Symbicort® 200 micrograms/6 micrograms per actuation – patient leaflet, side effects, dosage

1. What Symbicort is and what it is used for

Symbicort is an inhaler that is used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 and older. 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

  any of 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.

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

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 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

  levothyroxine).

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, breast-feeding and fertility

• 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.

3. How to use Symbicort

• Always use this medicine exactly as your doctor

  has told you. 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.

  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).

  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. 1. Shake the inhaler well for at least 5 seconds to mix the contents of the aerosol canister.
2. 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. 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. 4. Release your finger(s) from the counter.
5. 5. Wait for 10 seconds, shake well and then repeat steps 3 and 4.
6. 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. 1. Shake the inhaler well for at least 5 seconds to mix the contents of the aerosol canister.
2. 2. Remove the mouthpiece cover by pressing lightly on the bumps on the side. Check that the mouthpiece is not blocked.
3. 3.

   Hold your inhaler upright (using one or both hands).

   Breathe out gently.

4. 4.

   Place the mouthpiece gently between your teeth.

   Close your lips.

5. 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. 6. Hold your breath for 10 seconds, or for as long as it is comfortable.
7. 7. Before you breathe out, release your finger from the counter and remove the inhaler from your mouth. Keep the inhaler upright.
8. 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. 9. Replace the mouthpiece cover.
10. 10. Rinse your mouth with water after your daily morning and evening doses and spit it out.

Using a spacer device

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.

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.

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Symbicort Leaflet patient pMDI

200/6mcg-120D UK

SGK is a Matthews International Corporation

Black P130 P485

10.5 pt

6.0 pt

How will I know when to replace my Symbicort?

• 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 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 use Symbicort

• 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 stop using Symbicort

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.

If you have any further questions on the use of this medicine, 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 happens to you, stop using Symbicort straightaway and talk to your doctor immediately:

• 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.

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.

• 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. Reporting of side effects

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.

5. How to store Symbicort

• Keep this medicine out of the sight and reach of

  children.

• Do not use this medicine after the expiry date

  which is stated on the label, carton and foil wrapper after EXP. The expiry date refers to the last day of that month.

• As with most inhaled medicines in pressurised

  canisters, the effect of this medicine may decrease when the canister is cold. For best results, this medicine should be at room temperature before use. Do not refrigerate or freeze. Protect from frost and direct sunlight.

• 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.

  • Always replace the mouthpiece cover firmly and snap into position after using your inhaler.
  • 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. Warning: The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister. The canister should not be broken, punctured or burnt, even when it seems empty.

6. Contents of the pack and other information

What Symbicort contains

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. What Symbicort looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer The Marketing Authorisation for Symbicort is held by AstraZeneca UK Limited, 1 Francis Crick Avenue, Cambridge, CB2 0AA, UK.

Symbicort is manufactured by AstraZeneca Dunkerque Production (AZDP) 224 Avenue de la Dordogne, 59640, Dunkerque, France.

This medicinal product is authorised in the Member States of the EEA under the following names: Country Trade name and strength Austria Symbicort 160 Mikrogramm /

4,5 Mikrogramm/Inhalation Druckgasinhalation, Suspension Belgium Symbicort 160 microgram /

4,5 microgram/inhalatie, aërosol, suspensie

Symbicort 160 microgrammes / 4,5 microgrammes/inhalation, suspension pour inhalation en flacon pressurisé

Symbicort 160 Mikrogramm / 4,5 Mikrogramm/Inhalation, Druckgasinhalation, Suspension Bulgaria Симбикорт 160 микрограма /

4,5 микрограма/впръскване Суспензия под налягане за инхалация Croatia Symbicort 160 mikrograma /

4,5 mikrograma po potisku, stlačeni inhalat, suspenzija

Cyprus Symbicort 160 μικρογραμμάρια /

4,5 μικρογραμμάρια/ψεκασμό Czech Republic Symbicort 160 micrograms /

4,5 micrograms/inhalation, suspension in pMDI

Denmark Symbicort 160 mikrogram /

4.5 mikrogram/inhalation

Estonia Symbicort

Finland Symbicort 160 mikrog /4.5 mikrog/ inhalaatio

France Symbicort 200/6 micro grammes par inhalation, suspension pour inhalation en flacon préssurisé

Germany Symbicort 160 Mikrogramm /

4,5 Mikrogramm pro Inhalation

Druckgasinhalation, Suspension Greece Symbicort 160 μικρογραμμάρια /

4,5 μικρογραμμάρια/ψεκασμό Hungary Symbicort 4,5 mikrogramm /

160 mikrogramm/ adag túlnyomásos inhalációs szuszpenzió

Iceland Symbicort 160 míkrógrömm /

4,5 míkrógrömm/ inhalation Ireland Symbicort 200 micrograms /

6 micrograms/inhalation

Italy Symbicort

Latvia Symbicort 160 mikrogrami /

4.5 mikrogrami/ inhalācijā, izsmidzinājumā, aerosols inhalācijām zem spiediena

Lithuania Symbicort 160 mikrogramų/

4,5 mikrogramo/išpurškime suslėgtoji įkvepiamoji suspensija

Luxembourg Symbicort 160 microgrammes /

4,5 microgrammes/inhalation, suspension pour inhalation en flacon pressurisé

Malta Symbicort 200 micrograms /

6 micrograms/inhalation

Netherlands Symbicort aërosol 200/6, 200 microgram /

6 microgram per dosis, aërosol, suspensie

Norway Symbicort 160 mikrogram /

4.5 mikrogram/ inhalasjon Poland Symbicort

Portugal Symbicort 160 microgramas /

4,5 microgramas/inalação

Suspensão pressurizada para inalação Romania Symbicort 160 micrograme /

4.5 micrograme/inhalaţie, suspensie de inhalat presurizată

Slovakia Symbicort 160 mikrogamov /

4,5 mikrogamov/inhalačná dávka, inhalačná suspenzia v tlakovom obale Slovenia Symbicort 160 mikrogramov /

4,5 mikrograma na vdih, inhalacijska suspenzija pod tlakom

Spain Symbicort 160 microgramos /

4,5 microgramos/inhalación suspensión para inhalación en envase a presión Sweden Symbicort 160 mikrogram /

4.5 mikrogram/inhalation

United Kingdom Symbicort 200 micrograms/

6 micrograms per actuation pressurised inhalation, suspension

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Symbicort 200/6 Reference number 17901/0293 This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in October 2022. © AstraZeneca 2022

Symbicort is a trademark of the AstraZeneca group of companies.

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