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INTAL CFC-FREE INHALER 5MG PRESSURISED INHALATION SUSPENSION

Active substance(s): SODIUM CROMOGLICATE / SODIUM CROMOGLICATE DRIED MICRONISED

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PACKAGE LEAFLET: INFORMATION FOR THE
USER

Intal®

CFC-Free Inhaler
5mg
Pressurised inhalation,
suspension
sodium cromoglicate
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.

In this leaflet:
1. What Intal is and what it is used for
2. Before you use Intal
3. How to use Intal
4. Possible side effects
5. How to store Intal
6. Further information
1. What Intal is and what it is
used for
Intal CFC-free Inhaler (called Intal in this
leaflet) contains a medicine called sodium
cromoglicate. This belongs to a group of
medicines called anti-allergics.
It works by having an effect deep in the air
passages of your lungs. It also lowers your
response when you are exposed to substances
to which you are allergic.
Intal is used to help prevent asthma attacks
and may be called a ‘preventer’:
● Intal 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
Using a ‘reliever’ inhaler in Section 3)
2.Before you use Intal
Do not use this medicine and tell
your doctor if:
✖ You are allergic (hypersensitive) to sodium

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

Take special care with Intal
Check with your doctor or
pharmacist before using your
medicine if:
▲ You have recently stopped taking ‘steroids’
and your asthma is getting worse (see
Taking other medicines below)
▲ You are suffering from stress, trauma,
infections or other illnesses
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before using Intal.
Taking 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 Intal can
affect the way some other medicines work. Also
some medicines can affect the way Intal 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 Intal,
your doctor may decide to lower 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 using this medicine
if you are pregnant, might become pregnant
or think you may be pregnant.
If you are breast-feeding or planning to
breast-feed, talk to your doctor or pharmacist
before using this medicine.

3. How to use Intal
Always use Intal exactly as your doctor has
told you. You should check with your doctor
or pharmacist if you are not sure.
Using this medicine
● It is important to use this medicine every
day, even if you have no signs of asthma
● This medicine is taken by breathing in
through your mouth (see ‘How to use your
inhaler’ below)
● You may need to use Intal for several
weeks for it to work best
● 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
● If you feel the effect of your medicine is
too weak or too strong, do not change the
dose yourself, but ask your doctor,
especially if you think it is too weak
How much to use (adults, elderly and
children)
● The starting dose is two puffs (inhalations)
four times each day
● Taking puffs at meal times and at bedtime
may help you to remember to use it
● When your asthma gets better, your doctor
may suggest that you lower your daily dose
to one puff four times each day
● Your doctor may also suggest you take an
additional dose before exercise
● Sometimes when your asthma is bad or
when you come into contact with anything
to which you are allergic, your doctor may
change how much you use. Your dose may
be increased to two puffs six to eight times
each day

Using a ‘reliever’ inhaler
● If your doctor has advised you to use a
‘reliever’ inhaler at the same time as Intal,
it is best to use your ‘reliever’ inhaler
before using your Intal Inhaler. This will
open the airways and allow the Intal to get
down into them better
● Keep your ‘reliever’ inhaler 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 Intal 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 3 to 4 once more
6. Close
After use, always replace the mouthpiece
cover to keep out dust and fluff.

y

Important things to make sure you are using
the inhaler properly
● Practice in front of a mirror or with a
nurse, 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
● Adults should supervise the use of Intal in
small children.
If you or a child use more Intal than you
should
If you or a child uses more Intal than you
should, talk to a doctor as soon as possible.
If you forget to use Intal
If you forget a dose, take it as soon as you
remember it. However, 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 Intal
Keep using Intal until your doctor tells you to
stop. Do not stop using Intal just because you
feel better. If you stop, your illness may get
worse.

538131

Intal

When your doctor says that
you can stop using Intal,
your dose will be lowered
gradually over a week.

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.

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

1. Remove
● Remove the metal canister and put it in a
safe place
● Take off the mouthpiece cover

Do not put the metal canister
into water

2. Wash
● Wash the plastic body of the inhaler
thoroughly in hand hot water from both
ends

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



Do not remove the rubber cover
from the metal canister



If you have any further questions on the use
of this product, ask your doctor or
pharmacist.






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 Intal Inhaler you have
been given while the other inhaler is
drying

Stop using Intal and see a doctor or
go to a hospital straight away if:
You have an allergic reaction to Intal. The
signs may include: a rash, swallowing or
breathing problems, swelling of your lips,
face, throat or tongue
You have a bad attack of wheezing,
difficulty breathing or tightness in the
chest (something called bronchospasm).
People who are allergic to Intal can also
experience these side effects. If this
happens, do not use your Intal Inhaler. Use
your ‘reliever’ inhaler instead and contact
a doctor straight away. The doctor may
decide to stop your treatment with Intal
Lung problems including inflammation of
the lungs. This means you may have a lung
infection called ‘eosinophilic pneumonia’.
Signs include:
- feeling unwell or less hungry, a high
temperature (fever) lasting 2 to 3 days
- difficulty breathing, shortness of breath
and cough.

Talk to your doctor or pharmacist if any of
the side effects gets serious or lasts longer
than a few days, or if you notice any side
effects not listed in this leaflet:
● Sore throat - drinking water after you use
your inhaler may help this
● Coughing
● Headache
● Sneezing, runny or blocked nose

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 Intal
Keep this medicine in a safe place where
children cannot see or reach it.
Do not use Intal Inhaler after the expiry date
which is stated on the label and carton. The
expiry date refers to the last day of that
month.
Do not refrigerate or freeze. The aerosol
inhaler canister is pressurised. Protect the
aerosol from heat or direct sunlight, do not
puncture or incinerate even when it is empty.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Further Information
What Intal Inhaler contains
● The active substance is sodium
cromoglicate. Each puff (inhalation)
contains 5mg of sodium cromoglicate
● The other ingredients are polyvidone K30,
polyethylene glycol (PEG) 600, apaflurane
HFA 227 - a non ozone depleting propellant
● This product contains no
chlorofluorocarbons
What Intal Inhaler looks like and contents of
the pack
● Intal is a metered dose inhaler supplied in
an aluminium can fitted with a metering
valve which delivers 112 actuations. Each
actuation contains 5 mg of sodium
cromoglicate.
● Each can of Intal comes with a plastic
adaptor (inhaler) with a dust-cap
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street,
Guildford, Surrey, GU1 4YS, UK
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 December
2013
 Sanofi, 2001 – 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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