Becotide Evohaler 100 micrograms, Pressurised Inhalation Solution

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
Beclometasone dipropionate
Available from:
GlaxoSmithKline (Ireland) Limited
ATC code:
R03BA; R03BA01
INN (International Name):
Beclometasone dipropionate
Dosage:
100 microgram(s)
Pharmaceutical form:
Pressurised inhalation, solution
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Glucocorticoids; beclometasone
Authorization status:
Marketed
Authorization number:
PA1077/042/007
Authorization date:
2005-01-07

PHARMA CODE

3

Harmony AMS - Artwork Information Panel

Manufacturing Site Number:

62000000024837

Manufacturing Site(s):

GSK_EVREUX_FRANCE

Technical Drawing

(Do NOT include version number):

02_037_01

Product Market Trade Name:

Becotide

Approving Market(s):

Ireland-IRL

Material Spec:

(Do NOT include version number):

MSP-3500065

Colour Standard Reference:

Material Type:

Body Text Size:

9.0pt

Smallest Text Size:

9.0pt

Leading:

9.5pt

Horizontal Scale:

100%

Microtext:

AIP_Production_H_INDD - 04_2017 - Harmony - Version 2

2

BLACK

0

Additional Info (1):

Additional Info (2):

Additional Info (3):

200 mm Measuring Bar

If an e-banner DOES NOT appear on the top of this document, THEN this document has NOT been printed from the Harmony system.

Artwork copyright is the property of the GSK Group of Companies. All suppliers providing a service to GSK for printed components of any description must ensure that they have a licence for all fonts / software used in conjunction with GSK artwork.

The distribution and use of fonts / software without a licence constitutes an intellectual property infringement. GSK will not accept any liability for the breach of third party intellectual property rights by printed component suppliers.

The GSK certification / audit process requires suppliers to declare that they do not use unlicensed fonts / software and may require the supplier to produce evidence of such licence to GSK.

IMPORTANT

GSK LOC is responsible to approve the change documentation, artwork brief

and final artwork, ensuring that it is accurate, consistent and complete.

GSK SDC is responsible for site technical requirements

and pre-press suitability.

GSK Market is responsible to advise SDC when changes

required impact the following:

Formulation, Tablet embossing,

Storage conditions and Shelf Life

NOTE TO MARKET

Local approvers must ensure that trade mark and

copyright statements included in the brief

comply with guidance provided by

Legal: Global Trade Marks.

Package leaflet: Information for the user

Becotide Evohaler 50, 100 and 250 micrograms

Pressurised Inhalation Solution

(Beclometasone dipropionate)

Read all of this leaflet carefully before you start taking 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 or pharmacist. This includes any possible side-effects

not listed in this leaflet. See section 4.

What is in this leaflet:

What Becotide Evohaler is and what it is used for

What you need to know before you use Becotide Evohaler

How to use Becotide Evohaler

Possible side effects

How to store Becotide Evohaler

Contents of the pack and other information.

1. What Becotide Evohaler is and what it is used for

Becotide contains the active substance beclometasone dipropionate. Beclometasone dipropionate belongs

to a group of medicines called corticosteroids (often just called steroids). A very small dose of steroid is

needed when it is inhaled. This is because it is inhaled straight to your lungs.

Becotide works by reducing swelling and irritation in the lungs. It has what is called an ‘anti-inflammatory

action’.

Becotide helps to prevent asthma attacks in people who need regular treatment. This is why it is

sometimes called a ‘preventer’. It needs to be used regularly, every day.

Becotide will not help treat sudden asthma attacks where you feel breathless.

A different medicine is used for treating sudden attacks (called a ‘reliever’).

If you have more than one medicine, be careful not to confuse them.

Becotide is supplied to you in an inhaler. You breathe the medicine directly into your lungs.

Becotide contains norflurane. This is less harmful to the environment than older inhalers. Older inhalers

may taste differently to Becotide. This will make no difference to how your medicine works. It also contains

small amounts of ethanol (alcohol) and glycerol. At the usual dose, these amounts are so small that they

should not cause any problems.

2. What you need to know before you use Becotide Evohaler

Do not use Becotide:

if you are allergic to beclometasone dipropionate or any of the other ingredients of this medicine

(listed in section 6).

Warnings and precautions

Talk to your doctor, nurse or pharmacist before taking Becotide if:

you have ever been treated for tuberculosis (TB).

you have ever had thrush (candidiasis) in your mouth.

you are using Becotide at the same time as taking steroid tablets or injections. Also, if you have just

finished taking steroid tablets or injections. In both cases, you should carry a steroid warning card until

your doctor tells you not to carry one.

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before using

Becotide.

If your breathing or wheezing gets worse straight after using Becotide Evohaler, stop using it and tell

your doctor immediately.

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

Other medicines and Becotide Evohaler

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other

medicines, including medicines obtained without a prescription. This includes herbal medicines. Remember

to take this medicine with you if you have to go into hospital.

Some medicines may increase the effects of Becotide Evohaler and your doctor may wish to monitor you

carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

If you are taking metronidazole (an antibiotic) or disulfiram (a treatment for alcohol dependency), please

speak with your doctor before taking Becotide Evohaler.

Very rare (may affect up to 1 in 10,000 people)

sleeping problems or feeling worried, restless, nervous, over-excited or irritable. These effects are more

likely to occur in children

the way steroids are produced by your body may be affected when using Becotide. This is more likely to

happen if you use high doses for a long period of time. This can cause:

- children and young people to grow more slowly.

- something called ‘Cushing’s syndrome’. This happens when you have too much steroid in your body

and it can cause thinning of your bones and eye problems (such as cataracts and glaucoma).

Your doctor will help stop this happening by making sure you use the lowest dose of steroid which

controls your symptoms.

Frequency not known, but may also occur

Depression or aggression. These effects are more likely to occur in children.

Blurred vision

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 Becotide Evohaler

Keep this medicine out of the sight and reach of children.

Straight after use, replace the mouthpiece cover firmly and click it into position. Do not use excessive

force.

Do not refrigerate or freeze.

Protect from frost and direct sunlight.

If the Evohaler gets very cold, take the metal canister out of the plastic case and warm it in your hands

for a few min before use. NEVER use anything else to warm it up.

Do not store above 30°C.

The metal canister contains a pressurised liquid. Do not expose the canister to temperatures higher than

50°C. Do not puncture, break or burn it even if you think it is empty.

Do not use Becotide after the expiry date which is stated on the label and carton. The expiry date refers

to the last day of the month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw

away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Becotide contains

The active substance is beclometasone dipropionate

The other ingredients are norflurane (HFA 134a), ethanol (alcohol) and glycerol.

What Becotide looks like and contents of the pack

Pressurised inhalation solution. The pressurised canister contains a clear and colourless solution for

inhalation.

Each puff contains 50 micrograms, 100 micrograms or 250 micrograms beclometasone dipropionate.

There are 200 puffs in each canister.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24.

Manufacturer:

Glaxo Wellcome Production, Zone Industrielle No.2, 23 Rue Lavoisier, 27000 Evreux, La Madeleine France.

Becotide Evohaler is produced under license of Chiesi S.p.A.

This leaflet was last revised in August 2018

Trade marks are owned by or licensed to the GSK group of companies.

© 2018 GSK group of companies or its licensor.

62000000024837

62000000024837

Page 1 of 2

Project: CO-0005670

Site Code: 62000000024837

Document: PPC-0008826

Version: 4

Operator: LX745934

Date/Time Created: 31.Aug.2018 14:41 GMT+1

e-Banner

3

Harmony AMS - Artwork Information Panel

Manufacturing Site Number:

62000000024837

Manufacturing Site(s):

GSK_EVREUX_FRANCE

Technical Drawing

(Do NOT include version number):

02_037_01

Product Market Trade Name:

Becotide

Approving Market(s):

Ireland-IRL

Material Spec:

(Do NOT include version number):

MSP-3500065

Colour Standard Reference:

Material Type:

Body Text Size:

9.0pt

Smallest Text Size:

9.0pt

Leading:

9.5pt

Horizontal Scale:

100%

Microtext:

AIP_Production_H_INDD - 04_2017 - Harmony - Version 2

2

BLACK

0

Additional Info (1):

Additional Info (2):

Additional Info (3):

200 mm Measuring Bar

If an e-banner DOES NOT appear on the top of this document, THEN this document has NOT been printed from the Harmony system.

Artwork copyright is the property of the GSK Group of Companies. All suppliers providing a service to GSK for printed components of any description must ensure that they have a licence for all fonts / software used in conjunction with GSK artwork.

The distribution and use of fonts / software without a licence constitutes an intellectual property infringement. GSK will not accept any liability for the breach of third party intellectual property rights by printed component suppliers.

The GSK certification / audit process requires suppliers to declare that they do not use unlicensed fonts / software and may require the supplier to produce evidence of such licence to GSK.

IMPORTANT

GSK LOC is responsible to approve the change documentation, artwork brief

and final artwork, ensuring that it is accurate, consistent and complete.

GSK SDC is responsible for site technical requirements

and pre-press suitability.

GSK Market is responsible to advise SDC when changes

required impact the following:

Formulation, Tablet embossing,

Storage conditions and Shelf Life

NOTE TO MARKET

Local approvers must ensure that trade mark and

copyright statements included in the brief

comply with guidance provided by

Legal: Global Trade Marks.

Using Becotide with food and drink

You can use Becotide at any time of day, with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your

doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Becotide is not likely to affect you being able to drive or use any tools or machines.

Becotide Evohaler contains ethanol.

This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.

3. How to use Becotide Evohaler

Becotide come in three different strengths. Your doctor will have decided which strength you need. Always

take this medicine exactly as your doctor has told you. The label on it will usually tell you how much to take

and how often. Check with your doctor or pharmacist if you are not sure. Do not change the amount of

medicine you take, unless your doctor has told you to.

Using this medicine

Becotide is for inhalation by mouth only.

Instructions on how to use the inhaler are given as a step-by-step guide below.

It takes a few days for this medicine to work and it is very important that you use it regularly.

Do not stop using it even if you feel better, unless told to do so by your doctor.

Do not use more than you are told.

Do not use this medicine to treat a sudden attack of breathlessness – it will not help you. You should

use a quick-acting reliever inhaler (e.g. Ventolin) for this purpose.

Adults and adolescents aged 12 years and over

The usual dose is 200 to 2,000 micrograms a day, in divided doses.

The most an adult should take is 2,000 micrograms a day.

There is no need to adjust the dose in elderly patients or patients with liver or kidney problems.

Children over 4 years

The usual dose is 200 to 400 micrograms a day, in divided doses

The most a child should take is 400 micrograms a day.

It is recommended that children being treated with steroids, including Becotide have their height

checked regularly by their doctor.

If you are using high doses of an inhaled steroid for a long time you may sometimes need extra

steroids for example during stressful circumstances such as a road traffic accident or before an

operation. Your doctor may decide to give you extra steroid medicines during this time.

Instructions for use

Your doctor, nurse or pharmacist should show you how to use your inhaler. They should check how you use

it from time to time. Not using the Becotide inhaler properly or as prescribed, may mean that the medicine

will not help you as it should.

The medicine is contained in a pressurised canister in a plastic casing with a mouthpiece.

When using your inhaler for the first time, test that

it is working. Remove the mouthpiece cover by

gently squeezing the sides with your thumb and forefinger

and pull apart.

To make sure that it works, shake it well, point

the mouthpiece away from you and press the

canister to release a puff into the air. If you have not used

the inhaler for three days or more, release one puff of

medicine into the air.

Testing your inhaler

Stand or sit upright when using your inhaler.

Remove the mouthpiece cover (as shown in the first picture) . Check inside and outside to

make sure that the mouthpiece is clean and free of objects.

Using your inhaler

It is important to start to breathe in as slowly as possible just before using your inhaler.

After use always

replace the

mouthpiece cover

immediately to keep out

dust. Replace the cover

by firmly pushing and

snapping the cap into

position.

Place the mouthpiece in your mouth

between your teeth. Close your lips

around it. Do not bite.

Hold your breath, take the

inhaler from your mouth

and your finger from the top of the

inhaler. Continue holding your breath

for a few seconds, or as long as is

comfortable.

Breathe in through your mouth. Just after

starting to breathe in, press down on the

top of the canister to release a puff of medicine.

Do this while still breathing in steadily and

deeply.

Wait about

half a minute

between taking each

puff of medicine and

then repeat steps

3 to 7.

Practise in front of a mirror for the first few times. If

you see a ‘mist’ coming from the top of your inhaler

or the sides of your mouth you should start again.

If you or your child find it difficult to use the

Evohaler, a large volume spacer device may

improve the treatment with Becotide. Talk to your

doctor, nurse or pharmacist.

The Babyhaler spacer device is available for use in young children.

People with weak hands may find it easier to hold the inhaler with both hands. Put the two forefingers

on top of the inhaler and both thumbs on the bottom below the mouthpiece. If this does not help, a

special device called a Haleraid may make it easier. Talk to your doctor, nurse or pharmacist.

Cleaning your inhaler

To stop your inhaler blocking up, it is important to clean it at least once a week.

To clean your inhaler:

Pull the metal canister out of the plastic casing of the inhaler and remove mouthpiece cover.

Wipe the inside and outside of the mouthpiece and the plastic casing with a damp cloth.

Leave to dry in a warm place. Avoid excessive heat.

Replace the canister and mouthpiece cover.

DO NOT PUT THE METAL CANISTER IN WATER.

If you use more Becotide than you should

If you use more than you should, talk to your doctor as soon as possible.

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 forget to use Becotide Evohaler

If you forget to use your inhaler, take your next dose when it is due. Do not take a double dose to make up

for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop using this medicine and talk to your

doctor straight away. You may need urgent medical treatment.

allergic reactions (may affect up to 1 in 100 people) – the signs include skin rashes, redness, itching or

weals like nettle rash or hives

severe allergic reactions (may affect up to 1 in 10,000 people) - the signs include swelling of your face,

lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, itchy rash, feeling

faint and light headed and collapse

your breathing or wheezing gets worse straight after using your inhaler.

Talk to your doctor as soon as possible if:

after 7 days of using Becotide your shortness of breath or wheezing does not get better, or gets worse.

Other side effects include:

Very common (may affect more than 1 in 10 people)

thrush in the mouth and throat

Common (may affect up to 1 in 10 people)

sore throat

hoarseness of voice

Problems with your mouth and throat can be reduced by doing certain things straight after inhaling your

dose. These are brushing your teeth, rinsing your mouth or gargling with water and spitting it out. Tell your

doctor if you have these problems with your mouth or throat, but do not stop treatment unless you are

told to.

62000000024837

62000000024837

Shake the inhaler 4 or 5 times to

ensure that any loose objects are

removed and that the contents of the

inhaler are evenly mixed.

Hold the inhaler upright with your thumb

on the base, below the mouthpiece.

Breathe out as far as is comfortable.

Page 2 of 2

Project: CO-0005670

Site Code: 62000000024837

Document: PPC-0008826

Version: 4

Operator: LX745934

Date/Time Created: 31.Aug.2018 14:41 GMT+1

e-Banner

Health Products Regulatory Authority

23 November 2018

CRN008LW0

Page 1 of 11

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Becotide Evohaler 100 micrograms, Pressurised Inhalation Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One metered dose contains 100 micrograms of Beclometasone Dipropionate

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Pressurised Inhalation, Solution.

Clear and colourless solution in an aluminium canister with a valve.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Severe asthma requires regular medical assessment as death may occur. Patients with

severe asthma have constant symptoms and frequent exacerbations, with limited

physical capacity, and PEF values below 60% predicted at baseline with greater than

30% variability, usually not returning entirely to normal after a bronchodilator. These

patients will require high dose inhaled (see section 4.2) or oral corticosteroid therapy.

Sudden worsening of symptoms may require increased corticosteroid dosage which

should be administered under urgent medical supervision.

Adults:

Prophylactic management in:

Mild asthma (PEF values greater than 80% predicted at baseline with less than 20%

variability): Patients requiring intermittent symptomatic bronchodilator asthma

medication on more than an occasional basis.

Moderate asthma (PEF values 60 - 80% predicted at baseline with 20 - 30%

variability): Patients requiring regular asthma medication and patients with unstable

or worsening asthma on other prophylactic therapy or bronchodilator alone.

Severe asthma (PEF values less than 60% predicted at baseline with greater than 30%

variability): Patients with severe chronic asthma.

Health Products Regulatory Authority

23 November 2018

CRN008LW0

Page 2 of 11

Children:

Children who require prophylactic asthma medication.

4.2 Posology and method of administration

Becotide Evohaler is for oral inhalation use only.

Patients should be made aware of the prophylactic nature of therapy with inhaled

beclometasone dipropionate and that it should be taken regularly even when they

are asymptomatic.

The dosage of beclometasone dipropionate should be adjusted according to the

individual response.

If patients find that short-acting relief bronchodilator treatment becomes less

effective or they need more inhalations than usual, medical attention must be sought.

In patients who find co-ordination of a pressurised metered dose inhaler difficult, a

spacer may be used with Becotide Evohaler.

The Babyhaler spacer device is available for use in young children.

Adults and children over 12 years of age:

Patients should be given a starting dose of inhaled beclometasone dipropionate,

which is appropriate for the severity of their disease based on the following guidance:

Mild asthma: 200 to 600 micrograms per day in divided doses.

Moderate asthma: 600 to 1000 micrograms per day in divided doses.

Severe asthma: 1000 to 2000 micrograms per day in divided doses.

The dose may then be adjusted until control is achieved or reduced to the minimum

effective dose according to the individual response.

Children over 4 years of age:

Up to 400 micrograms per day in divided doses.

Children should be given a starting dose of inhaled beclometasone dipropionate,

which is appropriate for the severity of their disease.

The dose may then be adjusted until control is achieved or reduced to the minimum

effective dose according to the individual response.

Health Products Regulatory Authority

23 November 2018

CRN008LW0

Page 3 of 11

Special patient groups:

There is no need to adjust the dose in older people or in those with hepatic or renal

impairment.

Testing the inhaler:

Before using for the first time or if the inhaler has not been used for three days or

more: Remove the mouthpiece cover by gently squeezing the sides of the cover,

shake the inhaler well, and release one puff into the air to make sure that it works.

Using your inhaler:

Remove the mouthpiece cover by gently squeezing the sides of the cover.

Check the inside and outside of the inhaler including the mouthpiece for

the presence of loose objects.

Shake the inhaler well to ensure that any loose objects are removed and

that the contents of the inhaler are evenly mixed.

Hold the inhaler upright between fingers and thumb with your thumb on

the base, below the mouthpiece.

Breathe out as far as is comfortable and then place the mouthpiece in your

mouth between your teeth and close your lips around it but do not bite it.

Just after starting to breathe in through your mouth press down on the top

of the inhaler to release beclometasone dipropionate while still breathing

in steadily and deeply.

While holding your breath, take the inhaler from your mouth and take your

finger from the top of the inhaler. Continue holding your breath for as

long as is comfortable.

If you are to take further puffs keep the inhaler upright and wait about half

a minute before repeating steps 3 to 7.

Replace the mouthpiece cover by firmly pushing and snapping the cap into

position.

IMPORTANT:

Do not rush stages 5, 6 and 7. It is important that you start to breathe in as slowly as

possible just before operating your inhaler. Practise in front of a mirror for the first

few times. If you see mist coming from the top of your inhaler or the sides of your

mouth you should start again from stage 2.

If your doctor has given you different instructions for using your inhaler, please

follow them carefully. Tell your doctor if you have any difficulties.

Cleaning the inhaler

The inhaler should be cleaned at least once a week:

Health Products Regulatory Authority

23 November 2018

CRN008LW0

Page 4 of 11

Pull the metal canister out of the plastic casing of the inhaler and remove the

mouthpiece cover.

Wipe the plastic casing and mouthpiece with a damp cloth.

Leave to dry in a warm place. Avoid excessive heat.

Replace the canister and mouthpiece cover.

DO NOT PUT THE METAL CANISTER INTO WATER.

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

The management of asthma should follow a stepwise programme, and patient

response should be monitored clinically and by lung function tests.

Increasing use of short-acting inhaled beta-2-agonists to control symptoms indicates

deterioration of asthma control. Under these conditions, the patient's therapy plan

should be reassessed.

Sudden and progressive deterioration in asthma control is potentially life-threatening

and consideration should be given to increasing corticosteroid dosage. In patients

considered at risk, daily flow monitoring may be instituted.

Becotide Evohaler is not for use in acute attacks but for routine long-term

management. Patients will require a fast- and short-acting inhaled bronchodilator to

relieve acute asthmatic symptoms.

Patients' inhaler technique should be checked to make sure that aerosol actuation is

synchronised with inspiration of breath for optimum delivery of the drug to the lungs.

Lack of response or severe exacerbations of asthma should be treated by increasing

the dose of inhaled beclometasone dipropionate and, if necessary, by giving a

systemic steroid and/or an antibiotic if there is an infection.

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses

prescribed for long 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 and glaucoma, 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,

Health Products Regulatory Authority

23 November 2018

CRN008LW0

Page 5 of 11

therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at

which effective control is maintained (see section 4.8).

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

inhaled corticosteroid is regularly monitored.

Certain individuals can show greater susceptibility to the effects of inhaled

corticosteroid than do most patients.

Because of the possibility of impaired adrenal response, patients transferring from

oral steroid therapy to inhaled beclometasone dipropionate therapy should be

treated with special care, and adrenocortical function regularly monitored.

Following introduction of inhaled beclometasone dipropionate, withdrawal of

systemic therapy should be gradual and patients encouraged to carry a steroid

warning card indicating the possible need for additional therapy in times of stress.

Similarly replacement of systemic steroid treatment with inhaled therapy 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, including topical steroids.

Treatment with Becotide Evohaler should not be stopped abruptly.

As with all inhaled corticosteroids, special care is necessary in patients with active or

quiescent pulmonary tuberculosis.

As with other inhalation therapy, paradoxical bronchospasm may occur with an

immediate increase in wheezing after dosing. This should be treated immediately

with a fast-acting inhaled bronchodilator. Becotide Evohaler should be discontinued

immediately, the patient assessed, and if necessary alternative therapy instituted.

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 which have been reported after use of systemic and

topical corticosteroids.

Patients should be advised that this product contains small amounts of ethanol and

glycerol. At the normal doses the amounts of ethanol and glycerol are negligible and

do not pose a risk to patients.

Health Products Regulatory Authority

23 November 2018

CRN008LW0

Page 6 of 11

4.5 Interaction with other medicinal products and other forms of interactions

Beclomethasone 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.

Becotide Evohaler contains a small amount of ethanol. There is a theoretical potential

for interaction in particularly sensitive patients taking disulfiram or metronidazole.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is inadequate evidence of the safety of beclometasone dipropionate or

Norflurane (HFA 134aor Tetrafluoroethane) propellant in human pregnancy.

In animal reproduction studies with beclometasone dipropionate, adverse effects

typical of potent corticosteroids are only seen at high systemic exposure levels; direct

inhaled application ensures minimal systemic exposure.

Studies of the effect of Norflurane (HFA 134a) on reproductive function and

embryo-foetal development in animals have revealed no clinically relevant adverse

events.

No clinically relevant adverse events have been associated with the administration of

Norflurane (HFA 134a)propellant. Thus, it is unlikely that there will be any adverse

effects in humans.

Administration of drugs during pregnancy should only be considered if the expected

benefit to the mother is greater than any possible risk to the foetus.

Breast-feeding

The excretion of beclometasone dipropionate in milk has not been studied in animals.

It is reasonable to assume that beclometasone dipropionate is secreted in milk but at

the dosage used for direct inhalation, there is low potential for significant levels in

breast milk. Beclometasone dipropionate should only be used in a nursing mother if

the expected benefit justifies the risk to the newborn/infant.

4.7 Effects on ability to drive and use machines

Becotide Evohaler has no or negligible influence on the ability to drive and use

machines.

Health Products Regulatory Authority

23 November 2018

CRN008LW0

Page 7 of 11

4.8 Undesirable effects

Adverse reactions are listed below by system organ class and frequency. Frequencies

are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon

(≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (<1/10,000) including

isolated reports and not known (cannot be estimated from the available data). Very

common, common and uncommon reactions were generally determined from clinical

trial data. The incidence in placebo and comparator group has not been taken into

account in estimation of these frequencies. Rare and very rare reactions were

generally determined from spontaneous data.

Infections and infestations

Very common: Candidiasis of the mouth and throat.

Immune system disorders

Hypersensitivity reactions with the following manifestations have been reported:

Uncommon: Rash, urticaria, pruritus, erythema.

Very rare: Angioedema, respiratory symptoms (dyspnoea and/or bronchospasm) and

anaphylactoid/anaphylactic reactions.

Endocrine disorders

Possible systemic effects include (see section 4.4):

Very rare: Cushing’s syndrome, Cushingoid features, adrenal suppression, growth

retardation in children and adolescents, decrease in bone mineral density, cataract,

glaucoma.

Psychiatric disorders

Very rare: Anxiety, sleep disorders and behavioural changes, including hyperactivity

and irritability (predominantly in children).

Unknown: Depression, aggression (predominantly in children).

Respiratory, thoracic and mediastinal disorders

Common: Hoarseness, throat irritation.

The use of a large volume 'spacer' device may be considered.

Very rare: Paradoxical bronchospasm (see section 4.4).

Eye disorder

Not known: Vision, blurred (see section 4.4)

As with other inhalation therapy, paradoxical bronchospasm may occur with an

immediate increase in wheezing after dosing. This should be treated immediately

with a fast-acting inhaled bronchodilator. Becotide Evohaler should be discontinued

immediately, the patient assessed, and if necessary alternative therapy instituted.

Health Products Regulatory Authority

23 November 2018

CRN008LW0

Page 8 of 11

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 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

Further management should be as clinically indicated or as recommended by the

national poisons centre, where available.

There is no specific treatment for an overdose of beclometasone dipropionate. If

overdose occurs, the patient should be treated supportively with appropriate

monitoring as necessary.

Acute inhalation of beclometasone dipropionate doses in excess of those

recommended may lead to temporary suppression of adrenal function. This does not

need emergency action as adrenal function is recovered in a few days, as verified by

plasma cortisol measurements.

However if higher than recommended dosage is continued over prolonged periods,

some degree of adrenal suppression may result.Monitoring of adrenal reserve may

be necessary. In cases of beclometasone dipropionate overdose, therapy may still be

continued at clinically appropriate dosage (within the approved range) for symptom

control.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group, ATC code: not yet assigned

Beclometasone dipropionate is a pro-drug with weak glucocorticoid receptor binding

affinity. It is hydrolysed via esterase enzymes to the active metabolite

beclometasone-17-monopropionate (B-17-MP), which has high topical

anti-inflammatory activity.

5.2 Pharmacokinetic properties

Absorption

When administered via inhalation (via metered dose inhaler), systemic absorption of

unchanged beclometasone dipropionate (BDP) occurs through the lungs with

negligible oral absorption of the swallowed dose. There is extensive conversion of

BDP to its active metabolite B-17-MP within the lung prior to absorption. The

Health Products Regulatory Authority

23 November 2018

CRN008LW0

Page 9 of 11

systemic absorption of B-17-MP arises from both lung deposition and oral

absorption of the swallowed dose. The absolute bioavailability following inhalation is

approximately 60% of the nominal dose forB-17-MP. BDP is absorbed rapidly with

peak plasma concentrations first being observed (t

) at 0.3h. B-17-MP appears

more slowly with a t

of 1 h. There is an approximately linear increase in systemic

exposure with increasing inhaled dose. When administered orally the bioavailability

of BDP is negligible but pre-systemic conversion to B-17-MP results in approximately

40% of the dose being absorbed as B-17-MP.

Metabolism

BDP is cleared very rapidly from the systemic circulation, by metabolism mediated via

esterase enzymes that are found in most tissues. The main product of metabolism is

the active metabolite (B-17-MP). Minor inactive metabolites,

beclometasone-21-monopropionate (B-21-MP) and beclometasone (BOH), are also

formed but these contribute little to the systemic exposure.

Distribution

The tissue distribution at steady-state for BDP is moderate (20 L) but more extensive

for B-17-MP (424 L). Plasma protein binding is moderately high (87%).

Elimination

The elimination of BDP and B-17-MP is characterised by high plasma clearance (150

and 120 L/h) with corresponding terminal elimination half-lives of 0.5h and 2.7 h.

Following oral administration of tritiated BDP, approximately 60% of the dose was

excreted in the faeces within 96 hours mainly as free and conjugated polar

metabolites. Approximately 12% of the dose was excreted as free and conjugated

polar metabolites in the urine. The renal clearance of BDP and its metabolites is

negligible.

5.3 Preclinical safety data

Preclinical safety studies indicate that beclometasone dipropionate shows negligible

systemic toxicity when administered by the inhaled route.

The non-CFC propellant, Norflurane (HFA134a), has been shown to have no toxic

effect at very high vapour concentrations, far in excess of those likely to be

experienced by patients, in a wide range of animal species exposed daily for periods

of two years.

Health Products Regulatory Authority

23 November 2018

CRN008LW0

Page 10 of 11

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Norflurane (Hydrofluoroalkane (HFA) 134a)

Ethanol Anhydrous

Glycerol

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years

6.4 Special precautions for storage

Do not store above 30 °C.

Protect from frost and direct sunlight. Do not refrigerate or freeze.

As with most inhaled medications in aerosol canisters, the therapeutic effect of this

medication may decrease when the canister is cold.

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

The inhaler comprises an aluminium can fitted with a 50 microlitre metering valve,

plastic actuator and dust cap. Each canister contains 200 metered doses.

6.6 Special precautions for disposal

Any used medicinal product or waste material should be disposed of in accordance

with local requirements.

Patients should be carefully monitored in the proper use of their inhaler.

Health Products Regulatory Authority

23 November 2018

CRN008LW0

Page 11 of 11

7 MARKETING AUTHORISATION HOLDER

GlaxoSmithKline (Ireland) Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

8 MARKETING AUTHORISATION NUMBER

PA1077/042/007

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07 January 2005

Date of last renewal: 07 January 2010

10 DATE OF REVISION OF THE TEXT

November 2018

Similar products

Search alerts related to this product

View documents history

Share this information