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

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).

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.

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.

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.

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.