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SYMBICORT TURBOHALER 400/12 INHALATION POWDER

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

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Add/Amend to correct the number of doses in the Turbohaler which was granted
Uncommonin
(may
up to
1 in 100 people)
6. Contents of the pack and other information
incorrectly
theaffect
initial
application
by CM.
• 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 Turbohaler stop using Symbicort
Turbohaler 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.
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).
These effects are much less likely to happen with
inhaled corticosteroids than with corticosteroid
tablets.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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.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 Turbohaler
• Keep out of the sight and reach of children
• Do not store above 30°C.
• Keep the container/cap tightly closed, in order
to protect from moisture.
• Do not use the inhaler after the expiry date
which is stated on the carton or on the label of
your inhaler after EXP. The expiry date refers to
the last day of that month.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

Previously assessed against UK PIL dated September 2016
Ref: 1679/090817/1/F

PATIENT INFORMATION LEAFLET

What Symbicort Turbohaler contains
Symbicort ® Turbohaler ® 400/12, Inhalation powder
• Each inhaled dose (the dose leaving the By Aneela Mahmood at 5:23 pm, Aug 09, 2017
(budesonide / formoterol fumarate)
mouthpiece) delivers 320 micrograms of
Read
all
of
this
leaflet
carefully
before you
budesonide and 9 micrograms of formoterol
2. What you need to know before you use
start using this medicine because it contains
fumarate dihydrate. This corresponds to a
Symbicort Turbohaler
important
information
for
you.
dispensed dose of 400 micrograms of
Do
not use Symbicort Turbohaler:
• Keep this leaflet. You may need to read it again.
budesonide and 12 micrograms of formoterol
• if you are allergic to budesonide, formoterol or

If
you
have
any
further
questions,
ask
your
fumarate dihydrate.
the other ingredient of this medicine (listed in
doctor or pharmacist.
• The other ingredient is lactose.
section 6), which is lactose (which contains

This
medicine
has
been
prescribed
for
you
only.
(which contains milk proteins).
small amounts of milk protein).
Do not pass it on to others. It may harm them,

Mock-up

What Symbicort Turbohaler looks like and
contents of the pack
• Symbicort Turbohaler 400/12 is an inhaler with
white inhalation powder. The body of the inhaler
is white with a red turning grip. The turning grip
contains a Braille code with the number 6 for
identification, to differ from other AstraZeneca
inhaled products.
• Each Turbohaler contains 60 doses.
Manufacturer and Licence Holder
Manufactured by AstraZeneca AB, SE-151 85,
Sodertalje, Sweden and is procured from within
the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1679

Symbicort Turbohaler
400/12, Inhalation
powder

Symbicort and Turbohaler are registered
trademarks of AstraZeneca AB.
Leaflet revision date: 09/08/17

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
(UK) Limited,
Tel: 01527 505414 to
obtain the leaflet in a
format suitable for you



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.

Your medicine is called Symbicort Turbohaler
400/12, Inhalation powder and will be referred to
as Symbicort Turbohaler throughout the rest of this
leaflet.
What is in this leaflet:
1. What Symbicort Turbohaler is and what it is
used for
2. What you need to know before you use
Symbicort Turbohaler
3. How to use Symbicort Turbohaler
4. Possible side effects
5. How to store Symbicort Turbohaler
6. Contents of the pack and other information
1. What Symbicort Turbohaler is and what it is
used for
Symbicort Turbohaler is an inhaler that is used to
treat asthma in adults and adolescents aged 12-17
years. It is also used to treat the symptoms of
Chronic Obstructive Pulmonary Disease (COPD)
in adults aged 18 years and older. It 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.

Asthma
For asthma, your doctor will prescribe two asthma
inhalers:
Symbicort Turbohaler and a separate ‘reliever
inhaler’.




Use Symbicort Turbohaler every day. This helps
to prevent asthma symptoms from happening.
Use your ‘reliever inhaler’ when you get asthma
symptoms, to make it easier to breathe again.

Do not use Symbicort Turbohaler 400/12 as a
‘reliever inhaler’.
Chronic obstructive pulmonary disease
(COPD)
Symbicort Turbohaler can also be used to treat the
symptoms of COPD in adults. COPD is a
long-term disease of the airways in the lungs,
which is often caused by cigarette smoking.

Warnings and precautions
Talk to your doctor or pharmacist before using
Symbicort Turbohaler 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.
Other medicines and Symbicort Turbohaler
Tell your doctor or pharmacist if you are using,
have recently used or might use any other
medicines.
In particular, tell your doctor or pharmacist if you
are using 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
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 Turbohaler.
Also tell your doctor or pharmacist if you are going
to have a general anaesthetic for an operation or
for dental work.
Pregnancy breast-feeding and fertility
• If you are pregnant, or planning to get pregnant,
talk to your doctor before using Symbicort
Turbohaler - do not use Symbicort Turbohaler
unless your doctor tells you to.
• If you get pregnant while using Symbicort
Turbohaler, do not stop using Symbicort
Turbohaler but talk to your doctor immediately.

• If you are breast-feeding, talk to your doctor
before using Symbicort Turbohaler.
Driving and using machines
Symbicort Turbohaler has no or negligible effect
on your ability to drive or to use tools or machines.
Symbicort Turbohaler contains lactose
Symbicort Turbohaler contains lactose, which is a
type of sugar. If you have been told by your doctor
that you have an intolerance to some sugars, talk
to your doctor before using this medicine. The
amount of lactose in this medicine does not
normally cause problems in people who are
lactose intolerant.
The excipient lactose contains small amounts of
milk proteins, which may cause allergic reactions.

3. How to use Symbicort Turbohaler

• Always use this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
• It is important to use Symbicort Turbohaler every
day, even if you have no asthma or COPD
symptoms at the time.
• If you are using Symbicort Turbohaler for
asthma, your doctor will want to regularly check
your symptoms.
If you have been taking steroid tablets for your
asthma or COPD, your doctor may reduce the
number of tablets that you take, once you start to
use Symbicort Turbohaler. 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 Turbohaler.
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 asthma or
COPD symptoms
If you feel you are getting breathless or wheezy
while using Symbicort Turbohaler, you should
continue to use Symbicort Turbohaler 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 asthma or
COPD is not being properly controlled and you
may need different or additional treatment
immediately.

Asthma
Use your Symbicort Turbohaler 400/12 every
day. This helps to prevent asthma symptoms from
happening.
Adults (18 years and above)
• The usual dose is 1 inhalation, twice a day.
• Your doctor may increase this to 2 inhalations,
twice a day.
• If your symptoms are well controlled, your
doctor may ask you to take your medicine once
a day.
Adolescents (12 to 17 years)
• The usual dose is 1 inhalation, twice a day.
• If your symptoms are well controlled, your
doctor may ask you to take your medicine once
a day.
A lower strength of Symbicort Turbohaler is
available for children aged from 6 to 11 years.
Symbicort Turbohaler is not recommended to be
used in children who are younger than 6 years.
Your doctor (or asthma nurse) will help you to
manage your asthma. They will adjust the dose of
this medicine to the lowest dose that controls your
asthma. However, do not adjust the dose without
talking to your doctor (or asthma nurse) first.
Use your separate ‘reliever inhaler’ to treat
asthma symptoms when they happen. Always
keep your ‘reliever inhaler’ with you to use when
you need it. Do not use Symbicort Turbohaler
400/12 to treat asthma symptoms - use your
separate ‘reliever inhaler’.
Chronic Obstructive Pulmonary Disease
(COPD)
• Only to be used by adults (aged 18 years and
above).
• The usual dose is 1 inhalation twice a day.
Your doctor may also prescribe other
bronchodilator drugs, for example anticholinergics
(such as tiotropium or ipratropium bromide) for
your COPD disease.
Preparing your new Symbicort Turbohaler
Before using your new Symbicort Turbohaler for
the first time, you need to prepare it for use as
follows:
• Unscrew the cover and lift it
off. You may hear a rattling
sound.
• Hold your Turbohaler upright
with the red grip at the
bottom.
• Turn the red grip as far as it
will go in one direction. Then
turn it as far as it will go in
the other direction (it does not
matter which way you turn it
first). You should hear a
click sound.
• Do this again, turning the red
grip in both directions.
• Your Turbohaler is now ready for use.

How to take an inhalation
Every time you need to take an inhalation, follow
the instructions below.
1. Unscrew the cover and lift it off. You may hear a
rattling sound.
2. Hold your Turbohaler upright with the red grip
at the bottom.
3. Do not hold the mouthpiece when you load your
Turbohaler. To load your Turbohaler with a
dose, turn the red grip as far as it will go in one
direction. Then turn it as far as it will go in the
other direction (it does not matter which way
you turn it first). You should hear a click sound.
Your Turbohaler is now loaded and ready to
use. Only load your Turbohaler when you need
to use it.
4. Hold your Turbohaler away from your mouth.
Breathe out gently (as far as is comfortable).
Do not breathe out through your Turbohaler.
5. Place the mouthpiece gently
between your teeth. Close
your lips. Breathe in as
deeply and as hard as you
can through your mouth. Do
not chew or bite on the
mouthpiece.
6. Remove your Turbohaler from your mouth.
Then breathe out gently. The amount of
medicine that is inhaled is very small. This
means you may not be able to taste it after
inhalation. If you have followed the instructions,
you can still be confident that you have inhaled
the dose and the medicine is now in your lungs.
7. If you are to take a second inhalation, repeat
steps 2 to 6.
8. Replace the cover tightly
after use.
9. Rinse your mouth with water
after your daily morning
and/or evening doses, and
spit it out.
Do not try to remove or twist the mouthpiece. It is
fixed to your Turbohaler and must not be taken off.
Do not use your Turbohaler if it has been
damaged or if the mouthpiece has come apart
from your Turbohaler.
As with all inhalers, caregivers should ensure that
children prescribed Symbicort Turbohaler use
correct inhalation technique, as described above.
Cleaning your Turbohaler
Wipe the outside of the mouthpiece once a week
with a dry tissue. Do not use water or liquids.
When to start using a new Turbohaler
• The dose indicator tells you
how many doses
(inhalations)
are left in your Turbohaler,
starting with 60 doses
when it is full.
• The dose indicator is marked
in intervals of 10 doses.
Therefore it does not show every dose.
• When you first see a red mark at the edge of
the indicator window, there are approximately
20 doses left. For the last 10 doses, the
background of the dose indicator is red. When
the ‘0’ on the red background has reached the
middle of the window, you must start using your
new Turbohaler.

Note:
• The grip will still twist and ‘click’ even when your
Turbohaler is empty.
• The sound that you hear as you shake your
Turbohaler is produced by a drying agent and
not the medicine. Therefore the sound does not
tell you how much medicine is left in your
Turbohaler.
• If you load your Turbohaler more than once by
mistake before taking your dose, you will still
only receive one dose. However, the dose
indicator will register all the loaded doses.
If you use more Symbicort Turbohaler 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 exceed your prescribed
dose without seeking medical advice.
The most common symptoms that may occur if
you use more Symbicort Turbohaler than you
should are trembling, headache or a rapid heart
beat.
If you forget to use Symbicort Turbohaler
• 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 have any further questions on the use of
this medicine, 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 Turbohaler and talk to your
doctor immediately:
• Swelling of your face, particularly around your
mouth (tongue and/or throat and/or difficulty to
swallow) or hives together with difficulties to
breathe (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 occur, stop using your
Symbicort Turbohaler 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 Turbohaler.
• Thrush (a fungal infection) in the mouth. This is
less likely if you rinse your mouth out with water
after using your Symbicort Turbohaler.
• Mild sore throat, coughing and a hoarse voice.
• Headache.
• Pneumonia (infection of the lung) in COPD
patients.
Tell your doctor if you have any of the following
while taking Symbicort Turbohaler, they could be
symptoms of a lung infection:
• Fever or chills.
• Increased mucus production, change in mucus
colour.
• Increased cough or increased breathing
difficulties.
Ref:1679/090817/1/B

Expand Transcript

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.

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