Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Lactose monohydrate.

6.2   Incompatibilities
Not applicable.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials 
To be used within 90 days of opening the pouch.

6.4   Special precautions for storage
This medicinal product does not require any special storage conditions.
Keep the Genuair inhaler inside the pouch until the administration period starts.

6.5   Nature and contents of container

The inhaler device is a multicomponent device made of polycarbonate, acrylonitrile-butadiene-styrene, polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene and stainless steel. It is white-coloured with an integral dose indicator and a green dosage button. The mouthpiece is covered with a removable green protective cap. The inhaler is supplied in a plastic laminate pouch, placed in a cardboard carton.

Carton containing 1 inhaler with 30 unit doses.
Carton containing 1 inhaler with 60 unit doses.
Carton containing 3 inhalers each with 60 unit doses.

Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


Instructions for Use
Getting started

Read these instructions for Use before you start using the medicine

Become familiar with parts of your Genuair inhaler
Instructions for Use

Getting Started
Read this Instructions for Use before you start using the medicine.

Become familiar with the parts of Genuair inhaler.


Figure A

Before use:
 a) Before first use, tear open the sealed bag and remove the inhaler. Throw away the bag.
b) Do not press the green button until you are ready to take a dose.
c) Pull off the cap by lightly squeezing the arrows marked on each side (Figure B).


Figure B

STEP 1: Prepare your dose

1.1 Look in the opening of the mouthpiece and make sure nothing is blocking it (Figure C).
1.2 Look at the control window (should be red, Figure C).


1.3 Hold the inhaler horizontally with the mouthpiece facing you and the green button on top (Figure D)



1.4 Press the green button all the way down to load your dose (Figure E).

When you press the button all the way down, the control window changes from red to green.


Stop and Check:

1.6 Make sure the control window is now green (Figure G).

Your medicine is ready to be inhaled.
Go to ‘STEP 2: Inhale your medicine’.



Figure G



STEP 2: Inhale your medicine


2.1 Hold the inhaler away from your mouth and breathe out completely. Never breathe out into the inhaler (Figure I).



2.2 Hold your head upright, put the mouthpiece between your lips, and close your lips tightly around it
(Figure J).



2.3 Take a strong, deep breath through your mouth. Keep breathing in for as long as possible.


2.4 Take the inhaler out of your mouth.

2.5 Hold your breath for as long as possible.

2.6 Slowly breathe out. Away from the inhaler


Stop and Check:
2.7 Make sure the control window is now red (Figure K). This means you have inhaled your medicine correctly.



Push the cap back onto the mouthpiece after each use (Figure M).
Push the protective cap back onto the mouthpiece after each use (Figure M), to prevent contamination of the inhaler with dust or other materials. You should discard your inhaler if you lose the cap.



Additional information

What should you do if you accidently prepare a dose?
Store your inhaler with the protective cap in place until it is time to inhale your medicine, then remove the cap and start at Step 1.6.


How does the dose indicator work?
• The dose indicator shows the total number of doses left in the inhaler (Figure N).
• On first use, every inhaler contains at least 60 doses, or at least 30 doses, depending on the pack size.
• Each time you load a dose by pressing the green button, the dose indicator moves by a small amount towards the next number (50, 40, 30, 20, 10, or 0).


When should you get a new inhaler?
You should get a new inhaler:

• If your inhaler appears to be damaged or if you lose the cap, or
• When a red band appears in the dose indicator, this means you are nearing your last dose (Figure N), or
• If your inhaler is empty (Figure O).



How do you know that your inhaler is empty?

When the green button will not return to its full upper position and is locked in a middle position, you have reached the last dose (Figure O). Even though the green button is locked, your last dose may still be inhaled. After that, the inhaler cannot be used again and you should start using a new inhaler.



How should you clean the inhaler?

NEVER use water to clean the inhaler, as this may damage your medicine.


If you wish to clean your inhaler, just wipe the outside of the mouthpiece with a dry tissue or paper towel.



MANUFACTURER:
Industrias Farmaceuticas Almirall S.A., Spain

7.    REGISTRATION HOLDER:
AstraZeneca (Israel) Ltd.
1 Atirei Yeda St., Kfar Saba 4464301.