Tudorza Genuair: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.

What the medication is used for:

TUDORZA GENUAIR is used long term to help open the airways of adults with breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD).

What it does:

The active ingredient of TUDORZA GENUAIR is aclidinium bromide, which belongs to a group of medicines called bronchodilators. Bronchodilators help to open and relax the muscles of the airways. This allows more air to get in and out of the lungs. This makes it easier for patients with COPD to breathe and helps prevent shortness of breath and wheezing.

When it should not be used:

Do not use TUDORZA GENUAIR if you:

• are allergic to aclidinium bromide or any of

  the other ingredients of this medicine;

• are under 18 years of age;

• experience sudden severe symptoms of

  COPD (called a COPD flare-up), such as sudden shortness of breath or wheezing. Your doctor may give you other medicine to use for sudden breathing problems as needed.

What the medicinal ingredient is:

Aclidinium bromide.

What the nonmedicinal ingredients are:

Lactose monohydrate.

What dosage forms it comes in:

Dry powder for oral inhalation: 400 mcg aclidinium bromide. Your inhaler can contain either 30 or 60 metered doses.

WARNINGS AND PRECAUTIONS

BEFORE you use TUDORZA GENUAIR talk to your doctor or pharmacist if you:

• are pregnant or planning to become pregnant;

• are breastfeeding;
• are taking any medications including eye drops, this includes medications you can buy without prescription;
• have had heart problems recently;
• have eye problems such as glaucoma, eye pain, blurred vision, see halos around lights or coloured images;
• have an enlarged prostate, problems passing urine, or painful urination;
• have a severe allergy to milk proteins. Ask your doctor if you are not sure;
• have had allergies to atropine or related medicines, for example ipratropium, tiotropium or oxitropium;
• have allergies to food or drugs.

TUDORZA GENUAIR should not be used more frequently than twice daily. Do not exceed the prescribed dose.

Remember to tell any other doctor, dentist or pharmacist you consult that you are taking this medication.

Stop taking TUDORZA GENUAIR and seek medical help right away:

• 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.

Driving and using machines:

Avoid driving and using machines if you have blurred vision or headaches.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Tell your doctor if you have been or are using similar medicines for breathing problems, e.g. medicines containing tiotropium, ipratropium or glycopyrronium. Ask your doctor or pharmacist if you are not sure. The use of TUDORZA GENUAIR with these medicines is not recommended.

PROPER USE OF THIS MEDICATION

Always use TUDORZA GENUAIR 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, once in the morning and once in the evening;

• Use TUDORZA GENUAIR even when you

  have no breathing problems or other symptoms of COPD;

• Do not stop using the drug without consulting

  your doctor;

  Do not take a double dose to make up for a forgotten dose.

  Instructions for Use

  Before using the TUDORZA GENUAIR inhaler, read the full Instructions for Use. It is important that you read this information as the GENUAIR may work differently from inhalers you have used. If you have any questions ask your doctor or pharmacist.

  The Instructions for Use is divided into the following sections:

  • Getting started
  • Step 1: Prepare your dose
  • Step 2: Inhale your medicine
  • Additional information

Getting Started

TUDORZA GENUAIR is a multidose dry powder inhaler that uses your breath to deliver the medicine directly into your lungs. It is important that you become familiar with the parts of your GENUAIR inhaler (Figure A).

• You can use TUDORZA GENUAIR anytime

  before or after food or drink.

  Control window

  Green = inhaler ready to use Dose indicator

  Green button

Usual adult dose:

The recommended dose is one inhalation twice a day, once in the morning and once in the evening.

The recommended dose can be used for elderly patients and for patients with kidney or liver problems. No dose adjustments are necessary.

Overdose:

If you think you may have used more TUDORZA GENUAIR than you should, contact your doctor or pharmacist.

Protective cap

Before use:

Figure A

Control window

Red = confirms correct inhalation

Mouthpiece

Missed dose:

If you forget a dose of TUDORZA GENUAIR, inhale the dose as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.

1. a) Before first use, tear open the sealed bag and remove the inhaler. Throw away the bag.
2. b) Do not press the green button.
3. c) Pull off the protective cap by lightly squeezing

the arrows marked on each side (Figure B).

Squeeze here

and pull

When you press the button all the way down, the control window changes from red to green.

1.5 Release the green button (Figure F).

Figure B

STEP 1: Prepare your dose

1.1 Look in the opening of the mouthpiece and make

sure nothing is blocking it (Figure C).

1.2 Look at the control window. It should be red

(Figure C).

RED

Check mouthpiece opening

Figure E Figure F

Stop and Check:

1.6 Make sure the control window is now green

(Figure G). Your medicine is ready to be inhaled.

Go to ‘STEP 2: Inhale your medicine’.

Figure C

1.3 Hold the inhaler horizontally with the

mouthpiece facing you and the green button on top (Figure D).

Figure D

1.4 Press the green button all the way down to load

your dose (Figure E).

Figure G

Figure J

STEP 2: Inhale your medicine

2.1 Hold the inhaler away from your mouth, and

breathe out completely (Figure I). Never breathe out into the inhaler.

Figure I

2.2 Hold your head upright, put the mouthpiece

between your lips, and close your lips tightly around it.

2.4 Take the inhaler out of your mouth.

2.5 Hold your breath for as long as possible.

2.6 Slowly breathe out 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 medicine correctly.

2.3 Take a strong, deep breath through your

mouth. Keep breathing in for as long as possible (Figure J).

Figure K

What should you do if you accidently prepare a dose?

Do not tilt your inhaler. Store it with the protective cap in place until it is time to inhale your medicine, then remove the protective 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 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).

Push the protective cap back onto the mouthpiece after each use (Figure M). This prevents contamination of the inhaler with dust or other materials. You should discard your inhaler if you lose the protective cap.

Figure M

Additional information

Figure N When should you get a new inhaler?

You should get a new inhaler:

• If your inhaler appears to be damaged or if you lose the protective 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).

  Figure O

How do you know that your inhaler is empty?

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. How should you clean the inhaler?

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.

Like all medicines, TUDORZA GENUAIR can cause side effects, although not everybody gets them.

Side effects may include:

• headache;

• nasopharyngitis (inflammation or irritation of

  the nose and throat);

• cough;
• falls and injury;
• sinus inflammation (sinusitis);
• blurred vision;
• hoarseness (dysphonia);
• dizziness;
• mouth or tooth infection;
• thrush in the mouth or throat;
• inflammation of the mouth (stomatitis);
• pain, stiffness and swelling in the joints;

• rash, skin itching.

  SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT

  THEM

Symptom / effect Talk with

your doctor

or pharmacist

Stop

taking

drug and seek

immediate medical help

Only if

severe

In

all cases

Common

Nausea and/or diarrhea √ Uncommon

Dry mouth √

Heart failure: Fatigue;

shortness of breath; or

swelling of ankles or legs

√

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT

THEM

Symptom / effect Talk with

your doctor

or pharmacist

Stop taking drug and seek immediate medical help Only

if

severe

In

all cases

Hyperglycemia: High

level of blood sugar

(typical symptoms

include excessive thirst

or hunger and frequent

urination)

√

Vomiting and/or

abdominal pain

√

Faster heart beat √ Difficulty and pain

passing urine or a feeling

that your bladder has not

completely emptied

(urinary retention)

√

Rare

Glaucoma: New or

worsened pressure in

your eyes, eye pain or

discomfort, blurred

vision, seeing halos of

bright colours around

lights, red eyes

√

Unknown

Paradoxical

Bronchospasm:

Tightness of the chest

associated with

coughing, wheezing, or

breathlessness

immediately after

inhalation of TUDORZA

GENUAIR

√

Serious allergic

reactions: rash, hives,

swelling of the face,

mouth, lips and tongue

with or without breathing

problems

√

Difficulty breathing √

This is not a complete list of side effects. For any unexpected effects while taking TUDORZA GENUAIR, contact your doctor or pharmacist.

HOW TO STORE IT

Keep TUDORZA GENUAIR 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 the month.

Store between 15 to 30°C.

Keep the TUDORZA GENUAIR inhaler protected inside the sealed bag until you start to use it. Use the TUDORZA GENUAIR inhaler within 90 days of opening the bag.

Do not use the TUDORZA 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. You should follow local guidelines for domestic waste when throwing away the empty or unused inhaler. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Azurity Pharmaceuticals Ireland Limited.

TUDORZA^® and the logo are registered trademarks of Almirall, S.A., used under license by Azurity Pharmaceuticals, Inc.

GENUAIR^® is a registered trademark of the AstraZeneca group of companies, used under license by Azurity Pharmaceuticals, Inc.

The Azurity logo is a registered trademark of Azurity Pharmaceuticals, Inc.

© 2025-2026 Azurity Pharmaceuticals, Inc.

Last revised: OCT 19, 2026

MORE INFORMATION

NOTE: This Consumer Information Leaflet provides you with the most current information at the time of printing.

The most current information, the Consumer Information Leaflet plus the full Product Monograph, prepared for health professionals can be found at: www.azurity.ca or by contacting the sponsor, Azurity Pharmaceuticals Ireland Limited at: 1-833-523-3009

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