BUDESONIDE 200 MCG Inhalation powder

Зміст інструкції

1. Budesonide Viatris
2. Budesonide
   1. What is Budesonide Viatris, Novolizer 200 micrograms and what is it used for
   2. What you need to know before using Budesonide Viatris, Novolizer 200 micrograms
   3. How to use Budesonide Viatris, Novolizer 200 micrograms
   4. Possible side effects
   5. How to store Budesonide Viatris, Novolizer 200 micrograms
   6. Contents of the pack and other information
3. Budesonide Viatris
4. Budesonide
   1. What is Budesonide Viatris, Novolizer 400 micrograms and what is it used for
   2. What you need to know before using Budesonide Viatris, Novolizer 400 micrograms
   3. How to use Budesonide Viatris, Novolizer 400 micrograms
   4. Possible side effects
   5. How to store Budesonide Viatris, Novolizer 400 micrograms
   6. Contents of the pack and other information

Budesonide Viatris

Novolizer 200 micrograms powder for inhalation
Generic medicine

Budesonide

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Budesonide Viatris, Novolizer 200 micrograms is and what it is used for
• 2. What you need to know before you use Budesonide Viatris, Novolizer 200 micrograms
• 3. How to use Budesonide Viatris, Novolizer 200 micrograms
• 4. Possible side effects
• 5. How to store Budesonide Viatris, Novolizer 200 micrograms
• 6. Contents of the pack and other information

1. What is Budesonide Viatris, Novolizer 200 micrograms and what is it used for

Budesonide, the active ingredient contained in Budesonide Viatris, Novolizer 200 micrograms, is an
glucocorticoid (cortisone) for inhalation.
Budesonide Viatris, Novolizer 200 micrograms is used for the treatment of persistent asthma.

NOTE:
Budesonide Viatris, Novolizer 200 micrograms should not be used for the treatment of a sudden attack of a respiratory disorder (acute asthma attack or Status asthmaticus (an asthma attack that
occurs frequently and/or lasts for several days))

2. What you need to know before using Budesonide Viatris, Novolizer 200 micrograms

Do not use Budesonide Viatris, Novolizer 200 microgramsif you are allergic to budesonide or to the
milk proteins that are contained in small quantities in the excipient lactose monohydrate (listed in
section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Budesonide Viatris, Novolizer 200 micrograms.
Contact your doctor if you experience blurred vision or other visual disturbances.
For those who engage in sports: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive doping test.

Take special care with Budesonide Viatris, Novolizer 200 micrograms
If you suffer from pulmonary tuberculosis or fungal infections or other infections of the airways. This also
applies if you have had these diseases in the past. Ask your doctor for advice.
Budesonide is not suitable for the treatment of acute respiratory diseases or intense continuous spasms of the
bronchi (asthmatic status). Your doctor will be able to advise you on the use of short-acting bronchodilators for
inhalation (bronchodilators) as a remedy for these symptoms.
If you have a severe liver disease, the elimination of Budesonide may be impaired.
This can lead to an increase in Budesonide levels in the blood.
Any inhaled glucocorticoid can cause undesirable effects, particularly if used at high
doses for prolonged periods. These effects are less likely to occur with inhalation therapy than with the administration of glucocorticoids in tablets. Possible effects include disorders
of adrenal cortex function, Cushing's syndrome, Cushingoid appearance (hormonal disorder caused by high levels of cortisol in the blood with central obesity, “moon face”,
thinning of the skin, hypertension, etc.), decreased bone density, growth retardation
in children and adolescents, eye disorders (cataract and glaucoma) and more rarely a series of
psychological or behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety,
depression or aggression (particularly in children). For this reason, it is very important to use the
lowest dose capable of ensuring effective asthma control.
In the event that periods of stress or emergencies (e.g., severe infections, wounds and surgery) occur
within the first few months of switching from tablet intake to inhalation therapy, it may be necessary to continue systemic administration of glucocorticoids in the form of
tablets or injections. This also applies to patients who have received prolonged
treatment with high doses of inhaled glucocorticoids. They may have adrenal insufficiency and may
require systemic glucocorticoid coverage during periods of stress and/or for
elective surgery.
After switching to inhalation therapy, symptoms that had been suppressed with the
previous systemic glucocorticoid therapy may occur, for example symptoms of allergic rhinitis,
allergic skin rashes or rheumatic pains. These symptoms should be treated with
adequate additional pharmacological therapy.
Some patients may experience a general feeling of unwellness in a non-specific manner during the
transition period, despite improvement or maintenance of respiratory function. In this case, please consult your doctor, who will decide whether the treatment can be continued as planned or
if you have, for example, symptoms of reduced adrenal cortex function incompatible with
continued therapy.

Other medicines and Budesonide Viatris, Novolizer 200 micrograms
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
Some medicines can increase the effects of Budesonide Viatris, Novolizer 200 micrograms and the
doctor may want to monitor you closely if you are taking these medicines (including
some medicines for the treatment of HIV: nelfinavir, ritonavir, cobicistat and medicines for the
treatment of fungal infections: ketoconazole, itraconazole). Therefore, this combination should
be avoided. If this is not possible, the time interval between the administration of these
medicines and budesonide should be as long as possible.
In women treated also with estrogens and steroid contraceptives, an increase in plasma levels and a potentiation of the effects of corticoids has been observed, however these effects have not occurred in
cases of simultaneous administration of budesonide and low-dose oral contraceptives.
Since adrenal function may be suppressed, an ACTH stimulation test for the diagnosis
of pituitary insufficiency may give false results (low values).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Most results from prospective epidemiological studies and post-marketing data from
around the world have not shown an increased risk of adverse effects for fetuses and newborns of
mothers who have used budesonide by inhalation during pregnancy. It is important for both
the fetus and the mother that adequate asthma treatment is maintained during pregnancy.
As with other drugs administered during pregnancy, the benefit of administering budesonide to the mother must be weighed against the risks to the fetus.
Breastfeeding
Budesonide is excreted in breast milk. However, at therapeutic doses, no adverse effects on the infant are expected.
Maintenance therapy with inhaled budesonide (200 or 400
micrograms twice daily) in asthmatic women who are breastfeeding has led to negligible systemic exposure to budesonide in breastfed infants. Therefore, Budesonide Viatris, Novolizer
200 micrograms can be used during breastfeeding.

Driving and using machines
Budesonide does not affect the ability to drive vehicles or operate machinery.

Budesonide Viatris, Novolizer 200 micrograms contains a milk sugar (lactose),
10.7 mg of lactose monohydrate per inhaled dose.
Normally, the lactose content in a single dose does not cause any problems in people
affected by lactose intolerance. If you are intolerant, you should speak to your doctor.
The milk sugar (lactose) contains small amounts of milk proteins.

3. How to use Budesonide Viatris, Novolizer 200 micrograms

Use this medicine following the doctor's instructions exactly at all times.
If you have any doubts, consult your doctor or pharmacist.
Patients without previous treatment with glucocorticoids and patients previously treated with
glucocorticoids via inhalation.
Unless otherwise prescribed by your doctor, the following dosage is recommended for:

Adults (including the elderly) and children / adolescents over 12 years of age:
Recommended initial dose: 1-2 single doses (200-400 micrograms) one or two times a
day.
Maximum recommended dose: 4 single doses (800 micrograms) twice a day (daily dose:
1600 micrograms).

Children from 6 to 12 years:
Recommended initial dose: 1 single dose (200 micrograms) twice a day or 200

• 400 micrograms once a day.

Maximum recommended dose: 2 single doses (400 micrograms) twice a day (daily dose:
800 micrograms).
If administered once a day, it is advisable to take this dose in the evening.

Children under 6 years of age:
Budesonide Viatris 200 micrograms is not recommended in children under 6 years of age due to
insufficient safety and efficacy data.
Please help your children to use the Novolizer device correctly.

Children
It is recommended to regularly monitor the growth of children undergoing prolonged treatment with
inhaled glucocorticoids at high doses.

Elderly
Usually, no particular dosage adjustment is required. In general, the minimum effective dose necessary for
adequate control should be used.
In case of worsening of symptoms (recognised, for example, by persistent difficulty breathing and
increased use of other bronchodilator drugs via inhalation), you should consult your
doctor as soon as possible. If you have so far performed only one inhalation a day, it may be
necessary to inhale the same dose twice a day (in the morning and in the evening). In any case, your doctor
will decide whether your usual dose of Budesonide Viatris, Novolizer 200 micrograms needs to be
increased.
If you feel that the effect of Budesonide Viatris, Novolizer 200 micrograms is too
strong or too weak, talk to your doctor or pharmacist.
For the relief of acute asthma symptoms, you should always have with you short-acting bronchodilators for
inhalation (beta-2-agonists, such as salbutamol).
When switching from another inhaled Budesonide to Budesonide Viatris, Novolizer 200
micrograms, the treatment plan may need to be adjusted by your doctor.

Method of administration
For inhalation use.
Inhale as indicated in the instructions for use.

Important information for use
To reduce the risk of fungal infections in the mouth or throat (oral candidiasis) and hoarseness, it is recommended to
inhale before meals and/or rinse your mouth with water or brush your teeth after each
inhalation.

Duration of treatment
Budesonide Viatris, Novolizer 200 micrograms is indicated for long-term therapy. It must be
used regularly according to the recommended dosage scheme, even when no symptoms of asthma are present.
If you have not previously used glucocorticoids or have been treated only occasionally for a short
period with glucocorticoids, regular use of Budesonide Viatris, Novolizer 200 micrograms as
prescribed should lead to an improvement in breathing after about 10 days. However,
extreme congestion of the mucous membranes and inflammatory processes may obstruct the bronchial
passage to the point of preventing Budesonide from fully exerting its effects at the
pulmonary level. In such cases, therapy should initially be accompanied by the administration of
corticosteroid products (systemic glucocorticoids) in tablet form. Subsequently, the dose of
tablets should be gradually reduced while inhalational therapy continues.
If you have already used corticosteroid products for a prolonged period, you should switch to Budesonide Viatris,
Novolizer 200 micrograms when the symptoms are completely under control. Normally, in
this situation the function of the adrenal cortex is reduced and, therefore, the intake of
cortisone tablets (systemic corticosteroid administration) must be reduced
gradually and must not be stopped abruptly. At the beginning of the replacement therapy period, Budesonide Viatris, Novolizer 200 micrograms must be administered in addition to
the tablets for about 10 days. Then, depending on the response, the daily dose of cortisone tablets can be reduced gradually at intervals of 1-2 weeks.

If you inhale more Budesonide Viatris, Novolizer 200 micrograms than you should
It is important that you take the dose, as indicated on the medicine instructions or as recommended by
your doctor. Do not increase or decrease the dose without consulting your doctor.

If you forget to use Budesonide Viatris, Novolizer 200 micrograms
Do not take a double dose to make up for the missed dose.

If you stop using Budesonide Viatris, Novolizer 200 micrograms
Do not stop treatment with Budesonide Viatris, Novolizer 200 micrograms without consulting
your doctor, as this could lead to a worsening of the disease.
If you have any doubts about the use of this product, please contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Main side effects
Commonly, irritation of the oral mucosa (sore throat) accompanied by difficulty swallowing, hoarseness and cough may occur.
Treatment with Budesonide via inhalation may cause fungal infections in the mouth and throat (oropharyngeal candidiasis). Experience has shown that these fungal infections occur less frequently when inhalation is performed before meals and/or when the mouth is rinsed or teeth are brushed immediately after inhalation. In most cases, these infections respond to topical antifungal therapy without discontinuing treatment with Budesonide Viatris, Novolizer 200 micrograms.
As with other inhalation therapies, in rare cases, bronchospasm (paradoxical bronchospasm) may occur, which manifests as a temporary immediate increase in shortness of breath after administration. In this case only, you should stop using Budesonide Viatris, Novolizer 200 micrograms without prior consultation with your doctor and should still contact him immediately.
Inhalation of higher doses for a prolonged period may lead to increased susceptibility to infections. The ability to adapt to stress may be impaired.

List of all other side effects
Uncommon (may affect up to 1 in 100 people):
Depression, anxiety or worry, cataract, muscle spasms, tremor (shaking), blurred vision
Rare (may affect up to 1 in 1,000):
Allergic reactions (hypersensitivity) and swelling of the face, eyes, lips, mouth and throat (angioedema), anaphylactic reactions, suppression of the function of the adrenal cortex (adrenal suppression), growth retardation in children and adolescents;
restlessness, nervousness, abnormal behaviour, hyperactivity or irritability (these effects are more likely to occur in children); skin reactions such as hives (urticaria), eczema, topical skin inflammation (dermatitis), itching (pruritus), skin redness due to excessive filling of blood vessels (erythema), bruising, voice disorders and hoarseness (in children).
Very rare (may affect up to 1 in 10,000):
Decreased bone density.
Frequency not known (the frequency cannot be estimated from the available data):
Sleep problems, aggressiveness, excessive desire to be active accompanied by mental restlessness (psychomotor hyperactivity), glaucoma.
Lactose monohydrate contains small amounts of milk proteins and may therefore cause allergic reactions.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Budesonide Viatris, Novolizer 200 micrograms

Keep this medicine out of the sight and reach of children.
Do not use Budesonide Viatris, Novolizer 200 micrograms after the expiry date which is reported
on the label, the outer packaging and the cartridge container. The expiry date refers
to the last day of the month.

Storage conditions
Store in the original packaging. This medicine does not require any particular storage
conditions regarding temperature.
Storage conditions after opening: Keep the Novolizer device tightly closed, in order to
protect it from humidity.

Information regarding expiry after opening
Change the cartridge after six months from first opening. Do not use the powder inhaler for more than one year.
Note: The Novolizer device has been shown to function for at least 2000 single doses. Therefore, it can
be used with this device in one year before replacement a maximum of 10 cartridges
each containing 200 single doses and/or 20 cartridges each containing 100 single doses.
Do not dispose of any medicine in wastewater and household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Budesonide Viatris, Novolizer 200 micrograms contains

• The active ingredient is budesonide. Each actuation (puff) contains 200 micrograms of budesonide.
• The other ingredient is lactose monohydrate.

Appearance of Budesonide Viatris, Novolizer 200 micrograms and contents of the pack
Budesonide Viatris, Novolizer 200 micrograms, powder for inhalation, contains a white powder
(1.09 g or 2.18 g) in a cartridge containing 100 or 200 metered doses, inside a container
sealed with aluminum foil, as well as a Novolizer device for inhaling the powder.
All components are made of plastic materials.

Packs:
Sales packs:
1 cartridge containing 100/200 metered doses and 1 Novolizer device for inhaling the powder
2 cartridges containing 200 metered doses each and 1 Novolizer device for inhaling the powder.
Refills:
1 cartridge containing 200 metered doses
2 cartridges each containing 200 metered doses
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Healthcare Limited,
Damastown Industrial Park,
Mulhuddart, Dublin 15,
Dublin, Ireland

Manufacturer
McDermott Laboratories T/A Mylan Dublin Respiratory
Unit 25 Baldoyle Industrial Estate
Grange Road, Baldoyle
Dublin 13
Ireland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria:
Novolizer Budesonid Meda 200 Mikrogramm Pulver zur Inhalation
Belgium and Luxembourg:
Novolizer Budesonide 200 microgrammes, poudre pour inhalation
Finland:
Novopulmon Novolizer 200 mikrog/annos inhalaatiojauhe
France:
Novopulmon Novolizer 200 microgrammes/dose, poudre pour inhalation
Germany:
Novopulmon 200 Novolizer, Pulver zur Inhalation
Ireland:
Novolizer Budesonide 200 micrograms inhalation powder
United Kingdom (Northern Ireland):
Budelin Novolizer 200 micrograms, per actuation inhalation powder
Italy:
Budesonide Viatris Novolizer 200 microgrammi powder for inhalation
Netherlands:
Budesonid Novolizer 200 microgram, inhalatiepoeder
Portugal:
Budesonido Novolizer 200 microgramas pó para inalação
Spain:
Novopulm Novolizer 200 microgramos, polvo para inhalación
Sweden:
Novopulmon Novolizer 200 mikrogram/dos inhalationspulver

Instructions for use of Novolizer

• 1. PREPARATION: The Novolizer powder inhaler makes inhalation simple and reliable. Use, cartridge replacement and cleaning are simple and quick operations.

Position Novolizer in front of you. Apply slight simultaneous pressure on the knurled surfaces
on both sides of the cover, push it forward (←) and lift it up (↑).

Remove the aluminum protective foil from the cartridge container and remove the new
cartridge. However, this operation should only be performed immediately before using the cartridge. The
color code of the cartridge must match the color of the dosing button.

First filling:
Insert the cartridge into the Novolizer with the dose counter facing the mouthpiece (↓) Do not
press the dosing button while inserting the cartridge.

Refilling:
Note: The Novolizer must be cleaned each time the cartridge is changed after removing the
empty cartridge.
If you have already used the Novolizer device, first remove the empty cartridge and then insert
the new one (↓), do not press the dosing button while inserting the cartridge.
Replace the cover in its rails starting from the top (↓) pushing down on the colored button until
it clicks back into place (→).

The Novolizer is now filled and ready for use.

You can leave the cartridge in the Novolizer until the cartridge is exhausted or for a maximum of 6
months after insertion. The cartridge is finished if you see a “0” in the center of the dose counter. A new cartridge must then be inserted. Cartridges can only be used
in the original Novolizer inhaler.

• 2. USE: If possible, remain seated or standing during inhalation. When using the Novolizer, always keep it in a horizontal position. First remove the protective cap (←).

Press the colored dosing button firmly. You should hear a loud double click and the color of the
control window should change from red to green. Then, you can release the colored button. The green color in the
control window indicates that the Novolizer device is ready for use.

Exhale (but not into the Novolizer device). Put your lips tightly around the mouthpiece, inhale the
powder steadily, deeply and as quickly as possible (at maximum inhalation) and then
hold your breath for a few seconds. During this breath you should feel a distinct click, indicating
correct inhalation. Then continue with normal breathing.

Check that the color of the control window has changed back to red, this indicates a
correct inhalation. Replace the protective cap on the mouthpiece - the inhalation procedure is now
complete.
The number in the window at the top indicates the number of inhalations remaining.
The numerical scale 200 (respectively 100)-60 shows steps of 20 that 60 (respectively 50)-0
steps of 10.
If you do not hear the click sound and the color does not change, repeat the
procedure as described above.
NOTE: The colored dosing button should only be pressed immediately before inhalation. With
the Novolizer it is not possible to accidentally perform a double inhalation. The click and the color change
in the control window indicate that the inhalation has been performed correctly. If the
color in the control window does not change, the inhalation should be repeated. If the inhalation is not
completed correctly after several attempts, consult your doctor.

• 3. CLEANING:

The Novolizer powder inhaler must be cleaned at regular intervals, but at least every time the
cartridge is replaced.
Remove the protective cap and the mouthpiece
First remove the protective cap. Then grasp the mouthpiece and twist it slightly in
a counterclockwise direction (↑) until it loosens. Then remove it (←).

Cleaning
Turn the NOVOLIZER upside down. Grasp the cover along the sliding rails and move it forward (←)
and upwards (↑). Dust residues can be removed by tapping lightly.

Clean the mouthpiece, the cartridge compartment and the powder inhaler with a soft
lint-free dry cloth.
Do not use water or detergents.
Assembly – inserting the cover
After cleaning, insert the cover by sliding it up to the corner (↘) and pressing on this
position (↓).
Return the inhaler to its original position.

Assembly – Positioning the mouthpiece and protective cap
Insert the mouthpiece with the pin into the groove on the left and turn to the right until it clicks into place. Finish by repositioning the protective cap.

Note
the inhaler for the first time.

• The NOVOLIZER contains various active substances, does not use any propellants and is intended for reuse. This makes NOVOLIZER an extremely environmentally friendly product.
• It is not possible to overdose with NOVOLIZER. Even if the button is pressed several times, no additional dose of inhalation powder is available. Press the button only when you want to inhale. If you are unable to inhale correctly after several attempts, consult your doctor.
• The NOVOLIZER can be refilled using new cartridges* containing the active ingredient, and is thus suitable for long-term use (up to one year).
• Do not shake the filled NOVOLIZER.
• Help your children use the device correctly.
• Make sure that the NOVOLIZER is protected from moisture and heat and is always kept clean.

* Regarding the corresponding drugs, ask your doctor.
Viatris Healthcare Limited,
Damastown Industrial Park,
Mulhuddart, Dublin 15,
Dublin, Ireland
CE

Budesonide Viatris

Novolizer 400 micrograms powder for inhalation
Generic medicine

Budesonide

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Budesonide Viatris, Novolizer 400 micrograms is and what it is used for
• 2. What you need to know before you use Budesonide Viatris, Novolizer 400 micrograms
• 3. How to use Budesonide Viatris, Novolizer 400 micrograms
• 4. Possible side effects
• 5. How to store Budesonide Viatris, Novolizer 400 micrograms
• 6. Contents of the pack and other information.

1. What is Budesonide Viatris, Novolizer 400 micrograms and what is it used for

Budesonide, the active substance contained in Budesonide Viatris, Novolizer 400 micrograms, is an
glucocorticoid (cortisone) for inhalation.
Budesonide Viatris, Novolizer 400 micrograms is used for the treatment of persistent asthma.

NOTE:
Budesonide Viatris, Novolizer 400 micrograms should not be used for the treatment of a sudden
attack of a respiratory disorder (acute asthma attack or Status asthmaticus (an asthma attack that
occurs frequently and/or lasts for several days))

2. What you need to know before using Budesonide Viatris, Novolizer 400 micrograms

Do not use Budesonide Viatris, Novolizer 400 microgramsif you are allergic to budesonide or to the
milk proteins that are contained in small quantities in the excipient lactose monohydrate (listed
in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Budesonide Viatris, Novolizer 400 micrograms.
Contact your doctor if you experience blurred vision or other visual disturbances.
For those who engage in sports: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive doping test.

Take special care with Budesonide Viatris, Novolizer 400 micrograms
If you suffer from pulmonary tuberculosis or fungal infections or other infections of the airways. This also
applies if you have suffered from these diseases in the past. Ask your doctor for advice.
Budesonide is not suitable for the treatment of acute respiratory diseases or continuous intense spasms of the
bronchi (asthmatic status). Your doctor will be able to advise you on the use of short-acting bronchodilators for inhalation as a remedy for these symptoms.
If you have a severe liver disease, the elimination of Budesonide may be compromised.
This can lead to an increase in Budesonide levels in the blood.
Any inhaled glucocorticoid can cause undesirable effects, particularly if used at high
doses for prolonged periods. These effects are less likely to occur with inhalation treatment than with the administration of glucocorticoids in tablets. Possible effects include disorders
of adrenal cortex function, Cushing's syndrome, Cushingoid appearance (hormonal disorder caused by high levels of cortisol in the blood with central obesity, “moon face”,
thinning of the skin, hypertension, etc.), decreased bone density, growth retardation
in children and adolescents, eye disorders (cataract and glaucoma), and more rarely a series of
psychological or behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety,
depression or aggression (particularly in children). For this reason, it is very important to use the
lowest dose capable of ensuring effective asthma control.
In the event that periods of stress or emergencies (e.g., severe infections, wounds and surgery) occur
within the first few months of switching from taking tablets to inhalation treatment, it may be necessary to continue systemic administration of glucocorticoids in the form
of tablets or injections. This also applies to patients who have received prolonged treatment with high doses of glucocorticoids by inhalation. They may have adrenal insufficiency and systemic coverage with glucocorticoid may be necessary during periods of
stress and/or for elective surgery.
After switching to inhaled treatments, symptoms that had been suppressed with the
previous systemic glucocorticoid therapy may occur, for example, symptoms of allergic rhinitis,
allergic skin rashes or rheumatic pains. These symptoms should be treated with appropriate
additional pharmacological therapy.
Some patients may experience a general feeling of unwellness in a non-specific manner during the transition period, despite improvement or maintenance of respiratory function. In this case, please consult your doctor, who will decide whether the treatment can be continued as planned or
if you have - for example - symptoms of reduced adrenal cortex function incompatible
with continuing therapy.

Other medicines and Budesonide Viatris, Novolizer 400 micrograms
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
Some medicines can increase the effects of Budesonide Viatris, Novolizer 400 micrograms and the
doctor may want to monitor you closely if you are taking these medicines (including
some medicines for the treatment of HIV: nelfinavir, ritonavir, cobicistat and medicines for the
treatment of fungal infections: ketoconazole, itraconazole). Therefore, this combination should
be avoided. If this is not possible, the time interval between the administration of these
medicines and budesonide should be as long as possible.
In women treated with estrogens and steroid contraceptives, increased plasma levels and potentiation of the effects of corticosteroids have been observed, however these effects have not occurred in
cases of concomitant administration of budesonide and low-dose oral contraceptives.
Since adrenal function may be suppressed, an ACTH stimulation test for the diagnosis
of pituitary insufficiency may give false results (low values).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Most results from prospective epidemiological studies and post-marketing data from
around the world have not shown an increased risk of side effects for fetuses and newborns of
mothers who have used budesonide by inhalation during pregnancy. It is important for both
the fetus and the mother that adequate asthma treatment is maintained during pregnancy.
As with other drugs administered during pregnancy, the benefit of administering budesonide to the mother must be weighed against the risks to the fetus.
Breastfeeding
Budesonide is excreted in breast milk. However, no adverse effects on the infant are expected
at therapeutic doses. Maintenance therapy with budesonide by inhalation (200 or 400
micrograms twice daily) in asthmatic women who are breastfeeding has led to negligible systemic exposure to budesonide in breastfed infants. Therefore, Budesonide Viatris,
Novolizer 400 micrograms can be used during breastfeeding.

Driving and using machines
Budesonide has no influence on the ability to drive vehicles or operate machinery.

Budesonide Viatris, Novolizer 400 micrograms contains a milk sugar (lactose),
10.5 mg of lactose monohydrate per inhaled dose.
Normally, the lactose content in a single dose does not cause any problems in people
affected by lactose intolerance. If you are intolerant, you should talk to your doctor. The milk sugar (lactose) contains small amounts of milk proteins.

3. How to use Budesonide Viatris, Novolizer 400 micrograms

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor or pharmacist.
Patients without previous treatment with glucocorticoids and patients previously treated with
glucocorticoids via inhalation
Unless otherwise prescribed by your doctor, the following dosage is recommended for:

Adults (including the elderly) and children / adolescents over 12 years of age:
Recommended initial dose: 1 single dose (400 micrograms) one or two times a day
Recommended maximum dose: 2 single doses (800 micrograms) two times a day (daily dose
1600 micrograms)

Children from 6 to 12 years:
Recommended initial dose: 1 single dose (400 micrograms) once a day
Recommended maximum dose: 1 single dose (400 micrograms) two times a day (daily dose
800 micrograms)
If administered once a day, it is recommended to take this dose in the evening.

Children under 6 years of age:
Budesonide Viatris Novolizer 400 micrograms is not recommended in children under 6
years of age due to insufficient safety and efficacy data.
Please help your children use the Novolizer device correctly.

Children
It is recommended to regularly monitor the growth of children undergoing prolonged treatment with
inhaled glucocorticoids at high doses.

Elderly
Usually, no particular dosage adjustment is required. In general, the minimum effective dose necessary for adequate control should be used.
If symptoms worsen (recognised, for example, by persistent difficulty breathing and
increased use of other bronchodilator medications via inhalation), you should consult your
doctor as soon as possible. If you have so far performed only one inhalation a day, it may be
necessary to inhale the same dose twice a day (in the morning and evening). In any case, your doctor
will decide whether your usual dose of Budesonide Viatris, Novolizer 400 micrograms needs to be
increased.
If you feel that the effect of Budesonide Viatris, Novolizer 400 micrograms is too
strong or too weak, talk to your doctor or pharmacist.
For the relief of acute asthma symptoms, you should always have with you short-acting bronchodilators for inhalation (beta-2-agonists, such as salbutamol). When
switching from another inhaled Budesonide to Budesonide Viatris 400 micrograms, the treatment plan may need to be adjusted by your doctor.

Method of administration
For inhalation use.
Inhale as indicated in the instructions for use.

Important information for use
To reduce the risk of fungal infections in the mouth or throat (oral candidiasis) and hoarseness, it is recommended to
inhale before meals and/or rinse your mouth with water or brush your teeth after
each inhalation.

Duration of treatment
Budesonide Viatris, Novolizer 400 micrograms is indicated for long-term therapy. It should be
used regularly according to the recommended dosage schedule, even when no asthma symptoms are present.
If you have not previously used glucocorticoids or have been treated only occasionally for a short
period with glucocorticoids, regular use of Budesonide Viatris, Novolizer 400 micrograms as
prescribed should lead to an improvement in breathing after about 10 days. However,
extreme congestion of the mucous membranes and inflammatory processes may obstruct the bronchial passage to the point of preventing Budesonide from fully exerting its effects at the
pulmonary level. In such cases, therapy should initially be accompanied by the administration of
corticosteroid products (systemic glucocorticoids) in the form of tablets. Subsequently, the dose of
tablets should be gradually reduced while inhalational therapy continues.
If you have already used corticosteroid products for a prolonged period, you should switch to Budesonide Viatris,
Novolizer 400 micrograms when symptoms are completely under control. Normally, in
this situation, the function of the adrenal cortex is reduced and, therefore, the intake of
cortisone tablets (systemic corticosteroid administration) must be reduced
gradually and must not be stopped abruptly. At the beginning of the period of replacement of
therapy, Budesonide Viatris, Novolizer 400 micrograms must be administered in addition to
tablets for about 10 days. Then, depending on the response, the daily dose of cortisone tablets can be gradually reduced at intervals of 1-2 weeks.

If you inhale more Budesonide Viatris, Novolizer 400 micrograms than you should
It is important that you take the dose, as indicated on the medicine instructions or as recommended by
your doctor. Do not increase or decrease the dose without consulting your doctor.

If you forget to use Budesonide Viatris, Novolizer 400 micrograms
Do not take a double dose to make up for the missed dose.

If you stop using Budesonide Viatris, Novolizer 400 micrograms
Do not stop treatment with Budesonide Viatris, Novolizer 400 micrograms without consulting
your doctor, as this could lead to a worsening of the disease.
If you have any doubts about the use of this product, please contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Main side effects
Commonly, irritation of the oral mucosa (sore throat) accompanied by difficulty swallowing, hoarseness and cough may occur.
Treatment with Budesonide via inhalation may cause fungal infections in the mouth and throat (oropharyngeal candidiasis). Experience has shown that these fungal infections occur less frequently when inhalation is performed before meals and/or when the mouth is rinsed or teeth brushed immediately after inhalation. In most cases, these infections respond to topical antifungal therapy without discontinuing treatment with Budesonide Viatris, Novolizer 400 micrograms.
As with other inhalation therapies, in rare cases, bronchospasm (paradoxical bronchospasm) may occur, which manifests as a temporary immediate increase in shortness of breath after administration. In this case only, you should stop using Budesonide Viatris, Novolizer 400 micrograms without prior consultation with your doctor and should still contact him immediately.
Inhalation of higher doses for a prolonged period may lead to increased susceptibility to infections. The ability to adapt to stress may be impaired.

List of all other side effects
Uncommon (may affect up to 1 in 100 people)
Depression, anxiety or worry, cataract, muscle spasms, tremor, blurred vision.
Rare (may affect up to 1 in 1,000):
Allergic reactions (hypersensitivity) and swelling of the face, eyes, lips, mouth and throat (angioedema), anaphylactic reactions, suppression of adrenal cortex function (adrenal suppression), growth retardation in children and adolescents;
restlessness, nervousness, abnormal behaviour, hyperactivity or irritability (these effects are more likely to occur in children); skin reactions such as hives (urticaria), eczema, topical skin inflammation (dermatitis), itching (pruritus), redness of the skin due to excessive filling of blood vessels (erythema), bruising, voice disorders and hoarseness (in children).
Very rare (may affect up to 1 in 10,000):
Decreased bone density.
Frequency not known (the frequency cannot be estimated from the available data):
Sleep problems, aggressiveness, excessive desire to be active accompanied by mental restlessness (psychomotor hyperactivity), glaucoma.
Lactose monohydrate contains small amounts of milk proteins and may therefore cause allergic reactions.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Budesonide Viatris, Novolizer 400 micrograms

Keep this medicine out of the sight and reach of children.
Do not use Budesonide Viatris, Novolizer 400 micrograms after the expiry date which is reported
on the label, on the outer packaging and on the cartridge container. The expiry date refers
to the last day of the month.

Storage conditions
Store in the original packaging. This medicine does not require any particular storage
conditions regarding temperature.
Storage conditions after opening: Keep the Novolizer device tightly closed, in order to
protect it from humidity.

Information relating to expiry after opening
Change the cartridge after six months from first opening.
Do not use the powder inhaler for more than one year.
Note: The Novolizer device has been shown to work for at least 2000 single doses. Therefore, it can
be used with this device in one year before replacement a maximum of 20 cartridges
containing 100 single doses and / or 40 cartridges of 50 single doses.
Do not dispose of any medicine in wastewater and household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Budesonide Viatris, Novolizer 400 micrograms contains

• The active ingredient is budesonide. Each actuation (puff) contains 400 micrograms of budesonide.
• The other ingredient is lactose monohydrate.

Appearance of Budesonide Viatris, Novolizer 400 micrograms and contents of the pack
Budesonide Viatris, Novolizer 400 micrograms, powder for inhalation, contains a white powder
(0.545 g or 1.09 g) in a cartridge containing 50 or 100 metered doses within a sealed
container with an aluminium foil, as well as a Novolizer device for inhaling the powder.
All components are made of plastic materials.

Pack sizes:
Sales packs:
1 cartridge containing 50/100 metered doses and 1 Novolizer device for inhaling the powder
2 cartridges containing 100 metered doses each and 1 Novolizer device for inhaling the powder
Refills:
1 cartridge containing 50/100 metered doses
2 cartridges containing 100 metered doses each
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Healthcare Limited,
Damastown Industrial Park,
Mulhuddart, Dublin 15,
Dublin, Ireland

Manufacturer
McDermott Laboratories T/A Mylan Dublin Respiratory
Unit 25 Baldoyle Industrial Estate
Grange Road, Baldoyle
Dublin 13
Ireland

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria:
Novolizer Budesonid Meda 400 Mikrogramm Pulver zur Inhalation
Belgium and Luxembourg:
Novolizer Budesonide 400 microgrammes, poudre pour inhalation
France:
Novopulmon Novolizer 400 microgrammes/dose, poudre pour inhalation
Germany:
Novopulmon 400 Novolizer, Pulver zur Inhalation
Ireland:
Novolizer Budesonide 400 micrograms inhalation powder
United Kingdom (Northern Ireland):
Budelin Novolizer 400 micrograms per actuation inhalation powder
Italy:
Budesonide Viatris Novolizer 400 microgrammi polvere per inalazione
Netherlands:
Budesonid Novolizer 400 microgram, inhalatiepoeder
Portugal:
Budesonido Novolizer 400 microgramas pó para inalação
Spain:
Novopulm Novolizer 400 microgramos, polvo para inhalación

Instructions for use of Novolizer

• 1. PREPARATION: The Novolizer powder inhaler makes inhaling simple and reliable. Use, cartridge replacement and cleaning are simple and quick operations. Position Novolizer in front of you. Apply slight simultaneous pressure on the knurled surfaces on both sides of the cover, push it forward (←) and lift it up ( ↑ ).

Remove the aluminium protective foil from the cartridge container and remove the new
cartridge. However, this should only be done immediately before using the cartridge. The
colour code of the cartridge must match the colour of the dosing button.

First filling:
Insert the cartridge into the Novolizer with the dose counter facing the mouthpiece (↓) Do not press the dosing button while inserting the cartridge.

Refilling:
Note: The Novolizer must be cleaned each time the cartridge is changed after removing the
empty cartridge.
If you have already used the Novolizer device, first remove the empty cartridge and then insert
the new one (↓), do not press the dosing button while inserting the cartridge.
Replace the cover in its rails starting from the top (↓) by pushing down the coloured button until
it clicks back into place (→).

The Novolizer is now filled and ready for use.

You can leave the cartridge in the Novolizer until the cartridge is exhausted or for a maximum of 6
months after insertion. The cartridge is finished when you see a “0” in the centre of the dose counter. A new cartridge must then be inserted. Cartridges can only be used
in the original Novolizer inhaler.

• 2. USE: If possible, remain seated or standing during inhalation. When using the Novolizer, always hold it in a horizontal position. First remove the protective cap (←).

Press the coloured dosing button firmly. You should hear a loud double click and the colour of the control window must change from red to green. Then, you can release the coloured button. The green colour in the
control window indicates that the Novolizer device is ready for use.

Exhale (but not into the Novolizer device). Put your lips tightly around the mouthpiece, inhale the
powder steadily, deeply and as quickly as possible (at maximum inhalation) and then
hold your breath for a few seconds. During this breath you should feel a distinct click, indicating
correct inhalation. Then continue with normal breathing.

Check that the colour of the control window has changed back to red, this indicates a
correct inhalation. Replace the protective cap on the mouthpiece - the inhalation procedure is now
complete.
The number in the window at the top indicates the number of inhalations remaining.
The numerical scale 200 (respectively 100)-60 shows steps of 20 that 60 (respectively 50)-0
steps of 10.
If you do not hear the click and the colour does not change, repeat the procedure
as described above.
NOTE: The coloured dosing button should only be pressed immediately before inhalation. It is not possible to accidentally take a double inhalation with the
Novolizer. The click and the colour change in the control window indicate that the inhalation has been performed correctly. If the
colour in the control window does not change, the inhalation should be repeated. If the inhalation is not
completed correctly after several attempts, consult your doctor.

• 3. CLEANING:

The Novolizer powder inhaler should be cleaned at regular intervals, but at least every time the
cartridge is replaced.
Remove the protective cap and the mouthpiece
First remove the protective cap. Then grasp the mouthpiece and turn it slightly in
an anticlockwise direction (↑) until it loosens. Then remove it (←).

Cleaning
Turn the NOVOLIZER upside down. Grasp the cover along the sliding rails and move it forward
(←) and upwards (↑). Dust residues can be removed by gently tapping.

Clean the mouthpiece, the cartridge compartment and the powder inhaler with a soft
dry, lint-free cloth.
Do not use water or detergents.
Assembly – inserting the cover
After cleaning, insert the cover by sliding it in from the top (↘) and pressing down on this
position ( ↓ ).
Return the inhaler to its original position.

Assembly – Positioning the mouthpiece and protective cap
Insert the mouthpiece with the pin into the groove on the left and turn it to the right until it clicks into place. Finish by repositioning the protective cap.

Note
the inhaler for the first time.

• The NOVOLIZER contains various active substances, does not use any propellants and is designed to be reused. This makes NOVOLIZER an extremely environmentally friendly product.
• It is not possible to overdose with NOVOLIZER. Even if the button is pressed several times, no further dose of inhalation powder is available. Press the button only when you want to inhale. If you are unable to inhale correctly after several attempts, consult your doctor.
• The NOVOLIZER can be refilled using new cartridges* containing the active ingredient, and is therefore suitable for long-term use (up to one year)
• Do not shake the filled NOVOLIZER.
• Help your children with the correct use of the device.
• Make sure that the NOVOLIZER is protected from moisture and heat and is always kept clean.

* Regarding the corresponding drugs, ask your doctor.
Viatris Healthcare Limited,
Damastown Industrial Park,
Mulhuddart, Dublin 15,
Dublin, Ireland
CE