Symbicort Turbuhaler (Budesonide/Formoterol)

SYMBICORT TURBUHALER 160/4.5 micrograms/dose powder for inhalation For inhalation.

Active ingredient
Budesonide, Formoterol fumarate dihydrate

Excipients
Lactose monohydrate (contains milk proteins)

1. What is SYMBICORT Turbuhaler and what is it used for?

SYMBICORT TURBUHALER is an inhaler. 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.
    SYMBICORT TURBUHALER is available in packages containing 1 inhaler. The inhaler has a white body and a red dose loading collar.

    The powder that you have inhaled by breathing is white in color. Each inhaler contains 60 or 120 doses.
    Formoterol fumarate dihydrate belongs to the group of medicines called "long-acting beta-agonists" or "bronchodilators". It works by relaxing the muscles in your respiratory tract. This allows you to breathe easier.
    Your doctor has prescribed you this medicine to treat your asthma or chronic obstructive pulmonary disease (COPD).

    Asthma

    It is used to correct and control asthma symptoms. It is given from the 3rd step in the stepwise treatment of asthma.

    SYMBICORT TURBUHALER can be prescribed for asthma in two different ways:

    a) Some patients are prescribed two asthma inhalers together: SYMBICORT

    TURBUHALER as well as a 'relaxing inhaler'.

    These people are SYMBICORT TURBUHALER'! uses it every day. In this way, the emergence of asthma symptoms is prevented.

    They use the 'reliever inhaler' when asthma symptoms appear, to make it easier to breathe again.

    b) Some patients are prescribed SYMBICORT TURBUHALER alone as an asthma inhaler.

    These people use SYMBICORT TURBUHALER every day. In this way, the emergence of asthma symptoms is prevented.

    They also use SYMBICORT TURBUHALER to make it easier to breathe again when they need an extra dose to relieve their asthma symptoms. They do not need a separate inhaler for this.

    Chronic Obstructive Pulmonary Disease (COPD)

    It reduces the symptoms and frequency of attacks in moderate and severe COPD cases. COPD is a long-term disease of the airways and lungs, mostly caused by smoking.

2. How to use SYMBICORT Turbuhaler?

Instructions for proper use and dose/frequency of administration

Always use SYMBICORT TURBUHALER exactly as your doctor, nurse or pharmacist has told you. If you are unsure, ask one of these people.

It is important that you continue to use SYMBICORT TURBUHALER regularly, every day, even if you do not currently have symptoms of asthma or COPD.

If you are using SYMBICORT TURBUHALER for asthma, your doctor will want to check your asthma symptoms regularly.

Important information about your asthma or COPD symptoms

If you become breathless or wheezing while using SYMBICORT TURBUHALER, you should continue using SYMBICORT TURBUHALER but see your doctor as soon as possible as you may need additional treatment.

Contact your doctor IMMEDIATELY if you notice any of the following:

If your breathing gets worse or you wake up frequently at night with asthma symptoms

If you start to feel pressure in your chest in the morning or if the pressure in your chest is lasting longer than usual

These symptoms may mean that your asthma or COPD is not fully controlled and you may need other or additional treatment immediately.

Asthma

SYMBICORT TURBUHALER can be prescribed for asthma in two different ways. The dose and timing of SYMBICORT TURBUHALER you use will depend on how it has been prescribed for you:

a) If you have been prescribed SYMBICORT TURBUHALER plus a 'reliever inhaler', read the section 'a) Using SYMBICORT TURBUHALER plus a reliever inhaler.

b) If you have been prescribed SYMBICORT TURBUHALER alone as an asthma inhaler

Read section 'b) Use of SYMBICORT TURBUHALER as the sole asthma inhaler.

a) Using SYMBICORT TURBUHALER plus a reliever inhaler

Use SYMBICORT TURBUHALER every day. In this way, the emergence of asthma symptoms is prevented.

Adults (18 years and older):

The dose is usually 1 or 2 inhalations twice a day.

- Your doctor may increase the dose to 4 inhalations twice a day.

- If your symptoms are well controlled, your doctor may reduce your medication to once a day.

Your doctor (or asthma nurse) will help you cope with your asthma. They will adjust the dose of this medicine to the lowest dose necessary to keep your asthma under control. However, do not adjust the dose without talking to your doctor (or asthma nurse) first.

Always have it with you so that you can use it whenever you need it. To improve asthma symptoms, use your reliever inhaler - not the SYMBICORT TURBUHALER.

b) Use of SYMBICORT TURBUHALER as the sole asthma inhaler

Use SYMBICORT TURBUHALER in this way only with the advice of your doctor and if your age is 18 and over.

Use SYMBICORT TURBUHALER every day. In this way, the emergence of asthma symptoms is prevented. You can take the following doses:

1 inhalation in the morning and 1 inhalation in the evening, or

2 inhalations in the morning or

2 inhalations in the evening

Your doctor may increase the dose to 2 inhalations twice a day.

Also, use SYMBICORT TURBUHALER as a 'reliever inhaler' when asthma symptoms occur.

If your asthma symptoms occur, 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 one time.

Keep your SYMBICORT TURBUHALER with you at all times so that you can use it when needed.

Normally, no more than 8 total inhalations per day are needed. However, your doctor may temporarily allow you to use up to 12 inhalations per day.

If you regularly need 8 or more inhalations a day, talk to your doctor. Your treatment may need to be changed.

Do not use more than 12 inhalations in 24 hours.

If you experience asthma symptoms during exercise, use SYMBICORT TURBUHALER as described here. However, do not use SYMBICORT TURBUHALER just before exercise to prevent the appearance of asthma symptoms.

Chronic Obstructive Pulmonary Disease (COPD)

To be used only in adults (18 years and older)

The recommended dose is 2 inhalations twice a day.

Application route and method

Preparing SYMBICORT TURBUHALER for first use:

Before you start using SYMBICORT TURBUHALER for the first time, you can prepare it for use as follows:
Unscrew the cover. You may hear a clicking sound when turning the cap.
Hold the TURBUHALER upright with the red dose loading collar facing down.
Turn the red dose loading collar in one direction as far as possible. Then the other

in the same direction as possible (depending on which direction you turned first).

it doesn't matter). You should hear a 'click' during this process.
Repeat this process a second time by turning the red dose loading collar in both directions.
Your TURBUHALER is now ready for use.

How Do You Take Inhalation?

Follow the instructions below each time you need to take an inhalation.

1. Unscrew the cover. You may hear a clicking sound when turning the cap.

2. Hold the TURBUHALER upright with the red dose loading collar facing down.

4. What are the possible side effects?

Like all medicines, there may be side effects in people who are sensitive to the substances contained in SYMBICORT Turbuhaler.

Like all medicines, there may be side effects in people who are sensitive to the substances contained in SYMBICORT Turbuhaler.

If any of the following occur, stop taking SYMBICORT TURBUHALER and IMMEDIATELY inform your doctor or go to the nearest hospital emergency department:
Swelling on your face, especially around your mouth (tongue and/or throat and/or difficulty swallowing), or rash with difficulty breathing (angioedema) and/or sudden fainting. This indicates that you may have an allergy. This is a rare condition and affects less than 1 in 1,000 people.
Sudden wheezing after inhaling your medicine. This is a very rare condition and affects less than 1 in 10,000 people.

These are all very serious side effects. If you have one of these, you may need emergency medical attention or hospitalization.

Other possible side effects Common (affects less than 1 in 10 people)
Palpitations (feeling your heart palpitations), shaking or shaking. If these effects occur, they are usually mild and will go away with continued use of SYMBICORT TURBUHALER.
Oral thrush (a fungal infection). It is less likely to occur if you rinse your mouth with water after using TURBUHALER.
Mild sore throat, cough and hoarseness.
Headache

Uncommon (affects less than 1 in 100 people)
feeling tired, irritable, or excited
Sleeping disorders
feeling dizzy
Nausea (feeling sick or vomiting)
fast heartbeat
bruises on the skin
muscle cramps

Rare (affects less than 1 in 1,000 people)
skin rash, itching
Bronchospasm (twitching of the muscles in the airways causing wheezing). If wheezing develops immediately after using SYMBICORT TURBUHALER, stop using SYMBICORT TURBUHALER and talk to your doctor immediately.
Drop in blood potassium level
irregular heartbeat

Very rare (affects less than 1 in 10,000 people)
Depression
Behavioral disorders, especially in children
Chest pain or tightness (angina pectoris)
Increase in blood sugar (glucose) level