What is on this webpage

The following information answers some of the common questions people ask about Symbicort Turbuhaler. It does not contain all the information that is known about Symbicort Turbuhaler.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Symbicort Turbuhaler against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this information with the medicine. You may need to read it again.

What Symbicort Turbuhaler is used for

Symbicort Turbuhaler is used to treat the inflammation caused by your airway disease (asthma or chronic obstructive pulmonary disease (COPD)). It also widens the airways so that you find it easier to breathe. To get the best effect, you should use Symbicort Turbuhaler as prescribed by your doctor, even when you have no symptoms.

How Symbicort Turbuhaler works

Symbicort Turbuhaler contains both the medicines budesonide and eformoterol, 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.

Eformoterol works by widening your airways, making it easier for you to breathe. This effect starts within 1-3 minutes after inhaling the medicine and lasts for up to 12 hours. When you breathe in through the mouthpiece of the inhaler, your breath carries the medicine to your lungs. See the instructions on "How to use Turbuhaler" in the pack.

Symbicort Turbuhaler is not addictive.

Before you use Symbicort Turbuhaler

When you must not use it

Do not use Symbicort Turbuhaler if you are pregnant or breast feeding unless your doctor says to do so. Ask your doctor about the risks and benefits involved.

Do not use Symbicort Turbuhaler after the use by (expiry) date printed on the pack. It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.

Do not use Symbicort Turbuhaler if the packaging is torn or shows signs of tampering.

Symbicort Turbuhaler has been prescribed for your airway disease (asthma or chronic obstructive pulmonary disease). Do not use it to treat any other complaints unless your doctor tells you to.

Do not lend your Turbuhaler to anyone else even if their symptoms seem similar to yours.

You must tell your doctor if:

1. you have any allergies to

• Eformoterol, budesonide or lactose
• any other substances

If you have an allergic reaction, you may get a skin rash, hay fever or an asthma attack.

2. you have any of these medical conditions

• thyroid problems
• diabetes
• any heart problems
• problems with your potassium levels.

It may not be safe for you to take Symbicort Turbuhaler if you have any of these conditions.

Taking other medicines

You must tell your doctor if you are taking any other medicines, including

• medicines used to treat heart problems or high blood pressure
• medicines for glaucoma, including eye drops
• medicines used to treat fungal infections
• any other medicine that you buy at the chemist, supermarket or health food shop.

These medicines may be affected by Symbicort Turbuhaler, or may affect how well it works.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

If you have not told your doctor about any of these things, tell him/her before you take any Symbicort Turbuhaler.

Special warnings

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. Do not increase the dose of Symbicort Turbuhaler without talking to your doctor. Always carry your rescue medicine with you.

You should always be very careful with the use of medicines if you are pregnant or breastfeeding. If you do become pregnant while using Symbicort Turbuhaler you should contact your doctor as soon as possible.

Using Symbicort Turbuhaler

Your doctor will have explained why you are being treated with Symbicort Turbuhaler and told you what dose to take. Follow all directions given to you by your doctor carefully. They may differ from the information contained in this information.

If you have asthma your doctor will instruct you to use Symbicort Turbuhaler in either of the following ways:

A. Symbicort maintenance and reliever therapy for asthma

B. Symbicort maintenance therapy for asthma

If you have COPD your doctor will instruct you to use Symbicort Turbuhaler only as maintenance therapy:

C. Symbicort maintenance therapy for COPD.

The dosage of Symbicort Turbuhaler is individual and the maintenance dose should be taken even when you have no symptoms.

If you are instructed by your doctor to discontinue treatment with Symbicort Turbuhaler, follow any directions on dose reduction carefully.

Each pack of Symbicort Turbuhaler contains an instruction leaflet that tells you the correct way to use it. Please read this carefully.

Be sure to rinse your mouth out with water after using Symbicort Turbuhaler each time. If you don't you are more likely to develop thrush in your mouth.

A. Symbicort Maintenance and Reliever Therapy for Asthma

You take a maintenance dose of Symbicort Turbuhaler every day. You also use Symbicort Turbuhaler if you need extra doses for relief of asthma symptoms. This means that you use Symbicort Turbuhaler as your only inhaler both for regular daily use and as rescue medication. You will not need a separate inhaler for relief of symptoms.

Always carry Symbicort Turbuhaler with you for relief of symptoms. It is important that you contact your doctor if you find the treatment ineffective or if you exceed the highest recommended dose.

Symbicort 100/6 Turbuhaler

Usual doses for adults and adolescents 12 years and older:

• 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening.

• If you experience symptoms, take 1 additional inhalation and wait a few minutes. If you don't feel better, take another inhalation. You must not use more than 6 inhalations each time.

Usual doses for children (4 years and older)

• 1 inhalation once daily.

• If you experience symptoms, take 1 additional inhalation and wait a few minutes. If you don't feel better, take another inhalation. You must not use more than 4 inhalations each time.

Contact your doctor:

• If you need to take an increasing number of inhalations for symptom relief without getting better asthma control within 2 weeks, or

• If you regularly use more than 8 inhalations (4 inhalations for children) per day.

Never take more than 12 inhalations in total (8 inhalations for children) per day.

Symbicort 200/6 Turbuhaler

Usual doses for adults and adolescents 12 years and older:

• 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening. Your doctor may prescribe a maintenance dose of 2 inhalations twice daily.

• If you experience symptoms, take 1 additional inhalation and wait a few minutes. If you don't feel better, take another inhalation. You must not use more than 6 inhalations each time.

Contact your doctor:

• If you need to take an increasing number of inhalations for symptom relief without getting better asthma control within 2 weeks, or

• If you regularly use more than 8 inhalations (4 inhalations for children) per day.

Never take more than 12 inhalations in total (8 inhalations for children) per day.

B. Symbicort Maintenance Therapy for Asthma

You take a maintenance dose of Symbicort Turbuhaler every day. In addition, you use a separate inhaler, containing only a rapid-acting bronchodilator (airway widening medicine) for relief of asthma symptoms. This means that you use two separate inhalers.

Always carry your rescue medication with you for relief of symptoms. It is important that you contact your doctor if you find the treatment ineffective or if you exceed the highest recommended dose.

Symbicort 100/6 Turbuhaler

Usual doses for adults and adolescents 12 years and older:

• 1-2 inhalations once or twice daily.

• Maximum daily maintenance dose: 4 inhalations.

• Maximum dose during worsening asthma: 4 inhalations twice daily.

Usual doses for children (4 years and older)

• 1-2 inhalations twice daily

• Maximum daily dose: 4 inhalations

Symbicort 200/6 Turbuhaler

Usual doses for adults and adolescents 12 years and older:

• 1-2 inhalations once or twice daily

• Maximum daily maintenance dose: 4 inhalations.

• Maximum dose during worsening asthma: 4 inhalations twice daily.

Usual doses for children (4 years and older)

• 1 inhalation twice daily

• Maximum daily dose: 2 inhalations

Symbicort 400/12 Turbuhaler

Usual doses for adults and adolescents 12 years and older:

• 1 inhalation once or twice daily

• Maximum daily maintenance dose: 2 inhalations.

• Maximum dose during worsening asthma: 2 inhalations twice daily.

Usual doses for children (4 years and older)

• Not recommended for use in children.

If you have an Asthma Action Plan that you have agreed with your doctor, follow it closely at all times.

C. Symbicort Maintenance Therapy for Chronic Obstructive Pulmonary Disease (COPD)

Symbicort 200/6 Turbuhaler

Usual dose for adults (40 years and older)

• 2 inhalations twice daily

• Maximum daily maintenance dose: 4 inhalations

Symbicort 400/12 Turbuhaler

Usual dose for adults (40 years and older)

• 1 inhalation twice daily

• Maximum daily maintenance dose: 2 inhalations

If you forget to take it

If you miss a dose, it is not necessary to make up for the dose you have missed. Just take it when the next dose is due.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

Overdose

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 or pharmacist.

Please telephone your doctor or the National Poisons and Hazardous Chemicals Information Centre Ph: 0800 POISON (0800 764 766) or go to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too much Symbicort Turbuhaler, even if there are no signs of discomfort or poisoning.

While you are using Symbicort Turbuhaler

Take your Symbicort Turbuhaler regularly for your airway disease, even if you feel well.

See your doctor regularly to make sure that your airway disease is not getting worse. Your Symbicort Turbuhaler dose will be changed (up or down) by your doctor depending on your condition.

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.

Things you must not do

Do not stop taking Symbicort Turbuhaler for your airway disease unless you have discussed it with your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Symbicort Turbuhaler. Ask them to answer any questions you may have.

Usually you do not feel any side effects when you use Symbicort Turbuhaler. However, be sure to tell your doctor if any of the following side effects bother 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

• vomiting / nausea

• muscle cramps

Rare side effects

• skin rash and bruising

• itching

• irregular heartbeats

• facial swelling

• spasm in the airways

• high blood sugar levels

• depression

• chest pain

• behavioural symptoms

Important: This information alerts you to some of the situations when you should call your doctor. Other situations, which cannot be predicted, may arise. Nothing in this information should stop you from calling your doctor or pharmacist with any questions or concerns you have about using Symbicort Turbuhaler.

Tell your doctor if you notice anything else that is making you feel unwell or bothering you.

After using it

Cleaning

The Turbuhaler must be wiped with a clean dry tissue and must never get wet.

Full instructions on the right way to use and clean the Turbuhaler are inside each pack.

Storage

Symbicort Turbuhaler should be kept below 30°C. Always replace the cover after using Symbicort Turbuhaler.

Do not store Symbicort Turbuhaler or any other medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines.

Keep Symbicort Turbuhaler where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not leave Symbicort Turbuhaler in the car on hot days.

Disposal

Ask your pharmacist what to do with any Symbicort Turbuhaler you have left over if your doctor tells you to stop taking it, or you find that the expiry date has passed.

Product description

Symbicort Turbuhaler contains an inhalation powder which is a mixture of the active ingredients, budesonide and eformoterol. The other ingredient is lactose. Symbicort Turbuhaler contains very small amounts of lactose. It is unlikely that these will cause any problems in patients who are intolerant to lactose.

Symbicort Turbuhaler contains 60 or 120 doses.

Symbicort 100/6 Turbuhaler: One inhalation contains budesonide equivalent to 100 micrograms metered dose and eformoterol equivalent to 6 micrograms metered dose.

Symbicort 200/6 Turbuhaler: One inhalation contains budesonide equivalent to 200 micrograms metered dose and eformoterol equivalent to 6 micrograms metered dose.

Symbicort 400/12 Turbuhaler: One inhalation contains budesonide equivalent to 400 micrograms metered dose and eformoterol equivalent to 12 micrograms metered dose.

The inhaler is made of plastic parts.

Marketed by:

AstraZeneca Limited

P O Box 1301, Auckland.

Ph: (09) 623 6300 or 0800 363 200.

Trademarks herein are the property of the AstraZeneca Group.

Copyright - No part may be reproduced by any process without the prior written permission of AstraZeneca Limited

19 March 2007

What is Symbicort SMART?

Symbicort® Maintenance and Reliever Therapy (SMART®) is a way of managing your asthma.

It is a revolution because it combines all the inhalers that you normally need into one single inhaler to provide you with a more effective way to manage asthma.1-6

What is the difference between Symbicort SMART and my existing therapy?

Previously you would have probably used two or more inhalers to treat your asthma including:

• A preventer inhaler (usually brown or orange) to take every morning and at night.
• A symptom controller (usually green) to take every morning and night.
• A reliever inhaler (usually blue) to relieve symptoms as they occurred.

Symbicort SMART does all these things in one inhaler.

You only need one inhaler with Symbicort SMART

This inhaler should be taken every day as a preventer and also as a reliever when symptoms occur.1-6

Symbicort replaces your blue reliever inhaler and works just as quickly to relieve your symptoms.7

Symbicort can be used BOTH for regular daily maintenance treatment and as needed relief in response to symptoms.

How does SMART improve asthma control?

A blue reliever can only provide you with short-term relief. It does not treat the underlying causes of your asthma symptoms so does not work to prevent symptoms getting worse over time (typically a period of days).1

Symbicort SMART provides fast relief of your symptoms and also treats the underlying cause of your asthma symptoms with every inhalation.1-6

Studies worldwide show that using Symbicort SMART to treat the underlying cause of your asthma with every inhalation reduces severe asthma attacks more than using separate inhalers.1-6

When do I use SMART?

You should take Symbicort Turbuhaler in the morning and at night, like you currently take your preventer medication (usually a brown or orange and maybe a green inhaler as well).

You should also take your Symbicort Turbuhaler when you experience asthma symptoms, the way you currently use your reliever inhaler (usually blue).

You should therefore keep your Symbicort Turbuhaler with you at all times (replacing your blue reliever inhaler).

How many doses of SMART should I take?

Ask your doctor for a Symbicort SMART asthma action plan which will detail when to take your Symbicort Turbuhaler and how many times.

• Your doctor will instruct you on how many inhalations to take in the morning and at night.

• Your doctor will also tell you what to do if you are taking your Symbicort Turbuhaler too often as a reliever.

Frequently asked questions

What is Symbicort SMART?

Symbicort Maintenance And Reliever Therapy is a way to treat your asthma.

It is used in the morning, at night and as needed to treat any asthma symptoms (instead of a blue inhaler).

Why is the Symbicort SMART approach different?

Symbicort SMART not only relieves symptoms, but also treats the underlying cause of your asthma symptoms.

You will only need one inhaler for your asthma (instead of the two or three inhalers that you previously had).

Does this mean I can use other asthma treatments in the same way (e.g. Ventolin®, Bricanyl®, Salamol®, Pulmicort®, Beclazone®, Flixotide®, Oxis®, Serevent®, Seretide®)?

No, Symbicort Turbuhaler is the only inhaler that can be used as both your maintenance and reliever inhaler.

Does Symbicort Turbuhaler work like my blue inhaler?

In some ways Symbicort Turbuhaler works like your blue inhaler but in other ways it is very different.

• Symbicort works as fast as your blue inhaler to relieve your asthma symptoms quickly.

• Your blue inhaler only relieves symptoms while Symbicort also treats the underlying cause of your asthma symptoms.

Do I still need my blue inhaler?

No, you will not need your blue inhaler any longer. You should now use your Symbicort Turbuhaler to relieve your asthma symptoms.

Will I be taking extra medication that I don't need?

If you take Symbicort SMART as directed by your doctor you will not be taking any more medication than you need. If you have any concerns about your medication, please discuss this with your doctor.

How often should I take Symbicort SMART?

You doctor will instruct you on how many inhalations to take in the morning and at night. Your doctor will also tell you what to do if you are taking your Symbicort Turbuhaler too often as a reliever.

Ask your doctor for a Symbicort SMART asthma plan which will detail when to take your Symbicort inhaler and how many times.

What is the maximum number of Symbicort inhalations I can take in a day?

You generally should not need more than a couple of extra reliever inhalations of Symbicort in a day.

• You should not take more than 6 inhalations of Symbicort on a single occasion.

• You should not take more than 12 inhalations of Symbicort in a day.

Do I need to carry my Symbicort Turbuhaler with me?

Yes, you should carry your Symbicort Turbuhaler with you at all times for use as a reliever.

What should I do if I forget to take my maintenance dose of Symbicort?

If you miss a maintenance dose of Symbicort (i.e. either in the morning or at night), take your dose as soon as you remember.

What is an asthma action plan?

Your doctor should provide you with a personal asthma action plan to help you manage your asthma.

This plan will clearly tell you when to take your medication, how much medication to take and what are acceptable levels of asthma control.

It also explains how to recognise an asthma flare-up and what actions to take in these situations.

Ask your doctor for an asthma management plan if you don't already have one.

Is there an increased risk of side effects from using my Symbicort Turbuhaler as both maintenance and reliever therapy?

There is unlikely to be additional risks with Symbicort Maintenance And Reliever Therapy if taken as instructed by your doctor. However, care is needed to follow your doctor's instructions and to report any possible side effects if you are concerned.

All asthma medications have side effects. Serious side effects are rare with Symbicort. Please refer to www.medsafe.govt.nz or Consumer Medicine Information Sheet for a full list of potential side effects.

How do I use Symbicort Turbuhaler?

Follow the steps below and refer to the images:

1.Unscrew and remove the protective cover.

2. Hold the Turbuhaler upright. Twist the grip as far as it will go in one direction and then back again until you hear a click. Your Turbuhaler is now loaded with a dose.

3. Breathe out.

4. Place mouthpiece gently between your teeth. Breathe in forcefully and deeply through your Turbuhaler.

5. Breathe out. (You may need to repeat steps 2-5 depending on your prescription.

Dose indicator: When you see red in the window, it is time to get a new Turbuhaler.*

* When you see the dose indicator turn red do not worry if you can still hear powder in your Turbuhaler. The sound you hear is not medication but a drying agent. This helps to keep your medication dry.

Things you should know when using your Turbuhaler

• Do not wash Turbuhaler – if dirty, wipe with a dry tissue.
• Do not breathe out through Turbuhaler – you will make it damp inside.
• Do not forget to rinse your mouth out after inhaling your prescribed dose.
• Do not worry if you cannot taste or feel anything coming from Turbuhaler when you inhale – the amount of powder dispensed is very small.
• Do not worry if you cannot see that the dose indicator has moved for each individual dose loaded.

References

1. O'Byrne PM, et al. Am J Respir Crit Care Med 2005;171:129-136

2. Vogelmeier C, et al.Eur Resp J 2005;26:819-828.

3. Rabe KF, et al. Chest 2006;129:246-256.

4. Scicchitano R, et al. Curr Med Res Opin 2004;20:1403-1418.

5. Kuna P, et al. Int J Clin Pract 2007;61:725-736.

6. Rabe KF, et al. Lancet 2006;368:744-753.

7. Balanag VM et al. Pulm Pharm Ther 2006;19:139-147.

Your doctor will use a stepped approach to determine whether or not you are eligible for Symbicort. Each step and the treatment choice associated with it is based on the degree of control of your asthma symptoms. If you are not achieving satisfactory control of your asthma symptoms, your doctor may decide to move you to the next step.

	Step 1 : Reliever A reliever is a fast acting medicine, which is taken when needed to bring short term relief from asthma symptoms. Reliever inhalers are usually blue. Examples of reliever medicines are Bricanyl®, Salamol®, Ventolin® and Respigen®. If you regularly use a reliever and have daily symptoms of asthma, your doctor may consider adding a preventer to your treatment.
	Step 2 : Preventer A preventer is a medicine designed to reduce the inflammation in your airways, thereby controlling shortness of breath or asthma attacks. Preventer inhalers are usually brown, orange or dark red. Examples of preventer medicines are Beclazone®, Flixotide® and Pulmicort®. If you are using a preventer and continue to experience symptoms, your doctor may consider adding a symptom controller to your treatment.
	Step 3 : Symptom Controller A symptom controller or long acting inhaled reliever is a medicine that relaxes the muscles lining your airways for up to 12 hours. Symptom controllers don't have the same effect as preventers, and a preventer is always prescribed at the same time. Examples of symptom controller medicines are Oxis® and Serevent®. If you have been using a preventer and symptom controller for 3 months or more, your doctor may consider combination therapy.
	Step 4 : Combination Therapy Combination therapy contains both preventer and symptom controller medicine in one inhaler device. Examples of combination therapy are Symbicort® , Seretide® and Vannair®. Once on combination therapy, your doctor may consider Symbicort SMART, which combines the effects of all the inhalers that you normally use into one single inhaler. It is important to note that Symbicort Turbuhaler is the only inhaler that can be used in this way as both your maintenance and reliever inhaler.