Novopulm Novolizer 400 micrograms powder for inhalation

Patient Information Leaflet

Introduction

Patient Information Leaflet

Novopulm Novolizer 400 micrograms

Powder for inhalation

budesonide

Please read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Novopulm Novolizer 400 micrograms is and what it is used for.

2. What you need to know before using Novopulm Novolizer 400 micrograms.

3. How to use Novopulm Novolizer 400 micrograms.

4. Possible adverse effects.

5. How to store Novopulm Novolizer 400 micrograms.

6. Contents of the pack and other information.

1. What Novopulm Novolizer 400 micrograms is and what it is used for

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

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

NOTE:

Novopulm Novolizer 400 micrograms must not be used for the treatment of an acute breathing difficulty crisis (acute asthma attack, or Status asthmaticus (asthma attack occurring frequently and/or persisting for several days)).

2. What you need to know before using Novopulm Novolizer 400 micrograms

Do not use Novopulm Novolizer 400 micrograms

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

Warnings and precautions

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

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

Take special care with Novopulm Novolizer 400 micrograms

If you suffer from pulmonary tuberculosis, fungal infection, or any other airway infection. This also applies if you have previously suffered from these conditions. Inform your doctor.

Budesonide is not suitable for the treatment of an acute breathing difficulty crisis or severe, persistent bronchial spasms (Status asthmaticus). Your doctor will instruct you on the use of inhaled short-acting bronchodilators (bronchodilator) as rescue medication for relief of acute asthma symptoms.

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

Any inhaled glucocorticoid may cause side effects, particularly when high doses are used over prolonged periods. These effects are less likely with inhaled treatment than with oral glucocorticoid tablets. Possible effects include adrenal cortex dysfunction, Cushing's syndrome, Cushingoid features (hormonal disorders caused by high blood cortisol levels, with central obesity, "moon face", thinning of the skin, hypertension, etc.), decreased bone density, growth retardation in children and adolescents, as well as ocular disorders (cataracts and glaucoma), and more rarely a range of psychological and behavioral effects such as psychomotor hyperactivity, sleep disorders, anxiety, depression, or aggression (particularly in children). Therefore, it is important to use the lowest dose that maintains effective asthma control.

During the first few months after switching from tablet treatment to inhaled therapy, periods of stress or emergencies (e.g., severe infections, injuries, or surgery) may occur, and it might be necessary to resume systemic glucocorticoid treatment in the form of tablets or infusions. This also applies to patients who have received prolonged treatment with high doses of inhaled glucocorticoids. They may also have impaired adrenal cortex function, requiring systemic corticosteroid cover during periods of stress and/or elective surgery.

After switching to inhaled treatment, symptoms previously suppressed by prior systemic glucocorticoid therapy may reappear, e.g., allergic rhinitis, allergic eczema, or rheumatic symptoms. These symptoms should be treated additionally with appropriate medications.

Some patients may generally experience nonspecific discomfort during the transition period, despite maintained or even improved respiratory function. In such cases, consult your doctor. Your doctor will decide whether treatment can continue or should be discontinued, for example, if symptoms of adrenal insufficiency occur.

Using Novopulm Novolizer 400 micrograms with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines may increase the effects of Novopulm Novolizer 400 micrograms, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: nelfinavir, ritonavir, cobicistat, and antifungal medications: 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.

Elevated plasma concentrations and enhanced effects of corticosteroids have been observed in women treated with estrogens and steroid contraceptives, but no effects have been observed with budesonida when co-administered with low-dose oral contraceptive combinations.

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

Pregnancy and breastfeeding

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

Pregnancy

Most results from epidemiological studies and post-marketing data worldwide have not detected an increased risk of adverse effects on the fetus or newborn infants following the use of inhaled budesonide during pregnancy. It is important for both mother and fetus to maintain adequate asthma control during pregnancy.

As with any medicine used during pregnancy, the benefit of inhaled budesonide for the mother should be weighed against any potential risk to the fetus.

Breastfeeding

Budesonide passes into breast milk. However, at therapeutic doses, effects on the infant are not expected. Maintenance treatment with inhaled budesonide (200 or 400 micrograms twice daily) in asthmatic women during breastfeeding results in negligible systemic exposure to budesonide in breastfed infants. Therefore, Novopulm Novolizer 400 micrograms may be used during breastfeeding.

Driving and using machines:

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

Novopulm Novolizer 400 micrograms contains milk sugar (lactose), 10.5 mg of lactose monohydrate per delivered dose.

This medicine contains lactose. It may cause allergic reactions in patients with allergy to cow's milk protein. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before using this medicine.

If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before using this medicine.

3. How to use Novopulm Novolizer 400 micrograms

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

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

Unless otherwise directed by your doctor, the recommended normal dosage is as follows:

Adults (including elderly patients) and children/adolescents over 12 years of age:

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

Recommended maximum dose: 2 single doses (800 micrograms) twice daily (daily dose: 1,600 micrograms).

Children aged 6 to 12 years:

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

Recommended maximum dose: 1 single dose (400 micrograms) twice daily (daily dose: 800 micrograms).

When administered once daily, the dose should be taken in the afternoon-evening.

Children under 6 years of age:

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

Supervise the child to ensure correct handling of the Novolizer device.

Children

In children receiving long-term treatment with inhaled glucocorticoids, regular monitoring of growth is recommended.

Elderly patients

Dose adjustments are generally not required. In general, the lowest effective dose required for adequate control should be used.

If asthma symptoms worsen (recognizable, for example, by persistent respiratory symptoms and increased use of an inhaled bronchodilator), you should consult your doctor as soon as possible. If you were taking a single daily dose, you may now need the same total daily dose administered in two divided doses (morning and evening). In any case, your doctor will decide whether your usual dose of Novopulm Novolizer 400 micrograms needs to be increased.

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

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

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

Method of administration

For inhalation use only.

Follow the Instructions for Use to perform inhalation.

Important information for handling

To reduce the risk of fungal infection in the mouth and throat (oral candidiasis) and hoarseness, it is recommended that inhalation be performed before meals and/or that the mouth be rinsed with water or teeth brushed after each inhalation.

Duration of treatment

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

If you have never previously used glucocorticoids or have only received them occasionally for short periods, regular use of Novopulm Novolizer 400 micrograms will lead to improved breathing after approximately 10 days. However, severe mucus congestion 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, initiation of therapy should be supplemented with systemic corticosteroid tablets (systemic glucocorticoids). Subsequently, the tablet dose should be gradually reduced while continuing inhaled therapy.

If you have previously taken cortisone for prolonged periods, the switch to Novopulm Novolizer 400 micrograms should be made when your symptoms are fully controlled. Typically, in this situation adrenal cortical function is suppressed; therefore, systemic corticosteroid tablets must be tapered gradually without abrupt discontinuation. At the beginning of the transition period, Novopulm Novolizer 400 micrograms should be administered concurrently for approximately 10 days. Thereafter, depending on your response, the daily dose of cortisone tablets may be gradually reduced at intervals of one to two weeks.

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

It is important that you use the dose prescribed by your doctor or pharmacist. Do not increase or decrease the dose without consulting your doctor.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone (91) 562 04 20.

If you forget to use Novopulm Novolizer 400 micrograms:

Do not take a double dose to make up for forgotten doses.

If you stop using Novopulm Novolizer 400 micrograms:

Do not stop treatment with Novopulm Novolizer 400 micrograms without first consulting your doctor, as this could lead to worsening of your condition.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Most important adverse effects

Irritation of the oral mucosa (throat irritation), accompanied by difficulty swallowing, hoarseness, and cough, may occur frequently.

Treatment with inhaled budesonide 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 condition responds to topical antifungal therapy without discontinuing treatment with Novopulm Novolizer 400 micrograms.

As with other inhaled therapies, bronchospasm (paradoxical bronchospasm) may occur rarely, manifesting as a temporary increase in breathing difficulty and immediate worsening of wheezing after administration. In such cases only, you should stop using Novopulm Novolizer 400 micrograms without consulting your doctor first and then contact your doctor immediately.

Inhalation of high doses over a prolonged period may increase susceptibility to infections. The ability to adapt to stress may be impaired.

Other adverse effects

Uncommon (may affect up to 1 in 100 people):
Depression, anxiety or feeling of unease, cataracts, muscle cramps, tremor, 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 reaction;
suppression of adrenal cortex function (adrenal suppression), growth retardation in children and adolescents;
restlessness, nervousness, abnormal behavior, over-excitement or irritability (these effects are more frequent in children); skin reactions such as rash (urticaria), eczema, local inflammation of the skin (dermatitis), itching (pruritus), redness of the skin due to capillary congestion (erythema), bruising, voice disorders, and hoarseness (in children).

Very rare (may affect up to 1 in 10,000 people):
Reduction in bone density.

Frequency not known (cannot be estimated from available data):
Sleep disturbances, aggression, excessive activity accompanied by mental restlessness (psychomotor hyperactivity); glaucoma.

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Novopulm Novolizer 400 micrograms

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

Do not use this medicine after the expiry date stated after CAD or EXP on the label, carton, and cartridge packaging. The expiry date refers to the last day of the month indicated.

Storage conditions

Store in the original packaging. No special storage temperature requirements.

Storage conditions during use: Keep the Novolizer device completely closed to protect it from moisture.

Information on shelf life

Replace the cartridge 6 months after first opening.

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

Note: The Novolizer device has been shown to function for at least 2,000 single doses. Therefore, with this device, a maximum of 20 cartridges of 100 single doses and/or 40 cartridges of 50 single doses (within one year) can be used before replacement is required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Novopulm Novolizer 400 micrograms

The active substance is budesonide.

One inhalation (puff) contains 400 micrograms of budesonide.

The other component is lactose monohydrate.

Appearance of Novopulm Novolizer 400 micrograms and contents of the pack

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 aluminium foil lid, plus a powder inhaler, Novolizer.

All components are made from plastic materials.

Pack sizes:

Original sales packs:

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 packs:

1 cartridge with 50/100 measured doses.

2 cartridges with 100 measured 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

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorized in the European Economic Area and the United Kingdom (Northern Ireland) 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:
Novopulmonm 400 Novolizer, Pulver zur Inhalation

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 µg, inhalatiepoeder

Portugal:
Budesonido Novolizer 400 microgramas pó para inalação

Spain:
Novopulm Novolizer 400 microgramos, polvo para inhalación

Date of latest review of this leaflet: 09/2022

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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

Novolizer

1. PREPARATION:

The Novolizer Dry Powder Inhaler makes inhalation a simple and reliable process. Direct use, quick cartridge replacement, and easy cleaning are carried out quickly and easily.

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

Remove the protective aluminium foil from the cartridge container and take out the new cartridge. This operation should only be performed immediately before using the cartridge. The colour coding of the cartridge must match the colour of the dosing button.

First cartridge:

Insert the cartridge into the Novolizer Dry Powder Inhaler with the dose counter facing towards the mouthpiece (?). Do not press the dosing button during cartridge insertion.

Replacement:

Note: The Novolizer Dry Powder Inhaler must be cleaned each time the cartridge is changed, after removing the empty cartridge.

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

Replace the cap into its side guides from above (?) and push down towards the coloured dosing button until it clicks into place (?).

The Novolizer is now loaded and ready for use.

You may leave the cartridge in the Novolizer Dry Powder Inhaler until it is empty, or for up to 6 months after insertion. The cartridge is empty when a "0" appears in the middle of the dose counter. A new cartridge must then be inserted. Cartridges can only be used with the original dry powder inhaler.

2. USE:

Whenever possible, remain standing or sitting during inhalation. When using Novolizer, always keep it in a horizontal position. First, remove the protective cap (?).

Press the coloured dosing button fully down. You will hear a distinct double click and the colour in the control window will change from red to green. Then release the coloured button. The green colour in the control window indicates that the Novolizer is ready for use.

Breathe out first (but not into the Novolizer Dry Powder Inhaler). Place your lips around the mouthpiece, inhale the powder steadily, deeply and as quickly as possible (to maximum inhalation), and hold your breath for a few seconds. During this inhalation, you should hear an audible click, indicating correct inhalation. Then continue breathing normally.

Check that the colour in the control window has changed back to red, which also confirms correct inhalation. Replace the protective cap over the mouthpiece. This completes the inhalation procedure.

The number shown in the upper window indicates the number of inhalations remaining. The numerical scale 200 (respectively 100)-60 is displayed in steps of 20, and between 60 (respectively 50)-0 it is displayed in steps of 10. If you did not hear the click sound and no colour change occurred, repeat the procedure as described above.

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

With Novolizer, accidental overdose is not possible. The audible click and the colour change in the control window confirm that inhalation has been performed correctly. If the control window does not change back to red, the inhalation must be repeated. If inhalation is not successful after several attempts, you should consult your doctor.

3. CLEANING:

The Novolizer Dry Powder Inhaler should be cleaned regularly, but at least every time the cartridge is changed.

Remove the protective cap and the mouthpiece.

First, remove the protective cap. Then grasp the mouthpiece and turn it briefly counterclockwise (?) until it loosens. Then remove it (?).

Cleaning

Now turn the Novolizer upside down. Hold the loose dosing slider and move it forward (?) and upwards (?). Any powder residue can be removed by gently tapping.

Clean the mouthpiece, dosing slider and powder inhaler with a soft, lint-free dry cloth.

DO NOT use water or detergent.

Reassembly – Inserting the dosing slider

After cleaning, insert the dosing slider by sliding it downwards at an angle (?) and press it into place (?).

Return the inhaler to its normal position.

Reassembly – Fitting the mouthpiece and protective cap

Insert the mouthpiece with the pin into the left side of the upper slot and rotate it to the right until it clicks into place. Finish by replacing the protective cap.

Notes

• The Patient Information Leaflet describes how the medicine works. Please read it carefully in full before using the inhaler for the first time.

• The Novolizer, available with various active substances, uses no propellants and is designed to be rechargeable. This makes Novolizer an environmentally friendly product.

• Overdose with Novolizer is not possible. Even if the button is pressed several times, no additional powder will be available for inhalation. Press the button only when you are actually about to inhale. If you are unable to inhale correctly after several attempts, consult your doctor.

• Novolizer can be reloaded using new cartridges* containing the active substance, making it especially suitable for long-term use (up to one year).

• Do not shake the filled Novolizer.

• Please teach your children the correct way to use the device.

• Ensure your Novolizer is protected from moisture and heat, and remains clean at all times.

• For information regarding corresponding medicines, please consult your doctor.

Date of latest revision: 09/2022