INFORMATION FOR CONSUMERS

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Consumer Medicine Information

QVAR™ Autohaler™ 50 and 100

beclomethasone dipropionate extrafine aerosol 50µg and 100µg

ABOUT THIS LEAFLET

This leaflet answers some important basic questions about QVAR AUTOHALER but it does not contain all the available information. If you have any questions about QVAR AUTOHALER that are not answered by this leaflet ask your doctor or pharmacist.

Like all medicines QVAR AUTOHALER has potential risks as well as benefits. Your doctor and pharmacist always weigh a medicine's risks against its benefits before prescribing or dispensing it for you. If you have any concerns about using this medicine please discuss them with your doctor or pharmacist.

Keep this leaflet with your QVAR AUTOHALER because you may want to read it again.

WHAT'S IN QVAR AUTOHALER?

The name of your medication is QVAR AUTOHALER. It contains a medicine called beclomethasone dipropionate. Beclomethasone dipropionate belongs to the corticosteroid family of medicines. The amount of medicine in each puff of QVAR 50 AUTOHALER is 50 micrograms of beclomethasone dipropionate, and 100 micrograms in each puff of QVAR 100 AUTOHALER. Each QVAR AUTOHALER 200 dose contains at least 200 puffs.

WHAT QVAR AUTOHALER IS USED FOR

QVAR AUTOHALER is designed so the medicine can be inhaled (breathed in) into the lungs to help manage asthma. Asthma causes the lining of your lungs to become inflamed (red and swollen), making it difficult for you to breathe. QVAR AUTOHALER acts directly on your air passages to reduce inflammation. This helps to improve your condition and to prevent asthma attacks from occurring. QVAR AUTOHALER is therefore known as a "PREVENTER" medicine. It must be used every day even if you have no symptoms. There is no evidence that QVAR AUTOHALER is addictive.

Perhaps your doctor has prescribed QVAR AUTOHALER for another reason. Ask your doctor if you have any questions.

QVAR AUTOHALER is only available with a doctor's prescription.

BEFORE YOU USE QVAR AUTOHALER

When you must not use it

Do not use QVAR AUTOHALER:

• if you are allergic to beclomethasone dipropionate or to any of the other ingredients of QVAR AUTOHALER (listed at the end of this leaflet).
• to treat an acute asthma attack.
• after the expiry date on the canister.
• if the packaging is torn or shows signs of tampering.

WHAT YOU MUST TELL YOUR DOCTOR OR PHARMACIST

• Tell your doctor if you are allergic to any other medications or to substances such as foods, preservatives or dyes.
• Tell your doctor if:
  - you are pregnant or intend to become pregnant.
  - you are breast-feeding or plan to breast-feed.
  Your doctor or pharmacist will discuss the possible risks of using QVAR AUTOHALER during pregnancy or breast-feeding.
• Tell your doctor or pharmacist if you currently have an infection. Using QVAR AUTOHALER may hide some signs of infection. This could lead you to the mistaken belief that you are better or that the infection is not serious.
• 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 have or have had tuberculosis (TB).

Talk to your doctor or pharmacist if you are not sure whether to start using QVAR AUTOHALER.

HOW TO USE QVAR AUTOHALER

QVAR AUTOHALER is designed for ease of use. To make it work you just breathe in through the mouthpiece. There is no need to press and breathe in at the same time. A click and whoosh tells you that QVAR AUTOHALER has automatically released the correct dose of medicine.
Even if you have been using another type of inhaler or Autohaler please read the instructions on the other side of this leaflet before you start.
Your QVAR AUTOHALER may not help you as much as it should unless used correctly. If you have any problems or queries your doctor or pharmacist can show you the correct technique.
Children prescribed QVAR AUTOHALER should be supervised by a responsible adult.

To make sure your QVAR AUTOHALER delivers the correct dose you should clean it regularly as explained on the other side of this leaflet.

Please read below for instructions on how to use and care for your QVAR AUTOHALER.

If your QVAR AUTOHALER is new or has not been used for two weeks or more you must test fire it by releasing two puffs into the air.

There is no need to shake your QVAR AUTOHALER.

1. REMOVE THE MOUTHPIECE COVER by unclipping it from the back (Figure 1).
   
   
2. HOLD UPRIGHT AND PUSH LEVER UP AS SHOWN.
   • Push the lever up so that it stays up
   • Keep holding the Autohaler unit upright making sure your hand is not blocking the air vent at the bottom (marked X in Figure 2).
     
     
3. BREATHE OUT AND POSITION MOUTHPIECE.
   • Breathe out as far as you comfortably can and immediately close your lips around the mouthpiece (Figures 3 & 4).
     
         
4. BREATHE IN.
   • Breathe in slowly and deeply through the mouthpiece.
   • Do not stop breathing when you hear the 'click and whoosh' and feel the puff in your mouth. It is important to keep breathing in after the puff is released.
5. HOLD YOUR BREATH
   • Hold your breath for 10 seconds (Figure 5) and then breathe out slowly.
     
     
6. PUSH LEVER DOWN.
   • After each puff return the lever to the down position whilst holding the Autohaler unit upright (Figure 6).
     
     

If your doctor has prescribed more than one puff repeat steps 2 to 6. Replace the mouthpiece cover after use.

Remember to push the lever up before each puff and gently back down afterwards, always holding the Autohaler upright. This prepares the Autohaler for your next dose. The lever should be left down between treatments and the mouthpiece replaced to keep your QVAR AUTOHALER clean.

HOW TO TEST FIRE OR HOW TO TELL IF QVAR AUTOHALER IS EMPTY

1. REMOVE THE MOUTHPIECE COVER by unclipping it from the back (Figure 1).
2. Hold your QVAR AUTOHALER upright. Point the mouthpiece away from you so that the puffs of medicine will go into the air. PUSH THE LEVER UP so that it stays up (Figure 2)
   
       
3. RELEASE A PUFF by pushing the dose release slide (on the bottom of the Autohaler unit) in the direction of the arrow (Figure 3).
4. TO RELEASE A SECOND PUFF first return the lever to its down position (Figure 4), then repeat steps 2 and 3 as shown above
5. Always PUSH THE LEVER BACK DOWN after test firing. This prepares the QVAR AUTOHALER for your next dose.

Do not use the dose release slide to take your medicine. Your QVAR AUTOHALER will automatically release a dose when you begin to breathe in from the mouthpiece.

AFTER USING QVAR AUTOHALER

Clean the mouthpiece once a week.

Remove the mouthpiece cover and wipe the mouthpiece with a clean dry cloth or tissue. Do not wash or put any part of your Autohaler in water. Replace the mouthpiece cover. Do not push a cloth or anything else into any part of the Autohaler device, since it may damage the operating parts. Do not take the Autohaler device apart. Do not drop or hit the Autohaler. Always replace the mouthpiece cover after use.

How much, how often?

Use QVAR AUTOHALER only as directed by your doctor or pharmacist.

There are two strengths of QVAR AUTOHALER available and your doctor will have chosen the one which best suits your condition. QVAR is an extrafine aerosol, so more of each dose is delivered to your lungs. Your doctor may therefore prescribe a lower dose of QVAR than your previous CFC preventer inhaler.
With QVAR 50 AUTOHALER the usual dose in adults for mild to moderate asthma is one to four puffs twice a day. For more severe asthma the usual dose in adults is up to eight puffs twice a day.
In children the dose is one puff twice a day.
With QVAR 100 AUTOHALER the usual dose in adults for mild to moderate asthma is one to two puffs twice a day. For more severe asthma the usual dose in adults is up to four puffs twice a day.
Your doctor will tell you which strength of QVAR AUTOHALER to use and how many puffs to use each day.

Use QVAR AUTOHALER at the same time each day.

QVAR AUTOHALER has a different taste compared with CFC containing inhalers or Autohalers you may have used before.

If you forget to use QVAR AUTOHALER

Use it as soon as you remember and then go back to using it as you would normally. Ask your doctor or pharmacist if you are not sure what to do. If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

For how long should you keep using QVAR AUTOHALER

Do not stop using QVAR AUTOHALER until your doctor or pharmacist tells you to.

QVAR AUTOHALER helps control your condition. You must keep using it every day for as long as your doctor or pharmacist advises, even if you are feeling better.

If you use too much (overdose)

Too much use of any asthma inhaler may be harmful. Do not use more puffs than the recommended dose unless your doctor tells you to. If you use too much QVAR AUTOHALER for a long time your adrenal glands (small glands above the kidneys) may not work as well as they should.

If you think you or anyone else may have used too much QVAR AUTOHALER telephone your doctor or pharmacist, or the Poisons Information Centre (in Australia call 131126; in New Zealand call 0800 POISON or 0800 764 766) or go to the Accident and Emergency department at the nearest hospital. Do this even if there are no signs of discomfort or poisoning.

THINGS YOU MUST AND MUST NOT DO WHILE USING QVAR AUTOHALER

• If you have an Asthma Management Plan follow it closely at all times.
• Continue using QVAR AUTOHALER for as long as your doctor or pharmacist tells you. Visit your doctor regularly to check on your asthma condition.
• If you suddenly find it more difficult to breathe just after using QVAR AUTOHALER use a reliever inhaler and contact your doctor or pharmacist immediately.
• QVAR AUTOHALER is used to PREVENT asthma attacks. Always use QVAR AUTOHALER regularly as prescribed even if you are not suffering any asthma symptoms. If you think your asthma is getting worse (ie if you suffer more frequent asthma attacks) consult your doctor immediately.
• Tell any other doctors, pharmacists or dentists who are treating you that you are using QVAR AUTOHALER especially if:
  - you are about to be started on any new medication
  - you plan to have surgery that needs a general anaesthetic
• Tell your doctor if you become pregnant while using QVAR AUTOHALER.
• Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using QVAR AUTOHALER.
• Do not take any other medicines for your breathing problems without first checking with your doctor.
• Do not give QVAR AUTOHALER to any one else to use even if they have the same condition as you.
• Do not use QVAR AUTOHALER to treat any other complaints unless your doctor or pharmacist tells you to do so.
• Do not stop using QVAR AUTOHALER, or lower the dose, without first checking with your doctor or pharmacist.
• Do not use QVAR AUTOHALER to relieve acute attacks of asthma. If you become wheezy or tight in the chest before your next dose of QVAR AUTOHALER is due, use a reliever inhaler in the usual way.
• Do not use more puffs than you have been prescribed as this may cause you problems.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using QVAR AUTOHALER. Like all medications QVAR AUTOHALER can sometimes cause unwanted effects. While most of these are not serious, some of them may need medical treatment.

QVAR inhaler is a corticosteroid medicine. Corticosteroid medicines can have other side effects. These may include effects on the adrenal glands, bone density, vision and also growth in children and adolescents. These are more likely to occur when these medicines are used at high doses for long periods.

Tell your doctor or pharmacist if you notice and are worried by any of the following effects:

• sore, creamy-yellow raised patches in the mouth (thrush), or a hoarse voice. These problems are less likely to occur if you rinse your mouth out with water each time after using QVAR AUTOHALER. If thrush does occur, you can use a topical anti fungal therapy while continuing treatment with QVAR inhaler.
• narrowing of the airways, or chest tightness. This may happen if your lungs are very sensitive. If this occurs use a reliever inhaler. You may also prevent this effect by using your reliever inhaler before using your QVAR AUTOHALER. If this effect is severe stop using QVAR AUTOHALER and see your doctor immediately.
• Allergic reactions such as rashes, itching, redness and swelling of the lips, mouth, throat and eyes may occur. If you experience any of these you should see your doctor as soon as possible.

AFTER USING QVAR AUTOHALER

Cleaning

For normal hygiene the mouthpiece of the Autohaler should be cleaned weekly with a clean dry tissue or cloth. DO NOT WASH OR PUT ANY PART OF YOUR AUTOHALER IN WATER. It is important to keep your Autohaler clean and dry. It may not work if it gets wet or dirty. Follow the cleaning instructions at the end of this leaflet.

Storage

Keep your QVAR AUTOHALER in a cool dry place below 30°C. Keep QVAR AUTOHALER away from heat and dampness: do not store it in the bathroom or near a sink. Keep QVAR AUTOHALER away from direct heat and sunlight: do not leave it in the car or on a window sill.

Keep QVAR AUTOHALER out of reach of children, ideally in a locked cupboard at least 1½ metres above the ground.

Protect QVAR AUTOHALER from frost.

Disposal

Do not puncture the container or throw it into the fire even when it is empty as the canister may explode.

Ask your doctor or pharmacist what to do with any unused QVAR AUTOHALER.

PRODUCT DESCRIPTION

QVAR AUTOHALER consists of a metal canister sealed inside a plastic Autohaler unit. At the bottom of the Autohaler unit is a mouthpiece with a plastic cover. At the top of the Autohaler unit is a grey lever.

QVAR AUTOHALER comes in two different strengths, 50 and 100 micrograms. Each strength of QVAR AUTOHALER 200 dose contains at least 200 puffs.

Ingredients

Each puff of QVAR 50 AUTOHALER releases 50 micrograms of beclomethasone dipropionate.
Each puff of QVAR 100 AUTOHALER releases 100 micrograms of beclomethasone dipropionate.

QVAR AUTOHALER also contains:

• Ethanol (0.0059mL per puff)
• norflurane (a non-CFC propellant which does not deplete ozone from the atmosphere).

Sponsor/Supplier

QVAR AUTOHALER is supplied in Australia by:

iNova Pharmaceuticals (Australia) Pty Limited
(ABN: 88 000 222 408)
9-15 Chilvers Road
THORNLEIGH NSW 2120

QVAR AUTOHALER is supplied in New Zealand by:

iNova Pharmaceuticals (New Zealand) Limited
c/o Simpson Grierson
Level 27
88 Shortland Street
AUCKLAND

Developed and manufactured by:

3M Health Care Limited Loughborough UK

This leaflet was prepared in January 2007

Australian Register Numbers:

QVAR 50 Autohaler : AUST R 71991
QVAR 100 Autohaler : AUST R 71994

3M, QVAR and AUTOHALER are trademarks