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Remove the protective
Aluminium foil
aluminium foil from the
cartridge cylinder and
take out the new car­
tridge. However, this
should only be done just
before using the car­
tridge. The colour coding on the cartridge must
correspond to the colour of the dosage button.
First filling:
Insert the cartridge into
Powder Inhaler with the
dosage counter facing
the mouthpiece (). Do
not press the dosage
button while inserting
the cartridge.


The NOVOLIZER® Dry Powder Inhaler should be
cleaned at regular intervals, but at least every
time the cartridge is exchanged.

What is in this leaflet:
What Budelin Novolizer 400 micrograms
is and what it is used for
2. What you need to know before you use
Budelin Novolizer 400 micro­grams
How to use Budelin Novolizer 400
4. Possible side effects
How to store Budelin Novolizer 400
6. Contents of the pack and other informa­

Remove protective cap and mouthpiece
First remove the protec­
tive cap. Then grasp the
mouthpiece and turn it
briefly counter-clockwise
() until it becomes
loose. Then remove ().
Now turn the NOVO­
Dispensing slide
LIZER® upside down.
Grasp the loose dis­
pensing slide and move
it forwards () and up­
wards (). Any remain­
ing powder can be re­
moved by tapping lightly.
Clean the mouthpiece, the dispensing slide and
the powder inhaler with a soft and dry lint-free
Do NOT use water or detergent.

Budesonide, the active substance in Budelin
Novolizer 400 micrograms, is a glucocorti­
coid (corticosteroid) for inhalation.
Budelin Novolizer 400 micrograms is used
for regular treatment of persistent asthma.
Budelin Novolizer 400 micrograms should
not be used for treatment of a sudden attack
of respiratory distress (acute asthma attack
or Status asthmaticus (asthma a
­ttacks oc­
curring very frequently and/or persisting for
several days)).

Note: The NOVOLIZER® Dry Powder Inhaler
should be cleaned every time the cartridge is
­exchanged after removal of empty cartridge.
If you have already used the NOVOLIZER® Dry
Powder Inhaler, first remove the empty cartridge
and then insert the new one (). Do not press
the dosage button while inserting the cartridge.

Assembly – Insert dosage slide
After cleaning insert the
dosing slide by sliding
down at an angle ()
and press into position
Turn the inhaler back

Replace the cap into the
side guides from above
() and push down flat
towards the coloured
dosage button until it
snaps into place ().

Assembly – Fit mouthpiece and protective cap
Insert the mouthpiece
with the pin into the
groove on the left and
turn to the right until it
snaps into place. Finish
by replacing the protec­
tive cap.

Do not use Budelin Novolizer 400 micro­
grams if you are allergic (hypersensitive ) to
the active substance budesonide or to the
excipient lactose monohydrate (which con­
tains small amounts of milk proteins).


Warnings and precautions
Talk to your doctor or pharmacist before us­
ing Budelin Novolizer 400 micrograms.



is now
filled and ready for use.
You can leave the
cartridge in the NOVO­
LIZER® Dry Powder In­
haler until it has been
used up or for up to
6 months after in­sertion. The cartridge is used up
if you see a hatched "0" in the middle of the dos­
age counter. Then a new cartridge has to be in­
serted. The cartridges may only be used in the
original dry powder inhaler.
Whenever possible, sit
or stand while inhaling.
When using the NOVO­
LIZER® always keep it
horizontal. First remove
the protective cap ().
Completely depress the
coloured dosage button.
A loud double click will
be heard and the colour
of the control window
will change from red to
green. Then release the
coloured button. The
colour green in the con­
trol window indicates
that the NOVOLIZER®
device is ready for use.

Protective cap

Dosage button

Green colour indicates
ready for use

Control window

Exhale (but not into
Powder Inhaler). Put
your lips tightly around
the mouthpiece, inhale
the powder with a deep
breath and then hold
the breath for a few seconds. During this breath
a loud click should be heard, indicating correct.
Then continue with normal breathing.

Instructions for Use (Gebrauchsanleitung) in com­
pliance with the Medizinproduktegesetz (German Law
on Medical Devices)

T5007311_p01.indd 1

• The Patient Information Leaflet describes how
the drug works. Please read it through care­
fully before using the inhaler for the first time.
• The NOVOLIZER® which comes with various
active substances does not use any pro­
pellants and is designed for refilling. This
makes the NOVOLIZER® a very environmen­
tally friendly product.
• It is not possible to overdose with the
­NOVOLIZER®. Even if the button is pressed
several times, no more powder is available for
inhalation. Only press the button when you
­really want to inhale. If you cannot manage to
inhale correctly after several attempts, consult
your doctor.
• The NOVOLIZER® can be refilled using new
cartridges* containing the active substance
and is thus ideally suited to long-term usage
(up to one year).
• Do not shake the filled NOVOLIZER®.
• Please support your children in proper
­handling of the device.
• Make sure your NOVOLIZER® is protected
from moisture and heat and kept clean at all

Take special care in using Budelin Novolizer
400 micrograms, if you are suffering from
lung tuberculosis or fungal infection or from
other infection of the airways. This also ap­
plies if you have been affected by these
conditions in the past. Ask your doctor for
Budesonide is not suitable for treatment of
acute respiratory distress or severe continu­
ous spasm of the bronchial tubes (Status asthmaticus). Your doctor will advise you to
use a short‑acting inhaled bronchodilating
agent (bronchodilator) as rescue medication
to relieve the acute symptoms of your com­
If you have a severe liver disease, the elimi­
nation of Budesonide may be impaired. This
may lead to increased levels of Budesonide
in your blood.

Regarding corresponding medicines, please
ask your doctor.
MEDA Pharma GmbH & Co. KG
Benzstr. 1
61352 Bad Homburg (Germany)

Last Review April 2014

Dosage button

Dispensing slide

Any inhaled glucocorticoids effects, particu­
larly when using high doses for prolonged
periods. These effects are much less likely
to occur with inhalation treatment than with
the intake of glucocorticoid tablets. Possible
effects include disorders in the function of
the adrenal cortex, Cushing’s syndrome,
Cushingoid features (hormone disorder
caused by high levels of cortisol in the blood
with central obesitiy, ‘moon face’, thinning
of the skin, hypertension, etc.), decrease in
bone density, growth retardation in children
and adolescents as well as eye disease
(cataract and glaucoma), and more rarely, a
range of psychological or behavioural
effects including psychomotor hyperactivity,
sleep disorders, anxiety, depression or

After switching to inhalation treatment,
symptoms may occur that had been sup­
pressed by the previous systemic treatment
with glucocorticoids, e.g. symptoms of aller­
gic rhinitis, allergic rash or rheumatic com­
plaints. These symptoms should be treated
in addition by suitable medication.
Some patients might feel generally unwell in
a non-specific way during the switching period
despite maintenance or even improvement
in respiratory function. In such a case, please,
consult your doctor. He/she will then decide
whether treatment can be continued as
planned or if you have - for instance - symp­
toms of an insufficient function of the adre­
nal cortex conflicting with such continuation.
Other medicines and Budelin Novolizer 400
Tell your doctor or pharmacist if you are tak­
ing / using or have recently taken / used any
other medicines, including medicines ob­
tained without prescription.
Concomitant use of Budelin Novolizer 400
micrograms and ketoconazole or itracon­
azole (medicine for treatment of fungal dis­
ease) will significantly increase the blood
levels and thus the possible side effects of
Budesonide. Therefore the time interval be­
tween administration of ketoconazole or itra­
conazole and Budesonide should be as long
as possible. Concomitant administration of
Budelin Novolizer 400 micrograms the HIV
protease inhibitors nelfinavir and ritonavir
(medicines used to treat patients with HIV
infection) may also lead to increased blood
levels of Budesonide.
Raised plasma concentrations of cortico­
steroids and enhanced effects of cortico­
steroids have been observed in women also
treated with oestrogens and contraceptive
steroids, but no effect has been observed
with budesonide and concomitant intake of
low dose combination oral contraceptives.
Because adrenal function may be sup­
pressed, an ACTH stimulation test for diag­
nosing pituitary insufficiency might show
false results (low values).
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
Results from a large prospective epidemiologi­
cal study and from world-wide post marketing
experience indicate that inhaled bude­
during pregnancy has no adverse effects on
the health of the foetus / new born child.
As with other drugs the administration of
budesonide during pregnancy requires that the
benefits for the mother are weighed against
the risks for the foetus.
Budesonide is excreted in breast milk. How­
ever, at therapeutic doses no effects on the
suckling child are anticipated. Maintenance
treatment with inhaled budesonide (200 or 400
micrograms twice daily) in asthmatic nursing
women results in negligible systemic exposure
to budesonide in breast-fed infants. Therefore,
Budelin Novolizer 400 micrograms can be
used during breast feeding.
Driving and using machines
Budesonide has no influence on the ability to
drive and use machines.

27.08.14 13:34


Powder Inhaler makes
inhaling simple and reli­
able. Its straightforward
use, fast cartridge re­
placement and simple
cleaning are easy and
quickly done.
Place the NOVOLIZER® Dry Powder Inhaler in
front of you. Lightly press together the ribbed
surfaces on both sides of the cap, move the cap
forwards () and lift off ().

Should periods of stress or emergencies
(e.g. severe infections, injuries and surgery)
occur within the first few months of switch­
ing from intake of tablets to inhalation treat­
ment, it may be necessary to resume sys­
temic administration of glucocorticoids in
form of tablets or infusions. This applies also
to patients who have received prolonged
treatment with high doses of inhaled gluco­
corticoids. They may also have impaired
adrenocortical function and may need sys­
temic glucocorticoid cover during periods of
stress and/or for elective surgery.

additional NON PRINTING


Inadvertent overdosing is not possible with the
NOVOLIZER®. The click sound and the change
of the colour in the control window indicate that
inhalation has been performed correctly. If the
­colour of the control window does not back to
red, the inhalation should be repeated. If inhala­
tion is not completed correctly after several
­attempts, then you should consult your doctor.

Page 1 of 2
Typopharma # 114519

Control window

Sec. Edge Marks

Protective cap

247 x 340 mm

Cartridge cylinder

Korrektur notwendig/
correction required

NOTE: The coloured dosage button should only
be pressed immediately before inhalation.

aggression (particularly in children). There­
fore, it is important that the lowest dose is
administered at which effective control of
asthma is maintained.

contract manufacturer:

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.

Datum /date: Unterschrift/signature:

Active Substance: Budesonide


400 micrograms per actuation inhalation powder

1. proof 28.08.2014 mz
2. proof
3. proof
4. proof
5. proof
6. proof

Budelin® Novolizer®

changed back to red, also indicating a correct
inhalation. Replace the protective cap on the
mouthpiece – the inhalation procedure is now
The number in the top window indicates the
number of inhalations left. The numeric scale
200-60 is shown in steps of 20 and 60-0 in steps
of 10.If the click sound and change of the colour
did not appear, please repeat the procedure as
described above.

Meda Manufacturing GmbH, Köln
Fontsize 7,7 / 8,7 pt
technical 6 pt
Used Font Helvetica Neue
black / p490


Order File


Dosage counter

Budelin 400

Check that the colour of the control window has

Material No.
Replaced No.
Code No.
Drawing No.




Older people
Usually, no special dose adjustment is re­
quired. In general, the lowest effective dose
required for a sufficient control should be
In case of deterioration of symptoms (recog­
nized by e.g. persistent respiratory distress
and increased use of other inhaled broncho­
dilating agents) you should seek advice from
a medical doctor as soon as possible. If you
have inhaled only once a day so far, it may
become required in such a case to use the
same dose twice daily now (in the morning
and in the evening). In any case, you doctor
should decide if your usual dose of Budelin
Novolizer 400 micrograms needs to be in­
Should you have the impression that the
effect of Budelin Novolizer 400 micrograms
is either too strong or too weak, discuss this
with your doctor or pharmacist.
For the relief of acute symptoms of asthma,
you should carry along a short acting in­
haled bronchodilating agent (beta-2-agonist,
such as Salbutamol) at all times.
When you switch from another Budesonide
inhaler to Budelin Novolizer 400 micrograms,
the treatment plan may have to be adjusted
by your doctor.
Method of Administration
Inhalation use.
Inhale as shown in the Instructions for Use.
Important information for use
To reduce the risk of fungal infection in
mouth and throat (oral candidiasis) and
hoarseness it is recommended that inhala­
tion be performed before meals and/or that
the mouth is rinsed with water or the teeth
are brushed after each inhalation.

T5007311_p01.indd 2

Like all medicines, Budelin Novolizer
400 micrograms can cause side effects, al­
though not everybody gets them.
Most important side effects
Irritation of the oral mucosa (throat irritation)
accompanied by difficulty in swallowing,
hoarseness and cough may commonly oc­
Treatment with inhaled Budesonide may re­
sult in fungal disease in the mouth and the
throat (oropharyngeale candidiasis). Experi­
ence has shown that this fungal infection
occurs less often when inhalation is per­
formed before meals and/or when the
mouth is rinsed or the teeth are brushed af­
ter inhalation. In most cases this condition
responds to topical anti-fungal therapy with­
out discontinuing treatment with the Budelin
Novolizer 400 micrograms.
As with other inhalation therapies, in rare
cases bronchial spasm (paradoxical bron­
chospasm) may occur, manifested by a
temporary exacerbation of the respiratory
distress and a immediate increase in wheez­
ing after dosing. Only in such a case, you
should discontinue use of the Budelin No­
volizer 400 micrograms without previous
consultation and you must contact your
doctor immediately.
Inhalation of larger doses over a prolonged
period may lead to increased susceptibility
to infection. The ability to adapt to stress
can be impaired.
List of all other side effects
Rare (may affect up to 1 in 1,000 treated pa­
Allergic reactions (hypersensitivity) and
swelling of the face, eyes, lips, mouth and
throat (angioneurotic oedema), anaphylactic
reaction; suppression of the function of the
adrenal cortex (adrenal suppression), growth

Information concerning in-use shelf-life
Exchange the cartridge six months after first
Do not use the powder inhaler for more than
a year.
Note: The Novolizer device has been shown
to function for at least 2000 single doses.
Therefore a maximum of 20 cartridges
containing 100 single doses each and/or
40 cartridges containing 50 single doses
each can be used with this device (within a
single year) prior to replacement.

Novolizer® Budesonide 400 micrograms in­
halation powder
Budesonide Viatris® Novolizer® 400 micro­
grammi polvere per inalazione
The Netherlands:
Budesonide Novolizer® 400 microgram, in­
Budesonido Novolizer® 400 microgramas pó
para inalação
Novopulm® Novolizer® 400 microgramos,
polvo para inhalación
United Kingdom:
Budelin® Novolizer® 400 micrograms per ac­
tuation inhalation powder
This leaflet was last approved in 04/2014.

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
What Budelin Novolizer 400 micrograms
The active substance is budesonide.
Each actuation (puff) contains 400 micro­
grams of budesonide.
The other ingredient is Lactose mono­hydrate.
What Budelin Novolizer 400 micrograms
looks like and contents of the pack
Budelin Novolizer 400 micrograms, inha­
lation powder, contains a white powder
(0.545 g or 1.09 g) in a cartridge containing
50 or 100 metered doses packed in a
container sealed by aluminium foil plus a
Novolizer powder inhaler device.
All components are made of plastic ma­
Pack sizes:
Original sales packs:
1 cartridge containing 50/100 metered
doses and 1 Novolizer powder inhaler
2 cartridges containing 100 metered doses
each and 1 Novolizer powder inhaler device
Refill packs:
1 cartridge containing 50/100 metered
2 cartridges containing 100 metered doses
Not all pack sizes may be marketed


Korrektur notwendig/
correction required

Datum /date: Unterschrift/signature:


additional NON PRINTING

It is recommended that the growth of chil­
dren receiving prolonged treatment with
inhaled glucocorticoids at large doses is
regularly monitored.

If you have any further questions on the­
use of this product, ask your doctor or phar­

Storage conditions
Store in the original package. This medicinal
product does not require any special tem­
perature storage conditions.
In-Use storage conditions: Keep the
Novolizer device tightly closed, in order
to protect from moisture.

Page 2 of 2
Typopharma # 114519

Please support your children in proper
­handling of the Novolizer device.

If you stop using Budelin Novolizer
400 micrograms
Do not stop treatment with the Budelin
Novolizer 400 micrograms without talking
to your doctor first because this could lead
to an aggravation of the disease.

Do not use this medicine after the expiry
date which is stated on the label, the carton
and the cartridge container. The expiry date
refers to the last day of that month.


27.08.14 13:34

Sec. Edge Marks

Children below 6 years of age:
Budelin Novolizer 400 micrograms is not re­
commended for use in children below age 6
due to insufficient data on safety and efficacy.

If you forget to use Budelin Novolizer
400 micrograms
Do not take a double dose to make up for a
forgotten dose.

Keep out of the reach and sight of children.

247 x 340 mm

In case of once daily dosing, it is recom­
mended to take this dose in the evening.

If you inhale more Budelin Novolizer
400 micrograms than you should
It is important that you take your dose as
stated on the pharmacist’s label or as
advised by your doctor. You should not
increase or decrease your dose without see­
king medical advice.


This medicinal product is authorized in the
Member States of the EEC under the
following names:
[Name of Member States]
[Name of the medicinal product]
Novolizer® Budesonid Meda 400 Mikro­
gramm Pulver zur Inhalation
Belgium and Luxembourg:
Novolizer® Budesonide 400 microgrammes,
poudre pour inhalation
Novopulmon® Novolizer® 400 micro­
grammes/dose, poudre pour inhalation
Novopulmon® 400 Novolizer®, Pulver zur In­

contract manufacturer:

Children aged 6 to 12 years:
Initial recommended
1 single dose
(400 micrograms)
once a day
Maximum recom­
mended dose:
1 single dose
(400 micrograms)
twice daily
(daily dose:
800 micrograms)

Reporting of side effects
If you get any side effects, talk to your doc­
tor or pharmacist. This includes any possi­
ble side effects not listed in this leaflet. You
can also report side effects directly via the
Yellow Card Scheme at:
yellowcard. By reporting side effects, you
can help provide more information on the
safety of this medicine.

1. proof 28.08.2014 mz
2. proof
3. proof
4. proof
5. proof
6. proof

Adults (including older people) and
children/adolescents over 12 years of age:
Initial recommended
1 single dose
(400 micrograms)
once or twice daily
Maximum recom­
mended dose:
2 single doses
(800 micrograms)
twice daily (daily dose:
1600 micrograms)

If you have used cortisone products for a pro­
longed period already, you should be
switched to Budelin Novolizer 400 micro­
grams at a time when your symptoms are
completely under control. Normally, function
of the adrenal cortex is suppressed in this
situation and therefore, intake of cortisone
tablets (systemic corticoid administration)
should be reduced gradually and must not
be stopped abruptly. At the beginning of the
switchover period, Budelin Novolizer 400
micrograms should be given in addition for
approximately 10 days. Then, depending on
your response, the daily dose of the corti­
sone tablets can be reduced gradually at
intervals of one to two weeks.

Frequency not known (frequency cannot be
estimated from the available data):
Sleeping problems, anxiety or feeling wor­
ried, aggression, excessive urge to be active
accompanied by mental restlessness (psy­
chomotor hyperactivity); cataract, glauco­
ma; Lactose-monohydrate contains small
amounts of milk proteins and can therefore
cause allergic reactions.

MEDA Manufacturing GmbH
Neurather Ring 1
D-51063 Cologne
Tel: (+49)-221-6472-0
Fax: (+49)-221-6472-696)
MEDA Pharma GmbH & Co. KG
Benzstrasse 1
D-61352 Bad Homburg
VEMEDIA Manufacturing B.V.
Verrijn Stuartweg 60
NL-1112 AX Diemen

Meda Manufacturing GmbH, Köln
Fontsize 7,7 / 8,7 pt
technical 6 pt
Used Font Helvetica Neue
black / p490

Patients without previous treatment with glu­
cocorticoids and patients previously treated
with inhaled glucocorticoids
Unless otherwise prescribed by your doctor,
the following dosage is recommended for:

Very rare (may affect up to 1 in 10,000 treat­
ed patients):
Bone density is decreased

Marketing Authorization Holder
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Bishops Stortford
CM22 6PU

Order File

Always use Budelin Novolizer 400 micro­
grams exactly as your doctor has told you.
You should check with your doctor or phar­
macist if you are not sure.

If you have not used glucocorticoids pre­
viously or have been treated occasionally
only over a short period with glucocorticoids,
regular use of Budelin Novolizer 400 micro­­
grams as directed should lead to an im­
provement in breathing after approximately
10 days. However, extreme mucous con­
gestion and inflammatory processes may
obstruct the bronchial passages to such an
extent that Budesonide cannot fully exert its
effects in the lung. In such cases, initiation of
therapy should be supplemented with admini­
stration of cortisone products (systemic glu­
cocorticoids) in form of tablets. Later on, the
tablet dose should be reduced gradually but
inhalative therapy will be continued.

retardation in children and adolescents;
restlessnes, nervousness, depression, ab­
normal behaviour, over-excited or irritable
(these effects are more likely to occur in
children); skin reactions such as nettle rash
(urticaria), eczema, topical inflammation of
the skin (dermatitis), itching (pruritus), red­
ness of the skin by excessively filled blood
vessels (erythema), bruising, disturbance of
voice and hoarse voice (in children).

Budelin 400


Duration of treatment
Budelin Novolizer 400 micrograms is inten­
ded for long-term therapy. It should be used
regularly according to the recommended
treatment schedule even at times when no
symptoms are experienced.

Material No.
Replaced No.
Code No.
Drawing No.

Important information about some of the
ingredients of Budelin Novolizer 400 micro­
Budelin Novolizer 400 micrograms contains
milk sugar (lactose), 10.7 mg of lactose
monohydrate/delivered dose.
Normally, the content of lactose in a single
dose does not cause any problems in peo­
ple with lactose intolerance. If you are con­
cerned that you may have an intolerance,
you must talk to your doctor’.
Milk sugar (lactose) contains small amounts
of milk protein.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.