Prospect: information for the patient

Brimica Genuair 340micrograms/12micrograms powder for inhalation

aclidinium/formoterol fumarate dihydrate

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

• Keep this prospect, 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 prospect. See section4.

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

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

3.How to use Brimica Genuair

4.Possible adverse effects

5.Storage of Brimica Genuair

6.Contents of the package and additional information

Usage instructions

What is Brimica Genuair

This medication contains two active ingredients called aclidinium and formoterol fumarate dihydrate. Both belong to a group of medications called bronchodilators. What bronchodilators do is relax the muscle of your airways, which allows your airways to open up more and helps you breathe more easily. The Genuair inhaler administers the active ingredients directly into your lungs when you inhale.

What is Brimica Genuair used for

Brimica Genuair is used in adult patients who have difficulty breathing due to a lung disease called chronic obstructive pulmonary disease (COPD), in which the airways and alveoli in the lungs are damaged or blocked. By opening up the airways, the medication helps to relieve symptoms such as difficulty breathing. Regular use of Brimica Genuair will reduce the effects of COPD on your daily life.

Do not use Brimica Genuair:

• if you are allergic to aclidinium, formoterol fumarate dihydrate, 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 Brimica Genuair if you have any of the following symptoms/diseases:

• If you have asthma. This medication should not be used for the treatment of asthma.
• If you have heart problems.
• If you have epilepsy.
• If you have thyroid disorders (hyperthyroidism).
• If you have a tumor in an adrenal gland (pheochromocytoma).
• If you have difficulty urinating or have problems due to an enlarged prostate.
• If you have a condition called narrow-angle glaucoma, which causes high pressure in the eye.

Stop using Brimica Genuair and seek immediate medical help if you experience any of the following symptoms::

• If you experience sudden chest tightness, cough, wheezing, or difficulty breathing immediately after using the medication. See section 4.

Brimica Genuair is used as long-term maintenance treatment for COPD. Do not use this medication to treat a sudden attack of difficulty breathing or wheezing.

If the usual symptoms of COPD (difficulty breathing, wheezing, or cough) do not improve or worsen during treatment with Brimica Genuair, continue using the medication but seek medical attention as soon as possible for your doctor to determine if you need additional medication.

If you see halos around lights or images in color, have eye pain or discomfort, or experience temporary blurred vision, seek medical attention as soon as possible.

Dry mouth has been observed with medications like Brimica Genuair. Over time, dry mouth may be associated with dental caries, so it is essential to maintain good oral hygiene.

Children and adolescents

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

Use of Brimica Genuair with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. If you use Brimica Genuair with other medications, the effect of Brimica Genuair or the other medications may be altered.

Inform your doctor or pharmacist if you are taking:

• Any medication that may be similar to Brimica Genuair for the treatment of breathing difficulties.
• Medications that reduce the level of potassium in the blood. These include:

• oral corticosteroids (such as prednisolone),
• diuretics (such as furosemide or hydrochlorothiazide),
• specific medications used to treat respiratory diseases (such as theophylline).

• Beta-blockers used to treat high blood pressure and other heart conditions (such as atenolol or propranolol) or to treat glaucoma (such as timolol).
• Medications that may cause a type of change in the heart's electrical activity called "prolongation of the QT interval" (observed in an electrocardiogram). These include medications for:

• depression (such as monoamine oxidase inhibitors or tricyclic antidepressants),
• bacterial infections (such as erythromycin, clarithromycin, or telithromycin),
• allergic reactions (antihistamines).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor, pharmacist, or nurse before using this medication.Do not useBrimica Genuairunless your doctor recommends it.

Driving and operating machinery

It is unlikely that Brimica Genuair will affect your ability to drive or operate machinery. In some patients, this medication may cause blurred vision or dizziness. If you experience any of these adverse reactions, do not drive or operate machinery until the dizziness has passed and your vision has returned to normal.

Brimica Genuair contains lactose

This medication 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 of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is one inhalation in the morning and one inhalation at night.
• You can use Brimica Genuair at any time, before or after eating or drinking.
• Brimica Genuair effects last 12 hours, therefore, you should try to use Brimica Genuair at the same time every morning and night, as this will ensure that there is always enough medication in your body to help you breathe more easily throughout the day and night. Additionally, using it at the same time every day will 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 in these patients.
• Brimica Genuair is for inhalation use.
• Usage instructions:see the Usage Instructions at the end of this leaflet to learn how to use the Genuair inhaler. In case of doubt about how to use Brimica Genuair, consult your doctor or pharmacist.

Chronic Obstructive Pulmonary Disease (COPD) is a long-term disease, and therefore Brimica Genuair is for long-term use. The medication should be used every day, twice a day, and not just when you have breathing problems or other COPD symptoms.

If you use more Brimica Genuair than you should

If you think you have used more Brimica Genuair than you should, you are more likely to experience some of its side effects, such as blurred vision, dry mouth, nausea, tremors, headache, palpitations, or increased blood pressure; in this case, contact your doctor immediately or go to the nearest emergency unit. Bring the Brimica Genuair packaging with you. You may need medical assistance.

If you forget to use Brimica Genuair

If you forget a dose of Brimica Genuair, administer it as soon as possible and the next dose should be administered at the usual time. Do not administer a double dose to compensate for the missed doses.

If you interrupt treatment with Brimica 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 medicines, this medicine can cause side effects, although not everyone will experience them.

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), severe skin rash and itching (urticaria) as they may be symptoms of an allergic reaction. With the available data, it cannot be estimated how often this reaction occurs.

• experience chest pressure, cough, wheezing, or immediate difficulty breathing after using the medicine. They may be signs of a condition called "paradoxical bronchospasm", which is a severe and prolonged contraction of the respiratory tract muscles immediately after treatment with a bronchodilator. This reaction can occur rarely (affects 1 in 1,000 people).

Some side effects can be serious:if you experience any of these side effects, inform your doctor immediately.

Rare: may affect up to 1 in 100 patients

• Weakness or muscle spasms and/or abnormal heart rhythm, as they may be signs of a decrease in potassium levels in the blood
• Tiredness, increased thirst, and/or need to urinate more frequently than usual, as they may be signs of an increase in blood sugar levels
• Palpitations, as they may be a sign of an abnormally fast or irregular heart rhythm

Rare (may affect up to 1 in 1,000 patients)

• Sudden difficulty breathing or swallowing, inflammation of the tongue, throat, lips, or face, hives, and/or skin itching; they may be signs of an allergic reaction

Other side effects that may occur during the use of Brimica Genuair:

Common: may affect up to 1 in 10 patients

• Combination of sore throat and increased mucus; they may be signs of nasopharyngitis
• Headache
• Painful urination and/or frequent urination; they may be signs of urinary tract infection
• Cough
• Diarrhea
• Stuffy nose or congestion, increased mucus, and/or pain or sensation of pressure in the cheeks or forehead; they may be symptoms of sinusitis
• Dizziness
• Muscle cramps
• Nausea (feeling of discomfort)
• Difficulty falling asleep
• Dry mouth
• Muscle pain
• Dental abscess (infection)
• Elevated levels of a protein in the blood that is found in muscle tissue and is called creatine phosphokinase
• Tremors
• Anxiety

Uncommon

• Abnormal heart rhythm (tachycardia)
• Abnormal or irregular heart rhythm (arrhythmias)
• Chest pain or pressure (angina pectoris)
• Blurred vision
• Changes in voice tone (dysphonia)
• Difficulty urinating or feeling that the bladder is not fully emptied (urinary retention)
• Abnormal electrocardiogram (prolongation of the QT interval) that may lead to an abnormal heart rhythm
• Altered sense of taste (dysgeusia)
• Throat irritation
• Mouth inflammation (stomatitis)
• Increased blood pressure
• Nervousness
• Hives
• Skin itching

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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, the inhaler case, and the inhaler bag after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Keep the Genuair inhaler protected inside the closed bag until treatment begins.

Use within 60 days after opening the bag.

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

Once you have used the last dose, the inhaler must be discarded. Medications should not be thrown away. Ask your pharmacist how to dispose of the containers and unused medications. In this way, you will help protect the environment.

Composition of Brimica Genuair

• The active principles are aclidinium and formoterol fumarate dihydrate. Each dose released (the dose that comes out of the mouthpiece) contains 396 micrograms of bromide of aclidinium equivalent to 340 micrograms of aclidinium and 11.8 micrograms of formoterol fumarate dihydrate.
• The other component is lactose monohydrate (see the end of section 2 under the heading “Brimica Genuair contains lactose” for more information).

Appearance of the product and contents of the pack

Brimica Genuair is a white or almost white powder for inhalation.

The Genuair inhaleris a white device with an integrated dose indicator and an orange dosage button. The mouthpiece is covered by a removable orange protective cap. It is provided in an aluminum closed protective bag that contains a desiccant bag. After removing the inhaler from the bag, the bag and the desiccant must be thrown away.

Provided pack sizes:

Pack containing 1 inhaler with 30 doses.

Pack containing 1inhaler with 60doses.

Pack containing 3inhalers with 60doses each.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Covis Pharma Europe B.V.

Gustav Mahlerplein 2

1082MA Amsterdam

Netherlands

Responsible for manufacturing:

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 the Genuair inhaler.It is essential that you read this information, as Genuair may work differently from the inhalers you have used previously.We also make available a demonstration video of the use of the Genuair inhaler, which is available atwww.genuair.comandusing the code provided below. If you have any doubts about how to use the inhaler, consult 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 medicinal product

Familiarise yourself with the parts of your Genuair inhaler

Figure A

Before use:

• Before the first use,open the closed bag and remove the inhaler. Dispose of the bag and the desiccant.
• Do not pressthe orange button until you are ready to inhale a dose.
• Remove the protective cap by pressing lightly on the arrows that appearon either side (Figure B).

Figure B

Step 1: Prepare your dose

Figure C

Figure D

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

Make sure the orange button is back up.Do not tilt it.

Make sure you release the button so that the inhaler can work 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 the 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 orange button while inhaling.

Figure J

2.3Take adeep and strong breaththrough your mouth. Continue breathing in as long as possible.

A “click” will let you know that you have inhaled correctly. Continue breathing in as long as possible after hearing the “click”. Some patients may not hear the “click”. Use the control window to make sure you have inhaled correctly.

2.4Remove the inhaler from your mouth.

2.5Hold your breath 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 do not feel anything after inhaling.

Stop and check:

2.7Make sure 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 dispose of 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 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 band appears on the dose indicator, indicating that you are approaching the last dose (Figure N), or

• if your inhaler is empty (Figure O).

Figure N

How to know if your inhaler is empty?

When the orange button does not return to its original position and is stuck in a middle position, you have reached the last dose (Figure O). Even though the orange 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.