FORMATRIS NOVOLIZER 12 micrograms/DOSE, POWDER FOR INHALATION

Introduction

Patient Information Leaflet

Formatris Novolizer 12 micrograms/dose

Powder for inhalation

formoterol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Formatris Novolizer 12 micrograms is and what it is used for.
2. What you need to know before you use Formatris Novolizer 12 micrograms.
3. How to use Formatris Novolizer 12 micrograms.
4. Possible side effects
5. Storing 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 a powder for inhalation that contains formoterol. Formoterol belongs to a group of medicines known as long-acting beta-agonists. These medicines relax certain muscles, opening, for example, the airways in your lungs.

Formatris provides long-lasting relief (up to 12 hours) of symptoms such as wheezing, shortness of breath, and cough in patients with asthmawho are already being treated with inhaled glucocorticosteroids. It makes breathing easier by relaxing muscle spasms in the airways of the lungs. Continuous 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 with chronic obstructive pulmonary disease (COPD).

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

Do not use Formatrisif you are allergic (hypersensitive) to formoterol or to the other component 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 quick-acting bronchodilator (such as salbutamol).

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

It is very important that you continue to take your anti-inflammatory therapy (glucocorticosteroids). You should not reduce the dose of your 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 is not well controlled. In this case, you should contact your doctor for a new evaluation of your anti-asthmatic therapy.

Before taking Formatris, be especially careful and consult your doctorif you suffer from:

• any heart disease,
• blood pressure problems,
• diabetes,
• thyroid hyperactivity 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 re-evaluation of the 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 using, have recently used, or might use any other medicines.

In particular, these include:

• other beta-agonists (such as salbutamol, salmeterol) or ephedrine
• xanthine derivatives (such as theophylline)
• steroid medicines (such as prednisolone)
• diuretics or water pills (such as furosemide)
• digoxin
• antihistamines (such as terfenadine, astemizole)
• medicines for treating a rapid or irregular heartbeat (such as quinidine)
• phenothiazines (such as chlorpromazine) used to treat mental disorders or severe nausea and vomiting
• antibiotics (such as erythromycin)
• tricyclic antidepressants (such as amitriptyline) or monoamine oxidase inhibitors (phenelzine)
• hormones (such as L-thyroxine, oxytocin)

• beta-blockers for high blood pressure or angina (given orally, such as atenolol, metoprolol, or as eye drops, such as timolol)
• Some general anesthetics may interact with formoterol, causing heart problems and a decrease in blood pressure. Therefore, if you need to undergo surgery, you should inform the 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 diseaseor for thyroid problems, you may experience an increase in heart rate (pulsations).

Using Formatris with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Formoterol will only be used during pregnancy (in particular, during the first three months and at the end of it, as well as during childbirth), after carefully evaluating the situation.

It is not known whether formoterol passes into breast milk. 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 using machines:

Formatris has no effects on the ability to drive or use machines.

Formatris containsmilk sugar (lactose).

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

3. How to use Formatris Novolizer 12 micrograms

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

If the person taking the medicine is a child, they should know how to use the inhaler correctly, and should only do so with the help of an adult.

The recommended dose is:

Asthma

Adults (including elderly people) and adolescents over 12 years

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 of age or older

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, although occasionally a maximum of up to 4 inhalations may be allowed in a 24-hour period.

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 experience available in this age group is insufficient.

COPD (chronic obstructive pulmonary disease)

Adults (including elderly people) and adolescents over 12 years

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 may be administered to the prescribed dose for routine therapy to relieve symptoms, up to a maximum total daily dose of 4 inhalations. No more than 2 inhalations should be administered on one occasion.

Method of Administration

Inhalation route.

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

If you use more Formatris than you should

The symptoms of an overdose are the same as the side effects, which are, for example: 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 Toxicology Information Service. Telephone (91) 562 04 20.

If you forget 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 forgotten doses.

If you stop using Formatris

Do not stop or reduce the dose of Formatris, or any other medicine for your respiratory problems, without consulting your doctor first. Regular use of these medicines 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 gradually reducing the dose of Formatris to adjust your treatment to the minimum effective dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The possible side effects are listed below according to their frequency. If you are not sure what the following side effects are, ask your doctor to explain them to you.Most important side effectsAs with all inhalers, it is possible that the powder may cause wheezingimmediately after inhalation. This is a rare occurrence (it can affect up to 1 in 1,000 people).

In rare cases, an allergic reaction can lead to a condition known as angioedema, which consists of swelling of the face, lips, eyes, and throat. If you experience any of these allergic reactions, you should stop taking Formatris immediately and consult your doctor.

In very rare cases (it can affect up to 1 in 10,000 people), a severe chest pain(angina pectoris) may occur.

Other side effects

Common side effects (can affect up to 1 in 10 people):

Headaches, tremors, and palpitations.

Uncommon side effects (can affect up to 1 in 100 people):

Agitation, restlessness, sleep disorders, muscle cramps, and throat irritation.

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

Rapid or unusual heartbeat, nausea (feeling of dizziness), changes in potassium levels that can cause muscle weakness, nervousness, and wheezing. Allergic reactions such as skin reactions like rash, urticaria, and pruritus that cause a transient eruption, uneven swelling, redness, and itching.

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

Prolongation of the QTc interval, which can increase the risk of serious heart rhythm disorders in sensitive patients, hyperglycemia (increased glucose in the blood), changes in taste, fainting, and changes in blood pressure.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Formatris Novolizer 12 micrograms

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

Do not use this medicine after the expiry date which is stated on the label, carton, and blister pack. The expiry date is the last day of the month stated.

Storage conditions

Keep the cartridge in its original packaging until use.

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

Expiry information

Replace the cartridge 6 monthsafter first opening.

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

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

The Novolizer device should be cleaned at regular intervals, but at least every time the cartridge is changed. The instructions for cleaning the device are found in the instructions for use on the back of this leaflet.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Formatris Composition:

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

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

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

Appearance of Formatris and Package Contents

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

Original sales packages:

1 inhaler and a cartridge with at least 60 doses for inhalation

1 inhaler and two cartridges with at least 60 doses for inhalation each

Replacement packages:

1 cartridge with at least 60 doses for inhalation

2 cartridges with at least 60 doses for inhalation each

3 cartridges with at least 60 doses for inhalation each

Not all package 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 – Madrid

Spain

This medication is authorized in the Member States of the European Economic Area 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 last revision of this leaflet: December 2022

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

Tips for Living with Asthma

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

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

• Trying to avoid or reduce contact with elements that can trigger an asthma episode, such as animal skins, smoking (including passive smoking), molds, pollen, and dust mites.
• If you know that exercise acts as an asthma trigger 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 provider about how asthma affects your daily life, and develop a treatment plan with them that suits your particular lifestyle. Don't forget to take your asthma medications as prescribed by your doctor.
• If you have any doubts 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 the cartridge and device with labeling:)

Cartridge

Cartridge container

Sliding cap Dose counter Dose button

Control window

Protective cap

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

1. PREPARATION:

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

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

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

The small red disc on 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 Dry Powder Inhaler Novolizer with the dose counter facing the mouthpiece (?). Do not press the dose button during cartridge insertion.

Replacement:

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

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

Put the cap back on its lateral guides from above (?) and push it down towards the colored dose button until it clicks into place (?).

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

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

1. USE:

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

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

Exhale (but not over the Dry Powder Inhaler Novolizer). Place your lips around the mouthpiece, inhale the powder constantly, deeply, and as quickly as possible (until 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 back to red, which also indicates a correct inhalation. Put the protective cap back over the mouthpiece. This completes the inhalation procedure.

The figure 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 have not heard the click sound and the color has not changed, repeat the procedure as described above.

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

With the Novolizer device, it is not possible to accidentally 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 back to red, it is necessary to repeat the inhalation. If the inhalation is not performed correctly after several attempts, you should consult your doctor.

1. CLEANING:

The Dry Powder Inhaler Novolizer should be cleaned at regular intervals, but at least every 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 comes loose. Then, pull it out (?).

Cleaning

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

Clean the mouthpiece, dose counter, and inhaler with a soft, dry cloth, without threads.

DO NOT use water or detergent.

Assembly – Insertion of the dose counter

After cleaning, insert the dose counter by sliding it down at an angle (?) and pressing it to click into place (?).

Put the inhaler back in its normal position.

Assembly – Attachment of the mouthpiece and protective cap

Insert the mouthpiece with the pin on the left side of the upper slot, and turn it to the right until it clicks into place. Finally, put the protective cap back on.

Notes

• The Leaflet describes the operation of the medication. Please read it carefully in its entirety before using the inhaler for the first time.
• The Novolizer device presented with various active substances does not use any propellant and is designed to be recharged, making the Novolizer device a very environmentally friendly instrument.
• It is not possible to 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 actually going to inhale. If you do not manage to inhale correctly after several attempts, consult your doctor.
• The Novolizer device can be recharged 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 Novolizer device when it is full.
• Please teach your children the correct handling of the device.
• Make sure your Novolizer device is protected from moisture and heat and remains clean at all times.

• Regarding the corresponding medications, please consult your doctor.

Date of last revision: December 2022.