Skip to Content

SYMBICORT 200 MICROGRAMS/6 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SUSPENSION

Active substance(s): BUDESONIDE MICRONISED / FORMOTEROL FUMARATE DIHYDRATE MICRONISED

View full screen / Print PDF » Download PDF ⇩
Transcript
NOTAER2717GB

Package leaflet – Information for the user

Symbicort® 200 micrograms /6 micrograms per actuation
pressurised inhalation, suspension
budesonide/formoterol fumarate dihydrate

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• 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
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Symbicort is and what it is used for
2. What you need to know before you use Symbicort
3. How to use Symbicort
4. Possible side effects
5. How to store Symbicort
6. Contents of the pack and other information
1. What Symbicort is and what it is used for
Symbicort is an inhaler that is used to treat the
symptoms of Chronic Obstructive Pulmonary
Disease (COPD) in adults. COPD is a long-term
disease of the airways in the lungs, which is often
caused by cigarette smoking. Symbicort contains
two different medicines: budesonide and formoterol
fumarate dihydrate.
• Budesonide belongs to a group of medicines
called ‘corticosteroids’. It works by reducing
and preventing swelling and inflammation in
your lungs.
• Formoterol fumarate dihydrate belongs to
a group of medicines called ‘long-acting
beta2 adrenoceptor agonists’ or ‘bronchodilators’.
It works by relaxing the muscles in your airways.
This helps you to breathe more easily.
Do not use this medicine as a “reliever” inhaler.
2. What you need to know before you use
Symbicort
Do not use Symbicort:
• if you are allergic to budesonide, formoterol or
the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using
Symbicort if:
• You are diabetic.
• You have a lung infection.
• You have high blood pressure or you have ever
had a heart problem (including an uneven heart
beat, a very fast pulse, narrowing of the arteries
or heart failure).
• You have problems with your thyroid or adrenal
glands.
• You have low levels of potassium in your blood.
• You have severe liver problems.
Children and adolescents
Symbicort is not recommended for children and
adolescents under 18 years.
Other medicines and Symbicort
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are
taking any of the following medicines:
• Beta-blocker medicines (such as atenolol or
propranolol for high blood pressure), including
eyedrops (such as timolol for glaucoma).
• Medicines for a fast or uneven heart beat
(such as quinidine).
• Medicines like digoxin, often used to treat heart
failure.
• Diuretics, also known as ‘water tablets’ (such as
furosemide). These are used to treat high blood
pressure.
• Steroid medicines that you take by mouth
(such as prednisolone).
• Xanthine medicines (such as theophylline or
aminophylline). These are often used to treat
COPD or asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic anti-depressants (such as amitriptyline)
and the anti-depressant nefazodone.
• Phenothiazine medicines (such as
chlorpromazine and prochlorperazine).
• Medicines called ‘HIV-protease inhibitors’
(such as ritonavir) to treat HIV infection.
• Medicines to treat infections (such as
ketoconazole, itraconazole, voriconazole,
posaconazole, clarithromycin and telithromycin).
• Medicines for Parkinson’s disease (such as
leva-dopa).
• Medicines for thyroid problems (such as
levo‑thyroxine).
If any of the above applies to you, or if you are not
sure, talk to your doctor or pharmacist before using
Symbicort.
Also tell your doctor or pharmacist if you are going
to have a general anaesthetic for an operation or for
dental work.
Pregnancy and breast-feeding
• If you are pregnant, or planning to get pregnant,
talk to your doctor before using Symbicort - do
not use Symbicort unless your doctor tells you to.
• If you get pregnant while using Symbicort, do
not stop using Symbicort but talk to your doctor
immediately.
• If you are breast-feeding, talk to your doctor
before using Symbicort.
Driving and using machines
Symbicort has no or negligible effect on your ability
to drive or to use tools or machines.
3. How to use Symbicort
• Always use this medicine exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
• It is important to use Symbicort every day, even
if you have no COPD symptoms at the time.
The usual dose is 2 inhalations twice a day.
Symbicort is not recommended for children or
adolescents under 18 years of age.

If you have been taking steroid tablets for your
COPD, your doctor may reduce the number
of tablets that you take, once you start to use
Symbicort. If you have been taking oral steroid
tablets for a long time, your doctor may want
you to have blood tests from time to time. When
reducing oral steroid tablets, you may feel generally
unwell even though your chest symptoms may be
improving. You might experience symptoms such as
a stuffy or runny nose, weakness or joint or muscle
pain and rash (eczema). If any of these symptoms
bother you, or if symptoms such as headache,
tiredness, nausea (feeling sick) or vomiting (being
sick) occur, please contact your doctor immediately.
You may need to take other medication if you
develop allergic or arthritic symptoms. You should
speak to your doctor if you are concerned as to
whether you should continue to use Symbicort.
Your doctor may consider adding steroid tablets
to your usual treatment during periods of stress
(for example, when you have a chest infection or
before an operation).
Important information about your COPD
symptoms
If you feel you are getting breathless or wheezy
while using Symbicort, you should continue to use
Symbicort 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 feeling breathless.
• Your chest starts to feel tight in the morning or
your chest tightness lasts longer than usual.
• These signs could mean that your COPD is not
being properly controlled and you may need
different or additional treatment immediately.
Your doctor may also prescribe other bronchodilator
drugs, for example anticholinergics (such as
tiotropium or ipratropium bromide) for your COPD
disease.
Information about your Symbicort
• Before starting to use your Symbicort, remove it
from the foil wrapper. Throw away the wrapper as
well as the drying agent which is inside the
wrapper. If the drying agent has leaked out of its
packet, do not use the inhaler.
• After you have taken the inhaler out of its foil
wrapper, you should use it within 3 months. Write
the use by date (3 months from opening the
wrapper) on the inhaler label to remind
you when to stop using the inhaler.
• The parts of your inhaler are shown
in the picture. The inhaler will already
be assembled when you first receive
it. Do not take it apart. If the canister
becomes loose, put it back in the
inhaler and keep using the inhaler.
Preparing your Symbicort
You need to prepare your inhaler for use in the
following situations:
• If you are using your new Symbicort for the
first time.
• If you have not used it for more than 7 days.
• If it has been dropped.
To prepare your inhaler for use, follow the
instructions below:
1. Shake the inhaler well for at least 5 seconds to
mix the contents of the aerosol canister.
2. Remove the mouthpiece cover by pressing lightly
on the bumps on the side. The strap on the
mouthpiece cover will stay attached to the inhaler.
3. Hold the inhaler upright. Then press the counter
(on the top of the inhaler) to release a puff into
the air. You can use one or both hands, as
shown in the pictures.

4. Release your finger(s) from the counter.
5. Wait for 10 seconds, shake well and then repeat
steps 3 and 4.
6. Your inhaler is now ready for use.
How to take an inhalation
Each time you need to take an inhalation, follow the
instructions below:
1. Shake the inhaler well for at least 5 seconds to
mix the contents of the aerosol canister.
2. Remove the mouthpiece cover by pressing
lightly on the bumps on the side. Check that the
mouthpiece is not blocked.
3. Hold your inhaler upright (using one or both
hands). Breathe out gently.
4. Place the mouthpiece gently between your teeth.
Close your lips.
5. Start to breathe in slowly and deeply through
your mouth. Press the counter (on the top of
the inhaler) firmly to release
a puff. Keep breathing in for
a short while after pressing
the counter. Breathing in at
the same time as pressing
the counter ensures that the
medicine reaches your lungs.
6. Hold your breath for 10 seconds, or for as long
as it is comfortable.
7. Before you breathe out, release your finger from
the counter and remove the inhaler from your
mouth. Keep the inhaler upright.
8. Then breathe out slowly. To take another
inhalation, shake the inhaler well for at least
5 seconds and repeat steps 3 to 7.
9. Replace the mouthpiece cover.
10. Rinse your mouth with water after your daily
morning and evening doses and spit it out.
Caregivers should ensure that patients prescribed
Symbicort use correct inhalation technique. The use
with a spacer device has not been documented yet.
Cleaning your Symbicort
• Wipe the inside and outside of the mouthpiece at
least once a week with a dry tissue.
• Do not use water or liquids and do not remove
the canister from the inhaler.

How will I know when to replace my Symbicort?
• The counter on the top of your
inhaler tells you how many
puffs (actuations) are left in
your Symbicort. It starts with
120 puffs when it is full.
• Each time you take an inhalation,
or release a puff into the air, the
arrow counts down
towards zero (‘0’).
• When the arrow first enters the
yellow area, this means that
there are about 20 puffs left.
• When the arrow reaches ‘0’,
you must stop using your new
Symbicort. Your inhaler may
not feel empty and it may seem as though it still
works. However, you will not get the right amount
of medicine if you keep using it.
If you use more Symbicort than you should
If you use more Symbicort than you should, contact
your doctor or pharmacist for advice. The following
effects may happen: trembling, headache or a rapid
heartbeat.
If you forget to use Symbicort
• If you forget to take a dose, take it as soon as
you remember. However, if it is nearly time for
your next dose, skip the missed dose.
• Do not take a double dose to make up for a
forgotten dose.
If you stop taking Symbicort
Before you stop taking Symbicort, you should talk
to your doctor or your pharmacist. If you stop taking
Symbicort the signs and symptoms of COPD may
worsen.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If either of the following happens to you, stop
using Symbicort straightaway and talk to your
doctor immediately:
• Swelling of your face, particularly around your
mouth (tongue and/or throat and/or difficulty to
swallow) rash or hives together with difficulties
to breath (angioedema) and/or sudden feeling of
faintness. This may mean that you are having an
allergic reaction. This happens rarely, affecting
less than 1 in 1,000 people.
• Sudden acute wheezing or shortness of breath
immediately after using your inhaler. If either
of these symptoms occurs, stop using your
Symbicort straightaway and use your ‘reliever’
inhaler. Contact your doctor immediately as
you may need to have your treatment changed.
This happens very rarely, affecting less than
1 in 10,000 people.
Other possible side effects:
Common (may affect up to 1 in 10 people)
• Palpitations (awareness of your heart beating),
trembling or shaking. If these effects occur, they
are usually mild and usually disappear as you
continue to use Symbicort.
• Thrush (a fungal infection) in the mouth. This is
less likely if you rinse your mouth out with water
after using your Symbicort.
• Mild sore throat, coughing and a hoarse voice.
• Headache.
Uncommon (may affect up to 1 in 100 people)
• Feeling restless, nervous or agitated.
• Disturbed sleep.
• Feeling dizzy.
• Nausea (feeling sick).
• Fast heart beat.
• Bruising of the skin.
• Muscle cramps.
Rare (may affect up to 1 in 1,000 people)
• Rash, itching.
• Bronchospasm (tightening of the muscles in the
airways which causes wheezing). If the wheezing
comes on suddenly after using Symbicort
stop using Symbicort and talk to your doctor
immediately.
• Low levels of potassium in your blood.
• Uneven heart beat.
Very rare (may affect up to 1 in 10,000 people)
• Depression.
• Changes in behaviour, especially in children.
• Chest pain or tightness in the chest (angina
pectoris).
• An increase in the amount of sugar (glucose)
in your blood.
• Taste changes, such as an unpleasant taste in
the mouth.
• Changes in your blood pressure.

• After you have taken the inhaler out of its foil
wrapper, you should use it within 3 months. Write
the use by date (3 months from opening the
wrapper) on the inhaler label to remind you when
to stop using the inhaler.
• Always replace the mouthpiece cover firmly and
snap into position after using your inhaler.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines that are
no longer required. This will help to protect the
environment.
Warning: The canister 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.
6. Contents of the pack and other information
What Symbicort contains
The active substances are budesonide and
formoterol fumarate dihydrate. Each puff (actuation)
contains 200 micrograms of budesonide and
6 micrograms of formoterol fumarate dihydrate.
The other ingredients are apaflurane (HFA 227),
povidone and macrogol. This is a CFC-free inhaler.
What Symbicort looks like and contents of
the pack
Symbicort is an inhaler containing your medicine.
The pressurised canister, with attached dose
indicator, contains a white suspension for inhalation.
The canister is fitted into a red plastic actuator with
a white plastic mouthpiece and an integrated grey
plastic dust cap. Each inhaler contains 120 puffs
(actuations) after it has been prepared for use.
Each inhaler is individually packed in a foil wrapper
containing a drying agent.
Symbicort, 200 micrograms /6 micrograms/actuation
pressurised inhalation, suspension (Budesonide/
Formoterol fumarate dihydrate) is available in packs
of one inhaler.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Symbicort is held by
AstraZeneca UK Ltd, 600 Capability Green, Luton,
LU1 3LU, UK.
Symbicort is manufactured by AstraZeneca
Dunkerque Production ( AZDP) 224 Avenue de la
Dordogne, 59640, Dunkerque, France.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Country
Austria

Belgium

Bulgaria

Croatia

Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany

Greece
Hungary

Iceland
Ireland
Italy

Latvia

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.
• an effect on the adrenal gland (a small gland
next to the kidney).

Lithuania

These effects are much less likely to happen with
inhaled corticosteroids than with corticosteroid
tablets.

Poland
Portugal

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 Yellow Card Scheme,
Website: 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 Symbicort
• Keep this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date
which is stated on the label, carton and foil
wrapper after EXP. The expiry date refers to the
last day of that month.
• As with most inhaled medicines in pressurised
canisters, the effect of this medicine may
decrease when the canister is cold. For best
results, this medicine should be at room
temperature before use. Do not refrigerate or
freeze. Protect from frost and direct sunlight.

Luxembourg

Malta
Netherlands
Norway

Romania

Slovakia
Slovenia

Spain

Sweden
United Kingdom

Trade name and strength
Symbicort 160 Mikrogramm /
4,5 Mikrogramm/Inhalation
Druckgasinhalation, Suspension
Symbicort 160 microgram /
4,5 microgram/inhalatie, aërosol,
suspensie
Symbicort 160 microgrammes /
4,5 microgrammes/inhalation,
suspension pour inhalation en flacon
pressurisé
Symbicort 160 Mikrogramm /
4,5 Mikrogramm/Inhalation,
Druckgasinhalation, Suspension
Симбикорт 160 микрограма /
4,5 микрограма/впръскване
Суспензия под налягане за
инхалация
Symbicort 160 mikrograma /
4,5 mikrograma po potisku, stlačeni
inhalat, suspenzija
Symbicort 160 μικρογραμμάρια /
4,5 μικρογραμμάρια/ψεκασμό
Symbicort 160 mikrogramů /
4,5 mikrogramů
Symbicort 160 mikrogram /
4.5 mikrogram/inhalation
Symbicort
Symbicort 160 mikrog /4.5 mikrog/
inhalaatio
Symbicort 200 micro grammes /
6 micro grammes par inhalation
Symbicort 160 Mikrogramm /
4,5 Mikrogramm pro Inhalation
Druckgasinhalation, Suspension
Symbicort 160 μικρογραμμάρια /
4,5 μικρογραμμάρια/ψεκασμό
Symbicort 4,5 mikrogramm /
160 mikrogramm túlnyomásos
inhalációs szuszpenzió
Symbicort 160 míkrógrömm /
4,5 míkrógrömm/ inhalation
Symbicort 200 micrograms /
6 micrograms/inhalation
Symbicort 160 microgrammi /
4,5 microgrammi/erogazione,
sospensione pressurizzata per
inalazione
Symbicort 160 mikrogrami /
4.5 mikrogrami/ inhalācijā,
izsmidzinājumā, aerosols inhalācijām
zem spiediena
Symbicort 160 mikrogramo /
4,5 mikrogramo/išpurškime suslėgtoji
įkvepiamoji suspensija
Symbicort 160 microgrammes /
4,5 microgrammes/inhalation,
suspension pour inhalation en flacon
pressurisé
Symbicort 200 micrograms /
6 micrograms/inhalation
Symbicort 200/6, 200 microgram /
6 microgram/inhalatie
Symbicort 160 mikrogram /
4.5 mikrogram/ inhalasjon
Symbicort
Symbicort 160 microgramas /
4,5 microgramas/inalação
Suspensão pressurizada para inalação
Symbicort 160 micrograme /
4.5 micrograme/inhalaţie, suspensie
de inhalat presurizată
Symbicort 160 mikrogamov /
4,5 mikrogamov/inhalačná dávka
Symbicort 160 mikrogramov /
4,5 mikrograma na vdih, inhalacijska
suspenzija pod tlakom
Symbicort 160 microgramos /
4,5 microgramos/inhalación
suspensión para inhalación en
envase a presión
Symbicort 160 mikrogram /
4.5 mikrogram/inhalation
Symbicort 200 micrograms/
6 micrograms per actuation
pressurised inhalation, suspension

This leaflet was last revised in March 2016

Body text size

Smallest text size

10.5 pt

6.0 pt

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