Prospecto: information for the patient

Eklira Genuair 322micrograms powder for inhalation

aclidinium (bromide of aclidinium)

Read this prospectus carefully before starting to use this medication, because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. See section 4.

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

2.What you need to know before starting to use Eklira Genuair

3.How to use Eklira Genuair

4.Possible adverse effects

5.Storage of Eklira Genuair

6.Contents of the package and additional information

Usage instructions

What is Eklira Genuair

The active ingredient of Eklira Genuair is aclidinium bromide, which belongs to a class of medications called bronchodilators. Bronchodilators relax the airways and help keep the bronchioles open. Eklira Genuair is a dry powder inhaler that uses your breathing to administer the medication directly into the lungs. This facilitates breathing in patients with chronic obstructive pulmonary disease (COPD).

What is Eklira Genuair used for

Eklira Genuair is indicated to help open the airways and alleviate symptoms of COPD, a severe and chronic lung disease characterized by difficulty breathing. Regular use of Eklira Genuair may help you when you experience continuous difficulty breathing due to the disease to help minimize the effects of the disease on your daily life and reduce the number of exacerbations (worsening of COPD symptoms over several days).

No use Eklira Genuair:

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

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Eklira Genuair:

• if you have heart problems;
• if you see halos around lights or colors (glaucoma);
• if you have an enlarged prostate, urinary problems, or a blocked bladder.

Eklira Genuair is indicated for maintenance treatment and should not be used to treat a sudden attack of breathing difficulty or wheezing. If your COPD symptoms do not improve or worsen, consult your doctor as soon as possible.

The dry mouth, which has been observed with medications like Eklira Genuair, may be associated with tooth decay after prolonged use of the medication. Therefore, remember to take care of your oral hygiene.

Stop using Eklira Genuair and seek medical help immediately if:

• you experience chest tightness, cough, wheezing, or immediate difficulty breathing after using this medication. These may be signs of a condition called bronchospasm.

Children and Adolescents

Eklira Genuair should not be used in children or adolescents under 18 years of age.

Using Eklira Genuair with Other Medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor if you have used or are using similar medications for respiratory problems, such as medications containing tiotropium, ipratropium. In case of doubt, consult your doctor or pharmacist. Eklira Genuair is not recommended for use with these medications.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Do not use Eklira Genuair if you are pregnant or breastfeeding unless your doctor recommends it.

Driving and Operating Machines

The influence of Eklira Genuair on the ability to drive and operate machines is small. This medication may cause headaches, dizziness, or blurred vision. If you experience any of these adverse reactions, do not drive or operate machines until your headache has disappeared, your dizziness has passed, and your vision has normalized.

Eklira Genuair Contains Lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended dose is one inhalation twice a day, in the morning and at night.

Eklira Genuair effects last 12 hours, therefore, you should try to use the Eklira Genuair inhaler at the same time every morning and night. This ensures that there is always enough medication in your body to help you breathe more easily throughout the day and night. This will also help you remember to use it.

The recommended dose can be used in elderly patients and patients with kidney or liver problems. No dose adjustment is necessary.

Chronic Obstructive Pulmonary Disease (COPD) is a long-term condition, therefore, it is recommended to use Eklira Genuair every day, twice a day, and not only when you have breathing problems or other COPD symptoms.

Administration route

This medication is for inhalation use.

See the User Instructions to learn how to use the Genuair inhaler. In case of doubt about how to use Eklira Genuair, consult your doctor or pharmacist.

You can use Eklira at any time, before or after meals or drinks.

If you use more Eklira Genuair than you should

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

If you forget to use Eklira Genuair

If you forget a dose of Eklira Genuair, inhale the dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

Do not administer a double dose to compensate for the missed doses.

If you interrupt treatment with Eklira Genuair

This medication is for long-term treatment. If you want to stop treatment, consult your doctor first, as your symptoms may worsen.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, Eklira Genuair may cause adverse effects, although not everyone will experience them.

In rare cases, allergic reactions may occur (affecting up to 1 in 1,000 patients). Discontinue use of the medication and immediately contact your doctor if you experience swelling in the face, throat, lips, or tongue (with or without difficulty breathing or swallowing), dizziness, or fainting, rapid heart rate, or severe swelling with itching on the skin (hives), as these may be symptoms of an allergic reaction.

When using Eklira Genuair, the following adverse effects may occur:

Frequent:affecting up to 1 in 10 patients

• Headache
• Paranasal sinus inflammation (sinusitis)
• Common cold (nasopharyngitis)
• Cough
• Diarrhea
• Nausea

Infrequent:affecting up to 1 in 100 patients

• Motion sickness
• Dry mouth
• Mouth inflammation (stomatitis)
• Hoarseness (dysphonia)
• Increased heart rate (tachycardia)
• Sensation of a strong heartbeat (palpitations)
• Abnormal or irregular heartbeat (cardiac arrhythmias)
• Difficulty urinating (urinary retention)
• Blurred vision
• Rash
• Itching on the skin

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus.You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the inhaler label and the packaging after “CAD”. The expiration date is the last day of the month indicated.

Keep the Genuair inhaler inside the pouch until treatment begins.

Use within 90 days after opening the pouch.

Do not use Eklira Genuair if you observe that the packaging is damaged or shows signs of manipulation.

Once you have used the last dose, the inhaler must be discarded. Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of medications that you no longer need. This will help protect the environment.

Composition of Eklira Genuair

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

Appearance of the product and contents of the pack

Eklira Genuair is a white or almost white powder.

The Genuair inhaler device is white with an integrated dose indicator and a green dosing button. The mouthpiece is covered by a removable green protective cap. It is provided in a plastic bag.

Provided pack sizes:

Pack containing 1 inhaler with 30 doses.

Pack containing 1 inhaler with 60 doses.

Pack containing 3 inhalers with 60 doses each.

Only some pack sizes may be marketed.

Marketing authorisation holder

Covis Pharma Europe B.V.

Gustav Mahlerplein 2

1082MA Amsterdam

Netherlands

Manufacturer responsible

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell 41-61

08740 Sant Andreu de la Barca, Barcelona

Spain

For more information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of this leaflet:

The 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 your Genuair inhaler. It is essential that you read this information, as Genuair may work differently from inhalers you have used previously. If you have any questions about how to use your inhaler, ask your doctor, pharmacist, or nurse.

The instructions for use are divided into the following sections:

- How to start
- Step 1: Prepare your dose
- Step 2: Inhale your medicine
- Additional information

How to start

Read these instructions for use before starting to use the medicine

Familiarise yourself with the parts of your Genuair inhaler

Figure A

Before use:

1. Before the first use,open the sealed bag and remove the inhaler. Dispose of the bag.
2. Do not press the green button until you are ready to inhale a dose.
3. Remove the protective cap by pressing lightly on the arrows on either side (Figure B).

Figure B

Step 1: Prepare your dose

Figure C

Figure D

When you press the green button down and hold it until the end, the control window will change from red to green.

Ensure the green button is up.Do not tilt it.

Ensure you release the button so the inhaler can function correctly

Figure EFigure F

Stop and check:

Your medicine is ready to be inhaled.

Go to “Step 2: Inhale your medicine”.

FigureG

Step 2: Inhale your medicine

Read all steps from 2.1 to 2.7 before using. Do not tilt it.

2.1Keep the inhaler away from your mouth andexhale completely.Never exhale into the inhaler (Figure I).

Figure I

2.2Keep your head upright, place the mouthpiece between your lips, and close them firmly around the mouthpiece (Figure J).

Do not press the green button while inhaling.

Figure J

2.3Take adeep and strong inspirationthrough your mouth. Continue inhaling for as long as possible.

A “click” will let you know you have inhaled correctly. Continue inhaling for as long as possible after hearing the “click”. Some patients may not hear the “click”. Use the control window to ensure you have inhaled correctly.

2.4Remove the inhaler from your mouth.

2.5Hold your breath for as long as possible.

2.6Exhale slowly away from the inhaler.

Some patients may experience a sensation of sand in their mouth, or a slightly sweet or bitter taste. Do not inhale an extra dose if you do not notice any taste or feel nothing after inhaling.

Stop and check:

2.7Ensure the control window is now red (Figure K). This means you have inhaled your medicine correctly.

Figure K

Replace the protective cap on the mouthpiece after each use (Figure M), to prevent contamination of the inhaler with powder or other materials. You must discard your inhaler if you lose the cap.

Figure M

Additional information

What to do if you accidentally load 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 remaining in the inhaler (Figure N).
• At the first use, each inhaler contains at least 60 or 30 doses, depending on the pack size.
• Each time you load a dose by pressing the green button, the dose indicator moves slightly to 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 loses its cap, or
• When a red band appears on the dose indicator, indicating that you are approaching the last dose (Figure N), or
• When your inhaler is empty (Figure O).

Figure N

How to know if your inhaler is empty?

When the green button does not return to its original position and gets stuck in a middle position, you have reached the last dose (Figure O). Even though the green button is stuck, you can still inhale the last dose. After that, the inhaler cannot be used again and you must start using a new inhaler.

Figure O

How to clean the inhaler?

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

If you want to clean your inhaler, simply wipe the outside of the mouthpiece with a dry cloth or a paper towel.