BRETARIS GENUAIR (Inhalation Capsule)

2. What you need to know before you start using Bretaris Genuair

Do not use Bretaris Genuair:

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using Bretaris Genuair:

• if you have heart problems;
• if you see halos around lights or colored images (glaucoma);
• if you have an enlarged prostate, problems urinating, or an obstruction in your bladder.

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

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

Stop using Bretaris Genuair and seek medical help immediately if:

• you notice chest tightness, coughing, wheezing, or difficulty breathing immediately after using this medicine. 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 medicines

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. You should not use Bretaris Genuair if you are pregnant or breastfeeding unless your doctor has recommended it.

Driving and using machines

Bretaris Genuair has a minor influence on the ability to drive and use machines. This medicine may cause headache, dizziness, or blurred vision. If you experience any of these adverse reactions, do not drive or use machines until your headache has disappeared, the feeling of dizziness has passed, and your vision has returned to normal.

Bretaris Genuair contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to use Bretaris Genuair

Follow exactly the instructions for administration of this medicine given 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 in the evening.

The effects of Bretaris Genuair last 12 hours, so you should try to use the Bretaris Genuair inhaler at the same time every morning and evening. This will ensure that there is always enough medicine 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.

COPD is a long-term disease, so it is recommended to use Bretaris Genuair every day, twice a day, and not just when you have breathing problems or other COPD symptoms.

Method of administration

This medicine is for inhalation use only.

Refer to the Instructions for Use to learn how to use the Genuair inhaler. If you are in doubt about how to use Bretaris Genuair, consult your doctor or pharmacist.

You can use Bretaris Genuair 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, talk to your doctor or pharmacist.

If you forget to use Bretaris Genuair

If you miss 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 take a double dose to make up for a forgotten dose.

If you stop using Bretaris Genuair

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Bretaris Genuair can cause side effects, although not everybody gets them.

In rare cases, allergic reactions (may affect up to 1 in 1,000 patients) can occur. 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 severe swelling with itching of the skin (hives), as these may be symptoms of an allergic reaction.

The following side effects may occur when using Bretaris Genuair:

Common:may affect up to 1 in 10 patients

• Headache
• Inflammation of the paranasal sinuses (sinusitis)
• Common cold (nasopharyngitis)
• Cough
• Diarrhea
• Nausea

Uncommon:may affect up to 1 in 100 patients

• Dizziness
• Dry mouth
• Inflammation of the mouth (stomatitis)
• Hoarseness (dysphonia)
• Increased heart rate (tachycardia)
• Feeling of heart pounding (palpitations)
• Abnormal or irregular heartbeat (arrhythmias)
• Difficulty urinating (urinary retention)
• Blurred vision
• Rash
• Itching of the skin

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bretaris Genuair

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

Do not use this medicine after the expiry date which is stated on the inhaler label and the carton after “EXP”. The expiry date is the last day of the month shown.

Keep the Genuair inhaler in the bag until you start treatment.

Use within 90 days of opening the bag.

Do not use Bretaris Genuair if you notice the packaging is damaged or shows signs of tampering.

Once you have used the last dose, the inhaler should be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Bretaris Genuair Composition

• The active ingredient 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 "Bretaris Genuair contains lactose").

Appearance of the Product and Package Contents

Bretaris 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.

Available package sizes:

Package containing 1 inhaler with 30 doses.

Package containing 1 inhaler with 60 doses.

Package containing 3 inhalers with 60 doses each.

Only some package sizes may be marketed.

Marketing Authorization 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu.

Instructions for Use

This section contains information on how to use your Genuair inhaler. It is important that you read this information, as Genuair may work differently from inhalers you have used before. If you have any questions about how to use your inhaler, ask your doctor, pharmacist, or nurse for help.

The instructions for use are divided into the following sections:

• How to start
• Step 1: Prepare your dose
• Step 2: Inhale your medication
• Additional information

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

How to Start:

Read these instructions for use before starting to use the medication

Familiarize yourself with the parts of your Genuair inhaler

Before Use:

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

STEP 1: Prepare your dose

1. Check the mouthpiece opening and make sure nothing is blocking it (Figure C).

1. Check the control window (it should be red, Figure C).

1. Hold the inhaler horizontally with the mouthpiece facing you and the orange button at the top (Figure D).

1. Press the orange button down and all the way to load your dose (Figure E).

When you press the orange button down and all the way, the control window will change from red to green.

1. Release the orange button (Figure F).

Stop and Check:

1. Make sure the control window is now green (Figure G).

Your medication is ready to be inhaled.

Go to "STEP 2: Inhale your medication".

STEP 2: Inhale your medication

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

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

2.3 Take a strong and deep breaththrough your mouth. Continue breathing in for as long as possible.

2.4 Remove the inhaler from your mouth.

2.5 Hold your breath for as long as possible.

2.6 Breathe out slowly away from the inhaler.

Stop and Check:

2.7 Make sure the control window is now red (Figure K). This means you have inhaled your medication correctly.

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

Additional Information:

What should you do if you accidentally load a dose?

Keep your inhaler with the protective cap in place until it is time to inhale your medication, 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 left in the inhaler (Figure N).
• On the first use, each inhaler contains at least 60 or 30 doses, depending on the package size.
• Each time a dose is loaded by pressing the orange 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 you lose the cap, or
• When a red striped band appears on the dose indicator, this means you are approaching the last dose (Figure N), or
• If your inhaler is empty (Figure O).

How do you know if your inhaler is empty?

When the orange button does not return to its upper position and remains stuck in a middle position, it has reached the last dose (Figure O). Even when the orange button is stuck, you can still inhale the last dose. 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 it could damage your medication.

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