Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Symbicort Rapihaler?
Symbicort Rapihaler contains two active ingredients in one inhaler: budesonide and
formoterol fumarate dihydrate. Symbicort Rapihaler is used for treatment of asthma
in adults and adolescents (12 years and over) or Chronic Obstructive Pulmonary Disease
(COPD) in adults (18 years and over).
2. What should I know before I use Symbicort Rapihaler?
Do not use if you have ever had an allergic reaction to any medicine containing budesonide
or formoterol, or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
4. How do I use Symbicort Rapihaler?
Symbicort Rapihaler should be inhaled into your lungs through the mouth.
Follow all directions given to you by your doctor or pharmacist.
5. What should I know while using Symbicort Rapihaler?
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Things you should do
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If you have an Asthma Action Plan agreed with your doctor, follow it closely at all
times.
Have your reliever medicine available at all times. As advised by your doctor, this
may be your Symbicort Rapihaler (50/3 or 100/3) or another reliever medicine.
Rinse your mouth out with water after taking your daily morning and/or evening dose
of Symbicort Rapihaler and spit this out.
Remind any doctor, dentist or pharmacist you visit that you are using Symbicort Rapihaler.
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Things you should not do
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Do not stop using this medicine suddenly without checking with your doctor
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Driving or using machines
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Symbicort Rapihaler may cause dizziness, light-headedness, tiredness or drowsiness
in some people when they first start using it.
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Looking after your medicine
|
Keep your Symbicort Rapihaler in a cool dry place where the temperature stays below
30oC, with the cover firmly in place.
Dispose your Symbicort Rapihaler 3 months after removal from the foil pouch.
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6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. These include sore, yellowish, raised patches in the
mouth (thrush), hoarse voice, unpleasant taste in your mouth, pounding heart, headache,
trembling or muscle cramps. However, some side effects may need medical attention.
These include severe allergic reactions such as difficulty breathing, swelling of
the face, lips or tongue, severe rash or pneumonia (lung infection), signs include
fever or chills, increased phlegm or a change in colour, increased cough or difficulties
breathing. Serious side effects are rare.
Active ingredient(s):
budesonide / formoterol fumarate dihydrate
Consumer Medicine Information (CMI)
This leaflet provides important information about using Symbicort Rapihaler. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Symbicort Rapihaler.
Where to find information in this leaflet:
1. Why am I using Symbicort Rapihaler?
Symbicort Rapihaler is a pressurised metered dose inhaler (pMDI) or puffer. It contains
two active ingredients in one inhaler: budesonide and formoterol fumarate dihydrate.
Budesonide belongs to a group of medicines called corticosteroids. Budesonide acts
directly on your airways to reduce inflammation.
Formoterol belongs to a group of medicines called beta-2-agonists. Formoterol opens
up the airways to help you breathe more easily.
The medicine inside Symbicort Rapihaler is inhaled into the lungs for the treatment
of asthma in adults and adolescents (12 years and over) or Chronic Obstructive Pulmonary
Disease (COPD) in adults (18 years and over).
Asthma
Asthma is a disease where the airways of the lungs become narrow and inflamed (swollen),
making it difficult to breathe. This may for example be due to exercise, or exposure
to allergens (e.g. an allergy to house dust mites, smoke or air pollution), or other
things that irritate your lungs.
The budesonide in Symbicort Rapihaler helps to improve your condition and to prevent
asthma attacks from occurring.
The formoterol in Symbicort Rapihaler helps you breathe more easily.
Some people can take Symbicort Rapihaler when they need it – they use Symbicort Rapihaler
as an anti-inflammatory reliever to treat their symptoms when their asthma gets worse
and to help prevent asthma attacks, or to help prevent symptoms from happening (eg
before exercise or exposure to other triggers such as allergens).
Some people need to take Symbicort Rapihaler every day – they use their Symbicort
Rapihaler as a daily maintenance preventer to help maintain control of their asthma
symptoms and help prevent asthma attacks.
Chronic Obstructive Pulmonary Disease (COPD)
COPD (which includes chronic bronchitis and emphysema) is a long-term lung disease.
There is often permanent narrowing and persistent inflammation of the airways. Symptoms
may include difficulty in breathing (breathlessness or wheezing), coughing and increased
sputum (phlegm).
Symbicort Rapihaler when used as prescribed will help to control your COPD symptoms
(ie breathing difficulties).
2. What should I know before I use Symbicort Rapihaler
Warnings
Do not use Symbicort Rapihaler if:
you are allergic to any medicine containing budesonide or formoterol, or any of the
ingredients listed at the end of this leaflet. Always check the ingredients to make
sure you can use this medicine.
Check with your doctor if you:
have any allergies to any other medicines or foods.
have, or have had, any of the following medical conditions, as it may not be safe
for you to take Symbicort Rapihaler:
thyroid problems
diabetes
heart problems
liver problems
tuberculosis (TB)
low levels of potassium in the blood.
currently have an infection. If you take Symbicort Rapihaler while you have an infection,
the medicine may hide some of the signs of an infection. This may make you think,
mistakenly, that you are better or that it is not serious.
have any other medical conditions.
have any questions about how you should be using your Symbicort Rapihaler.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor will discuss the possible risks and benefits of using Symbicort Rapihaler
during pregnancy and while breastfeeding.
Children
Do not give Symbicort Rapihaler to a child under 12 years, unless directed to by the
child’s doctor.
Symbicort Rapihaler is not recommended for use in children under 12 years.
Asthma Action Plan
If you have asthma, ask your doctor or pharmacist if you have any questions about
your Asthma Action Plan.
Your healthcare professional should give you a personal Asthma Action Plan to help
manage your asthma. This plan will include what medicines to take as a reliever when
you have symptoms or sudden attacks of asthma, medicines you can take to prevent symptoms
from occurring (eg prior to exercise or allergen exposure) and if you need to take
daily maintenance medicines to help control your asthma. It will also provide advice
on when to seek urgent medical attention such as when your asthma suddenly worsens
or worsens over a period of time.
It is important that you discuss with your doctor both your exposure to triggers and
how often your exercise, as these could impact how your doctor prescribes your Symbicort
Rapihaler.
3. What if I am taking other medicines?
Some medicines may interfere with Symbicort Rapihaler and affect how it works. These
include:
medicines used to treat heart problems or high blood pressure such as beta-blockers,
diuretics and antiarrhythmics (disopyramide, procainamide and quinidine)
medicines used to treat glaucoma such as beta-blockers
medicines used to treat depression or other mood/mental disorders such as tricyclic
antidepressants, monoamine oxidase inhibitors and phenothiazines
medicines used to treat hayfever, coughs, colds and runny nose such as antihistamines
medicines used to treat fungal infections (eg ketoconazole)
xanthine derivatives (eg theophylline) which are a class of medicines used to treat
asthma and COPD
medicines used to treat Addison’s disease (when there is inadequate production of
a natural steroid hormone by the adrenal gland) or another condition where there is
too much salt lose in the urine (eg fludrocortisone)
These medicines may be affected by Symbicort Rapihaler or may affect how well it works.
You may need different amounts of your medicine, or you may need to use different
medicines. Your doctor or pharmacist will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Symbicort Rapihaler.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while using Symbicort Rapihaler.
4. How do I use Symbicort Rapihaler?
How to use your Symbicort Rapihaler
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
Each pack of Symbicort Rapihaler contains an instruction for use leaflet that tells
you the correct way to use it. Please read this carefully.
If you are not sure how to use the Symbicort Rapihaler, ask your doctor or pharmacist
to show you how.
How much to take
Asthma (Adults and children 12 years and over)
Your healthcare professional should give you a personal Asthma Action Plan to help
manage your asthma. This plan will include what medicines to take as a reliever when
you have symptoms or sudden attacks of asthma, medicines you take prevent symptoms
from occurring (eg prior to exercise or allergen exposure) and if you need to take
daily maintenance medicines to help control your asthma.
It is important that you discuss with your doctor both your exposure to triggers and
how often you exercise, as these could impact how your doctor prescribes your Symbicort
Rapihaler.
Your doctor may have prescribed Symbicort Rapihaler for you to use as:
a. an anti-inflammatory reliever medicine only,
b. both an anti-inflammatory reliever and daily maintenance preventer medicine or,
c. as a daily maintenance preventer only, where another medicine is use as a reliever.
If your asthma has been under control for some time, your doctor may tell you to take
less inhalations of Symbicort Rapihaler, prescribe you a lower strength of Symbicort
Rapihaler or recommended that you use Symbicort Rapihaler in a different way.
If you are using more inhalations of your reliever medicine or you are wheezing or
breathless more than usual tell your doctor as your asthma may be getting worse.
Ask your doctor if you have any questions about how you should be using your Symbicort
Rapihaler.
Anti-inflammatory reliever only (Symbicort Rapihaler 100/3)
For patients aged 12 years and over, Symbicort Rapihaler 100/3 can be used to treat
asthma symptoms when they happen and to help stop asthma symptoms from happening (eg
just before exercise or before you get exposed to other triggers).
If you get asthma symptoms, take 2 inhalations and wait a few minutes. If you do not
feel better, take 2 more inhalations.
Your doctor will tell you how many inhalations to take before exercising or exposure
to other triggers to help stop symptoms from happening.
Do not use more than 12 inhalations on a single occasion or more than 24 inhalations
in any day. If your symptoms continue to worsen over 3 days, despite using additional
inhalations, tell your doctor.
Have your Symbicort Rapihaler reliever with you at all times.
Anti-inflammatory reliever plus maintenance therapy (Symbicort Rapihaler 50/3 and
100/3)
For patients aged 12 years and over, Symbicort Rapihaler 50/3 and 100/3 can be used
to treat asthma symptoms when they happen. Symbicort Rapihaler 100/3 can also be used
to help stop asthma symptoms from happening (eg just before exercise or before you
get exposed to other triggers).
If you get asthma symptoms, take 2 inhalations of Symbicort Rapihaler 50/3 or 100/3
and wait a few minutes. If you do not feel better, take 2 more inhalations.
Your doctor will tell you how many inhalations of Symbicort Rapihaler 100/3 to take
before exercising or exposure to other triggers to help stop symptoms from happening.
Have your Symbicort Rapihaler 50/3 or 100/3 reliever with you at all times.
You also need to take your Symbicort Rapihaler (50/3 or 100/3) daily as your maintenance
preventer. The usual maintenance dose is 4 inhalations per day (given either as 2
inhalations in the morning and evening or as 4 inhalations in either the morning or
evening). Your doctor may prescribe a maintenance dose of Symbicort Rapihaler 100/3,
4 inhalations twice a day.
Do not use more than 12 inhalations on a single occasion or more than 24 inhalations
of Symbicort Rapihaler (as needed and daily dose) in any day. If your symptoms continue
to worsen over 3 days, despite using additional inhalations, tell your doctor.
NOTE: Symbicort Rapihaler 200/6 is not recommended to be used as anti-inflammatory
reliever medicine.
Daily fixed dose maintenance therapy (Symbicort Rapihaler 50/3, 100/3 and 200/6)
For patients aged 12 years and over, Symbicort Rapihaler 50/3, 100/3 and 200/6 can
be used as a daily fixed-dose maintenance preventer.
The usual dose of Symbicort Rapihaler 50/3 and 100/3 is 2 or 4 inhalations twice a
day. Do not take more than 8 inhalations a day.
The usual dose of Symbicort Rapihaler 200/6 is 2 inhalations twice a day. Do not take
more than 4 inhalations a day.
Symbicort Rapihaler 200/6 can also be given as a higher dose in patients aged 18 years
and over. The usual dose is 4 inhalations twice a day. Do not take more than 8 inhalations
per day.
Have your separate reliever with you at all times.
COPD (Adults)
The usual dose (also maximum recommended dose) is 2 inhalations of Symbicort Rapihaler
200/6 twice a day.
Your doctor should tell you the best way to manage your symptoms and any flare ups.
This may include additional medicines (such as reliever medicines) to use when you
have sudden attacks of breathlessness.
If you are using more inhalations of your reliever medicine or you are wheezing or
breathless more than usual tell your doctor.
If your COPD gets worse, your doctor may give you some additional medicines (such
as oral corticosteroids or antibiotics).
How long to use your Symbicort Rapihaler
If your doctor has told you to take Symbicort Rapihaler daily, it is important that
you use it every day even if you feel well.
Symbicort Rapihaler helps control your asthma or COPD but does not cure it.
Keep using it for as long as your doctor tells you to. Do not stop using it unless
your doctor tells you to.
If you forget to use Symbicort Rapihaler
If you miss a dose of Symbicort Rapihaler, take your dose as soon as you remember.
Do not use a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are using Symbicort Rapihaler as a reliever medicine, consult your doctor on
the correct use of the product.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to use your medicine, ask your pharmacist for some
hints.
If you use too much Symbicort Rapihaler
If you think that you have used too much Symbicort Rapihaler, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you use too much Symbicort Rapihaler, you may feel sick or vomit, have a fast or
irregular heartbeat, a headache, tremble, feel shaky, agitated, anxious, tense, restless,
excited or be unable to sleep.
5. What should I know while using Symbicort Rapihaler?
Things you should do
If you have an Asthma Action Plan that you have agreed with your doctor, follow it
closely at all times.
Keep using Symbicort Rapihaler for as long as your doctor tells you to, even if you
are feeling well.
See your doctor regularly to make sure that your asthma or COPD is not getting worse.
Have your reliever medicine available at all times. As advised by your doctor, this may be your Symbicort Rapihaler (50/3 or 100/3) or
another reliever medicine.
If you become pregnant while using Symbicort Rapihaler, tell your doctor.
Rinse your mouth out with water after taking your daily morning and/or evening dose
of Symbicort Rapihaler and spit this out. If you don’t rinse your mouth, you are more likely to develop thrush in your mouth.
You do not have to rinse mouth if you have to take occasional doses of Symbicort Rapihaler
for relief of asthma symptoms (ie as an anti-inflammatory reliever).
Tell your doctor if you notice any of the following symptoms:
weight gain
roundness of face
acne
a tendency to bruise easily
Call your doctor straight away if you:
are taking Symbicort Rapihaler for COPD and you notice any signs of pneumonia (infection
of the lung). Signs include fever or chills, increased phlegm/sputum production or
change in colour, increased cough or increased breathing difficulties. Pneumonia is
a serious medical condition and will require urgent medical attention.
Remind any doctor, dentist or pharmacist you visit that you are using Symbicort Rapihaler.
Things you should not do
Do not stop using this medicine suddenly without checking with your doctor.
Do not take any other medicines for your asthma or COPD without checking with your
doctor.
Do not give Symbicort Rapihaler to anyone else, even if they have the same condition
as you.
Do not use Symbicort Rapihaler to treat any other complaints unless your doctor tells
you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Symbicort
Rapihaler affects you.
Symbicort Rapihaler may cause dizziness, light-headedness, tiredness or drowsiness
in some people when they first start using it.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Storage
Keep your Symbicort Rapihaler in a cool dry place where the temperature stays below
30°C.
Always replace the mouthpiece cover after using Symbicort Rapihaler.
Discard Symbicort Rapihaler within 3 months after removal from the foil pouch.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
WARNING
The canister in Symbicort Rapihaler contains a pressurised liquid. Do not expose to
temperatures higher than 50°C. Do not pierce the canister. The canister should not
be broken, punctured or burnt, even when it seems empty.
Cleaning
The Symbicort Rapihaler mouthpiece must be wiped with a clean dry cloth/tissue and
must never get wet.
Full instructions on the right way to use and clean Symbicort Rapihaler are inside
each pack.
Getting rid of any unwanted medicine
Since some medicine may remain inside your Symbicort Rapihaler you should always return
it to your pharmacist for disposal including:
when you have taken all your doses and the dose counter is on zero (‘0’ – see instructions
in the pack), or
3 months after removal from the foil pouch, or
it is damaged or past its expiry date, or
your doctor/pharmacist has told you to stop using it.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are using Symbicort Rapihaler.
If you get any side effects, do not stop using Symbicort Rapihaler without first talking
to your doctor or pharmacist.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
|
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Mouth/throat-related:
sore, yellowish, raised patches in the mouth (thrush)
hoarse voice
irritation of the tongue and mouth
coughing
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These are less likely to happen if you rinse your mouth out after every time you use
your usual morning and/or evening dose of Symbicort Rapihaler.
Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Heart-related:
fast or irregular heart rate or pounding heart
chest pain
Nervous system-related:
feeling anxious, nervous, restless or upset
headache
trembling or shakiness
feeling light-headed or dizzy
thirsty
unpleasant taste in your mouth
tiredness
Gut-related:
nausea (feeling sick)
diarrhoea
Skin-related:
skin rash
skin bruising
Others:
difficulty sleeping
muscle twitching or cramps
weight gain
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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mood changes
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Speak to your doctor if you notice any of these.
You may need urgent medical attention.
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Serious side effects
Other side effects
Growth
Corticosteroids taken into the lungs for long periods (eg 12 months) may affect how
children/adolescents grow. In rare cases, some children/adolescents may be sensitive
to the growth effects of corticosteroids, so the doctor may monitor a child's/adolescent's
height.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Some of these side effects (for example, changes in blood sugars) can only be found
when your doctor does test from time to time to check your progress.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems.
By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Symbicort Rapihaler contains
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Active ingredients
(main ingredient)
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budesonide
formoterol fumarate dihydrate
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Other ingredients
(inactive ingredients)
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apaflurane (HFA-227)
macrogol 1000
povidone
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Do not take this medicine if you are allergic to any of these ingredients.
Symbicort Rapihaler does not contain lactose, sucrose, gluten, tartrazine or any other
azo dyes.
What Symbicort Rapihaler looks like
Symbicort Rapihaler is a pressurised metered dose inhaler with a dose counter. The
inhaler is comprised of a pressurised aluminum canister with an attached dose counter,
a red plastic casing body with a white mouthpiece and attached grey mouthpiece cover.
Each inhaler is individually wrapped in a foil laminate pouch (containing a sachet
of drying agent).
Symbicort Rapihaler is available in the following presentations*:
50/3: Each pack contains 1 inhaler of 120 inhalations of the medicine. [AUST R 158898]
100/3: Each pack contains 1 inhaler of 120 inhalations of the medicine. [AUST R 158899]
200/6: Each pack contains 1 inhaler of 60 (sample) or 120 inhalations of the medicine.
[AUST R 115555]
*not all presentations might be available in Australia
Who distributes Symbicort Rapihaler
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342
This leaflet was prepared on September 2024.
® Symbicort Rapihaler is a registered trade mark of the AstraZeneca group of companies.
© AstraZeneca 2024
VV-RIM-01328007 v12