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Active substance(s): BUDESONIDE

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First filling:
Insert the cartridge into
Powder Inhaler with the
dosage counter facing
the mouthpiece (È). Do
not press the dosage
button while inserting
the cartridge.


Remove protective cap and mouthpiece
First remove the protecMouthpiece
tive cap. Then grasp the
mouthpiece and turn it
briefly counter-clockwise
(Ç) until it becomes
loose. Then remove (Å).
Now turn the NOVODispensing slide
LIZER® upside down.
Grasp the loose dispensing slide and move
it forwards (Å) and upwards (Ç). Any remaining powder can be removed 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.

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 (È). 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 (Ì)
and press into position
Turn the inhaler back

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

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 protective cap.

Dosage button


The NOVOLIZER® is now
filled and ready for use.
You can leave the
cartridge in the NOVOLIZER® Dry Powder Inhaler 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 dosage counter. Then a new cartridge has to be inserted. The cartridges may only be used in the
original dry powder inhaler.
Whenever possible, sit
or stand while inhaling.
When using the NOVOLIZER® always keep it
horizontal. First remove
the protective cap (Å).
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 control 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 compliance with the Medizinproduktegesetz (German Law
on Medical Devices)

T5007310_p01.indd 1

Budesonide, the active substance in Budelin
Novolizer 200 micrograms, is a glucocorticoid (corticosteroid) for inhalation.
Budelin Novolizer 200 micrograms is used
for regular treatment of persistent asthma.
Budelin Novolizer 200 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)).

Dispensing slide

Do not use Budelin Novolizer 200 micrograms if you are allergic (hypersensitive ) to
the active substance budesonide or to the
excipient lactose monohydrate (which contains small amounts of milk proteins).
Warnings and precautions
Talk to your doctor or pharmacist before
using Budelin Novolizer 200 micrograms.

• The Patient Information Leaflet describes how
the drug works. Please read it through carefully before using the inhaler for the first time.
• The NOVOLIZER® which comes with various
active substances does not use any propellants and is designed for refilling. This
makes the NOVOLIZER® a very environmentally 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
200 micrograms, if you are suffering from
lung tuberculosis or fungal infection or from
other infection of the airways. This also applies 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 continuous 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 complaints.
If you have a severe liver disease, the elimination 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

Any inhaled glucocorticoids may cause side
effects, particularly 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 aggression (particularly in chil-

After switching to inhalation treatment,
symptoms may occur that had been suppressed by the previous systemic treatment
with glucocorticoids, e.g. symptoms of allergic rhinitis, allergic rash or rheumatic complaints. 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 - symptoms of an insufficient function of the adrenal cortex conflicting with such continuation.
Other medicines and Budelin Novolizer 200
Tell your doctor or pharmacist if you are taking / using or have recently taken / used any
other medicines, including medicines obtained without prescription.
Concomitant use of Budelin Novolizer 200
micrograms and ketoconazole or itraconazole (medicine for treatment of fungal disease) will significantly increase the blood
levels and thus the possible side effects of
Budesonide. Therefore the time interval between administration of ketoconazole or itraconazole and Budesonide should be as long
as possible. Concomitant administration of
Budelin Novolizer 200 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 corticosteroids and enhanced effects of corticosteroids 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 suppressed, an ACTH stimulation test for diagnosing 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 of pharmacist
for advice before taking this medicine.
Results from a large prospective epidemiological study and from world-wide post marketing
experience indicate that inhaled budesonide
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. However, 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 200 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 10:24


What is in this leaflet:
1. What Budelin Novolizer 200 micrograms
is and what it is used for
2. What you need to know before you use
Budelin Novolizer 200 micrograms
3. How to use Budelin Novolizer 200
4. Possible side effects
5. How to store Budelin Novolizer 200
6. Contents of the pack and other information

additional NON PRINTING

Remove the protective
Aluminium foil
aluminium foil from the
cartridge cylinder and
take out the new cartridge. However, this
should only be done just
before using the cartridge. The colour coding on the cartridge must
correspond to the colour of the dosage button.

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

Page 1 of 2
Typopharma # 114517

Powder Inhaler makes
inhaling simple and reliable. Its straightforward
use, fast cartridge replacement 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 (Å) and lift off (Ç).

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 change
back to red, the inhalation should be repeated. If
inhalation is not completed correctly after several
attempts, then you should consult your doctor.

Sec. Edge Marks

Control window

247 x 340 mm

Protective cap


Cartridge cylinder

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

Korrektur notwendig/
correction required

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

dren). Therefore, 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


200 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 / p185


Order File


Dosage counter

Budelin 200

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 required. In general, the lowest effective dose
required for a sufficient control should be
In case of deterioration of symptoms (recognized by e.g. persistent respiratory distress
and increased use of other inhaled bronchodilating 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 200 micrograms needs to be increased.
Should you have the impression that the
effect of Budelin Novolizer 200 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 inhaled bronchodilating agent (beta-2-agonist,
such as Salbutamol) at all times.
When you switch from another Budesonide
inhaler to Budelin Novolizer 200 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 inhalation be performed before meals and/or that

T5007310_p01.indd 2

If you have any further questions on the use
of this product, ask your doctor or pharmacist.
Like all medicines, Budelin Novolizer
200 micrograms can cause side effects,
although 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
Treatment with inhaled Budesonide may result in fungal disease in the mouth and the
throat (oropharyngeale candidiasis). Experience has shown that this fungal infection
occurs less often when inhalation is performed before meals and/or when the
mouth is rinsed or the teeth are brushed after inhalation. In most cases this condition
responds to topical anti-fungal therapy without discontinuing treatment with the Budelin
Novolizer 200 micrograms.
As with other inhalation therapies, in rare
cases bronchial spasm (paradoxical bronchospasm) may occur, manifested by a
temporary exacerbation of the respiratory
distress and a immediate increase in wheezing after dosing. Only in such a case, you
should discontinue use of the Budelin Novolizer 200 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 patients):
Allergic reactions (hypersensitivity) and
swelling of the face, eyes, lips, mouth and
throat (angioneurotic oedema), anaphylactic
reaction; suppression of the function of the

Storage conditions
Store in the original package. This medicinal
product does not require any special temperature storage conditions.
In-Use storage conditions: Keep the
Novolizer device tightly closed, in order
to protect from moisture.
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 10 cartridges
containing 200 single doses each and/or
20 cartridges containing 100 single doses
each can be used with this device (within a
single year) prior to replacement.
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 200 micrograms
The active substance is budesonide.
Each actuation (puff) contains 200 micrograms of budesonide.

Novolizer® Budesonide 200 micrograms inhalation powder
Budesonide Viatris® Novolizer® 200 microgrammi polvere per inalazione
The Netherlands:
Budesonide Novolizer® 200 microgram, inhalatiepoeder
Novopulmon® Novolizer® 200 mikrog/dose
Budesonido Novolizer® 200 microgramas pó
para inalação
Novopulm® Novolizer® 200 microgramos,
polvo para inhalación
Novopulmon® Novolizer® 200 mikrogram/
dos inhalationspulver
United Kingdom:
Budelin® Novolizer® 200 micrograms per actuation inhalation powder
This leaflet was last approved in 04/2014.

The other ingredient is Lactose monohydrate.
What Budelin Novolizer 200 micrograms
looks like and contents of the pack
Budelin Novolizer 200 micrograms, inhalation powder, contains a white powder
(1.09 g or 2.18 g) in a cartridge containing
100 or 200 metered doses packed in a
container sealed by aluminium foil plus a
Novolizer powder inhaler device.
All components are made of plastic materials.
Pack sizes:
Original sales packs:
1 cartridge containing 100/200 metered
doses and 1 Novolizer powder inhaler
2 cartridges containing 200 metered doses
each and 1 Novolizer powder inhaler device
Refill packs:
1 cartridge containing 100 metered doses
(UK and Ireland only)
1 cartridge containing 200 metered doses
2 cartridges containing 200 metered doses


Korrektur notwendig/
correction required

Datum /date: Unterschrift/signature:


additional NON PRINTING

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

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.

Page 2 of 2
Typopharma # 114517

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

If you stop using Budelin Novolizer
200 micrograms
Do not stop treatment with the Budelin
Novolizer 200 micrograms without talking
to your doctor first because this could lead
to an aggravation of the disease.

Keep out of the reach and sight of children.


27.08.14 10:24

Sec. Edge Marks

Children below 6 years of age:
Budelin Novolizer 200 micrograms is not recommended for use in children below age 6
due to insufficient data on safety and efficacy.

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


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 200 Mikrogramm Pulver zur Inhalation
Belgium and Luxembourg:
Novolizer® Budesonide 200 microgrammes,
poudre pour inhalation
Novopulmon® Novolizer® 200 mikrogram/
Novopulmon® Novolizer® 200 mikrog/annos
Novopulmon® Novolizer® 200 microgrammes/dose, poudre pour inhalation
Novopulmon® 200 Novolizer®, Pulver zur Inhalation

247 x 340 mm

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

If you inhale more Budelin Novolizer
200 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 seeking medical advice.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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.

contract manufacturer:

Children aged 6 to 12 years:
Initial recommended
1 single dose
(200 micrograms)
twice or
200 - 400 micrograms
once a day
Maximum recommended dose:
2 single doses
(400 micrograms)
twice daily
(daily dose:
800 micrograms)

Frequency not known (frequency cannot be
estimated from the available data):
Sleeping problems, anxiety or feeling worried, aggression, excessive urge to be active
accompanied by mental restlessness (psychomotor hyperactivity); cataract, glaucoma; 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

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 -2 single doses
(200 - 400 micrograms)
once or twice daily
Maximum recommended dose:
4 single doses
(800 micrograms)
twice daily (daily dose:
1600 micrograms)

If you have used cortisone products for a prolonged period already, you should be
switched to Budelin Novolizer 200 micrograms 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 200
micrograms should be given in addition for
approximately 10 days. Then, depending on
your response, the daily dose of the cortisone tablets can be reduced gradually at
intervals of one to two weeks.

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

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

Meda Manufacturing GmbH, Köln
Fontsize 7,7 / 8,7 pt
technical 6 pt
Used Font Helvetica Neue
black / p185

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

If you have not used glucocorticoids previously or have been treated occasionally
only over a short period with glucocorticoids,
regular use of Budelin Novolizer 200 micrograms as directed should lead to an improvement in breathing after approximately
10 days. However, extreme mucous congestion 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 administration of cortisone products (systemic glucocorticoids) in form of tablets. Later on, the
tablet dose should be reduced gradually but
inhalative therapy will be continued.

Not all pack sizes may be marketed

Order File

Always use Budelin Novolizer 200 micrograms exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.

Duration of treatment
Budelin Novolizer 200 micrograms is intended for long-term therapy. It should be used
regularly according to the recommended
treatment schedule even at times when no
symptoms are experienced.

adrenal cortex (adrenal suppression), growth
retardation in children and adolescents;
restlessnes, nervousness, depression, abnormal 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), redness of the skin by excessively filled blood
vessels (erythema), bruising, disturbance of
voice and hoarse voice (in children).

Budelin 200


the mouth is rinsed with water or the teeth
are brushed after each inhalation.

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

Important information about some of the
ingredients of Budelin Novolizer 200 micrograms:
Budelin Novolizer 200 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 people with lactose intolerance. If you are concerned that you may have an intolerance,
you must talk to your doctor’.
Milk sugar (lactose) contains small amounts
of milk protein.

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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.