Symbicort

Package leaflet: Information for the user

Symbicort, (80 micrograms + 2.25 micrograms)/dose, inhalation aerosol, suspension
budesonide + formoterol fumarate dihydrate
Please read all of this leaflet carefully before 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 personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the 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

What Symbicort is
Symbicort is a medicine delivered via an inhaler, used for the treatment of asthma in adults and adolescents aged 12 to 17 years. Symbicort contains two different active substances: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called "corticosteroids".
• Formoterol fumarate dihydrate belongs to a group of medicines called "long-acting beta2-adrenergic agonists" or "bronchodilators".

For what conditions is Symbicort used
Symbicort is used in the treatment of asthma and may be prescribed either as a single maintenance therapy or together with a separate reliever inhaler:
Some patients are prescribed two inhalers for the treatment of asthma: one containing Symbicort and a separate reliever inhaler.

• These patients use Symbicort daily. This helps prevent asthma symptoms.
• If these patients experience asthma symptoms, they use the reliever inhaler to help them breathe more easily.
  For some patients, Symbicort is prescribed as the only inhaler used in asthma treatment.
• These patients use Symbicort daily. This helps prevent asthma symptoms.
• These patients also use Symbicort when they feel the need for additional inhalations to relieve asthma symptoms and restore normal breathing, and as otherwise directed by their doctor also for the prevention of asthma symptoms (for example, during physical exercise or exposure to allergens). These patients do not need to use a separate reliever inhaler in such situations.

How Symbicort works

• Budesonide works by reducing and preventing inflammation and swelling in the lungs.
• Formoterol fumarate dihydrate works by relaxing the muscles in the airways, making breathing easier.

2. Information before using Symbicort

When not to use Symbicort:

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

Warnings and precautions
Before starting treatment with Symbicort, consult a doctor or pharmacist if the patient has:

• diabetes
• a respiratory tract infection
• high blood pressure or if there has ever been a heart condition (including heart rhythm disorders, very fast heartbeat, narrowed blood vessels, or heart failure)
• thyroid or adrenal gland disorders
• low blood potassium levels
• severe liver disease. If blurred vision or other visual disturbances occur during treatment with Symbicort, contact a doctor.

Children
This medicine should not be used in children under 12 years of age.
Symbicort and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• β-blockers used for high blood pressure – such as atenolol or propranolol
• Eye drops – such as timolol used in the treatment of glaucoma
• Medicines used for rapid or irregular heartbeat – such as quinidine
• Medicines such as digoxin – often used in the treatment of heart failure
• Diuretics (water pills) used for high blood pressure – such as furosemide
• Oral steroids – such as prednisolone
• Xanthine derivatives – such as theophylline or aminophylline. These are medicines often used in the treatment of asthma
• Other bronchodilators – such as salbutamol
• Antidepressants – such as amitriptyline and nefazodone
• Phenothiazine medicines – such as chlorpromazine and prochlorperazine
• Medicines used for HIV infection – such as ritonavir
• Medicines used for infections – such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin
• Medicines used in Parkinson's disease – such as levodopa
• Medicines used for thyroid disorders – such as levothyroxine. If any of the above apply to the patient or if the patient has any doubts, talk to a doctor or pharmacist before using Symbicort.

Also inform the doctor or pharmacist if general anesthesia is planned due to a surgical or dental procedure.
Pregnancy and breastfeeding

• If the patient is pregnant or planning to become pregnant, she should consult a doctor before using Symbicort – Symbicort should not be used without medical advice.
• If a patient being treated with Symbicort becomes pregnant, she should not stop taking Symbicort but should contact her doctor immediately.
• If the patient is breastfeeding, she should talk to her doctor before using Symbicort.

Driving and operating machinery
Symbicort has no effect or has a negligible effect on the ability to drive vehicles, use tools, or operate machinery.

3. How to use Symbicort

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.

• It is important to use Symbicort every day, even if you currently have no asthma symptoms.
• Your doctor will regularly monitor your asthma symptoms.
• Your doctor may consider adding oral steroid tablets to your usual treatment during periods of stress (e.g. during a respiratory infection or before surgery).

Symbicort may be prescribed as the only inhaler for asthma treatment or together with a separate
reliever inhaler. You should take two puffs (inhalations) of Symbicort to receive a full dose. The amount
of Symbicort you should take and the duration of treatment depend on your doctor’s prescription.
a) If Symbicort has been prescribed together with a separate reliever inhaler, read section “a) Using
Symbicort with a separate reliever inhaler”.
b) If Symbicort has been prescribed as the only inhaler for asthma treatment, read section “b) Using
Symbicort as the only inhaler for asthma treatment”.

a) Using Symbicort with a separate relie wan inhaler
You should use Symbicort every day. This helps prevent asthma symptoms.

Adults (aged 18 years and older)

• The usual dose is 2–4 inhalations twice daily.
• Your doctor may increase the dose to 8 inhalations twice daily.
• If your asthma symptoms are well controlled, your doctor may advise you to take the medicine once daily.

Adolescents (aged 12 to 17 years)

• The usual dose is 2–4 inhalations twice daily.
• If your asthma symptoms are well controlled, your doctor may advise you to take the medicine once daily.

Your doctor (or nurse) will help you manage your asthma symptoms. They will adjust your dose to the
lowest amount that controls your asthma. However, do not adjust the dose or stop treatment on your own
without first consulting your doctor (or nurse).
If asthma symptoms occur, use the separate reliever inhaler to treat them.

• Always carry your reliever inhaler with you so you can use it whenever needed.
• Do not use Symbicort to treat asthma symptoms – use the reliever inhaler instead.

b) Using Symbicort as the only inhaler for asthma treatment
Symbicort should be used this way only if prescribed by your doctor and if you are 12 years of age or
older.
You should use Symbicort every day. This helps prevent asthma symptoms. You may use the medicine
according to one of the following dosing regimens:

• 2 inhalations in the morning and 2 in the evening, or
• 4 inhalations in the morning, or
• 4 inhalations in the evening.

Your doctor may increase the dose to 4 inhalations twice daily.
Symbicort should also be used as a reliever medicine to treat asthma symptoms when they occur and to
prevent asthma symptoms (e.g. during physical exercise or exposure to allergens).

• If you experience asthma symptoms, take 2 inhalations and wait a few minutes.
• If you do not feel better, take another 2 inhalations.
• Do not take more than 12 inhalations at one time.

Always carry your Symbicort inhaler with you so you can use it whenever needed.
Usually, there is no need to use more than a total of 16 inhalations per day. However, your doctor may
allow you to use up to 24 inhalations per day for a limited period.
If you regularly need to use 16 or more inhalations per day, you should make an appointment with your
doctor or nurse. Your treatment may need to be changed.
Do not use more than 24 inhalations of this medicine in one day.
If you experience asthma symptoms during physical exercise, use Symbicort as described here. It is
important to discuss with your doctor the use of Symbicort for preventing asthma symptoms; the frequency
of physical exercise and exposure to allergens may affect your prescribed treatment.

Symbicort and oral steroids
If you are taking oral steroid tablets for asthma, your doctor may reduce the number of oral steroid
tablets when starting Symbicort. If you have been taking oral steroids for a long time, your doctor may
occasionally recommend blood tests. After reducing the dose of oral steroids, your general well-being may
worsen, even though your respiratory symptoms may improve. Symptoms may include:

• nasal congestion or watery nasal discharge
• weakness
• joint or muscle pain
• rash (skin eruption). Contact your doctor immediately if you experience any of the following:
• headache
• fatigue
• nausea
• vomiting. If you experience any of the above symptoms, contact your doctor immediately – other medicines may be needed. If you have any doubts about continuing Symbicort, consult your doctor.

Use in children
Other forms of this medicine are suitable for use in children; please consult your doctor or pharmacist.

Important information about asthma symptoms
If you experience shortness of breath or wheezing while using Symbicort, continue using Symbicort but
contact your doctor as soon as possible, as additional treatment may be needed.
Contact your doctor immediately if:

• breathing difficulties worsen or you frequently wake up at night due to asthma.
• you experience chest tightness in the morning after waking up or chest tightness lasts longer than usual.

These symptoms may indicate inadequate asthma control and may require immediate initiation of a
different or additional treatment.

Information about the Symbicort inhaler

• Before starting to use Symbicort, remove it from the foil packaging. Discard the foil packaging and the desiccant (moisture absorber) inside. Do not use the inhaler if the desiccant has escaped from its sealed pouch.

• After removing the inhaler from the foil, it can be used for 3 months. Write the expiry date (3 months after opening the foil pack) on the inhaler label to help remember when to stop using it.
• The parts of the inhaler are shown in the picture. The inhaler is pre-assembled in the packaging. If the canister becomes loose, reattach it to the inhaler and continue using it.

Preparing the Symbicort inhaler for use
Prepare the inhaler for use in the following situations:

• When using a new Symbicort inhaler for the first time.
• If the inhaler has not been used for more than 7 days.
• If the inhaler has been dropped.

To prepare the inhaler, follow these steps:

1. Shake the inhaler vigorously for at least 5 seconds to mix the contents of the aerosol canister.
2. Remove the protective cap from the mouthpiece by gently pressing the side tabs. The cap will remain attached to the inhaler by a strap.
3. Hold the inhaler upright. Press the dose counter (at the top of the inhaler) to release one puff into the air. You may use one or both hands, as shown in the pictures.

4. Release pressure on the dose counter.
5. Wait 10 seconds, shake the device vigorously, and repeat steps 3 and 4.
6. The inhaler is now ready for use.

Using the inhaler
To take an inhalation, always follow these steps:

1. Shake the inhaler vigorously for at least 5 seconds to mix the contents of the aerosol canister.
2. Remove the protective cap from the mouthpiece by gently pressing the side tabs. Check that the mouthpiece is not blocked.
3. Hold the inhaler upright (with one or both hands). Breathe out calmly.

4. Gently place the inhaler mouthpiece between your teeth. Close your lips around it (seal your lips around the mouthpiece).
5. Begin to breathe in slowly and deeply through your mouth. Firmly press the dose counter (at the top of the inhaler) to release the dose. Continue inhaling for a few seconds after pressing the counter. Inhaling at the same time as pressing the counter ensures the medicine reaches your lungs.
6. Hold your breath for 10 seconds or as long as possible without discomfort.
7. Before exhaling, release pressure on the counter and remove the inhaler from your mouth. Keep the inhaler upright.
8. Then breathe out slowly. To take a second inhalation, shake the inhaler vigorously for at least 5 seconds and repeat steps 3 to 7.
9. Replace the protective cap on the mouthpiece.
10. Rinse your mouth with water after taking the morning and evening doses. Do not swallow the water.

Using a spacer device
Your doctor, nurse, or pharmacist may recommend using a spacer device (e.g. AeroChamber Plus
Flow Vu or AeroChamber Plus). Follow the instructions provided in the leaflet included with the
spacer device.

Cleaning the Symbicort inhaler

• Wipe the inside and outside of the mouthpiece with a dry cloth at least once a week.
• Do not use water or other liquids.
• Do not detach the medicine canister from the inhaler.

How to know when to replace your Symbicort inhaler

• The counter at the top of the inhaler shows how many inhalations remain in the Symbicort inhaler. Initially, it shows 60 or 120 inhalations when the canister is full.

• Each time you take an inhalation or release a puff into the air, the arrow moves, counting down to zero (“0”).
• When the arrow enters the yellow zone, approximately 20 inhalations remain.

• When the arrow reaches “0”, stop using the Symbicort inhaler. The inhaler may still seem to work and feel full, but continued use will not deliver the correct dose of medicine.

Using more than the recommended dose of Symbicort
It is important to take this medicine exactly as prescribed or directed by your doctor. Do not exceed the
prescribed dose without consulting your doctor.
If you use more than the recommended dose of Symbicort, consult your doctor or pharmacist. Possible
symptoms include tremors, headache, or rapid heartbeat.

Missed dose of Symbicort

• If you miss an inhalation, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a missed inhalation.

Stopping use of Symbicort
Before stopping Symbicort, consult your doctor or pharmacist.
Stopping Symbicort may cause your asthma symptoms to worsen.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Symbicort must be discontinued immediately and medical advice sought without delay
if the patient develops any of the following symptoms:

• Swelling of the face, particularly around the mouth (tongue and (or) throat and (or) difficulty swallowing), rash or urticaria occurring simultaneously with breathing difficulties (angioedema) and (or) sudden feeling of weakness (fainting). These may indicate an allergic reaction. Such reactions are rare, occurring in fewer than 1 in 1,000 patients.
• Sudden worsening of wheezing or breathlessness occurring immediately after inhaling Symbicort. If either of these symptoms occurs, Symbicort must be discontinued immediately and a rescue inhaler used, if available. Medical advice must be sought immediately, as a change in treatment may be necessary. These symptoms occur very rarely, in fewer than 1 in 10,000 patients.

Other possible adverse reactions:
Common (may occur in fewer than 1 in 10 patients)

• Palpitations (awareness of heartbeat), tremors. If such symptoms occur, they are usually mild and typically resolve during continued treatment with Symbicort.
• Oral candidiasis (fungal infection in the mouth). The risk of oral candidiasis is reduced if the patient rinses the mouth with water after each morning and evening dose of Symbicort.
• Mild sore throat, cough, and hoarseness.
• Headache.

Uncommon (may occur in fewer than 1 in 100 patients)

• Anxiety, nervousness, or restlessness.
• Sleep disturbances.
• Dizziness.
• Nausea.
• Rapid heartbeat.
• Skin bruising.
• Muscle cramps.
• Blurred vision.

Rare (may occur in fewer than 1 in 1,000 patients)

• Rash, itching.
• Bronchospasm (constriction of the airway muscles causing wheezing). If wheezing occurs immediately after taking the medicine, Symbicort must be discontinued and medical advice sought immediately.
• Low blood potassium levels.
• Irregular heartbeat.

Very rare (may occur in fewer than 1 in 10,000 patients)

• Depression.
• Behavioral changes, particularly in children.
• Pain or pressure in the chest (symptoms of angina).
• Increased blood sugar (glucose) levels.
• Taste disturbances, such as unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled glucocorticosteroids may affect the body's production of steroid hormones,
particularly when used long-term at high doses. Symptoms include:

• Changes in bone mineral density (osteoporosis)
• Cataract (clouding of the lens in the eye)
• Glaucoma (increased pressure in the eye)
• Slowed growth rate in children and adolescents
• Adrenal suppression (affecting the small glands located near the kidneys).

The likelihood of these effects is considerably lower with inhaled glucocorticosteroids
than with oral glucocorticosteroid tablets.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Symbicort

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label of the container, carton, and foil pack after "EXP". The expiry date refers to the last day of the stated month.
• After removing the inhaler from the foil packaging, it can be used for 3 months. Enter the expiry date (3 months after opening the foil packaging) on the label of the inhaler to help you remember when to stop using the device.
• As with most pressurized inhalation medicines, the effectiveness of this medicine may be reduced if the container is cold. For best results, store this medicine at room temperature before use.
• Do not store in a refrigerator or freeze. Protect from frost and direct sunlight.
• After using the inhaler, always replace the protective cap firmly over the mouthpiece and snap it into the correct position.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment. Warning: The container contains pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce the container. Even if the container appears to be empty, do not crush, puncture, or burn it.

6. Contents of the pack and other information

What Symbicort contains
The active substances in this medicine are budesonide and formoterol fumarate dihydrate. Each inhalation of
Symbicort contains 80 micrograms of budesonide and 2.25 micrograms of formoterol fumarate dihydrate.
The other ingredients are: apaflurane (HFA 227), povidone K 25 and macrogol 1000. The inhaler does not contain
chlorofluorocarbons.
What Symbicort looks like and contents of the pack
Symbicort is a medicine in an inhaler. The pressurised container, with an integrated dose counter, contains a white
suspension for inhalation. The container is fitted with a red plastic metering valve and a white plastic mouthpiece, and has an integrated grey plastic cap. Each inhaler contains 60 or 120 doses after preparation for use. Each inhaler is individually packed in a foil pack containing a desiccant.
Symbicort (80 micrograms + 2.25 micrograms)/dose, pressurised inhalation, suspension (budesonide + formoterol fumarate dihydrate) is available in packs containing one inhaler.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
AstraZeneca AB
151 85 Södertälje
Sweden
Manufacturer:
AstraZeneca Dunkerque Production
224 Avenue de la Dordogne
59640 Dunkerque
France
This medicinal product is authorised in the Member States of the European Economic Area
under the following names:
Austria: Symbicort 80 Mikrogramm/2,25 Mikrogramm/Inhalation Druckgasinhalation, Suspension; Belgium:
Symbicort 80 microgram/2,25 microgram/inhalatie, aërosol, suspensie; Symbicort 80 microgrammes/2,25
microgrammes/inhalation, suspension pour inhalation en flacon pressurisé; Symbicort 80 Mikrogramm/2,25
Mikrogramm/Inhalation, Druckgasinhalation, Suspension; Bulgaria: Симбикорт 80 микрограма/2,25
микрограма/впръскване Суспензия под налягане за инхалация; Croatia: Symbicort 80
mikrograma/2,25 mikrograma po potisku, stlačeni inhalat, suspenzija; Cyprus: Symbicort 80
μικρογραμμάρια/2,25 μικρογραμμάρια/ψεκασμό; Czech Republic: Symbicort 80 micrograms/2,25
micrograms/inhalation, suspension in pMDI; Denmark: Symbicort 80 mikrogram/2.25 mikrogram/inhalation;
Estonia: Symbicort; Finland: Symbicort 80 mikrog/2.25 mikrog/inhalaatio; France: Symbicort 100/3
microgrammes par inhalation, suspension pour inhalation en flacon préssurisé; Greece: Symbicort 80
μικρογραμμάρια/2,25 μικρογραμμάρια/ψεκασμό; Hungary: Symbicort 2,25 mikrogramm/80 mikrogramm/
adag túlnyomásos inhalációs szuszpenzió; Iceland: Symbicort 80 míkrógrömm/2,25 míkrógrömm/
inhalation; Italy: Symbicort; Latvia: Symbicort 80 mikrogrami/2.25 mikrogrami/ inhalācijā,
izsmidzinājumā, aerosols inhalācijām zem spiediena; Lithuania: Symbicort 80 mikrogramų/2,25
mikrogramo/išpurškime suslėgtoji įkvepiamoji suspensija; Luxembourg: Symbicort 80 microgrammes/2,25
microgrammes/inhalation, suspension pour inhalation en flacon pressurisé; Malta: Symbicort 100
micrograms/3 micrograms/inhalation, pressurised inhalation, suspension; Netherlands: Symbicort aërosol
100/3, 100 microgram/3 microgram per dosis, aërosol, suspensie; Norway: Symbicort 80 mikrogram/2.25
mikrogram/ inhalasjon; Poland: Symbicort; Portugal: Symbicort 80 microgramas/2,25
microgramas/inalação Suspensão pressurizada para inalação; Romania: Symbicort 80 micrograme/2,25
micrograme/inhalație, suspensie de inhalat presurizată; Slovakia: Symbicort 80 mikrogramov/2,25
mikrogramov/inhalačná dávka, inhalačná suspenzia v tlakovom obale; Slovenia: Symbicort 80
mikrogramov/2,25 mikrograma na vdih, inhalacijska suspenzija pod tlakom; Spain: Symbicort 80
microgramos/2,25 microgramos/inhalación suspensión para inhalación en envase a presión; Sweden:
Symbicort 80 mikrogram/2.25 mikrogram/inhalation; United Kingdom: Symbicort 100 micrograms/3
micrograms actuation pressurised inhalation, suspension