Symbicort, 200 micrograms/6 micrograms per actuation, pressurised inhalation, suspension

• 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.

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

• if you are allergic to budesonide, formoterol or any of the other ingredients of this medicine (listed in section 6).

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.

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

Symbicort is not recommended for children and adolescents under 18 years.

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 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.

• 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.

Symbicort has no or negligible effect on your ability to drive or to use tools or machines.

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.

• 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.

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.
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.

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.

Your doctor, nurse or pharmacist may suggest that you use a spacer device (e.g. AeroChamber Plus Flow Vu or AeroChamber Plus). Follow the instructions in the leaflet that is packed with the spacer device.

• 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.

• The counter on the top of your inhaler tells you how many puffs (actuations) are left in your Symbicort. It starts with 120 puffs when it is full.
• Each time you take an inhalation, or release a puff into the air, the arrow counts down towards zero (‘0’).
• When the arrow first enters the yellow area, this means that there are about 20 puffs left.
• When the arrow reaches ‘0’, you must stop using your new Symbicort. Your inhaler may not feel empty and it may seem as though it still works. However, you will not get the right amount of medicine if you keep using it.

If you use more Symbicort than you should, contact your doctor or pharmacist for advice. The following effects may happen: trembling, headache or a rapid heartbeat.

• 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.

Before you stop using Symbicort, you should talk to your doctor or your pharmacist. If you stop using Symbicort the signs and symptoms of COPD may worsen.

• Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) rash 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 occurs, stop using your Symbicort 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.

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.
• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth out with water after using your Symbicort.
• 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, they could be symptoms of a lung infection:

• Fever or chills.
• Increased mucus production, change in mucus colour.
• Increased cough or increased breathing difficulties.

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 stop using Symbicort 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substances are budesonide and formoterol fumarate dihydrate. Each puff (actuation) contains 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.

The other ingredients are apaflurane (HFA 227), povidone and macrogol. This is a CFC-free inhaler.

This medicine contains fluorinated greenhouse gases. Each inhaler contains 10.6 g of apaflurane (HFC-227ea) corresponding to 0.034 tonne CO2 equivalent (global warming potential GWP= 3,220).

Symbicort is an inhaler containing your medicine. The pressurised canister, with attached dose indicator, contains a white suspension for inhalation. The canister is fitted into a red plastic actuator with a white plastic mouthpiece and an integrated grey plastic dust cap. Each inhaler contains 120 puffs (actuations) after it has been prepared for use. Each inhaler is individually packed in a foil wrapper containing a drying agent.

Symbicort, 200 micrograms/6 micrograms/actuation pressurised inhalation, suspension (Budesonide/Formoterol fumarate dihydrate) is available in packs of one inhaler.

The Marketing Authorisation for Symbicort is held by

Symbicort is manufactured by