Duaklir Genuair

Patient Information Leaflet: Information for the patient

Duaklir Genuair 340 micrograms/12 micrograms inhalation powder

aclidinium/formoterol fumarate dihydrate
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Duaklir Genuair is and what it is used for
2. What you need to know before using Duaklir Genuair
3. How to use Duaklir Genuair
4. Possible side effects
5. How to store Duaklir Genuair
6. Contents of the pack and other information
   Instructions for Use

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

What Duaklir Genuair is
This medicine contains two active substances, aclidinium and formoterol fumarate dihydrate. Both
belong to a group of medicines called bronchodilators. Bronchodilators relax the muscles of the airways,
allowing the airways to open wider and helping you to breathe more easily. The Genuair inhaler releases
the active substances directly into the lungs when you inhale.

What Duaklir Genuair is used for
Duaklir Genuair is used in adult patients with breathing difficulties due to a lung disease called chronic
obstructive pulmonary disease (COPD), in which the airways and air sacs in the lungs are damaged or become blocked.
By opening the airways, this medicine helps relieve symptoms such as shortness of breath. Regular use of Duaklir Genuair
reduces the impact of COPD on daily life.

2. What you need to know before 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 using Duaklir Genuair if you experience any of the following symptoms/conditions:

• if you have asthma. This medicine must not be used for the treatment of asthma;
• if you have heart problems;
• if you suffer from epilepsy;
• if you have a problem with your thyroid gland (thyrotoxicosis);
• if you have a tumour in one of your adrenal glands (pheochromocytoma);
• if you have difficulty urinating or problems due to an enlarged prostate;
• if you have a condition called narrow-angle glaucoma, which causes increased eye pressure.

Stop taking Duaklir Genuair and contact your doctor immediately if you experience any of the following:

• sudden chest tightness, cough, wheezing, or shortness of breath immediately after using the medicine. See Section 4.

Duaklir Genuair is indicated as a maintenance (long-term) treatment for COPD. Do not use this medicine to treat sudden episodes of shortness of breath or wheezing.
If the common symptoms of COPD (shortness of breath, wheezing, cough) do not improve or worsen during treatment with Duaklir Genuair, you may continue to use it, but you must consult your doctor as soon as possible, as you may need another medicine.
If you see halos around lights or coloured images, experience eye pain or disturbances, or suffer from temporary blurred vision, consult your doctor as soon as possible.
Dry mouth, which may occur with medicines such as Duaklir Genuair, may over time be associated with dental caries; therefore, it is important to maintain good oral hygiene.
Children and adolescents
Duaklir Genuair must not be used in children or adolescents under 18 years of age.
Other medicines and Duaklir Genuair
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. If you use Duaklir Genuair together with other medicines, 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 treating breathing difficulties.
• Medicines that reduce the amount of potassium in the blood. These include: o oral corticosteroids (such as prednisolone); o diuretics (such as furosemide or hydrochlorothiazide); o some medicines used to treat respiratory conditions (such as theophylline).
• Medicines known as beta-blockers, which may be used to treat high blood pressure or other heart problems (such as atenolol or propranolol), or to treat glaucoma (such as timolol).
• Medicines that may cause a type of change in the heart's electrical activity known as QT interval prolongation (detectable on an electrocardiogram). These include medicines used to treat: o depression (such as monoamine oxidase inhibitors or tricyclic antidepressants); o bacterial infections (such as erythromycin, clarithromycin, telithromycin); o allergic reactions (antihistamines).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor, pharmacist, or nurse for advice before using this medicine. You must not use Duaklir Genuair during pregnancy or while breastfeeding, unless your doctor has specifically instructed you to do so.
Driving and using machines
Duaklir Genuair does not affect or affects only negligibly the ability to drive or use machines. In some patients, this medicine may cause blurred vision or dizziness. If you experience any of these effects, do not drive or operate machinery until dizziness has resolved or vision has returned to normal.
Duaklir Genuair contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to use Duaklir Genuair

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• The recommended dose is one inhalation in the morning and one inhalation in the evening.
• You may use Duaklir Genuair at any time before or after food or drink.
• The effects of Duaklir Genuair last for 12 hours; therefore, you should try to use Duaklir Genuair at the same time each morning and each evening. This ensures that a sufficient amount of the medicine remains in your body at all times, helping you to breathe more easily throughout the day and night. Taking your medicine at regular intervals will also help you remember to use it.
• The recommended dose can be used in elderly patients and in patients with renal or hepatic impairment. Dose adjustments are not required for these patients.
• Duaklir Genuair is for inhalation use only.
• Instructions for use: for instructions on how to use the Genuair inhaler, please refer to the Instructions for Use. If you have any doubts about how to use Duaklir Genuair, consult your doctor or pharmacist.

COPD is a chronic disease; therefore, Duaklir Genuair is intended for long-term use. It is recommended to use the medicine every day, twice daily, and not only when experiencing breathing difficulties 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, feeling unwell, trembling/tremors, headache, palpitations, or increased blood pressure. You should immediately contact your doctor or go to the nearest emergency department. Show the Duaklir Genuair packaging. Medical treatment may be necessary.

If you forget to take Duaklir Genuair
If you forget a dose of Duaklir Genuair, take it as soon as possible and then take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

If you stop using Duaklir Genuair
This medicine is intended for long-term use. If you wish to stop treatment, speak to your doctor first, as your symptoms may worsen.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking 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), or severe itchy rash on the skin (urticaria), as these may be symptoms of an allergic reaction. The frequency of this reaction cannot be estimated from the available data.
• You experience chest tightness, cough, shortness of breath or breathlessness immediately after using the medicine. These may be signs of a condition called "paradoxical bronchospasm", which is an excessive and prolonged contraction of the airway muscles occurring immediately after treatment with a bronchodilator. This reaction may occur rarely (affecting up to 1 in 1,000 people).

Some of these could be serious: if you experience any of these side effects, seek medical advice immediately.
Uncommon (may affect up to 1 in 100 people)

• Muscle weakness or cramps and/or changes in heart rhythm, as these could be signs of low potassium levels in the blood
• Fatigue, increased thirst and/or increased frequency of urination, as these could be signs of elevated blood sugar levels
• Palpitations, as these could be signs of an unusually fast heartbeat 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, skin rash and/or itching – these could be signs of an allergic reaction.

Other side effects that may occur during use of Duaklir Genuair:
Common (may affect up to 1 in 10 people)

• Combination of sore throat and runny nose – these could be signs of nasopharyngitis
• Headache
• Painful and/or frequent urination – these could be signs of urinary tract infection
• Cough
• Diarrhea
• Blocked, runny or congested nose, and/or pain or pressure sensation in the cheeks or forehead – these could be signs of sinusitis
• Dizziness
• Muscle cramps
• Nausea (feeling unwell)
• Difficulty falling asleep
• Dry mouth
• Muscle pain
• Abscess (infection) of the tissues at the base of a tooth
• Increased blood levels of a protein found in muscle known as creatine phosphokinase
• Chills/tremors
• Anxiety

Uncommon

• Fast heartbeat (tachycardia)
• Abnormal or irregular heartbeat (cardiac arrhythmias)
• Chest pain or tightness in the chest (angina pectoris)
• Blurred vision
• Changes in voice (dysphonia)
• Difficulty urinating or sensation that the bladder is not completely emptied (urinary retention)
• Changes in the heart trace (prolongation of the QT interval) which could lead to irregular heart rhythm
• Alteration of taste (dysgeusia)
• Throat irritation
• Inflammation of the mucous membrane of the mouth (stomatitis)
• Increased blood pressure
• Restlessness
• Skin rash
• Itching of the skin

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system detailed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Duaklir Genuair

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the inhaler, on the box and on the inhaler pouch after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Keep the Genuair inhaler protected inside the sealed pouch until the start of the treatment period.
Use within 60 days after opening the pouch.
Do not use Duaklir Genuair if you notice that the packaging is damaged or shows any visible signs of deterioration.
After taking the last dose, the inhaler must be discarded. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use.
This will help protect the environment.

6. Package Contents and Other Information

What Duaklir Genuair Contains

• The active substances are aclidinium and formoterol fumarate dihydrate. Each delivered dose (the dose exiting 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 (for further information, see the end of section 2 under "Duaklir Genuair contains lactose").

Description of the Appearance of Duaklir Genuair and Contents of the Package
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 supplied sealed within a laminated aluminium protective pouch containing a desiccant sachet. After removing the inhaler from the pouch, the pouch and desiccant should be discarded.
Available pack sizes:
Carton containing 1 inhaler with 30 doses.
Carton containing 1 inhaler with 60 doses.
Carton containing 3 inhalers, each with 60 doses.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Covis Pharma Europe B.V.
Gustav Mahlerplein 2
1082MA Amsterdam
The Netherlands

Manufacturer:
Industrias Farmacéuticas Almirall, S.A.
Ctra. de Martorell 41-61
08740 Sant Andreu de la Barca, Barcelona
Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Covis Pharma Europe B.V. Covis Pharma Europe B.V.
Tel: 80013067 Tel: 880000890

България Luxembourg/Luxemburg
Covis Pharma Europe B.V. Covis Pharma Europe B.V.
Tel: 008002100654 Tel: 80024119

Česká republika Magyarország
Covis Pharma Europe B.V. Covis Pharma Europe B.V.
Tel: 800144474 Tel.: 0680021540

Danmark Malta
Zentiva Denmark ApS Covis Pharma Europe B.V.
Tlf: +45 787 68 400 Tel: 80065149

Deutschland Nederland
Zentiva Pharma GmbH Covis Pharma Europe B.V.
Tel: +49 (0) 800 53 53 010 Tel: 08000270008

Eesti Norge
Covis Pharma Europe B.V. Zentiva Denmark ApS
Tel: 8000100776 Tlf: +47 219 66 203

Ελλάδα Österreich
Specialty Therapeutics IKE Covis Pharma Europe B.V.
Τηλ: +30 213 02 33 913 Tel: 0800006573

España Polska
Zentiva Spain S.L.U. Covis Pharma Europe B.V.
Tel: +34 931 815 250 Tel.: 0800919353

France Portugal
Zentiva France Zentiva Portugal, Lda
Tél: +33 (0) 800 089 219 Tel: +351210601360

Hrvatska România
Covis Pharma Europe B.V. Covis Pharma Europe B.V.
Tel: 08004300 Tel: 0800410175

Ireland Slovenija
Covis Pharma Europe B.V. Covis Pharma Europe B.V.
Tel: 1800937485 Tel: 080083003

Ísland Slovenská republika
Zentiva Denmark ApS Covis Pharma Europe B.V.
Sími: +354 539 0650 Tel: 0800008203

Italia Suomi/Finland
Covis Pharma Europe B.V. Zentiva Denmark ApS
Tel: 800168094 Puh/Tel: +358 942 598 648

Κύπρος Sverige
Specialty Therapeutics IKE Zentiva Denmark ApS
Τηλ: +30 213 02 33 913 Tel: +46 840 838 822

Latvija United Kingdom (Northern Ireland)
Covis Pharma Europe B.V. Zentiva, k.s.
Tel: 80005962 Tel: +44 (0) 800 090 2408

More detailed information on this medicinal product 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 to read
these instructions, as Genuair may work differently from inhalers you have used previously. If you
have any doubts about how to use the inhaler, please consult your doctor, pharmacist, or nurse for
assistance.
The Instructions for Use are divided into the following sections:

• Preliminary steps
• Step 1: Prepare the dose
• Step 2: Inhale the medicine
• Additional information

Preliminary Steps
Read these Instructions for Use before starting to use this medicine.
Familiarize yourself with the components of the Genuair inhaler.
Control window
Indicator Orange button
Green = inhaler ready for use
of dose

Protective
cap
Control window
Red = confirms correct inhalation
Mouthpiece
Figure A
Before use:
a) Before first use, open the sealed bag and remove the inhaler. Discard the bag and the desiccant.
b) Do not press the orange button until you are ready to take a dose.
c) Remove the cap by gently pressing the arrows on both sides (Figure B).

Press here
and pull
Figure B
STEP 1: Prepare the dose
1.1 Look into the mouthpiece opening and ensure nothing is blocking it (Figure C).
1.2 Look at the control window (it must be red, Figure C).

Figure C
1.3 Hold the inhaler horizontally with the mouthpiece facing towards you and the orange button pointing
straight upwards (Figure D).

Figure D
1.4 Press the orange button fully down to load the dose (Figure E).
When the button is pressed fully down, the control window changes from red to green.
Ensure the orange button is pointing straight upwards. Do not tilt.
1.5 Release the orange button (Figure F).
Make sure you have released the button so that the inhaler can function correctly.

Figure E Figure F
Stop and Check:
1.6 Ensure that the control window is now green (Figure G).
Your medicine is now ready to inhale.
Proceed to ‘STEP 2: Inhale the medicine’.

GREEN
Figure G
What to do if the control window is still red after pressing the button (Figure H).

Figure H
The dose has not been prepared. Go back to ‘STEP 1: Prepare the dose’ and repeat steps 1.1 to 1.6.
STEP 2: Inhale the medicine
Read all steps from 2.1 to 2.7 completely before use. Do not tilt.
2.1 Hold the inhaler away from your mouth and breathe out fully. Never breathe out into the inhaler (Figure I).

Figure I
2.2 Keep your head upright, place the mouthpiece between your lips, and close your lips firmly around it (Figure J).
Do not press the orange button while inhaling.

Figure J
2.3 Take a strong and deep breath through your mouth. Hold your breath as long as possible.
You will hear a ‘click’ which indicates that you are inhaling correctly. Hold your breath as long as possible after hearing the ‘click’. Some patients may not hear the ‘click’. Use the control window to confirm that inhalation was successful.
2.4 Remove the inhaler from your mouth.
2.5 Hold your breath as long as possible.
2.6 Breathe out slowly away from the inhaler.
Some patients may experience a gritty sensation in the mouth, or a slightly sweet or bitter taste. Do not take an additional dose even if you do not taste anything or do not feel anything after inhalation.
Stop and Check:
2.7 Ensure that the control window is now red (Figure K). This means you have inhaled the medicine correctly.

Figure K
What to do if the control window is still green after inhalation (Figure L).

Figure L
This means you did not inhale the medicine correctly. Go back to ‘STEP 2: Inhale the medicine’ and repeat steps 2.1 to 2.7.
If the control window remains green, 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 breathed out fully. Then, take a strong and deep breath through the mouthpiece.
Contact your doctor if the control window remains green after repeated attempts.
Press the protective cap back over the mouthpiece after each use (Figure M), to prevent contamination of the inhaler with dust or other materials. You must dispose of your inhaler if you have lost the cap.

Figure M
Additional Information
What should you do if you have accidentally prepared a dose?
Store your inhaler with the protective cap in place until you are ready to inhale the medicine, then remove the cap and start from 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 first use, each inhaler contains at least 60 doses or at least 30 doses, depending on the pack size.
• Each time a dose is loaded by pressing the orange button, the dose indicator moves in small increments to the next number (50, 40, 30, 20, 10, or 0).

When should you request a new inhaler?
You should request a new inhaler:

• If your inhaler appears damaged or if you have lost the cap, or
• When a red band appears in the dose indicator, meaning it is nearly empty (Figure N), or
• If your inhaler is empty (Figure O).

Red band
Dose
indicator
Figure N
How do you know when the inhaler is empty?
When the orange button does not return fully upwards and remains stuck in an intermediate position, the last dose has been reached (Figure O). Although the orange button is stuck, the last dose can still be inhaled. After this dose, 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 this may damage the medicine.
If you wish to clean your inhaler, wipe the outside of the mouthpiece with a dry cloth or tissue.
ANNEX IV
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION OF THE TERMS OF THE MARKETING AUTHORISATION
Scientific conclusions
Taking into account the assessment of the Pharmacovigilance and Risk Assessment Committee (PRAC) regarding the final report of the mandated non-interventional PASS study for the medicine mentioned above, the scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) are as follows:
The study results show that aclidinium increases the risk of cardiac arrhythmias and atrial fibrillation compared to LABAs and other LAMAs. Furthermore, the results also show that aclidinium/formoterol FDC increases the risk of any cardiac arrhythmias and atrial fibrillation compared to LABAs or other LAMA/LABA combinations. Therefore, in light of the available data from the final PASS study report, the PRAC considered that changes to the product information are required.
The CHMP agrees with the scientific conclusions of the PRAC.
Grounds for the variation of the terms of the marketing authorisation
Based on the scientific conclusions of the study results for the medicine mentioned above, the CHMP considers that the benefit-risk balance of this medicine remains unchanged, subject to the proposed changes to the product information.
The CHMP recommends a variation to the terms of the marketing authorisation of the medicine mentioned above.