Budesonide Viatris

Package leaflet: Information for the user

Budesonide Viatris

Novolizer 200 micrograms inhalation powder
Equivalent medicine
Budesonide
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 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

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

Budesonide, the active substance in Budesonide Viatris, Novolizer 200 micrograms, is a
glucocorticoid (corticosteroid) for inhalation.
Budesonide Viatris, Novolizer 200 micrograms is used for the treatment of persistent asthma.
NOTE:
Budesonide Viatris, Novolizer 200 micrograms must not be used for the treatment of a sudden
respiratory problem (acute asthma attack or Status asthmaticus (asthma attack occurring frequently and/or lasting for several days)).

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

Do not use Budesonide Viatris, Novolizer 200 micrograms if you are allergic to budesonide or to milk proteins, which are present in small amounts 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 athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.
Exercise particular caution with Budesonide Viatris, Novolizer 200 micrograms
If you suffer from pulmonary tuberculosis, fungal infections, or other airway infections. This also applies if you have previously had any of these conditions. Consult your doctor.
Budesonide is not suitable for the treatment of acute respiratory conditions or severe, persistent bronchospasms (status asthmaticus). Your doctor will advise you on using short-acting inhaled bronchodilators as relief medication for these symptoms.
If you have severe liver disease, elimination of budesonide may be impaired. This could lead to increased blood levels of budesonide.
Any inhaled glucocorticoid may cause adverse effects, especially when used at high doses over prolonged periods. These effects are less likely with inhaled therapy compared to oral glucocorticoid tablets. Possible effects include adrenal suppression, Cushing's syndrome, Cushingoid appearance (a 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 range of psychological or behavioral effects such as psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (particularly in children). Therefore, it is very important to use the lowest dose that effectively controls asthma.
If periods of stress or emergencies (e.g., severe infections, injuries, or surgery) occur within the first few months after switching from oral tablets to inhaled therapy, it may be necessary to continue systemic glucocorticoid treatment 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 systemic glucocorticoid coverage may be required during periods of stress and/or elective surgery.
After switching to inhaled therapy, symptoms previously suppressed by prior systemic glucocorticoid treatment may reappear, such as allergic rhinitis symptoms, allergic skin rashes, or rheumatic pain. These symptoms should be treated with appropriate additional pharmacological therapy.
Some patients may experience non-specific general malaise during the transition period, despite improvement or maintenance of respiratory function. In such cases, consult your doctor, who will determine whether treatment can continue as planned or whether you may have symptoms of reduced adrenal cortex function that are incompatible with continuing therapy.
Other medicines and Budesonide Viatris, Novolizer 200 micrograms
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Some medicines may increase the effects of Budesonide Viatris, Novolizer 200 micrograms, and your doctor may want to monitor you closely if you are taking these medicines (including certain HIV treatments: nelfinavir, ritonavir, cobicistat, and antifungal medicines: ketoconazole, itraconazole). Therefore, this combination should be avoided. If avoidance is not possible, the time interval between administration of these medicines and budesonide should be as long as possible.
Increased plasma levels and enhanced effects of corticosteroids have been observed in women also receiving estrogens and steroid contraceptives; however, these effects have not occurred with concomitant administration of budesonide and low-dose oral contraceptives.
Since adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary insufficiency may yield false results (low values).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Most data from prospective epidemiological studies and worldwide post-marketing experience have not shown an increased risk of adverse effects in fetuses and newborns of mothers who used inhaled budesonide during pregnancy. It is important for both the fetus and the mother that asthma is adequately managed during pregnancy. As with any other medicine used during pregnancy, the benefit of budesonide for the mother should be weighed against any potential risk to the fetus.
Breastfeeding
Budesonide is excreted in breast milk. However, at therapeutic doses, no effects on the breastfed infant are expected. Maintenance therapy with inhaled budesonide (200 or 400 micrograms twice daily) in breastfeeding women with asthma results in negligible systemic exposure to budesonide in breastfed infants. Therefore, Budesonide Viatris, Novolizer 200 micrograms may 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 problems in people with lactose intolerance. If you are lactose intolerant, you should discuss this with your doctor.
The milk sugar (lactose) contains small amounts of milk proteins.

3. How to use Budesonide Viatris, Novolizer 200 micrograms

Use this medicine exactly as directed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
Patients without prior treatment with glucocorticoids and patients previously treated with
inhaled glucocorticoids.
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) once or twice daily.
Maximum recommended dose: 4 single doses (800 micrograms) twice daily (daily dose: 1600 micrograms).
Children aged 6 to 12 years:
Recommended initial dose: 1 single dose (200 micrograms) twice daily or 200–400 micrograms once daily.

Maximum recommended dose: 2 single doses (400 micrograms) twice daily (daily dose: 800 micrograms).
If administered once daily, it is recommended 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 data on safety and efficacy.
Please assist your children in the correct use of the Novolizer device.
Children
It is recommended to regularly monitor the growth of children undergoing long-term treatment with high-dose inhaled glucocorticoids.
Elderly
Usually, no special dose adjustment is required. In general, the lowest effective dose necessary for adequate control should be used.
If your symptoms worsen (recognized, for example, by persistent breathing difficulties and increased use of other inhaled bronchodilator medicines), you should consult your doctor as soon as possible. If you have previously taken only one inhalation per day, you may need to inhale the same dose twice daily (morning and 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, speak with your doctor or pharmacist.
For relief of acute asthma symptoms, you should always have short-acting inhaled bronchodilators (beta-2 agonists, such as salbutamol) available.
When switching from another inhaled budesonide to Budesonide Viatris, Novolizer 200 micrograms, your treatment plan may need to be adjusted by your doctor.
Method of administration
For inhalation use only.
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 to rinse the mouth with water or brush 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 dosing schedule, even when asthma symptoms are not present.
If you have not previously used glucocorticoids or have only occasionally been treated briefly with glucocorticoids, regular use of Budesonide Viatris, Novolizer 200 micrograms as prescribed should lead to improved breathing after about 10 days. However, severe mucosal congestion and inflammatory processes may obstruct the bronchial passages to the extent that Budesonide cannot fully exert its effects in the lungs. In such cases, initial therapy should be accompanied by administration of corticosteroid products (systemic glucocorticoids) in tablet form. Subsequently, the dose of tablets should be gradually reduced while continuing inhaled therapy.
If you have previously used corticosteroid products for a prolonged period, you should switch to Budesonide Viatris, Novolizer 200 micrograms when symptoms are fully controlled. Normally, in this situation adrenal cortical function is reduced, and therefore the intake of cortisone tablets (systemic corticosteroid administration) must be gradually tapered and must not be stopped abruptly. At the beginning of the therapy substitution period, Budesonide Viatris, Novolizer 200 micrograms should be administered in addition to the tablets for approximately 10 days. Then, depending on response, the daily dose of cortisone tablets may be gradually reduced 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 in the medicine’s instructions or as advised 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 a 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 worsening of the disease.
If you have any doubts about using this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Main side effects
Irritation of the oral mucosa (throat irritation) accompanied by difficulty swallowing, hoarseness, and cough may commonly occur.
Inhaled treatment with Budesonide 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 the need to discontinue treatment with Budesonide Viatris, Novolizer 200 micrograms.
As with other inhaled therapies, in rare cases, bronchospasm (paradoxical bronchospasm) may occur, which manifests as a temporary immediate increase in breathlessness after administration. In such cases only, you must stop using Budesonide Viatris, Novolizer 200 micrograms without prior consultation with your doctor and must contact your doctor immediately.
Prolonged use of higher doses 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 (trembling), blurred vision
Rare (may affect up to 1 in 1,000 people):
Allergic reactions (hypersensitivity) and swelling of the face, eyes, lips, mouth, and throat (angioneurotic edema), anaphylactic reactions, suppression of adrenal cortex function (adrenal suppression), growth retardation in children and adolescents; restlessness, nervousness, abnormal behaviour, hyperexcitability or irritability (these effects are more likely to occur in children); skin reactions such as urticaria (urticaria), eczema, topical inflammation of the skin (dermatitis), pruritus (pruritus), skin redness due to excessive blood vessel filling (erythema), bruising, voice disorders and hoarseness (in children).
Very rare (may affect up to 1 in 10,000 people):
Decreased bone mineral density.
Frequency not known (frequency cannot be estimated from the available data):
Sleep disturbances, aggression, excessive desire for activity accompanied by mental restlessness (psychomotor hyperactivity), glaucoma.
Monohydrate lactose contains small amounts of milk proteins and may therefore cause allergic reactions.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address: 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 stated on the label, on the outer carton 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 special storage conditions regarding temperature.
Storage conditions after opening: Keep the Novolizer device tightly closed in order to protect it from moisture.
Information on expiry after opening
Replace the cartridge six months after first opening. Do not use the powder inhaler for longer than one year.
Note: The Novolizer device has been shown to function for at least 2000 single doses. Therefore, up to 10 cartridges containing 200 single doses each and/or 20 cartridges containing 100 single doses each may be used with this device within one year before replacement.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Budesonide Viatris, Novolizer 200 micrograms contains

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

What Budesonide Viatris, Novolizer 200 micrograms looks like 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 sealed container with an aluminium foil lid, together with a Novolizer inhalation device.
All components are made from plastic materials.

Pack sizes:
Retail packs:
1 cartridge containing 100/200 metered doses and 1 Novolizer inhalation device
2 cartridges each containing 200 metered doses and 1 Novolizer inhalation device

Refills:
1 cartridge containing 200 metered doses
2 cartridges each containing 200 metered doses

Not all pack sizes may be marketed.

Marketing Authorization 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 European Economic Area countries under the following names:

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 polvere per inalazione

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 dry powder inhaler enables simple and reliable inhalation. Using the device, replacing the cartridge, and cleaning are quick and easy procedures.

Position the Novolizer in front of you. Gently press simultaneously on the knurled surfaces on both sides of the cap and push it forward (←), then lift it up (↑).

Remove the aluminum protective foil from the cartridge container and take out the new cartridge. However, this step should only be performed 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 towards the mouthpiece (↓). Do not press the dosing button while inserting the cartridge.

Refilling:
Note: The Novolizer must be cleaned every 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 cap into its tracks starting from the top (↓), pressing down the coloured button until it clicks into place (→).

The Novolizer is now filled and ready for use.

The cartridge may remain in the Novolizer until it is empty or for a maximum of 6 months after insertion. The cartridge is empty when a "0" appears in the centre of the dose counter. A new cartridge must then be inserted. Cartridges may only be used with the original Novolizer inhaler.

2. USE: If possible, remain seated or standing while inhaling. Always hold the Novolizer horizontally when using it. First, remove the protective cap (←).

Firmly press down the coloured dosing button. You must hear a loud double click, and the colour in the control window must change from red to green. You may then release the coloured button. The green colour in the control window indicates that the Novolizer device is ready for use.

Breathe out (but not into the Novolizer device). Place your lips tightly around the mouthpiece, inhale the powder steadily, deeply, and as quickly as possible (maximum inhalation), then hold your breath for a few seconds. During this breath, you should hear a distinct click, indicating correct inhalation. Then resume normal breathing.

Check that the colour in the control window has changed back to red, indicating a successful inhalation. Replace the protective cap onto the mouthpiece – the inhalation procedure is now complete.
The number in the upper window indicates the number of inhalations remaining.
The numerical scale from 200 (respectively 100) to 60 shows increments of 20, and from 60 (respectively 50) to 0 shows increments of 10.
If you do not hear the clicking sound and there is no colour 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 perform a double inhalation with the Novolizer. The click and the colour change in the control window confirm that the inhalation has been correctly performed. If the colour in the control window does not change, repeat the inhalation. If inhalation is not successfully completed after several attempts, consult your doctor.

3. CLEANING:

The Novolizer dry powder inhaler should be cleaned regularly, 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 counterclockwise (↑) until it loosens. Then remove it (←).

Cleaning
Turn the NOVOLIZER upside down. Grasp the cap along the sliding tracks and move it forward (←) and upward (↑). Residual powder can be removed by gently tapping.

Clean the mouthpiece, cartridge compartment, and powder inhaler with a soft, dry, lint-free cloth.
Do not use water or cleaning agents.
Reassembly – inserting the cap
After cleaning, insert the cap by sliding it into the corner (↘) and press down into this position (↓).
Return the inhaler to its original position.

Reassembly – positioning the mouthpiece and protective cap
Insert the mouthpiece with its pin into the groove on the left and turn it to the right until it clicks into place. Finish by replacing the protective cap.

Note

• The package leaflet describes how the medicine works. Read it carefully before using the inhaler for the first time.
• The NOVOLIZER contains various active substances, uses no propellant, and is designed for repeated use. This makes NOVOLIZER an extremely environmentally friendly product.
• Overdose with NOVOLIZER is not possible. Even if the button is pressed multiple times, no additional dose of powder is available for inhalation. Press the button only when you intend 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 substance, making it suitable for long-term use (up to one year).
• Do not shake the filled NOVOLIZER.
• Assist your children in the correct use of the device.
• Ensure that the NOVOLIZER is protected from moisture and heat and is always kept clean.

* For information on corresponding medicines, please consult your doctor.
Viatris Healthcare Limited,
Damastown Industrial Park,
Mulhuddart, Dublin 15,
Dublin, Ireland
CE

Patient Information Leaflet

Budesonide Viatris

Novolizer 400 micrograms inhalation powder
Generic medicine
Budesonide
Please read this leaflet carefully before using this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 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

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

Budesonide, the active substance in Budesonide Viatris, Novolizer 400 micrograms, is a
glucocorticoid (corticosteroid) for inhalation.
Budesonide Viatris, Novolizer 400 micrograms is used for the treatment of persistent asthma.
NOTE:
Budesonide Viatris, Novolizer 400 micrograms must not be used for the treatment of a sudden
respiratory problem (acute asthma attack or Status asthmaticus (asthma attack occurring frequently and/or lasting for several days))

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

Do not use Budesonide Viatris, Novolizer 400 micrograms if you are allergic to budesonide or to milk proteins, which are present in small amounts 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 athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Exercise particular caution with Budesonide Viatris, Novolizer 400 micrograms
If you have pulmonary tuberculosis, fungal infections, or other airway infections. This also applies if you have previously suffered from these conditions. Consult your doctor.
Budesonide is not suitable for treating acute respiratory disorders or severe, continuous bronchial spasms (status asthmaticus). Your doctor will advise you on using short-acting inhaled bronchodilators as relief for these symptoms.
If you have severe liver disease, elimination of budesonide may be impaired. This could lead to increased levels of budesonide in the blood.
Any inhaled glucocorticoid may cause adverse effects, especially when used at high doses over prolonged periods. These effects are less likely with inhaled therapy compared to oral glucocorticoids. Possible effects include adrenal cortex dysfunction, Cushing's syndrome, Cushingoid appearance (a 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 range of psychological or behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (particularly in children). Therefore, it is very important to use the lowest dose that effectively controls asthma.
If periods of stress or emergencies (e.g., severe infections, injuries, or surgery) occur within the first few months after switching from oral tablets to inhaled therapy, it may be necessary to continue systemic glucocorticoid treatment 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 systemic glucocorticoid coverage may be required during periods of stress and/or elective surgery.
After switching to inhaled therapy, symptoms previously suppressed by prior systemic glucocorticoid treatment may reappear, such as allergic rhinitis symptoms, allergic skin rashes, or rheumatic pain. These symptoms should be treated with appropriate additional pharmacological therapy.
Some patients may experience non-specific general malaise during the transition period, despite improvement or maintenance of respiratory function. In such cases, consult your doctor, who will determine whether treatment can continue as planned or whether you are experiencing, for example, symptoms of reduced adrenal cortex function incompatible with continuing therapy.
Other medicines and Budesonide Viatris, Novolizer 400 micrograms
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Some medicines may increase the effects of Budesonide Viatris, Novolizer 400 micrograms, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: nelfinavir, ritonavir, cobicistat, and antifungal agents: ketoconazole, itraconazole). Therefore, this combination should be avoided. If avoidance is not possible, the time interval between administration of these medicines and budesonide should be as long as possible.
Increased plasma levels and enhanced effects of corticosteroids have been observed in women also receiving estrogens and steroid contraceptives; however, these effects have not been observed with concomitant administration of budesonide and low-dose oral contraceptives.
Because adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary insufficiency may yield false results (low values).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist 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 in fetuses and newborns of mothers who used inhaled budesonide during pregnancy. It is important for both the fetus and the mother that asthma is adequately managed during pregnancy. As with any medicine taken during pregnancy, the benefit of administering budesonide to the mother must be weighed against any potential risks to the fetus.
Breastfeeding
Budesonide is excreted in breast milk. However, at therapeutic doses, no effects on the breastfed infant are expected. Maintenance therapy with inhaled budesonide (200 or 400 micrograms twice daily) in breastfeeding women with asthma has resulted in negligible systemic exposure to budesonide in breastfed infants. Therefore, Budesonide Viatris, Novolizer 400 micrograms may 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 problems in people with lactose intolerance. If you are lactose intolerant, you should discuss this with your doctor. The milk sugar (lactose) contains small amounts of milk proteins.

3. How to use Budesonide Viatris, Novolizer 400 micrograms

Use this medicine exactly as instructed by your doctor.
If you have any doubts, consult your doctor or pharmacist.

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

Adults (including elderly) and children/adolescents over 12 years of age:
Recommended initial dose: 1 single dose (400 micrograms) once or twice daily
Maximum recommended dose: 2 single doses (800 micrograms) twice daily (daily dose: 1600 micrograms)

Children aged 6 to 12 years:
Recommended initial dose: 1 single dose (400 micrograms) once daily
Maximum recommended dose: 1 single dose (400 micrograms) twice daily (daily dose: 800 micrograms)

If administered once daily, 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 data on safety and efficacy.

Please assist your children in correctly using the Novolizer device.

Children
It is recommended to regularly monitor the growth of children undergoing long-term treatment with high doses of inhaled glucocorticoids.

Elderly
Generally, no special dose adjustment is required. In general, the lowest effective dose necessary for adequate control should be used.

If your symptoms worsen (recognized, for example, by persistent breathing difficulties and increased use of other inhaled bronchodilator medicines), you should consult your doctor as soon as possible. If you have so far taken only one inhalation per day, you may need to inhale the same dose twice daily (in the morning and evening). In any case, your doctor will decide whether your usual dose of Budesonide Viatris, Novolizer 400 micrograms should be increased.

If you feel that the effect of Budesonide Viatris, Novolizer 400 micrograms is too strong or too weak, speak to your doctor or pharmacist.

For relief of acute asthma symptoms, you should always have with you short-acting inhaled bronchodilators (beta-2 agonists, such as salbutamol). When switching from another inhaled budesonide to Budesonide Viatris 400 micrograms, your treatment plan may need to be adjusted by your doctor.

Method of administration
For inhalation use only.
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 to rinse the mouth with water or brush the 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 dosing schedule, even when asthma symptoms are not present.

If you have not previously used glucocorticoids or have only occasionally been treated briefly with glucocorticoids, regular use of Budesonide Viatris, Novolizer 400 micrograms as prescribed should lead to improved breathing after about 10 days. However, severe mucosal swelling and inflammatory processes may obstruct the bronchial passages to such an extent that budesonide cannot fully exert its effects in the lungs. In such cases, initial treatment should be accompanied by administration of corticosteroid medicines (systemic glucocorticoids) in tablet form. Subsequently, the tablet dose should be gradually reduced while continuing inhaled therapy.

If you have previously used corticosteroid medicines for a prolonged period, you should switch to Budesonide Viatris, Novolizer 400 micrograms when symptoms are fully under control. Normally, in this situation, adrenal cortex function is reduced; therefore, the intake of corticosteroid tablets (systemic corticosteroid administration) must be gradually reduced and must not be stopped abruptly. At the beginning of the therapy substitution period, Budesonide Viatris, Novolizer 400 micrograms should be administered in addition to the tablets for approximately 10 days. Then, depending on the response, the daily tablet dose of corticosteroids 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 in the medicine's instructions or as advised 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 your condition.

If you have any doubts about using this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Main side effects
Irritation of the oral mucosa (throat irritation) accompanied by difficulty swallowing, hoarseness, and cough may commonly occur.
Inhaled treatment with Budesonide 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 the need to discontinue treatment with Budesonide Viatris, Novolizer 400 micrograms.
As with other inhaled therapies, bronchospasm (paradoxical bronchospasm) may occur rarely, manifesting as a temporary immediate increase in breathlessness after administration. In such cases only, you must stop using Budesonide Viatris, Novolizer 400 micrograms without prior consultation with your doctor and must contact your doctor immediately.
Inhalation of higher doses over 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 (trembling), blurred vision.
Rare (may affect up to 1 in 1,000 people):
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, hyperexcitability or irritability (these effects are more likely to occur in children); skin reactions such as urticaria (urticaria), eczema, localised inflammation of the skin (dermatitis), pruritus (pruritus), skin redness due to excessive blood vessel congestion (erythema), bruising, voice disorders and hoarseness (in children).
Very rare (may affect up to 1 in 10,000 people):
Decrease in bone density.
Frequency not known (frequency cannot be estimated from the available data):
Sleep disturbances, aggression, excessive desire to be active accompanied by mental restlessness (psychomotor hyperactivity), glaucoma.
Monohydrate lactose contains small amounts of milk proteins and may therefore cause allergic reactions.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the label, the outer carton 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 special storage conditions regarding temperature.
Storage conditions after opening: Keep the Novolizer device firmly closed in order to protect it from moisture.
Information on expiry after opening
Replace the cartridge six months after 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, up to 20 cartridges containing 100 single doses and/or 40 cartridges containing 50 single doses may be used with this device within one year before replacement.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Budesonide Viatris, Novolizer 400 micrograms contains

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

What Budesonide Viatris, Novolizer 400 micrograms looks like and contents of the pack
Budesonide Viatris, Novolizer 400 micrograms, inhalation powder, contains a white powder
(0.545 g or 1.09 g) in a cartridge containing 50 or 100 metered doses inside a sealed container
with an aluminium foil lid, together with a Novolizer device for inhaling the powder.
All components are made from plastic materials.
Pack sizes:
Retail 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 Authorization 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 European Economic Area Member States under the
following names:
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 enables simple and reliable inhalation. Using, replacing the cartridge, and cleaning are quick and easy operations. Position the Novolizer in front of you. Apply gentle, simultaneous pressure on the ribbed surfaces on both sides of the cap, push it forward (←), and lift it up (↑).

Remove the aluminum protective film from the cartridge holder and take out 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.
Reinsert the cap into its tracks starting from the top (↓), pressing down the coloured button until it clicks back into place (→).

The Novolizer is now filled and ready for use.

The cartridge may remain in the Novolizer until it is empty or for a maximum of 6 months after insertion. The cartridge is empty when a "0" appears in the centre of the dose counter. A new cartridge must then be inserted. Cartridges can only be used with the original Novolizer inhaler.

2. USE: If possible, remain seated or standing during inhalation. Always hold the Novolizer horizontally when using it. First, remove the protective cap (←).

Firmly press down the coloured dosing button. You should hear a loud double click, and the colour in the control window should change from red to green. You may then release the coloured button. The green colour in the control window indicates that the Novolizer device is ready for use.

Breathe out (but not into the Novolizer device). Place your lips tightly around the mouthpiece, inhale the powder steadily, deeply, and as quickly as possible (maximum inhalation), then hold your breath for a few seconds. During this breath, you should hear a distinct click, indicating correct inhalation. Then resume normal breathing.

Check that the colour in the control window has changed back to red—this indicates a successful inhalation. Replace the protective cap on the mouthpiece—the inhalation procedure is now complete.
The number in the upper window indicates the number of inhalations remaining.
The numerical scale from 200 (respectively 100) to 60 shows increments of 20; from 60 (respectively 50) to 0, increments of 10.
If you do not hear the clicking sound and no colour change occurs, repeat the procedure as described above.
NOTE: The coloured dosing button should only be pressed immediately before inhalation. It is not possible to accidentally perform a double inhalation with the Novolizer. The click and colour change in the control window confirm that inhalation has been correctly performed. If the colour in the control window does not change, repeat the inhalation. If inhalation is not completed correctly after several attempts, consult your doctor.

3. CLEANING:

The Novolizer powder inhaler must be cleaned regularly, 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 counterclockwise (↑) until it loosens. Then remove it (←).

Cleaning
Turn the NOVOLIZER upside down. Grasp the cover along the sliding tracks and move it forward (←) and upward (↑). Residual powder can be removed by gently tapping.

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

Reassembly – positioning the mouthpiece and protective cap
Insert the mouthpiece with its pin into the groove on the left and turn it to the right until it clicks into place. Finish by replacing the protective cap.

Note

• The package leaflet describes how the medicine works. Read it carefully before using the inhaler for the first time.
• The NOVOLIZER contains various active substances, uses no propellants, and is designed for reuse. This makes NOVOLIZER an extremely eco-friendly product.
• Overdose with NOVOLIZER is not possible. Even if the button is pressed multiple times, no additional dose of inhaled powder is available. Press the button only when you wish 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, making it suitable for long-term use (up to one year).
• Do not shake the filled NOVOLIZER.
• Help your children use the device correctly.
• Ensure that the NOVOLIZER is protected from moisture and heat and is always kept clean.

* For information on corresponding medicines, please consult your doctor.
Viatris Healthcare Limited,
Damastown Industrial Park,
Mulhuddart, Dublin 15,
Dublin, Ireland
CE