Intal® CFC-FreeInhaler

Sodium Cromoglycate


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Intal CFC-Free.

It does not contain all the information that is known aboutIntal CFC-Free.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighedthe risks of you using Intal CFC-Free against the benefits he/sheexpects it will have for you.

If you have any concerns about using this medicine ask yourdoctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Intal CFC-Free is used for

Intal CFC-Free is inhaled into the lungs for the treatment ofasthma.

Asthma is a disease where the lining of the lungs becomes inflamed(red and swollen), making it difficult to breathe. This may be dueto an allergy to house dust mites, smoke, air-borne pollution or otherirritants.

Intal CFC-Free is used to prevent bronchial asthma due to allergy,exercise, cold air or irritants, in both adults and children.

With regular use, Intal CFC-Free will help prevent asthma symptomsfrom occurring.

Intal CFC-Free will not relieve the symptoms of an asthma attackonce the attack has started.

You should follow your doctor's advice and prescribed treatmentto get relief from a sudden asthma attack.

Intal CFC-Free can also be used before exercise or before exposureto dust or other known asthma triggers, such as pollens or dust mite.This should prevent the symptoms (wheeze, cough, breathlessness) thesetriggers can cause.

Intal CFC-Free works by reducing the inflammationof the airways which occurs in asthma.

Your doctor may have prescribed Intal CFC-Free for another reason.

Ask your doctor if you have any questions about why IntalCFC-Freehas been prescribed for you.

There is no evidence that IntalCFC-Free is addictive.

Before you use Intal CFC-Free

When you must not use it

Do not use Intal CFC-Free if you have an allergy to IntalCFC-Free or any of the ingredients listed at the end of this leaflet. If you have an allergic reaction you may get a skin rash,have difficulty in breathing, get symptoms of hayfever or feel faint.

Do not use Intal CFC-Free after the expiry date (EXP) printedon the pack. If you use this medicine after the expiry date has passed,it may not work as well or may be harmful.

Do not use Intal CFC-Free if the packaging is torn or showssigns of tampering.

If you are not sure whether you should start using Intal CFC-Free,contact your doctor or pharmacist.

Before you use it

Ask your doctor to write an asthma management plan for youbefore you begin to use IntalCFC-Free. Intal CFC-Free is only one part of a general plan to helpyou manage your asthma.

You should discuss this plan regularly with your doctor to checkyour treatment.

As part of your asthma action plan you will probably need totake another sort of medicine called a "reliever" to relieve the symptomsof an asthma attack which has started.

If you need treatment for a sudden asthma attack, use the "reliever"medicine your doctor has prescribed for you.

Tell your doctor or pharmacist if you have allergies to:

  • any other medicines
  • any other substances, such as foods, preservativesor dyes

Tell your doctor or pharmacist if you are pregnant or intendto become pregnant.

Tell your doctor or pharmacist if you are breast-feeding orplan to breast-feed. Intal CFC-Free is not known to be harmful in pregnancy, however,it does pass into breast milk.

Therefore, if you are pregnant or breastfeeding you should discusswith your doctor the risks and benefits involved, before using IntalCFC-Free.

Taking other medicines

Tell your doctor or pharmacist if you are using any other medicines,including any that you buy without a prescription from your pharmacy,supermarket or health food shop.

Intal CFC-Free can be used with most other medicines which areused to prevent or treat asthma.

How to use IntalCFC-Free

If you are not sure how to use an inhaler, ask your doctor orpharmacist.

Children should only use their inhaler on medical advice andwith the help of an adult.

If your child has difficulty using the inhaler properly, askyour doctor or pharmacist for advice on the use of a spacer device.Young children may benefit from the use of a spacer with their inhaler.

If your inhaler is new, you will need to prime the inhaler bypressing the canister down 4 times before you use it. If you use yourinhaler again within two days, there is no need to prime it again.

If your inhaler is not used for three to seven days, you willneed to prime it with 2 sprays.

If your inhaler is not used for more than 7 days, you will needto prime it with 4 sprays.

Follow the instructions below:

  1. Remove the cover fromthe mouthpiece, and shake the inhaler vigorously.
  2. Holding the inhaler wellaway from your mouth, breathe out gently (but not fully). To avoidcondensation and blockage of the spray, DO NOT breathe out throughthe mouthpiece.
  3. Place the mouthpiece inyour mouth and close your lips around it. After starting to breathein slowly and deeply through your mouth, press the metal canisterfirmly to release the powder, and continue to breathe in.
  4. Remove the inhaler fromyour mouth and hold your breath for 10 seconds, or as long as is comfortable,before breathing out slowly.
  5. If you are to take a secondinhalation, you should wait at least one minute before repeating steps2, 3 and 4. After use replace the cover on the mouthpiece.

Note – if you are using a spacer with the inhaler, be carefulto follow the instructions provided with the spacer.

When to use it

The usual starting dose is two puffs four times a day. Somepatients may require higher doses.

If you forget to use it

If you forget to use your IntalCFC-Free inhaler, use it as soonas you remember, and then go back to using your medicine as you wouldnormally.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to use your medicine, ask yourpharmacist for some hints.

How long to use it

Intal CFC-Free helps control your condition. Therefore you mustuse Intal CFC-Free every day.

Continue using the medicine for as long as your doctor or pharmacisttells you.

Do not stop using it unless your doctor or pharmacist tellsyou to – even if you feel better.

If you take too much (overdose)

Immediately telephone your doctor or pharmacist or the PoisonsInformation Centre (telephone 13 11 26), or go to Accident and Emergencyat your nearest hospital, if you think that you or anyone else mayhave used too much Intal CFC-Free. Do thiseven if there are no signsof discomfort or poisoning.

You may need urgent medical attention.

While you are using Intal CFC-Free

Things you must do

If you have an Asthma Action Plan that you have agreed withyour doctor, follow it closely at all times.

Continue using Intal CFC-Free for as long as your doctor orpharmacist tells you.

Visit your doctor regularly to check on your asthma condition.

Tell any other doctors, dentists and pharmacists who are treatingyou that you are using Intal CFC-Free.

If you are about to be started on any new medicine, tell yourdoctor or pharmacist that you are using Intal CFC-Free.

If you become pregnant, while using Intal CFC-Free, tell yourdoctor or pharmacist.

Things you must not do

Do not take any other medicines for your breathing problemswithout checking with your doctor.

Do not give Intal CFC-Free to anyone else, even if they havethe same condition as you.

Do not use Intal CFC-Free to treat any other complaints unlessyour doctor or pharmacist tells you to.

Do not stop using Intal CFC-Free or lower the dosage, withoutchecking with your doctor or pharmacist.

Do not use Intal CFC-Free to relieve acute attacks of asthma.If you become wheezy or tight in the chest before your next dose ofIntal CFC-Free is due, use a 'reliever puffer' in the usual way.

Things to be careful of

Be careful driving or operating machinery until you know howIntal CFC-Free affects you.

Side Effects

Tell your doctor or pharmacist as soon as possible if youdo not feel well while you are using Intal CFC-Free. All medicines can have side effects. Sometimes they are serious,most of the time they are not. You may need medical treatment if youget some of the side effects.

Ask your doctor or pharmacist to answer any questions you mayhave.

If you get any side effects, do not stop using Intal CFC-Freewithout first talking to your doctor or pharmacist.

Tell your doctor or pharmacist if you notice any of the followingand they worry you:

  • sore throat
  • cough
  • difficulty breathing

These side effects are usually mild.

Rare side effects may include:

  • swelling with fluid in tissues
  • headache
  • stomach pain
  • diarrhoea
  • painful joints
  • sore muscles
  • skin rashes

Other side effects not listed above may occur in some patients.

Tell your doctor or pharmacist if you notice anything else thatis making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Storage

Keep your inhaler in a cool dry place where the temperaturestays below 30 degrees C.

Do not leave Intal CFC-Free in the car on hot days or on windowsills. Heat, light and dampness can destroy some medicines.

Do not store Intal CFC-Free or any other medicine in the bathroomor near a sink or stove.

Keep Intal CFC-Free where young children cannot reach it. A locked cupboard at leastone-and-a-half metres above groundis a good place to store medicines.

Disposal

If your doctor or pharmacist tells you to stop using Intal CFC-Freeor it has passed its expiry date, ask your pharmacist what to do withany that are left over. Do not puncture the container or throw itinto a fire.

Intal CFC-Free description

What Intal CFC-Free looks like

Intal CFC-Free Inhaler is supplied in a canister containing200 doses.

Ingredients

Each Intal CFC-Free dose contains 1mg sodium cromoglycate asthe active ingredient.

Each Intal CFC-Free Inhaler also contains povidone, macrogol600 and 1,1,1,2,3,3,3-heptafluoropropane.

Intal CFC-Free does not contain any chlorofluorocarbons (CFCs).

After using IntalCFC-Free

Cleaning instructions

This pack contains an extra mouthpiece that can be used whilethe other mouthpiece is being dried after washing.

Intal CFC-Free does not contain CFC, which harms the environment,and contributes to the depletion of the ozone layer. A new propellantis used which is more environmentally friendly and is in keeping withour responsibility to support the phasing out of all CFC-containingproducts in Australia. Unfortunately, this new propellant tends toresult in more blockage in the mouthpiece, which can only be preventedby daily cleaning and drying of the mouthpiece.

It is therefore, very important to keep Intal CFC-Free inhalerclean and dry to prevent build up of excess powder in the mouthpiece.

YOUR MOUTHPIECE MUST BE REGULARLY CLEANED AND DRIED.

FOR BEST RESULTS WASH MOUTHPIECE EVERY NIGHT TO PREVENT BUILDUP OF EXCESS POWDER WHICH CAN CAUSE BLOCKAGE.

Follow Instructions Below

  1. Remove blue cap and metalcanister with white rubber cap from mouthpiece before washing.
  2. Wash the white plasticmouthpiece in hand-hot water through the top for a minute.
  3. Wash through the bottomfor a minute.
  4. Shake out the excess waterfrom inside by tapping the mouthpiece on a hard surface.
  5. Leave overnight to drythoroughly.
  6. Before replacing the canisterinto the mouthpiece make sure that the white rubber cap firmly sitsonto the metal canister.
  7. When the mouthpiece iscompletely dry replace the metal canister.

IMPORTANT:

Never try to unblock the mouthpiece with a pin – this will damagethe inhaler. Never wash the metal canister.

If the inhaler is blocked you may wish to take the added stepof soaking the mouthpiece in hot water for 20 minutes after removingthe canister, then following steps 2-7 above.

For further instructions please call 1800 818 806

Intal CFC-Free is made in the UK and distributed in Australiaby:
sanofi aventis Australia pty ltd
12-24 TalaveraRoad
Macquarie Park, NSW 2113
Freecall No: 1800 818 806

This leaflet was approved June 2008

Australian Registration Number: AUST R 93909

Published by MIMS March 2009