SYMBICORT RAPIHALER®

Budesonide and eformoterol fumarate dihydrate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Symbicort Rapihaler. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

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

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

Keep this leaflet with your Symbicort Rapihaler. You may need to read it again.

What Symbicort Rapihaler is used for?

Symbicort Rapihaler is a pressurised metered dose inhaler (pMDI) or "puffer".

Symbicort Rapihaler is inhaled into the lungs for the treatment of asthma or Chronic Obstructive Pulmonary Disease (COPD).

Symbicort Rapihaler contains two active ingredients in one inhaler: budesonide and eformoterol.

• Budesonide belongs to a group of medicines called corticosteroids. Budesonide acts directly on your airways to reduce inflammation.
• Eformoterol belongs to a group of medicines called beta-2-agonists. Eformoterol opens up the airways to help you breathe more easily.

ASTHMA 
Asthma is a disease where the airways of the lungs become narrow and inflamed (swollen), making it difficult to breathe. This may be due to an allergy to house dust mites, smoke, air pollution or other things that irritate your lungs.

The budesonide in Symbicort helps to improve your condition and to prevent asthma attacks from occurring. It is a 'preventer' and needs to be taken regularly.

The eformoterol in Symbicort helps you breathe more easily. It should also be taken regularly to help control your symptoms.

Symbicort Rapihaler when used regularly will help prevent asthma attacks and make it easier to breathe normally.

Symbicort Rapihaler can also be used as a "reliever" to treat your symptoms when your asthma gets worse. When used regularly, it will help prevent asthma attacks.

Chronic Obstructive Pulmonary Disease (COPD) 
COPD (which includes chronic bronchitis and emphysema) is a long-term lung disease. There is often permanent narrowing and persistent inflammation of the airways. Symptoms may include difficulty in breathing (breathlessness or wheezing), coughing and increased sputum.

Symbicort Rapihaler when used as prescribed will help to control your COPD symptoms (ie breathing difficulties).

Ask your doctor if you have any questions about why Symbicort Rapihaler has been prescribed for you. Your doctor may have prescribed it for another reason.

Symbicort Rapihaler is not addictive.

This medicine is available only with a doctor's prescription.

Before you use Symbicort Rapihaler

When you must not use it

Do not use Symbicort Rapihaler if you have an allergy to:

• any medicine containing eformoterol or budesonide
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

• rash, itching or hives on the skin
• shortness of breath, wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body

Do not give Symbicort Rapihaler to a child under 12 years, unless directed by the child's doctor. Symbicort Rapihaler is not recommended for use in children under 12 years.

Do not use Symbicort Rapihaler after the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using this medicine, talk to your doctor.

Before you start to use it

If you have asthma, ask your doctor or pharmacist if you have any questions about your Asthma Action Plan.Your doctor should give you a personal Asthma Action Plan to help manage your asthma. This plan will include what medicines to take regularly to control your asthma, as well as what "reliever" medicines to use when you have sudden attacks of asthma. Your doctor may have prescribed Symbicort Rapihaler for you to use as both a "preventer" and "reliever" medicine.

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• thyroid problems
• diabetes
• heart problems
• liver problems
• tuberculosis (TB)
• low levels of potassium in the blood

It may not be safe for you to take Symbicort Rapihaler if you have, or have had, any of these conditions.

Tell your doctor if you currently have an infection. If you take Symbicort Rapihaler while you have an infection, the medicine may hide some of the signs of an infection. This may make you think, mistakenly, that you are better or that it is not serious.

Tell your doctor if you are pregnant or intend to become pregnant or breastfeeding. Your doctor will discuss the possible risks and benefits of using Symbicort Rapihaler during pregnancy and while breastfeeding.

If you have not told your doctor or pharmacist about any of the above, tell them before you start using Symbicort Rapihaler.

Taking other medicines

Tell your doctor or pharmacist if you are using any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Symbicort Rapihaler may interfere with each other. These include:

• medicines used to treat heart problems or high blood pressure such as beta-blockers, diuretics and antiarrhythmics (disopyramide, procainamide and quinidine)
• medicines used to treat glaucoma such as beta-blockers
• medicines used to treat depression or other mood/mental disorders such as tricyclic antidepressants, monoamine oxidase inhibitors and phenothiazines
• medicines used to treat hayfever, coughs, colds and runny nose such as antihistamines
• medicines used to treat fungal infections (eg ketoconazole)
• xanthine derivatives (eg theophylline) which are a class of medicines used to treat asthma and COPD.

These medicines may be affected by Symbicort Rapihaler or may affect how well it works. You may need different amounts of your medicines, or you may need to use different medicines. Your doctor or pharmacist will advise you.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using Symbicort Rapihaler.

How to use Symbicort Rapihaler

How to use your Rapihaler

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

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

If you are not sure how to use the Rapihaler, ask your doctor or pharmacist to show you how.

How much to take

ASTHMA (Adults and children 12 years and over) 
Your doctor should give you a personal Asthma Action Plan to help manage your asthma. This plan will include what medicines to take regularly to control your asthma as well as what "reliever" medicines to use when you have a sudden attack of asthma.

Your doctor may have prescribed Symbicort Rapihaler for you to use as both a "preventer" and "reliever" medicine.

Symbicort Rapihaler 50/3 and 100/3 
If you are using Symbicort Rapihaler (50/3 or 100/3) as a "preventer" medicine, the usual dose is 2 or 4 puffs twice a day.

Your doctor may also tell you to use Symbicort Rapihaler as a "reliever" medication. This means that Symbicort Rapihaler can be used when needed to provide relief of your asthma symptoms. If you are using Symbicort Rapihaler (50/3 or 100/3) as both a "preventer" and "reliever" medicine, do not use more than 12 puffs on a single occasion or more than 24 puffs in any day. If your symptoms continue to worsen over three days, despite using additional puffs, tell your doctor.

Symbicort Rapihaler 200/6 
Symbicort Rapihaler 200/6 is not recommended to be used as a "reliever" medication.

As a "preventer" medicine, the usual dose is 2 puffs twice a day.

• Adults (18 years and over): 
  Symbicort Rapihaler 200/6 can also be used as 4 puffs twice a day. Your doctor may tell you to take less if your asthma has been under control.

If your asthma has been under control for some time, your doctor may tell you to take less puffs of Symbicort Rapihaler or prescribe you a lower strength of Symbicort Rapihaler.

If you are using more inhalations of your reliever medicine or you are wheezing or breathless more than usual tell your doctor as your asthma may be getting worse.

COPD (Adults) 
The usual dose (also maximum recommended dose) is 2 puffs of Symbicort Rapihaler 200/6 twice a day.

Your doctor should tell you the best way to manage your symptoms and any flare ups. This may include additional medicines (such as "reliever" medicines) to use when you have sudden attacks of breathlessness.

If you are using more inhalations of your reliever medicine or you are wheezing or breathless more than usual tell your doctor.

If your COPD gets worse, your doctor may give you some additional medicines (such as oral corticosteroids or antibiotics).

If you forget to use it

If you miss a dose of Symbicort Rapihaler, take your dose as soon as you remember.

Do not use a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are using Symbicort Rapihaler as a "reliever" medication, consult your doctor on the correct use of the product.

If you are not sure what to do, ask your doctor or pharmacist.

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

How long to use it

Use Symbicort Rapihaler every day even if you feel well.

Symbicort Rapihaler helps control your asthma or COPD, but does not cure it.

Keep using it for as long as your doctor tells you to. Do not stop using it unless your doctor tells you to.

If you take too much (overdose)

Telephone your doctor, pharmacist or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have used too much Symbicort Rapihaler.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you use too much Symbicort Rapihaler, you may feel sick or vomit, have a fast or irregular heartbeat, a headache, tremble, feel shaky, agitated, anxious, tense, restless, excited or be unable to sleep.

While you are using Symbicort Rapihaler

Things you must do

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

Keep using Symbicort Rapihaler for as long as your doctor tells you to, even if you are feeling well.

See your doctor regularly to make sure that your asthma or COPD is not getting worse.

Have your "reliever" medicine available at all times. As advised by your doctor, this may be your Symbicort Rapihaler (50/3 or 100/3) or another "reliever" medication.

Rinse your mouth out with water after taking your regular morning and/or evening dose of Symbicort Rapihaler and spit this out. If you don't you are more likely to develop thrush in your mouth. You do not have to rinse your mouth if you have to take occasional extra puffs of Symbicort Rapihaler for relief of asthma symptoms.

Tell any other doctors, dentists and pharmacists who are treating you that you are using Symbicort Rapihaler.

If you become pregnant while using Symbicort Rapihaler, tell your doctor.

Patients taking Symbicort Rapihaler for COPD should tell their doctor or pharmacist immediately if they notice any signs of pneumonia (infection of the lung). Signs include fever or chills, increased mucus production or change in mucus colour, increased cough or increased breathing difficulties. Pneumonia is a serious medical condition and will require urgent medical attention.

Things you must not do

Do not take any other medicines for your asthma or COPD without checking with your doctor.

Do not give Symbicort Rapihaler to anyone else, even if they have the same condition as you.

Do not use Symbicort Rapihaler to treat any other complaints unless your doctor tells you to.

Do not stop using Symbicort Rapihaler without checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how Symbicort Rapihaler affects you.

Symbicort Rapihaler may cause dizziness, light-headedness, tiredness or drowsiness in some people when they first start using it.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Symbicort Rapihaler.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

If you get any side effects, do not stop using Symbicort Rapihaler without first talking to your doctor or pharmacist.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

• sore, yellowish, raised patches in the mouth (thrush)
• hoarse voice
• irritation of the tongue and mouth
• coughing

These are less likely to happen if you rinse your mouth out after every time you use your usual morning and/or evening dose of Symbicort Rapihaler.

• Trembling or shakiness
• Feeling anxious, nervous, restless or upset
• Fast or irregular heart rate or pounding heart
• Chest pain
• Headache
• Feeling light-headed or dizzy
• Thirsty
• Unpleasant taste in your mouth
• Nausea (feeling sick)
• Diarrhoea
• Difficulty sleeping
• Muscle twitching or cramps
• Skin rash
• Tiredness
• Weight gain
• Skin bruising

These side effects are usually mild.

Tell your doctor or pharmacist immediately if you notice any of the following:

• Difficulty breathing or worsening of your breathing problems
• Swelling of the face, lips, tongue or other parts of the body
• Severe rash
• Mood changes

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

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

Other side effects not listed above may occur in some patients.

Some of these side effects (for example, changes in blood sugars) can only be found when your doctor does tests from time to time to check your progress.

Corticosteroids taken into the lungs for long periods (eg 12 months) may affect how children/adolescents grow. In rare cases, some children/adolescents may be sensitive to the growth effects of corticosteroids, so the doctor may monitor a child's/adolescent's height.

After using Symbicort Rapihaler

Cleaning

The Rapihaler mouthpiece must be wiped with a clean dry cloth/tissue and must never get wet. Full instructions on the right way to use and clean Symbicort Rapihaler are inside each pack.

Storage

Keep your Symbicort Rapihaler in a cool dry place where the temperature stays below 30°C.

Always replace the mouthpiece cover after using Symbicort Rapihaler.

Discard Symbicort Rapihaler within 3 months after removal from the foil pouch.

Do not store Symbicort Rapihaler or any other medicine in the bathroom or near a sink. Do not leave it in the car on hot days or on a windowsill. Heat and dampness can destroy some medicines.

Keep it 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.

WARNING: 
The canister in Symbicort Rapihaler contains a pressurised liquid. Do not expose to temperatures high than 50°C. Do not pierce the canister. The canister should not be broken, punctured or burnt, even when it seems empty.

Disposal

Your Symbicort Rapihaler should always be returned to your pharmacist for disposal including:

• when you have taken all your doses and the dose counter reaches zero ('0' - see instructions in the pack), or
• 3 months after removal from the foil pouch, or
• it is damaged or past its expiry date, or
• your doctor/pharmacist has told you to stop using it.

Product description

What it looks like

Symbicort Rapihaler is a pressurised metered dose inhaler with a dose counter. The inhaler is comprised of a pressurised aluminium canister with an attached dose counter, a red plastic casing body with a white mouthpiece and attached grey mouthpiece cover. Each inhaler is individually wrapped in a foil laminate pouch (containing a sachet of drying agent).

Symbicort Rapihaler contains 120 puffs (inhalations) and is available in three strengths: 50/3, 100/3 and 200/6. Each pack contains 1 inhaler.

Ingredients

Symbicort Rapihaler contains budesonide and eformoterol fumarate dihydrate as the active ingredients. The other ingredients are apaflurane (HFA-227), macrogol 1000 and povidone.

Symbicort Rapihaler does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone: 1800 805 342

This leaflet was prepared 28 March 2017

Australian Registration Numbers

50/3 - 158898

100/3 - 158899

200/6 - 115555

® Symbicort Rapihaler is a registered trademark of the AstraZeneca group of companies.

© AstraZeneca, 2017