SYMBICORT TURBOHALER 100/6 INHALATION POWDER

Active substance: FORMOTEROL FUMARATE DIHYDRATE

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S1254 LEAFLET Symicort 20130911

Rare (affects less than 1 in 1,000 people)

S1254 LEAFLET Symicort 20130911

Take special care with Symbicort Turbohaler

5. How to store Symbicort Turbohaler
PACKAGE LEAFLET: INFORMATION FOR THE USER



Rash, itching.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



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.



Do not store above 30°C.



When not in use, Symbicort Turbohaler should be stored with
the cover tightly closed.



Do not use Symbicort Turbohaler after the expiry date which is
stated on the label and carton. The expiry date refers to the last
day of the month.

Your medicine is Symbicort 100/6 Turbohaler but will be referred to
as Symbicort Turbohaler throughout the remainder of the leaflet.



If the inhaler shows any other signs of deterioration, you should
seek the advice of your pharmacist who will tell you what to do.



Read all of this leaflet carefully before you start taking this
medicine.

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of the
medicines that are no longer required. This will help to protect
the environment.



Low levels of potassium in your blood.



Uneven heart beat.

Very rare (affects less than 1 in 10,000 people)


Depression.



Chest pain or tightness in the chest (angina pectoris).




Taste changes, such as an unpleasant taste in the mouth.
Changes in your blood pressure.

What Symbicort Turbohaler contains



Symbicort Turbohaler also contains lactose (which contains
milk proteins).

glaucoma (increased pressure in the eye)



a slowing of the rate of growth of children and adolescents



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.

You have problems with your thyroid or adrenal glands.



You have low levels of potassium in your blood.
You have severe liver problems.



Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor or
pharmacist.

Taking other medicines

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.

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.

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.

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 eye drops (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).

6. Further information



Xanthine medicines (such as theophylline or aminophylline).
These are often used to treat asthma.

1. What Symbicort Turbohaler is and what it is used for



Other bronchodilators (such as salbutamol).

Symbicort Turbohaler is an inhaler. It contains two different
medicines: budesonide and formoterol fumarate dihydrate.



Tricyclic anti-depressants (such as amitriptyline) and the antidepressant nefazodone.

Budesonide belongs to a group of medicines called
‘corticosteroids’. It works by reducing and preventing swelling
and inflammation in your lungs.



Mono-Amine Oxidase Inhibitors, also known as MAOIs (such as
phenelzine).





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.

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).

In this leaflet:
1. What Symbicort Turbohaler is and what it is used for

What Symbicort Turbohaler looks like and contents of the pack

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.

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).



cataract (clouding of the lens in the eye)







Each actuation provides 100 micrograms of budesonide and 6
micrograms formoterol fumarate dihydrate.

changes in bone mineral density (thinning of the bones)



You have a lung infection.



6. Further information





You are diabetic.





An increase in the amount of sugar (glucose) in your blood.

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 behaviour, especially in children.



SYMBICORT 100/6 TURBOHALER
(budesonide/ formoterol fumarate)

Before you use Symbicort Turbohaler, tell your doctor or pharmacist
if:





Symbicort Turbohaler is a white, plastic, inspiratory-flow driven,
multidose powder inhaler containing white rounded granules
with a red turning grip embossed with a braille code.
Each Symbicort Turbohaler contains 120 actuations.

2. Before you use Symbicort Turbohaler
3. How to use Symbicort Turbohaler
4. Possible side effects
5. How to store Symbicort Turbohaler

Product Licence holder
Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
Symbicort Turbohaler is manufactured by AstraZeneca AB, S-151
85 Sodertalje, Sweden.
POM

PL No. 19488/1254

Leaflet revision date: 11 September 2013
Symbicort and Turbohaler are registered trade marks of
AstraZeneca AB, Sweden.
S1254 LEAFLET Symicort 20130911

Your doctor has prescribed this medicine to treat asthma. It is not
suitable for people with severe asthma. It can be prescribed for
asthma in two different ways.
a) Some people are prescribed two asthma inhalers:
Symbicort Turbohaler and a separate ‘reliever inhaler’.


They use Symbicort Turbohaler every day. This helps to
prevent asthma symptoms from happening.

If any of the above applies to you, or if you are not sure, talk to your
doctor or pharmacist before using Symbicort Turbohaler.



They use their ‘reliever inhaler’ when they get asthma
symptoms, to make it easier to breathe again.

Also tell your doctor or pharmacist if you are going to have a
general anaesthetic for an operation or for dental work.

b) Some people are prescribed Symbicort Turbohaler as their
only asthma inhaler.

Pregnancy and breast-feeding



They use Symbicort Turbohaler every day. This helps to
prevent asthma symptoms from happening.





They also use Symbicort Turbohaler when they need extra
doses for relief of asthma symptoms, to make it easier to
breathe again. They do not need a separate inhaler for this.

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.

2. Before you use Symbicort Turbohaler
Do not use Symbicort Turbohaler if:


You are allergic (hypersensitive) to budesonide, formoterol, or
the other ingredient, which is lactose (which contains small
amounts of milk proteins).

Driving and using machines
Symbicort Turbohaler has no or negligible effect on your ability to
drive or to use tools or machines.

Important information about some of the ingredients of
Symbicort Turbohaler
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 an allergic reaction.
3. How to use Symbicort Turbohaler


Always use Symbicort Turbohaler 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 Turbohaler every day, even if
you have no asthma symptoms at the time.



Your doctor will want to regularly check your asthma 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).

Adolescents (12 to 17 years)

How to take an inhalation

If you use more Symbicort Turbohaler than you should



The usual dose is 1 or 2 inhalations, twice a day.



If your symptoms are well controlled, your doctor may ask you
to take your medicine once a day.

Every time you need to take an inhalation, follow the instructions
below.

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.

Children (6 to 11 years)


The usual dose is 2 inhalations, twice a day.

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 to treat
asthma symptoms - use your reliever inhaler.
b) Using Symbicort Turbohaler as your only asthma inhaler
Only use Symbicort Turbohaler in this way if your doctor has told
you to and if you are aged 18 or above.
Use your Symbicort Turbohaler every day. This helps to prevent
asthma symptoms from happening. You can take:


1 inhalation in the morning and 1 inhalation in the evening

or


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.

2 inhalations in the evening.

Also use Symbicort Turbohaler as a ‘reliever inhaler’ to treat
asthma symptoms when they happen.


If you get asthma symptoms, take 1 inhalation and wait a few
minutes.

Important information about your asthma symptoms



If you do not feel better, take another inhalation.

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:

A total daily dose of more than 8 inhalations is not normally needed.
However, your doctor may allow you to take up to 12 inhalations a
day for a limited period.



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 is not being properly
controlled and you may need different or additional treatment
immediately.
Asthma
Symbicort Turbohaler can be prescribed for asthma in two different
ways. The amount of Symbicort Turbohaler to use and when to use
it depends on how it has been prescribed for you.
a) If you have been prescribed Symbicort Turbohaler and a
separate reliever inhaler, read the section called ‘a) Using
Symbicort Turbohaler and a separate reliever inhaler’.
b) If you have been prescribed Symbicort Turbohaler as your only
inhaler, read the section called ‘b) Using Symbicort Turbohaler
as your only asthma inhaler’.
a) Using Symbicort Turbohaler and a separate reliever inhaler

Always keep your Symbicort Turbohaler with you, so you can use it
when you need it.

If you regularly need to use 8 or more inhalations a day, make an
appointment to see your doctor or nurse. They may need to change
your treatment.
Do not use more than 12 inhalations in total in 24 hours.
If you are doing exercise and you get asthma symptoms, use
Symbicort Turbohaler as described here. However, do not use
Symbicort Turbohaler just before exercise to stop asthma
symptoms from happening.

9. Rinse your mouth with water after your
daily morning and/or evening doses, and
spit it out.

Adults (18 years and above)


Your doctor may increase this to 4 inhalations, twice a day.



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.



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 product, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, Symbicort Turbohaler can cause side effects,
although not everybody gets them.
If either of the following happen 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 swallowing) or hives together with
difficulty breathing (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 (affects less than 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.

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 either 60 or 120 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:


Feeling restless, nervous or agitated.



Disturbed sleep.



Feeling dizzy.



Nausea (feeling sick).



Fast heart beat.



Bruising of the skin.



Muscle cramps.

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.





The grip will still twist and ‘click’ even when your Turbohaler is
empty.



Uncommon (affects less than 1 in 100 people)

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.

Your Turbohaler is now ready for use.

The usual dose is 1 or 2 inhalations, twice a day.



As with all inhalers, caregivers should ensure that children
prescribed Symbicort Turbohaler use correct inhalation technique,
as described above.

Before using your new Symbicort Turbohaler for the first time, you
need to prepare it for use as follows:

Use your Symbicort Turbohaler every day. This helps to prevent
asthma symptoms from happening.



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.

Preparing your new Symbicort Turbohaler



If you forget to use Symbicort Turbohaler

7. If you are to take a second inhalation,
repeat steps 2 to 6.

Do not take more than 6 inhalations at a single time.



The most common symptoms that may occur if you use more
Symbicort Turbohaler than you should are trembling, headache or a
rapid heart beat.

8. Replace the cover tightly after use.
2 inhalations in the morning

or


1. Unscrew the cover and lift it off. You may hear a rattling sound.

If your symptoms are well controlled, your doctor may ask you
to take your medicine once a day.
S1254 LEAFLET Symicort 20130911

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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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