Intal Cfc-Free Inhaler 5mg Pressurised Inhalation Suspension
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Patient Information Leaflet Intal® CFC-Free Inhaler 5mg Pressurised inhalation, suspension (sodium cromoglicate)
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.
The name of your medicine is Intal CFC-Free Inhaler 5mg Pressurised inhalation, suspension, but will be referred to as Intal throughout the remainder of the leaflet.
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.
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.
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.
1. Remove
• Remove 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 Intal 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
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Do not put the metal canister into water
Do not remove the rubber cover from the metal canister
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 out of the sight and reach of children.
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.
The inhaler canister is pressurised. Do not pierce or burn the canister even when empty. Do not refrigerate or freeze. Do not store above 30°C. Store in a dry place.
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
Each Intal is a pressurised metered-dose inhaler with an aluminium canister fitted with a metering valve which delivers 112 actuations and has an off white plastic body with red removable cap. The pressurised canister contains a white to off white suspension for inhalation.
Also contains: sodium cromoglicate.
Each inhalation (actuation) 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
Intal inhaler is available in pack of 1 x 112 inhalations.
Manufactured by Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE Gouda, The Netherlands or Sanofi-Aventis, London Road, Holmes Chapel, CW4 8BE, Cheshire, UK.. Procured from within the EU. Product Licence holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by Maxearn Ltd, Bolton BL6 4SA
PL 20774/1371 Intal CFC-Free Inhaler 5mg Pressurised inhalation, suspension
Leaflet date 2nd December 2014
Intal is a registered trademark of Fisons Limited
PP3/1371/V1
POM
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Intal can cause side effects, although not everybody gets them.
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