Budesonide Teva Pharma Nebulise Solution 1mg/2ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BUDESONIDE

Available from:

Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC code:

R03BA02

INN (International Name):

BUDESONIDE 1 mg

Pharmaceutical form:

NEBULISER SUSPENSION

Composition:

BUDESONIDE 1 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Withdrawn

Authorization date:

2013-10-31

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

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
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
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Budesonide Teva Pharma 0.25 mg/2ml Nebuliser Suspension:
One ampoule of 2 ml suspension contains 0.25 mg budesonide.
Budesonide Teva Pharma 0.5 mg/2 ml Nebuliser Suspension:
One ampoule of 2 ml suspension contains 0.5 mg budesonide.
Budesonide Teva Pharma 1 mg/2 ml Nebuliser Suspension:
One ampoule of 2 ml suspension contains 1 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.
Page 2 of 14
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 increa