DUAKLIR GENUAIR 340/12 micrograms inhalation powder

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

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

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

• If you have asthma. This medicine should not be used to treat asthma.
• If you have heart problems.
• If you have epilepsy.
• If you have thyroid disorders (thyrotoxicosis).
• If you have a tumor in an adrenal gland (pheochromocytoma).
• If you have difficulty urinating or problems due to an enlarged prostate.
• If you have a eye 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 notice sudden tightness in the chest, coughing, wheezing, or difficulty breathing immediately after using the medicine. See section 4.

Duaklir Genuair is used as a maintenance treatment (long-term) for COPD. This medicine should not be used to treat a sudden attack of difficulty breathing or wheezing.

If your usual COPD symptoms (difficulty breathing, wheezing, or coughing) 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 they can determine if you need another medication.

If you see halos around lights or colored images, 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. In the long term, dry mouth may be associated with tooth decay, so it is important that you take care of your oral hygiene.

Children and adolescents

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

Using Duaklir Genuair with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. If you use Duaklir Genuair with other medicines, the effect of Duaklir Genuair or the other medicines may be altered.

Tell your doctor or pharmacist if you are taking:

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

• oral corticosteroids (such as prednisolone),
• diuretics (such as furosemide or hydrochlorothiazide),
• certain 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, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before using this medicine. You should not use Duaklir Genuair if you are pregnant or breastfeeding unless your doctor has recommended it.

Driving and using machines

Duaklir Genuair is unlikely to affect your ability to drive or use machines. However, some patients may experience blurred vision or dizziness. If you experience any of these side effects, do not drive or use machines until the dizziness has stopped and your vision has returned to normal.

Duaklir Genuair contains lactose

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

3. How to use Duaklir Genuair

Follow the instructions for administration of this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

• The recommended dose is one inhalation in the morning and one inhalation in the evening.
• You can use Duaklir Genuair at any time, before or after meals or drinks.
• The effects of Duaklir Genuair last for 12 hours, so you should try to use Duaklir Genuair at the same time every morning and evening, as this will ensure that there is always enough medicine in your body to help you breathe more easily throughout the day and night. Also, 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 in patients with kidney or liver problems. No dose adjustment is needed in these patients.
• Duaklir Genuair is for inhalation use only.
• Instructions for use:see the Instructions for Use at the end of this package leaflet for instructions on how to use the Genuair inhaler. If you are not sure how to use Duaklir Genuair, ask your doctor or pharmacist.

COPD is a long-term disease, and therefore Duaklir Genuair is for long-term use. The medicine should be used every day, twice a day, and not just when you have breathing problems or other symptoms of COPD.

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 room. Take the Duaklir Genuair package with you. You may need medical attention.

If you forget to use Duaklir Genuair

If you forget a dose of Duaklir Genuair, use it as soon as possible and use the next dose at the usual time. Do not use a double dose to make up for forgotten doses.

If you stop using Duaklir Genuair

This medicine is for long-term treatment. If you want to stop treatment, talk to 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, this medicine can cause side effects, although not everybody gets 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), hives, or severe itching of the skin (urticaria), as these may be signs of an allergic reaction. The frequency of this reaction cannot be estimated from the available data.

• experience tightness in the chest, coughing, wheezing, or difficulty breathing immediately after using the medicine. These may be signs of a condition called "paradoxical bronchospasm", which is a severe and prolonged contraction of the muscle in the airways 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, tell your doctor immediately.

Uncommon(may affect up to 1 in 100 people)

• Weakness or muscle spasms and/or abnormal heart rhythm, as these may be signs of a low level of potassium in the blood
• Fatigue, increased thirst, and/or need to urinate more frequently than usual, as these may be signs of a high level of sugar in the blood
• Palpitations, as this may be a sign of an abnormally fast or irregular heart rhythm

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

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

Other side effects that may occur when using Duaklir Genuair:

Common(may affect up to 1 in 10 people)

• Combination of sore throat and increased mucus; these may be signs of nasopharyngitis
• Headache
• Pain when urinating and/or frequent urination; these may be signs of a urinary tract infection
• Coughing
• Diarrhea
• Stuffy or runny nose, increased mucus, and/or pain or pressure in the cheeks or forehead; these may be symptoms of sinusitis
• Dizziness
• Muscle cramps
• Feeling sick (nausea)
• Difficulty sleeping
• Dry mouth
• Muscle pain
• Abscess (infection) of the gum
• High levels in the blood of a protein that is found in muscle tissue and is called creatine phosphokinase
• Tremors
• Anxiety

Uncommon

• Fast heart rate (tachycardia)
• Abnormal or irregular heart rhythm (cardiac arrhythmias)
• Chest pain or discomfort (angina pectoris)
• Blurred vision
• Changes in the tone of the voice (dysphonia)
• Difficulty urinating or feeling that the bladder is not fully empty (urinary retention)
• Abnormal electrocardiogram (prolongation of the QT interval) that may lead to an abnormal heart rhythm
• Altered sense of taste (dysgeusia)
• Sore throat
• Inflammation of the mouth (stomatitis)
• Increased blood pressure
• Nervousness
• 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. Storing Duaklir 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, the inhaler case, and the inhaler bag after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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

Use within 60 days of opening the bag.

Do not use Duaklir Genuair if you notice that the package 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. Container Contents and Additional Information

Duaklir Genuair Composition

• The active substances are aclidinium and formoterol fumarate dihydrate. Each delivered dose (the dose that comes out of the mouthpiece) contains 396 micrograms of aclidinium bromide 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 Container Contents

Duaklir Genuair is a white or almost white inhalation powder.

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

Available container sizes:

Container containing 1 inhaler with 30 doses.

Container containing 1 inhaler with 60 doses.

Container containing 3 inhalers with 60 doses each.

Only some container 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 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 questions 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 Medication
• Additional Information

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:

• Before the first use, open the closed bag and remove the inhaler. Dispose of the bag and the desiccant.
• Do not press the orange button until you are ready to inhale a dose.
• 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).
2. Check the control window (it should be red, Figure C).

1. Hold the inhaler horizontally with the mouthpiece facing you and the orange button on 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”.

Figure G

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).

Figure J

2.3 Take a strong and deep breaththrough your mouth. Keep 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 container 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 loses its 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 fully return to its top 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.