Consumer medicine information

Qvar Autohaler and Inhaler

Beclometasone dipropionate

BRAND INFORMATION

Brand name

Qvar

Active ingredient

Beclometasone dipropionate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Qvar Autohaler and Inhaler.

SUMMARY CMI

Qvar® Autohaler® and Inhaler

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using QVAR?

QVAR contains the active ingredient beclometasone dipropionate. Beclometasone dipropionate is a corticosteroid that acts directly on your air passages to reduce inflammation. This helps to improve your condition and to prevent asthma attacks.

For more information, see Section 1. Why am I using QVAR? in the full CMI.

2. What should I know before I use QVAR?

Do not use if you have ever had an allergic reaction to QVAR or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use QVAR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with QVAR and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use QVAR?

  • Your doctor will prescribe the strength and dose of QVAR for you to take that best suit your condition.
  • Follow all directions given by your doctor or other healthcare professionals and never change the dose yourself.

More instructions can be found in Section 4. How do I use QVAR? in the full CMI.

5. What should I know while using QVAR?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using QVAR.
  • If you are going to have surgery, tell the surgeon or anaesthetist that you are using QVAR.
  • Do not use QVAR if you are pregnant, intend to become pregnant or breastfeeding.
  • Continue using QVAR for as long as your doctor or pharmacist tells you. Visit your doctor regularly to check on your asthma condition.
Things you should not do
  • Do not use QVAR to relieve acute attacks of asthma. Use a reliever inhaler as has been prescribed.
  • Do not take any other medicines for your breathing problems without checking with your doctor.
  • Do not use QVAR to treat any other conditions unless your doctor or pharmacist tells you to.
  • Do not stop using QVAR or lower the dose without checking with your doctor or pharmacist.
Looking after your medicine
  • Keep your QVAR device clean and dry. It may not work if it gets wet or dirty.
  • Do not wash or put any part of your QVAR device in water.
  • Clean the mouthpiece with a clean dry cloth or tissue.
  • Store in a cool dry place where the temperature stays below 30°C and keep out of reach of children.

For more information, see Section 5. What should I know while using QVAR? in the full CMI.

6. Are there any side effects?

Less serious side effects include sore, creamy-yellow raised patches in the mouth (thrush), a hoarse voice, rashes, itching or irritation and redness and swelling of the face, lips, mouth, throat and eyes. Serious side effects include narrowing of the airways or chest tightness, changes to your eyesight or vision including blurred vision or other visual disturbances, stunted growth or a reduced growth rate in children and adolescents.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Qvar® Autohaler® and Inhaler (queue-var auto-hailer and queue-var in-hailer)

Active ingredient(s): Beclometasone dipropionate (beck-low-meth-a-zone die-pro-pee-one-ate)


Consumer Medicine Information (CMI)

This leaflet provides important information when using QVAR Autohaler or Qvar Inhaler. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions when using QVAR Autohaler or Qvar Inhaler.

Where to find information in this leaflet:

1. Why am I using QVAR?
2. What should I know before I use QVAR?
3. What if I am taking other medicines?
4. How do I use QVAR?
5. What should I know while using QVAR?
6. Are there any side effects?
7. Product details

1. Why am I using QVAR?

QVAR contains the active ingredient beclometasone dipropionate.

Beclometasone dipropionate is a corticosteroid that acts directly on your air passages to reduce inflammation. This helps to improve your condition and to prevent asthma attacks.

QVAR is designed to enable the medicine to be inhaled into the lungs to help manage your asthma.

Asthma causes the lining of your lungs to become inflamed (red and swollen), making breathing difficult.

QVAR (sometimes also called a "PREVENTOR" medicine) is used to PREVENT asthma attacks and must be used every day even if you have no symptoms.

There is no evidence that QVAR is addictive.

2. What should I know before using QVAR?

Warnings

Do not use QVAR:

  • If you are allergic to beclometasone dipropionate, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine. 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.
  • To treat an acute asthma attack
  • After the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

Check with your doctor if you:

  • Have allergies to any other medicines, foods, preservatives or dyes
  • Have or have previously suffered from tuberculosis
  • Have an infection.
    - Using QVAR may mask some signs of an infection
  • Have any other medical conditions or take any medicines for any other condition
  • Are unsure whether you should start using QVAR.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Do not use QVAR if you are pregnant or intend to become pregnant. QVAR may affect your developing baby if used during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed. Nursing mothers should avoid using QVAR as it is probable that the active ingredient, beclometasone dipropionate, passes into breast milk, and there is a possibility that your baby may be affected.

Use in children

Do not give QVAR to a child under the age of 5 years as the safety and effectiveness of QVAR in children younger than 5 years have not been established.

3. What if I am taking other medicines?

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

Some medicines may interfere with QVAR and affect how it works.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect QVAR.

4. How do I use QVAR?

How to use QVAR:

Use QVAR Autohaler or QVAR Inhaler only as directed by your doctor.

QVAR Autohaler and QVAR Inhaler both come in strengths of 50 micrograms per puff (QVAR 50) and 100 micrograms per puff (QVAR 100). Your doctor will have prescribed the strength which best suits your condition. QVAR is an extra fine aerosol, so more of each dose is delivered to your lungs. Because of this, your doctor may prescribe a lower dose of QVAR than your previous preventer inhaler.

Follow the instructions provided and use QVAR until your doctor tells you to stop.

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

Adults

  • QVAR 50 Autohaler and QVAR 50 Inhaler: 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
  • QVAR 100 Autohaler and QVAR 100 Inhaler: 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.

Children

  • QVAR 50 Autohaler and QVAR 50 Inhaler: the recommended dose in children five years and over is one puff twice a day.
  • Children should be supervised by a responsible adult when using QVAR.

When to use QVAR:

Taking QVAR at the same times each day will deliver the best effect for you and will also help you remember when to take it.

How long to use QVAR:

Continue using QVAR for as long as your doctor tells you. QVAR helps to control your condition but does not cure it. It is important to keep using QVAR even if you feel well or have no symptoms.

How to use QVAR:

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

Even if you have been using another type of autohaler or inhaler read the instructions in this leaflet before you start. If you do not understand the instructions, ask your doctor or pharmacist for help.

Qvar Autohaler Instructions for Use:

If this is a new QVAR Autohaler or has not been used for two weeks or more, you must test fire it by releasing two puffs into the air away from your face.

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 the QVAR Autohaler has automatically released the correct dose of medicine.

There is no need to shake the QVAR Autohaler.

STEP 1: Remove the Mouthpiece Cover:

By unclipping it from the back.

STEP 2: Hold Upright and Push Lever Up:

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.

STEP 3: Breathe Out and Position Mouthpiece:

Breathe out as far as you comfortably can and immediately close your lips around the mouthpiece.

STEP 4: Breath In:

Breath 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.

STEP 5: Hold Your Breathe:

Hold your breath for 10 seconds and then breathe out slowly.

STEP 6: Push Lever Down:

After each puff return the lever to the down position whilst holding the autohaler unit upright.

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 Tell if Your Qvar Autohaler is Empty:

STEP 1: Remove the Mouthpiece Cover:

By unclipping it from the back.

STEP 2: Hold Your Qvar Autohaler Upright:

Point the mouthpiece away from you so that the puffs of medicines will go into the air.

STEP 3: Push the Lever Up:

So that it stays up.

STEP 4: Release a Puff:

By pushing the dose release slide (on the bottom of the autohaler unit) in the direction of the arrow.

STEP 5: To Release a Second Puff:

First return the lever to its down position, then repeat steps 2 and 3 as shown above.

STEP 6: 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.

Qvar Inhaler Instructions for Use:

If this is a new QVAR Inhaler or has not been used for two weeks or more, you must test fire it by releasing two puffs into the air away from your face.

There is no need to shake the QVAR Inhaler.

STEP 1: Clear the Mouthpiece:

Remove the cover and check that the mouthpiece is clean.

STEP 2: Breath Out:

Hold the inhaler unit upright and breath out as far as you comfortably can.

STEP 3: Position the Mouthpiece, Breathe in and Press:

Immediately close your lips around the mouthpiece. Start breathing in slowly, and firmly press the metal canister downwards until a puff is released. Complete your breath as fully and deeply as possible.

STEP 4: Hold Your Breathe:

Hold your breath for 10 seconds and then breathe out slowly.

If your doctor has prescribed more than one puff repeat steps 2 to 4.

Replace the mouthpiece cover after use.

If you forget to take QVAR:

QVAR should be used regularly at the same time each day.

If you miss your dose at the usual time and it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you have trouble remembering to take QVAR, ask your doctor or pharmacist for some hints.

If you take too much QVAR:

Too much use of any asthma inhaler may be harmful. If you think that you have taken too much QVAR, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using QVAR?

Things you should do:

  • If you have an Asthma Management Plan, always follow it closely.
  • Always use QVAR regularly as prescribed, even if you are not suffering any asthma symptoms.
  • Continue using QVAR for as long as your doctor or pharmacist tells you. Visit your doctor regularly to check on your asthma condition.
  • If you are going to have surgery, tell the surgeon or anaesthetist that you are using QVAR. It may affect other medicines used during surgery.
  • Ask your doctor to regularly check the height of children and adolescents who are using QVAR. Long term use of inhaled steroids may cause growth to be stunted.

Call your doctor straight away if you:

  • Take your dose of QVAR and suddenly find it more difficult to breathe or tightness across your chest. Use a reliever inhaler and immediately contact your doctor or pharmacist.
  • Think your asthma is getting worse (i.e. you suffer more frequent asthma attacks)
  • Become pregnant while using QVAR.

If you are about to start on any new medicines, remind any doctor, dentist, or pharmacist you visit that you are using QVAR.

Things you should not do:

  • Do not use QVAR to relieve acute attacks of asthma. If you become wheezy or tight in the chest before your next dose is due, use a reliever inhaler as prescribed.
  • Do not take any other medicines for your breathing problems without first checking with your doctor.
  • Do not give your medicine to anyone else to use, even if they have the same condition as you.
  • Do not use QVAR to treat any other conditions unless your doctor or pharmacist tells you to do so.
  • Do not stop using QVAR suddenly or lower the dose without first checking with your doctor or pharmacist
  • Do not use more puffs than the recommended dose unless your doctor tells you to. If you use too much QVAR for a long time your adrenal glands (small glands above the kidneys) may not work as well as they should.

Driving or using machines:

Be careful before you drive or use any machines or tools until you know how QVAR affects you.

Drinking alcohol:

Tell your doctor if you drink alcohol.

Looking after your medicine:

Follow the instructions in the carton on how to take care of your medicine properly.

Cleaning

  • Keep your QVAR Autohaler or Inhaler clean and dry. Do not wash it or put it in water. It may not work if it gets wet or dirty.
  • Clean the mouthpiece once a week. Remove the mouthpiece cover and wipe it with a clean dry cloth or tissue.
  • Do not push a cloth or anything else into any part of the device as this may damage the operating parts.
  • Do not drop or hit the device or take it apart.
  • Replace the mouthpiece cover after use.

Storage

Store below 30°C and protect from frost.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine:

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

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
  • Sore, creamy-yellow raised patches in the mouth (thrush)
  • Hoarse voice
Rinsing your mouth out with water after using QVAR can reduce these side effects.
Speak to your doctor is you are worried about these less serious side effects.
  • Rashes
  • Itching and irritation
  • Redness and swelling of the face, lips, mouth, throat and eyes
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Narrowing of the airways or chest tightness (this may occur if your lungs are very sensitive)
  • Use a reliever inhaler (using a reliever inhaler before using QVAR may also prevent this effect).
  • If this effect is severe stop using QVAR.
  • Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
Changes to your eyesight or vision including blurred vision or other visual disturbances (these may be signs of more serious issues)Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
Stunted growth or a reduced growth rate in children and adolescents that are using QVAR. Taking higher doses of inhaled steroids over a long time may cause children and adolescents to grow more slowly than others.Speak to your doctor if you are worried and get them to check their height regularly.
Very rarely QVAR may cause Cushing's syndrome (a condition of the adrenal gland) with the following symptoms: Cushingoid features such as round (moon-shaped) face, weight gain, high blood pressure, anxiety, sleeping disorders or increased irritability (mainly in children).Speak to your doctor if you are worried and they can advise what you need to do.

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

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What QVAR contains:

Active ingredient
(main ingredient)
Beclometasone dipropionate
Other ingredients
(inactive ingredients)
Ethanol
Norflurane
Potential allergensEthanol

Do not take this medicine if you are allergic to any of these ingredients.

What QVAR looks like:

QVAR 50 AUTOHALER* and QVAR 100 AUTOHALER* are colourless solutions supplied in a metal canister 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. Each canister of QVAR Autohaler contains at least 200 puffs.

Australian registration numbers:

QVAR 50 Autohaler: AUST R 71991

Qvar 100 Autohaler: AUST R 71994

QVAR 50 INHALER and QVAR 100 INHALER are colourless solutions supplied in a metal canister inside a plastic inhaler unit. At one end of the inhaler unit is a mouthpiece with a plastic cover. Each canister of QVAR Inhaler contains at least 200 puffs.

Australian registration numbers:

QVAR 50 Inhaler: AUST R 71992

Qvar 100 Inhaler: AUST R 71993

* Not available in New Zealand

Who distributes QVAR:

Australia

iNova Pharmaceuticals (Australia) Pty Limited
Level 10, 12 Help Street
Chatswood NSW 2067
Tel: 1800 630 056

New Zealand

iNova Pharmaceuticals (New Zealand) Pty Limited
Auckland
Tel: 0508 375 394

This leaflet was prepared in December 2023.

Published by MIMS February 2024

BRAND INFORMATION

Brand name

Qvar

Active ingredient

Beclometasone dipropionate

Schedule

S4

 

1 Name of Medicine

Beclomethasone dipropionate.

2 Qualitative and Quantitative Composition

Beclometasone dipropionate (BDP) is a white to creamy white, odourless powder; it is slightly soluble in water, very soluble in chloroform and freely soluble in acetone and alcohol. Qvar also contains ethanol and norflurane (HFA-134a), a propellant which does not contain chlorofluorocarbons (CFCs).

Excipients with known effects.

Ethanol (alcohol) 11.85% v/v.
Qvar 50 Inhaler and Autohaler deliver 50 microgram of BDP per inhalation. Qvar 100 Inhaler and Autohaler deliver 100 microgram of BDP per inhalation.
Qvar Autohaler is a breath actuated inhaler which automatically releases a metered dose of medication during inhalation through the mouthpiece and overcomes the need for patients to coordinate actuation with inspiration. Qvar Inhaler is a conventional press and breathe metered dose inhaler (PandB MDI). There are no differences in formulation between the Autohaler and the Inhaler products.
Qvar contains BDP in solution, resulting in an extra fine aerosol. The aerosol droplets of Qvar are on average much smaller (Mass Median Aerodynamic Diameter (MMAD), MMAD range 0.8 to 1.2 microns) than the particle sizes delivered by CFC suspension formulations (MMAD range 3.5 to 4 microns) or dry powder formulations (MMAD approximately 10 microns) of BDP. The smaller particle size for Qvar results in greater deposition in the airways and less deposition in the oropharynx than beclometasone products formulated in CFCs.
Radiolabelled deposition studies demonstrated that for Qvar the majority of BDP (> 55% dose ex-actuator) is deposited in the lungs and a small amount (< 35% dose ex-actuator) is deposited in the oropharynx. In contrast, approximately 4-7% dose from the actuator of BDP formulated in chlorofluorocarbons (CFC-BDP) is deposited in the lungs and over 90% is deposited in the oropharynx. The imaging data suggest that for Qvar, BDP is deposited widely throughout the central, intermediate and peripheral airways whereas deposition is limited to the central airways for CFC-BDP. The smaller particle size of Qvar explains the different deposition patterns compared with CFC-BDP. These delivery characteristics result in equivalent therapeutic effects being achieved at lower total daily doses of Qvar compared to CFC-BDP, and account for the recommended dosage adjustment when switching patients from CFC-BDP to Qvar (see Section 4.2 Dose and Method of Administration).

3 Pharmaceutical Form

Beclometasone dipropionate 50 mcg per actuation pressurised inhalation aerosol can (Qvar 50 Autohaler): colourless solution.
Beclometasone dipropionate 50 mcg per actuation pressurised inhalation aerosol can (Qvar 50 Inhaler): colourless solution.
Beclometasone dipropionate 100 mcg per actuation pressurised inhalation aerosol can (Qvar 100 Autohaler): colourless solution.
Beclometasone dipropionate 100 mcg per actuation pressurised inhalation aerosol can (Qvar 100 Inhaler): colourless solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Qvar is indicated for the prophylactic management of asthma.

4.2 Dose and Method of Administration

The recommended total daily dose of Qvar is lower than that for current CFC-BDP products and should be adjusted to the individual patient.
Proper instruction and good inhaler technique is necessary to get maximum benefit from Qvar Inhaler. For patients who are unable to successfully coordinate actuation of the metered dose inhaler with inhalation Qvar Autohaler should be substituted. Patients should be advised that Qvar may have a different taste and feel than a CFC inhaler.
Qvar delivers a consistent dose of BDP whether or not the canister is shaken; without the need for the patient to wait between individual actuations; regardless of storage orientation; regardless of periods without use of up to 14 days (do not need to test fire); at temperatures as low as -10°C.
Patients should be instructed to rinse their mouth out each time after using Qvar.

Use of a spacer.

Qvar is designed to be used without a spacer. However, where a spacer is considered necessary the AeroChamber Plus is a suitable device for use with Qvar Inhaler. Use of an AeroChamber Plus spacer with Qvar Inhaler reduces the amount of BDP deposited in the oropharynx without affecting deposition in the lungs. A change in the make of spacer or a change in the formulation of Qvar may be associated with alterations in the amount of BDP delivered to the lungs, the clinical significance of which is uncertain. In these situations the patient should be monitored for any loss of asthma control.
Patients who use a spacer should be instructed to breathe in and out after each actuation of Qvar into the spacer. Any delay should be kept to a minimum. Static on the walls of the spacer may cause variability in the amount of BDP delivered. Patients should be instructed to wash the spacer in warm water and detergent and allow to air dry without rinsing or dying with a cloth. This should be performed before initial use of the spacer and at least monthly thereafter.

Starting and maintenance dose.

The recommended dose of Qvar in adults is as follows.
For mild to moderate asthma: 50 microgram to 200 microgram twice daily.
For more severe asthma: doses up to 400 microgram twice daily.
Maximum recommended daily dose is 800 microgram.

Use in children.

In children aged five years and over the recommended dose of Qvar is 50 microgram twice daily.
Qvar must be used on a regular basis even when patients are asymptomatic. When patients' symptoms remain satisfactorily controlled, the dose of Qvar can be gradually reduced to the minimum effective dose to maintain control. Doses of BDP can be titrated up or down by switching between Qvar 50 and Qvar 100 as required.
Comparative clinical studies show that asthma patients achieve equivalent pulmonary function and control of symptoms with Qvar at lower total daily doses than CFC-BDP inhalers. These studies demonstrate clinical equivalence between CFC-BDP and Qvar inhalers when given in a dose ratio of 2.5 to 1.

Transferring patients from other inhaled corticosteroids to Qvar.

Step 1.

Consider the dose of the inhaled corticosteroid appropriate to the patients' current condition. Symptomatic patients may require an increased dose of their current inhaled corticosteroid and this increased dose should be considered in transferring patients to Qvar.

Step 2.

Convert the appropriate inhaled corticosteroid dose to the Qvar dose according to Table 1.

Special patient groups.

Elderly and patients with hepatic or renal impairment.

No special dosage recommendations are made.

Patients not receiving systemic corticosteroids.

For patients who are inadequately controlled with bronchodilators and who are not receiving systemic corticosteroids, it is recommended that they continue to use a bronchodilator when treatment with Qvar commences. Any improvement in respiratory function is usually apparent in 1 to 4 weeks. Some of the patients who do not respond during this period may have excessive mucus in their bronchi so that BDP is unable to penetrate to its site of action. A short course of systemic steroids in relatively high dosage should be given to eliminate mucus and other inflammatory changes in the lungs. Continuation of treatment with Qvar usually maintains the improvement achieved with the oral steroid while it is being withdrawn gradually. Exacerbation of asthma caused by infection is usually controlled by appropriate antibiotic treatment and, if necessary, by increasing the dose of Qvar. However, it may be necessary to give a short, intensive course of systemic steroids to tide over the duration of the stress.

Steroid dependent patients.

As recovery from impaired adrenocortical function, caused by prolonged systemic steroid therapy is slow, adrenocortical function should be monitored regularly. The patient's asthma should be in a stable state before being given inhaled steroids in addition to the usual maintenance dose of systemic steroid.
Withdrawal of systemic steroids should be gradual, starting about seven days after the introduction of Qvar therapy. For daily oral doses of prednisolone 10 mg or less, dose reduction in 1 mg steps at intervals of not less than one week is recommended. The dose reduction scheme should be chosen to correlate with the magnitude of the maintenance systemic steroid dose.
Some patients feel unwell experiencing aches and pains, tiredness and even depression during the withdrawal phase despite maintenance or even improvement of respiratory function. These withdrawal symptoms should be treated symptomatically and the patient should be encouraged to persevere with the inhaler and withdrawal of systemic steroids. However, if there are objective signs of adrenal insufficiency, it may be necessary to resume systemic steroid treatment temporarily.
Most patients can be successfully transferred to inhaled steroids with maintenance of good respiratory function, but special care is necessary for the first months after the transfer until the hypothalamic pituitary adrenal (HPA) system has sufficiently recovered to enable the patient to cope with emergencies such as trauma, surgery or severe infections. It may be advisable to provide such patients with a supply of oral steroid to use in such emergencies. The dose of inhaled steroids should be increased at this time and then gradually reduced to the maintenance level after the systemic steroid has been discontinued.
Discontinuation of systemic steroids may cause exacerbation of allergic diseases such as atopic eczema and rhinitis previously controlled by the systemic BDP. These should be treated symptomatically with antihistamines and/or topical therapy.

4.3 Contraindications

Hypersensitivity to beclomethasone dipropionate or any other ingredient in Qvar.

4.4 Special Warnings and Precautions for Use

Asthma management.

Qvar is not indicated for immediate relief of asthma attacks or status asthmaticus. If the prescribed dose of Qvar is no longer effective or symptoms get worse, the patient must seek medical attention for review of maintenance therapy.
Asthma management should be adjusted according to individual need based on lung function and clinical monitoring. Increasing use of a β2-agonist may be a sign of worsening asthma. Under these circumstances a reassessment of the patient's therapy plan may be required and increasing glucocorticosteroid therapy should be considered. This is important since poor asthma control can result in potential life threatening situations and increased use of β2-agonists may cause deterioration of asthma control.

Systemic effects.

Inhaled steroid products are designed to direct glucocorticoid activity to the lungs in order to reduce the overall systemic glucocorticoid exposure and side effects. In sufficient doses, however, all inhaled steroids can have adverse effects, notably depression of the hypothalamic pituitary adrenal (HPA) axis, Cushing's syndrome, Cushingoid features, reduction of bone density, retardation of growth in children and adolescents, cataract and glaucoma and more rarely a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). In steroid dependent patients prior systemic steroid usage may be a contributing factor, but such effects can occur amongst patients who regularly use only inhaled steroids. It is important, therefore, that the dose of inhaled steroid is titrated to the lowest dose at which effective control is maintained. Clinical studies in adult asthmatics treated with Qvar within the dose range 100-800 microgram daily have demonstrated mean values for adrenal function and response within normal range. The lowest dose of Qvar that causes suppression of the HPA axis (as indicated by 24 hour urinary cortisol concentrations), effects on bone mineral density or growth retardation in children has not yet been established.

Transfer from systemic steroids.

Patients who have received systemic steroids need special management when being transferred to inhaled steroid therapy. As recovery from impaired adrenocortical function caused by prolonged systemic steroid therapy is slow, adrenocortical function should be monitored regularly. Patients should have stable asthma before being given inhaled steroids in addition to the usual maintenance dose of systemic steroid. (See Section 4.2 Dose and Method of Administration).
Discontinuation of systemic steroids may cause exacerbation of allergic diseases such as atopic eczema and rhinitis. These should be treated symptomatically with antihistamines and/or topical therapy.
In patients who have been transferred from oral steroids to inhalation therapy, systemic steroid therapy may need to be reinstated rapidly during periods of stress or where airways obstruction or mucus significantly compromises the inhaled route of administration. The dose of inhaled steroids should be increased at this time and then gradually reduced to the maintenance level after the systemic steroid has been discontinued. Respiratory tract infections should be treated with appropriate antimicrobial therapy. The effect of BDP on recurrent lung infection is not known. Caution is necessary in patients with active or latent pulmonary tuberculosis.

Propellant.

Qvar contains a hydrofluoroalkane propellant (norflurane). In animal studies, narcosis and sensitisation to the arrhythmogenic effects of adrenaline were observed following inhalation of norflurane at high exposure concentrations. The potency of the cardiac sensitisation was less than that of trichlorofluoromethane (CFC-11). In humans norflurane is absorbed into the circulation following inhalational administration, although plasma concentrations are low and elimination is rapid. Excessive use of Qvar should be avoided as this carries a potential hazard from the propellant as well as from overdosage of the BDP in the formulation.

Visual disturbance.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Use in the elderly.

No data available.

Paediatric use.

To minimise the systemic effects of orally inhaled corticosteroids, the dose should be titrated down to the lowest that provides effective asthma control. The safety and efficacy of Qvar in children under the age of five has not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No clinically significant drug interactions have been associated with therapeutic doses of BDP.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

The potential impairment of fertility has not been adequately investigated in animal studies of BDP.
(Category B3)
There is inadequate clinical evidence of the safety of Qvar used during pregnancy. In animals, systemic administration of relatively high doses of BDP can cause abnormalities of foetal development including growth retardation and cleft palate. Inhalational administration of a norflurane based formulation of BDP to pregnant rats caused retardation of foetal growth and development, and red adrenal glands. Qvar should be avoided for use in pregnancy unless the expected benefit to the patient outweighs the risk to the foetus.
It is probable that BDP is excreted in milk. However, given the relatively low doses used by the inhalation route, the levels are likely to be low. Studies of inhaled BDP have not been done in lactating animals. In breastfeeding mothers the therapeutic benefits of Qvar should be weighed against the potential hazards to mother and baby.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

When using Qvar an occasional incidence of hoarseness and/or a rare occurrence of candidiasis of throat and mouth may occur. Patients may find it helpful to rinse out their mouth with water after using their inhaler to reduce the risk of candidiasis and hoarseness. Topical antifungal therapy can be used for the treatment of candidiasis while continuing treatment with Qvar.
As with other inhaled therapy, paradoxical bronchospasm with wheezing may occur immediately after dosing. Immediate treatment with an inhaled short acting bronchodilator is required. Qvar should be discontinued immediately and alternate prophylactic therapy introduced.
Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These may include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma (see Section 4.4 Special Warnings and Precautions for Use).
Very rarely Qvar may cause, Cushing's syndrome, Cushingoid features, anxiety, sleeping disorders or behavioural changes including hyperactivity, aggression and irritability (predominantly in children).
Hypersensitivity reactions including rashes, urticaria, pruritus and erythema, and oedema of the eyes, face, lips and throat (angioedema) have been reported.

Clinical trial data.

Table 2 shows the adverse events reported amongst adult patients in multiple dose studies of inhaled Qvar for 6 to 12 weeks. Table 3 shows the adverse events reported amongst adult and paediatric patients in large multicentre trials of inhaled Qvar vs CFC-BDP for 12 months. Each table includes all adverse events probably or possibly related to Qvar with an incidence of 1% or greater. A dash represents an incidence of less than 1%.
The following adverse reactions, probably or possibly related to the use of Qvar, were recorded during clinical trials with a frequency of less than 1%.

Application site disorders.

Uncommon: cough, increased asthma symptoms.

General disorders.

Uncommon: chest pain. Rare: asthenia, back pain, fatigue, oedema, pain.

Cardiovascular disorders, general.

Rare: hypertension.

Central and peripheral nervous system disorders.

Uncommon: dizziness, dysphonia, migraine. Rare: neuropathy, tremor, vertigo.

Gastrointestinal system disorders.

Uncommon: abdominal pain, constipation. Rare: dyspepsia, GI disorders (unspecified), nausea, tongue discolouration, toothache.

Heart rate and rhythm disorders.

Rare: palpitations.

Metabolic and nutritional disorders.

Uncommon: weight increase.

Musculoskeletal system disorders.

Uncommon: myalgia.

Myo, endo, pericardial and valve disorders.

Rare: angina pectoris.

Platelet, bleeding and clotting disorders.

Uncommon: epistaxis.

Psychiatric disorders.

Uncommon: increased appetite. Rare: anxiety, depression, insomnia.

Resistance mechanism disorders.

Uncommon: infection. Rare: infection bacterial.

Respiratory system disorders.

Uncommon: bronchitis, coughing, upper respiratory tract infection. Rare: acute asthma episode, haemoptysis, respiratory disorder, sinusitis.

Skin and appendages disorders.

Uncommon: rash. Rare: photosensitivity reaction, skin disorder, urticaria.

Vascular (extracardiac) disorders.

Uncommon: purpura.

Post marketing.

Eye disorders.

Vision blurred.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
The harmful effect that follows inhalation of large amounts of Qvar over a short time period is suppression of HPA function. Specific emergency action need not be taken. Treatment with Qvar should be continued at the recommended dose to control the asthma; HPA function recovers in a day or two.
If excessive doses of BDP were taken over a prolonged period a degree of atrophy of the adrenal cortex could occur in addition to HPA suppression. In this event the patient should be treated as steroid dependent and transferred to a suitable maintenance dose of a systemic steroid such as prednisolone. Regular tests of adrenal function are advised. Once the condition is stabilised, the patient should be returned to Qvar by the recommended method (see Section 4.2 Dose and Method of Administration).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Bronchial inflammation is known to be an important component in the pathogenesis of asthma.
Inflammation occurs in both large and small airways. BDP is a synthetic glucocorticoid. Glucocorticoids have multiple anti-inflammatory effects, inhibiting both inflammatory cells and release of inflammatory mediators. It is presumed that these anti-inflammatory actions play an important role in the efficacy of BDP in controlling symptoms and improving lung function in asthma although the exact mechanism of action of beclomethasone in the lungs is unknown. Inhaled BDP probably acts topically at the site of deposition in the bronchial tree after inhalation. Inhaled BDP at recommended doses reduces systemic exposure compared to oral administration, thereby minimising systemic side effects, including pituitary adrenal suppression.

Clinical trials.

A pharmacodynamic study in 43 steroid naive asthmatics given either placebo, 200, 400 or 800 microgram/day of Qvar; or 800 microgram/day of CFC-BDP for 14 days showed a linear correlation between reduction in 24 hour urinary free cortisol levels (24h-UFC) and dose of BDP administered, as well as between BDP dose and serum total beclomethasone levels. The mean 24h-UFC, a sensitive marker of adrenal function, remained within the normal range for all dosing regimens. A daily dose of 800 microgram Qvar caused similar reductions in 24h-UFC levels as a daily dose of 800 microgram of CFC-BDP. Results from the secondary parameters of plasma cortisol and the ACTH stimulation test supported the findings of 24h-UFC and showed no differences to CFC-BDP and placebo at Qvar doses up to 800 microgram/day.
In two 12 week trials conducted in patients with symptomatic moderate (n = 347) and symptomatic moderately severe (n = 233) asthma, plasma cortisol levels were monitored as a secondary safety assessment to determine HPA axis suppression. The mean percentage change of plasma cortisol values from baseline and the number of patients with plasma cortisol values below the normal reference was similar for HFA-placebo, 800 microgram/day Qvar and 800 microgram/day CFC-BDP.
In a 12 month study in 473 asthmatic patients given either Qvar in a dose range of 200 to 800 microgram/day or CFC-BDP in a dose range of 400 to 1600 microgram/day, adrenal function was assessed by plasma cortisol levels and response to cosyntropin. No differences in mean plasma cortisol levels or clinically significant changes in cortisol levels from baseline were seen between the two treatment groups, and no significant difference in response to cosyntropin was seen between the treatment groups. The effect of Qvar on bone metabolism was assessed by serum osteocalcin concentrations. No clinically meaningful differences in serum osteocalcin levels were found between the treatment groups.
A 12 month multicentre study in 520 paediatric patients with asthma demonstrated that the effect on growth of 100-200 microgram/day of Qvar from the Autohaler was comparable to those of 200-400 microgram/day of CFC-BDP from a PandB MDI with spacer. The effect of Qvar on bone metabolism was assessed by serum osteocalcin levels, PICP, 1-CTP and urine deoxypyridinoline/ creatinine ratio. No treatment differences were found between the treatment groups. Analysis of adrenal function, as assessed by 24 h-UFC, plasma cortisol levels and response to low dose ACTH stimulation showed no significant differences between Qvar or CFC-BDP treatments across all doses.
Clinical studies indicate that CFC-BDP and Qvar inhalers are clinically equivalent when given in a dose ratio of 2.5 to 1.

Qvar versus CFC-BDP.

In controlled clinical trials in adults Qvar was effective at controlling asthma at doses as low as 50 microgram twice daily (100 microgram/day), below the recommended dose of CFC-BDP. Comparable asthma control was achieved at lower daily doses of Qvar than with CFC-BDP (e.g. 200 microgram of Qvar twice a day provided comparable asthma control as 400 microgram or 500 microgram of CFC-BDP twice a day). The improvement in FEV1 across doses was greater for Qvar than for CFC-BDP, indicating a beneficial shift in the dose response curve for Qvar. Improved efficacy of Qvar compared to CFC-BDP is due to its increased relative airways availability (as a consequence of a smaller mean particle size and improved pulmonary deposition). Because of this, doses of Qvar required to achieve the same effect as CFC-BDP are 2 to 2.5 times lower than CFC-BDP (see Section 4.2 Dose and Method of Administration).
A 12 month large multicentre safety study in paediatric patients with asthma showed that stable patients on CFC-BDP (200-400 microgram/day with spacer) can be switched to lower daily doses of Qvar (100-200 microgram/day via Autohaler) with good maintenance of asthma control.
Clinical studies indicate that CFC-BDP and Qvar inhalers are clinically equivalent when given in a dose ratio of 2.5 to 1.

Qvar versus budesonide.

A 6 week randomised, open label study in adult patients with symptomatic moderate asthma receiving 400 microgram/day budesonide dry powder inhaler (DPI) showed that 400 microgram/day Qvar delivered via the Autohaler provided equivalent control of asthma as 800 microgram budesonide DPI. Equivalent asthma control was shown by equivalent improvement in peak flow parameters, asthma symptoms, sleep disturbance and beta-agonist use.
In an 8-week randomised, open-label study in adult patients with symptomatic moderate to severe asthma receiving 500-1000 microgram/day CFC-BDP, 800 microgram/day Qvar delivered via the Autohaler provided equivalent asthma control to 1600 microgram/day budesonide DPI. An equivalent mean change from baseline in AM PEF was observed over the 8-week study period for the two treatment groups. Statistically significant improvements from baseline were seen in asthma symptom and sleep disturbance scores for patients in both groups.
These studies demonstrate that Qvar at half the daily dose of budesonide DPI provides equivalent asthma control in symptomatic adult asthma patients. Both treatments were well tolerated and there were no clinically significant differences in the safety profiles of the two treatments.

Qvar versus fluticasone.

In a 6 week randomised, double-blind, double-dummy, parallel study, adult patients with symptomatic asthma taking a total daily dose of 200-500 microgram CFC-BDP, 100-250 microgram CFC-FP or 200-400 microgram budesonide were randomised to receive either 400 microgram/day Qvar or 400 microgram/day CFC-fluticasone (FP). Results of this study showed a clinically equivalent mean change from baseline in AM PEF over the 6 week study period. Equivalent asthma control was shown by equivalent improvements in peak flow parameters, asthma symptoms, sleep disturbance and beta-agonist use.
In an 8-week randomised open-label study adult patients with symptomatic asthma receiving up to 500 microgram/day FP or 500-1000 microgram/day BDP or 400-800 microgram/day budesonide were switched to 800 microgram/day Qvar or 1000 microgram/day HFA-fluticasone. There was an equivalent mean change from baseline in AM PEF observed over the 8-week study for the two treatment groups. No statistically significant differences in pulmonary parameters, asthma symptoms, sleep disturbance and beta-agonist use were seen for patients in both groups.
These studies demonstrate equivalent asthma control with Qvar and fluticasone in patients with symptomatic asthma. Both treatments were well tolerated and there were no clinically significant differences in the safety profiles of the two treatments.

5.2 Pharmacokinetic Properties

BDP is hydrolysed in the lungs to beclomethasone monopropionate before reaching the systemic circulation and is further metabolised during its passage through the liver. The principal route of elimination of BDP and its metabolites is in the faeces. Between 10% and 15% of any orally administered dose is excreted in the urine, as both conjugated and free metabolites of BDP.
The pharmacokinetics of beclomethasone and of total beclomethasone have been measured over 24 hours in mild asthmatics given single and multiple doses of Qvar. Total beclomethasone was obtained by hydrolysing any BDP and beclomethasone monopropionate in the serum samples to beclomethasone. The peak serum concentration for total beclomethasone is achieved within 30 minutes. The mean values of the peak serum concentrations after multiple dosing of 100 microgram, 200 microgram or 400 microgram twice daily for 14 days are proportional to the dose. The mean peak serum concentration after the highest recommended dose of 400 microgram twice daily is approximately 1 nanogram/mL.
Pharmacokinetic studies comparing Qvar and CFC-BDP demonstrated that a dose of 200 microgram of Qvar achieved comparable total beclomethasone levels as a dose of 400 microgram of CFC-BDP. This finding is consistent with the deposition results, which showed increased lung deposition and reduced oropharyngeal deposition for Qvar compared with CFC-BDP. Pharmacokinetic data in the paediatric population shows that the AUC for the dominant active metabolite 17-BMP after administration of 200 microgram of Qvar from the Autohaler is similar to that of 400 microgram of CFC-BDP given via an inhaler with spacer.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

Potential carcinogenicity and mutagenicity have not been adequately investigated in animal studies of BDP. Other glucocorticoids (budesonide, prednisolone and triamcinolone acetate) have been shown to increase the incidence of hepatocellular tumours in rats by a nongenotoxic mechanism.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Avoid storage in direct sunlight or heat. Protect from frost. As the canister is pressurised no attempt should be made to puncture or dispose of it by burning.

6.5 Nature and Contents of Container

Each 200 dose canister provides 200 inhalations. 1's.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Its molecular formula is C28H37ClO7 (molecular weight: 521.1).

Chemical structure.


CAS number.

5534-09-8.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes