Qvar 100 inhaler

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Beclometasone dipropionate
Available from:
CST Pharma Ltd
ATC code:
R03BA01
INN (International Name):
Beclometasone dipropionate
Dosage:
100microgram/1dose
Pharmaceutical form:
Pressurised inhalation
Administration route:
Inhalation
Class:
No Controlled Drug Status
Prescription type:
Caution - AMP level prescribing advised
Product summary:
BNF: 03020000; GTIN: 5055946803685

PATIENT INFORMATION LEAFLET

Qvar

®

100 Inhaler

(beclometasone dipropionate)

Your medicine will be referred to as Qvar Inhaler throughout this leaflet.

Qvar is also available in another strength.

Read all of this leaflet carefully before you start using this medicine

because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to

others. It may harm them, even if their signs of illness are the same as

yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.

This includes any possible side effects not listed in this leaflet. See

section 4.

What is in this leaflet

1. What Qvar Inhaler is and what it is used for

2. What you need to know before you use Qvar Inhaler

3. How to use Qvar Inhaler

4. Possible side effects

5. How to store Qvar Inhaler

6. Contents of pack and other information

1. What Qvar Inhaler is and what it is used for

Qvar Inhaler contains beclometasone dipropionate, which is one of a

group of medicines known as corticosteroids.

Qvar Inhaler is used to prevent the symptoms of mild, moderate, or

severe asthma, in patients who require regular treatment.

How your medicine works

Qvar Inhaler works deep in your lungs to make breathing easier by

reducing the inflammation, swelling and irritation in the airways. This

type of medicine is known as a ‘preventer’. It needs to be taken

regularly every day, even if you have no symptoms.

This inhaler will not give immediate relief of wheezing or

breathlessness during a sudden asthma attack. You will need to use a

‘reliever’ inhaler, which contains a different medicine. You should still

continue to use this inhaler.

2. What you need to know before you use Qvar Inhaler

Do not use Qvar Inhaler if you:

are allergic to beclometasone dipropionate or any of the other

ingredients of this medicine (listed in section 6)

are allergic to other similar inhalers.

are suffering from a sudden attack of breathlessness. It will not help.

Use a quick-acting ‘reliever’ inhaler for this purpose and carry it with

you at all times.

Warnings and precautions

Talk to your doctor before taking this medicine if:

you are suffering from tuberculosis (TB) now or

have you suffered from it in the past.

you must avoid alcohol for any reason.

your asthma seems to be getting worse. Perhaps

you are more wheezy and short of breath than usual, your ‘reliever’

inhaler seems to be less effective, you require more puffs from your

‘reliever’ inhaler than usual, or you do not seem to be getting better.

Your doctor may need to increase the dose of your steroid inhaler or

give you a course of steroid tablets, or change your treatment

altogether. If you have an infection in your chest your doctor may

prescribe a course of antibiotics.

when transferring from steroid tablets to an inhaler you find that, even

if your chest is getting better, you feel generally unwell, you develop a

rash, eczema or a runny nose and sneezing (rhinitis). Do not stop

treatment with your inhaler unless your doctor tells you to.

Important points to remember while you are using this medicine:

Your doctor may prescribe this inhaler to replace steroid tablets, which

may mean for a short time you have to take both medicines. It is

important to follow your doctor’s advice. Whilst you are reducing the

number of steroid tablets that you take you may feel generally unwell

even though you can breathe as well as normal or better. If you have

other allergies you may find that stopping your steroid tablets makes

them worse. If this happens keep using your inhaler and tell your

doctor.

If you have been treated for a long time with high doses of inhaled

steroid, you may require a course of steroid tablets or possibly a

steroid injection in times of stress. For example, during admission to

hospital after a serious accident, before an operation, during an acute

attack of asthma or if you have a chest infection or other serious

illness.

Your doctor will decide if you need any extra steroid treatment and will

also advise you as to how long you need to take the course of steroid

tablets and how you should reduce these as you get better.

There may be times when you need to take steroid tablets as well as

using your inhaler, for example if you have worsening asthma attacks,

you get a chest infection or you need an operation. Your doctor may

give you a small supply of steroid tablets to be taken in these

situations; if he does you will be given full instructions on how and

when to take them. Contact your doctor immediately if you think that

you need to take steroid tablets, even if you have your own supply.

You should have been given a steroid card with this inhaler, if you

have not, please ask your pharmacist for one. Make sure you carry

your steroid card with you at all times until your doctor decides that it is

no longer necessary.

Visit your doctor regularly for a review of your condition.

If you have to go into hospital, remember to take all your inhalers and

other medicines with you.

Contact your doctor if you experience blurred vision or other visual

disturbances

Other medicines and Qvar Inhaler

Please tell your doctor or pharmacist if you are taking or have recently

taken any other medicines, including any medicines obtained without a

prescription.

In particular tell your doctor if you are taking:

Disulfiram

Metronidazole

Some medicines may increase the effects of Qvar Inhaler and your

doctor may wish to monitor you carefully if you are taking these

medicines (including some medicines for HIV: ritonavir, cobicistat).

Pregnancy, breast-feeding and fertility

If you are pregnant, planning to become pregnant or are breast-

feeding, ask your doctor for advice before taking this medicine.

Driving and using machines

Qvar Inhaler is not known to affect your ability to drive or operate

machinery.

Important information about some of the ingredients of Qvar

Inhaler:

Qvar Inhaler contains a small amount of alcohol.

3. How to use Qvar Inhaler

Always take this medicine exactly as your doctor or pharmacist has told

you. Check with your doctor or pharmacist if you are not sure.

There are two strengths of Qvar Inhaler available and your doctor will

have chosen the strength which best suits your condition.

This inhaler has a softer feel and a different taste than other inhalers you

may have used before. This inhaler is an extra fine inhaler which results

in more of each dose being delivered to your lungs. Your doctor may,

therefore, prescribe a lower dose of this inhaler than your previously

used inhaler.

Even when your doctor has prescribed a lower dose you may find that

the number of puffs you are asked to take from this inhaler is the same

as from your previous inhaler; this is because this inhaler may be a lower

strength product (which means that each puff of this inhaler contains less

beclometasone dipropionate than your old inhaler).

Do not take more puffs than your doctor has told you to. In some

circumstances, your doctor may prescribe more than the usual number

of puffs. The usual number of puffs to take is:

Qvar 50 Inhaler

Adults (including the elderly) and children over 12 years

Mild Asthma

The starting dose is one puff twice a day. This may be increased up to

two puffs twice a day.

Moderate Asthma

The starting dose is two puffs twice a day. This may be increased up to

four puffs twice a day.

Severe Asthma

The starting dose is four puffs twice a day. This may be increased up

to eight puffs twice a day.

The maximum dose is a total of sixteen puffs a day.

Qvar 100 Inhaler

Adults (including the elderly) and children over 12 years

Mild Asthma

The Qvar 100 Inhaler device is not suitable for the starting dose. It is

suitable for an increased dose of one puff twice a day.

Moderate Asthma

The starting dose is one puff twice a day. This may be increased to two

puffs twice a day.

Severe Asthma

The starting dose is two puffs twice a day. This may be increased up to

four puffs twice a day.

The maximum dose is a total of eight puffs a day.

Use in children under 12 years

Qvar Inhaler is not recommended for use in children under 12 years.

What to do if you think your treatment is not working

If you think your usual treatment is not working, for example your

symptoms are not getting better, or are getting worse, or you need to use

more puffs from your reliever inhaler, or if your reliever inhaler does not

seem to be working as well as usual, or your peak flow falls, please tell

your doctor. Your asthma may be getting worse.

If you use more Qvar Inhaler than you should

It is important that you take your dose as stated on the pharmacist’s

label, or as advised by your doctor. You should not increase or decrease

your dose without seeking medical advice.

If you accidentally take more puffs than recommended, please tell your

doctor.

If you forget to use Qvar Inhaler

If you forget to use this inhaler at your usual time, take your

recommended number of puffs as soon as you remember unless it is

nearly time to use your inhaler again. DO NOT take a double dose to

make up for a forgotten dose. Then continue to use your inhaler regularly

at the correct time, as prescribed by your doctor.

If you stop using Qvar Inhaler

This inhaler must be used regularly, even when you feel well. You must

not stop using your inhaler unless your doctor tells you to.

Ask your doctor for a prescription for a replacement inhaler before this

one is empty.

If your doctor decides to stop treatment, return the inhaler to your doctor

or pharmacist for safe disposal.

If you have any further questions on the use of this medicine, ask your

doctor or pharmacist.

Using your Qvar Inhaler

Before use

If this is a new inhaler or if you have not used your inhaler for two

weeks or more, it must be tested before use by removing the

mouthpiece cover and pressing down on the canister inside the

inhaler.

Release 2 puffs into the air, away from you.

How to use your inhaler

1. Take the cover off the mouthpiece.

2. Breathe out as far as is comfortable and

then immediately place the mouthpiece in

your mouth and close your lips around it.

3. Start to breathe in slowly and deeply through

your mouth and press down on the canister

inside the inhaler as shown. This releases

one puff of medicine. It is important that you

carry on breathing in after the puff is

released.

4. Hold your breath for 10 seconds, then

breathe out slowly. If your doctor has

prescribed more than one puff repeat steps

2 to 4 again. After use, replace the cover on

the mouthpiece.

1301

19.02.18[17]

Some people find it difficult to press their inhaler and breathe in

at the same time.

A spacer device helps to overcome this problem. The spacer that fits

Qvar Inhaler is called the AeroChamber Plus

spacer device. If you

use the AeroChamber Plus

spacer device, please follow the

instructions provided with it. Your doctor, nurse or pharmacist will be

able to advise you about the AeroChamber Plus

device.

Alternatively your doctor may wish to prescribe the Qvar Autohaler

device which automatically releases a puff of medication as you

breathe in.

How to tell when your Qvar Inhaler device is empty

When the canister is completely empty you will not feel or hear any

propellant being discharged.

Cleaning instructions

For normal hygiene, the mouthpiece of your inhaler should be cleaned

weekly with a clean, dry tissue or cloth. You should also rinse your

mouth with water after using your inhaler.

Do not wash or put any part of your inhaler in water

If you have any further questions on the use of this medicine, ask your

doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not

everybody gets them.

If immediately after taking a puff of this inhaler, you feel wheezy or

tight chested do not take any more puffs. Use your reliever inhaler

to help your breathing and contact your doctor immediately.

Stop using your inhaler and tell your doctor immediately or go to

the casualty department at your nearest hospital if the following happens:

an allergic reaction (swelling of the lips, face or neck leading to severe

difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect. You may need urgent medical

attention or hospitalisation.

Treatment with Qvar Inhaler may affect the normal production of

corticosteroids in the body. Keep using your inhaler but see your

doctor as soon as possible if you become unwell, particularly with any

of the following:

abdominal pain

weakness

vomiting.

This is especially important if you have been exposed to other stress

such as other illness, surgery, or infection.

In addition, the following side effects have been reported for high doses,

taken for prolonged periods:

bone thinning

clouding of the lens of the eye (cataract) resulting in blurred vision

loss of vision due to abnormally high pressure in the eye.

The following side effects may also occur in patients taking

beclometasone dipropionate. If you experience any of these effects,

keep using your inhaler but see your doctor if they last for a while or

they are worrying you:

hoarseness

difficulty in swallowing accompanied by earache and swollen glands,

sore throat (pharyngitis)

a sore mouth or thrush (white spots in your mouth and throat). These

are less likely if you rinse your mouth out with water after using your

inhaler. If you get thrush your doctor may recommend a medicine to

treat you

feeling sick

headache

feeling dizzy or faint

tremor

change in taste

difficulty in breathing, increase in wheezing, shortness of breath and

cough (bronchospasm)

sleeping problems, depression or feeling worried, restless, nervous,

over-excited or irritable. These effects are more likely to occur in

children (Frequency not known).

Blurred vision (uncommon (may affect up to 1 in 100 people))

Children or adolescents who are using the inhaler for a prolonged period

may grow more slowly. Your doctor may therefore wish to monitor the

height of a child receiving prolonged treatment with Qvar Inhaler.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This

includes any possible side effects not listed in this leaflet. You can also

report side effects directly via the Yellow Card Scheme

at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in

the Google Play or Apple App Store. By reporting side effects, you can

help provide more information on the safety of this medicine.

5. How to store Qvar Inhaler

Keep out of the sight and reach of children.

Do not store above 25

C. Avoid storage in direct sunlight or heat. Protect

from frost. You can use your inhaler at temperatures as low as -10

Do not use Qvar Inhaler after the expiry date that is stated on the outer

packaging. The expiry date refers to the last day of that month.

The canister is pressurised and should not be punctured or burnt even if

it seems empty Medicines should not be disposed of via wastewater or

household waste. If your doctor decides to stop treatment, return the

inhaler to your doctor or pharmacist far safe disposal.

These measures will help to protect the environment.

6.Contents of pack and other information

Your Qvar Inhaler does not contain CFCs; instead, the inhaler contains a

hydrofluoroalkanes (called propellant HFA-134a or norflurane) as an

inactive ingredient. Hydrofluoroalkanes have been developed as a

replacement for CFCs.

What Qvar Inhaler contains:

The active ingredient is beclometasone dipropionate.

Each actuation delivers beclometasone dipropionate 100 micrograms

into the mouthpiece.

The other ingredients are HFA-134a (norflurane) and ethanol.

What Qvar Inhaler looks like and contents of the pack:

Qvar Inhaler is a pressurised inhalation, solution in a canister enclosed

in a brick red body with a grey mouthpiece.

Your inhaler contains 100 or 200 puffs,

Manufacturer and Product Licence holder

Qvar Inhaler is manufactured by 3M Health Care Limited, 1, Derby Road,

Loughborough, LE11 1SL. UK. Procured from the EU by Product

Licence holder Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow,

Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet Revision date (Ref:) 19.02.18[17]

Qvar

is a trademark of Teva Pharmaceuticals International GmbH.

Aerochamber Plus is a registered trademark of Trudell Medical

International.

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 020 8423 2111 to obtain the

leaflet in a format suitable for you.

For further information about asthma, contact Asthma UK, the

independent UK charity working to conquer asthma:

Asthma UK, Summit House,

70 Wilson Street,

London, EC2A 2DB

Asthma Helpline: 0845 7 010203

(Open Monday to Friday, 9am to 5pm, calls charged at local rates).

Qvar

100 Inhaler PL 20636/1301

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Qvar Easi-Breathe 100 micrograms per actuation inhaler

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Beclometasone Dipropionate 100 micrograms per metered (ex-valve) dose.

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Pressurised inhalation, solution

colourless

solution

pressurised

aluminium

canister

fitted

with

metering valve and an actuator.

Qvar

Easi-Breathe

contains

propellant,

which

does

contain

chlorofluorocarbons (CFCs).

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Prophylactic management of mild, moderate or severe asthma.

4.2

Posology and method of administration

Posology

Qvar Easi-Breathe is for inhalation use only.

Patients should be instructed in the proper use of their inhaler, including rinsing out

their mouth with water after use..

NOTE: The recommended total daily dose of Qvar Easi-Breathe is lower than

that for current beclometasone dipropionate containing products and should be

adjusted to the needs of the individual patient.

ADULT STARTING AND MAINTENANCE DOSE:

It is important to gain control of asthma symptoms and optimise pulmonary function

as soon as possible. When patients’ symptoms remain under satisfactory control, the

dose should be titrated to the lowest dose at which effective control of asthma is

maintained.

To be effective inhaled Qvar Easi-Breathe must be used on a regular basis even when

patients are asymptomatic.

THERAPY IN NEW PATIENTS SHOULD BE INITIATED AT THE FOLLOWING

Mild asthma:

100 to 200 micrograms per day in two divided doses.

Moderate asthma:

200 to 400 micrograms per day in two divided doses.

Severe asthma:

400 to 800 micrograms per day in two divided doses.

Patients on budesonide inhalers may be transferred to Qvar as described below

The general approach to switching patients to Qvar involves two steps as detailed

below. Specific guidance on switching well-controlled and poorly-controlled

(symptomatic) patients is given below the table.

Step 1: Consider the dose of budesonide-containing inhalers appropriate to the

patient’s current condition.

Step 2: Convert the budesonide inhaler dose to the Qvar dose according to the table

below.

Total Daily Dose (mcg/day)

Budesonide

inhaler

200-

400-500

600-750

800-

1000

1100

1200-

1500

1600-

2000

QVAR

Patients with well-controlled asthma using budesonide inhaler products should be

switched to Qvar at a dose in accordance with the table above.

For example:

Patients on 2 puffs twice daily of budesonide 100 micrograms would change to 2

puffs twice daily of Qvar 50 micrograms.

Patients with poorly-controlled asthma may be switched from budesonide inhaler

products to Qvar at the same microgram for microgram dose up to 800 micrograms

daily.

Alternatively the patient’s current budesonide inhaler dose can be doubled and this

dose can be converted to the Qvar dose according to the table above.

Patients on fluticasone inhalers may be transferred to the same total daily dose of

Qvar up to 800 micrograms daily.

Once transferred to Qvar Easi-Breathe the dose should be adjusted to meet the needs

of the individual patient.

The maximum recommended dose is 800 micrograms per day in divided doses.

The same total daily dose in micrograms from either Qvar Easi-Breathe 50 (a lower

strength) or Qvar Easi-Breathe 100 Inhaler provides the same clinical effect.

Patients should be instructed in the proper use of their inhaler, including rinsing out

their mouth with water after use. Patients should be advised that Qvar Easi-Breathe

may have a different taste and feel than a CFC inhaler.

Paediatric population

There are no data to date on Qvar Easi-Breathe in children under 12 years of age,

hence no definitive dosage recommendation can be made.

Special patient groups

No special dosage recommendations are made for elderly or patients with hepatic or

renal impairment.

Method of administration

The aerosol spray is inhaled through the mouth into the lungs. The inhaler should be

primed by firing two shots into the air before first use or if the inhaler has not been

used for a period of two weeks or longer.

After removal of the cap the inhaler mouthpiece should be placed in the mouth with

the lips closed around it. The patient should breathe in slowly and deeply through the

mouthpiece. They should be advised not to stop breathing when the inhaler delivers

the dose into their mouth but carry on until they have taken a deep breath to ensure

optimal delivery of the product.

For normal hygiene, the mouthpiece of the inhaler should be cleaned weekly with a

clean dry tissue or cloth. The inhaler should not be washed or immersed in water at

any time.

Full instructions for use are given in the Patient Information Leaflet, which should be

read carefully by the patient before use.

Qvar Easi-Breathe delivers a consistent dose

- whether or not the canister is shaken by the patient

- without the need for the patient to wait between individual actuations

- regardless of storage orientation or periods without use of up to 14 days

- at temperatures as low as -10°C.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section

6.1.

4.4

Special warnings and precautions for use

Patients should be properly instructed on the use of the inhaler to ensure that the drug

reaches the target areas within the lungs.To be effective, Qvar Easi-Breathe must be

used by patients on a regular basis, even when patients do not have asthma symptoms.

When symptoms are controlled, maintenance Qvar Easi-Breathe therapy should be

reduced in a stepwise manner to the minimum effective dose. Inhaled steroid

treatment should not be stopped abruptly.

Patients with asthma are at risk of acute attacks and should have regular assessments

of their asthma control including pulmonary function tests.

Qvar Easi-Breathe is not indicated for the immediate relief of asthma attacks. Patients

therefore need to have relief medication (inhaled short-acting bronchodilator)

available for such circumstances.

Severe asthma requires regular medical assessment, including lung-function testing,

as there is a risk of severe attacks and even death. Patients should be instructed to

seek medical attention if short-acting relief bronchodilator treatment becomes less

effective, or more inhalations than usual are required as this may indicate

deterioration of asthma control. If this occurs, patients should be assessed and the

need for increased anti-inflammatory therapy considered (eg. higher doses of inhaled

corticosteroid or a course of oral corticosteroid)

Severe asthma exacerbations should be managed in the usual way i.e. by increasing

the dose of inhaled beclometasone dipropionate, giving a systemic steroid if

necessary, and/or an appropriate antibiotic if there is an infection, together with

agonist therapy.

Treatment with Qvar should not be stopped abruptly.

However, systemic effects of inhaled corticosteroids may occur, particularly at high

doses prescribed for prolonged periods. These effects are much less likely to occur

than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome,

Cushingoid features, adrenal suppression, growth retardation in children and

adolescents, decrease in bone mineral density, cataract, glaucoma, blurred vision, and

more rarely, a range of psychological or behavioural effects including psychomotor

hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in

children). It is important, therefore, that the dose of inhaled corticosteroid is titrated

to the lowest dose at which effective control of asthma is maintained.

It is recommended that the height of children receiving prolonged treatment with

inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be

reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to

the lowest dose at which effective control of asthma is maintained. In addition,

consideration should be given to referring the patient to a paediatric respiratory

specialist.

Prolonged treatment with high doses of inhaled corticosteroids, particularly higher

than the recommended doses, may result in clinically significant adrenal suppression.

Additional systemic corticosteroid cover should be considered during periods of

stress or elective surgery.

Patients who have received systemic steroids for long periods of time or at high

doses, or both, need special care and subsequent management when being transferred

to inhaled steroid therapy. Patients should have stable asthma 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 Easi-Breathe therapy. For daily oral doses of prednisolone of

10mg or less, dose reduction in 1mg steps, at intervals of not less than one week is

recommended. For patients on daily maintenance doses of oral prednisolone greater

than 10mg, larger weekly reductions in the dose might be acceptable. The dose

reduction scheme should be chosen to correlate with the magnitude of the

maintenance systemic steroid dose.

As recovery from impaired adrenocortical function, caused by prolonged systemic

steroid therapy is slow, adrenocortical function should be monitored regularly.

Patients should be advised that they may feel unwell in a non-specific way during

systemic steroid withdrawal despite maintenance of, or even improved respiratory

function. Patients should be advised to persevere with their inhaled product and to

continue withdrawal of systemic steroids, even if feeling unwell, unless there is

evidence of HPA axis suppression.

Patients weaned off oral steroids whose adrenocortical function is impaired should

carry a steroid warning card indicating that they may need supplementary systemic

steroids during periods of stress, eg. worsening asthma attacks, chest infections,

major intercurrent illness, surgery, trauma, etc.

Discontinuation of systemic steroids may also cause exacerbation of allergic diseases

such as atopic eczema and rhinitis. These should be treated as required with topical

therapy, including corticosteroids and/or antihistamines.

Like other corticosteroids, caution is necessary in patients with active or latent

pulmonary tuberculosis.

Patients should be advised to seek medical attention for review of maintenance Qvar

Easi-Breathe therapy if peak flow falls, symptoms worsen or if the short-acting

bronchodilator becomes less effective and increased inhalations are required. This

may indicate worsening asthma.

Most patients can be successfully transferred to inhaled steroids with maintenance of

good respiratory function, but special care is necessary for the first few months after

the transfer, until the hypothalamic-pituitary-adrenal (HPA) system has sufficiently

recovered to enable the patient to cope with stressful emergencies such as trauma,

surgery or serious infections. Patients should, therefore, carry a steroid warning card

to indicate the possible need to re-instate systemic steroid therapy rapidly during

periods of stress or where airways obstruction or mucus significantly compromises

the inhaled route of administration. In addition, it may be advisable to provide such

patients with a supply of corticosteroid tablets to use in these circumstances. 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.

Beclometasone dipropionate, like other inhaled steroids, is absorbed into the systemic

circulation from the lungs. Beclometasone dipropionate and its metabolites may exert

detectable suppression of adrenal function. Within the dose range 100-800

micrograms daily, clinical studies with Qvar Easi-Breathe have demonstrated mean

values for adrenal function and responsiveness within the normal range.

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.

Patients should be advised that this product contains small amounts of ethanol. At the

normal doses, the amounts of ethanol are negligible and do not pose a risk to patients

(see section 4.5).

4.5

Interaction with other medicinal products and other forms of interaction

Qvar Easi-Breathe contains a small amount of ethanol. There is a theoretical potential

for interaction in particularly sensitive patients taking disulfiram or metronidazole.

Beclometasone

less

dependent

CYP3A

metabolism

than

some

other

corticosteroids, and in general interactions are unlikely; however the possibility of

systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir,

cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is

advised with the use of such agents.

4.6

Fertility, pregnancy and lactation

The potential risk of this product for humans is unknown.

Qvar Easi-Breathe

There is no experience of this product in pregnancy and lactation in humans, therefore

the product should only be used if the expected benefits to the mother are thought to

outweigh any potential risk to the foetus or neonate

Beclometasone dipropionate

Pregnancy

There is inadequate evidence of safety in human pregnancy.

Administration of

corticosteroids to pregnant animals can cause abnormalities of foetal development

including cleft palate and intra-uterine growth retardation. There may therefore, be a

risk of such effects in the human foetus. It should be noted, however, that the foetal

changes in animals occur after relatively high systemic exposure. Beclometasone

dipropionate is delivered directly to the lungs by the inhaled route and so avoids the

high level of exposure that occurs when corticosteroids are given by systemic routes.

The use of beclometasone dipropionate in pregnancy requires that the possible

benefits of the drug be weighed against the possible hazards. The drug has been in

widespread use for many years without apparent ill consequence.

Breast-feeding

No specific studies examining the transfer of beclometasone dipropionate into the

milk of lactating animals have been performed. It is probable that beclometasone

dipropionate is excreted in milk. However, given the relatively low doses used by the

inhalation route, the levels are likely to be low. In mothers breast feeding their baby

the therapeutic benefits of the drug should be weighed against the potential hazards to

mother and baby.

There is no experience with or evidence of safety of propellant HFA 134a in human

pregnancy or lactation. However, studies on the effect of HFA 134a on reproductive

function and embryofoetal development in animals have revealed no clinically

relevant adverse effects.

4.7

Effects on ability to drive and use machines

Not relevant

4.8

Undesirable effects

A serious hypersensitivity reaction including oedema of the eye, face, lips and throat

(angioedema) has been reported rarely.

As with other inhaled therapy, paradoxical bronchospasm may occur after dosing.

Immediate treatment with a short-acting bronchodilator should be initiated, Qvar

should be discontinued immediately and an alternate prophylactic treatment

introduced.

Systemic effects of inhaled corticosteroids may occur, particularly with high doses

prescribed for prolonged periods. These include adrenal suppression, growth

retardation in children, decrease in bone mineral density and the occurrence of

cataract and glaucoma.

Commonly, when taking Qvar, hoarseness and candidiasis of the throat and mouth

may occur. To reduce the risk of hoarseness and candida infection, patients are

advised to rinse their mouth after using their inhaler.

Based on the MedDra system organ class and frequencies, adverse events are listed in

the table below according to the following frequency estimate: very common (

1/10); common (

1/100 to <1/10); Uncommon (

1/1,000 to <1/100); rare (

1/10,000

to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the

available data).

MedDra – system organ class

Frequency and Symptom

Infections and infestations

Common: Candidiasis in mouth and

throat

Immune system disorders

Rare: Allergic reactions, angioedema in

eyes, throat, lips and face

Endocrine disorders

Very rare: Adrenal suppression

, growth

retardation

(in children and

adolescents), bone density decreased

Nervous system disorders

Uncommon: Headache, vertigo, tremor

Eye disorders

Uncommon:

Vision, blurred (see also

section 4.4)

Very rare: Cataract

, glaucoma

Not known:

Central serous retinopathy

Respiratory, thoracic and mediastinal

Common: Hoarseness, pharyngitis

disorders

Uncommon: Cough, increased asthma

symptoms

Rare: Paradoxical bronchospasm

Gastrointestinal disorders

Common: Taste disturbances

Uncommon: Nausea

Skin and subcutaneous tissue disorders

Uncommon: Urticaria, rash, pruritus,

erythema, purpura

Musculoskeletal and connective tissue

disorders

Very rare: Decrease bone mineral density

Psychiatric Disorders

Unknown: Psychomotor hyperactivity,

sleep disorders, anxiety, depression,

aggression, behavioural changes

(predominantly in children)

*Systemic reactions are a possible response to inhaled corticosteroids, especially

when a high dose is prescribed for a prolonged time (see section 4.4 Special warnings

and precautions for use).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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

via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9

Overdose

Acute overdosage is unlikely to cause problems. The only harmful effect that

follows inhalation of large amounts of the drug over a short time period is

suppression of HPA function. Specific emergency action need not be taken.

Treatment with Qvar Easi-Breathe should be continued at the recommended

dose to control the asthma; HPA function recovers in a day or two.

If excessive doses of beclometasone dipropionate were taken over a prolonged

period a degree of atrophy of the adrenal cortex could occur in addition to

suppression.

this

event

patient

should

treated

steroid

dependent and transferred to a suitable maintenance dose of a systemic steroid

such as prednisolone. Once the condition is stabilised, the patient should be

returned to Qvar Easi-Breathe by the method described above in section 4.4.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Glucocorticoids, ATC Code: R03B A01

Qvar contains beclometasone dipropionate in solution in propellant HFA-134a

resulting in an extrafine aerosol. The aerosol droplets are on average much

smaller than the beclometasone dipropionate particles delivered by CFC-

suspension

formulations

powder

formulations

beclometasone

dipropionate. The extrafine particle fraction will be 60% ± 20% of the drug

particles

3.3 microns per shot, ex-actuator.

Radio-labelled

deposition

studies

adults

with

mild

asthma

have

demonstrated that the majority of drug (>55% ex-actuator) is deposited in the

lung and a small amount (<35% ex-actuator) is deposited in the oropharynx.

These studies were performed with Qvar Aerosol. Qvar Aerosol is a ‘press and

breathe’ inhaler, whereas Qvar Autohaler is a breath-activated inhaler.

Inhaled

beclometasone

dipropionate

well

established

management of asthma. It is a synthetic glucocorticoid and exerts a topical,

anti-inflammatory effect on the lungs, with fewer systemic effects than oral

corticosteroids.

Comparative clinical studies have demonstrated that asthma patients achieve

equivalent pulmonary function and control of symptoms with Qvar at lower

total daily doses than CFC containing beclometasone dipropionate aerosol

inhalers.

Pharmacodynamic studies in patients with mild asthma given Qvar for 14

days, have shown that there is a linear correlation among urinary free cortisol

suppression,

dose

administered,

serum

total-beclometasone

levels

obtained. At a daily dose of 800 micrograms Qvar, suppression of urinary free

cortisol was comparable with that observed with the same daily dose of CFC

containing beclometasone dipropionate, indicating a wider safety margin, as

Qvar is administered at lower doses than the CFC product.

5.2

Pharmacokinetic properties

The pharmacokinetic profile of Qvar aerosol (an equivalent inhaler) shows

that the peak serum concentration for total- beclometasone (BOH) (total of any

beclometasone

beclometasone

dipropionate

monopropionate

hydrolysed to beclometasone OH) after single and multiple doses is achieved

after 30 minutes.

The value at the peak is approximately 2 nanograms/ml after a total daily dose

of 800 micrograms and the serum levels after 100, 200 and 400 micrograms

proportional.

principal

route

elimination

beclometasone

dipropionate and its several metabolites is in the faeces. Between 10% and

15% of an orally administered dose is excreted in the urine, as both conjugated

and free metabolites of the drug.

In both single dose and multiple dose pharmacokinetic studies of Qvar aerosol,

a dose of 200 micrograms of Qvar aerosol achieved comparable total-BOH

levels,

dose

micrograms

containing

beclometasone

dipropionate aerosol. This provided the scientific rationale for investigating

lower total daily doses of Qvar aerosol to achieve the same clinical effect.

Pharmacokinetic studies with Qvar Easi-Breathe have not been carried out in

any special populations.

5.3

Preclinical safety data

In animal studies, propellant HFA-134a has been shown to have no significant

pharmacological effects other than at very high exposure concentrations, then

narcosis and a relatively weak cardiac sensitising effect were found. The

potency

cardiac

sensitisation

less

than

that

CFC-11

(trichlorofluoromethane).

In studies to detect toxicity, repeated high dose levels of propellant HFA-134a

indicated that safety margins based on systemic exposure would be of the

order 2200, 1314 and 381 for mouse, rat and dog with respect to humans.

There are no reasons to consider propellant HFA-134a as a potential mutagen,

clastogen or carcinogen judged from in vitro and in vivo studies including

long-term administration by inhalation in rodents.

Studies of propellant HFA-134a administered to pregnant and lactating rats

and rabbits have not revealed any special hazard.

animals,

systemic

administration

relatively

high

doses

cause

abnormalities of foetal development including growth retardation and cleft

palate. There may therefore be a very small risk of such effects in the human

foetus. However, inhalation of beclometasone dipropionate into the lungs

avoids the high level of exposure that occurs with administration by systemic

routes.

Safety studies with Qvar aerosol (an equivalent inhaler) in rat and dog showed

few, if any, adverse effects other than those normally associated with general

steroid exposure including lymphoid tissue alterations such as reduction in

thymus, adrenal and spleen weights.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Propellant HFA-134a (Norflurane)

Ethanol anhydrous

6.2

Incompatibilities

Not applicable

6.3

Shelf life

3 years

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