Novolizer Budesonide 400 micrograms inhalation powder

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Budesonide

Available from:

Mylan IRE Healthcare Limited

ATC code:

R03BA; R03BA02

INN (International Name):

Budesonide

Dosage:

400 microgram(s)

Pharmaceutical form:

Powder for Inhalation

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Glucocorticoids; budesonide

Authorization status:

Not marketed

Authorization date:

2005-12-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NOVOLIZER BUDESONIDE®
400 MICROGRAMS INHALATION POWDER
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 symptoms 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 Novolizer Budesonide 400 micrograms is and what it is used for
2. What you need to know before you use Novolizer Budesonide 400
micrograms
3. How to use Novolizer Budesonide 400 micrograms
4. Possible side effects
5. How to store Novolizer Budesonide 400 micrograms
6. Contents of the pack and other information
1. WHAT NOVOLIZER BUDESONIDE 400 MICROGRAMS IS AND WHAT IT IS USED FOR
Budesonide, the active substance in Novolizer Budesonide 400
micrograms, is a glucocorticoid
(corticosteroid) for inhalation.
Novolizer Budesonide 400 micrograms is used for regular treatment of
persistent asthma.
NOTE:
Novolizer Budesonide 400 micrograms should not be used for treatment
of a sudden attack of respiratory
distress (acute asthma attack or Status asthmaticus (asthma attacks
occurring very frequently and/or
persisting for several days)).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NOVOLIZER BUDESONIDE 400
MICROGRAMS
DO NOT USE NOVOLIZER BUDESONIDE 400 MICROGRAMS
if you are allergic to budesonide or to milk proteins,
that are contained in small amounts in the excipient lactose
monohydrate.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Novolizer Budesonide.
Contact your doctor if you
experience blurred vision or other visual disturbances.
TAKE SPECIAL CARE IN USING NOVOLIZER BUDESONIDE 400 MICROGRAMS
, if you are suffering from lung
t

Summary of Product characteristics

Health Products Regulatory Authority
26 November 2020
CRN00C1X4
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Novolizer Budesonide 400 micrograms inhalation powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Budesonide
One delivered dose contains 400 micrograms of budesonide.
Excipient with known effect:
10.5 mg of lactose monohydrate/delivered dose
The delivered dose is the dose which is available for the patient
after passing the mouthpiece.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Inhalation powder.
White powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Regular treatment of persistent asthma.
Note: budesonide is not intended to be used as a reliever of acute
asthma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
If a patient is switched to Novolizer Budesonide 400 micrograms from
an alternative inhalation device the dose should be
reviewed and adjusted, as necessary, on an individual basis. The
active substance, dose regimen and method of delivery should
be considered.
Steroid naive patients and patients previously controlled on inhaled
steroids:
Adults (including older people) and children/adolescents over 12 years
of age:
Initial recommended dose: 200- 400 micrograms once or twice daily
Maximum recommended dose: 800 micrograms twice daily
Children 6 - 12 years:
Initial recommended dose: 200 micrograms twice or 200 –400
micrograms once daily
Maximum recommended dose: 400 micrograms twice daily
Children below 6 years of age:
Novolizer Budesonide 400 micrograms is not recommended for use in
children below age 6 due to insufficient data on safety
and efficacy.
Note: For the 200 micrograms doses a 200 micrograms strength is
available.
Health Products Regulatory Authority
26 November 2020
CRN00C1X4
Page 2 of 10
The dose should be adapted to the requirements of each individual, the
severity of the disease and the clinical response of the
patient. The dose should be adjusted until control is achieved and
then should be t