PosologyThe recommended dose is one inhalation of 322 µg 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.
Elderly populationNo dose adjustments are required for elderly patients (see section 5.2).
Renal impairmentNo dose adjustments are required for patients with renal impairment (see section 5.2).
Hepatic impairmentNo dose adjustments are required for patients with hepatic impairment (see section 5.2).
Paediatric populationThere is no relevant use of Eklira Genuair in children and adolescents (under 18 years of age) in the indication of COPD.
Method of administrationFor inhalation use.
Instructions for use:Becoming familiar with Eklira Genuair:Remove the Genuair inhaler from the pouch and become familiar with its components.
How to use Eklira Genuair
SummaryTo use your Genuair inhaler there are 2 steps you need to perform after removing the cap:Step 1 - Press and RELEASE the green button and breathe out completely, away from the inhaler.Step 2 - Place your lips tightly around the mouthpiece and inhale STRONGLY and DEEPLY through the inhaler.After inhalation, remember to replace the protective cap.
Getting Started• Before first use, tear the sealed pouch along the notch and remove the Genuair inhaler.• When you are about to take your dose of medicinal product, remove the protective cap by lightly squeezing the arrows marked on each side and pulling outwards (see image 1).• Look to see that nothing is blocking the mouthpiece.• Hold the Genuair inhaler horizontally with the mouthpiece towards you and the green button facing straight up (see image 2).
STEP 1: PRESS and RELEASE the green button and breathe out completely, away from the inhaler.• Before bringing the inhaler to your mouth, press the green button all the way down (see image 3), then RELEASE it (see image 4).
DO NOT CONTINUE TO HOLD THE GREEN BUTTON DOWN.
Stop and Check: Make sure dose is ready for inhalation• Make sure the coloured control window has changed to green (see image 5).• The green control window confirms that your medicinal product is ready for inhalation.IF THE COLOURED CONTROL WINDOW STAYS RED, PLEASE REPEAT PRESS AND RELEASE ACTIONS (SEE STEP 1).• Before bringing the inhaler to your mouth, breathe out completely. Do not breathe out into the inhaler.STEP 2: Inhale STRONGLY and DEEPLY through the mouthpiece.• Put your lips tightly around the mouthpiece of the Genuair inhaler and breathe in STRONGLY and DEEPLY through your mouth (see image 6).This strong, deep breath pulls the medicinal product through the inhaler into your lungs.
• While you breathe in you will hear a CLICK which signals that you are using the Genuair inhaler correctly.• Keep breathing in even after you have heard the inhaler CLICK to be sure you get the full dose.• Remove the Genuair inhaler from your mouth and hold your breath for as long as is comfortable, then breathe out slowly through your nose.Note: Some patients may experience a mild sweet or slightly bitter taste, depending on the patient, when inhaling the medicinal product. Do not take an extra dose if you do not taste anything after inhaling.
Stop and Check: Make sure you have inhaled correctly• Make sure the control window has turned to red (see image 7). This confirms that you have inhaled your full dose correctly.
IF THE COLOURED CONTROL WINDOW IS STILL GREEN, PLEASE REPEAT INHALING STRONGLY AND DEEPLY THROUGH THE MOUTHPIECE (SEE STEP 2).• If the window still does not change to red, you may have forgotten to release the green button before inhaling or may not have inhaled correctly. If that happens, try again.Make sure you have RELEASED the green button and take a STRONG deep breath in through the mouthpiece.Note: If you are unable to inhale correctly after several attempts, consult your doctor.• Once the window has turned red, replace the protective cap by pressing it back onto the mouthpiece (see image 8).
When should you get a new Genuair inhaler?• The Genuair inhaler is equipped with a dose indicator to show you approximately how many doses are left in the inhaler. The dose indicator moves down slowly, displaying intervals of 10 (60, 50, 40, 30, 20, 10, 0) (see image A). Every Genuair inhaler will deliver at least 60 doses.• When a red striped band appears in the dose indicator (see image A), this means you are nearing your last dose and you should obtain a new Genuair inhaler.Note: If your Genuair inhaler appears to be damaged or if you lose the cap, your inhaler should be replaced. You DO NOT NEED to clean your Genuair inhaler. However, if you wish to clean it you should do so by wiping the outside of the mouthpiece with a dry tissue or paper towel. NEVER use water to clean the Genuair inhaler, as this may damage your medicine.
How do you know that your Genuair inhaler is empty?• When 0 (zero) appears in the middle of the dose indicator, you should continue using any doses remaining in the Genuair inhaler.• When the last dose has been prepared for inhalation, the green button will not return to its full upper position, but will be locked in a middle position (see image B). Even though the green button is locked, your last dose may still be inhaled. After that, the Genuair inhaler cannot be used again and you should start using a new Genuair inhaler.