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Intal Cfc-Free Inhaler 5mg Pressurised Inhalation Suspension

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PACKAGE LEAFLET; INFORMATION FOR THE

USER

Intal®

CFC-Free Inhaler

5mg

Pressurised inhalation

suspension

sodium cromoglicate

sanofi^5

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

I.What Intal is and what it is	•
used for	l

Intal CFC-free Inhaler (called Intal in this leaflet) contains a medicine called sodium cromoglicate. This belongs to a group of medicines called anti-allergies.

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 a I ready 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

I 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.

I Take special care with Intal I Check with your doctor or I pharmacist before using your medicine if;

A You have recently stopped taking ‘steroids’ and your asthma is getting worse (see Taking other medicines below)

A 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.

|@PBTaking other medicines

[jfi] Please tell your doctor or pharmacist if you a re ta ki ng or have recently ta ken 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.

I n pa rticu la r, tell your doctor if you are a Iso using a steroid medicine:

• This can be either an inhaler (such as beclometasone) ora 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 in haler’ 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

• You r doctor may a Iso suggest you take a n 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 thesame timeas Intal, it is best to use your‘reliever’ inhaler before using your Intal Inhaler. This will open the ai ways 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’ in haler to control your symptoms

Howto 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, release4 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.

Turn

Over

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 su re to have you r I i ps 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 ora child use more Intal than you should

If you ora 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 fora minute

• Wash through the bottom fora minute

• Then wash the mouthpiece cover

3. Dry

• Sha ke off a ny water that is left a nd 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 backdown onto the metal canister

• Use the second Intal In haler 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 i nha ler with a pin, as this will damage the inhaler

Do not put the metal canister into water

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.

4. Possible side effects

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

I 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. m h ra .gov.u k/yel lowca rd 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 ch i I d re n ca n not see o r rea ch i t.

Do not use Intal In haler 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 howto 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

HFA227 - 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