Bronchitol (Page 4 of 5)

HEALTHCARE PRACTITIONER INSTRUCTIONS FOR USE

Healthcare Practitioner Instructions
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Patient Information

BRONCHITOL® (BRONK-ih-tol)

(mannitol) inhalation powder

for oral inhalation use

What is BRONCHITOL?

  • BRONCHITOL is a prescription medicine that is used along with other therapies to improve lung function in people 18 years of age and older with cystic fibrosis (CF).
  • BRONCHITOL is only for adults who have passed the BRONCHITOL Tolerance Test (BTT). Your first dose of BRONCHITOL is given during the BTT by your healthcare provider and tests if BRONCHITOL is right for you. Your healthcare provider will use equipment to monitor you and have medicine ready if you have bronchospasms during the test. If you have bronchospasms during your BTT, then you should not be prescribed BRONCHITOL.

BRONCHITOL should not be used in children and adolescents. It is not known if BRONCHITOL is safe and effective in children under 18 years of age.

Do not take BRONCHITOL if you:

  • have had an allergic reaction to mannitol or any parts of the BRONCHITOL capsule. See the end of this Patient Information leaflet for a complete list of ingredients in BRONCHITOL.
  • do not pass the BTT.

Before you use BRONCHITOL, tell your healthcare provider about all your medical conditions, including if you:

  • have ever coughed up blood or had blood in your mucus (sputum).
  • are pregnant or planning on becoming pregnant. It is not known if BRONCHITOL will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while using BRONCHITOL.
  • are breastfeeding or plan to breastfeed. It is not known if BRONCHITOL passes into your breast milk or if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby while using BRONCHITOL.

Tell your healthcare provider about all medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of the medicines you take and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use BRONCHITOL?

See the step-by-step Patient Instructions for Use at the end of this Patient Information leaflet.

  • BRONCHITOL is for oral inhalation only.
  • Do not use BRONCHITOL until your healthcare provider has given you the BTT and approved you for treatment. Ask your healthcare provider or pharmacist if you have any questions.
  • Use BRONCHITOL exactly as your healthcare provider tells you to use it.
  • Do not swallow BRONCHITOL capsules. BRONCHITOL capsules should be used only with the provided inhaler device.
  • An inhaled short-acting bronchodilator should be used 5 to15 minutes before every dose of BRONCHITOL.
  • Use BRONCHITOL 2 times each day. Breathe in (inhale) through your mouth (oral inhalation) the capsule contents in 10 single BRONCHITOL capsules using the BRONCHITOL inhaler:
    • 1 time in the morning
    • 1 time at least 2 to 3 hours before bedtime
  • If you use too much BRONCHITOL, call your healthcare provider or go to the nearest emergency room right away if you have any unusual symptoms, such as feelings that you cannot breathe, have wheezing, or cough a lot.
  • Do not stop using BRONCHITOL or any other medicines unless told to do so by your healthcare provider because your symptoms might get worse.
  • Your healthcare provider may change your medicines as needed.

Call your healthcare provider or get emergency medical care right away if your breathing problems get worse while taking BRONCHITOL.

What are the possible side effects of BRONCHITOL?

BRONCHITOL may cause serious side effects, including:

  • sudden breathing problems immediately after inhaling your medicine. Use your short-acting bronchodilator or rescue medicine if you have sudden breathing problems. Get emergency medical care right away if your bronchodilator or rescue medicine does not relieve the symptoms.
  • coughing up of blood (hemoptysis). This is a serious but common side effect. Coughing up blood in your mucus can happen while you are using BRONCHITOL. Call your healthcare provider or get emergency medical care right away if you cough up a large amount of blood.

The most common side effects of BRONCHITOL include:

  • cough
  • coughing up of blood
  • pain or irritation in the back of your mouth and throat and discomfort when swallowing
  • vomiting
  • fever
  • joint pain
  • bacteria in your sputum

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of BRONCHITOL. You can ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Chiesi USA, Inc. at 1-888-661-9260.

How should I store BRONCHITOL?

  • Store BRONCHITOL at room temperature between 68°F to 77°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.
  • Throw away the BRONCHITOL inhaler after 7 days and get a new one.

Keep BRONCHITOL and all medicines out of the reach of children.

General information about the safe and effective use of BRONCHITOL.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BRONCHITOL for a condition for which it was not prescribed. Do not give BRONCHITOL to other people, even if they have the same symptoms that you have. It may harm them.

This leaflet summarizes the most important information about BRONCHITOL. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about BRONCHITOL that is written for health professionals.

What are the ingredients in BRONCHITOL?

Active ingredient: mannitol

Inactive ingredients: There are no inactive ingredients in BRONCHITOL.

Capsules: gelatin and water. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide E172.

Manufactured by:

Pharmaxis Ltd

20 Rodborough Road

Frenchs Forest NSW

2086 AUSTRALIA

Manufactured for:

Chiesi USA, Inc.

Cary, NC 27518

USA

1-888-661-9260

BRONCHITOL is registered in the US Patent and Trademark Office.

All trademarks referenced herein are the property of their prospective owners.

For more information about BRONCHITOL or how to use your inhaler, call 1-888-661-9260.

This Patient Information has been approved by the U.S. Food and Drug Administration 10/2020

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:

7-Day Treatment Pack

  • 140 Capsules (14 blister packs)
  • 1 Inhaler
  • Prescribing Information

4-Week Treatment Pack

  • 560 Capsules (56 blister packs)
  • 4 Inhalers
  • Prescribing Information
Blister Pack and Inhaler
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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 to 15 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).

Figure A

Clean and dry hands well (See Figure B).

Figure B

Inhaler use steps for inhalation of the contents of a single capsule:

Step 1. Remove cap (See Figure C)

Figure C

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

Figure D
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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.

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

Figure F

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

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

Do not breathe out into inhaler.

Figure H

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.

Figure I
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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).

Figure I
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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.

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

Figure L

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

Figure M
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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 1-888-661-9260.

Manufactured by:

Pharmaxis Ltd

20 Rodborough Road

Frenchs Forest NSW

2086 AUSTRALIA

Manufactured for:

Chiesi USA, Inc.

Cary, NC 27518

USA

1-888-661-9260

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: 10/2020

CTBR-009-0817-00-SPL

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