Brodilaten 1.25 mg/2.5 ml Nebuliser solution

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
SALBUTAMOL SULFATE
Available from:
Noridem Enterprises Ltd
ATC code:
R03AC; R03AC02
INN (International Name):
SALBUTAMOL SULFATE
Dosage:
1.25/2.5 milligram(s)/millilitre
Pharmaceutical form:
Nebuliser solution
Therapeutic area:
Selective beta-2-adrenoreceptor agonists; salbutamol
Authorization number:
PA1122/024/001
Authorization date:
2019-09-13

Package leaflet: Information for the user

Brodilaten 1.25 mg / 2.5 mL

Nebuliser solution

Brodilaten 2.5 mg / 2.5 mL

Nebuliser solution

Brodilaten 5.0 mg / 2.5 mL

Nebuliser solution

Salbutamol

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, nurse 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, nurse or pharmacist. This

includes any possible side effects not

listed in this leaflet. See section 4.

The name of your medicine is the

following:

Brodilaten 1.25 mg / 2.5 mL Nebuliser

solution

Brodilaten 2.5 mg / 2.5 mL Nebuliser

solution

Brodilaten 5.0 mg / 2.5 mL Nebuliser

solution

In the rest of this leaflet your medicine is

called Brodilaten.

What is in this leaflet

What Brodilaten is and what it is used for

What you need to know before you use

Brodilaten

How to use Brodilaten

Possible side effects

How to store Brodilaten

Contents of the pack and other

information

1.

What Brodilaten is and what it is used

for

Brodilaten contains a medicine called

salbutamol. This belongs to a group of

medicines called fast-acting bronchodilators.

Bronchodilators help the airways in your

lungs to stay open. This makes it easier

for air to get in and out.

They help to relieve chest tightness,

wheezing and cough.

Brodilaten 1.25 mg/2.5 mL: This low dose

is adapted for use in children and infants

only to treat severe asthma attacks, where

inhalation of high doses of salbutamol

is required. Brodilaten is used to treat

breathing problems in people with asthma

and other chest illnesses. It is usually given

to people who suffer quite badly from these

conditions. Brodilaten is also given to treat

severe attacks of asthma.Brodilaten is a

liquid contained in an ampoule. The liquid is

put into a machine called a nebuliser. This

machine makes a fine mist for you to breathe

in through a face mask.

2.

What you need to know before you

use Brodilaten

Do not use Brodilaten:

if you are allergic to salbutamol sulfate

or any of the other ingredients of this

medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, nurse or pharmacist

before using Brodilaten if:

your asthma is active (for example you

have frequent symptoms or flare ups

or limited physical ability). Your doctor

may start or increase a medicine to

control your asthma such as an inhaled

corticosteroid.

you have high blood pressure.

you are diabetic.

you have an overactive thyroid gland.

you have a history of heart problems

such as an irregular or fast heartbeat or

angina.

you use another nebuliser solution such

as ipratropium bromide, make sure the

mist does not get in your eyes. This can

be prevented by using a mouthpiece

instead of a face mask or goggles.

you are taking xanthine derivatives

(such as theophylline) or steroids to treat

asthma.

you are taking water tablets (diuretics),

sometimes used to treat high blood

pressure or a heart condition.

if you have taken other drugs used to

relieve stuffy nose (such as ephedrine

or pseudoephedrine) or other medicines

used to treat asthma.

A condition known as lactic acidosis has

been reported in association with high

therapeutic doses of salbutamol, mainly

in patients being treated for an acute

bronchospasm (see Section 3 and 4).

Increase in lactate levels may lead to

shortness of breath and hyperventilation

even though there may be improvement in

your wheezing. If you feel that your medicine

is not working as well as usual and you need

to use the nebuliser more than your doctor

has recommended, immediately talk to a

doctor.

Other medicines and Brodilaten

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.

In particular tell your doctor, nurse or

pharmacist if you are taking:

medicines for an irregular or fast

heartbeat.

other medicines for your asthma.

Remember to take this medicine with you if

you go to hospital.

Brodilaten with food and drink

You can use Brodilaten at any time of day,

with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think

you may be pregnant or are planning to have

a baby, ask your doctor, nurse or pharmacist

for advice before using this medicine.

Driving and using machines

Brodilaten is not likely to affect you being

able to drive or use any tools or machines.

You should not drive or use machinery while

using the nebuliser as this makes the mist

for you to inhale.

3.

How to use Brodilaten

Always use this medicine exactly as your

doctor has told you. Check with your doctor,

nurse or pharmacist if you are not sure.

Using this medicine

do not inject or swallow the liquid.

Brodilaten should only be inhaled using

your nebuliser

do not let the liquid, or the mist

produced by the nebuliser get into

your eyes. You can wear glasses or

goggles to protect them.

your doctor, nurse or pharmacist should

show you how to use your medicine.

each small plastic container (ampoule)

contains some liquid.

the liquid is put into a nebuliser. This

makes a fine mist for you to breathe in

through a face mask or mouthpiece.

use your nebuliser in a well-ventilated

room as some of the mist will be

released into the air and may be

breathed in by others.

Adults, adolescents aged 12 years and

over and children 4 to 11 years of age

The usual starting dose is 2.5 mg up to

four times daily. Increased to 5 mg up to

four times daily if required.

Brodilaten 1.25 mg/2.5 mL: This low-dose

presentation is not suitable for treating

adults, but is suitable for children and

infants.

Infants and children: 50 to 150 micrograms

of salbutamol / kg (i.e. 0.1 to 0.3 mL/kg

of Brodilaten 1.25 mg in nebulized form)

without generally exceeding 5 mg of

salbutamol in nebulised form for toddlers

over 18 months up to 2 years old (i.e. four

single doses of Brodilaten 1.25 mg or one

single dose of Brodilaten 5.0 mg in nebulised

form) and 2.5 mg of salbutamol for infants

and toddlers under 18 months (i.e. two single

doses of Brodilaten 1.25 mg or one single

dose of Brodilaten 2.5 mg in nebulised form).

Using your ampoules

Your ampoules are overwrapped in a

non-transparent protective pouch. Do not

open the protective pouch until you need

to use them.

Open the protective pouch. Hold the strip

of ampoules in one hand, with your other

hand hold the last ampoule in the row.

Twist the ampoule downwards and away

from you.

Return the remaining ampoules to the

protective pouch. Write the discard date,

in the space provided on the pouch as a

reminder. The discard date is 3 months

from the date you opened the protective

pouch. Return the opened pouch to the

box.

Hold the top of the ampoule you have

just removed. Open the ampoule.

Put the open end of the ampoule into

the nebuliser bowl and squeeze slowly.

Make sure that all the contents are

emptied into the nebuliser.

Assemble the nebuliser and use it as

directed.

Diluting your ampoules

do not dilute the contents of an

ampoule unless you are told to by

your doctor.

if your doctor has told you to dilute the

solution, empty the contents of the

ampoule into the nebuliser bowl.

add the amount of sterile normal saline

your doctor has told you to use.

put the top on the nebuliser bowl and

shake gently to mix the contents.

If dilution is necessary then only sterile

normal saline should be used.

After use

use a new ampoule for each dose. Only

open a new one when you are ready

to use it. If there is any liquid left over,

throw it away.

Do not save it to use again.

throw away any solution remaining in the

nebuliser bowl.

clean your nebuliser in the

recommended way.

If you use more Brodilaten than you

should

If you use more medicine than you should,

talk to a doctor as soon as possible.

The following effects may happen:

your heart is beating faster than usual

you feel shaky

hyperactivity

These effects usually wear off in a few hours.

If you forget to use Brodilaten

If you forget a dose, take it as soon as

you remember it.

Arial 9 pt - 140 x 415 mm

However, if it is time for the next dose,

skip the missed dose.

Do not take a double dose to make up

for a forgotten dose.

If you stop using Brodilaten

Do not stop using Brodilaten without talking

to your doctor.

If you think this medicine is not working

well enough for you

If your medicine does not seem to be

working as well as usual, talk to your doctor

as soon as possible. Your chest problem

may be getting worse and you may need

a different medicine. Do not take extra

Brodilaten unless your doctor tells you to.

If you have any further questions on the use

of this medicine, ask your doctor, nurse or

pharmacist.

4.

Possible side effects

If your breathing or wheezing gets worse

straight after taking this medicine, stop

using it immediately, and tell your doctor

as soon as possible.

Like all medicines, this medicine can cause

side effects, although not everybody gets

them. The following side effects may happen

with this medicine:

Allergic reactions (may affect up to 1 in

10,000 people)

If you have an allergic reaction, stop taking

Brodilaten and see a doctor straight away.

Signs of an allergic reaction include: swelling

of the face, lips, mouth, tongue or throat

which may cause difficulty in swallowing or

breathing, itchy rash, feeling faint and light

headed, and collapse.

Talk to your doctor as soon as possible if:

you feel your heart is beating faster or

stronger than usual (palpitations). This is

usually harmless, and usually stops after

you have used the medicine for a while.

you may feel your heartbeat is uneven or

it gives an extra beat.

These side effects may affect up to 1 in

10 people. If any of these happen to you, talk

to your doctor as soon as possible.

Do not stop using this medicine unless

told to do so.

Tell your doctor if you have any of the

following side effects which may also happen

with this medicine:

Common (may affect up to 1 in 10 people)

feeling shaky

headache

Uncommon (may affect up to 1 in

100 people)

mouth and throat irritation

muscle cramps

Rare (may affect up to 1 in 1,000 people)

a low level of potassium in your blood

increased blood flow to your extremities

(peripheral dilatation)

Very rare (may affect up to 1 in

10,000 people)

changes in sleep patterns and changes

in behavior, such as restlessness and

excitability

The following side effects can also

happen but the frequency of these are not

known:

chest pain, due to heart problems such

as angina. Tell your doctor, nurse or

pharmacist if this occurs. Do not stop

using this medicine unless told to do so

a condition known as lactic acidosis

which may cause stomach pain,

hyperventilation, shortness of breath

even though there may be improvement

in your wheezing, cold feet and hands,

irregular heartbeat or thirst

Additional side effects in children and

adolescents

In addition, very rare adverse events of

psychiatric / behavioral disorders regarding

nervousness and agitation, as well as

pruritus have been reported 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

For UK: Yellow Card Scheme, Website:

www.mhra.gov.uk/yellowcard or search for

MHRA Yellow Card in the Google Play or

Apple App Store.

For IE: HPRA Pharmacovigilance,

Earlsfort Terrace, IRL - Dublin 2,

Tel: +353 10 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 Brodilaten

Keep this medicine out of the sight and

reach of children. Store below 25°C.

Store the ampoules in the outer carton and

pouch, in order to protect from light.

When you open the protective pouch:

note the date of opening.

add 3 months to this date. This will be

the ‘discard after’ date.

write the ‘discard after’ date in the space

provided on the pouch

do not use any unused ampoules

remaining from that pouch after the

‘discard after’ date, return them to your

pharmacist for destruction.

if the pouch has not been opened, do

not use Brodilaten after the expiry date,

which is stated on the carton, labels and

pouch after ‘EXP’. The expiry date refers

to the last day of that month.

if you are told to stop taking this

medicine return any unused Brodilaten to

your pharmacist to be destroyed.

Discard any partly used opened or damaged

single dose containers.

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 Brodilaten contains

1.25 mg / 2.5 mL: The active substance

is salbutamol sulfate. Each 2.5 mL

ampoule contains 1.25 mg of salbutamol

(as salbutamol sulfate).

2.5 mg / 2.5 mL: The active substance

is salbutamol sulfate. Each 2.5 mL

ampoule contains 2.5 mg of salbutamol

(as salbutamol sulfate).

5.0 mg / 2.5 mL: The active substance

is salbutamol sulfate. Each 2.5 mL

ampoule contains 5 mg of salbutamol (as

salbutamol sulfate).

The other ingredients are sodium

chloride, water for injections and sulfuric

acid (for pH adjustment).

What Brodilaten looks like and contents

of the pack

Brodilaten 1.25 mg / 2.5 mL Nebuliser

solution is packed in strips of 5 overwrapped

in non-transparent aluminium protective

pouch. Each carton contains 10, 20, 30, 50

or 60 ampoules.

Brodilaten 2.5 mg / 2.5 mL Nebuliser solution

is packed in strips of 5 overwrapped in non-

transparent aluminium protective pouch.

Each carton contains 10, 20, 30, 50 or

60 ampoules.

Brodilaten 5.0 mg / 2.5 mL Nebuliser solution

is packed in strips of 5 overwrapped in non-

transparent aluminium protective pouch.

Each carton contains 10, 20, 30, 50 or

60 ampoules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and

Manufacturer

Marketing Authorisation Holder: Noridem

Enterprises Limited, Evagorou & Makariou,

Mitsi Building 3, Office 115, 1065 Nicosia,

Cyprus.

Manufacturer: DEMO S.A.

PHARMACEUTICAL INDUSTRY,

km National Road Athens-Lamia, 14568

Krioneri, Attiki, Greece, T: +30 210 8161802,

F: +30 210 8161587.

This medicinal product is authorised in

the Member States of the EEA under the

following names:

United Kingdom: Brodilaten 1.25 mg / 2.5 mL

Nebuliser solution

Brodilaten 2.5 mg / 2.5 mL

Nebuliser solution

Brodilaten 5.0 mg / 2.5 mL

Nebuliser solution

Greece:

Brodilaten 1,25 mg / 2,5 mL

Διάλυμα για εισπνοή με

εκνεφωτή

Brodilaten 2,5 mg / 2,5 mL

Διάλυμα για εισπνοή με

εκνεφωτή

Brodilaten 5,0 mg / 2,5 mL

Διάλυμα για εισπνοή με

εκνεφωτή

Germany:

Salbutamol Noridem 1,25 mg

Lösung für einen Vernebler

Salbutamol Noridem 2,5 mg

Lösung für einen Vernebler

Salbutamol Noridem 5 mg

Lösung für einen Vernebler

Ireland:

Brodilaten 1.25 mg / 2.5 mL

Nebuliser solution

Brodilaten 2.5 mg / 2.5 mL

Nebuliser solution

Brodilaten 5.0 mg / 2.5 mL

Nebuliser solution

France:

SALBUTAMOL NORIDEM

1,25 mg / 2,5 mL Solution

pour inhalation par nébuliseur

SALBUTAMOL NORIDEM

2,5 mg / 2,5 mL Solution

pour inhalation par nébuliseur

SALBUTAMOL NORIDEM

5,0 mg / 2,5 mL Solution

pour inhalation par nébuliseur

This leaflet was last revised in 01/2019.

If this leaflet is difficult to

see or read please contact

the following address for

help: Athlone Laboratories,

Ballymurray, Co. Roscommon,

Ireland, Tel +353-9066-61109,

Email medical@athlone-

laboratories.com.

Health Products Regulatory Authority

16 September 2019

CRN008LHM

Page 1 of 7

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Brodilaten 1.25 mg/2.5 ml Nebuliser solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

2.5 mL of nebuliser solution contain 1.25 mg salbutamol (as salbutamol sulfate).

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Nebuliser solution.

Clear and colourless solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Symptomatic treatmentof acute severe asthma in children and infants.

Note: Acute severe asthma requires hospital treatment in the intensive care unit.

4.2 Posology and method of administration

Posology

Paediatric Population(under 12 years):

This low-dose presentation is not suitable for treating adults, but is suitable for children and infants.

Infants:

For infants and toddlers under 18 months: 50 to 150 microg of salbutamol / kg (i.e. 0.1 to 0.3 mL/kg of Brodilaten 1.25 mg in

nebulised form) without generally exceeding 2.5 mg of salbutamol (i.e. two single doses of Brodilaten 1.25 mg or one single

dose of Brodilaten 2.5 mg in nebulised form).

For toddlers over 18 months up to 2 years old: 50 to 150 microg of salbutamol / kg (i.e. 0.1 to 0.3 mL/kg of Brodilaten 1.25 mg

in nebulized form) without generally exceeding 5 mg (i.e. four single doses of Brodilaten 1.25 mg or one single dose of

Brodilaten5 mg in nebulised form).

Children:

For children aged 2 – 4 years: 50 to 150 microg of salbutamol / kg (i.e. 0.1 to 0.3 mL/kg of Brodilaten 1.25 mg in nebulized

form) without generally exceeding 5 mg (i.e. four single doses of Brodilaten 1.25 mg or one single dose of Brodilaten 5 mg in

nebulised form).

For children aged 4 – 11 years: 2.5 mg to 5 mg salbutamol up to four times a day.

The duration of action of the bronchiodilatory effect of inhaled salbutamol is between four and six hours.

Under medical supervision, the nebulisation may be repeated every 20 to 30 minutes depending on the clinical result and

tolerance of the treatment, without generally exceeding four nebulisations per day.

The clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient hypoxaemia may occur,

supplemental oxygen therapy should be considered.

Brodilaten is intended to be used undiluted. However, if prolonged delivery time (more than 10 minutes) is required, the

solution may be diluted with sterile normal saline to a 1:1 dilution.

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16 September 2019

CRN008LHM

Page 2 of 7

Method of administration

Brodilaten is for inhalation use only, to be breathed in through the mouth, under the direction of a physician, using a suitable

nebuliser.

The solution should not be injected or swallowed.

For single use only. Use immediately after first opening the single-dose container. Any solution remaining in the nebuliser

after nebulisation should be discarded.

Brodilaten may be administered from a suitable nebuliser, e.g. PARI LC SPRINT nebuliser, after the single dose ampoule has

been opened and its contents transferred to the nebuliser chamber. For full instructions on the use of the nebuliser the patient

should be instructed to read the leaflet of the respective device carefully before starting the inhalation.

Active substance delivery characteristics were studied in vitro using the PARI JuniorBoy SX compressor with LC SPRINT junior

familie nebuliser device (for infants) and PARI TurboBoy SX compressor with LC SPRINT junior familie nebuliser device (for

children) with the following settings:

Salbutamol

Droplet size

distribution

(micrometer)

Active substances

delivery rate

(micrograms/min)

Total active

substances

delivered

(micrograms/2.5

Settings

Infants

Children

Infants

Children

1.25mg /

2.5mL

0.24

2.60

7.39

52.6

87.0

236.7

300.6

Min / Max

Flow:

6.0 L

Min / Max

Operating

Pressure:

The delivered dose of Brodilaten may vary depending on the nebuliser system used. Τhe use of an alternative nebuliser

system(s) may alter the pulmonary deposition of the active substance, this in

turn may alter the efficacy and safety of the product and dose adjustment may then become necessary.

The nebulised solution may be inhaled through a face mask, T-piece or via an endotracheal tube. Intermittent positive pressure

ventilation (IPPV) may be used but is rarely necessary. When there is a risk of anoxia through hypoventilation, oxygen should

be added to the inspired air.

As many nebulisers operate on a continuous flow basis, it is likely that some nebulised drug will be released into the local

environment. Brodilaten should therefore be administered in a well-ventilated room, particularly in hospitals when several

patients may be using nebulisers at the same time.

Dilution: Brodilaten may be diluted with sterile normal saline. Solutions in nebulisers should be replaced daily.

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

Brodilaten must only be used by inhalation, to be breathed in through the mouth, and must not be injected or swallowed.

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Page 3 of 7

Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires

regular medical assessment, including lung-function testing, as patients are at risk of severe attacks and even death. Physicians

should consider using the maximum recommended dose of inhaled corticosteroid and/or oral corticosteroid therapy in these

patients.

Patients receiving treatment at home should seek medical advice if treatment with Brodilaten becomes less effective. The

dosage or frequency of administration should only be increased on medical advice.

Patients being treated with Brodilaten may also be receiving other dosage forms of short-acting inhaled bronchodilators to

relieve symptoms. Increasing use of bronchodilators, in particular short-acting inhaled β

agonists to relieve symptoms,

indicates deterioration of asthma control. The patient should be instructed to seek medical advice if short-acting relief

bronchodilator treatment becomes less effective or more inhalations than usual are required. In this situation patients should

be assessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled

corticosteroid or a course of oral corticosteroid).

Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.

Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from

post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol. Patients

with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving

salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart

disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either

respiratory or cardiac origin.

Sportsmen should be warned that this drug contains an active substance, which may induce a positive result in anti-doping

controls.

Brodilaten should be used with care in patients known to have received large doses of other sympathomimetic drugs.

Potentially serious hypokalaemia may result from β

2

agonist therapy, mainly from parenteral and nebulised administration.

Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment

with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations.

In common with other βadrenoceptor agonists, salbutamol can induce reversible metabolic changes such as increased blood

glucose levels. Diabetic patients may be unable to compensate for the increase in blood glucose and the development of

ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.

Lactic acidosis has been reported in association with high therapeutic doses of intravenous and nebulised short-acting βagonist

therapy, mainly in patients being treated for an acute exacerbation of bronchospasm in severe asthma or chronic obstructive

pulmonary disease (see Section 4.8 and 4.9). Increase in lactate levels may lead to dyspnoea and compensatory

hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification

of short-actingβagonist treatment. It is therefore recommended that patients are monitored for the development of elevated

serum lactate and consequent metabolic acidosis in this setting.

A small number of cases of acute angle-closure glaucoma have been reported in patients treated with a combination of

nebulised salbutamol and ipratropium bromide. A combination of nebulised salbutamol with nebulised anticholinergics should

therefore be used cautiously. Patients should receive adequate instruction in correct administration and be warned not to let

the solution or mist enter the eye.

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness

of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting bronchodilator and therefore should be treated

with an alternative presentation or a different rapid acting inhaled bronchodilator and should be treated straightaway.

Brodilaten should be discontinued immediately, the patient assessed and alternative therapy instituted, if necessary. For

on-going use a different rapid-acting may be required.

4.5 Interaction with other medicinal products and other forms of interactions

Salbutamol and non-selective βblocking drugs such as propranolol, should not usually be prescribed together.

Health Products Regulatory Authority

16 September 2019

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Page 4 of 7

4.6 Fertility, pregnancy and lactation

Pregnancy

Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any

possible risk to the fetus. As with the majority of drugs, there is little published evidence of the safety of salbutamol in the early

stages of human pregnancy, but in animal studies there was evidence of some harmful effects on the fetus at very high dose

levels.

Breast-feeding

As salbutamol is probably secreted in breast milk, its use in nursing mothers requires careful consideration. It is not known

whether salbutamol has a harmful effect on the neonate, and so its use should be restricted to situations where it is felt that

the expected benefit to the mother is likely to outweigh any potential risk to the neonate.

Fertility

There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in animals

(see section 5.3).

4.7 Effects on ability to drive and use machines

Brodilaten has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10),

common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000). Very

common and common events were generally determined from clinical trial data. Rare, very rare and unknown events were

generally determined from spontaneous data.

System Organ Class

Frequency

Adverse Drug Reaction

Immune system disorders

Very rare

Hypersensitivity reactions including angioedema, urticaria,

bronchospasm, hypotension and collapse

Metabolism and nutrition disorders

Rare

Hypokalaemia.

Potentially serious hypokalaemia may result from β

2

agonist

therapy

Unknown

Lactic acidosis (see section 4.4)

Nervous system disorders

Common

Tremor, headache

Very rare

Hyperactivity

Cardiac disorders

Common

Tachycardia

Uncommon

Palpitations

Very rare

Cardiac arrhythmias including atrial fibrillation,

supraventricular tachycardia and extrasystoles

Unknown

Myocardial ischaemia* (see section 4.4)

Vascular disorders

Rare

Peripheral vasodilatation

Respiratory, thoracic and mediastinal disorders

Very rare

Paradoxical bronchospasm

Gastrointestinal disorders

Uncommon

Mouth and throat irritation

Musculoskeletal and connective tissue disorders

Uncommon

Muscle spasm

* reported spontaneously in post-marketing data therefore frequency regarded as unknown.

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness

of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting bronchodilator and therefore should be treated

with an alternative presentation or a different rapid-acting inhaled bronchodilator and should be treated straightaway.

Brodilaten should be discontinued immediately, the patient assessed and alternative therapy instituted, if necessary. For

on-going use a different rapid-acting may be required.

Paediatric population

In addition, very rare adverse events of psychiatric / behavioral disorders regarding nervousness and agitation, as well as

pruritus have been reported in paediatric population.

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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

The most common signs and symptoms of overdose with salbutamol are transient βagonist pharmacologically mediated

events, including tachycardia, tremor, hyperactivity and metabolic effects including hypokalaemia and lactic acidosis (see

sections 4.4 and 4.8). Any effects of overdosage are therefore likely to be related to the salbutamol component. Manifestations

of overdosage with salbutamol may include nausea, vomiting and hyperglycemia, particularly in children and when overdose is

due to oral salbutamol.

Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored. Metabolic

acidosis has also been observed with overdosage of salbutamol, including lactic acidosis which has been reported in

association with high therapeutic doses as well as overdoses of short-acting βagonist therapy, therefore monitoring for

elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea

despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Andrenergics, inhalants. Selective β

2

andrenoreceptoragonists

ATC code: R03AC02

Salbutamol is a selective β

2

agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in

reversible airways obstruction. At therapeutic doses it acts on the β

2

adrenoceptors of bronchial muscle. With its fast onset of

action, it is particularly suitable for the management and prevention of asthma attacks.

5.2 Pharmacokinetic properties

Salbutamol administered intravenously has a half-life of 4 to 6 hours and is cleared partly renally, and partly by metabolism to

the inactive 4'-O-sulfate (phenolic sulfate) which is also excreted primarily in the urine. The faeces are a minor route of

excretion. Most of a dose of salbutamol given intravenously, orally or by inhalation is excreted within 72 hours. Salbutamol is

bound to plasma proteins to the extent of 10%.

After administration by the inhaled route between 10 and 20% of the dose reaches the lower airways. The remainder is

retained in the delivery system or is deposited in the oropharynx from where it is swallowed. The fraction deposited in the

airways is absorbed into the pulmonary tissues and circulation, but is not metabolised by the lung. On reaching the systemic

circulation it becomes accessible to hepatic metabolism and is excreted, primarily in the urine, as unchanged drug and as the

phenolic sulfate.

The swallowed portion of an inhaled dose is absorbed from the gastrointestinal tract and undergoes considerable first-pass

metabolism to the phenolic sulfate. Both unchanged drug and conjugate are excreted primarily in the urine.

5.3 Preclinical safety data

Non-clinical data reveal no special safety concerns for humans based on conventional studies of safety pharmacology,

repeated dose toxicity, genotoxicity and carcinogenicity. Effects seen in repeat dose toxicity studies were related to the

βadrenergic activity of salbutamol.

In mice dosed subcutaneously in the range 0.025-2.5 mg/kg, cleft palate formation occurred in 4.5% and 9.3% of foetuses at

0.25 and 2.5 mg/kg, respectively (approximately 1/10 and 1.0 times the maximum recommended daily inhalation dose clinically

on a mg/m

basis). A reproduction study in rabbits revealed cranioschisis in 37% of foetuses administered salbutamol orally at

50 mg/kg (approximately 80 times the clinical dose on the basis given above).

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In an oral fertility and general reproductive performance study in rats at doses of 2 and 50 mg/kg/day, with the exception of a

reduction in number of weanlings surviving to day 21 post partum at 50 mg/kg/day, there were no adverse effects on fertility,

embryofetal development, litter size, birth weight or growth rate.

High doses of βadrenoceptor agonists have been shown to induce mesovarian leiomyomas in rats. No such findings have been

found in humans.

Findings concerning teratogenicity in rabbits at high systemic dosage exposure and the induction of benign mesovarian

leiomyomas in rats are not considered of clinical concern.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium chloride

Water for injections

Sulfuric acid (for pH adjustment)

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years if unopened.

3 months after opening the overwrap protective pouch (see below).

6.4 Special precautions for storage

Store below 25°C.

Store the ampoules in the original outer carton and pouch, in order to protect from light.

The ampoules should be protected from light after opening the overwrap protective pouch.

6.5 Nature and contents of container

Brodilaten are supplied as packs of 10, 20, 30, 50 or 60 of low density polyethylene ampoules overwrapped in non-transparent

protective aluminium pouches and packed in carton boxes. Each ampoule contains 2.5 mL of solution.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Partly used, opened or damaged single-dose containers should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Noridem Enterprises Ltd

Evagorou & Makariou

Mitsi Building 3, Office 115

1065 Nicosia

Cyprus

8 MARKETING AUTHORISATION NUMBER

PA1122/024/001

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9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 13

September 2019

10 DATE OF REVISION OF THE TEXT

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