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NEDOCROMIL SODIUM 2MG CFC-FREE INHALER

Active substance(s): NEDOCROMIL SODIUM MICRONISED DRIED

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Tilade 2mg CFC-Free Inhaler
(nedocromil sodium)

2mg per actuation pressurised inhalation suspension
The name of your medicine is Tilade 2mg CFC-Free Inhaler. However
throughout the rest of this leaflet it will be referred to as Tilade.
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 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 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.
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.
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

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












3.





Wash through the top for a minute
Wash through the bottom for a minute
Then wash the mouthpiece cover
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

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



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 refrigerate or freeze.
Do not store above 30°C and protect it from direct sunlight.
The metal canister is pressurised.
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.
If your medicine shows any sign of deterioration consult your
pharmacist who will advise you what to do.

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, levomenthol and
heptafluoropropane (HFA 227)

This product contains no chlorofluorocarbons.
What Tilade looks like and contents of the pack

Tilade is a pressurised metered dose inhaler with a yellow plastic
device and green removable cap. There are two inhaler cases in a
pack.

Tilade is an aluminium canister with a device to measure 112
actuations (puffs)

Each pack contains 1 aerosol canister
Tilade 2mg CFC-Free Inhaler is manufactured by Aventis Pharma,
Holmes Chapel, Cheshire, CW4 8BE, UK.
Procured from within the EU and repackaged in the UK by the Parallel
Import Product Licence holder: CD Pharma Ltd, Unit 3, Manor Point,
Manor Way, Borehamwood, Herts., WD6 1EE.
Tilade 2mg CFC-Free Inhaler

PL No. 20492/0371

POM

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.
Tilade is a registered trademark of Fisons Ltd.
Date of preparation 31st July 2014

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nedocromil Sodium 2mg CFC-Free Inhaler
2mg per actuation pressurised inhalation suspension
The name of your medicine is Nedocromil Sodium 2mg CFC-Free Inhaler.
However throughout the rest of this leaflet it will be referred to as
Nedocromil.
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 Nedocromil is and what it is used for
2. Before you use Nedocromil
3. How to use Nedocromil
4. Possible side effects
5. How to store Nedocromil
6. Further information

1. What Nedocromil is and what it is used for
Nedocromil contains a medicine called nedocromil sodium. Nedocromil 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
Nedocromil is used to prevent asthma attacks and may be called a
‘preventer’.
• Nedocromil 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 Nedocromil
Do not use this medicine and tell your doctor if:
• You are allergic (hypersensitive) to nedocromil sodium or any of the
other ingredients of Nedocromil (listed in Section 6). Signs of an
allergic reaction to Nedocromil 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 Nedocromil.
Take special care with Nedocromil
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 Nedocromil
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 Nedocromil can
affect the way some other medicines work. Also some medicines can
affect the way Nedocromil 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 Nedocromil, 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.

3. How to use Nedocromil
Always use Nedocromil 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
• Nedocromil 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 Nedocromil. 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 Nedocromil inhaler, it is best to use your ‘reliever’ inhaler
before using your Nedocromil inhaler. This will open the airways and
allow the Nedocromil 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

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
Nedocromil has no known effect on your ability to drive or use any tools or
machines.

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 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 Nedocromil than you should
If you or a child use more Nedocromil than you should, talk to a doctor or
go to a hospital straight away. However, using too much is unlikely to
cause problems.
If you forget to use Nedocromil
If you have forgotten to use Nedocromil, 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 Nedocromil
Do not stop using Nedocromil or reduce the number of puffs you take
without telling your doctor.
If you stop your treatment suddenly your symptoms may come back.
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


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 Nedocromil inhaler you have been given while the
other inhaler is drying
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

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












Keep this medicine in a safe place where children cannot see or
reach it.
Always replace the dust cap after use.
Do not use Nedocromil 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 refrigerate or freeze.
Do not store above 30°C and protect it from direct sunlight.
The metal canister is pressurised.
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.
If your medicine shows any sign of deterioration consult your
pharmacist who will advise you what to do.

6. Further Information
What Nedocromil contains

The active substance is nedocromil sodium. Each actuation (puff)
contains 2mg of nedocromil sodium.

The other ingredients are povidone K30, macrogol, levomenthol and
heptafluoropropane (HFA 227)

This product contains no chlorofluorocarbons.
What Nedocromil looks like and contents of the pack

Nedocromil is a pressurised metered dose inhaler with a yellow
plastic device and green removable cap. There are two inhaler
cases in a pack.

Nedocromil is an aluminium canister with a device to measure 112
actuations (puffs)

Each pack contains 1 aerosol canister
Nedocromil 2mg CFC-Free Inhaler is manufactured by Aventis Pharma,
Holmes Chapel, Cheshire, CW4 8BE, UK.
Procured from within the EU and repackaged in the UK by the Parallel
Import Product Licence holder: CD Pharma Ltd, Unit 3, Manor Point,
Manor Way, Borehamwood, Herts. WD6 1EE.
Nedocromil Sodium 2mg CFC-Free Inhaler
PL No. 20492/0371

POM

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.
Date of preparation 31st July 2014

Expand view ⇕

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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