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Package leaflet: Information for the user

Pulmozyme® 2500 U/2.5 ml
Nebuliser Solution
Dornase alfa
Please read all of this leaflet carefully before
you start using this medicine because it
contains important information for you.
Always use this medicine exactly as described
in this leaflet or as your doctor or pharmacist
have told you.
● Keep this leaflet. You may need to read it
● 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 any of the side effects become serious or
troublesome, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist. See section 4.
What is in this leaflet
1. What Pulmozyme is and what it is used for
2. What you need to know before you use
3. How to use Pulmozyme
4. Possible side effects
5. How to store Pulmozyme
6. Contents of the pack and other information

1. What Pulmozyme is and what it
is used for
Pulmozyme contains a medicine called
dornase alfa. It is a man-made version of a
protein found in your body called ‘DNase’.
Pulmozyme is used for people with cystic
fibrosis. It helps by breaking down the thick
mucus found in lungs. This helps lungs of
people with cystic fibrosis to work better.
Pulmozyme is breathed in (inhaled) using
something called a 'nebuliser' (see Section 3:
How to use Pulmozyme). As well as using
Pulmozyme you will normally keep taking the
other medicines you use for cystic fibrosis (see
'Other medicines and Pulmozyme' in section 2).

2. What you need to know before
you use Pulmozyme
Do not use Pulmozyme:
● if you are allergic (hypersensitive) to
dornase alfa or any of the other ingredients
in Pulmozyme (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using
Pulmozyme is not recommended for use by
children under 5 years of age. Check with
your doctor or pharmacist before using
Pulmozyme if it has been prescribed for a
child under 5 years of age.
Other medicines and
Please tell your doctor or
pharmacist if you are
taking or have recently
taken any other medicines.
This includes medicines that you buy without
a prescription and herbal medicines. This is
because Pulmozyme may affect the way some
medicines work. Also some other medicines
may affect the way Pulmozyme works.
You can carry on using your usual treatments
for cystic fibrosis when you are using
Pulmozyme (such as antibiotics, pancreatic
enzymes, bronchodilators and painkillers). If
you are not sure about this, talk to your doctor
or pharmacist before using Pulmozyme.
Pregnancy and breast-feeding
Do not use Pulmozyme if you are pregnant,
trying to get pregnant or breast-feeding, unless
your doctor has told you to.
Driving and using machines
Pulmozyme is not likely to affect you being
able to drive or use any tools or machines.

3. How to use Pulmozyme
Always use Pulmozyme exactly as your doctor
has told you. Pulmozyme is breathed in
(inhaled) using a nebuliser (see ‘Which
nebuliser to use’). You should check with
your doctor if you are not sure.
Keep having your standard chest physiotherapy
when you are using Pulmozyme.
People 5 years of age and over
● You should use Pulmozyme every day.
● The recommended dose is one ampoule
every day, inhaled using your nebuliser.
● If you are over 21, your doctor may tell you
to use one ampoule twice a day.
People under 5 years of age
● Pulmozyme is not recommended in children
under 5 years of age.
Which nebuliser to use:
Use a nebuliser such as:
● Hudson T Up-draft II/Pulmo-Aide, Airlife
Misty/Pulmo-Aide, customised Respirgard/
Pulmo-Aide, or AcornII/Pulmo-Aide.
● Pulmozyme may also be used with a
reusable nebuliser system, such as the Pari
LL/Inhalierboy, Pari LC/Inhalierboy or
Master, Aiolos/2 Aiolos, Side Stream/CR50
or MobilAire or Porta-Neb.
● The Pari eFlow Rapid nebuliser, a general
purpose electronic vibrating membrane
nebuliser may be used. The Pari eFlow
Rapid nebuliser should be cleaned according
to manufacturer’s instructions. In addition it
is recommended to use the Pari EasyCare
cleaning accessory after every seventh use.
● Ultrasonic nebulisers must not be used,
as they may stop Pulmozyme from working
Please read carefully and follow the
manufacturers’ instructions for use of each
Talk to your doctor as they will be able to tell
you which nebulisers can be used with
How to use Pulmozyme with the nebuliser
When getting your nebuliser ready for use
with Pulmozyme, please remember these
important points:
● Do not mix Pulmozyme with any other
liquids or medicines in the nebuliser.
10188560_NP9344.indd 1

● Do not use any left over Pulmozyme, this
should always be thrown away.
● If you have a ‘re-usable’ nebuliser,
remember to clean it after use. The makers
of the nebuliser will be able to give you the
best advice on how to clean their equipment
after using Pulmozyme.
● If someone else uses your Pulmozyme by
mistake, they should talk to a doctor
straight away.
To use your nebuliser
● Make sure that the nebuliser is clean.
● Snap the top off one Pulmozyme ampoule.
● Pour the contents into the nebuliser
● Follow the nebuliser instructions and inhale
the Pulmozyme straight away.
If you use more Pulmozyme than you
If you use more Pulmozyme than you should,
talk to a doctor straight away.
If you forget to use Pulmozyme
● If you forget to take a dose, take it as soon
as you remember.
● If it is nearly time for the next dose, skip
the missed dose.
● Do not take a double dose to make up for a
forgotten dose.
If you stop using Pulmozyme
If you stop using Pulmozyme your chest
symptoms may get worse. Talk to your doctor
if you would like to stop using Pulmozyme.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Pulmozyme can cause side
effects, although not everyone will get them.
Side effects from Pulmozyme are rare. They
affect less than 1 in 1000 people.
Side effects include:
● Chest pain.
● Fever.
● Upset stomach (indigestion).
● Changes to your voice including hoarseness
or loss of voice.
● Sore throat.
● Difficulty breathing.
● A runny or blocked nose and sneezing
● Irritation of your eye (conjunctivitis). The
signs include redness and itchiness of the
eye and a discharge from the eye.
● Skin rash, which may be lumpy and itchy
● When you start your treatment, your lung
function may get worse and you may
produce more mucus than normal. This
usually gets better with time.
If any of the side effects become serious or
troublesome, or if you notice any side effects
not listed in this leaflet,
please tell your doctor or
Reporting of side effects
If you get any side effects,
talk to your doctor or pharmacist.This includes
any possible side effects not listed in this leaflet.
You can also report side effects directly (see
details below). By reporting side effects you
can help provide more information on the
safety of this medicine.
Malta: ADR Reporting, at,
United Kingdom: Yellow Card Scheme at

5. How to store Pulmozyme
● Pulmozyme ampoules must be stored in a
refrigerator (2°C to 8°C) in the original
carton, to protect them from light.
● You can still use an ampoule if it has been
left out of the refrigerator for only a short
time at a higher temperature (only left out
once and for no longer than 24 hours at
temperatures up to 30°C).
● Keep this medicine out of the sight and
reach of children.
● Do not use Pulmozyme after the expiry date
(EXP) which is printed on the pack. The
expiry date refers to the last day of that
● Do not throw away any left over ampoules
via wastewater or household waste.
Instead, return them to your pharmacist so
that they can be disposed of carefully.
These measures will help protect the
environment. Only keep them if your doctor
tells you to.

6. Content of the pack and other
What Pulmozyme contains
● The active ingredient in Pulmozyme
2500 U/2.5 ml Nebuliser Solution is
dornase alfa. This is also known as
recombinant human deoxyribonuclease 1 or
rhDNase. Each 2.5 ml (millilitres) of liquid
medicine contains 2500 Units
(or 2.5 milligrams) of dornase alfa.
● Other ingredients are sodium chloride,
calcium chloride dihydrate and water for
What Pulmozyme looks like and contents of
the pack
Pulmozyme Nebuliser Solution is provided in
clear plastic ampoules. The ampoules contain
2.5 ml of liquid medicine. The medicine is
clear and colourless to slightly yellowish.
Pulmozyme is supplied in cartons containing
either 6 or 30 ampoules. Not all pack sizes
may be marketed.
Marketing Authorisation Holder
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom
Roche Pharma AG
Emil-Barell-Str. 1
D-79639 Grenzach-Wyhlen
This leaflet was last revised in July 2017.

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13.06.2017 14:33:33

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.