Prospect: information for the patient

Duaklir Genuair 340micrograms/12micrograms powder for inhalation

aclidinio/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 Duaklir Genuair and for what it is used

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

3.How to use Duaklir Genuair

4.Possible adverse effects

5.Storage of Duaklir Genuair

6.Contents of the package and additional information

Usage instructions

What is Duaklir Genuair

This medicine contains two active ingredients called aclidinium and formoterol fumarate dihydrate. Both belong to a group of medicines 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 Duaklir Genuair used for

Duaklir 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 medicine helps to relieve symptoms such as difficulty breathing. Regular use of Duaklir Genuair will reduce the effects of COPD on your daily life.

Do not use Duaklir Genuair:

• if you are allergic to aclidinium, formoterol fumarate dihydrate or any of the other ingredients of this medicine (listed in Section 6).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Duaklir Genuair if you have any of the following symptoms/conditions:

• If you have asthma. This medicine 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 Duaklir 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 medicine. See Section 4.

Duaklir Genuair is used as long-term maintenance treatment for COPD. Do not use this medicine 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 Duaklir Genuair, you should continue using the medicine but you should also see your doctor as soon as possible so that he or she can determine if you need other medication.

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

Dry mouth has been observed with medicines like Duaklir Genuair. Over time, dry mouth can be associated with dental caries, so it is essential to take good care of your oral hygiene.

Children and adolescents

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

Use of Duaklir Genuair with other medicines

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine. If you use Duaklir Genuair with other medicines, it is possible that the effect of Duaklir Genuair or the other medicines may be altered.

Inform your doctor or pharmacist if you are taking:

• Any medicine that may be similar to Duaklir Genuair for the treatment of breathing difficulties.
• Medicines that reduce the level of potassium in the blood. These include:

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

• Medicines called beta-blockers that may be used to treat high blood pressure and other heart conditions (such as atenolol or propranolol) or to treat glaucoma (such as timolol).
• Medicines that may cause a type of change in the electrical activity of the heart called "prolongation of the QT interval" (which is seen on an electrocardiogram). These include medicines for the treatment of:

• 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 medicine. Do not use Duaklir Genuair if you are pregnant or breastfeeding unless your doctor has recommended it.

Driving and operating machinery

It is unlikely that Duaklir Genuair will affect your ability to drive or operate machinery. In some patients, this medicine 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.

Duaklir Genuair contains lactose

This medicine contains lactose. If your doctor has told you that you are intolerant to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions for this medication as 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.
• The effects of Duaklir Genuair last 12 hours, so you should try to use Duaklir Genuair at the same time every morning and night to 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. If you are unsure about how to use Duaklir Genuair, consult your doctor or pharmacist.

Chronic Obstructive Pulmonary Disease (COPD) is a long-term condition, and therefore Duaklir 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 Duaklir Genuair than you should

If you think you have used more Duaklir 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 Duaklir Genuair packaging with you. You may need medical assistance.

If you forget to use Duaklir Genuair

If you forget a dose of Duaklir 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 Duaklir Genuair

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop using the medicine and contact your doctor immediately if you:

• experience swelling in the face, throat, lips, or tongue (with or without difficulty breathing or swallowing), hives, or severe skin itching (urticaria) as they may be symptoms of an allergic reaction. With the available data, the frequency of this reaction cannot be estimated.

• 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 may 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 1,000 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 frequent need to urinate, as they may be signs of an increase in blood sugar levels
• Palpitations, as they may be a sign of an abnormally accelerated heart rate or abnormal heart rhythm

Very 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 Duaklir 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 called creatine phosphokinase, which is found in muscle tissue
• Tremors
• Anxiety

Uncommon

• Accelerated heart rate (tachycardia)
• Abnormal or irregular heart rhythm (arrhythmias)
• Chest pain or pressure (angina pectoris)
• Blurred vision
• Changes in voice tone (dysphonia)
• Difficulty urinating or sensation of incomplete bladder emptying (urinary retention)
• Abnormal electrocardiogram (prolongation of the QT interval) that may lead to abnormal heart rhythm
• Altered sense of taste (dysgeusia)
• Irritation of the throat
• Inflammation of the mouth (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 theAppendix V. By reporting side effects, you can contribute to providing more information on 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 storage conditions.

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

Use within 60 days after opening the bag.

Do not use Duaklir 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 disposed of. Medications should not be thrown away. Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. In this way, you will help protect the environment.

Composition of Duaklir Genuair

• The active principles are aclidinium and formoterol fumarate dihydrate. Each released dose (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

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

The Genuair inhaler is 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 a closed aluminium protective pouch that contains a desiccant sachet. After removing the inhaler from the pouch, the pouch and desiccant must be thrown away.

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

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 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 the 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 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 pouch and remove the inhaler. Dispose of the pouch and desiccant.
• Do not press the orange button until you are ready to inhale a dose.
• Remove the protective cap by pressing the arrows on either side (Figure B).

Figure B

Step 1: Prepare your dose

Figure C

Figure D

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

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

Make sure you release the orange 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

What to do if the control window remains red after pressing the button (Figure H).

Figure H

The dose is not loaded.Go back to “Step 1: Prepare your dose” and repeat steps 1.1 to 1.6.

What to do if the control window remains green after inhaling (Figure L).

Figure L

This means you have not inhaled your medicine correctly.Go back to “Step 2: Inhale your medicine” and repeat steps 2.1 to 2.7.

If the control window remains unchanged to red, you may have forgotten to release the orange button before inhaling, or you may not have inhaled strongly enough. If this happens, try again. Make sure you have released the orange button and that you have exhaled completely. Then take a deep and strong breath through the mouthpiece.

Please contact your doctor if the control window remains green after several attempts.