Patient Information Leaflet

Formatris Novolizer 12 micrograms/dose

Powder for inhalation

formoterol

Read this leaflet carefully before you start using this medicine because 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

Formatris provides long-lasting relief (up to 12 hours) of symptoms such as wheezing, shortness of breath, and cough in patients withasthmaalready being treated with inhaled glucocorticosteroids. It facilitates breathing by relaxing muscle spasms in the airways of the lungs. The continued use of Formatris along with inhaled glucocorticosteroids will help prevent respiratory problems.

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Formatris.

Formatris should not be used (and is not sufficient) as the first treatment for asthma.

Formatris should not be used to treat an acute asthma attack. In these situations, you should use your immediate-acting bronchodilator (for example, salbutamol).

If you are an asthma patient,you will also need to receive treatment with glucocorticosteroids, in order to achieve optimal treatment of bronchial inflammation.

It is of great importance that you continue takingyour anti-inflammatory therapy (glucocorticosteroids). You should not reduce the dose of anti-inflammatory therapy (glucocorticosteroids) after introducing formoterol without your doctor's authorization, even if your symptoms improve.

If you need to take your medication to prevent exercise-induced asthma more frequently than usual, it may be a sign that your asthma control is not sufficient. In this case, you should contact your doctor for a new evaluation of your asthma therapy.

Before takingFormatris, be especially careful and consult your doctorif you suffer from

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

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

The fact that your symptoms continue or worsen, or that you need to take more doses of formoterol to control your symptoms, usually indicates a worsening of the disease; in these cases, you should contact your doctor for a reevaluation of your treatment.

Children

This medicine is not recommended for use in children under 6 years.

Use of Formatris with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

Particularly, the following are included:

• other beta-agonists (for example, salbutamol, salmeterol) or ephedrine
• xanthine derivatives (for example, theophylline)
• steroids (for example, prednisolone)
• diuretics or urine tablets (for example, furosemide)
• digoxin
• antihistamines (for example, terfenadine, astemizol)
• medicines for the treatment of rapid or irregular heart rate (for example, quinidine)
• phenothiazines (for example, chlorpromazine) used to treat mental disorders or intense nausea and vomiting
• antibiotics (for example, erythromycin)
• tricyclic antidepressants (for example, amitriptyline) or monoamine oxidase inhibitors (phenelzine)
• hormones (for example, L-thyroxine, oxytocin)

• beta-blockersfor high blood pressure or angina (administered orally, for example, atenolol, metoprolol, or as eye drops, for example, timolol)
• Some general anesthetics may interact with formoterol, causing cardiac problems and a decrease in blood pressure. Therefore, if you are to undergo asurgical procedure, you should inform the hospital staff that you are taking Formatris.
• As with other medicines of this type, if Formoterol is taken withalcohol, or with medicines forparkinson's diseaseorthyroid problems, you may experience an increase in heart rate (pulsations).

Use of Formatris with food, drinks, and alcohol

You should avoid consuming alcohol, as it may cause an increase in heart rate (pulsations). Foods and other drinks have not been shown to alter the efficacy of Formatris.

Pregnancy and breastfeeding

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

Formoterol will only be used during pregnancy (particularly during the first three months and at the end of it, as well as during delivery), after careful consideration of the situation.

The passage of formoterol into breast milk is unknown. Therefore, the administration of Formatris during breastfeeding should only be considered if the expected benefit is greater than any possible risk to the child.

Driving and operating machines:

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

Formatris containslactose.

Normally, the lactose content of a single dose does not cause any problems in people with lactose intolerance. The lactose may contain small amounts of milk proteins.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. If the person taking the medication is a child, they should know how to use the inhaler correctly, and only do it with the help of an adult.

The recommended dose is:

Asthma

Adults (including elderly people) and adolescents over 12 years old

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

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

Use in children 6 years old or more

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

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

The usual daily dose should not exceed 2 inhalations, however, and occasionally, a maximum of up to 4 inhalations in 24 hours may be authorized.

Use in children under 6 years old

It is not recommendedto use Formatris Novolizer in children under 6 years old, as the available experience in this age group is insufficient.

Chronic Obstructive Pulmonary Disease (COPD)

Adults (including elderly people) and adolescents over 12 years old

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 can be administered beyond those prescribed for the usual therapy for symptom relief, up to a maximum total daily dose of 4 inhalations. No more than 2 inhalations should be administered at the same time.

Administration Method

Inhalation route.

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

If you use more Formatris than you should

The symptoms of an overdose are consistent with the adverse effects, such as: tremors, headaches, palpitations, nausea, and vomiting.

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

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

If you forgot to use Formatris

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

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

If you interrupt the administration of Formatris

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

If you feel dizzy or very agitated, or if you experience unusually rapid heartbeats, it is possible that your dose of Formatris is too high. Inform your doctor as soon as possible.

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

Most important side effects
As with all inhalers, it is possible that the powder may cause coughing immediately after inhalation.This is a rare incidence (it may affect up to 1 in 1,000 people)..
In rare cases, an allergic reaction may lead to a condition known as angioneuritic edema, characterized by the inflammation of the face, lips, eyes, and throat.. If you experience any of these allergic reactions, you must stop taking Formatris immediately and consult with your doctor
In very rare cases (it may affect up to 1 in 10,000 people), it may cause intense chest pain (angina pectoris).

Other side effects

Frequent side effects(may affect up to 1 in 10 people):

Headaches, tremors, and palpitations.

Less frequent side effects(may affect up to 1 in 100 people):

Restlessness, anxiety, sleep disturbances, muscle cramps, and throat irritation.

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

Frequent or irregular heartbeats, nausea (feeling of dizziness), variations in potassium levels that may cause muscle weakness, nervousness, and coughing. Allergic reactions such as skin reactions like exanthema, urticaria, and pruritus that lead to a transient rash, uneven swelling, redness, and itching.

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

Prolongation of the QTc interval, which, in sensitive patients, may increase the risk of severe arrhythmias, hyperglycemia (elevated blood glucose), changes in taste, fainting, and variations in blood pressure

Reporting 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

Storage Conditions

Keep the cartridge in its original packaging until use.

After opening the cartridge packaging and inserting it into the Novolizer device, store Formatris in a dry place, protected from humidity and at a temperature below 25 °C.

Expiration Date Information

Replace the cartridge6 monthsafter first opening.

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

Note: The Novolizer devicemust be replaced after 2000 inhalations. Therefore, a maximum of 33 cartridges containing 60 single doses (in the same year) must be used with this device.

The Novolizer device must be cleaned at regular intervals, but at least each time the cartridge is changed. The cleaning instructions for the device are found in the usage instructions on the reverse of this prospectus.

Medications must not be disposed of through drains or in the trash. Dispose of packaging and medications that are no longer needed at the SIGRE collection pointat the pharmacy. In case of doubt, ask your pharmacist how to dispose of packaging and medications that are no longer needed. This will help protect the environment.

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 (in the form of dihydrochloride fumarate).

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

Appearance of Formatris and contents of the package

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

Packages for sale:

1 inhaler powder and a cartridge with at least 60 doses to inhale

1 inhaler powder and two cartridges with at least 60 doses to inhale each

Replacement packages:

1 cartridge with at least 60 doses to inhale

2 cartridges with at least 60 doses to inhale each

3 cartridges with at least 60 doses to inhale each

All package sizes may not 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

You can request more information about this medicine by contacting 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 member states of the European Economic Area and the United Kingdom (Northern Ireland) with 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

December 2022 date of the last review of this prospectus:

“Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”

Living with Asthma

Asthma can be controlled in different ways. Your doctor will design a treatment plan with you that will suit your individual needs, and which should help reduce your asthma symptoms and the number of asthma attacks.

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

• Try to avoid or reduce contact with elements that can trigger an asthma episode, such as, for example, animal skins, smoking (including passive smoking), mold, pollen, and house dust mites.

• If you know that exercise acts as a trigger for asthma in your case, make sure you have followed the doctor's instructions before starting any form of exercise.

• Be frank with your doctor or healthcare professional responsible for your asthma treatment about how asthma affects your daily life, and develop a treatment plan with them that suits your particular lifestyle. Do not forget to take your asthma medication as prescribed by your doctor.

• If you have any doubts about your medication, consult your pharmacist, healthcare professional, or doctor.

INSTRUCTIONS FOR USE

Novolizer

(Illustration of the cartridge and device with labeling:)

Cartridge

Cartridge container

Sliding capDose counterDosing button

Control window

Protective cap

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

1. PREPARATION:

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

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

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

First cartridge:

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

Replacement:

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

If you have already used the Novolizer Dry Powder Inhaler, 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 cap back in its lateral guides from above (?) and push down towards the colored dosing button, until it fits in its place (?).

Now, your Novolizer device is loaded and ready to use.

You can leave the cartridge in the Novolizer Dry Powder Inhaler until it is empty, or until 6 months after its insertion. The cartridge is empty if you see a "0" in the middle of the dose counter. You then have to insert a new cartridge. The cartridges can only be used in the original dry powder inhaler.

2. USE:

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

Press the dosing button completely. You will hear a double audible click and the color of the control window will change from red to green. Release the colored button. The green color in the control window indicates that the Novolizer device is ready to use.

Release the air (but not over the Novolizer Dry Powder Inhaler). 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, you should hear an audible click, which indicates a correct inhalation. Then, continue breathing normally.

Check that the color of the control window has changed again to red, which also indicates a correct inhalation. Replace the protective cap over the mouthpiece. This way, you have completed the inhalation procedure.

The number that appears in the upper window indicates the number of inhalations remaining. The numerical scale 60-0 is shown in steps of 10. If you do not hear the sound of the click and there is no color change, repeat the procedure as described above.

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

The Novolizer device does not allow 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, you must repeat the inhalation. If the inhalation is not carried out correctly after several attempts, you should consult your doctor.

3. CLEANING:

The Novolizer Dry Powder Inhaler should 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, remove it (?).

Cleaning

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

Clean the mouthpiece, the dosing button, and the 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 press it to fit it in place (?).

Put the inhaler back in its normal position.

Assembly – Fit 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 place. Finally, put the protective cap back on.

Notes

• The Prospect describes the operation of the medicine. Please read it carefully in its entirety before using the inhaler for the first time.

• The Novolizer device that is presented with various active substances does not use any propellant and is designed to be reloaded, making the Novolizer device a very environmentally friendly device.

• It is not possible to have an overdose with the Novolizer device. Even pressing the button several times, there is no more powder available for inhalation. Press the button only when you are really going to inhale. If you cannot inhale correctly after several attempts, consult your doctor.

• The Novolizer device can be reloaded using new cartridges* that contain the active substance and is therefore particularly suitable for long-term use (up to one year).

• Do not shake the full Novolizer device.

• Please teach your children the correct handling of the device.

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

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

December 2022 date of the last review: