Bretaris Genuair

Package leaflet: Information for the patient

Bretaris Genuair 322 micrograms powder for inhalation

Aclidinium (aclidinium bromide)
Please read all of this leaflet carefully before you start 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

What is Bretaris Genuair
The active substance in Bretaris Genuair is aclidinium bromide, which belongs to a group of medicines
called bronchodilators. Bronchodilators relax the muscles in the airways and help keep the bronchioles open. Bretaris Genuair is a dry powder inhaler that uses your breath to deliver the medicine directly into the lungs, making it easier for patients with chronic obstructive pulmonary disease (COPD) to breathe.
What Bretaris Genuair is used for
Bretaris Genuair is indicated to help open the airways and relieve symptoms of COPD, a serious long-term lung disease characterized by difficulty breathing. Regular use of Bretaris Genuair can help when you experience shortness of breath due to the disease, help limit the impact of the disease on your daily life, and reduce the number of exacerbations (worsening of COPD symptoms lasting for several days).

2. What you need to know before using Bretaris Genuair

Do not use Bretaris Genuair

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before 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 bladder blockage.

Bretaris Genuair is intended as a maintenance therapy and must not be used to treat sudden attacks of breathlessness or wheezing. If your COPD symptoms (shortness of breath, wheezing, cough) do not improve or worsen, you must consult your doctor as soon as possible.
Dry mouth, which may occur with medicines such as Bretaris Genuair, especially after prolonged use, may be associated with dental caries. Therefore, remember to pay attention to oral hygiene.
Stop taking Bretaris Genuair and contact your doctor immediately:

• if you experience chest tightness, cough, wheezing or breathlessness immediately after using the medicine. These could be signs of a condition called bronchospasm.

Children and adolescents
Bretaris Genuair must not be used in children and adolescents under 18 years of age.
Other medicines and Bretaris Genuair
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 currently using similar medicines for breathing problems, such as medicines containing tiotropium or ipratropium. If you have any doubts, consult your doctor or pharmacist. The use of Bretaris Genuair together with these medicines is not recommended.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. You must not use Bretaris Genuair during pregnancy or while breastfeeding, unless your doctor has specifically instructed you to do so.
Driving and using machines
Bretaris Genuair may slightly affect your ability to drive or use machines. This medicine may cause headache, dizziness or blurred vision. If you experience any of these effects, do not drive or operate machinery until your headache has resolved, dizziness has disappeared, and your vision has returned to normal.
Bretaris Genuair contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to use Bretaris Genuair

Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

• The recommended dose is one inhalation twice daily, in the morning and evening.
• The effects of Bretaris Genuair last for 12 hours; therefore, you should try to use the Bretaris Genuair inhaler at the same time each morning and evening. This ensures that a sufficient amount of the medicine is always present in your body, helping you to breathe more easily throughout the day and night. It will also help you remember to take it.

The recommended dose may be used in elderly patients and in patients with kidney or liver problems. Dose adjustments are not required.
COPD is a chronic disease, therefore it is recommended that you use Bretaris Genuair every day, twice daily, and not only when you experience breathing difficulties or other COPD symptoms.
Route of administration
This medicine is for inhalation use only.

• 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 Bretaris Genuair, consult your doctor or pharmacist.

You may use Bretaris Genuair at any time before or after eating or drinking.
If you use more Bretaris Genuair than you should
If you think you have used more Bretaris Genuair than you should, consult your doctor or pharmacist.
If you forget to use Bretaris Genuair
If you forget a dose of Bretaris Genuair, inhale the missed 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 the forgotten dose.
If you stop using Bretaris Genuair
This medicine is intended for long-term use. If you wish to stop treatment, discuss this with 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 everyone gets them.
Very rarely, allergic reactions may occur (may affect up to 1 in 1,000 people). 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 if you develop severely itchy blisters on the skin (urticaria), as these may be symptoms of an allergic reaction.

The following side effects may occur during use of Bretaris Genuair:
Common: may affect up to 1 in 10 people

• Headache (cephalalgia)
• Inflammation of the sinuses (sinusitis)
• Common cold (nasopharyngitis)
• Cough
• Diarrhoea
• Nausea

Uncommon: may affect up to 1 in 100 people

• Dizziness
• Dry mouth
• Inflammation of the mouth (stomatitis)
• Hoarseness (dysphonia)
• Fast heartbeat (tachycardia)
• Abnormal or irregular heartbeat (cardiac arrhythmias)
• Awareness of heartbeat (palpitations)
• Difficulty passing urine (urinary retention)
• Blurred vision
• Rash
• Itching of the skin

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 Bretaris 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 and on the inhaler’s box after “Exp.” or “EXP”. The expiry date refers to the last day of that month.
Keep the inhaler inside the bag until the start of the administration period.
Use within 90 days after opening the bag.
Do not use Bretaris Genuair if you notice that the packaging is damaged or shows any signs of tampering.
After taking the last dose, the inhaler must be discarded. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Package Contents and Other Information

What Bretaris Genuair Contains

• The active substance 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”).

Description of the Appearance of Bretaris Genuair and Contents of the Pack
Bretaris Genuair is a white or almost white powder.
The Genuair inhaler is white in colour, with an integrated dose indicator and a green dosing button. The mouthpiece is covered by a removable green protective cap. It is supplied in a plastic bag.
Pack sizes:
Box containing 1 inhaler with 30 doses.
Box containing 1 inhaler with 60 doses.
Box containing 3 inhalers, each with 60 doses.
Not all pack sizes may be marketed.

Marketing Authorisation 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 Authorisation Holder:

België/Belgique/Belgien Lietuva
Covis Pharma Europe B.V. UAB “BERLIN CHEMIE MENARINI BALTIC”
Tél/Tel: 80013067 Tel: +370 52 691 947

България Luxembourg/Luxemburg
“Берлин-Хеми/А. Менарини България” EООД Covis Pharma Europe B.V.
тел.: +359 2 454 09 50 Tél/Tel: 80024119

Česká republika Magyarország
Berlin-Chemie/A.Menarini Ceska republika s.r.o. Berlin-Chemie/A. Menarini Kft.
Tel: +420 267 199 333 Tel.: +36 1799 7320

Danmark Malta
Covis Pharma Europe B.V. Covis Pharma Europe B.V.
Tlf: 80711260 Tel: 80065149

Deutschland Nederland
Berlin-Chemie AG Covis Pharma Europe B.V.
Tel: +49 (0) 30 67070 Tel: 08000270008
Covis Pharma Europe B.V.
Tel: +49 (0) 3031196978

Eesti Norge
OÜ Berlin-Chemie Menarini Eesti Covis Pharma Europe B.V.
Tel: +372 667 5001 Tlf: 80031492

Ελλάδα Österreich
MENARINI HELLAS AE A. Menarini Pharma GmbH
Τηλ: +30 210 8316111-13 Tel: +43 1 879 95 85-0

España Polska
Laboratorios Menarini S.A. Covis Pharma Europe B.V.
Tel: +34-93 462 88 00 Tel.: 0800919353

France Portugal
MENARINI France A. Menarini Portugal – Farmacêutica, S.A.
Tél: +33 (0)1 45 60 77 20 Tel: +351 210 935 500

Hrvatska România
Berlin-Chemie Menarini Hrvatska d.o.o. Berlin-Chemie A.Menarini S.R.L.
Tel: + 385 1 4821 361 Tel: +40 21 232 34 32

Ireland Slovenija
Covis Pharma Europe B.V. Berlin-Chemie / A. Menarini Distribution
Tel: 1800937485 Ljubljana d.o.o.
Tel: +386 01 300 2160

Ísland Slovenská republika
Covis Pharma Europe B.V. Berlin-Chemie / A. Menarini Distribution
Sími: 8007279 Slovakia s.r.o.
Tel: +421 2 544 30 730

Italia Suomi/Finland
Istituto Luso Farmaco d’Italia S.p.A. Covis Pharma Europe B.V.
Tel: +39 02 5165551 Puh/Tel: 0800413687

Κύπρος Sverige
Covis Pharma Europe B.V. Covis Pharma Europe B.V.
Τηλ: 80091079 Tel: 0200898678

Latvija United Kingdom (Northern Ireland)
SIA Berlin-Chemie/Menarini Baltic Covis Pharma Europe B.V.
Tel: +371 67103210 Tel: 08004334029

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 your 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 Medication
• Additional Information

Preliminary Steps
Read these Instructions for Use before starting to use this medicine.
Become familiar with the components of the Genuair inhaler.

Dose Indicator
Viewing Window
Green Button

Green = inhaler ready for use
Protective Cap
Viewing Window
Red = confirms correct inhalation
Mouthpiece
Figure A

Before Use:
a) Before first use, open the sealed bag and remove the Genuair inhaler from the bag.
b) Do not press the green 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 Check the viewing window (it should be red, Figure C).

RED
Check the mouthpiece opening
Figure C

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

Figure D

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

Figure E Figure F

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

GREEN
Figure G

What to do if the viewing 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 Medication
Read steps 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 green button while inhaling.

Figure J

2.3 Take a strong and deep breath in through your mouth. Hold your breath as long as possible.
You will hear a ‘click’ which indicates you are inhaling correctly. Hold your breath as long as possible after hearing the ‘click’. Some patients may not hear the ‘click’. Use the viewing window to confirm correct inhalation.
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 feel nothing after inhalation.

Stop and Check:
2.7 Ensure that the viewing window is now red (Figure K). This means you have correctly inhaled the medication.

Figure K

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

Figure L

This means you did not inhale the medication correctly. Go back to STEP 2: Inhale the Medication and repeat steps 2.1 to 2.7.
If the viewing window still does not turn red, you may have forgotten to release the green button before inhaling, or you may not have inhaled strongly enough. If this occurs, try again. Make sure you have released the green button and that you have breathed out fully. Then, take a strong and deep breath in through the mouthpiece.
Contact your doctor if the viewing window remains green after repeated attempts.
Replace the protective cap 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 lose the cap.

Figure M

Additional Information
What should you do if you accidentally prepared a dose?
Store your inhaler with the protective cap in place until you are ready to inhale the medication, 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 you load a dose by pressing the green 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).

The dose indicator moves slowly from 60 to 0: 60, 50, 40, 30, 20, 10, 0.

Red band
Dose Indicator
Figure N

How do you know when the inhaler is empty?
When the green button does not return fully upwards and remains stuck in an intermediate position, the last dose has been reached (Figure O). Although the green button is stuck, the final dose can still be inhaled. After this dose, the inhaler can no longer be used and you must start using a new inhaler.

Stuck
Figure O

How to clean the inhaler?
NEVER use water to clean the inhaler, as this may damage the medication.
If you wish to clean your inhaler, wipe the outer part of the mouthpiece with a dry cloth or tissue.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND REASONS FOR THE VARIATION OF THE TERMS OF THE MARKETING AUTHORISATION

Scientific Conclusions
Taking into account the evaluation by the Pharmacovigilance and Risk Assessment Committee (PRAC) of the final report of the non-interventional PASS study mandated for the medicinal product mentioned above, the scientific conclusions of the Committee for Human Medicinal Products (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 should be made.
The CHMP agrees with the scientific conclusions of the PRAC.

Reasons for the Variation of the Terms of the Marketing Authorisation
Based on the scientific conclusions of the study results for the medicinal products mentioned above, the CHMP considers that the benefit-risk balance of these medicinal products remains unchanged, subject to the proposed amendments to the product information.
The CHMP recommends a variation to the terms of the marketing authorisation for the medicinal products mentioned above.