Formatris Novolizer 12 micrograms/dose, powder for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Formatris Novolizer 12 micrograms/dose

Inhalation powder

formoterol

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 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 these adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Formatris Novolizer 12 micrograms is and what it is used for.
2. What you need to know before using Formatris Novolizer 12 micrograms.
3. How to use Formatris Novolizer 12 micrograms.
4. Possible adverse effects.
5. How to store Formatris Novolizer 12 micrograms.
6. Contents of the pack and other information.

1. What Formatris Novolizer 12 micrograms is and what it is used for

Formatris Novolizer is an inhalation powder containing formoterol. Formoterol belongs to a group of medicines known as long-acting beta-agonists. These medicines relax certain muscles, for example, opening up the airways in the lungs.

Formatris provides long-lasting relief (up to 12 hours) of symptoms such as wheezing, shortness of breath, and cough in patients with asthma who are already being treated with inhaled glucocorticosteroids. It makes breathing easier by relaxing muscle spasms in the airways of the lungs. Regular use of Formatris together with inhaled glucocorticosteroids will help prevent breathing problems.

Formatris is also used to relieve symptoms such as wheezing, shortness of breath, and cough in patients with chronic obstructive pulmonary disease (COPD).

2. What you need to know before using Formatris Novolizer 12 micrograms

Do not use Formatris if you are allergic (hypersensitive) to formoterol or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before you start using Formatris.

Formatris must not be used (and is not sufficient) as initial treatment for asthma.

Formatris must not be used to treat an acute asthma attack. In such situations, you must use your fast-acting bronchodilator (e.g., salbutamol).

If you are an asthma patient, you must also be receiving glucocorticosteroid therapy in order to achieve optimal treatment of bronchial inflammation.

It is very important that you continue your anti-inflammatory therapy (glucocorticosteroids). You must not reduce the dose of your anti-inflammatory therapy (glucocorticosteroids) after starting formoterol without your doctor’s approval, even if your symptoms improve.

If you need to take your medication to prevent exercise-induced asthma more frequently than usual, this may be a sign that your asthma control is inadequate. In this case, you should contact your doctor for a reassessment of your anti-asthma therapy.

Before taking Formatris, take special care and consult your doctor if you have:

• any heart disease,
• high blood pressure problems,
• diabetes,
• hyperactive thyroid disorders, or
• adrenal gland problems.

As with any other inhaled therapy, there is a risk of paradoxical bronchospasm (immediate increase in wheezing and shortness of breath) immediately after using the inhaler. If this occurs, you must consult your doctor immediately.

If your symptoms persist or worsen, or if you need to increase the number of formoterol doses required to control your symptoms, this usually indicates worsening of the disease; in such cases, you must contact your doctor for a reassessment of treatment.

Children

The use of this medicine is not recommended in children under 6 years of age.

Using Formatris with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, include:

• other beta-agonists (e.g., salbutamol, salmeterol) or ephedrine

• xanthine derivatives (e.g., theophylline)

• steroid medicines (e.g., prednisolone)

• diuretics or water tablets (e.g., furosemide)

• digoxin

• antihistamines (e.g., terfenadine, astemizole)

• medicines for treating rapid or irregular heartbeat (e.g., quinidine)

• phenothiazines (e.g., chlorpromazine) used to treat mental disorders or severe nausea and vomiting

• antibiotics (e.g., erythromycin)

• tricyclic antidepressants (e.g., amitriptyline) or monoamine oxidase inhibitors (e.g., phenelzine)

• hormones (e.g., L-thyroxine, oxytocin)

• beta-blockers for high blood pressure or angina (taken orally, such as atenolol, metoprolol, or as eye drops, e.g., timolol)

• Some general anaesthetics may interact with formoterol, causing heart problems and lowering of blood pressure. Therefore, if you are undergoing surgery, you must inform hospital staff that you are taking Formatris.

• As with other medicines of this type, if formoterol is taken with alcohol, or with medicines for Parkinson’s disease or for thyroid problems, you may experience an increased heart rate (palpitations).

Using Formatris with food, drinks and alcohol

You should avoid consuming alcohol, as it may cause an increased heart rate (palpitations). Food and other drinks have not been shown to affect the effectiveness of Formatris.

Pregnancy and lactation

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.

Formoterol should only be used during pregnancy (particularly during the first three months and at the end of pregnancy, as well as during labour) after careful assessment of the situation.

It is unknown whether formoterol is excreted in human milk. Therefore, administration of Formatris during breastfeeding should only be considered if the expected benefit outweighs any possible risk to the infant.

Driving and use of machines:

Formatris has no effect on the ability to drive or operate machinery.

Formatris contains milk sugar (lactose).

Normally, the lactose content of a single dose does not cause problems in individuals with lactose intolerance. Milk sugar (lactose) may contain small amounts of milk proteins.

3. How to use Formatris Novolizer 12 micrograms

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. If the person taking the medicine is a child, they must know how to use the inhaler correctly and should only do so with the help of an adult.

Recommended dose:

Asthma

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

The usual dose is 1 inhalation in the morning and 1 inhalation again at night. In more severe cases of asthma, your doctor may prescribe 2 inhalations twice daily.

The maximum daily dose is 4 inhalations (2 inhalations twice daily).

Use in children aged 6 years and older

The usual dose is 1 inhalation in the morning and 1 inhalation again at night. In more severe cases of asthma, your doctor may prescribe 2 inhalations twice daily.

The usual daily dose should not exceed 2 inhalations, although occasionally a maximum of up to 4 inhalations within a 24-hour period may be authorized.

Use in children under 6 years of age

The use of Formatris Novolizer is not recommended in children under 6 years of age, as the available experience in this age group is insufficient.

COPD (chronic obstructive pulmonary disease)

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

The usual dose is 1 inhalation in the morning and 1 inhalation again at night.

The usual daily dose should not exceed 2 inhalations.

If necessary, additional inhalations beyond those prescribed for regular therapy may be administered for symptom relief, up to a maximum total daily dose of 4 inhalations. No more than 2 inhalations should be administered on a single occasion.

Administration Method

For inhalation use only.

Perform inhalations as described in the "Instructions for Use" shown on the reverse of this leaflet.

If you use more Formatris than you should

Symptoms of an overdose are consistent with the adverse effects, such as: tremors, headache, palpitations, nausea, and vomiting.

If you experience any of these reactions, you should consult your doctor immediately.

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

If you forget to use Formatris

Take the missed dose as soon as you remember; if it is almost time for your next dose, simply take the next dose at the regular time.

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

If you stop using Formatris

Do not interrupt or reduce the dose of Formatris, or of any other medication for your respiratory problems, just because you feel better, without first consulting your doctor. Regular use of these medications is very important.

If you feel dizzy or very restless, or if you experience unusually rapid heartbeats, your dose of Formatris may be too high. Inform your doctor as soon as possible.

Once your symptoms are under control, your doctor may consider gradually reducing the dose of Formatris to adjust your treatment to the lowest effective dose.

If you have any questions or doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

The possible adverse effects are listed below according to their frequency. If you are unsure about any of the following adverse effects, please ask your doctor to explain them.

Most important adverse effects
As with all inhalers, the powder may cause wheezing immediately after inhalation. This is a rare occurrence (may affect up to 1 in 1,000 people).
On rare occasions, an allergic reaction may lead to a condition known as angioneurotic edema, which involves swelling of the face, lips, eyes, and throat. If you experience any of these allergic reactions, you must stop taking Formatris immediately and consult your doctor.
In very rare cases (may affect up to 1 in 10,000 people), severe chest pain (angina pectoris) may occur.

Other adverse effects

Frequent adverse effects (may affect up to 1 in 10 people):
Headaches, tremors, and palpitations.

Uncommon adverse effects (may affect up to 1 in 100 people):
Agitation, restlessness, sleep disorders, muscle cramps, and throat irritation.

Rare adverse effects (may affect up to 1 in 1,000 people):
Fast or irregular heartbeat, nausea (feeling of dizziness), changes in potassium levels that may cause muscle weakness, nervousness, and wheezing. Allergic reactions such as skin reactions including exanthema, urticaria, and pruritus, leading to transient rash, uneven swelling, redness, and itching.

Very rare adverse effects (may affect up to 1 in 10,000 people):
Prolongation of the QTc interval which, in susceptible patients, may increase the risk of serious cardiac rhythm disorders, hyperglycaemia (increased blood glucose), taste disturbances, fainting, and changes in blood pressure.

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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Formatris Novolizer 12 micrograms

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

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

Storage conditions

Keep the cartridge in its original packaging until ready for use.

After opening the cartridge packaging and inserting it into the Novolizer device, store Formatris in a dry place, protected from moisture and at a temperature not exceeding 25 °C.

Information on expiry

Replace the cartridge 6 months after first opening.

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

Note: The Novolizer device must be replaced after 2000 inhalations. Therefore, a maximum of 33 cartridges containing 60 single doses each should be used with this device (within one year).

The Novolizer device should be cleaned regularly, but at least every time the cartridge is changed. Cleaning instructions for the device are provided in the instructions for use on the reverse of this leaflet.

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

6. Contents of the pack and other information

Composition of Formatris:

Formatris Novolizer 12 micrograms is a dry powder for inhalation. The active substance is formoterol.

One inhalation contains 8.36 micrograms of formoterol (as fumarate dihydrate).

The other component is lactose monohydrate (milk sugar). Formatris contains 11.488 mg of lactose per inhalation.

Appearance of Formatris and contents of the pack

Formatris, powder for inhalation, contains a white powder in a cartridge, and is available in the following pack sizes:

Original sale packs:

• 1 dry powder inhaler and 1 cartridge containing at least 60 inhalable doses
• 1 dry powder inhaler and 2 cartridges containing at least 60 inhalable doses each

Replacement packs:

• 1 cartridge containing at least 60 inhalable doses
• 2 cartridges containing at least 60 inhalable doses each
• 3 cartridges containing at least 60 inhalable 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 medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

This medicinal product is authorized in European Economic Area (EEA) Member States and the United Kingdom (Northern Ireland) under the following names:

Austria:
Novolizer Formoterol Meda 12 µg Pulver zur Inhalation

Belgium and Luxembourg:
Novolizer Formoterol 12 microgrammes, poudre pour inhalation

Germany:
Formoterol Novolizer 12 Mikrogramm, Pulver zur Inhalation

France:
Asmelor Novolizer 12 microgrammes/dose, poudre pour inhalation

Italy:
Formoterolo Viatris Novolizer 12 microgrammi polvere per inalazione

Netherlands:
Formoterol Novolizer 12 µg, inhalatiepoeder

Portugal:
Formoterol Novolizer 12 microgramas/dose, pó para inalação

Spain:
Formatris Novolizer 12 microgramos/dosis, polvo para inhalación

United Kingdom (Northern Ireland):
Formatris Novolizer 12 micrograms per actuation inhalation powder

Date of the latest revision of this leaflet: December 2022

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

Tips for Living with Asthma

Asthma can be managed in various ways. Your doctor will work with you to design a treatment plan tailored to your individual needs, which should help reduce your asthma symptoms and the number of asthma attacks.

You can also contribute to the success of your treatment, for example:

• By trying to avoid or reduce exposure to triggers of asthma attacks, such as animal dander, smoking (including passive smoking), moulds, pollen, and house dust mites.
• If you know that exercise triggers asthma in your case, make sure you follow your doctor's instructions before starting any physical activity.
• Be open with your doctor or healthcare provider about how asthma affects your daily life, and work together to develop a treatment plan that fits your lifestyle. Do not forget to take your asthma medication exactly as prescribed by your doctor.
• If you have any questions about your medication, consult your pharmacist, healthcare provider, or doctor.

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

Novolizer

(Illustration of cartridge and device with labelling:)

Cartridge
Cartridge container
Sliding cover
Dose counter
Dosing button
Control window
Protective cap

(Note: The following texts are accompanied by corresponding illustrations.)

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 cover, slide the cover forward (?) and lift it up (?).

Remove the aluminium protective 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 dosing button.

The small red disc at the bottom of the cartridge cylinder is a drying agent and must be discarded after removing the cartridge.

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

Your Novolizer device 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 you see a "0" in the middle of the dose counter. You must then insert a new cartridge. 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 device, always keep it in a horizontal position. First, remove the protective cap (?).

Press the coloured dosing button fully. You will hear an audible 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 device is ready for use.

Breathe out (but not over 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 60–0 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 the Novolizer device, 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 colour in 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 at regular intervals, 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 it loosens. Then remove it (?).

Cleaning:

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

Clean the mouthpiece, dosing slider, and 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 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 peg 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 the operation of the medicine. Please read it carefully in full before using the inhaler for the first time.
• The Novolizer device, which is available with different active substances, uses no propellants and is designed to be reloaded, making the Novolizer device particularly environmentally friendly.
• Accidental overdose is not possible with the Novolizer device. 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.
• The Novolizer device 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 filled Novolizer device.
• Please teach your children the correct use of the device.
• Ensure that your Novolizer device is protected from moisture and heat and kept clean at all times.

* For information regarding the corresponding medicines, please consult your doctor.

Date of latest revision: December 2022