Budesonide Teva Pharma 0.5 mg/2 ml Nebuliser Suspension

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Budesonide
Available from:
Teva Pharma B.V.
ATC code:
R03BA; R03BA02
INN (International Name):
Budesonide
Dosage:
0.5 mg/2ml
Pharmaceutical form:
Nebuliser suspension
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Glucocorticoids; budesonide
Authorization status:
Marketed
Authorization number:
PA0749/207/002
Authorization date:
2014-03-07

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET

1. What Budesonide Teva Nebuliser Suspension is

and what it is used for

2. What you need to know before you use

Budesonide Teva Nebuliser Suspension

3. How to use Budesonide Teva Nebuliser

Suspension

4. Possible side effects

5. How to store Budesonide Teva Nebuliser

Suspension

6. Contents of the pack and other information

1

What Budesonide Teva Nebuliser Suspension

is and what it is used for

Budesonide belongs to a group of steroids called

glucocorticosteroids which can be used to reduce

or prevent inflammatory reactions (swelling) in the

lungs.

This medicine can be used in adults, adolescents,

children and infants aged 6 months and older.

Your medicine is used for the treatment of asthma.

It is used in patients where other types of inhaler,

such as a pressurised inhaler or an inhaler

containing a dry powder are unsatisfactory or

inappropriate.

Budesonide Nebuliser suspension can also be

used to treat very serious pseudocroup (laryngitis

subglottica) in infants and children who are in

hospital.

2

What you need to know before you use

Budesonide Teva Nebuliser Suspension

Do not use Budesonide Teva Nebuliser Suspension

if you are allergic to budesonide or any of the

other ingredients of this medicine (listed in

section 6).

Warnings and precautions

Talk to your doctor before using Budesonide Teva

Nebuliser Suspension if any of the following apply

to you:

if you have or have had tuberculosis

if you have or have had a liver disease or

problems with your liver;

if you have a fungal infection, viral or other

infection of the airways, e.g. a cold or chest

infection.

Contact your doctor if you experience blurred

vision or other visual disturbances.

Budesonide is a steroid. You should be aware that

you could fail an anti-doping test as a result of

using this medicine. You should discuss this with

your doctor if you have any concerns.

Children and adolescents

In rare cases, long term treatment with budesonide

can slow down the normal growth of children and

adolescents. If your child uses this medicine for a

long time, it is normal that the doctor will want to

monitor their height on a regular basis.

Other medicines and Budesonide Teva Nebuliser

Suspension

Please tell your doctor or pharmacist if you

are taking or have recently taken any other

medicines, including medicines obtained without a

prescription.

Some medicines may increase the effects of

Budesonide and your doctor may wish to monitor

you carefully if you are taking these medicines

(including some medicines for HIV: ritonavir,

cobicistat):

medicines for the treatment of a fungal infection

such as ketoconazole or itraconozole

antibiotic medicines, erythromycin and

clarithromycin

other medicines which help you to breathe

oestrogens and contraceptive steroids.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you

may be pregnant or are planning to have a baby,

you should not use Budesonide Teva Nebuliser

Suspension unless your doctor tells you to. If you

become pregnant whilst taking this medicine you

should tell your doctor as soon as possible.

Driving and using machines

Budesonide Teva Nebuliser Suspension is not likely

to affect you being able to drive or use any tools or

machines.

3

How to use Budesonide Teva Nebuliser

Suspension

Always use this medicine exactly as your doctor

has told you. Check with your doctor or pharmacist

if you are not sure.

Your doctor will advise you of the correct dose,

which will depend on how bad your asthma is.

You may find that your asthma improves within 3

days, but it can take between 2 – 4 weeks before

the full effect is achieved. It is important that you

keep using your medicine as instructed by your

doctor even if you feel better.

The recommended doses are as follows:

Asthma

Adults (including older people) and adolescents of

12 years and over:

The usual dose is 0.5 to 2 mg of budesonide daily.

This dose will normally be taken on two separate

occasions during the day although if your asthma

is stable and not severe your doctor may advise

you to take this medicine once a day. Your doctor

will tell you how and when it is best to take your

medicine and you should always follow their

instructions.

Infants and children (aged 6 months to 11 years)

The usual dose is 0.25 mg to 1 mg of budesonide

daily. The doctor will advise you on how your child

should take their medicine and this will usually

be on two separate occasions during the day.

However if their asthma is stable and not severe

your doctor may advise that they should take this

medicine once a day.

Pseudocroup

The usual dose for infants and children is 2 mg

per day. This may be given as a single treatment

(2 ampoules of the 1mg/2ml presentation) or 1 mg

may be given followed by another 1 mg 30 minutes

later. Dosing can be repeated every 12 hours up to

a maximum of 36 hours or until improvement.

Instructions for use

Your medicine must be used with a jet nebuliser.

The “mist” produced is then inhaled through a

mouthpiece or face mask. Ultrasound nebulisers

should not be used with this medicine.

To take your medicine, follow these steps:

1. Remove one of the sterile plastic containers

(ampoule) from the labelled strip by twisting and

pulling (diagram A).

2. Shake the ampoule gently in a circular motion

for about 10 seconds or until no sediment is

seen.

3. Hold the ampoule upright and twist off the top

(diagram B).

4. Squeeze all of the liquid from the ampoule into

the nebuliser cup (diagram C). Replace the top

of the nebuliser cup and dispose of the empty

ampoule carefully.

5. Connect one end of the cup to the mouthpiece or

face mask and the other end to the air pump.

6. Gently shake the cup once more then turn on

the nebuliser. Breathe in the “mist” calmly and

deeply using the mouthpiece or face mask

7. When no more mist comes out of the

mouthpiece or face mask, your treatment is

complete

8. Rinse your mouth with water. Spit out the water.

Do not swallow it. If you have used a face mask,

you should also wash your face. It is important

to do this as it can reduce the risk of some side

effects associated with this medicine.

9. You should clean your nebuliser after each use.

Wash the nebuliser container and mouthpiece

or face mask in warm water using a mild

detergent in accordance with the manufacturer’s

instructions. The nebuliser should then be rinsed

well and dried by connecting the nebuliser

container to the air pump.

It is important that you always follow the

manufacturer’s instructions that come with the

nebuliser. If you are not sure about how to use the

nebuliser, talk to your doctor or pharmacist.

Your doctor may also prescribe the following:

Your doctor may consider adding steroid tablets

to your treatment during periods of stress (e.g.

if you have an infection), or if you have been

taking a high dose of an inhaled steroid for a

long time, or before an operation.

If you have been taking steroid tablets for your

asthma, your doctor may reduce the number

of tablets that you take once you start to use

Budesonide Teva Nebuliser Suspension. You

might experience some symptoms as a result

of this including a stuffy or runny nose, a lack of

energy, depression, eczema (a type of skin rash)

and joint and/or muscle pain. If any of these

symptoms bother you or persist, please contact

your doctor.

Your doctor may ask you to mix this medicine

with 0.9% saline or solutions containing other

active substances, which work on the respiratory

system such as salbutamol, terbutaline, sodium

BUDESONIDE TEVA 0.25 MG

NEBULISER SUSPENSION

BUDESONIDE TEVA 0.5 MG

NEBULISER SUSPENSION

BUDESONIDE TEVA 1 MG

NEBULISER SUSPENSION

Budesonide

32050514

cromoglycate and ipratropium bromide. If so

follow their instructions carefully. The admixture

should be used within 30 minutes. You must not

mix this medicine unless specifically instructed

by your doctor.

If you use more Budesonide Teva Nebuliser

Suspension than you should contact your doctor or

pharmacist as soon as possible. Remember to take

the pack and any remaining ampoules with you. It

is important that you use 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 Budesonide Teva Nebuliser

Suspension do not take the missed dose or a

double dose to make up for the one you missed.

Simply take your next dose on time.

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.

All medicines can cause allergic reactions,

although serious allergic reactions are very rare.

Tell your doctor immediately if you get any sudden

wheeziness, difficulty in breathing, swelling of

the eyelids, face or lips, rash or itching (especially

affecting your whole body).

Rarely, inhaled drugs such as budesonide can

cause acute wheezing and/or shortness of breath. If

this occurs, stop using your medicine immediately

and seek medical advice.

The following side effects have been reported;.

Common side effects (may affect up to 1 in 10

people):

Soreness and/or irritation in the mouth

(including oral thrush), throat irritation, difficulty

in swallowing and cough.

Uncommon side effects (may affect up to 1 in 100

people):

Anxiety

Depression

Tremor

Clouding of the lens in the eye (Cataract)

Muscle spasm

Blurred vision.

Rare side effects (may affect up to 1 in 1,000

people):

Skin reactions including itching, rash, bruising,

inflammation, redness of the skin and/or skin

eruptions, swelling, slowing of growth in

children and adolescents, hypersensitivity (an

allergy to the medicine) and bronchospasm

(tightening of the muscles in the airways

resulting in wheezing).

Suppression of your adrenal gland (a small

gland next to the kidney) can also occur. The

major symptoms of adrenal supression include

headaches, tiredness, feeling and being sick,

weight loss, stomach pains and lack of appetite.

Feeling restless, nervous and irritable (these

effects are more likely to occur in children).

Hoarseness, change in the voice.

Very rare side effects (may affect up to 1 in 10,000

people):

Decrease in bone mineral density (thinning of

the bones).

Side effects with unknown frequency:

Glaucoma (increased pressure in the eye),

aggression, sleeping problems and excitability.

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

national reporting system listed in Appendix V. By

reporting side effects you can help provide more

information on the safety of this medicine.

5

How to store Budesonide Teva Nebuliser

Suspension

Keep this medicine out of the sight and reach of

children.

Do not use this medicine after the expiry date

which is stated on the outer pack, sachet and

ampoule after EXP. The expiry date refers to the

last day of that month.

Do not freeze.

Store in the upright position.

After first opening the sachet, the ampoules inside

should be used within 3 months (it is a good idea

to mark the opening date on the foil sachet to help

you remember). Store the ampoule in the opened

sachet. The opened sachet should be stored in the

outer carton to protect from light and they should

not be frozen.

Each ampoule is for single use only.

Opened ampoule: use immediately. Discard any

unused portion.

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 protect the environment.

6

Contents of the pack and other

information

What Budesonide Teva Nebuliser Suspension con-

tains

The active substance is budesonide.

Budesonide 0.25 mg Nebuliser Suspension

contains 0.25 mg of budesonide as the active

substance in each single dose 2 ml ampoule.

Budesonide 0.5 mg Nebuliser Suspension contains

0.5 mg of budesonide as the active substance in

each single dose 2 ml ampoule.

Budesonide 1 mg Nebuliser Suspension contains

1 mg of budesonide as the active substance in

each single dose 2 ml ampoule.

The other ingredients are Disodium Edetate,

Sodium Chloride, Polysorbate 80 E433, Citric

Acid Monohydrate E330, Sodium Citrate E331

and Water for Injection.

What Budesonide Teva Nebuliser Suspension

looks like and contents of the pack

Your medicine comes in the form of plastic single

dose ampoules containing 2 ml of a white to off

white sterile suspension to be nebulised (made

into a fine mist for inhalation).

Strips of 5 ampoules are packed into a foil sachet,

which are then packed into a carton. There are 5,

10, 15, 20, 25, 30, 40, 50 or 60 ampoules in each

carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Pharma B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

Manufacturer:

Norton Healthcare Limited t/a IVAX

Pharmaceuticals UK

Runcorn

Cheshire

WA7 3FA

Merckle GmbH

Ludwig-Merckle-Str. 3

89143 Blaubeuren

Germany

This medicinal product is authorised in the Mem-

ber States of the EEA under the following names:

Belgium

Budesonide Teva

0,125 mg/ml, 0,25 mg/ml and

0,5 mg/ml vernevelsuspensie

Denmark

Budesonide Teva Pharma

Finland

Budesonide Teva 0,5 mg/ml

sumutinsuspensio

Buderatio 0,25 mg/ml

sumutinsuspensio

Ireland

Budesonide Teva Pharma

0.5 mg/2 ml and 1 mg/2 ml

Nebuliser Suspension

Malta

Budesonide Teva Pharma

0.25 mg/2 ml, 0.5 mg/2 ml and

1 mg/2 ml Nebuliser Suspension

Netherlands

Budesonide Teva Steri-Neb

0,25 mg/2 ml, 0,5 mg/2 ml and

1,0 mg/2 ml, vernevelsuspensie

Norway

Budesonid Teva

Poland

Nebbud

Sweden

Budesonide Teva Pharma

This leaflet was last revised in February 2019.

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Budesonide Teva Pharma 0.5 mg/2 ml Nebuliser Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One ampoule of 2 ml suspension contains 0.5 mg budesonide.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Nebuliser suspension.

A white to off white suspension in a single dose ampoule.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Budesonide Nebuliser Suspension is indicated in adults, adolescents, children and infants aged six months and older.

Asthma

Budesonide Nebuliser Suspension is indicated for the use in persistent bronchial asthma, in patients where use of a pressurised

inhaler or dry powder formulation is unsatisfactory or inappropriate.

Pseudocroup

Very serious pseudocroup (laryngitis subglottica), in which hospitalisation is indicated.

4.2 Posology and method of administration

For inhalation use.

Posology

Asthma

The dose should be given twice daily. Administration once daily may be considered in cases of mild to moderate stable asthma.

Initial dosage:

The initial dose should be tailored to the severity of the disease and thereafter should be adjusted on an individual basis. The

following doses are recommended but the minimum effective dose should always be sought.

Children aged 6 months and above:

0.25 – 1.0 mg daily. For patients in maintenance therapy with oral steroids a higher initial dosage up to 2.0 mg daily should be

considered.

Adults (including older people) and children/adolescents over 12 years of age:

0.5 – 2.0 mg daily. In very severe cases the dosage may be increased further.

Maintenance dose:

The maintenance dose should be adjusted to meet the requirements of the individual patient taking into account the severity

of the disease and clinical response of the patient. When the desired clinical effect has been obtained, the maintenance dose

should be reduced to the minimum required for control of symptoms.

Children aged 6 months and above:

0.25 – 1.0 mg daily.

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Adults (including older people) and children/adolescents over 12 years of age:

0.5 – 2.0 mg daily. In very severe cases the dose may be further increased.

Pseudocroup

In infants and children with pseudocroup, the commonly used dose is 2 mg of nebulised budesonide. This is given as a single

administration, or as two 1 mg doses separated by 30 minutes. Dosing can be repeated every 12 hours for a maximum of 36

hours or until clinical improvement.

Paediatric population

The safety and efficacy of Budesonide Nebuliser Suspension in infants aged less than six months has not yet been established.

Method of administration

Asthma

Administration once daily:

Administration once daily should be considered for children and adults with mild to moderate stable asthma and with a

maintenance dose between 0.25 and 1 mg budesonide daily. Once-daily administration may be initiated both in patients who

are not receiving corticosteroid treatment and in well-controlled patients who are already taking inhaled steroids. The dose

may be given in the morning or the evening. If a worsening of the asthma occurs, the daily dose should be increased by

administering the dose twice daily.

Onset of effect:

An improvement of the asthma following administration of budesonide may occur within 3 days after initiation of therapy. The

maximum effect will only be obtained after 2 - 4 weeks of treatment.

Patients in maintenance therapy with oral glucocorticosteroids:

With Budesonide Nebuliser Suspension it is possible to replace or considerably reduce the dose of oral glucocorticosteroids

and still maintain or improve the control of asthma. When transferral from oral steroids to inhaled budesonide is started, the

patient should be in a relatively stable phase.

Initially, a high dose of inhaled budesonide should be administered. It may be co-administered with the previously used oral

glucocorticosteroid for approximately 10 days. The oral dose is then reduced (by for example 2.5 mg prednisolone or

equivalent dose per month) to the lowest possible level. In many patients it is possible to completely replace the oral

glucocorticosteroid entirely with inhaled budesonide.

When tapering off systemic corticosteroids some patients may experience steroid withdrawal symptom, e.g., muscle and/or

joint pain, lack of energy and depression or even a decreased lung function. Such patients must be advised to continue inhaled

budesonide therapy, but they should also be examined for any objective signs of adrenocortical insufficiency. If such signs are

present, the dose of the systemic corticosteroids should be temporarily increased and then tapered off even more slowly. In

periods of stress or severe asthma attacks, patients in the transition phase may require treatment with systemic corticosteroids.

For further information on the withdrawal of corticosteroids, see section 4.4.

Dosage schedule:

The following schedule should be followed:

Dosage in mg

Volume of Budesonide Nebuliser Suspension

0.25 mg/2 ml

0.5 mg/2 ml

1 mg/2 ml

0.25

2 ml

4 ml

2 ml

0.75***

2 ml

plus

2 ml

4 ml

2 ml

1.5**

2 ml

plus

2 ml

4 ml

* either 2 ampoules of Budesonide Nebuliser Suspension 0.5 mg/2 ml or one ampoule of Budesonide Nebuliser Suspension 1

mg/2 ml

** One ampoule of Budesonide Nebuliser Suspension 0.5 mg/2 ml plus one ampoule of Budesonide Nebuliser Suspension 1

mg/2 ml.

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*** One ampoule of Budesonide Nebuliser Suspension 0.25 mg/2 ml plus one ampoule of Budesonide Nebuliser Suspension

0.5 mg/2 ml.

Division of the dose and miscibility:

Budesonide Nebuliser Suspension may be mixed with 0.9% sodium chloride solution and with solutions for inhalation

containing terbutaline, salbutamol, sodium cromoglycate or ipratropium.

Nebuliser:

Budesonide Nebuliser Suspension must be administered with a jet nebuliser supplied with a mouthpiece or mask. The

nebuliser should be connected to an air compressor with adequate air flow (6-8 l/min), and the filling volume should be 2-4 ml.

There can be variation in the performance (dose delivered) between nebulisers, even those of the same make and model

Note! Ultrasound nebulisers are not suitable for nebulisation of Budesonide Nebuliser Suspension and therefore cannot be

recommended.

Instructions for use:

To minimise the risk of oropharyngeal candida infection, the patient should rinse their mouth out with water after inhaling.

- Prepare the nebuliser for use according to the manufacturer’s instructions.

- Open the foil envelope and take out the strip of ampoules. Remove an ampoule from the strip by twisting and pulling

(Figure 1).

- Shake the ampoule gently for about 10 seconds or until no sediment is seen.

- Hold the ampoule in the upright position and twist off the upper tab (Figure 2).

- Turn the ampoule upside down and squeeze the contents into the reservoir (chamber) of the nebuliser (Figure 3).

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- The ampoule is for single use. Therefore after each administration any unused medication should be discarded and the

nebuliser chamber washed and cleaned. Wash the nebuliser chamber and mouthpiece or face mask in warm water or mild

detergent. Rinse well and dry by connecting the nebuliser chamber to the compressed air inlet of the compressor.

- Patients should be instructed to rinse their mouth out with water after inhaling the prescribed dose to minimise the risk of

oropharyngeal thrush.

- Patients should also wash their face with water after using the face mask to prevent facial skin irritation.

4.3 Contraindications

Hypersensitivity to budesonide or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Budesonide Nebuliser Suspension is not suitable for the treatment of acute dyspnoea or status asthmaticus. These conditions

should be treated with short acting β-sympathomimetics and other bronchodilators.

The transfer of patients treated with oral corticosteroid to the inhaled corticosteroid and their subsequent management

requires special care. The patients should be in a reasonably stable state before initiating a high dose of inhaled corticosteroid

in addition to their usual maintenance dose of systemic corticosteroid. After about 10 days, withdrawal of the systemic

corticosteroid is started by reducing the daily dose gradually (by for example 2.5 milligrams prednisolone or the equivalent

each month) to the lowest possible level. It may be possible to completely replace the oral corticosteroid with inhaled

corticosteroid. Transferred patients whose adrenocortical function is impaired may need supplementary systemic corticosteroid

during periods of stress e.g. surgery, infection or worsening asthma attacks.

Patients who have required high dose emergency corticosteroid therapy or prolonged treatment at the highest recommended

dosage of inhaled corticosteroids, may also be at risk of impaired adrenal function. These patients may exhibit signs and

symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid treatment should be

considered during periods of stress or elective surgery.

During transfer from oral therapy to inhaled budesonide, symptoms may appear that had previously been suppressed by

systemic treatment with glucocorticosteroids, for example symptoms of allergic rhinitis, eczema, muscle and joint pain. Specific

treatment should be co-administered to treat these conditions.

Patients who have previously been dependent on oral corticosteroids may, as a result of prolonged systemic corticosteroid

therapy, experience effects of impaired adrenal function. Recovery may take a considerable amount of time after cessation of

oral corticosteroid therapy and hence oral steroid-dependent patients transferred to budesonide may remain at risk from

impaired adrenocortical function for some considerable time. In such circumstances hypothalamic pituitary adrenocortical

(HPA) axis function should be monitored regularly.

Some patients may feel unwell in a non-specific way during the withdrawal of systemic corticosteroids despite maintenance or

even improvement in respiratory function.Such patients should be encouraged to continue treatment with inhaled budesonide

and withdrawal of oral corticosteroid unless there are clinical signs to indicate the contrary, for example signs which might

indicate adrenal insufficiency.

The elimination of corticosteroids may be affected by liver function disorders. The elimination rate is reduced and systemic

exposure is increased. Possible side effects must be expected.

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As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. If

this occurs, treatment with inhaled budesonide must be immediately discontinued. The patient must be assessed and an

alternative treatment be initiated, if needed.

When an acute episode of dyspnoea occurs despite a well monitored treatment, a rapid acting inhaled bronchodilator should

be used and medical reassessment should be considered. If, despite maximum doses of inhaled corticosteroids, asthma

symptoms are not adequately controlled, patients may require short-term treatment with systemic corticosteroids. In such

cases, it is necessary to maintain the inhaled corticosteroid therapy in association with treatment by the systemic route.

Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for long periods. These effects are

much less likely to occur with inhalation treatment 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, 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.

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 used of systemic and topical corticosteroids.

Exacerbation of clinical symptoms of asthma may be due to acute respiratory tract bacterial infections and treatment with

appropriate antibiotics may be required. Such patients may need to increase the dose of Budesonide Nebuliser Suspension and

a short course of oral corticosteroids may be required. A rapid-acting inhaled bronchodilator should be used as ‘rescue’

medication to relieve acute asthma symptoms.

Special caution is needed in patients with active or quiescent pulmonary tuberculosis, and in patients with fungal or viral

infections of the respiratory tract. This should be taken into account with the treatment of asthma in patients who also have a

respiratory tract infection; both the asthma and the respiratory tract infection should be treated adequately.

In patients with excessive mucous secretion in the respiratory tract, short term therapy with oral corticosteroids may be

necessary.

Oral candidiasis can occur during treatment with inhaled corticosteroids. In such cases, treatment with an appropriate

antimycotic agent may be necessary and in some patients discontinuation of the corticosteroid may be necessary (see section

4.2).

It is recommended to inhale the nebulised corticosteroid via a mouthpiece rather than a face mask in order to prevent local

skin irritations of the face. When a face mask is used, the face should be washed with water after completion of the

nebulisation.

The nebuliser chamber and the mouth piece (or face mask) should be cleaned with hot water and mild detergent after every

administration. They should then be rinsed well with water and dried by connecting the nebuliser chamber to the compressor.

Concomitant use of ketoconazole, HIV protease inhibitors or other potent CYP3A4 inhibitors should be avoided. If this is not

possible, the period between treatments should be as long as possible (see section 4.5).

Recent epidemiological studies show that there is an increased incidence of pneumonia in patients with Chronic Obstructive

Pulmonary Disease (COPD) treated with inhaled corticosteroids, with an adjusted odds ratio of 1.7. Care should be exercised in

prescribing budesonide for those patients whose respiratory disease might have a component of COPD.

Paediatric population

There is insufficient data available regarding the possible growth-inhibiting effect of budesonide in children aged from six

months to four years of age.

Influence on growth

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

monitored. If growth is slowed, therapy should be re-evaluated with the aim of reducing the dose of inhaled corticosteroid. The

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benefits of the corticosteroid therapy and the possible risks of growth suppression must be carefully weighed. In addition,

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

4.5 Interaction with other medicinal products and other forms of interactions

The metabolism of budesonide is primarily mediated by CYP 3A4. Inhibitors of this enzyme such as ketoconazole, itraconazole

and HIV protease inhibitors (ritanovir and saquinavir) can, therefore, increase systemic exposure to budesonide several fold

(see section 4.4). Because there are no data to support a dosage recommendation, the combination should be avoided. If this is

not possible, the period between treatments should be as long as possible and a reduction of the budesonide dose could also

be considered.

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic

side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid

side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

Because adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false

results (low values).

Limited data about this interaction for high-dosed inhaled budesonide indicate that marked increases in plasma levels (on

average four-fold) can occur if itraconozole, 200 mg once daily, is administered concomitantly with inhaled budesonide (single

dose of 1000 µg).

Other potent CYP3A4 inhibitors such as erythromycin and clarithromycin are also likely to markedly increase plasma

concentrations of budesonide.

Raised plasma concentrations of and enhanced effects of corticosteroids have been observed in women also treated with

oestrogens and contraceptive steroids, but no effect has been observed with budesonide and concomitant intake of low dose

combination oral contraceptives.

Concomitant administration of cimetidine can cause a slight increase in the plasma concentration of budesonide, which is

generally not clinically relevant.

The suppressive effect on adrenal function is additive, if used with systemic or intranasal steroids.

4.6 Fertility, pregnancy and lactation

Pregnancy

Most results from prospective epidemiological studies and world-wide post-marketing data have not been able to detect an

increased risk for adverse effects for the foetus and newborn child from the use of inhaled budesonide during pregnancy. It is

important for both foetus and mother to maintain an adequate asthma treatment during pregnancy. As with other drugs

administered during pregnancy, the benefit of the administration of budesonide for the mother should be weighed against the

risks to the foetus.

Breast-feeding

Budesonide is excreted into breast milk. However, at therapeutic doses of budesonide no effects on the suckling child are

anticipated. Budesonide can be used during breastfeeding.

Maintenance treatment with inhaled budesonide (200 or 400 micrograms twice daily) in asthmatic nursing women results in

negligible systemic exposure to budesonide in breast-fed infants.

In a pharmacokinetic study, the estimated daily infant dose was 0.3% of the daily maternal dose for both dose levels, and the

average plasma concentration in infants was estimated to be 1/600

of the concentrations observed in maternal plasma,

assuming complete infant oral bioavailability. Budesonide concentrations in infant plasma samples were all less than the limit

of quantification.

Based on the data from inhaled budesonide and the fact that budesonide exhibits linear pharmacokinetic properties within the

therapeutic dosage intervals after nasal, inhaled, oral and rectal adminstrations, at therapeutic doses of budesonide, exposure

to the suckling child is anticipated to be low.

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4.7 Effects on ability to drive and use machines

Budesonide Nebuliser Suspension has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Occasionally, signs or symptoms of systemic glucocorticosteroid-side effects may occur with inhaled glucocorticosteoids,

probably depending on dose, exposure time, concomitant and previous corticosteroid exposure, and individual sensitivity.

List of adverse reactions

The frequencies of adverse events are ranked according to the following: very common (≥1/10), common (≥1/100 to <1/10),

uncommon (≥1/1000 to <1/100), rare (≥1/10000 to < 1/1000), very rare (<1/10000) and not known (cannot be estimated from

the available data).

System Organ Class

Frequency

Undesirable effect

Infections and infestations

Common

Oropharyngeal candidiasis

Immune system disorders

Rare

Immediate and delayed hypersensitivity reactions*

including rash, contact dermatitis, urticaria, angioedema

and anaphylactic reaction

Endocrine disorders

Rare

Signs and symptoms of systemic corticosteroid effects

including adrenal suppression and growth retardation**

Psychiatric disorders

Uncommon

Rare

Not known

Anxiety, depression

Restlessness, nervousness, behavioural changes

(predominantly in children)

Sleep disorders, psychomotor hyperactivity, aggression

Nervous system disorders

Uncommon

Tremor

Eye disorders

Uncommon

Not known

Cataracts, vision, blurred (see also section 4.4)

Glaucoma

Respiratory, thoracic and mediastinal disorders

Common

Rare

Cough, throat irritation

Bronchospasm, dysphonia, hoarseness

Gastrointestinal disorders

Common

Oral mucosal irritation, difficulty in swallowing

Skin and subcutaneous disorders

Rare

Bruising, skin reactions, pruritus, erythema

Musculoskeletal and connective tissue disorders

Uncommon

Rare

Muscle spasm

Growth retardation

Investigations

Very rare

Bone density decreased

*Refer to Description of selected adverse reactions; facial skin irritation, below.

** Refer to Paediatric population, below.

Description of selected adverse reactions

Facial skin irritation, as an example of a hypersensitivity reaction, has occurred in some cases when a nebuliser with a face mask

has been used. To prevent irritation the facial skin should be washed with water after using the face mask.

In placebo-controlled studies, cataract was also uncommonly reported in the placebo group.

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Clinical trials with 13119 patients on inhaled budesonide and 7278 patients have been pooled. The frequency of anxiety was

0.52% on inhaled budesonide and 0.63% on placebo; that of depression was 0.67% on inhaled budesonide and 1.15% on

placebo.

There is an increased risk of pneumonia in patients with newly diagnosed COPD starting treatment with inhaled corticosteroids.

However weighted assessment of eight pooled clinical trials involving 4643 COPD patients treated with budesonide and 3643

patients randomised to non-inhaled corticosteroid (non-ICS) treatments did not demonstrate an increased risk for pneumonia.

The results from the first seven of these eight trials have been published as a meta-analysis.

Treatment with inhaled budesonide may result in candida infection in the oropharynx. Experience has shown that candida

infection occurs less often when inhalation is performed before meals and/or when the mouth is rinsed after inhalation. In

most cases this condition responds to topical anti-fungal therapy without discontinuing treatment with inhaled budesonide.

Coughing can usually be prevented by inhaling a β

-adrenoceptor agonist (e.g. terbutaline) 5 – 10 minutes before

administration of Budesonide Nebuliser Suspension.

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

include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and

glaucoma, and susceptibility to infections. The ability to adapt to stress may be impaired. The systemic effects described,

however, are much less likely to occur with inhaled budesonide than with oral corticosteroids.

Paediatric population

Due to the risk of growth retardation in the paediatric population, growth should be monitored as described in section 4.4.

There are limited data available on the safety and efficacy of Budesonide Nebuliser Suspension in overweight or obese children,

however, weight loss is a key target that must be considered.

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

Acute overdosage with budesonide, even in excessive doses, is not expected to be a clinical problem.

Symptoms

The only harmful effect after a large amount of sprays during a short period is a suppression of the cortex function. If it is a

matter of chronic use of very high doses, effects such as a degree of cortex atrophy in addition to adrenocortical suppression

may occur.

Treatment

Acute overdose: There is no need to take acute measures; treatment with budesonide should continue with the lowest possible

maintenance dose. The impaired adrenocortical function will repair automatically within a few days.

Chronic overdose: The patient should be treated as steroid dependent and be transferred to a suitable maintenance dose with

a systemic steroid e.g. prednisolone. When the condition is stabilised, the patient should continue treatment with inhaled

budesonide at the recommended dose.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Glucocorticoids, ATC code: R03B A02

Mechanism of action

Budesonide is a halogen-free glucocorticosteroid, which possesses a high local anti-inflammatory action with few systemic

effects. The exact mechanism of action of glucocorticoids in the treatment of asthma is not fully understood. Anti-inflammatory

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actions (including T-cells, eosinophilic cells and mast cells) such as inhibition of inflammatory mediator release and inhibition of

cytokine-mediated immune response are considered important.

Pharmacodynamic effects

A clinical study in patients with asthma comparing inhaled and oral budesonide at doses calculated to achieve similar systemic

bioavailability demonstrated statistically significant evidence of efficacy with inhaled but not oral budesonide compared with

placebo. Thus the therapeutic effect of conventional doses of inhaled budesonide may be largely explained by its direct action

on the respiratory tract.

Budesonide has demonstrated anti-anaphylactic and anti-inflammatory effect in challenge tests in experimental animals and in

patients. This effect has manifested itself as reduced bronchial obstruction in both the immediate and late allergic reaction.

It was also demonstrated that budesonide reduces the airways’ reactivity to histamine and metacholine in hyperreactive

patients. Treatment with inhaled budesonide has been used to effectively prevent exercise-induced asthma.

Influence on plasma cortisol concentration

Studies in healthy volunteers with budesonide have shown dose-related effect on plasma and urinary cortisol. At

recommended doses, budesonide causes significantly less effect on adrenal function than prednisone 10 mg, as shown by

ACTH test.

Paediatric population

Limited data from long-term studies suggest that most children and adolescents treated with inhaled budesonide ultimately

achieve their adult target height. However, an initial small but transient reduction in growth (approximately 1 cm) has been

observed. This generally occurs within the first year of treatment (see section 4.4).

Clinical – asthma

The efficacy of budesonide nebuliser suspension has been evaluated in a large number of studies and it has been shown that

budesonide is effective in both adults and children as once- or twice-daily medication for prophylactic treatment of persistent

asthma.

Clinical – croup

A number of studies in children with croup have compared budesonide nebuliser suspension with placebo. Examples of

representative studies evaluating the use of budesonide nebuliser suspension for the treatment of children with croup are

given below.

Efficacy in children with mild to moderate croup

A randomised, double-blind placebo-controlled study in 87 children (aged 7 months to 9 years), admitted to hospital with

clinical diagnosis of croup, was conducted to determine whether budesonide nebuliser suspension improves croup symptom

scores or shortens the duration of stay in hospital. An initial dose of budesonide (2 mg) or placebo was given followed either

by budesonide 1 mg or placebo every 12 hours. Budesonide statistically significantly improved croup score at 12 and 24 hours

and at 2 hours in patients with an initial croup score above 3. There was also a 33% reduction in the length of hospital stay.

Efficacy in children with moderate to severe croup

A randomised, double-blind, placebo controlled study compared the efficacy of budesonide nebuliser suspension and placebo

in the treatment of croup in 83 infants and children (aged 6 months to eight years) admitted to hospital for croup. Patients

received either budesonide 2 mg or placebo every 12 hours for a maximum of 36 hours or until discharge for hospital. The

total croup symptom score was assessed at 0, 2, 6, 12, 24, 36 and 48 hours after initial dose. At 2 hours, both the active and

placebo groups showed a similar improvement in croup symptom score, with no statistically significant difference between the

groups. By six hours, the croup symptom score in the budesonide group was statistically significantly improved compared with

the placebo group, and this improvement versus placebo was similarly evident at 12 and 24 hours.

5.2 Pharmacokinetic properties

Absorption

In adults the systemic bioavailability of budesonide following administration of Budesonide Nebuliser Suspension via a jet

nebuliser is approximately 15% of the nominal dose and 40% to 70% of the dose delivered to the patient. Only a small quantity

of the systemically available dose originates from the swallowed portion of the medicine. The maximum plasma concentration,

which is reached 10 to 30 minutes after the start of the nebulisation, is approximately 4 nmol/l after a single dose of 2 mg.

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Distribution

Budesonide has a Volume of Distribution in adults of approximately 3.0 l/kg and plasma protein binding is on average 85 to

90%.

Biotransformation

Approximately 90% of budesonide is converted by first-pass biotransformation in the liver via CYP3A4 into metabolites with a

low glucocorticosteroid activity. The glucocorticosteroid activity of the most important metabolites, 6-β-hydroxy budesonide

and 16-alpha-hydroxy prednisolone, is less than 1% of the activity of budesonide.

Elimination

The metabolites are excreted unchanged or conjugated primarily via the kidneys. No unchanged budesonide was recovered in

the urine. In healthy adults, budesonide has a high systemic clearance (approximately 1.2 l/min) and an average elimination

half life of 2 – 3 hours after intravenous administration.

Linearity

In clinically relevant doses, the pharmacokinetics for budesonide is dose proportional.

Paediatric population

Budesonide has a systemic clearance of approximately 0.5 l/ml in children (4 – 6 years of age) with asthma. On a per kilogram

basis, the budesonide clearance in children is 50% higher than that in adults. In children with asthma, the elimination half life of

budesonide after inhalation is about 2.3 hours; this is about the same as that in healthy adults. In children aged 4 – 6 years of

age with asthma, the systemic bioavailability of budesonide after administration of nebulised budesonide via a jet nebuliser

(Pari LC Jet Plus

with Pari Master

compressor) is approximately 6% of the nominal dose and 26% of the dose that is

administered to the patient. The systemic availability in children is approximately half of that in healthy adults.

The maximum plasma concentration that occurs 20 minutes after the start of a 1 mg budesonide nebulisation is approximately

2.4 nmol/l in children aged 4 – 6 years with asthma. The exposure (C

and AUC) of budesonide after a single dose of 1 mg via

nebulisation in 4 – 6 year old children is comparable to that of healthy adults, who were given the same dose of budesonide

using the same nebulisation system.

5.3 Preclinical safety data

The acute toxicity of budesonide is low and of the same order of magnitude and type as that of other glucocorticosteroids.

Results from subacute and chronic toxicity, as well as genotoxicity and carcinogenicity studies did not pose any special risk to

humans when budesonide was given in therapeutic doses.

Although there was an increased incidence of brain gliomas in male rats, this could not be verified in a repeat study. Available

clinical experience indicates there are no suggestions that budesonide induces brain gliomas or other primary neoplasms in

man.

Glucocorticosteroids, including budesonide, have produced teratogenic effects in animal studies, including cleft palate and

skeletal abnormalities. Similar effects are considered unlikely to occur in humans at the recommended dose levels.

Results from animal studies have also identified an involvement of excess prenatal glucocorticosteroids, in increased risk for

intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticosteroid receptor density,

neurotransmitter turnover and behaviour at exposures below the teratogenic dose range.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Disodium Edetate

Sodium Chloride

Polysorbate 80 E433

Citric Acid Monohydrate E330

Sodium Citrate E331

Water for Injections

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6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf life

Unopened: 2 years

After first opening the foil sachet: 3 months.

Opened ampoule: use immediately. Discard any unused portion.

6.4 Special precautions for storage

Do not freeze.

Store in the upright position. Store the ampoule in the opened sachet. The opened sachet should be stored in the outer carton

to protect from light and should not be frozen. For shelf life of the opened sachet see section 6.3.

6.5 Nature and contents of container

Single dose ampoule made of low density polyethylene. Each ampoule contains 2 ml of suspension. Strips of five ampoule

units are packed into a foil sachet and sachets are packed into a carton.

Pack sizes:

5, 10, 15, 20, 25, 30, 40, 50 or 60 ampoules for single use only.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Budesonide Nebuliser Suspension can be mixed with 0.9% saline and with solutions of terbutaline, salbutamol, sodium

cromoglicate or ipratropium bromide. The admixture should be used within 30 minutes.

Each ampoule is for single use only. Discard any unused suspension.

The product is sterile until opened.

Any unused product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Teva Pharma B.V.

Swansweg 5

2031GA Haarlem

Netherlands

8 MARKETING AUTHORISATION NUMBER

PA0749/207/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 7

March 2014

Date of last renewal: 4

July 2023

10 DATE OF REVISION OF THE TEXT

February 2020

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