Salbutamol Neutec 2.5 mg/2.5 ml nebuliser solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SALBUTAMOL SULFATE

Available from:

Neutec Inhaler Ireland Limited

ATC code:

R03AC02

INN (International Name):

SALBUTAMOL SULFATE

Pharmaceutical form:

Nebuliser solution

Therapeutic area:

salbutamol

Authorization status:

Not marketed

Authorization date:

2023-06-30

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SALBUTAMOL NEUTEC 2.5 MG 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, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Salbutamol Neutec is and what it is used for
2.
What you need to know before you use Salbutamol Neutec
3.
How to use Salbutamol Neutec
4.
Possible side effects
5.
How to store Salbutamol Neutec
6.
Contents of the pack and other information
1.
WHAT SALBUTAMOL NEUTEC IS AND WHAT IT IS USED FOR
Salbutamol Neutec contains a medicine called salbutamol. This belongs
to a group of medicines called
short and 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.
Salbutamol Neutec is used to treat breathing problems in people with
asthma and other lung conditions
that cause narrowing of the airways (such as chronic obstructive
pulmonary disease). They are usually
given to people who suffer seriously from these conditions when other
forms of treatment do not seem
to work. Salbutamol Neutec can be used to treat adults, adolescents
and children, aged 4 to 11 years.
Salbutamol Neutec is provided in a small plastic container that
contains a liquid. 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 SALBUTAMOL NEUTEC
DO NOT USE SALBUTAMOL NEUTEC IF:
•
you are allergic to salbutamol sulphate

Summary of Product characteristics

Health Products Regulatory Authority
22 March 2024
CRN00F26G
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salbutamol Neutec 2.5 mg/2.5 ml nebuliser solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mL single-dose container contains 2.5 mg of salbutamol (as
salbutamol sulphate), which is equivalent to 1 mg of
salbutamol per 1 mL.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution.
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Salbutamol Neutec is indicated in adults, adolescents and children,
aged 4 to 11 years.
Salbutamol Neutec is indicated for symptomatic treatment of acute
reversible airway obstruction in patients with asthma or in
patients with severe chronic obstructive pulmonary disease (COPD) when
the use of a metered dose inhaler or dry powder
inhaler is ineffective or impossible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents aged 12 years and over_
The starting dose of salbutamol by wet inhalation is 2.5 mg. This may
be increased to 5 mg. Treatment may be repeated up to
four times daily. In adult dosing, up to 40 mg per day, can be given
under strict medical supervision in hospital for the
treatment of severe airways obstruction.
_Paediatric population_
For children aged 4 to 11 years: The starting dose of salbutamol by
wet inhalation is 2.5 mg. This may be increased to 5 mg.
Treatment may be repeated up to four times daily.
Other pharmaceutical forms may be more appropriate for administration
in children under 4 years old.
As transient hypoxaemia may occur, supplemental oxygen therapy should
be considered.
_ _
Method of administration
Salbutamol inhaled formulations are administered by the inhaled route
only, to be breathed in through the mouth with a
nebuliser. The solution must not be injected or swallowed.
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Salbutamol Neutec is intended to be used undiluted.
Salbutamol Neutec may be adm