Symbicort 400/12mcg Turbuhaler 120 Doses

SYMBICORT(R) TURBUHALER(R)

Budesonide and eformoterol fumarate dihydrate powder for inhalation
Consumer Medicine Information

What is in this leaflet?

This leaflet answers some common questions 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 benefits and risks. Your doctor has weighed the risks of you using Symbicort Turbuhaler 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 Turbuhaler.

You may need to read it again.

What Symbicort Turbuhaler is used for?

Symbicort Turbuhaler is inhaled into the lungs for the treatment of 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.

Symbicort Turbuhaler contains budesonide and eformoterol in one inhaler. Your doctor may have previously prescribed you Pulmicort(R) Turbuhaler or Oxis(R) Turbuhaler for your asthma. Budesonide is the main ingredient in Pulmicort Turbuhaler, and eformoterol is the main ingredient in Oxis Turbuhaler.

Budesonide belongs to a family of medicines called corticosteroids. Budesonide acts directly on your airways to reduce inflammation. This helps to improve your condition and to prevent asthma attacks from occurring. It is a “preventer” and needs to be taken regularly.

Eformoterol belongs to a family called beta-2-agonists. Eformoterol opens up the airways to help you breathe more easily. It should be taken regularly to help control your symptoms.

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

Symbicort Turbuhaler can also be used as a “reliever” when needed to treat your symptoms when your asthma gets worse and when used regularly will help prevent asthma attacks.

Ask your doctor if you have any questions about why Symbicort Turbuhaler has been prescribed for you.

Your doctor may have prescribed it for another reason.

Symbicort Turbuhaler is not addictive.

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

Before you use Symbicort Turbuhaler

When you must not use it

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

  • any medicine containing eformoterol, budesonide
  • any of the ingredients listed at the end of this leaflet
  • Some of the symptoms of an allergic reaction may include:

  • skin rash
  • shortness of breath
  • wheezing or difficulty breathing
  • Do not use Symbicort Turbuhaler 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 that you should start using this medicine, talk to your doctor.

    Do not give Symbicort Turbuhaler to a child under 12 years, unless directed to by the child`s doctor.

    Symbicort Turbuhaler is not recommended for use in children under 12 years.

    Before you start to use it

    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 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 Turbuhaler if you have, or have had, any of these conditions.

    Tell your doctor if you currently have an infection.

    If you take Symbicort Turbuhaler 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 Turbuhaler during pregnancy and while breastfeeding.

    Tell your doctor if you drink alcohol regularly.

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

    Taking other medicines

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

    Tell your doctor if you are taking any other medicines, including:

  • medicines used to treat heart problems or high blood pressure such as beta-blockers or diuretics
  • medicines used to treat glaucoma such as beta-blockers
  • medicines used to treat depression or other mood disorders such as tricyclic antidepressants, monoamine oxidase inhibitors
  • medicines used to treat hayfever, coughs, colds and runny nose
  • medicines used to treat fungal infections
  • medicines used to treat Parkinson`s disease
  • medicines used to treat thyroid problems
  • These medicines may be affected by Symbicort Turbuhaler, or may affect how well it works. You may need different amounts of your medicine, or you may need to use different medicines. Your doctor or pharmacist will advise you.

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

    How to use Symbicort Turbuhaler

    How to use your Turbuhaler

    Each pack of Symbicort Turbuhaler 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 Turbuhaler, ask your doctor or pharmacist to show you how.

    How much to take

    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 for you to use as both a “preventer” and “reliever” medicine.

    Always take the dose that your doctor tells you to and follow all directions given to you by your doctor carefully.

    Symbicort Turbuhaler 100/6 and 200/6

    If you are using Symbicort Turbuhaler (100/6 or 200/6) as a “preventer” medicine, the usual dose for adults and adolescents (12 years and over) is 1 – 2 inhalations twice a day.

    Your doctor may also tell you to use Symbicort Turbuhaler as a “reliever”, medication. This means that Symbicort Turbuhaler can be taken when needed to provide relief of your asthma symptoms. If you are using Symbicort Turbuhaler (100/6 or 200/6) as both a “preventer” and “reliever” medicine, do not use more than 6 inhalations on a single occasion or more than 12 inhalations in any day. If your symptoms continue to worsen over three days, despite using additional inhalations, tell your doctor.

    Symbicort Turbuhaler 400/12

  • This strength is recommended only for patients aged 18 years and over.
  • Symbicort 400/12 is not recommended to be used as “reliever” medication.
  • The usual dose is 2 inhalations twice a day. Your doctor may also tell you to take 1 inhalation twice a day, if your asthma has been under control.
  • Do not take more than 2 inhalations twice a day of Symbicort Turbuhaler 400/12.
  • If your asthma has been under control for some time, your doctor may tell you to take less inhalations of Symbicort Turbuhaler or prescribe you a lower strength of Symbicort Turbuhaler.
  • 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.

    If you forget to use it

    If you miss a dose of Symbicort Turbuhaler, 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 Tubuhaler as 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 Turbuhaler every day even if you feel well.

    Symbicort Turbuhaler helps control your asthma, 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 Turbuhaler.

    Do this even if there are no signs of discomfort or poisoning.

    You may need urgent medical attention.

    If you use too much Symbicort Turbuhaler, 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 Turbuhaler

    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 Turbuhaler 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 is not getting worse.

    Your doctor may change your dose of Symbicort Turbuhaler (up or down) depending on your condition.

    Have your “reliever” medicine available at all times.

    Rinse your mouth out with water after taking your regular morning and/or evening dose 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 doses of Symbicort for relief of asthma symptoms.

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

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

    Things you must not do

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

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

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

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

    Things to be careful of

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

    Symbicort Turbuhaler 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 Turbuhaler.
  • 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 Turbuhaler 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 Turbuhaler.

  • 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 or 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.

    After using Symbicort Turbuhaler

    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 Symbicort Turbuhaler are inside each pack.

    Storage

    Keep your Turbuhaler in a cool dry place where the temperature stays below 30 degrees C, with the cover firmly in place.

    Do not store Symbicort Turbuhaler or any other medicine in the bathroom or near a sink.

    Do not leave it in the car or on a window sill.

    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.

    Disposal

    Symbicort Turbuhaler should be thrown away after you have taken the number of doses indicated on the pack.

    If your doctor or pharmacist tells you to stop using Symbicort Turbuhaler or it has passed its expiry date, ask your pharmacist what to do with any you have left.

    Product description

    What it looks like

    Symbicort Turbuhaler is a plastic inhaler containing the medication as a dry powder.

    Symbicort Turbuhaler 100/6 and 200/6 are available in pack sizes of 60 or 120 doses.

    Symbicort Turbuhaler 400/12 contains 60 doses and is available in packs of 1 or 2 Turbuhalers.

    Ingredients

    Symbicort Turbuhaler contains budesonide and eformoterol fumarate dihydrate as the active ingredients, plus lactose.

    The amount of lactose contained in Symbicort Turbuhaler is very small and does not normally cause problems in lactose intolerant people.

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

    Sponsor

  • AstraZeneca Pty Ltd
  • ABN 54 009 682311
  • Alma Road
  • NORTH RYDE NSW 2113
  • This leaflet was prepared in November 2006.
  • Australian Registration Numbers:
  • Symbicort Turbuhaler
  • 100/6 – 80875
  • 200/6 – 80876
  • 400/12 – 80877
  • (R) Symbicort, Pulmicort, Oxis, and Turbuhaler are trademarks of the AstraZeneca group of companies.
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