Beclazone 200 micrograms CFC-Free Inhaler, Pressurised Inhalation Solution

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Beclometasone dipropionate anhydrous
Available from:
Norton Waterford
ATC code:
R03BA; R03BA01
INN (International Name):
Beclometasone dipropionate anhydrous
Dosage:
200 microgram(s)
Pharmaceutical form:
Pressurised inhalation, suspension
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Glucocorticoids; beclometasone
Authorization status:
Marketed
Authorization number:
PA0436/021/011
Authorization date:
1997-11-14

PATIENT INFORMATION LEAFLET

BECLAZONE

®

200 micrograms CFC-FREE INHALER PRESSURISED INHALATION SOLUTION

Beclometasone dipropionate

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

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. Do not pass it to others. It may harm them, even if their

symptoms are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not

listed in this leaflet. See section 4.

In this leaflet

What Beclazone CFC-Free Inhaler is and what it is used for

Before you use Beclazone CFC-Free Inhaler

How to use Beclazone CFC-Free Inhaler

Possible side effects

How to store Beclazone CFC-Free Inhaler

Further information

1.

WHAT BECLAZONE CFC-FREE INHALER IS AND WHAT IT IS USED FOR

Effect

Beclazone CFC-Free Inhaler contains Beclometasone Dipropionate, which belongs to a group of medicines

called corticosteroids. Beclometasone dipropionate works on your lungs to help prevent asthma attacks by

reducing the swelling and irritation in the walls of the small air passages. This eases your breathing problems.

Very little corticosteroid gets absorbed into your body. This medicine is not the same type of steroid used by

body-builders and athletes to increase their performance.

Usage

Beclazone CFC-Free Inhalers are used to

prevent

asthma. This type of medicine is known as a ‘preventer’.

You must keep on taking this type of medicine regularly, even when you do not seem to have your asthma

symptoms.

Do not use

Beclazone CFC-Free Inhalers to relieve an asthma attack, wheezing or breathlessness. You will

probably need a different kind of medicine in a different coloured pack for this purpose. You may be using an

inhaler that widens your airways during an asthma attack. This type of inhaler is known as a ‘reliever’. You

can safely use your ‘reliever’ with your Beclazone CFC-Free Inhaler.

2.

BEFORE YOU USE BECLAZONE CFC-FREE INHALER

Do not use Beclazone CFC-Free Inhaler

If you are allergic to beclometasone dipropionate (active ingredient) or to any of the other ingredients of

Beclazone CFC-Free Inhaler.

If you suffer from or have ever suffered from tuberculosis (TB).

Take special care with Beclazone CFC-Free Inhaler

Contact your doctor if you experience blurred vision or other visual disturbances.

Because your inhaler is used to prevent asthma attacks, it is important to use it regularly, even when you feel

well.

It may take a few days for this medicine to work. Do not stop using your inhaler unless you are told to by a

doctor.

If you have started to use Beclazone CFC-Free Inhaler with, or instead of, taking steroid tablets you should

carry a steroid warning card (if you have one) until your doctor tells you that you no longer need to carry it.

Consult a doctor immediately if your usual treatment is not working. Your doctor will tell you if you need any

extra treatment. Your dosage should only be increased on medical advice.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including

medicines that you obtained without a prescription.

The following medicines may influence the effect of Beclazone CFC-Free Inhaler:

Other asthma medicines, such as bronchodilators, or other corticosteroids in tablet form

Some medicines may increase the effects of Beclazone CFC-Free Inhaler and your doctor may wish to

monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir,

cobicistat).

Taking Beclazone CFC-Free Inhaler with food or drink

Beclazone CFC-Free Inhaler should be used as prescribed by your doctor.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Beclazone CFC-Free Inhaler should

only be used if recommended by a doctor.

Breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Beclazone CFC-Free Inhaler should

only be used if recommended by a doctor.

Driving and using machines

Beclazone CFC-Free Inhaler does not affect the ability to drive or to use machinery.

3.

HOW TO USE BECLAZONE CFC-FREE INHALER

If you use more Beclazone CFC-Free 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.

All patients are different and your doctor may have prescribed a different dose for you.

The usual dose for Beclazone CFC-Free Inhaler is:

Adults and the elderly:

Take one to two puffs twice daily.

Usually the most you would take in 24 hours is five puffs.

Beclazone 200 micrograms CFC-Free Inhaler is not recommended for use in children.

Hepatic or renal impairment:

Dose adjustments are not required. Follow your doctor’s instructions.

Instructions for use of the inhaler

Important

Before using your inhaler, please read this leaflet carefully and follow the instructions carefully. If you are not

sure how or when to use your inhaler, ask your doctor or a pharmacist.

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

inhaler, take any inhalers you have left back to your pharmacist.

If you find it difficult to use your inhaler with one hand, as shown in the diagrams, use both hands.

You must spray your inhaler at the same time as you breathe in.

Children may need help to use Beclazone CFC-Free Inhaler. Parents can help by spraying the aerosol when

the child begins to breathe in.

Using the Inhaler

Test spray the inhaler before you use it for the first time and also if you have not used the inhaler for five days.

Take the cap off the inhaler. Make sure the mouthpiece is clean and free of fluff and dirt.

Hold the inhaler upright with your thumb on the base and your first finger on the top of the

can. Shake the inhaler vigorously up and down.

Breathe out normally as far as you comfortably can. Then hold the mouthpiece firmly

between your lips. Breathe in slowly and deeply. As you first start to breathe in, press the

aerosol can with your first finger to spray the aerosol and release the medicine. Continue to

breathe in slowly and deeply.

Take the inhaler out of your mouth and hold your breath for 10 seconds, or for as long as

you comfortably can. Breathe out slowly.

If you need more than one puff, wait for about one minute and then start again from step 2.

Put the cap back on the inhaler.

Note

Do not rush step 3. It is important that you start to breathe in as slowly as possible just before using your

inhaler. Practice in front of a mirror for the first few times. If you see ’mist’ coming from the top of the inhaler

or from the sides of your mouth you should start again from step 2.

Cleaning the inhaler

You must keep your inhaler clean, especially the mouthpiece. This will prevent deposits from the aerosol

building up.

CLEAN YOUR INHALER AT LEAST ONCE A WEEK.

Take the metal can from the plastic body and rinse the plastic body and cap in warm water. Do not use very

hot water to clean your inhaler.

Dry thoroughly (leave to dry overnight if possible) but do not use direct heat.

Put the metal can back in the plastic mouthpiece and replace the cap. Do not put the metal can into water.

What to do if your breathing gets worse

If you notice that you are more short of breath and your wheeze is getting worse, tell your doctor immediately.

He or she will tell you if you need any extra treatment.

If you take more Beclazone CFC-Free Inhaler than you should

Your dose has been carefully worked out for you. It is important that you do not take too much. If you

accidentally take more puffs than your doctor has recommended, don’t worry. However, if you regularly use

more than your recommended dose, you should tell your doctor as soon as possible.

If you forget to take Beclazone CFC-Free Inhaler

Failure to allow the mouthpiece to dry properly will result in an increase in blockage problems.

Do not take a double dose to make up for a forgotten dose. If you forget to use your inhaler, take your

recommended number of puffs when you remember. Then continue your treatment as prescribed by your

doctor.

4.

POSSIBLE SIDE EFFECTS

Like all medicines Beclazone CFC-Free Inhaler can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience hypersensitivity (allergic) reactions. These include rash,

swelling of the face, eyes, lips and throat and wheezing (because of narrowed airways).

Infections and infestations:

Common side effects (affecting more than 1 in 100 and less than 1 in 10 individuals):

Candidiasis (thrush) in

the mouth and throat, which is seen as white spots. Rinsing your mouth with water immediately after using

your inhaler will help prevent this from occurring. If you have these symptoms, tell your doctor but do not

stop using your inhaler unless your doctor tells you to.

Immune system disorders:

Rare side effects (affecting more than 1 in 10,000 and less than 1 in 1,000 individuals)

: Hypersensitivity

reactions as described above.

Respiratory, thoracic and mediastinal disorders:

Common side effects (affecting more than 1 in 100 and less than 1 in 10 individuals):

Hoarseness and throat

irritation.

Rare side effects (affecting more than 1 in 10,000 and less than 1 in 1,000 individuals):

Wheezing, difficulty

in breathing or tightness in your chest. If this happens, stop using your inhaler and tell your doctor

immediately.

Skin and subcutaneous tissue disorders:

Very rare side effects (affecting less than 1 in 10,000 individuals including isolated reports):

Itching, rash and

reddening of the skin.

Musculoskeletal and connective tissue disorders:

Very rare side effects (affecting less than 1 in 10,000 individuals including isolated reports):

Decreased bone

density.

Endocrine disorders:

Very rare side effects (affecting less than 1 in 10,000 individuals including isolated reports):

Decrease in

function of the adrenal gland, which is responsible for producing some hormones that control your body.

Decrease in growth, particularly in children and adolescents.

Eye disorders:

Uncommon side effects (affecting more than 1 in 1,000 and less than 1 in 100 individuals):

Blurred vision.

Very rare side effects (affecting less than 1 in 10,000 individuals including isolated reports):

Cataracts

(formation of a film over the eye lens). Glaucoma (a disease in which the eye pressure increases).

Frequency not known, but may also occur:

Central serous retinopathy.

Psychiatric disorders:

Frequency not known, but may also occur:

Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable.

These effects are more likely to occur in children.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not

listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace,

IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:

medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this

medicine.

5.

HOW TO STORE BECLAZONE CFC-FREE INHALER

Keep out of the sight and reach of children.

Do not use Beclazone CFC-Free Inhaler after the expiry date, which is stated on the label and carton after

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

Do not store above 25°C.

Do not refrigerate or freeze. If your inhaler gets very cold, remove the metal can and warm it in your hands for

a few minutes before you use it. Do not warm the can in any other way.

The canister contains a pressurised liquid.

Do not expose to temperatures higher than 50°C.

Do not

pierce the canister.

Do not puncture, break or burn the can, even if it seems empty.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose

of medicines no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

What Beclazone CFC-Free Inhaler contains

The active substance is beclometasone dipropionate

Each puff (metered dose) of Beclazone 200 micrograms CFC-Free Inhaler contains 200 micrograms of

beclometasone dipropionate.

The other ingredients are ethanol anhydrous (alcohol) and the propellant norflurane (HFA-134a). This

medicine does not contain any CFCs.

Contents of pack

The name of your medicine is

Beclazone 200 micrograms CFC-Free Inhaler Pressurised Inhalation Solution

Each pack of Beclazone CFC-Free Inhaler contains a single inhaler that supplies 200 metered doses.

For inhalation use. Pressurised Inhalation, Solution.

Marketing Authorisation Holder and Manufacturer:

Norton Waterford T/A IVAX Pharmaceuticals Ireland

IDA Industrial Estate

Waterford

Ireland.

This leaflet was last revised in September 2017.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Beclazone 200 micrograms CFC-Free Inhaler, Pressurised Inhalation Solution.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One metered dose contains 200 micrograms Beclometasone dipropionate

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Pressurised Inhalation, Solution

The product is a colourless solution which is to be administered by inhalation using an appropriate delivery device

(metered dose inhaler) in which it is supplied.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Beclazone 200 micrograms CFC-Free Inhaler is indicated for those asthmatic patients who have been shown to require

high doses of beclometasone dipropionate (BDP) to control their symptoms.

It may also be indicated for those patients

whose asthma is no longer controlled by maximum maintenance doses of bronchodilators and lower doses of BDP.

Some patients with severe asthma require oral

corticosteroid therapy in addition to BDP for the adequate control

their symptoms.

Many of these patients may,

on transfer to Beclazone 200 micrograms CFC-Free Inhaler, be able to

reduce significantly, or eliminate their requirement for additional oral corticosteroids.

4.2 Posology and method of administration

The preparation is intended for oral inhalation only. For optimum results, beclometasone dipropionate should be used

regularly. The initial dose of inhaled beclometasone dipropionate should be appropriate to the severity of the disease.

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

Adults:

The dose range is from 50 mcg twice daily to 500 mcg twice daily (maximum daily dose 1000 mcg) depending on the

patients’ asthma severity.

The maintenance dose is normally 200 - 400 mcg per day in divided doses.

If necessary,

higher doses of up to 1000

mcg in divided doses may be used.

Beclazone 200 and 250 micrograms CFC-Free Inhalers are not recommended for use in children due to insufficient data on

safety and efficacy.

When asthma symptoms remain under satisfactory control the dose may be gradually reduced to the minimum effective

dose to maintain symptom control.

The therapeutic effect occurs after a few days’ treatment and reaches its maximum after 2-3 weeks.

When transferring a patient

to Beclazone CFC-Free inhaler from other inhaler devices switch at

same dose and titrate

individually if necessary.

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Route of administration:

For inhalation use.

4.3 Contraindications

Hypersensitivity to beclometasone dipropionate or to any of the excipients.

4.4 Special warnings and precautions for use

Steroid

dependent patients: The transfer of steroid

dependent patients to beclometasone dipropionate inhaler, and their

subsequent management, needs special care mainly because recovery from impaired adrenocortical function, caused by

prolonged systemic steroid therapy,

is slow.

The patient

should be in a reasonably stable state before being given

beclometasone dipropionate inhaler in addition to his/her usual

maintenance dose of systemic steroid.

After about

week,

gradual

withdrawal

of the systemic steroid is started by reducing the daily dose by 1mg prednisolone,

or its

equivalent

of other corticosteroids,

less than weekly intervals.

Patients treated with systemic steroids for long

periods

time

who have

received high doses

may have

adrenocortical

suppression.

With these

patients

adrenocortical

function should be monitored regularly and their dose of systemic steroid reduced cautiously.

Some

patients feel

unwell

(i.e.

headache,

nausea,

articular

muscular

discomfort)

during the withdrawal

phase despite

maintenance or even improvement of respiratory function. They should be encouraged to persevere with the inhaler and

withdrawal

of systemic steroid continued unless there are objective signs of adrenal

insufficiency.

Spirometric and

clinical

assessment

should be provided while reducing oral

corticotherapy.

Most

patients

can be successfully

transferred to beclometasone dipropionate inhaler with maintenance of good respiratory function,

special

care is

necessary for the first months after the transfer until the pituitary

adrenal system has sufficiently recovered to enable

the patient to cope with emergencies such as trauma, surgery or infections.

Transferred patients whose adrenocortical function is impaired should carry a warning card indicating that they need

supplementary systemic steroid during periods of stress or elective surgery.

They should also be given a supply of oral steroid to use in emergency,

for example when the asthma worsens as a

result of a chest infection.

The dose of beclometasone dipropionate inhaler should be increased at this time and then

reduced to the maintenance level after the systemic steroid has been discontinued.

Patients with high blood levels of Candida precipitins, indicating a previous infection, are more likely to develop

candidiasis of the mouth and throat (thrush), (See section 4.8 “Undesirable Effects”). All patients may find it helpful to

rinse their mouth with water after using the inhaler.

Paradoxical bronchospasm may occur.

If such does appear, use should cease and alternative therapy introduced.

Replacement of systemic steroid treatment with beclometasone dipropionate inhaler sometimes unmasks allergies such

as allergic rhinitis or eczema previously controlled by the systemic drug.

These allergies should be symptomatically

treated with antihistamine and/or topical preparations.

Patients should be instructed in the proper use of the inhaler to ensure that the drug reaches the target areas within the

lungs.

Actuation of

the aerosol

should be synchronised with inspiration.

They should also be made aware that

beclometasone dipropionate inhaler has to be used regularly for optimum benefit even when they are asymptomatic.

Patients being treated with Beclazone 50 or 100 micrograms CFC-Free Inhaler may be transferred directly to treatment

with beclometasone dipropionate 200 micrograms CFC-Free Inhaler (at the same total daily dose up to a maximum of

1000 mcg).

In the majority of patients no significant

effects on plasma or urinary free cortisol

occur until

doses of

1,000 micrograms per day are exceeded.

Some patients receiving 2,000 µg of beclometasone dipropionate CFC-Free

Inhaler per day have shown reduced plasma or urinary free cortisol although short-term adrenal reserve remains intact.

In any patients the risk of developing adrenal suppression should be balanced against the therapeutic advantages and

precautions should be taken to provide systemic steroid cover in situations of prolonged stress.

Particular care is required in patients with a history of, or existent tuberculosis.

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Particular care should be taken to minimise the use of topical corticosteroids in patients with immunosuppression.

Beclometasone dipropionate inhaler is not intended for the treatment of an acute asthma attack.

Special care is needed in patients with viral, bacterial, and fungal infections of the eye or the mouth or respiratory tract.

In the case of bacterial infection of the respiratory tract an adequate antibiotic co-medication may be required.

Increasing use of

bronchodilators,

in particular

short-acting inhaled beta-2-agonists,

to relieve symptoms indicates

deterioration of asthma control.

Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. The

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 dose,

result

in clinically significant

adrenal

suppression.

Additional

systemic corticosteroid cover

should be considered

during periods of stress or elective surgery.

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

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.

4.5 Interaction with other medicinal products and other forms of interaction

Concurrent administration of barbiturates, phenytoin or rifampicin may enhance the metabolism and reduce the effects

oral

corticosteroids.

Response to anti

coagulants may be reduced and,

on some occasions enhanced,

by oral

corticosteroids. Concurrent administration of oral corticosteroids or potassium

depleting diuretics such as thiazides or

frusemide may cause excessive potassium loss.

No known interactions have been reported for inhaled beclometasone

dipropionate.

Beclometasone is less dependent on 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

No specific

studies

have

been performed examining the

safety in human pregnancy and lactation for

BDP.

Beclometasone inhalation may be associated with intrauterine growth retardation in humans.

Studies in animals have

shown reproductive toxicity (see section 5.3).

The use of

beclometasone in pregnancy requires that

the possible

benefits of the drug be weighed against the possible hazards.

The transfer of beclometasone into milk has not

been examined.

is reasonable to assume that

beclometasone is

excreted in milk but at the doses used for inhalation there is low potential for significant levels in breast milk.

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4.7 Effects on ability to drive and use machines

Beclazone 200 micrograms CFC-Free Inhaler has no influence on the ability to drive and use machinery.

4.8 Undesirable effects

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 available data).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal

product

is important.

allows continued

monitoring of

the benefit/risk balance of

the medicinal

product.

Healthcare professionals are asked to report

suspected adverse reactions via HPRA Pharmacovigilance,

Earlsfort

Terrace,

IRL - Dublin 2;

Tel:

+353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

The acute toxicity of

beclometasone dipropionate is low.

The only harmful

effect

that

follows inhalation of large

amounts of the drug over a short period is suppression of hypothalamic

pituitary

adrenal (HPA) function. No special

emergency action need be taken. Treatment with beclometasone dipropionate should be continued at the recommended

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

In the unlikely event of grossly excessive intake of beclometasone dipropionate for weeks or months on end, a degree

of adrenocortical

atrophy could occur in addition to suppression of HPA function.

The patient

should be treated as

steroid

dependent and transferred to a suitable maintenance dose of a systemic steroid such as prednisolone. Once the

patient's condition has stabilised he/she should be transferred to beclometasone dipropionate by the method described

(4.4).

Infections and infestations

Common (

1/100 to <1/10)

Candidiasis in mouth and throat

Immune system disorders

Rare (

1/10,000 to <1/1,000)

Allergic reactions: angioedema in eyes,

throat, lips and face

Endocrine disorders

Very rare (<1/10,000, including isolated reports)

Adrenal suppression (systemic effect)

Growth retardation in children and

adolescents

Eye disorders

Uncommon (

1/1,000 to < 1/100)

Very rare (<1/10,000, including isolated reports)

Not known

Blurred vision (see also section 4.4)

Cataract, glaucoma (systemic effect)

Central serous retinopathy

Respiratory, thoracic and mediastinal disorders

Common (

1/100 to <1/10)

Rare (

1/10,000 to <1/1,000)

Hoarseness and throat irritation

Paradoxical bronchospasm

Skin and subcutaneous tissue disorders

Very rare (<1/10,000, including isolated reports)

Urticaria, rash, pruritus, erythema

Musculoskeletal and connective tissue disorders

Very rare (<1/10,000, including isolated reports)

Decreased bone mineral density

(systemic effect)

Psychiatric disorders

Not known

Psychomotor hyperactivity, sleep

disorders, anxiety, depression,

aggression, behavioural changes

(predominantly in children)

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5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Anti-asthmatics, Inhalants Glucocorticoids

ATC Code: R03B A01

Beclometasone dipropionate given by inhalation has a glucocorticoid anti-inflammatory action within the lungs.

exact mechanism responsible for this anti-inflammatory effect is unknown.

5.2 Pharmacokinetic properties

Beclometasone dipropionate is readily absorbed after oral inhalation.

About 25% of an inhaled dose reaches the lungs.

The drug and its metabolites are excreted chiefly in the faeces via biliary elimination, and to a lesser extent in the urine.

5.3 Preclinical safety data

Preclinical studies in rats and dogs with beclometasone dipropionate formulated in HFA-134a propellant have shown

dose related typical signs of glucocorticoid excess.

Beclometasone dipropionate is non-genotoxic.

No evidence of carcinogenicity was observed in a 95-week study in

rats.

Studies in animals with beclometasone and other corticosteroids have shown foetal

abnormalities (cleft

palate) and

embryolethality at high doses and growth retardation and functional deficiencies (adrenal suppression, increased risk of

cardiovascular disease) at lower doses.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol Anhydrous 99.5%

Norflurane 134a (HFA-134a)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not

store above 25°C.

Do not

refrigerate or freeze.The canister contains a pressurised liquid.

Do not

expose to

temperatures higher than 50°C. Do not pierce the canister.

6.5 Nature and contents of container

Pressurised container fitted with a metering valve.

The can is of 19ml nominal capacity manufactured from aluminium with either a debossed or a plain base.

The can

opening is configured to accept 20 mm valves. Each pack contains a single inhaler which supplies a minimum of 200

actuations.

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6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

Patients should be properly instructed in the correct use of the inhaler. Instructions for use are included on the Patient

Information Leaflet supplied with each inhaler.

The canister is pressurised; it must not be burnt, punctured or broken even when apparently empty.

Medicines no longer required should not be disposed of via wastewater or the municipal sewage system.

Return them

to your pharmacy or ask your pharmacist how to dispose of them in accordance with the national regulations.

These

measures will help to protect the environment.

7 MARKETING AUTHORISATION HOLDER

Norton Waterford

T/A IVAX Pharmaceuticals Ireland

Unit 301

IDA Industrial Park

Waterford

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0436/021/011

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 14

November 1997

Date of last renewal: 14

November 2007

10 DATE OF REVISION OF THE TEXT

September 2017

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