TILADE CFC- FREE INHALER 2MG PER ACTUATION PRESSURISED INHALATION SUSPENSION

Active substance: NEDOCROMIL SODIUM MICRONISED DRIED

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PACKAGE LEAFLET: INFORMATION FOR THE
USER

Tilade®

CFC-Free Inhaler
2mg per actuation
pressurised inhalation
suspension
nedocromil sodium
Is this leaflet hard to see
or read?
Phone 0845 372 7101
for help
Read all of this leaflet carefully before you
start using this medicine
● 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.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
● If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist. See section 4.

In this leaflet:
1. What Tilade is and what it is used for
2. Before you use Tilade
3. How to use Tilade
4. Possible side effects
5. How to store Tilade
6. Further information
1.What Tilade is and what it is
used for
Tilade CFC-Free Inhaler (called Tilade
throughout this leaflet) contains a medicine
called nedocromil sodium. Tilade is used to
treat asthma.
● It works by helping to stop tissues from
swelling
● This helps stop the narrowing of the
airways that happens in asthma
Tilade is used to prevent asthma attacks and
may be called a ‘preventer’.
● Tilade will not help an asthma attack that
has already started
● You will need to use a different inhaler,
called a ‘reliever’, for these attacks (see
Section 3)
2.Before you use Tilade
Do not use this medicine and tell
your doctor if:
✖ You are allergic (hypersensitive) to

nedocromil sodium or any of the other
ingredients of Tilade (listed in Section 6).
Signs of an allergic reaction to Tilade
include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat
or tongue
Do not take this medicine if the above applies
to you. If you are not sure, talk to your
doctor or pharmacist before using Tilade.

Take special care with Tilade
Check with your doctor or
pharmacist before taking your
medicine if:
▲ You are using any other inhalers
If you are not sure if the above applies to you,
talk to your doctor or pharmacist before
using Tilade
Using other medicines
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines. This includes medicines
you buy without a prescription, including
herbal medicines. This is because Tilade can
affect the way some other medicines work.
Also some medicines can affect the way
Tilade works.
In particular, tell your doctor if you are also
using a steroid medicine:
● This can be either an inhaler (such as
beclometasone) or a tablet (such as
prednisolone)
● If you are using a steroid as well as Tilade,
your doctor may decide to reduce the
amount of steroid taken or gradually stop
the steroid altogether
If your steroid treatment has been reduced or
stopped and your asthma then gets worse
you must tell your doctor straight away. They
may wish to increase or re-start the steroid
treatment.
Pregnancy and breast-feeding
Talk to your doctor before taking this
medicine if you are pregnant, might become
pregnant, or are breast-feeding.
Driving and using machines
Tilade has no known effect on your ability to
drive or use any tools or machines.

3.How to use Tilade
Always use Tilade exactly as your doctor has
told you. Make sure that you know:
● How to use the inhaler
● When to use it
● How many puffs you should take each time
You should check with your doctor or
pharmacist if you are not sure.
How much to use
● The usual starting dose for adults and
children over 6 years is 2 puffs four times a
day
● Taking puffs at meal times and at bed time
may help you to remember to take it
● Your doctor may tell you to take more or
less puffs depending on how bad your
asthma is. As your asthma gets better,
your doctor may suggest that you reduce
your daily dose to 2 puffs twice a day. If
this happens, use your inhaler in the
morning when you wake and again before
you go to bed
● Tilade is not recommended for use in
children 6 years of age and younger. Check
with your doctor or pharmacist before
using
Using this medicine
● This medicine may not help your
symptoms straight away. You may need to
use your inhaler for several weeks for it to
work best. It only works if you use it every
day, even when you feel well
● Your asthma may get worse if you have an
infection, are unwell or come into contact
with anything to which you are allergic. If
this happens, talk to a doctor straight
away. You may need to go to hospital for
treatment





If you have to go to a doctor, dentist or
hospital for any reason, tell them that you
are using Tilade. Also take all your inhalers
and any other medicines you are taking
with you (in their packaging if possible)
It may be helpful to rinse your mouth with
water after using the inhaler. This will help
stop any unpleasant taste or coughing.

Using a ‘reliever’ inhaler
● If your doctor has advised you to use a
‘reliever’ inhaler at the same time as the
Tilade inhaler, it is best to use your
‘reliever’ inhaler before using your Tilade
inhaler. This will open the airways and
allow the Tilade to get down into them
better
● Keep your ‘reliever’ inhaler available at all
times in case of a sudden attack or if your
asthma gets worse. Talk to your doctor if it
takes more puffs than usual from your
‘reliever’ inhaler to control your symptoms
How to use your inhaler (An adult should
help small children use their inhaler properly)
1. Open
Remove the mouthpiece cover and check that
the mouthpiece is clean
2. Shake
Shake the inhaler well
(at least 5 times)
● If you are using this
inhaler for the first
time, release 4 puffs
into the air
● If the inhaler has not
been used for more
than 3 days, release 2 puffs into the air

3. Inhale
● Hold the inhaler
upright with your
thumb on the base
● Hold the inhaler well
away from your mouth
● Breathe out as far as is
comfortable
● DO NOT breathe out through the inhaler.
This is to stop moisture from collecting
and blocking the spray






Put the mouthpiece in
your mouth and close
your lips tightly
around it
Start to breathe in
Slowly and deeply
through your mouth
then….
Immediately press the metal canister
down firmly to release a puff of medicine,
while keeping breathing in slowly and
deeply

4. Hold
● Remove the inhaler
from your mouth and
hold your breath for
about 10 seconds, or
as long as is
comfortable
● Breathe out slowly
5. Repeat
If your doctor has told you to take 2 puffs
each time you use your inhaler:
● Wait for one minute after the first puff.
Then repeat steps 2 to 4 once more
6. Close
After use, always replace the
mouthpiece cover to keep out dust
Turn
Over
and fluff.

Important things to make sure you are
using the inhaler properly
Practice in front of a mirror or with a
pharmacist or doctor from time to time. If
you see a mist escaping from your mouth or
around the sides of the canister you need to
try to use your inhaler better:
● Be sure to have your lips closed properly
around the mouthpiece
● Be sure to start breathing in before
pressing the canister
If you or a child use more Tilade than you
should
If you or a child use more Tilade than you
should, talk to a doctor or go to a hospital
straight away. However, using too much is
unlikely to cause problems.

How to clean
It is very important to keep the plastic body
of the inhaler clean. This helps to stop the
build up of powder. Clean the plastic body at
least twice a week. No harm will come from
washing the plastic body and mouthpiece
cover every day.
1. Remove
● Take out the metal canister and put it in a
safe place
● Take off the mouthpiece cover
2. Wash
● Wash the plastic body of the inhaler
thoroughly in hand-hot water from both
ends

551315

Tilade

4.Possible side effects
Like all medicines, Tilade can cause side
effects, although not everybody gets them.



Do not put the metal canister
into water
Do not remove the rubber cover
from the metal canister



If you forget to use Tilade
If you have forgotten to use Tilade, take your
next dose as soon as you remember. Do not
take a double dose to make up for a dose you
have missed.
If you stop using Tilade
Do not stop using Tilade or reduce the
number of puffs you take without telling your
doctor.
If you stop your treatment suddenly your
symptoms may come back.

If the inhaler becomes blocked
● Soak the plastic mouthpiece in hand-hot
water for 20 minutes before you wash it
under the tap from both ends (as above)
● Never try to unblock the inhaler with a
pin, as this will damage the inhaler

Wash through the top for a minute
Wash through the bottom for a minute
● Then wash the mouthpiece cover
3. Dry
● Shake off any water that is left and leave to
dry in a clean warm place overnight
● When completely dry, put the metal
canister back into the plastic body of the
inhaler. Then replace the mouthpiece
cover
● If the metal canister will not slide easily
into the plastic mouthpiece, press the
white rubber cover firmly back down onto
the metal canister
● Use the second Tilade inhaler you have
been given while the other inhaler is
drying



Stop using Tilade and see a doctor
or go to a hospital straight away if:
You have severe wheezing, coughing or
breathlessness. Inhaler medicines can
sometimes make this happen straight after
you use them. If this happens, do not use
your Tilade inhaler. Use your “reliever”
inhaler instead and contact a doctor
straight away. The doctor may decide to
prescribe a different treatment for your
asthma
You have an allergic reaction to Tilade. The
signs may include: a rash, swallowing or
breathing problems, swelling of your lips,
face, throat or tongue

Tell your doctor or pharmacist if you have
any of these side effects that are well
known:
Very common (affects more than 1 in 10
people)
● headache
● feeling or being sick
● Indigestion or stomach pain
● Mild coughing or wheezing
Common (affects 1 to 10 people in a 100)
● Unusual or unpleasant taste
Frequency not known
● Throat irritation or sore throat
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.

You can also report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this
medicine.
5.How to store Tilade












Keep this medicine in a safe place where
children cannot see or reach it.
Always replace the dust cap after use.
Do not use Tilade after the expiry date.
This is given in two places: on the canister
label and on the carton. In both places it
is given as EXP followed by the month and
the year. The inhaler should not be used
after the last day of that month.
Do not store in a refrigerator or freezer.
The metal canister is pressurised. Do not
expose to temperatures above 50°C and
protect it from direct sunlight.
Do not puncture, break or burn the
canister even if it seems empty.
Do not keep the inhaler if your doctor
decides to stop treatment or if it is empty.
Ask your pharmacist how to dispose of
medicines no longer required. Medicines
should not be disposed of via wastewater
or household waste. These will help to
protect the environment.

6.Further Information
What Tilade contains
● The active substance is nedocromil
sodium. Each actuation (puff) contains
2mg of nedocromil sodium.
● The other ingredients are povidone K30,
macrogol 600, levomenthol and
heptafluoropropane (HFA 227)
● This product contains no
chlorofluorocarbons.
What Tilade looks like and contents of the
pack
● Tilade is an aluminium canister with a
device to measure 112 actuations (puffs)
● Each pack contains either 1 or 2 aerosol
canisters
● Each canister comes with a plastic adaptor
(inhaler) with a dustcap
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street, Guildford
Surrey, GU1 4YS, UK
Tel: Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Aventis Pharma
Holmes Chapel, Cheshire, CW4 8BE, UK
This leaflet does not contain all the
information about your medicine. If you
have any questions or are not sure about
anything, ask your doctor or pharmacist.
This leaflet was last revised in October
2013.
© sanofi, 2005-2013

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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.

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