Bretaris Genuair
aclidinium bromide
Aclidinium (aclidinium bromide)
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What Bretaris Genuair is and what it is used for
What you need to know before you use Bretaris Genuair
How to use Bretaris Genuair
Possible side effects
How to store Bretaris Genuair
Contents of the pack and other information
Instructions for Use
The active ingredient of Bretaris Genuair is aclidinium bromide, which belongs to a group of medicines called bronchodilators. Bronchodilators relax airways and help keep bronchioles open.
Bretaris Genuair is a dry powder inhaler that uses your breath to deliver the medicine directly into
your lungs. This makes it easier for chronic obstructive pulmonary disease (COPD) patients to breathe.
Bretaris Genuair is indicated to help open the airways and relieve symptoms of COPD, a serious, long- term lung disease characterised by breathing difficulties. Regular use of Bretaris Genuair can help you
when you have ongoing shortness of breath related to your disease to help you minimise the effects of the disease on your everyday life and reduce the number of flare-ups (the worsening of your COPD symptoms for several days).
if you are allergic to aclidinium bromide or any of the other ingredients of this medicine (listed in
section 6).
Talk to your doctor, pharmacist or nurse before using Bretaris Genuair:
if you have had heart problems recently.
if you see halos around lights or coloured images (glaucoma).
if you have an enlarged prostate, problems passing urine, or a blockage in your bladder.
Bretaris Genuair is indicated for maintenance treatment and should not be used to treat a sudden attack of breathlessness or wheezing. If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse you should contact your doctor for advice as soon as possible.
Dry mouth, which has been observed with medicines like Bretaris Genuair, may after using your medicine for a long time, be associated with tooth decay. Therefore, please remember to pay attention to oral hygiene.
Stop taking Bretaris Genuair and seek medical help immediately:
- if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. These may be signs of a condition called bronchospasm.
Bretaris Genuair is not for use in children or adolescents below 18 years of age.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Inform your doctor if you have been or are using similar medicines for breathing problems, such as medicines containing tiotropium, ipratropium. Ask your doctor or pharmacist if you are not sure. The use of Bretaris Genuair with these medicines is not recommended.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine. You should not use Bretaris Genuair if you are pregnant or are breast-feeding unless your doctor tells you so.
Bretaris Genuair may have minor influence on the ability to drive and use machines. This medicine may cause headache, dizziness or blurred vision. If you are affected by any of these side effects do not
drive or use machinery until the headache has cleared, the feeling of dizziness has passed and your vision has returned to normal.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one inhalation twice a day in the morning and evening.
The effects of Bretaris Genuair last for 12 hours; therefore, you should try to use your Bretaris Genuair inhaler at the same time every morning and evening. This ensures that there is always enough
medicine in your body to help you breathe more easily throughout the day and night. It will also help
you to remember to use it.
The recommended dose can be used for elderly patients and for patients with kidney or liver problems. No dose adjustments are necessary.
COPD is a long-term disease; therefore, it is recommended that Bretaris Genuair is used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.
The medicine is for inhalation use.
Refer to the Instructions for Use for instructions on how to use the Genuair inhaler. If you are not sure of how to use Bretaris Genuair, contact your doctor or pharmacist.
You can use Bretaris Genuair any time before or after food or drink.
If you think you may have used more Bretaris Genuair than you should, contact your doctor or pharmacist.
If you forget a dose of Bretaris Genuair, inhale the dose as soon as you remember. However, if it is
nearly time for your next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
This medicine is for long-term use. If you want to stop treatment, first talk to your doctor, as your
symptoms may worsen.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions may rarely occur (may affect up to 1 in 1,000 people). Stop using the medicine and contact your doctor immediately if you develop swelling of your face, throat, lips or tongue (with or without difficulty breathing or swallowing), dizziness or fainting, faster heart rate or if you get raised severely itchy bumps on your skin (hives) as these may be symptoms of an allergic reaction.
The following side effects may occur whilst using Bretaris Genuair:
Headache
Inflammation of the sinuses (sinusitis)
Common cold (nasopharyngitis)
Cough
Diarrhoea
Nausea
Dizziness
Dry mouth
Inflammation of the mouth (stomatitis)
Hoarseness (dysphonia)
Faster heart beat (tachycardia)
Sensation of heart beating (palpitations)
Difficulty passing urine (urinary retention)
Blurred vision
Rash
Itching of the skin
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. . You can also report side effects directly via thenationalreporting
system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 and carton after “EXP”. The expiry date refers to the last day of that month.
Keep the inhaler inside the pouch until the administration period starts. To be used within 90 days of opening the pouch.
Do not use the Bretaris Genuair if you notice that the pack is damaged or shows signs of tampering.
After you have taken the last dose, the inhaler has to be disposed of. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is aclidinium bromide. Each delivered dose contains 375 micrograms aclidinium bromide equivalent to 322 micrograms of aclidinium.
The other ingredient is lactose monohydrate (refer to Section 2 “Bretaris Genuair contains lactose”).
Bretaris Genuair is a white or almost white powder.
The Genuair inhaler device is white coloured with an integral dose indicator and a green dosage
button. The mouthpiece is covered with a removable green protective cap. It is supplied in a plastic pouch.
Pack sizes supplied:
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.
AstraZeneca AB
SE-151 85 Södertälje Sweden
Industrias Farmacéuticas Almirall, S.A.
Ctra. de Martorell 41-61
08740 Sant Andreu de la Barca, Barcelona Spain
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UAB “BERLIN-CHEMIE MENARINI BALTIC” Tel: +370 52 691 947
“Берлин-Хеми/А. Менарини България”
EООД
тел.: +359 2 454 0950
Berlin-Chemie/A.Menarini Ceska republika s.r.o.
Tel: +420 267 199 333
Berlin-Chemie/A. Menarini Kft.
Tel.: +36 23501301
Associated Drug Co. Ltd Tel: +356 2277 8000
Berlin-Chemie AG Tel: +49 (0) 30 67070
AstraZeneca BV
Tel: +31 79 363 2222
AstraZeneca GmbH Tel: +49 41 03 7080
OÜ Berlin-Chemie Menarini Eesti
Tel: +372 667 5001
AstraZeneca AS
Tlf: +47 21 00 64 00
MENARINI HELLAS AE
Τηλ: +30 210 8316111-13
A. Menarini Pharma GmbH.
Tel: +43 1 879 95 85-0
Laboratorios Menarini S.A.
Tel: +34-93 462 88 00
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel.: +48 22 566 21 00
MENARINI France
Tél: +33 (0)1 45 60 77 20
Menarini Portugal – Farmacêutica, S.A.
Tel: +351 210 935 500
Berlin-Chemie Menarini Hrvatska d.o.o. Tel: + 385 1 4821 361
Berlin-Chemie A.Menarini S.R.L. Tel: +40 21 232 34 32
AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100
Vistor hf.
Sími: +354 535 70 00
Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o.
Tel: +386 01 300 2160
Berlin-Chemie / A. Menarini Distribution
Slovakia s.r.o.
Tel: +421 2 544 30 730
Laboratori Guidotti S.p.A. Tel: +39- 050 971011
AstraZeneca Oy
Puh/Tel: +358 10 23 010
Αλέκτωρ Φαρµακευτική Λτδ
Τηλ: +357 22490305
AstraZeneca AB
Tel: +46 8 553 26 000
SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210
AstraZeneca UK Ltd Tel: +44 1582 836 836
This section contains information on how to use your Genuair inhaler. It is important that you read this information as the Genuair may work differently from inhalers you have used previously. If you have any questions about how to use your inhaler, please ask your doctor, pharmacist or nurse for
assistance.
The Instructions for Use is divided into the following sections:
Getting started
Step 1: Prepare your dose
Step 2: Inhale your medicine
Additional information
Become familiar with the parts of your Genuair inhaler.
Green = inhaler ready to use
Red = confirms correct inhalation
Mouthpiece
Before first use, tear open the sealed bag and remove the inhaler. Throw away the bag.
Do not press the green button until you are ready to take a dose.
Pull off the cap by lightly squeezing the arrows marked on each side (Figure B).
Squeeze here and pull
Look in the opening of the mouthpiece and make sure nothing is blocking it (Figure C).
Look at the control window (should be red, Figure C).
Hold the inhaler horizontally with the mouthpiece facing you and the green button on top (Figure D).
Press the green button all the way down to load your dose (Figure E).
When you press the button all the way down, the control window changes from red to green. Make sure the green button is on top. Do not tilt.
Release the green button (Figure F).
Make sure you release the button so the inhaler can work correctly.
Make sure the control window is now green (Figure G).
Your medicine is ready to be inhaled. Go to ‘STEP 2: Inhale your medicine’.
The dose is not prepared. Go back to ‘STEP 1 Prepare your dose’ and repeat steps 1.1 to 1.6.
Read steps 2.1 to 2.7 fully before use. Do not tilt.
Hold the inhaler away from your mouth, and breathe out completely. Never breathe out into the inhaler (Figure I).
Hold your head upright, put the mouthpiece between your lips, and close your lips tightly around it (Figure J).
Take a strong, deep breath through your mouth. Keep breathing in for as long as possible.
A ‘click’ will let you know that you are inhaling correctly. Keep breathing in as long as possible after you hear the ‘click’. Some patients may not hear the ‘click’. Use the control window to ensure you have inhaled correctly.
Take the inhaler out of your mouth.
Hold your breath for as long as possible.
Slowly breathe out away from the inhaler.
Some patients may experience a grainy sensation in their mouth, or a slightly sweet or bitter taste. Do not take an extra dose even if you do not taste or feel anything after inhaling.
Make sure the control window is now red (Figure K). This means you have inhaled your medicine correctly.
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 still does not change to red, you may have forgotten to release the green button before inhaling, or you may not have inhaled strongly enough. If this happens, try again. Make sure you have released the green button, and you have breathed out completely. Then take a strong, deep breath through the mouthpiece.
Push the protective cap back onto the mouthpiece after each use (Figure M), to prevent contamination of the inhaler with dust or other materials. You should discard your inhaler if you lose the cap.
Whatshouldyoudoifyouaccidentlyprepareadose?
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.
Howdoesthedoseindicatorwork?
The dose indicator shows the total number of doses left in the inhaler (Figure N).
On first use, every 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 by a small amount towards the next number (50, 40, 30, 20, 10, or 0).
Whenshouldyougetanewinhaler?
You should get a new inhaler:
If your inhaler appears to be damaged or if you lose the cap, or
When a red band appears in the dose indicator, this means you are nearing your last dose (Figure N), or
If your inhaler is empty (Figure O).
Howdoyouknowthatyourinhalerisempty?
When the green button will not return to its full upper position and is locked in a middle position, you have reached the last dose (Figure O). Even though the green button is locked, your last dose may still be inhaled. After that, the inhaler cannot be used again and you should start using a new inhaler.
Figure O
Howshouldyoucleantheinhaler?
NEVER use water to clean the inhaler, as this may damage your medicine.
If you wish to clean your inhaler, just wipe the outside of the mouthpiece with a dry tissue or paper towel.