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Bronchitol
mannitol

Package Leaflet: Information for the user


Bronchitol 40 mg inhalation powder, hard capsules

Mannitol


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


What is in this leaflet

  1. What Bronchitol is and what it is used for

  2. What you need to know before you use Bronchitol

  3. How to use Bronchitol

  4. Possible side effects

  5. How to store Bronchitol

  6. Contents of the pack and other information


  1. What Bronchitol is and what it is used for What Bronchitol is

    Bronchitol contains a medicine called mannitol which is a mucolytic agent.


    What Bronchitol is used for

    Bronchitol is for use in adults 18 years of age and over. As well as using Bronchitol you will normally keep using the other medicines you take for cystic fibrosis.


    How Bronchitol works

    Bronchitol is inhaled into the lungs to help with cystic fibrosis, an inherited disease that affects the glands in the lungs, gut and pancreas that secrete fluids such as mucus and digestive juices.


    Bronchitol helps by increasing the amount of water on the surface of your airways and in your mucus. This helps your lungs to clear mucus more easily. It also helps improve the condition of your lungs and your breathing. As a result you may get a ‘productive cough’, which also helps to remove mucus from your lungs.


  2. What you need to know before you use Bronchitol Do not use Bronchitol

    • if you are allergic to mannitol

    • if you are sensitive to mannitol. Before you are started on Bronchitol, your doctor will check whether your airways are too sensitive to mannitol. If you are too sensitive to mannitol, your airways will become narrower, and you may find it harder to breathe.

      If either of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using this medicine.


      Warnings and precautions

      Talk to your doctor or pharmacist before using this medicine:

    • if you have asthma;

    • if you have ever coughed up blood or had blood in your sputum;

    • if you have severe cystic fibrosis, in particular if your lung function measured by the Forced Expiratory Volume in first second of expiration (FEV1) is usually less than 30%.


      Inhaling medicines can cause chest tightness and wheezing and this can happen immediately after taking this medicine. Your doctor will help you take your first dose of Bronchitol and check your lung function before, during and after dosing. Your doctor may ask you to use other medicines such as a bronchodilator before taking Bronchitol.


      Inhaling medicines can also cause cough and this can happen with Bronchitol. Talk to your doctor if the cough won’t go away or worries you.


      Children and adolescents

      Bronchitol should not be used by children and adolescents under the age of 18. This is because there is limited information in this group of people.


      Other medicines and Bronchitol

      Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.


      You can carry on using your medicines for cystic fibrosis when you are using Bronchitol, this includes inhaled antibiotics such as tobramycin and colistimethate sodium. If you are not sure, talk to your doctor or pharmacist before using Bronchitol.


      Pregnancy and breast-feeding

    • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. You should avoid using this medicine if you are pregnant.

    • If you are breast-feeding or plan to breast-feed ask your doctor for advice before using this

      medicine. It is not known if this medicine passes into the breast milk.


      Driving and using machines

      Bronchitol is not likely to affect your ability to drive or use any tools or machines.


  3. How to use Bronchitol


Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.


Always take your bronchodilator before using Bronchitol.


How much to use


Adults 18 years of age and over


Initiation dose

Before you are prescribed Bronchitol your doctor will help you take your first dose of Bronchitol and test your lung function at each step to make sure you aren’t sensitive to mannitol. The first dose is taken in 4 steps:-


Step 1 – 1 capsule (40 mg)

Step 2 – 2 capsules (80 mg)

Step 3 – 3 capsules (120 mg)

Step 4 – 4 capsules (160 mg)


At the end of the initiation dose you will have taken 10 capsules (400 mg) which is the same as the usual dose.

Treatment dose (2-week packs)


Order of using this medicine

Use Bronchitol as part of your normal daily treatment routine. The suggested order is as follows, unless otherwise advised by your doctor:

  1. Use your bronchodilator;

  2. Wait 5 to 15 minutes;

  3. Use your Bronchitol before physiotherapy if this is part of your treatment routine.

  4. Dornase alfa (Pulmozyme) if this is part of your treatment routine

  5. Inhaled antibiotics if this is part of your treatment routine


How to use your medicine

- Bronchitol is breathed in (inhaled) as a powder from the capsule using the inhaler supplied in the pack. It is for inhalation use only and must not be administered by any other route. The capsules must not be swallowed.


Cleaning the inhaler - Usually your inhaler will give you the correct dose of medicine for 7 days without needing cleaning. However, if your inhaler does need cleaning, the steps to follow are:

  1. Ensure your inhaler is empty.

  2. Wash your inhaler in warm water with the mouth-piece open.

  3. Shake it until there are no large water droplets left in the inhaler.

  4. Leave it to dry in the air - lay it on its side with the mouth-piece open.

  5. You must let it fully dry, this can take up to 24 hours. While it is drying, use your other inhaler.