<!DOCTYPE DOCUMENT SYSTEM "icon.dtd" []>

<DOCUMENT author="perl program" datec=020199 title="leaflet" book="ABPI" edition="1996-97" section="company">
<DIV type=0>

<HEAD weight="bold"  justified="center" >
WHAT YOU SHOULD KNOW ABOUT 
</HEAD>


<FIGURE></FIGURE>


<BLOCK>

<EMPH weight="bold">
THIS LEAFLET APPLIES ONLY TO PULMICORT RESPULES 0.5 MG.
</EMPH>

</BLOCK>


<BLOCK>
If you have any questions or are unsure about anything, ask your doctor or pharmacist (chemist).  Remember Pulmicort Respules are only for your use.  Only a doctor can prescribe them.  Never give them to anyone else even if their symptoms are similar to yours.
</BLOCK>

<DIV type=1>

<HEAD weight="bold" >
WHAT IS IN YOUR MEDICINE ?
</HEAD>


<BLOCK>
Pulmicort Respules 0.5 mg contain budesonide – there is 0.5 mg of budesonide in each Respule.  They also contain disodium edetate, sodium chloride, polysorbate 80, citric acid, sodium citrate and purified water.  Each Respule contains 2 ml of a suspension to be nebulised (made into a fine mist for inhalation). 
</BLOCK>


<BLOCK>
The Respules are packed in strips of 5 inside a foil envelope; each carton contains 20 Respules.
</BLOCK>


<BLOCK>
Budesonide belongs to a group of medicines called steroids, which are used to reduce inflammation.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
WHO HAS MADE YOUR MEDICINE ?
</HEAD>


<BLOCK>
Pulmicort Respules 0.5 mg are made by Astra Pharmaceuticals Pty Ltd. , North Ryde, Australia for Astra Pharmaceuticals (UK) Limited, Kings Langley, Hertfordshire, England, WD4 8DH, the marketing authorisation holder.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
WHAT ARE PULMICORT RESPULES USED FOR ?
</EMPH>

</BLOCK>


<BLOCK>
This medicine is used to treat asthma. It is also used for infants and children with croup.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
BEFORE TAKING YOUR MEDICINE !
</HEAD>


<BLOCK>
Make sure you have told your doctor about any other medicines that you are taking including those you have bought without prescription .
</BLOCK>


<BLOCK>
Please read the following questions carefully. They have been asked to check the medicine is suitable for you to take.  If the answer to any of these questions is 
<EMPH weight="bold">
YES
</EMPH>
 you should talk to your doctor 
<EMPH weight="bold">
BEFORE
</EMPH>
 taking this medicine
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Have you ever had an allergic reaction to budesonide (Pulmicort) or any of the  other ingredients (listed earlier) ?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Have you ever had tuberculosis (TB) ?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Have you got a chest infection ?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
If you are pregnant or breast feeding, your doctor will advise on whether you should take Pulmicort Respules. If you become pregnant whilst using Pulmicort Respules, contact your doctor for advice.
</BLOCK>

</ITEM>

</LIST>



</DIV>
<DIV type=1>

<HEAD weight="bold" >
TAKING YOUR MEDICINE
</HEAD>


<BLOCK>
If you have been taking steroid tablets for your asthma, your doctor may reduce the number of tablets that you take once you start to use Pulmicort Respules.  You might t experience some symptoms as a result of this, in particular: stuffy nose, joint or muscle pain and rush (eczema), if so tell your doctor.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
DOSAGE FOR ASTHMA
</EMPH>
 Usually, the adult and children (12 years and older) starting dose is 1 to 2 mg twice a day, although more may be needed. Young children (under 12 years old) are usually prescribed lower doses (0.5 mg  - 1 mg twice a day).  Your doctor will advise you of the correct dose. This will depend on the severity of your asthma.  As your asthma improves your doctor may lower your dose.
</BLOCK>


<BLOCK>
You may find that your asthma improves after you first take Pulmicort Respules, but it can take up to a few weeks to achieve the full effect.  You must keep taking it regularly - even when you feel well.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
DOSAGE FOR CROUP
</HEAD>


<BLOCK>
The usual dose in infants and children with croup is 2 mg.  This may be given all in one go or half may be given then the second half 30 minutes later.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
WHAT HAPPENS IF YOU USE TOO MUCH?
</HEAD>


<BLOCK>
If you take too much talk to your doctor or pharmacist.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
FORGOTTEN TO TAKE A DOSE?
</HEAD>


<BLOCK>
If you forget to take an occasional dose don’t worry, it is not necessary to compensate for the dose you have missed just take the next one at your usual time.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
INSTRUCTIONS FOR USE
</HEAD>


<BLOCK>
The content of your Pulmicort Respules must be used with a nebuliser. The mist produced is then inhaled through the mouthpiece or a face mask.
</BLOCK>


<BLOCK>
To take your medicine follow these steps:
</BLOCK>


<LIST type="ordered">

<ITEM>

<BLOCK>
Break off the Respule from the strip leaving the rest in the foil envelope.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Shake the Respule gently.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Open the Respule by twisting the wing tab off.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Place the open end of the Respule firmly inside the nebuliser cup and squeeze slowly.  Replace the top of the nebuliser cup.  Throw the empty Respule away.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Connect one end of the cup to the mask or mouthpiece and the other end to the air pump.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Gently shake the cup once more then start to nebulise.  During nebulising breathe in the mist of the nebulised medicine calmly and deeply.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
The length of nebulisation time will vary with the type of medicine or nebuliser you use, but when no more mist comes out of the mouthpiece, treatment is completed.
</BLOCK>

</ITEM>

</LIST>




<LIST type="ordered">

<ITEM>

<BLOCK>
You should rinse your mouth with water when you finish (spit out the water, do not swallow it).  If you have used a face mask, wash your face well.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
You must wash the nebuliser cup and mouthpiece (or face mask) in warm soapy water and rinse well after each use.  Then dry these parts by connecting up to the air outlet or compressor and blow air through them.
</BLOCK>

</ITEM>

</LIST>



<BLOCK>

<EMPH weight="bold">
Note:
</EMPH>
 Ultrasonic nebuliser should not be used with Pulmicort Respules.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
AFTER TAKING YOUR PULMICORT RESPULES Side effects that may occur when taking
</HEAD>


<BLOCK>
Pulmicort Respules are:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Sore mouth (oral thrush). This is less likely if you rinse your mouth out with water after taking Pulmicort Respules.  Occasionally a rash may occur when using the face mask, washing the face can prevent this.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Mild sore throat, coughing and a hoarse voice.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Very occasionally inhaled drugs may cause acute wheezing, if this occurs stop using Pulmicort Respules.
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
immediately and seek medical advice.
</BLOCK>


<BLOCK>
Tell your doctor if you experience any of these or notice anything else unusual.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
STORING YOUR MEDICINE
</HEAD>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Once you have opened a single Respule it should be used within 12 hours.  After this time the Respule and any remaining contents should be thrown away.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do not use your Respules after the expiry date printed on the carton and foil envelope.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Once a foil envelope has been opened, the Respules inside should be used within 3 months (it’s best to mark the opening date on the foil envelope to help you remember).
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Store Pulmicort Respules at room temperature (below 30°C) in its original carton and foil and out of direct sunlight.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Keep in a place where children cannot reach it.
</BLOCK>

</ITEM>

</LIST>


<DIV type=2>

<HEAD>
Date of leaflet revision: September 1995 &copy; Copyright Astra Pharmaceuticals Ltd. 1995
</HEAD>

<DIV type=3>

<HEAD weight="bold"  justified="center" >
WHAT YOU SHOULD KNOW ABOUT 
</HEAD>


<FIGURE></FIGURE>


<BLOCK>

<EMPH weight="bold">
THIS LEAFLET APPLIES ONLY TO PULMICORT RESPULES 1 MG.
</EMPH>

</BLOCK>


<BLOCK>
If you have any questions or are unsure about anything ask your doctor or pharmacist (chemist).
</BLOCK>


<BLOCK>
Remember Pulmicort Respules are only for your use. Only a doctor can prescribe them.
</BLOCK>


<BLOCK>
Never give them to anyone else even if their symptoms are similar to yours.
</BLOCK>


</DIV>

</DIV>

</DIV>
<DIV type=1>

<HEAD weight="bold" >
WHAT IS IN YOUR MEDICINE ?
</HEAD>


<BLOCK>
Pulmicort Respules 1 mg contain budesonide  – there is 1 mg of budesonide in each Respule.  They also contain disodium edetate, sodium chloride, polysorbate 80, citric acid, sodium citrate and purified water.
</BLOCK>


<BLOCK>
Each Respule contains 2 ml of a suspension to be nebulised (made into a fine mist for inhalation).
</BLOCK>


<BLOCK>
The Respules are packed in strips of 5 inside a foil envelope; each carton contains 20 Respules.
</BLOCK>


<BLOCK>
Budesonide belongs to a group of medicines called steroids, which are used to reduce inflammation .
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
WHO HAS MADE YOUR MEDICINE ?
</HEAD>


<BLOCK>
Pulmicort Respules 1 mg are made by Astra Pharmaceuticals Pty Ltd, North Ryde Australia for Astra Pharmaceuticals (UK) Limited, Kings Langley, Hertfordshire, England WD4 8DH, the marketing authorisation holder.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
WHAT ARE PULMICORT RESPULES USED FOR ?
</EMPH>

</BLOCK>


<BLOCK>
This medicine is used to treat asthma.  It is also used for infants and children with croup.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
BEFORE TAKING YOUR MEDICINE !
</HEAD>


<BLOCK>
Make sure you have told your doctor about any other medicines that you are taking including those you have bought without prescription .
</BLOCK>


<BLOCK>
Please read the following questions carefully.  They have been asked to check the medicine is suitable for you to take.  If the answer to any of these questions is 
<EMPH weight="bold">
YES
</EMPH>
 you should talk to your doctor 
<EMPH weight="bold">
BEFORE
</EMPH>
 taking this medicine:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Have you ever had an allergic reaction to budesonide (Pulmicort) or any of the other ingredients (listed earlier) ?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Have you ever had tuberculosis (TB) ?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Have you got a chest infection ?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
If you are pregnant or breast feeding, your doctor will advise on whether you should take Pulmicort Respules.  If you become pregnant whilst using Pulmicort Respules contact your doctor for advice .
</BLOCK>

</ITEM>

</LIST>



</DIV>
<DIV type=1>

<HEAD weight="bold" >
TAKING YOUR MEDICINE
</HEAD>


<BLOCK>
If you have been taking steroid tablets for your asthma, your doctor may reduce the number of tablets that you take once you start to use Pulmicort Respules.  You might experience some symptoms as a result of this, in particular: stuffy nose, joint or muscle pain and rash (eczema), if so tell your doctor.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
DOSAGE FOR ASTHMA
</EMPH>
 Usually, the adult and children ( 12 years and alder) starting dose is 1 to 2 mg twice a day, although more may be needed.  Young children (under 12 years old) are usually prescribed lower doses (0.5 mg – 1 mg twice a day).  Your doctor will advise you of the correct dose.  This will depend on the severity of your asthma.   As your asthma improves your doctor may lower your dose.
</BLOCK>


<BLOCK>
You may find that your asthma improves after you first take Pulmicort Respules, but it can take up to a few weeks to achieve the full effect. You must keep taking it regularly - even when you feel well.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
DOSAGE FOR CROUP
</HEAD>


<BLOCK>
The usual dose in infants and children with croup is 2 mg.  This may be given all in one go, or half may be given then the second half 30 minutes later.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
WHAT HAPPENS IF YOU USE TOO MUCH ?
</HEAD>


<BLOCK>
If you take too much talk to your doctor or pharmacist.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
FORGOTTEN TO TAKE A DOSE ?
</HEAD>


<BLOCK>
If you forget to take an occasional dose don't worry, it is not necessary to compensate for the dose you have missed just take the next one at your usual time.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
INSTRUCTIONS FOR USE
</HEAD>


<BLOCK>
The content of your Pulmicort Respules must be used with a nebuliser.  The mist produce is then inhaled through the mouthpiece or a face mask.
</BLOCK>


<LIST type="ordered">

<ITEM>

<BLOCK>
To take your medicine follow these steps: Break off the Respule from the strip leaving the rest
<EMPH weight="bold">
 
</EMPH>
in the foil envelope.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Shake the Respule gently.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Open the Respule by twisting the wing tab off.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Place the open end of the Respule firmly inside the nebuliser cup and squeeze slowly.  Replace the top of the nebuliser cup.  Throw the empty Respule away.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Connect one end of the cup to the mask or mouthpiece and the other end to the air pump.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Gently shake the cup once more then start to nebulise.  During nebulising breathe in the mist of the nebulised medicine calmly and deeply.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
The length of nebulisation time will vary with the type of medicine or nebuliser you use, but when no more mist comes out of the mouthpiece, treatment is completed.
</BLOCK>

</ITEM>

</LIST>




<LIST type="ordered">

<ITEM>

<BLOCK>
You should rinse your mouth with water when you finish (spit out the water, do not swallow it). If you hove used a face mask, wash your face well.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
You must wash the nebuliser cup and mouthpiece (or face mask) in warm soapy water and rinse well after each use.  Then dry these parts by connecting up to the air outlet or compressor and blow air through them
</BLOCK>

</ITEM>

</LIST>



<BLOCK>

<EMPH weight="bold">
Note:
</EMPH>
 Ultrasonic nebuliser should not be used with Pulmicort Respules.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
AFTER TAKING YOUR PULMICORT RESPULES
</HEAD>


<BLOCK>
Side effects that may occur when taking Pulmicort Respules are:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Sore mouth (oral thrush).  This is less likely if you rinse your mouth out with water after taking Pulmicort Respules.  Occasionally a rash may occur when using the face mask, washing the face can prevent this.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Mild sore throat, coughing and a hoarse voice.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Very occasionally inhaled drugs may cause acute wheezing, if this occurs stop using Pulmicort Respules immediately and seek medical advice.
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
Tell your doctor if you experience any of these or notice anything else unusual.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
STORING YOUR MEDICINE
</HEAD>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Once you have opened a single Respule it should be used within 12 hours.  After this time the Respule and any remaining contents should be thrown away.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do not use your Respules after the expiry date printed on the carton and foil envelope.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Once a foil envelope has been opened, the Respules inside should be used within 3 months (it's best to mark the opening date on the foil envelope to help you remember).
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Store Pulmicort Respules at room temperature (below 30°C) in its original carton and foil, and out of direct sunlight.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Keep in a place where children cannot reach it.
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
Date of leaflet revision: September 1995 &copy; Copyright Astra Pharmaceuticals Ltd. 1995
</BLOCK>

</DIV>

</DIV>

</DOCUMENT>
