Bronchitol

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

mannitol

Available from:

Pharmaxis Europe Limited

ATC code:

R05CB16

INN (International Name):

mannitol

Therapeutic group:

Cough and cold preparations

Therapeutic area:

Cystic Fibrosis

Therapeutic indications:

Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.

Product summary:

Revision: 19

Authorization status:

Authorised

Authorization date:

2012-04-13

Patient Information leaflet

24
B. PACKAGE LEAFLET
25
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.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or pharmacist.
−
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
−
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Bronchitol 40 mg inhalation powder, hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 40 mg mannitol.
Mean delivered dose per capsule is 32.2 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule.
Clear colourless hard capsules marked with ‘PXS 40 mg’ and
containing white or almost white
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bronchitol is indicated for the treatment of cystic fibrosis (CF) in
adults aged 18 years and above as an
add-on therapy to best standard of care.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Initiation dose assessment _
Before commencing treatment with Bronchitol all patients should be
assessed for bronchial
hyperresponsiveness to inhaled mannitol during administration of their
initiation dose (see sections 4.4
and 5.1).
The patient’s initiation dose of Bronchitol must be used under the
supervision and monitoring of an
experienced physician or another health care professional
appropriately trained and equipped to
perform spirometry, monitor oxygen saturation (SpO
2
), and manage acute bronchospasm (see sections
4.4 and 4.8) including appropriate use of resuscitation equipment.
The patient should be pre-medicated with a bronchodilator 5-15 minutes
prior to the initiation dose but
after the baseline FEV
1
and SpO
2
(Oxygen saturation in the blood) measurement. All FEV
1
measurements and SpO
2
monitoring should be performed 60 seconds after dose inhalation.
Training the patient to practice correct inhaler technique during the
initiation dose assessment is
important.
The initiation dose assessment must be performed according to the
following steps:
Step 1: Patients baseline FEV
1
and SpO
2
is measured prior to the initiation dose
Step 2: Patient inhales 40 mg (1x40 mg capsules) and SpO
2
is monitored
Step 3: Patient inhales 80 mg (2x40 mg capsules) and SpO
2
is monitored
Step 4: Patient inhales