BUDESONIDE TEVA PHARMA 0.25 mg/2ml Nebuliser Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BUDESONIDE

Available from:

Teva Pharma B.V.

ATC code:

R03BA02

INN (International Name):

BUDESONIDE

Dosage:

0.25 mg/2ml

Pharmaceutical form:

Nebuliser Suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Glucocorticoids

Authorization status:

Authorised

Authorization date:

2014-03-07

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BUDESONIDE TEVA PHARMA 0.25 MG/2 ML NEBULISER SUSPENSION
BUDESONIDE TEVA PHARMA 0.5 MG/2 ML NEBULISER SUSPENSION
BUDESONIDE TEVA PHARMA 1 MG/2 ML NEBULISER SUSPENSION
BUDESONIDE
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 PHARMA NEBULISER SUSPENSION IS AND WHAT IT IS
USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BUDESONIDE TEVA PHARMA NEBULISER
SUSPENSION
3.
HOW TO USE BUDESONIDE TEVA PHARMA NEBULISER SUSPENSION
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE BUDESONIDE TEVA PHARMA NEBULISER SUSPENSION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT BUDESONIDE TEVA PHARMA 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 PHARMA NEBULISER
SUSPENSION
DO NOT USE BUDESONIDE TEVA PHARMA NEBULISER SUSPENSION
-
if you are allergic to budesonide or any of the other ingredients of
thi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Budesonide Teva Pharma 0.25 mg/2 ml Nebuliser Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule of 2 ml suspension contains 0.25 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.
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