Alvesco Inhaler 160mcg 120 Dose CFC Free

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Alvesco.

It does not contain all the available information.

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

All medicines have risks and benefits. Your doctor has weighed the risks of you using Alvesco against the benefits he/she expects it will have for you.

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

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

What Alvesco is used for

Alvesco is inhaled into the lungs for the treatment of asthma. Asthma is a disease where the lining of the lungs becomes inflamed (red and swollen), making it difficult to breathe.

Alvesco contains a medicine called ciclesonide, which belongs to a family of medicines called corticosteroids.

Alvesco metered dose inhalers deliver a measured amount of ciclesonide, which acts directly on your air passages to reduce inflammation and help keep the air passages open.

In doing so, this medication helps to improve your condition and to prevent asthma attacks from occurring. It is a 'preventer' and needs to be taken regularly.

Alvesco will NOT give you immediate relief of wheezing or breathlessness during sudden, severe or continuous asthma attacks. In this situation you should use a quick acting "reliever" inhaler, which contains a different medicine, a so-called bronchodilator.

Your doctor may prescribe Alvesco to replace corticosteroid tablets, which will mean that you need to take both medicines for a short period of time. It is important to follow your doctor's instructions for taking your medicines.

Alvesco is available only with a doctor's prescription.

Before you use Alvesco

When you must not use it

Do not use Alvesco if you have an allergy to ciclesonide or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Do not use Alvesco to treat an acute asthma attack.

Alvesco is not recommended for use in children under 5 years of age.

Do not use Alvesco after the expiry date (EXP) printed on the pack. If you take this medication after the expiry date has passed, it may not work as well.

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

If you are not sure whether you should start using Alvesco, contact your doctor.

Before you start to use it

Tell your doctor if you have allergies to:
any other medicines
to any other substances, such as foods, preservatives or dyes

Tell your doctor if you are being treated for any fungal infections. Some treatments may interact with Alvesco.

Tell your doctor if you are pregnant or intend to become pregnant. Like most medicines Alvesco is not recommended during pregnancy. If it is necessary for you to use Alvesco, your doctor will discuss the risks and benefits of using it during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed. Your doctor will discuss the possible risks and benefits of using Alvesco while breastfeeding.

Tell your doctor if you currently have an infection. If you take Alvesco while you have an infection, the medication 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 have or have had tuberculosis (TB).

Also tell your doctor if you have or are currently suffering from liver disease.

Using other medicines

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

It is especially important that you notify your doctor if you are taking any medicine to treat fungal infections, such as ketoconazole, as these medicines may affect the way Alvesco works.

How to use Alvesco

The correct way to use your Alvesco inhaler is explained on the instructions for use leaflet that comes inside the Alvesco package. If you do not use your Alvesco inhaler correctly your lungs might get less medicine than needed. So please read these instructions carefully before you start.

To make sure your Alvesco inhaler delivers the correct dose you should clean it regularly as outlined in the instruction leaflet.

Your doctor may have advised that you use a spacer device with your inhaler. This is also recommended for children 6-11 years of age.

If so, the AeroChamber Plus is considered a suitable device for use with Alvesco.

If you are not sure how to use an inhaler, ask your doctor or pharmacist.

How much to use

Your doctor will have spoken to you about how much of your medicine you need to take and this will depend on your individual need.

Your doctor will normally start you on 80 micrograms once daily, if you are not currently using a preventer medication. Otherwise your starting dose will depend on your current medication and how well your asthma is controlled.

There are 2 strengths of Alvesco and your doctor will have chosen the one which best suits your asthma. The number of puffs you are required to take daily will depend on the strength of Alvesco you are using.

Your doctor may adjust your dose so that you are taking the lowest dose of Alvesco that will control your symptoms.

When your doctor is changing you from a corticosteroid tablet to Alvesco, you will be asked to take both medicines for a period of time. Your dose of corticosteroid tablets will gradually be reduced to the lowest possible level. It is important you follow your doctor's instructions.

If you forget to use it

If you forget to use your Alvesco inhaler, just take the next dose when it is due. DO NOT take a double number of puffs to make up for the missed dose.

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

How long to use it

Alvesco helps control your asthma . Therefore you must use Alvesco every day. Continue using Alvesco for as long as your doctor tells you.

Do not stop using it unless your doctor tells you to - even if you feel better.

If you use too much (overdose)

Do not use more puffs than the recommended dose unless your doctor tells you to.

The risk of effects from taking too many puffs of Alvesco is low. But, if you are worried that you or anyone else may have used too much Alvesco telephone your doctor or pharmacist, or the Poisons Information Centre (in Australia call 131126; in New Zealand call 0800 764 766).

While you are using Alvesco

Things you must do

If you have an Asthma Management plan continue to follow it closely.

Tell your doctor or pharmacist that you are using Alvesco if you are about to be started on any new medicines.

Tell your doctor or pharmacist if you feel the effect of Alvesco is too strong or too weak.

If you plan to have surgery (that needs a general anaesthetic), tell your doctor or dentist that you are using Alvesco.

If you become pregnant while using Alvesco, tell your doctor.

Things you must not do

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

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

Do not use Alvesco to treat any other complaints unless your doctor or pharmacist tells you to.

Do not stop using Alvesco, or lower the dosage, without checking with your doctor or pharmacist.

Things to be careful of

If Alvesco does not have its usual effect

If your asthma gets worse, tell your doctor. Your doctor may tell you to take extra puffs of Alvesco or add another medicine (such as a 'reliever puffer') to your treatment.

If your breathing suddenly becomes more difficult just after you have used Alvesco, you will need to use a 'reliever puffer' and tell your doctor immediately.

Tell your doctor as soon as possible if:
your 'reliever puffer' does not help your breathing as much as usual
the effect of your 'reliever puffer' does not last as long as usual
you need more puffs of your 'reliever puffer' than usual to get relief.

Side effects

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

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

Tell your doctor or pharmacist if you notice any of the following and they worry you:
hoarse voice
increased difficulty in breathing immediately following the use of Alvesco.

If you experience any of the following, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
swelling of the lips, mouth or tongue.

You may need urgent medical attention or hospitalisation.

Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Corticosteroid tablets can lead to more side effects than a corticosteroid inhaler such as Alvesco. If you have been taking corticosteroids before or during the use of Alvesco, the risk of these side effects may continue for a period of time.

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

Alvesco does not cause any problems with your ability to drive a car or operate machinery.

There is no evidence that Alvesco is addictive.

After using Alvesco

Cleaning

The correct way to clean your Alvesco inhaler is explained on the instructions for use leaflet that comes inside the Alvesco package.

Storage

Keep your inhaler in a cool dry place where the temperature stays below 25°C.

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

Do not leave it in the car on hot days or on windowsills. Heat and dampness can destroy some medicines.

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

Disposal

If your doctor tells you to stop using Alvesco or it has passed its expiry date, ask your pharmacist what to do with any of the medicine that is left over.

Do not puncture or incinerate even when empty as the canister may explode.

Product description

What it looks like

The Alvesco inhaler comprises an aluminium canister inside a plastic inhaler unit. The inhaler unit has a mouthpiece and a plastic cover.

Alvesco comes in two different strengths:

Alvesco 80 (AUST R 93724) - each puff delivers 80 micrograms of ciclesonide.

Each inhaler contains 120 puffs.

Alvesco 160 (AUST R 93725) - each puff delivers 160 micrograms of ciclesonide.

Alvesco 160 is available containing either 60 puffs or 120 puffs.

Ingredients

Active ingredients:
ciclesonide
Other ingredients:
norflurane (a non-CFC propellant which does not deplete ozone from the atmosphere)
ethanol

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

Sponsor/Distributor

Nycomed Pty Ltd
2-4 Lyonpark Road
North Ryde NSW 2113
Australia
For medical enquiries, call (AUST) 1800 675 957

Alvesco® is a registered trademark of Nycomed GmbH.

This leaflet was prepared in July 2008.