Leaflet: information for the user

Novopulm Novolizer 400 micrograms

Aerosol for inhalation

budesonide

6. Contents of the pack and additional information.

Budesonide, the active ingredient of Novopulm Novolizer 400 micrograms, is a glucocorticoid (corticosteroid) for inhalation.

Novopulm Novolizer 400 micrograms is used for the routine treatment of persistent asthma.

NOTE:

Novopulm Novolizer 400 microgramsshould notbe used for the treatment of a respiratory crisis (acute asthma attack, orStatus asthmaticus(frequent or persistent asthma attack)).

Do not use Novopulm Novolizer 400 micrograms

If you are allergic to budesonide or to milk proteins, which are contained in small amounts in the lactose monohydrate excipient (included in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Novopulm Novolizer 400 micrograms.

Contact your doctor if you experience blurred vision or other visual disturbances.

Be especially careful with Novopulm Novolizer 400 micrograms

If you have pulmonary tuberculosis or fungal infection or other airway infections. This also applies if you have had these problems in the past. Inform your doctor.

Budesonide is not suitable for the treatment of an acute asthma crisis or severe continuous bronchospasm (status asthmaticus).Your doctor will instruct you on the use of inhaled bronchodilator medications with short action (bronchodilator) as rescue medication for acute asthma symptoms.

If you have severe liver problems, the elimination of budesonide may be altered. This may lead to an increase in budesonide in the blood.

Any inhaled corticosteroid may cause side effects, particularly when used at high doses for prolonged periods. These effects occur with less probability with inhaled treatment than with oral administration of corticosteroids. The possible effects include adrenal cortex dysfunction, Cushing's syndrome, Cushingoid features (hormonal disorders caused by high levels of cortisol in the blood with central obesity, "moon face", skin thinning, hypertension, etc.), bone density decrease, growth retardation in children and adolescents, as well as eye disorders (cataracts and glaucoma), and more rarely a series of psychological and behavioral effects such as hyperactivity, sleep disorders, anxiety, depression, or aggression (particularly in children). Therefore, it is essential to administer the lowest dose that maintains effective asthma control.

During the first months after a change from oral treatment to inhaled treatment, periods of stress or emergencies (e.g., severe infections, injuries, and surgery) may occur, and it may be necessary to resume systemic administration of corticosteroids in the form of tablets or infusions. This also applies to patients who have received prolonged treatment with high doses of inhaled corticosteroids.They may also have adrenal cortex dysfunction, requiring coverage with systemic corticosteroids during periods of stress and/or elective surgery.

After switching to inhaled treatment, symptoms that had been suppressed by the previous systemic corticosteroid treatment may appear, e.g., allergic rhinitis symptoms, allergic eczema, or rheumatic symptoms. These symptoms should be treated additionally with appropriate medications.

Some patients may experience nonspecific discomfort during the transition period, despite maintenance or even improvement of respiratory function. In this case, consult your doctor. The doctor will decide whether to continue or interrupt treatment if, for example, you present symptoms of adrenal insufficiency.

Use of Novopulm Novolizer 400 micrograms with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Some medications may increase the effects of Novopulm Novolizer 400 micrograms, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: nelfinavir, ritonavir, cobicistat, and medications for fungal infections: ketoconazole, itraconazole).

As a consequence, this combination should be avoided. If this is not possible, the interval between the administration of these medications and budesonide should be as long as possible.

In women treated with estrogens and steroid contraceptives, elevated plasma concentrations and intensified corticosteroid effects have been observed, but no effects have been observed with budesonide and concomitant administration of low-dose oral contraceptives.

Since adrenal function may be suppressed, false results (low values) may occur in ACTH stimulation tests for the diagnosis of pituitary insufficiency.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The majority of results from epidemiological studies and post-marketing data worldwide have not been able to detect an increase in the risk of adverse effects in the fetus or newborns after the use of inhaled budesonide during pregnancy. It is essential to maintain adequate asthma treatment during pregnancy for both the mother and the fetus.

As with other medications administered during pregnancy, the benefit of administering inhaled budesonide to the mother should be weighed against the risks to the fetus.

.

Lactation

Budesonide passes into breast milk.However, at therapeutic doses, no effects are expected in the infant.Maintenance treatment with budesonide inhaler (200 or 400 micrograms twice a day) in lactating women with asthma results in an insignificantsystemic exposure to budesonide in infants.Therefore, Novopulm Novolizer 400 micrograms can be used during lactation.

Driving and operating machinery:

Budesonide has no influence on the ability to drive and operate machinery.

Novopulm Novolizer 400 micrograms contains lactose. It may cause allergic reactions in patients with milk protein allergy. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before using this medication.

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before using this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Patients starting treatment with glucocorticoids and patients previously treated with inhaled glucocorticoids.

Unless your doctor tells you otherwise, the recommended normal dose is as follows:

Adults (including the elderly) and children/adolescents over 12 years:

Recommended initial dose: 1 single dose (400 micrograms) once or twice a day.

Maximum recommended dose: 2 single doses (800 micrograms) twice a day (daily dose: 1,600 micrograms).

Children aged 6 to 12 years:

Recommended initial dose: 1 single dose (400 micrograms) once a day.

Maximum recommended dose: 1 single dose (400 micrograms) twice a day (daily dose: 800 micrograms).

When administered once a day, the dose should be administered in the afternoon-evening.

Children under 6 years:

Novopulm Novolizer 400 micrograms is not recommended for use in children under 6 years of age due to insufficient safety and efficacy data.

Supervise the child for proper handling of the Novolizer device.

Children

Regularly monitor growth in children receiving prolonged treatment with inhaled glucocorticoids.

Older adults

Normally, no special dose adjustments are required. In general, the lowest effective dose should be used.

In case of a deterioration of asthma symptoms (e.g., persistent respiratory symptoms and increased use of an inhaled bronchodilator), consult your doctor as soon as possible. If you were receiving a single daily dose, you may now need the same dose but administered twice a day (morning and evening). In any case, your doctor will decide if you need to increase your usual dose of Novopulm Novolizer 400 micrograms.

Inform your doctor or pharmacist if you think the effect of Novopulm Novolizer 400 micrograms is too strong or too weak.

At all times, you should carry a short-acting bronchodilator inhaler (beta-2-agonist, such as salbutamol) for acute asthma symptom relief.

When switching from another budesonide inhaler to Novopulm Novolizer 400 micrograms, the treatment plan should be adjusted by your doctor.

Administration form

Inhalation.

Follow the Instructions for Use to perform the inhalation.

Important handling information

To reduce the risk of oral candidiasis and hoarseness, it is recommended that the inhalation be performedbefore mealsand/or the mouth be rinsed with water or teeth brushed after each inhalation.

Treatment duration

Novopulm Novolizer 400 micrograms is intended for long-term therapy. It should be administered regularly, according to the recommended treatment schedule, even during asymptomatic periods.

If you have never used glucocorticoids previouslyor if you have only received them occasionally for short periods, regular use of Novopulm Novolizer 400 microgramswill result in improved breathing after approximately 10 days. However, extreme mucosal congestion and inflammatory processes may obstruct the bronchial tubes to the point where budesonide cannot exert its full effects on the lung. In such cases, initiation of therapy should be supplemented with the administration of oral cortisone (systemic glucocorticoids). Subsequently, the cortisone dose should be gradually reduced but continued with inhalation therapy.

If you have already used cortisone for prolonged periods, the switch to Novopulm Novolizer400 micrograms should be made when your symptoms are completely controlled. Normally, in this situation, adrenal cortical function is suppressed, and therefore, oral cortisone (systemic corticosteroids) should be gradually reduced without abrupt interruption. At the beginning of the transition period, Novopulm Novolizer 400 micrograms should be administered simultaneously for approximately 10 days. Then, depending on your response, the daily dose of oral cortisone can be gradually reduced at intervals of one to two weeks.

If you inhale more Novopulm Novolizer 400 micrograms than you should:

It is essential to use the dose indicated by your doctor or pharmacist. Do not increase or decrease the dose without consulting your doctor.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone (91) 562 04 20.

If you forget to use Novopulm Novolizer 400 micrograms

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Novopulm Novolizer 400 micrograms

Do not interrupt treatment with Novopulm Novolizer 400 micrograms without consulting your doctor first, as this may lead to a worsening of your disease.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Most important side effects

Frequent side effects may include oral mucosa irritation (throat irritation), accompanied by difficulty swallowing, hoarseness, and coughing.

Inhaled budesonide treatment may result in fungal infection of the mouth and throat (oropharyngeal candidiasis). Experience has shown that this fungal infection occurs less frequently when inhalation is performed before meals and/or when the mouth is rinsed or teeth are brushed after inhalation. In most cases, this pathology responds to topical antifungal therapy without interrupting treatment with Novopulm Novolizer 400 micrograms.

As with other inhalation therapies, in rare cases, bronchial spasm (paradoxical bronchospasm) may occur, which manifests as a temporary increase in respiratory difficulty and an immediate increase in panting after administration. In such cases, the use of Novopulm Novolizer 400 micrograms should be interrupted without prior consultation and the patient should contact their doctor immediately.

Prolonged inhalation of large doses may increase susceptibility to infections. Adaptation to stress may be altered.

Other side effects

Rare (may affect up to 1 in 100 people)

Depression, anxiety, or feeling of concern, cataracts, muscle spasms, tremors, blurred vision.

Rare (may affect up to 1 in 1,000 people):

Allergic reactions (hypersensitivity) and facial swelling, eye, lip, mouth, and throat swelling (angioneurotic edema), anaphylactic reaction;

Suppression of adrenal cortex function (adrenal suppression), growth delay in children and adolescents;

Restlessness, nervousness, abnormal behavior, over-excitement, or irritability (these effects are more common in children); skin reactions such as rash (urticaria), eczema, topical skin inflammation (dermatitis), itching (pruritus), skin redness due to capillary congestion (erythema), bruises, voice changes, and hoarseness (in children)

Very rare (may affect up to 1 in 10,000 people):

Bone density reduction.

Unknown frequency (cannot be estimated from available data): Sleep problems, aggression, excessive activity accompanied by mental restlessness (psychomotor hyperactivity); glaucoma.

Lactose monohydrate contains small amounts of milk proteins and may cause allergic reactions.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears after CAD or EXP on the label, the box, and the cartridge packaging. The expiration date is the last day of the month indicated.

Storage Conditions

Store in the original packaging. No special storage temperature is required.

Storage Conditions in Use: Keep the Novolizer device perfectly closed to protect it from moisture.

Expiration Period Information

Replace the cartridge 6 months after the first opening.

Do not use the powder inhaler for more than 1 year.

Note: It has been demonstrated that the Novolizer device functions for at least 2000 single doses. Therefore, with this device, a maximum of 20 cartridges of 100 single doses and/or 40 cartridges of 50 single doses (within a single year) can be used before replacing it.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Novopulm Novolizer 400 micrograms

The active ingredient is budesonide.

One inhalation (puff) contains 400 micrograms of budesonide.

The other component is lactose monohydrate.

Appearance of Novopulm Novolizer 400 micrograms and packaging contents

Novopulm Novolizer 400 micrograms, powder for inhalation, contains a white powder (0.545 g or 1.09 g) in a cartridge with 50 or 100 measured doses, packaged in a sealed container with an aluminum foil and a powder inhaler, Novolizer.

All components are made of plastic materials.

Packaging sizes:

Original sales packaging:

1 cartridge with 50/100 measured doses and 1 powder inhaler, Novolizer.

2 cartridges with 100 measured doses each and 1 powder inhaler, Novolizer.

Replacement packaging:

1 cartridge with 50/100 measured doses

2 cartridges with 100 measured doses each.

All packaging sizes may not be marketed.

Marketing authorization holder::

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Manufacturer:

McDermott Laboratories T/A Mylan Dublin Respiratory

Unit 25 Baldoyle Industrial Estate

Grange Road, Baldoyle

Dublin 13

Ireland

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the European Economic Area and the United Kingdom (Northern Ireland) with the following names:andUnited Kingdom (Northern Ireland)with 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:

Novopulmonm 400 Novolizer, Pulver zur Inhalation

United Kingdom (Northern Ireland):

Budelin Novolizer 400 micrograms per actuation inhalation powder

Italy:

Budesonide Viatris Novolizer 400microgrammi polvere per inalazione

Netherlands:

Budesonid Novolizer 400 µg, inhalatiepoeder

Portugal:

Budesonido Novolizer 400 microgramaspó para inalação

Spain:

Novopulm Novolizer 400 microgramos, polvo para inhalación

Last review date of this leaflet: 09/2022

For more detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

I N S T R U C C I O N E S D E U S O

Novolizer

1. PREPARACIÓN:

The Powder Inhaler Novolizer makes inhalation a simple and reliable process. Its direct use, the rapid replacement of the cartridge, and easy cleaning are carried out in a simple and quick way.

Place the Powder Inhaler Novolizer in front of you. Press the rough surfaces on both sides of the lid, slide the lid forward(?) and lift it up(?).

Remove the aluminum foil from the container of the cartridge, and extract the new cartridge. This operation must be performed only immediately before using the cartridge. The color coding of the cartridge must correspond to the color of the dosing button.

First cartridge:

Insert the cartridge into the Powder Inhaler Novolizerwith the dosing counter oriented towards the mouthpiece(?). Do not press the dosing button during the insertion of the cartridge.

Replacement:

Nota: The Powder Inhaler Novolizermust be cleaned every time the cartridge is changed, after removing the empty cartridge.

If you have already used the Powder Inhaler Novolizer,remove the empty cartridge first and then insert the new one(?).Do not press the dosing button during the insertion of the cartridge.

Place the lid back in its lateral guides from above(?) and push down towards the colored dosing button, until it fits in its place(?).

Now, Novolizer is loaded and ready to be used.

You can leave the cartridge in the Powder Inhaler Novolizeruntil it is empty, or until 6 months after its insertion. The cartridge is empty if the "0" is seen in the middle of the dosing counter. A new cartridge must be inserted at this time. Cartridges can only be used in the original powder inhaler.

2. UTILIZACIÓN:

Whenever possible, stand or sit during inhalation. When usingNovolizerkeep it always in a horizontal position.Remove the protective cap(?).

Press the colored dosing button completely. A double audible click will be heard and the color of the control window will change from red to green. Release the colored button. Thegreen color in the control window indicates thatNovolizeris ready to be used.

Release the air (but not over the Powder Inhaler Novolizer). Place your lips around the mouthpiece, inhale the powder constantly, deeply, and as quickly as possible (until the maximum inhalation) and hold your breath for a few seconds. During this inspiration, a audible click should be heard, indicating a correct inhalation. Then, continue breathing normally.

Check that the color of the control window has changed again to red, indicating a correct inhalation. Replace the protective cap over the mouthpiece. This completes the inhalation procedure.

The number that appears in the upper window indicates the number of inhalations remaining. The scale 200 (respectively 100)-60 is shown in steps of 20 and between 60 (respectively 50)-0 is shown in steps of 10. If no audible click is heard and no color change occurs, repeat the procedure as described above.

NOTE: The colored dosing button should only be pressed immediately before inhalation.

With Novolizer, it is not possible to produce an accidental overdose. The audible click and the color change in the control window indicate that the inhalation has been carried out correctly. If the color of the control window does not change again to red, it is necessary to repeat the inhalation. If the inhalation is not carried out correctly after several attempts, you should consult your doctor.

3. LIMPIEZA:

The Powder Inhaler Novolizermust be cleaned at regular intervals, but at least every time the cartridge is changed.

Remove the protective cap and the mouthpiece.

First, remove the protective cap. Then, hold the mouthpiece and turn it briefly in the opposite direction to the clock hands(?) until it becomes loose. Then, extract it(?).

Cleaning

Now, turn the Novolizer upside down. Hold the loose dosing button and slide it forward(?) and up(?). Any powder residue can be removed by giving gentle knocks.

Clean the mouthpiece, the dosing button, and the powder inhaler with a soft, dry cloth, without threads.

DO NOT use water or detergent.

Assembly – Insertion of the dosing button

After cleaning, insert the dosing button by sliding it down at an angle(?) and pressing it to fit it in its place(?).

Put the inhaler back in its normal position.

Assembly – Engagement of the mouthpiece and protective cap

Insert the mouthpiece with the pin on the left side of the upper groove and turn it to the right, until it fits in its place. Finally, put the protective cap back on.

Notes

• This leaflet describes the operation of the medication. Please read it carefully in its entirety before using the inhaler for the first time.
• The Novolizer, which is presented with various active substances, does not use any propellant and is designed to be reloaded. This makes Novolizer a very environmentally friendly product.
• It is not possible to produce an overdose with Novolizer. Even pressing the button several times, there is no more powder available for inhalation. Press the button only when you are actually going to inhale. If you cannot inhale correctly after several attempts, consult your doctor.
• Novolizer can be reloaded using new cartridges* containing the active substance and is therefore especially suitable for long-term use (up to one year).
• Do not shake the full Novolizer.
• Please teach your children the correct handling of the device.
• Make sure your Novolizer is protected from moisture and heat, and is kept clean at all times.

* In relation to the corresponding medications, please consult your doctor.

Last review date: 09/2022