Symbicort mite Turbuhaler 80 mikrogram/4,5 mikrogram/inhalation Inhalationspulver

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

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Bipacksedel Bipacksedel (PIL)

04-06-2020

Aktiva substanser:
budesonid; formoterolfumaratdihydrat
Tillgänglig från:
Paranova Läkemedel AB
ATC-kod:
R03AK07
INN (International namn):
budesonide; formoterol
Dos:
80 mikrogram/4,5 mikrogram/inhalation
Läkemedelsform:
Inhalationspulver
Sammansättning:
formoterolfumaratdihydrat 4,5 mikrog Aktiv substans; budesonid 80 mikrog Aktiv substans; laktosmonohydrat Hjälpämne
Receptbelagda typ:
Receptbelagt
Terapiområde:
Formoterol och budesonid
Bemyndigande status:
Avregistrerad
Godkännandenummer:
22596
Tillstånd datum:
2005-11-17

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B. PACKAGE LEAFLET

Package leaflet: Information for the user

Symbicort mite Turbuhaler 80 micrograms/4.5 micrograms /inhalation, Inhalation Powder

Budesonide/Formoterol fumarate dihydrate

Read all of this leaflet carefully before you start using 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:

What Symbicort mite Turbuhaler is and what it is used for

What you need to know before you use Symbicort mite Turbuhaler

How to use Symbicort mite Turbuhaler

Possible side effects

How to store Symbicort mite Turbuhaler

Contents of the pack and other information

1.

What Symbicort mite Turbuhaler is and what it is used for

Symbicort mite Turbuhaler is an inhaler that is used to treat asthma in adults, adolescents and children

aged 6 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 beta

adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways.

This helps you to breathe more easily.

This medicine 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 mite Turbuhaler and a separate

‘reliever inhaler’.

They use Symbicort mite Turbuhaler every day. This helps to prevent asthma symptoms from

happening.

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

again.

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

They use Symbicort mite Turbuhaler every day. This helps to prevent asthma symptoms from

happening.

They also use Symbicort mite Turbuhaler 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.

2.

What you need to know before you use Symbicort mite Turbuhaler

Do not use Symbicort mite Turbuhaler:

if you are allergic to budesonide, formoterol or the other ingredient of this medicine (listed in

section 6), which is lactose (which contains small amounts of milk protein).

Warnings and precautions

Talk to your doctor or pharmacist before using Symbicort mite Turbuhaler 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.

Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and Symbicort mite Turbuhaler

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 mite Turbuhaler.

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 mite

Turbuhaler - do not use Symbicort mite Turbuhaler unless your doctor tells you to.

If you get pregnant while using Symbicort mite Turbuhaler, do not stop using Symbicort mite

Turbuhaler but talk to your doctor immediately.

If you are breast-feeding, talk to your doctor before using Symbicort mite Turbuhaler.

Driving and using machines

Symbicort mite Turbuhaler has no or negligible effect on your ability to drive or to use tools or

machines.

Symbicort mite Turbuhaler contains lactose

Symbicort mite Turbuhaler 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 reaction.

3.

How to use Symbicort mite Turbuhaler

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 mite Turbuhaler 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 mite Turbuhaler. 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 mite Turbuhaler.

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 symptoms

If you feel you are getting breathless or wheezy while using Symbicort mite Turbuhaler, you should

continue to use Symbicort mite Turbuhaler 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 is not being properly controlled and you may need different

or additional treatment immediately.

Asthma

Symbicort mite Turbuhaler can be prescribed for asthma in two different ways. The amount of

Symbicort mite Turbuhaler to use and when to use it depends on how it has been prescribed for you.

If you have been prescribed Symbicort mite Turbuhaler and a separate reliever inhaler, read the

section called ‘a) Using Symbicort mite Turbuhaler and a separate reliever inhaler’.

If you have been prescribed Symbicort mite Turbuhaler as your only inhaler, read the section

called ‘b) Using Symbicort mite Turbuhaler as your only asthma inhaler’.

a) Using Symbicort mite Turbuhaler and a separate reliever inhaler

Use your Symbicort mite Turbuhaler every day.

This helps to prevent asthma symptoms from

happening.

Adults (18 years and above)

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

Your doctor may increase this to 4 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 or 2 inhalations, twice a day.

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

day.

Children (6 to 11 years)

The usual dose is 2 inhalations, twice a day.

Symbicort mite Turbuhaler 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 mite Turbuhaler to

treat asthma symptoms - use your reliever inhaler.

b) Using Symbicort mite Turbuhaler as your only asthma inhaler

Only use Symbicort mite Turbuhaler in this way if your doctor has told you to and if you are aged 12

or above.

Use your Symbicort mite Turbuhaler 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 inhalations in the morning

or

2 inhalations in the evening.

Also use Symbicort mite Turbuhaler as a ‘reliever inhaler’ to treat asthma symptoms when they

happen.

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

If you do not feel better, take another inhalation.

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

Always keep your Symbicort mite Turbuhaler Inhaler with you, so you can use it when you need it.

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.

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 mite Turbuhaler as described

here. However, do not use Symbicort mite Turbuhaler just before exercise to stop asthma symptoms

from happening.

Preparing your new Symbicort mite Turbuhaler Inhaler

Before using your

new

Symbicort mite Turbuhaler Inhaler

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 Symbicort mite Turbuhaler Inhaler 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. It does

not matter whether the click comes on the first or the second twist.

Do this again, turning the red grip in both directions.

Your Symbicort mite Turbuhaler Inhaler is now loaded and ready for use.

How to take an inhalation

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

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

Hold your Symbicort mite Turbuhaler Inhaler upright

with the red grip at the bottom.

Do not

hold the mouthpiece when you load your Symbicort mite Turbuhaler Inhaler. To load

your Symbicort mite Turbuhaler Inhaler 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. It does not matter whether the click comes on the first or

the second twist. Your Symbicort mite Turbuhaler Inhaler is now loaded and ready to use. Only

load your Symbicort mite Turbuhaler Inhaler when you need to use it.

Hold your Symbicort mite Turbuhaler Inhaler away from your mouth. Breathe out gently (as far

as is comfortable). Do not breathe out through your Symbicort mite Turbuhaler Inhaler.

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.

Remove your Symbicort mite Turbuhaler Inhaler 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.

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

Replace the cover tightly after use.

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 Symbicort mite Turbuhaler Inhaler

and must not be taken off. Do not use your Symbicort mite Turbuhaler Inhaler if it has been damaged

or if the mouthpiece has come apart from your Symbicort mite Turbuhaler Inhaler.

As with all inhalers, caregivers should ensure that children prescribed Symbicort mite Turbuhaler use

correct inhalation technique, as described above.

Cleaning your Symbicort mite Turbuhaler Inhaler

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 inhaler

The dose indicator tells you how many doses (inhalations) are left in your Symbicort mite

Turbuhaler Inhaler, 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

Symbicort mite Turbuhaler Inhaler.

Note:

The grip will still twist and ‘click’ even when your Symbicort mite Turbuhaler Inhaler is empty.

The sound that you hear as you shake your Symbicort mite Turbuhaler Inhaler is produced by a

drying agent and not the medicine. Therefore, the sound does not tell you how much medicine is

left in your Symbicort mite Turbuhaler Inhaler.

If you load your Symbicort mite Turbuhaler Inhaler 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 mite Turbuhaler 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 after if you use more Symbicort mite Turbuhaler than

you should are trembling, headache or a rapid heart beat.

If you forget to use Symbicort mite Turbuhaler

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.

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, this medicine can cause side effects, although not everybody gets them.

If either of the following happen to you, stop using Symbicort mite Turbuhaler 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 if

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 mite Turbuhaler Inhaler 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 mite Turbuhaler.

Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth out with

water after using your Symbicort mite Turbuhaler.

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.

Blurred vision.

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 mite Turbuhaler stop using Symbicort

mite Turbuhaler 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 national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Symbicort mite Turbuhaler

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date that 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.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how

to throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Symbicort mite Turbuhaler contains

The active substances are budesonide and formoterol. Each inhaled dose contains 80 micrograms of

budesonide and 4.5 micrograms of formoterol fumarate dihydrate.

The other ingredient is lactose monohydrate (which contains milk proteins).

What Symbicort mite Turbuhaler looks like and contents of the pack

Symbicort mite Turbuhaler is an inhaler containing your medicine. The inhalation powder is white in

colour. Each Inhaler contains either 60 or 120 doses and has a white body 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.

Symbicort mite Turbuhaler is available in packs of 1, 2, 3, 10 or 18 inhaler(s) containing 60 (or

120) doses.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following

names:

Country

Trade name and strength

Austria

Symbicort mite Turbohaler 80 μg/4.5 μg/inhalation

Belgium

Symbicort mite Turbohaler 80 μg/4.5 μg/inhalation

Bulgaria

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Croatia

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Cyprus

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Czech Republic

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Denmark

Symbicort mite Turbuhaler 80 μg/4.5 μg/inhalation

Estonia

Symbicort Turbuhaler, 80 μg/4.5 μg

Finland

Symbicort Turbuhaler mite 80 μg/4.5 μg/inhalation

France

Symbicort Turbuhaler 100 μg/6 μg/inhalation

Germany

Symbicort mite Turbohaler 80 μg/4.5 μg/inhalation

Greece

Symbicort Turbuhaler

80 μg/4.5 μg/inhalation

Hungary

Symbicort mite Turbuhaler 80 μg/4.5 μg/inhalation

Iceland

Symbicort mite Turbuhaler 80 μg/4.5 μg/inhalation

Ireland

Symbicort

Turbohaler 100 μg/6 μg/inhalation

Italy

Symbicort

mite 80 μg/4.5 μg/inhalation

Latvia

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Lithuania

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Luxembourg

Symbicort

mite Turbohaler 80 μg/4.5 μg/inhalation

Malta

Symbicort Turbohaler 100 μg/6 μg/inhalation

Netherlands

Symbicort

Turbuhaler 100 μg/6 μg/inhalation

Norway

Symbicort mite Turbuhaler 80 μg/4.5 μg/inhalation

Poland

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Portugal

Symbicort

Turbohaler 80 μg/4.5 μg/inhalation

Romania

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Slovakia

Symbicort Turbuhaler 100 μg/6 μg/inhalation

Slovenia

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Spain

Symbicort Turbuhaler 80 μg/4.5 μg/inhalation

Sweden

Symbicort mite Turbuhaler 80 μg/4.5 μg/inhalation

United Kingdom

Symbicort Turbohaler

100 μg/6 μg/inhalation

This leaflet was last revised in 2020-12-17

[To be completed nationally]

Detailed and updated information on this product

is available by scanning the QR Code included in

the PIL and outer carton with a smartphone. The

same information is also available on the

following URL: <[country specific URL to be

included]>

<and the <NCA> website, to be

completed nationally>

QR code area

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