFETY CATCH                     H                       ‫נצרה‬ 


CLEAR BASE

PIERCING ELEMENT            T


CARTRIDGE


• 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 Spiriva 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 Spiriva Respimat inhaler performance.
If necessary, wipe the outside of Spiriva Respimat inhaler with a damp cloth.


When to get a new Spiriva Respimat


Spiriva Respimat                                        Prescribing information Solution for inhalation                                 July 2019



• Your Spiriva 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 Spiriva Respimat locks automatically – no more doses can be released. At this point, the clear base cannot be turned any further.

•    Spiriva 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 thenarrow 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.


Spiriva Respimat                                     Prescribing information Solution for inhalation                              July 2019
3. Replace clear base
• Put the clear base back into place until it clicks.
• Do not remove the clear base again.



Spiriva Respimat                                      Prescribing information Solution for inhalation                               July 2019


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).



Spiriva Respimat                                        Prescribing information Solution for inhalation                                 July 2019


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 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.