PULMICORT NEBULISATION SUSPENSION 1MG

Active substance: BUDESONIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000D

PULMICORT NEBULISATION SUSPENSION 1mg
(Budesonide)
Patient Information Leaflet

In this leaflet:
1. What Pulmicort Nebulisation suspension 1mg is and what it is used for
2. Before you use Pulmicort Nebulisation suspension 1mg
3. How to use Pulmicort Nebulisation suspension 1mg
4. Possible side effects
5. How to store Pulmicort Nebulisation suspension 1mg
6. Further information
1. What Pulmicort Nebulisation suspension 1mg is and what it is used for
Pulmicort Nebulisation suspension 1mg contains a medicine called budesonide. This belongs to a group
of medicines called ‘corticosteroids’. It works by reducing and preventing swelling and inflammation in
your lungs.
• Pulmicort Nebulisation suspension 1mg is used to treat asthma. They are also used to treat
croup in infants and children.
• A nebule is a small plastic container that contains a liquid. The liquid is put into a machine
called a nebuliser. This machine turns the medicine into a fine mist which you breathe in
through a face mask or mouthpiece.

Take special care with Pulmicort Nebulisation suspension 1mg
Before you use Pulmicort Nebulisation suspension 1mg, tell your doctor or pharmacist if:
• You have a lung infection.
• You have a cold or chest infection.
• You have liver problems.

WARNING!

Driving and using machines
Pulmicort Nebulisation suspension 1mg is not likely to affect you being able to drive or use any tools or
machines.

DATE:

Q.A.
APPROVED:

Pregnancy and breast-feeding
• If you are pregnant, or planning to get pregnant, talk to your doctor before using Pulmicort
Nebulisation suspension 1mg - do not use Pulmicort Nebulisation suspension 1mg unless
your doctor tells you to.
• If you get pregnant while using Pulmicort Nebulisation suspension 1mg, do not stop using
Pulmicort Nebulisation suspension 1mg but talk to your doctor immediately.
• If you are breast-feeding, talk to your doctor before using Pulmicort Nebulisation suspension
1mg.

08/05/13
TVT CHECKED
6464/0449D
CODE:

DT

DATE OF PROOF:

Pulmicort neb suspension 1mg

ARTWORKER:



PRODUCT:

05-0269
CUSTOMER: Waymade

PRE-PRESS NO.:



3. How to use Pulmicort Nebulisation suspension 1mg
Always use Pulmicort Nebulisation suspension 1mg exactly as your doctor, nurse or pharmacist
has told you. Ask one of them for advice if you are not sure.
The solution in a Nebule must be put into a nebuliser and made into a fine mist before it can be
breathed in. It is then inhaled through a face mask or mouthpiece. Instructions for using your
nebuliser are given after the section ‘How much to take’.

Note: Do not use an ultrasonic nebuliser with Pulmicort Nebulisation suspension 1mg.


Your asthma may improve within 2 days. However, it can take up to 4 weeks for the medicine to
have its full effect. It is important to use Pulmicort Nebulisation suspension 1mg every day,
even if you have no asthma symptoms at the time.

How much to take
Asthma
Your doctor will tell you how much to take. This will depend on how severe your asthma is.
Your doctor may lower your dose as your asthma improves.
• The usual starting dose in adults and children over 12 years is 1 mg to 2 mg (milligrams), twice a
day.
• Children under 12 years are usually prescribed lower doses (0.5 mg to 1 mg, twice a day).
Croup
The usual dose for infants and children is 2 mg a day. This may be given all in one go, or 1 mg may be
given followed by another 1 mg 30 minutes later.
Instructions for using Pulmicort Nebulisation suspension 1mg
1. Break off a Nebule from the strip. Leave the rest in the foil envelope.
2. Shake the Nebule gently.
3. Hold upright. Twist off the top of the Nebule to open.
4. Place the open end of the Nebule firmly inside the nebuliser cup. Squeeze slowly to put the liquid in
the cup.
5. Throw the empty Nebule away. Put the top back on the nebuliser cup.
6. Connect one end of the cup to the face mask or mouthpiece.
7. Connect the other end of the cup to the air pump.
8. Gently shake the cup.
9. Turn on the nebuliser and breathe in the mist calmly and deeply using the face mask or mouthpiece. If
you are using a face mask, make sure the face mask fits tightly.
10. You will know when your treatment is complete because the fine mist will stop coming out of your
mask or mouthpiece.
11. How long it takes to nebulise all the medicine depends on the type of equipment you use. It will also
depend on the amount of medicine to be used.
12. Rinse your mouth with water. Spit out the water. Do not swallow it. If you have used a face mask,
wash your face as well.
13. After each use, you must wash the nebuliser cup and mouthpiece (or face mask) in warm soapy water
and rinse well. After washing, dry these parts by connecting to the air outlet or the compressor and
blow air through them.

Colour
Swatch

Black

WARNING!

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Steroid medicines.
• Medicines to treat fungal infections (such as itraconazole and ketoconazole).
• HIV protease inhibitors (such as ritonavir and nelfinavir).

DATE:

CUSTOMER
APPROVED:

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This
includes medicines that you buy without a prescription and herbal medicines. This is because Pulmicort
Nebulisation suspension 1mg can affect the way some medicines work and some medicines can have an
effect on Pulmicort Nebulisation suspension 1mg.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Read all of this leaflet carefully before you start taking 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 get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

2. Before you use Pulmicort Nebulisation suspension 1mg
Do not use Pulmicort Nebulisation suspension 1mg if:
• You are allergic (hypersensitive) to budesonide or any of the other ingredients of Pulmicort
Nebulisation suspension 1mg (listed in Section 6: Further information).

PROOF HISTORY:
v.1 - waymade - 08/05/13

Notes:

Leaflet Flat Size = 148 x
01/13

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Important information about your asthma symptoms
If you feel you are getting breathless or wheezy while using Pulmicort Nebulisation suspension 1mg, you
should continue to use Pulmicort Nebulisation suspension 1mg but go to see your doctor as soon as
possible, as you may need additional treatment.
Contact your doctor immediately if:
• Your breathing is getting worse or you often wake up at night with asthma.
• Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.
These signs could mean that your condition is not being properly controlled and you may need different or
additional treatment immediately.
If you use more Pulmicort Nebulisation suspension 1mg than you should
It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor.
You should not increase or decrease your dose without seeking medical advice. If you use more Pulmicort
Nebulisation suspension 1mg than you should, contact your doctor or pharmacist for advice.

4. Possible side effects
Like all medicines, Pulmicort Nebulisation suspension 1mg can cause side effects, although not
everybody gets them.
If either of the following happen to you, stop using Pulmicort Nebulisation suspension 1mg and
talk to your doctor immediately:
• Swelling of your face, particularly around your mouth (with possible swelling of the lips, tongue,
eyes and ears), rash, itching, contact dermatitis (a skin problem), hives and bronchospasm
(tightening of the muscles in the airways which causes wheezing). This may mean that you are
having an allergic reaction. This happens rarely, affecting less than 1 in 1,000 people.
• Sudden wheezing after inhaling your medicine. This happens very rarely, affecting less than
1 in 10,000 people.
Other possible side effects:
Common (affects less than 1 in 10 people)
• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth out with water
after using Pulmicort Nebulisation suspension 1mg.
• Mild sore throat, coughing and a hoarse voice.

WARNING!

Rare (affects less than 1 in 1,000 people)
• Rash on the face after using the face mask. You can stop this from happening by washing your
face after using the face mask.
• Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable.
These effects are more likely to occur in children.
• Bruising of the skin.
• Loss of voice.
• Hoarse voice (in children).

If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.


DATE:
08/05/13




TVT CHECKED



6. Further information
Your medicine is called Pulmicort Nebulisation suspension 1mg. Each 2ml dose unit of suspension
contains 1mg of the active ingredient budesonide in a white/off white suspension for nebulising in a plastic
nebule.
Pulmicort Nebulisation suspension 1mg contains the following inactive ingredients:
disodium edetate, sodium chloride, polysorbate 80, citric acid, sodium citrate and purified water.
Pulmicort Nebulisation suspension 1mg contains a foil envelope of 5 individual doses.
These are packed in cartons of 5 or 20 doses.
POM

6464/0449D

DATE OF PROOF:



PL No: 6464/0449 1mg nebulisation suspension

This product is manufactured by AstraZeneca AB, Sodertalje, Sweden, or, Biofabri, S.L., A Relva,
s/n - O Porrino (Pontevedra), Spain, and is procured within the EU and repackaged by the Product
Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 08.05.2013

CODE:

PRODUCT:

Pulmicort neb suspension 1mg

ARTWORKER:

DT

Q.A.
APPROVED:
CUSTOMER: Waymade

PRE-PRESS NO.:

05-0269



5. How to store Pulmicort Nebulisation suspension 1mg
Pulmicort Nebulisation suspension 1mg should be stored upright. Do not store above 30°C.
Keep in its original foil packaging to protect from light.
Once you have opened a single nebule, it should be used within 12 hours. After this time the
nebule and any remaining contents should be thrown away.
Once a foil envelope has been opened, the nebules inside should be used within 3 months.
(It is best to mark the opening date on the envelope to help you remember).
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop using the nebulising suspension, please take it back to the
pharmacist for safe disposal. Only keep the nebulising suspension if your doctor tells you to.
If the nebulising suspension shows visible signs of deterioration, you should consult your
pharmacist who will advise you what to do.

Pulmicort® is a registered trademark of ASTRAZENECA AB

Colour
Swatch

Black

WARNING!

DATE:

Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if
you use high doses for a long time. The effects include:
• changes in bone mineral density (thinning of the bones).
• cataract (clouding of the lens in the eye).
• glaucoma (increased pressure in the eye).
• a slowing of the rate of growth of children and adolescents (rare).
• an effect on the adrenal gland (a small gland next to the kidney) (rare).
These effects are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.1 - waymade - 08/05/13

Leaflet Flat Size = 148 x
01/13

If you forget to use Pulmicort Nebulisation suspension 1mg
If you forget to take a dose, skip the missed dose and take the next dose as usual.

Expand view ⇕

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.

Hide
(web3)