INSTRUCTIONS FOR USE¹ Novolizer®

1. PREPARATION:

The NOVOLIZER® Dry 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 (^) and lift off (4¹).

#

#

Remove the protective 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.

First filling:

Insert the cartridge into the NOVOLIZER^® Dry Powder Inhaler with the dosage counter facing the mouthpiece (^). Do not press the dosage button while inserting the cartridge.

Refilling:

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.

Check that the colour of the control window has changed back to red, also indicating a correct inhalation. Replace the protective cap on the mouthpiece - the inhalation procedure is now complete.

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.

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

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.

3. CLEANING:

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

Remove protective cap and mouthpiece First remove the protective cap. Then grasp the mouthpiece and turn it briefly counter-clockwise (4") until it becomes loose. Then remove (^).

Cleaning

Now turn the NOVO-LIZER^® upside down.

Grasp the loose dispensing slide and move it forwards (^) and upwards (4¹). 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 cloth.

Do NOT use water or detergent.

Assembly - Insert dosage slide After cleaning insert the dosing slide by sliding down at an angle (^l) and press into position

W.

Turn the inhaler back over.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Budelin® Novolizer®

o

CO

r-

o

o

lO

200 micrograms per actuation inhalation powder

Active Substance: 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.

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

The NOVOLIZER® is now filled and ready for use.

You can leave the cartridge in the NOVO-LIZER® 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.

2. USAGE:

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 control window indicates that the NOVOLIZER^® device is ready for use.

Exhale (but not into the NOVOLIZER^® Dry 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.

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.

Notes

•    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 times.

•    Regarding corresponding medicines, please ask your doctor.

MEDA Pharma GmbH & Co. KG Benzstr. 1

61352 Bad Homburg (Germany)

(€

Last Review April 2014

¹ Instructions for Use (Gebrauchsanleitung) in compliance with the Medizinproduktegesetz (German Law on Medical Devices)

o

CO

I^s

o

o

LO

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 micrograms

4.    Possible side effects

5.    How to store Budelin Novolizer 200 micrograms

6.    Contents of the pack and other information

1.    WHAT BUDELIN NOVOLIZER 200 MICROGRAMS IS AND WHAT IT IS USED FOR

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.

NOTE:

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)).

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE BUDELIN NOVOLIZER 200 MICROGRAMS

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.

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 advice.

Budesonide is not suitable for treatment of acute respiratory distress or severe continuous spasm of the bronchial tubes (Status as-thmaticus). 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.

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-

dren). Therefore, it is important that the lowest dose is administered at which effective control of asthma is maintained.

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.

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 micrograms

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.

Pregnancy

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.

Breast-feeding

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.

0/

D

fT3

C

o>

‘l/l

_c

u

l/l

a}

c

aj

fT3

~o

£

qj

up

<D

qj

_Q

fO

Q)

‘<D

□

, c

3 •.£ tj a/ qj

□

re

£

qj

U)

aJ

£

qj

CO

N

E

r—

O

<N

00

O

c

<u

3

<U

Z

Q- ro

iv .y

co %

^ +■» — IV Q.

N VO I

QJ

LZ

-§ <L>

<y "2

S O

£

o    o    o    o    o

2    2    2    2    2

Cl Cl Cl Cl Cl

r—    cn    ro    'vf    lo

a

u

J2

-Q

cc

Q.

z

o

ft!

cn

3

O

2

zs

+->

u

E

45

D

C

ft!

U

E

o    ^

°    O    «    §

C    ro    VO    ^M

IV

=8= CM A3

QJ O CD Q_

of

(X3

C

'i/i

u

<D

c

D

<U

rtS

~o

E

QJ

i/i

<V

<v

_Q

fO

'<y

□

I ^-=5

ib cr

o

E <=

3 O

□

rtS

E

0J

U)

(V

E

<v

CD

N

E

v—

o

<N

oo    <2

©    £

00    ro

<N

O O O O O O

o o o o o o

Q_ Q_ Q_ Q_ Q_ Q_

<— CN CO LO VO

03

—    4->

3

U

IV

r—

LO

=#: <N $2

QJ

lZ

3 ~o

s 6

D

C

03

E

u

CD O Ui Q_

E

E

o