Bronchitol (Mannitol): Uses, Side Effects and Dosage

PATIENT INSTRUCTIONS FOR USE

BRONCHITOL® (mannitol) inhalation powder for oral inhalation use

This Patient Instructions for Use contains information on how to take BRONCHITOL.

Each BRONCHITOL box contains:

Important Information You Need to Know Before Using BRONCHITOL

• Do not use BRONCHITOL until your healthcare provider has performed the BRONCHITOL Tolerance Test (BTT) and approved you for treatment. This is to make sure you get the right treatment if you have a severe reaction.
• For oral inhalation only
• Do not swallow BRONCHITOL capsules.
• Use an inhaled short-acting bronchodilator 5 to15 minutes before every dose of BRONCHITOL.

• Use BRONCHITOL 2 times each day. Inhale through your mouth (oral inhalation) the capsule contents in 10 single BRONCHITOL capsules:

  • 1 time in the morning
  • 1 time at least 2 to 3 hours before bedtime

Preparing to use BRONCHITOL

BRONCHITOL is supplied to people in cartons containing 140 or 560 capsules in blister packs. Supplies you will need to use BRONCHITOL:

• 1 Blister pack
• 1 Inhaler
• Bronchodilator (and spacer for bronchodilator if needed)
• Sink or hand washing station

Before using BRONCHITOL:

Use an inhaled bronchodilator 5 to15 minutes before using BRONCHITOL (See Figure A).

Clean and dry hands well (See Figure B).

Inhaler use steps for inhalation of the contents of a single capsule: Step 1. Remove cap (See Figure C).

Step 2. Twist open inhaler by turning the mouthpiece to the right. (See Figure D).

Step 3. Take 1 capsule out of the blister pack and put it in the chamber. (See Figure E).

Do not place capsule into the mouthpiece of the inhaler.

Step 4. Hold inhaler upright and turn the mouthpiece to the left until it locks in place. (See Figure F).

Step 5. Push both piercing buttons at the same time. Release both piercing buttons at the same time (See Figure G).

Keep inhaler upright. Never keep piercing buttons pressed.

Step 6. Breathe out (exhale) fully (See Figure H).

Do not breathe out into inhaler.

Step 7. Close lips around the mouthpiece and take a steady deep breath in through your mouth. Do not breathe through your nose. Remove inhaler from mouth. Hold breath for 5 seconds before exhaling, do not breathe out (exhale) into inhaler (See Figure I).

You should hear a rattling sound while breathing in. If you do not, tap bottom of inhaler firmly and repeat steps 6 and 7.

Step 8. Open the inhaler by turning the cap to the right. If powder is left in capsule, repeat steps 6 and 7. After the capsule is empty, throw away. (See Figure J).

Step 9. Repeat steps 3 to 8 for all 10 capsules in 1 blister pack (See Figure K).

Breathe in (inhale) contents of each capsule one after another until all 10 capsules in the blister pack are used.

Step 10. After inhaling contents of all 10 capsules, close mouthpiece and place cap on inhaler (See Figure L).

Step 11. Continue using BRONCHITOL for 7 days then throw away (discard) the inhaler (See Figure M).

How should I store BRONCHITOL?

• Store BRONCHITOL at room temperature between 68°F to77°F (20°C to 25°C).
• If your BRONCHITOL capsules are stored at temperatures more than 86°F (30°C), throw them away.
• Do not freeze BRONCHITOL.
• Do not refrigerate BRONCHITOL.
• Keep BRONCHITOL and all medicines out of the reach of children.

Cleaning your BRONCHITOL inhaler.

• Your inhaler should give you the correct dose of medicine for 7 days without needing cleaning. However, if your inhaler does need cleaning:

  • Make sure your inhaler is empty.
  • Wash your inhaler in warm water with the mouthpiece open.
  • Shake it until there are no large water droplets left in the inhaler.
  • Leave it to dry in the air by laying it on its side with the mouthpiece open.
  • Allow the inhaler to dry fully (or completely) after it has been washed.

Caring for your BRONCHITOL inhaler.

• Keep your inhaler dry and always make sure your hands are completely dry before using it.
• Do not breathe or cough into your inhaler.
• Do not take your inhaler apart.
• Do not place a capsule directly into the mouthpiece of your inhaler.
• Do not leave a used capsule in your inhaler chamber.
• Use a new inhaler after 7 days.
• If your inhaler breaks, call to your healthcare provider.

For more information about BRONCHITOL or how to use your inhaler, call 1-888-276-2144.

Manufactured by:

Arna Pharma Pty Ltd.

20 Rodborough Road

Frenchs Forest NSW

2086 AUSTRALIA

Manufactured for:

Pharmaxis Europe Limited

108 Q House Furze Road,

Sandyford Dublin 18,

D18AY29 Ireland

1-888-276-2144

BRONCHITOL is registered in the US Patent and Trademark Office.

This Patient Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 06/2024