Novopulm Novolizer 200 micrograms powder for inhalation

Package Leaflet: Information for the user

Introduction

Package leaflet: information for the user

Novopulm Novolizer 200 micrograms

Inhalation powder

budesonide

Read the entire package 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What Novopulm Novolizer 200 micrograms is and what it is used for

Budesonide, the active substance of Novopulm Novolizer 200 micrograms, is a glucocorticoid (corticosteroid) for inhalation.

Novopulm Novolizer 200 micrograms is used for the regular treatment of persistent asthma.

NOTE:

Novopulm Novolizer 200 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 200 micrograms

Do not use Novopulm Novolizer 200 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

Consult your doctor or pharmacist before starting to use Novopulm Novolizer 200 micrograms.

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

Take special care with Novopulm Novolizer 200 micrograms

If you have 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 crisis or persistent severe bronchial spasms (Status asthmaticus). Your doctor will instruct you on the use of short-acting inhaled 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 disturbances, anxiety, depression, or aggression (particularly in children). Therefore, it is important to use the lowest dose that maintains effective asthma control.

During the first months after switching from tablet treatment to inhaled therapy, periods of stress or emergencies (e.g., severe infections, injuries, and surgery) may require resumption of 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 cortical function, requiring systemic corticosteroid coverage during periods of stress and/or elective surgery.

After switching to inhaled therapy, symptoms previously suppressed by prior systemic glucocorticoid treatment 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. The doctor will decide whether treatment can continue or should be discontinued, for example, if symptoms of adrenal insufficiency occur.

Using Novopulm Novolizer 200 micrograms with other medicines

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

Some medicines may increase the effects of Novopulm Novolizer 200 micrograms, so your doctor will perform careful monitoring if you are taking these medicines (including some for HIV: 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.

Elevated plasma concentrations and enhanced effects of corticosteroids have been observed in women treated with estrogens and steroid contraceptives; however, no such effects have been observed with budesonida when used concomitantly with low-dose oral contraceptive combinations.

Since adrenal function may be suppressed, false results (low values) 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 are planning 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 following inhaled budesonide use during pregnancy. It is important for both mother and fetus to maintain adequate asthma treatment during pregnancy.

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

Breastfeeding

Budesonide passes into breast milk. However, at therapeutic doses, effects on the breastfed infant are not expected. Maintenance treatment 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, Novopulm Novolizer 200 micrograms may be used during breastfeeding.

Driving and using machines:

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

Novopulm Novolizer 200 micrograms contains milk sugar (lactose), 10.7 mg lactose monohydrate per delivered dose.

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

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

3. How to use Novopulm Novolizer 200 micrograms

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

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

Unless otherwise indicated 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: 1–2 single doses (200–400 micrograms) once or twice daily.

Recommended maximum dose: 4 single doses (800 micrograms) twice daily (daily dose: 1,600 micrograms).

Children aged 6 to 12 years:

Recommended initial dose: 1 single dose (200 micrograms) twice daily, or 200–400 micrograms once daily.

Recommended maximum dose: 2 single doses (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 200 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. As a rule, the lowest dose required for effective control should be used.

If your asthma symptoms worsen (evident, for example, by persistent breathing difficulties 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 night). In any case, your doctor will decide whether your usual dose of Novopulm Novolizer 200 micrograms needs to be increased.

Inform your doctor or pharmacist if you feel that the effect of Novopulm Novolizer 200 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 200 micrograms, your treatment regimen must be adjusted by your doctor.

Method of administration

For inhalation use.

Follow the Instructions for Use when inhaling the medication.

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 you rinse your mouth with water or brush your teeth after each inhalation.

Duration of treatment

Novopulm Novolizer 200 micrograms is intended for long-term therapy. It should be administered regularly according to the recommended treatment schedule, even during periods when the patient is asymptomatic.

If you have never previously used glucocorticoids or have only used them occasionally for short periods, regular use of Novopulm Novolizer 200 micrograms will lead to improved breathing after approximately 10 days. However, severe mucosal 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 corticosteroids for prolonged periods, switching to Novopulm Novolizer 200 micrograms should occur when your symptoms are fully controlled. Typically, in this situation, adrenal cortex function is suppressed, and therefore systemic corticosteroid tablets must be tapered gradually without abrupt discontinuation. At the start of the transition period, Novopulm Novolizer 200 micrograms should be administered concurrently for approximately 10 days. Thereafter, depending on your response, the daily dose of corticosteroid tablets may be gradually reduced at intervals of one to two weeks.

If you inhale more Novopulm Novolizer 200 micrograms than you should

It is important to 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 200 micrograms

Do not take a double dose to make up for a missed dose.

If you stop using Novopulm Novolizer 200 micrograms

Do not stop treatment with Novopulm Novolizer 200 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 will experience 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 the need to interrupt treatment with Novopulm Novolizer 200 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. Only in such cases should the use of Novopulm Novolizer 200 micrograms be stopped without prior consultation, and you should 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 spasm, 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 behaviour, 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 changes 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 may 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 200 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.

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 10 cartridges of 200 single doses and/or 20 cartridges of 100 single doses (within one year) can be used before replacement is required.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Novopulm Novolizer 200 micrograms

The active substance is budesonide.

One inhalation (puff) contains 200 micrograms of budesonide.

The other component is lactose monohydrate.

Appearance of Novopulm Novolizer 200 micrograms and contents of the pack

Novopulm Novolizer 200 micrograms, powder for inhalation, contains a white powder (1.09 g or 2.18 g) in a cartridge with 100 or 200 measured doses, packed in a sealed container with an aluminum foil laminate, together with a dry powder inhaler, Novolizer.

All components are made from plastic materials.

Pack sizes:

Original sales packs:

• 1 cartridge with 100/200 measured doses and 1 dry powder inhaler, Novolizer.
• 2 cartridges with 200 measured doses each and 1 dry powder inhaler, Novolizer.

Replacement packs:

• 1 cartridge with 100 measured doses (UK and Ireland only).
• 1 cartridge with 200 measured doses.
• 2 cartridges with 200 measured doses each.

Not all pack sizes may be commercially available.

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 member states and the United Kingdom (Northern Ireland) 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

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

Date of most recent 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 simple and reliable. Its straightforward 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 textured surfaces on both sides of the cap, slide the cap forward (?) and lift it off (?).

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

First cartridge:

Insert the cartridge into the Novolizer dry powder inhaler with the dose counter facing the mouthpiece (?). Do not press the dose 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 dose button during cartridge insertion.

Replace the cap by placing it into the side guides from above (?) and press down towards the coloured dose button until it clicks into place (?).

Your Novolizer is now loaded and ready for use.

The cartridge may remain 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 should 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 the Novolizer, always keep it in a horizontal position. First, remove the protective cap (?).

Press the coloured dose 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 (but not over the Novolizer dry powder inhaler). Place your lips around the mouthpiece and inhale the powder steadily, deeply, and as quickly as possible (to maximum inhalation), then hold your breath for a few seconds. During this inhalation, 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, which also confirms correct inhalation. Replace the protective cap over the mouthpiece. This completes the inhalation procedure.

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

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

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

3. CLEANING:

The Novolizer dry powder inhaler should be cleaned regularly, but at least each time the cartridge is changed.

Remove the protective cap and mouthpiece.

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

Cleaning

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

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

DO NOT use water or detergent.

Reassembly – Inserting the dose slider

After cleaning, insert the dose slider by sliding it down 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 turn 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 the Novolizer an environmentally friendly product.

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

• The 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 use of the device.

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

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

Date of most recent review: 09/2022