Eklira Genuair

Package leaflet: Information for the patient

Eklira Genuair 322 micrograms inhalation powder

Aclidinium (aclidinium bromide)
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Eklira Genuair is and what it is used for
2. What you need to know before using Eklira Genuair
3. How to use Eklira Genuair
4. Possible side effects
5. How to store Eklira Genuair
6. Contents of the pack and other information Instructions for Use

1. What is Eklira Genuair and what is it used for

What is Eklira Genuair
The active substance of Eklira Genuair is aclidinium bromide, which belongs to a group of medicines
called bronchodilators. Bronchodilators relax the muscles of the airways and help keep the bronchioles open. Eklira Genuair is a dry powder inhaler that uses your breath to deliver the medicine directly into the lungs, making it easier for patients with chronic obstructive pulmonary disease (COPD) to breathe.
What Eklira Genuair is used for
Eklira Genuair is indicated to help open the airways and relieve symptoms of COPD, a serious long-term lung disease characterized by difficulty breathing. Regular use of Eklira Genuair can help when you are short of breath due to the disease and will help reduce the impact of the disease on your daily life and reduce the number of exacerbations (worsening of COPD symptoms lasting for several days).

2. What you need to know before using Eklira Genuair

Do not use Eklira Genuair

• if you are allergic to aclidinium bromide or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Eklira Genuair:

• if you have heart problems;
• if you see halos around lights or coloured images (glaucoma);
• if you have an enlarged prostate, difficulty urinating, or a blocked bladder.

Eklira Genuair is intended as a maintenance therapy and must not be used to treat sudden attacks of breathlessness or wheezing. If your COPD symptoms (shortness of breath, wheezing, cough) do not improve or worsen, you must consult your doctor as soon as possible.
Dry mouth, which may occur with medicines such as Eklira Genuair, after long-term use of the medicine, may be associated with dental caries. Therefore, remember to pay attention to oral hygiene.
Stop taking Eklira Genuair and contact your doctor immediately:

• if you experience chest tightness, cough, wheezing or breathlessness immediately after using the medicine. These could be signs of a condition called bronchospasm.

Children and adolescents
Eklira Genuair must not be used in children and adolescents under 18 years of age.
Other medicines and Eklira Genuair
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you have used or are currently using similar medicines for breathing problems, such as medicines containing tiotropium or ipratropium. If you have any doubts, consult your doctor or pharmacist. The use of Eklira Genuair together with these medicines is not recommended.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. You must not use Eklira Genuair during pregnancy or while breastfeeding, unless your doctor has specifically instructed you to do so.
Driving and using machines
Eklira Genuair has a minor influence on the ability to drive vehicles or use machines. This medicine may cause headache, dizziness or blurred vision. If you experience any of these effects, do not drive or operate machinery until the headache has resolved, the dizziness has disappeared, and your vision has returned to normal.
Eklira Genuair contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to use Eklira Genuair

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• The recommended dose is one inhalation twice daily, in the morning and evening.
• The effects of Eklira Genuair last for 12 hours; therefore, you should try to use the Eklira Genuair inhaler at the same time each morning and each evening. This ensures that a sufficient amount of the medicine is always present in your body, helping you to breathe more easily throughout the day and night. It will also help you remember to take it.

The recommended dose can be used in elderly patients and in patients with kidney or liver problems. Dose adjustments are not necessary.
COPD is a chronic disease; therefore, it is recommended that you use Eklira Genuair every day, twice daily, and not only when you experience breathing difficulties or other COPD symptoms.

Route of administration
This medicine is for inhalation use.
For instructions on how to use the Genuair inhaler, refer to the Instructions for Use. If you have any doubts about how to use Eklira Genuair, consult your doctor or pharmacist.
You may use Eklira Genuair at any time before or after eating or drinking.

If you use more Eklira Genuair than you should
If you think you have used more Eklira Genuair than you should, contact your doctor or pharmacist.

If you forget to use Eklira Genuair
If you forget a dose of Eklira Genuair, inhale the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for the forgotten dose.

If you stop using Eklira Genuair
This medicine is intended for long-term use. If you wish to stop treatment, discuss this with your doctor first, as your symptoms may worsen.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Very rarely, allergic reactions may occur (may affect up to 1 in 1,000 people). Stop using the medicine and contact your doctor immediately if you experience swelling of the face, throat, lips or tongue (with or without difficulty breathing or swallowing), dizziness or fainting, rapid heartbeat, or develop severely itchy blisters on the skin (urticaria), as these could be symptoms of an allergic reaction.

The following side effects may occur during treatment with Eklira Genuair:
Common: may affect up to 1 in 10 people

• Headache (cephalalgia)
• Inflammation of the sinuses (sinusitis)
• Common cold (nasopharyngitis)
• Cough
• Diarrhoea
• Nausea

Uncommon: may affect up to 1 in 100 people

• Dizziness
• Dry mouth
• Inflammation of the mouth (stomatitis)
• Hoarseness (dysphonia)
• Rapid heartbeat (tachycardia)
• Abnormal or irregular heartbeat (cardiac arrhythmias)
• Awareness of heartbeat (palpitations)
• Difficulty in urination (urinary retention)
• Blurred vision
• Skin rash
• Itching of the skin

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eklira Genuair

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the box of the inhaler after "Exp." or "EXP". The expiry date refers to the last day of that month.
Keep the inhaler inside the bag until the start of the treatment period.
Use within 90 days after opening the bag.
Do not use Eklira Genuair if you notice that the packaging is damaged or shows any signs of tampering.
After taking the last dose, the inhaler must be disposed of. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.

6. Package contents and other information

What Eklira Genuair contains

• The active substance is aclidinium bromide. Each delivered dose contains 375 micrograms of aclidinium bromide, equivalent to 322 micrograms of aclidinium.
• The other component is lactose monohydrate (see section 2 “Eklira Genuair contains lactose”).

Description of the appearance of Eklira Genuair and contents of the pack

Eklira Genuair is a white or almost white powder.
The Genuair inhaler is white in colour, with an integrated dose indicator and a green dosing button. The mouthpiece is covered by a removable green protective cap. It is supplied in a plastic bag.

Pack sizes:
Box containing 1 inhaler with 30 doses.
Box containing 1 inhaler with 60 doses.
Box containing 3 inhalers, each with 60 doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Covis Pharma Europe B.V.
Gustav Mahlerplein 2
1082 MA Amsterdam
The Netherlands

Manufacturer:
Industrias Farmacéuticas Almirall, S.A.
Ctra. de Martorell 41-61
08740 Sant Andreu de la Barca, Barcelona
Spain

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Covis Pharma Europe B.V. Covis Pharma Europe B.V.
Tel: 80013067 Tel: 880000890

България Luxembourg/Luxemburg
Covis Pharma Europe B.V. Covis Pharma Europe B.V.
Tel: 008002100654 Tel: 80024119

Česká republika Magyarország
Covis Pharma Europe B.V. Covis Pharma Europe B.V.
Tel: 800144474 Tel.: 0680021540

Danmark Malta
Zentiva Denmark ApS Covis Pharma Europe B.V.
Tlf: +45 787 68 400 Tel: 80065149

Deutschland Nederland
Zentiva Pharma GmbH Covis Pharma Europe B.V.
Tel: +49 (0) 800 53 53 010 Tel: 08000270008

Eesti Norge
Covis Pharma Europe B.V. Zentiva Denmark ApS
Tel: 8000100776 Tlf: +47 219 66 203

Ελλάδα Österreich
Specialty Therapeutics IKE Covis Pharma Europe B.V.
Tel: +30 213 02 33 913 Tel: 0800006573

España Polska
Zentiva Spain S.L.U. Covis Pharma Europe B.V.
Tel: +34 931 815 250 Tel.: 0800919353

France Portugal
Zentiva France Zentiva Portugal, Lda
Tél: +33 (0) 800 089 219 Tel: +351210601360

Hrvatska România
Covis Pharma Europe B.V. Covis Pharma Europe B.V.
Tel: 08004300 Tel: 0800410175

Ireland Slovenija
A. Menarini Pharmaceuticals Ireland Ltd Covis Pharma Europe B.V.
Tel: +353 1 284 6744 Tel: 080083003

Ísland Slovenská republika
Zentiva Denmark ApS Covis Pharma Europe B.V.
Sími: +354 539 0650 Tel: 0800008203

Italia Suomi/Finland
Covis Pharma Europe B.V. Zentiva Denmark ApS
Tel: 800168094 Puh/Tel: +358 942 598 648

Κύπρος Sverige
Specialty Therapeutics IKE Zentiva Denmark ApS
Tel: +30 213 02 33 913 Tel: +46 840 838 822

Latvija United Kingdom (Northern Ireland)
Covis Pharma Europe B.V. Zentiva, k.s.
Tel: 80005962 Tel: +44 (0) 800 090 2408

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Instructions for Use

This section contains information on how to use the Genuair inhaler. It is important to read this
information, as Genuair may work differently from inhalers you have used previously. If you have
any doubts about how to use your inhaler, please consult your doctor, pharmacist, or nurse for
assistance.
The instructions for use are divided into the following sections:

• Preliminary steps
• Step 1: Prepare the dose
• Step 2: Inhale the medicine
• Additional information

Preliminary Steps
Read these instructions for use before starting to use this medicine.
Familiarize yourself with the components of the Genuair inhaler.
Indicator
Dose
Control window
Green button

Green = inhaler ready
for use
Protective
Cap
Control window
Red = confirms correct
inhalation
Mouthpiece
Figure A
Before use:
a) Before first use, open the sealed bag and remove the Genuair inhaler from the bag.
b) Do not press the green button until you are ready to take a dose.
c) Remove the cap by gently pressing the arrows on both sides (Figure B).

Press here and
pull
Figure B
STEP 1: Prepare the dose
1.1 Look into the mouthpiece opening and make sure nothing is blocking it (Figure C).
1.2 Look at the control window (it must be red, Figure C).

RED
Check the mouthpiece
opening
Figure C
1.3 Hold the inhaler horizontally with the mouthpiece facing towards you and the green button
pointing straight upwards (Figure D).

Figure D
1.4 Press the green button fully down to load the dose (Figure E).
When the green button is pressed fully down, the control window changes from red to green.
Ensure the green button is pointing straight upwards. Do not tilt.
1.5 Release the green button (Figure F).
Make sure you have released the button so that the inhaler functions correctly.

Figure E Figure F
Stop and Check:
1.6 Make sure the control window is now green (Figure G).
Your medicine is now ready to inhale.
Proceed to ‘STEP 2: Inhale the medicine’.

GREEN
Figure G
What to do if the control window is still red after pressing the button (Figure H).

Figure H
The dose has not been prepared. Go back to ‘STEP 1: Prepare the dose’ and repeat steps 1.1 to 1.6.
STEP 2: Inhale the medicine
Read all steps from 2.1 to 2.7 completely before use. Do not tilt.
2.1 Hold the inhaler away from your mouth and breathe out fully. Never breathe out into the
inhaler (Figure I).

Figure I
2.2 Keep your head upright, place the mouthpiece between your lips, and close your lips firmly
around it (Figure J).
Do not press the green button while inhaling.

Figure J
2.3 Take a strong, deep breath in through your mouth. Hold your breath as long as possible.
You will hear a ‘click’, which indicates you are inhaling correctly. Hold your breath as long as
possible after hearing the ‘click’. Some patients may not hear the ‘click’. Use the control window to
confirm you have inhaled correctly.
2.4 Remove the inhaler from your mouth.
2.5 Hold your breath as long as possible.
2.6 Breathe out slowly away from the inhaler.
Some patients may feel a granular sensation in the mouth or a slightly sweet or bitter taste. Do not
take an extra dose even if you do not taste anything or do not feel anything after inhalation.
Stop and Check:
2.7 Make sure the control window is now red (Figure K). This means you have inhaled the medicine
correctly.

Figure K
What to do if the control window is still green after inhalation (Figure L).

Figure L
This means you did not inhale the medicine correctly. Go back to ‘STEP 2: Inhale the medicine’ and repeat steps 2.1 to 2.7.
If the control window still does not turn 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 that you have breathed out fully. Then take a strong, deep breath in through the mouthpiece.
Contact your doctor if the control window remains green after repeated attempts.
Close the protective cap back over the mouthpiece after each use (Figure M) to prevent contamination of the inhaler with dust or other materials. You must dispose of your inhaler if you have lost the cap.

Figure M
Additional Information
What should you do if you have accidentally prepared a dose?
Store your inhaler with the protective cap in place until you are ready to inhale the medicine, then remove the cap and start from step 1.6.
How does the dose indicator work?

• The dose indicator shows the total number of doses remaining in the inhaler (Figure N).
• At first use, each 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 forward in small increments to the next number (50, 40, 30, 20, 10, or 0).

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

• If your inhaler appears damaged or if you have lost the cap, or
• When a red band appears in the dose indicator, meaning it is nearly empty (Figure N), or
• If your inhaler is empty (Figure O).

The dose indicator moves slowly
from 60 to 0: 60, 50, 40, 30, 20, 10, 0.

Red band
Dose
Indicator
Figure N
How do you know when the inhaler is empty?
When the green button no longer returns fully to the upright position and remains stuck in an intermediate position, the last dose has been reached (Figure O). Although the green button is stuck, the final dose can still be inhaled. After this dose, the inhaler can no longer be used and you must start using a new inhaler.

Stuck
Figure O
How to clean the inhaler?
NEVER use water to clean the inhaler, as this may damage the medicine.
If you wish to clean your inhaler, wipe the outer part of the mouthpiece with a dry cloth or tissue.
ANNEX IV
SCIENTIFIC CONCLUSIONS AND REASONS FOR THE VARIATION OF THE TERMS OF THE MARKETING AUTHORISATION
Scientific Conclusions
Taking into account the assessment of the Pharmacovigilance Risk Assessment Committee (PRAC) for the final report of the mandated non-interventional PASS study for the medicines mentioned above, the scientific conclusions of the Committee for Human Medicinal Products (CHMP) are as follows:
The study results show that aclidinium increases the risk of cardiac arrhythmias and atrial fibrillation compared to LABAs and other LAMAs. Furthermore, the results also show that aclidinium/formoterol FDC increases the risk of any cardiac arrhythmias and atrial fibrillation compared to LABAs or other LAMA/LABA combinations. Therefore, in light of the available data from the final PASS study report, the PRAC considered that changes to the product information are required.
The CHMP agrees with the scientific conclusions of the PRAC.
Reasons for the variation of the terms of the marketing authorisation
Based on the scientific conclusions of the study results for the medicines mentioned above, the CHMP considers that the benefit-risk balance of these medicines remains unchanged, subject to the proposed changes to the product information.
The CHMP recommends a variation to the terms of the marketing authorisation for the medicines mentioned above.