Prospecto: information for the patient

Bretaris Genuair 322micrograms powder for inhalation

aclidinium (bromide of aclidinium)

Read this prospectus carefully before starting to use this medication, as 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 should 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 do not appear in this prospectus. See section 4.

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

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

3.How to use Bretaris Genuair

4.Possible adverse effects

5.Storage of Bretaris Genuair

6.Contents of the package and additional information

Usage instructions

What is Bretaris Genuair

The active ingredient of Bretaris Genuair is aclidinium bromide, which belongs to a class of medications called bronchodilators. Bronchodilators relax the airways and help keep the bronchioles open. Bretaris 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 Bretaris Genuair used for

Bretaris Genuair is indicated to help open the airways and alleviate symptoms of COPD, a severe and long-term lung disease characterized by difficulty breathing. Regular use of Bretaris 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 Bretaris Genuair:

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

Warnings and Precautions

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

• if you have heart problems;
• if you see halos around lights or images in color (glaucoma);
• if you have an enlarged prostate, urinary problems, or a blockage in your bladder.

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

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

Stop using Bretaris 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

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

Using Bretaris 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 medications similar to Bretaris Genuair for respiratory problems, such as medications containing tiotropium, ipratropium. In case of doubt, consult your doctor or pharmacist. The use of Bretaris Genuair with these medications is not recommended.

Pregnancy and Breastfeeding

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

Driving and Operating Machines

The influence of Bretaris 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.

Bretaris Genuair contains lactose

If your doctor has told you that you have an intolerance to certain sugars, 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.

The effects of Bretaris Genuair last 12 hours, therefore, you should try to use the Bretaris 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 in 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 Bretaris 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 Bretaris Genuair, consult your doctor or pharmacist.

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

If you use more Bretaris Genuair than you should

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

If you forget to use Bretaris Genuair

If you forget a dose of Bretaris 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 Bretaris 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, Bretaris Genuair can produce adverse effects, although not all people will experience them.

In rare cases, allergic reactions may occur (affecting up to 1 in 1000 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 Bretaris 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 on 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 Bretaris 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 Bretaris Genuair

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

Appearance of the product and contents of the pack

Bretaris Genuair is a white or almost white powder.

The Genuair inhaler is a white device 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.

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

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 contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

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 back 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”.

Figure G

Step 2: Inhale your medicine

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

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

Figure I

2.2Hold 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 breaththrough your mouth. Continue breathing in for as long as possible.

A “click” will let you know you have inhaled correctly. Continue breathing in 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 gritty sensation 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).
• In 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 to get a new inhaler?

You should get a new inhaler:

• If your inhaler appears to be damaged or you lose the 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 is stuck in a middle position, you have reached the last dose (Figure O). Although 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.