Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Covis Pharma Europe B.V., Gustav Mahlerplein 2, 1082MA Amsterdam, The Netherlands
Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) (see section 5.1).
The recommended dose is one inhalation of 322 micrograms aclidinium twice daily.
If a dose is missed the next dose should be taken as soon as possible. However, if it is nearly time for the next dose, the missed dose should be skipped.
No dose adjustments are required for elderly patients (see section 5.2).
No dose adjustments are required for patients with renal impairment (see section 5.2).
No dose adjustments are required for patients with hepatic impairment (see section 5.2).
There is no relevant use of Bretaris Genuair in children and adolescents (under 18 years of age) for the indication of COPD.
For inhalation use.
Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers the patients may have used previously. It is important to instruct the patients to carefully read the Instructions for Use in the Package Leaflet, which is packed together with each inhaler.
For Instructions for Use, see section 6.6.
High doses of aclidinium bromide may lead to anticholinergic signs and symptoms. However, single inhaled doses up to 6,000 µg aclidinium bromide have been administered to healthy subjects without systemic anticholinergic adverse reactions. Additionally, no clinically relevant adverse reactions were observed following 7-day twice daily dosing of up to 800 µg aclidinium bromide in healthy subjects.
Acute intoxication by inadvertent medicinal product ingestion of aclidinium bromide is unlikely due to its low oral bioavailability and the breath-actuated dosing mechanism of the Genuair inhaler.
3 years.
To be used within 90 days of opening the pouch.
Keep the inhaler inside the pouch until the administration period starts.
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 doses.
Carton containing 1 inhaler with 60 doses.
Carton containing 3 inhalers each with 60 doses.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Read these Instructions for Use before you start using the medicine.
Become familiar with the parts of your Genuair inhaler.
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).
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.
Make sure the green button is on top. Do not tilt.
1.5 Release the green button (Figure F).
Make sure you release the button so the inhaler can work correctly.
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’.
What to do if the control window is still red after pressing the button (Figure H).
The dose is not prepared. Go back to ‘STEP 1 Prepare your dose’ and repeat steps 1.1 to 1.6
Read steps 2.1 to 2.7 fully before use. Do not tilt.
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).
Do not hold the green button down while inhaling.
2.3 Take a strong, deep breath through your mouth. Keep breathing in for as long as possible.
A ‘click’ will let you know that you are inhaling correctly. Keep breathing in as long as possible after you hear the ‘click’. Some patients may not hear the ‘click’. Use the control window to ensure you have inhaled correctly.
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.
Some patients may experience a grainy sensation in their mouth, or a slightly sweet or bitter taste. Do not take an extra dose even if you do not taste or feel anything after inhaling.
Stop and Check
2.7 Make sure the control window is now red (Figure K). This means you have inhaled your medicine correctly.
What to do if the control window is still green after inhalation (Figure L).
This means you have not inhaled your medicine correctly. Go back to ‘STEP 2 Inhale your medicine’ and repeat steps 2.1 to 2.7.
If the control window still does not change to red, you may have forgotten to release the green button before inhaling, or you may not have inhaled strongly enough. If this happens, try again. Make sure you have released the green button, and you have breathed out completely. Then take a strong, deep breath through the mouthpiece.
Please contact your doctor if the control window is still green after repeated attempts.
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.
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?
When should you get a new inhaler?
You should get a new inhaler:
Dose indicator moves slowly from 60 to 0: 60, 50, 40, 30, 20, 10, 0.
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.
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