1. Why am I using BRETARIS GENUAIR?

BRETARIS GENUAIR contains the active ingredient aclidinium bromide. BRETARIS GENUAIR is used to open the airways and make breathing easier to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) as a long-term maintenance bronchodilator treatment.

For more information, see Section 1. Why am I using BRETARIS GENUAIR? in the full CMI.

2. What should I know before I use BRETARIS GENUAIR?

Do not use if you have ever had an allergic reaction to BRETARIS GENUAIR or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use BRETARIS GENUAIR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with BRETARIS GENUAIR and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use BRETARIS GENUAIR?

• The recommended dose is one inhalation of BRETARIS GENUAIR twice daily, once in the morning and once at night, 12 hours apart.

More instructions can be found in Section 4. How do I use BRETARIS GENUAIR? in the full CMI.

5. What should I know while using BRETARIS GENUAIR?

For more information, see Section 5. What should I know while using BRETARIS GENUAIR? in the full CMI.

6. Are there any side effects?

Common side effects include inflammation of the throat and nasal passages, headache, cough, diarrhoea and nausea. Side effects that require urgent medical attention are serious allergic reactions which can include the following: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fast or irregular heart beat; or dizziness or fainting.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRETARIS® GENUAIR®

Active ingredient: aclidinium bromide

Consumer Medicine Information (CMI)

This leaflet provides important information about using BRETARIS GENUAIR. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using BRETARIS GENUAIR.

Where to find information in this leaflet:

1. Why am I using BRETARIS GENUAIR?

BRETARIS GENUAIR contains the active ingredient aclidinium bromide. BRETARIS GENUAIR belongs to a group of medicines called bronchodilators, which 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 used 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 and will help you to minimise the effects of the disease on your everyday life.

BRETARIS GENUAIR is used for maintenance treatment of your COPD; it 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.

2. What should I know before I use BRETARIS GENUAIR?

Warnings

BRETARIS GENUAIR is a maintenance bronchodilator and should not be used for the relief of acute episodes of bronchospasm, including a sudden attack of breathlessness or wheezing.

Do not use BRETARIS GENUAIR if:

• you are allergic to aclidinium bromide, or any of the ingredients listed at the end of this leaflet.
• you are allergic to atropine or related bronchodilator medicines, for example ipratropium, tiotropium or oxitropium.
• always check the ingredients to make sure you can use this medicine.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin

Check with your doctor if you:

Have or have had any of the following medical conditions:

• heart problems
• see halos around lights and coloured images, have eye pain or discomfort or temporary blurring of vision (narrow angle glaucoma)
• an enlarged prostate, problems passing urine, or a blockage in your bladder
• rare hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.
• take any medicines for any other condition

BRETARIS GENUAIR may cause dryness in the mouth, which may cause tooth decay after using your medicine for a long time. Therefore, please remember to pay attention to oral hygiene.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

If it is necessary for you to use this medicine during pregnancy or while breastfeeding, your doctor will discuss with you the benefits and risks involved.

Children and adolescents

• BRETARIS GENUAIR is not for use in children or adolescents below 18 years of age.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with BRETARIS GENUAIR and affect how it works.

These include other medicines used to treat breathing difficulties, such as tiotropium, ipratropium, oxitropium, glycopyrronium or aclidinium (called anticholinergics).

You may need to take different amounts of your medicines or you may need to take different medicines. Your doctor and pharmacist will have more information

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect BRETARIS GENUAIR.

4. How do I use BRETARIS GENUAIR?

How much to use

• The recommended dose is one inhalation twice a day in the morning and night, 12 hours apart.
• Follow the instructions provided and use BRETARIS GENUAIR until your doctor tells you to stop.

When to use BRETARIS GENUAIR

• BRETARIS GENUAIR should be used at the same time every morning and at night as the effects last for 12 hours. This ensures that there is always enough medicine in your body to help you breathe more easily throughout the day and night.

How to use BRETARIS GENUAIR

• Refer to the booklet contained within the carton for instructions on how to use the BRETARIS GENUAIR inhaler.

• If you are not sure of how to use BRETARIS GENUAIR, ask your doctor or pharmacist.

If you forget to use BRETARIS GENUAIR

BRETARIS GENUAIR should be used regularly at the same time each day. If you miss your dose at the usual time, inhale the dose as soon as you remember.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you use too much BRETARIS GENUAIR

If you think that you have used too much BRETARIS GENUAIR, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using BRETARIS GENUAIR?

Things you should do

Use this medicine exactly as your doctor has prescribed.

Try not to miss any doses and use it even if you feel well.

If you find that the usual dose of BRETARIS GENUAIR is not giving as much relief as before, or does not last as long as usual, contact your doctor so that your condition can be checked.

This is important to ensure your COPD is controlled properly.

Call your doctor straight away if you:

• Become pregnant while using this medicine

Remind any doctor, dentist or pharmacist you visit that you are using BRETARIS GENUAIR, especially if you are about to be started on any new medicine.

Things you should not do

• Do not stop using this medicine suddenly.
• Do not exceed the recommended daily dose.
• Do not take any other medicines for your breathing problems without checking with your doctor.
• Do not give your medicine to anyone else, even if they have the same condition as you.
• Do not use BRETARIS GENUAIR to treat other complaints unless your doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how BRETARIS GENUAIR affects you.

BRETARIS GENUAIR may cause headache, dizziness or blurred vision in some people. If you have any of these symptoms, do not drive, operate machinery, or do anything else that could be dangerous.

Looking after your medicine

• Keep the BRETARIS GENUAIR inhaler protected in the sealed pouch until you need to start using it.
• Keep your inhaler below 30°C.

Follow the instructions provided on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

The inhaler must be used within 90 days of opening the pouch.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date, or if the packaging is torn or shows signs of tampering.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people. Some of these side effects (abnormal blood test results including high blood sugar levels) can only be found when your doctor does tests from time to time to check your progress.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What BRETARIS GENUAIR contains

Do not take this medicine if you are allergic to any of these ingredients.

What BRETARIS GENUAIR looks like

BRETARIS is a white or almost white powder.

The BRETARIS 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 sealed pouch.

(AUST R 206071).

Who distributes BRETARIS GENUAIR

A. Menarini Australia Pty Ltd
Sydney, Australia

Medical Information: 1800 644 542

BRETARIS® is a registered trademark of Almirall, S.A. GENUAIR® is a registered trademark of AstraZeneca AB

This leaflet was prepared in September 2025.

For the most up to date version of this document, please go to www.menarini.com.au/cmi

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