Symbicort prescribing information

Symbicort™ Turbuhaler™ inhalation powder 80/4.5, 160/4.5 and 320/9 micrograms/inhalation

Read all of this information carefully before you start taking/using this medicine.

This is the international prescribing information for Symbicort. It is important that you read your local prescribing information for full details, as prescribing information may vary from country to country.

If you have further questions, please ask your doctor or your pharmacist.

This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

What Symbicort Turbuhaler is and what it is used for Before you take Symbicort Turbuhaler How to take Symbicort Turbuhaler Possible side effects Storing Symbicort Turbuhaler Instructions for use

The active substances in Symbicort Turbuhaler are budesonide and formoterol.

The other ingredient is lactose.

What Symbicort Turbuhaler is and what it is used for

Symbicort Turbuhaler contains an inhalation powder. The powder is a mixture of the medicines budesonide and formoterol which have different ways of treating your airway disease (asthma or chronic obstructive pulmonary disease). Your airway disease is caused by an inflammation in the airways. Budesonide reduces and prevents this inflammation. Formoterol widens your airways and makes it easier for you to breathe. This effect starts within 1-3 minutes after you have inhaled the medicine and lasts for up to 12 hours. When you breathe in through the mouthpiece of the inhaler, the medicine follows your breath to your lungs (see “Instructions for use” at the end of this page).

Symbicort Turbuhaler contains either 60 or 120 doses (check the label).

Symbicort Turbuhaler 80/4.5 micrograms/inhalation: 1 inhalation contains 80 micrograms of budesonide and 4.5 micrograms of formoterol.

Symbicort Turbuhaler 160/4.5 micrograms/inhalation: 1 inhalation contains 160 micrograms of budesonide and 4.5 micrograms of formoterol.

Symbicort Turbuhaler 320/9 micrograms/inhalation: 1 inhalation contains 320 micrograms of budesonide and 9 micrograms of formoterol.

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Before you take Symbicort Turbuhaler

• Inform your doctor if you have had any unusual reactions to budesonide, formoterol or lactose (which are found in Symbicort Turbuhaler) or to any other medicines.
• In some cases Symbicort Turbuhaler should be used with particular care. You should always inform your doctor about other health-related problems, especially if you have or have had heart problems, diabetes, low blood potassium or a disturbed thyroid function.
• Always inform your doctor about all medicines you take, including those you have bought without a prescription. Some medicines for high blood pressure, heart conditions, fungal infections and some eye drops may alter the effect of Symbicort Turbuhaler if you use them at the same time.
• Symbicort Turbuhaler has been prescribed for your airway disease (asthma or chronic obstructive pulmonary disease). Do not use it for other problems unless your doctor tells you to. Never lend your Turbuhaler to someone else.

Pregnancy and breast-feeding

Before you start using Symbicort Turbuhaler, tell your doctor if you are pregnant, trying to become pregnant or if you are breast-feeding.

If you become pregnant while using Symbicort Turbuhaler you should contact your doctor as soon as possible.

Driving and using machines

Symbicort Turbuhaler does not affect your ability to drive or to operate any tools or machines.

Important information about the ingredient lactose in Symbicort Turbuhaler

Symbicort Turbuhaler contains very small amounts of lactose. It is unlikely that these will cause any problems in patients who are intolerant to lactose.

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How to take Symbicort Turbuhaler

• The dosage of Symbicort Turbuhaler is individual. It should be taken regularly, even when you have no symptoms. Your doctor will adjust the dose to the lowest one that controls your airway symptoms. Follow your doctor’s directions carefully. They may differ from the information contained in this page.
• Do not increase the dose of Symbicort Turbuhaler without talking to your doctor. You must contact your doctor as soon as possible if you need to use your rescue medicine inhaler more often than usual to control your airway disease. Always carry your rescue medicine with you.
• Before you start using Symbicort Turbuhaler for the first time, it is important that you read the “Instructions for use” at the end of this leaflet and follow the instructions carefully.
• Young children may have difficulties in handling Turbuhaler. It is therefore necessary to make sure that the child can follow the instructions for use.
• Remember: Always rinse your mouth out with water after each dosing occasion

Symbicort Turbuhaler 80/4.5 micrograms/inhalation

Asthma

Usual doses for adults and adolescents (12 years and older): 1-2 inhalations once or twice daily. Your doctor may prescribe doses up to a maximum of 4 inhalations twice daily.

Usual doses for children (4 years and older): 1-2 inhalations twice daily. Maximum daily dose: 4 inhalations.

Symbicort Turbuhaler 160/4.5 micrograms/inhalation

Asthma

Usual doses for adults and adolescents (12 years and older): 1-2 inhalations once or twice daily. Your doctor may prescribe doses up to a maximum of 4 inhalations twice daily.

Usual doses for children (4 years and older): 1 inhalation twice daily. Maximum daily dose: 2 inhalations.

Chronic obstructive pulmonary disease

Usual doses for adults (18 years and older): 2 inhalations twice daily. Maximum daily dose: 4 inhalations.

Symbicort Turbuhaler 320/9 micrograms/inhalation

Asthma

Usual doses for adults and adolescents (12 years and older): 1 inhalation once or twice daily. Your doctor may prescribe doses up to a maximum of 2 inhalations twice daily.

Children under 12 years: Symbicort Turbuhaler 320/9 micrograms/inhalation has not yet been fully tested in children under 12 years and should therefore not be used by children unless prescribed by your doctor.

Chronic obstructive pulmonary disease

Usual doses for adults (18 years and older): 1 inhalation twice daily. Maximum daily dose: 2 inhalations.

If you take more Symbicort Turbuhaler than you should

Use only the number of inhalations your doctor has prescribed. Using more will increase the risk of side effects.

The most common symptoms and signs that may occur after overdosage are:

• trembling
• headache
• rapid heartbeat

If you use too much Symbicort Turbuhaler over a longer period (months) it is possible that you may get side effects related to budesonide. If you think this may have happened to you or if any of the above mentioned symptoms bother you, please discuss it with your doctor.

If you forget to take a dose

If you forget to take an occasional dose of Symbicort Turbuhaler it is not necessary to compensate for the dose you missed. Just take the next dose as prescribed.

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Possible side effects

Like all medicines, Symbicort Turbuhaler may cause side effects. Usually you do not feel any side effects when you use Symbicort Turbuhaler. The side effects which have been seen with Symbicort Turbuhaler are no different from those previously seen with Pulmicort Turbuhaler (budesonide) and Oxis Turbuhaler (formoterol). However, be sure to contact your doctor if any of the following side effects bothers you or if any other unusual effects bother you:

Common side effects

• mild irritation in the throat
• coughing
• hoarseness
• thrush (fungal infection in mouth and throat)
• headache
• trembling
• rapid heartbeat

Less common side effects

• sleep difficulties
• restlessness, nervousness and anxiety
• dizziness
• sickness
• muscle cramps

Rare side effects

• skin rash and bruising
• itching
• spasm in the airways
• depression
• behavioural disturbances
• facial swelling
• high blood sugar levels
• chest pain
• irregular heartbeats

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How to store Symbicort Turbuhaler

Keep out of the reach and sight of children.

Do not store above 30°C.

Always replace the cover after using Symbicort Turbuhaler.

Use by date

Do not use Symbicort Turbuhaler after the expiry date marked on the inhaler and the outer carton.

Disposal

Always be sure to dispose of your used Turbuhaler in a responsible way, since some of the medicine will remain inside it. Ask your pharmacist for advice.

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Instructions for use

Please read the complete instructions carefully before you start to take your medication.

Symbicort™ Turbuhaler™ (budesonide/formoterol) Inhalation powder

Figure 1.

Turbuhaler is a multidose inhaler from which very small amounts of powder are administered (Figure 1). When you breathe in through Turbuhaler the powder is delivered to your lungs. It is therefore important that you inhale forcefully and deeply through the mouthpiece.

How to prepare a new inhaler for use

Before using Turbuhaler for the first time you need to prepare the inhaler for use.

1. Unscrew and lift off the cover. A rattling sound is heard when you unscrew the cover.
2. Figure 2.Hold the inhaler upright with the red grip downwards (Figure 2). Do not hold the mouthpiece when you turn the grip. Turn the grip as far as it will go in one direction and then back again as far as it will go. It does not matter which way you turn first. During this procedure you will hear a click. Perform the procedure twice.

The inhaler is now ready for use, and you should not repeat this procedure again. To take a dose, please continue according to the instructions below.

How to use Symbicort Turbuhaler

To administer one dose, simply follow the instructions below.

1. Unscrew and lift off the cover. A rattling sound is heard when you unscrew the cover.
2. Hold the inhaler upright with the red grip downwards (Figure 2). Do not hold the mouthpiece when you turn the grip. To load the inhaler with a dose turn the grip as far as it will go in one direction, and then back again as far as it will go. It does not matter which way you turn first. During this procedure you will hear a click.
3. Breathe out. Do not breathe out through the mouthpiece.
4. Figure 3.Place the mouthpiece gently between your teeth, close your lips and inhale forcefully and deeply through your mouth (Figure 3). Do not chew or bite on the mouthpiece.
5. Remove the inhaler from your mouth, before breathing out.
6. If more than one dose has been prescribed, repeat steps 2-5.
7. Replace the cover by screwing it back on tightly.
8. Rinse your mouth with water. Do not swallow.

NOTE!

Do not try to remove the mouthpiece since it is fixed to the inhaler. The mouthpiece can be rotated, but do not twist it unnecessarily. As the amount of powder dispensed is very small, you may not be able to taste it after inhalation. However, you can still be confident that you have inhaled the dose if you have followed the instructions.

If you by mistake perform the loading procedure more than once before taking your dose, you will still only receive one dose. The dose indicator will, however, register all the loaded doses.The sound heard if you shake the inhaler is not produced by the medication but by a drying agent.

How will I know when to replace my inhaler?

Figure 4.

The dose indicator (Figure 4) tells you approximately how many doses are left in the inhaler, starting with either 60 or 120 when full.

The indicator is marked in intervals of 10 doses. Therefore it does not show the loading of each individual dose.

You should be reassured that Turbuhaler delivers the dose even if you may not notice a movement in the dose indicator.

Figure 5.

For the last 10 doses, the background of the indicator is red. When the zero reaches the middle of the window (Figure 5), it is time for you to discard the inhaler

Please note that even when the dose indicator registers zero, it is still possible to turn the grip. However, the indicator stops moving and the zero remains in the window.

Cleaning

Wipe the outside of the mouthpiece regularly (once a week) with a dry tissue. Do not use water or other liquids when you clean the mouthpiece.

Disposal

Always be sure to dispose of your used Turbuhaler responsibly, since some of the medicine will remain inside it.

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THIS INFORMATION WAS PREPARED
5 March 2003