Leaflet: information for the user

BRONCORAL NEO 12 micrograms/actuation Solution for inhalation in a pressurized container

Formoterol fumarate dihydrate

Read this leaflet carefully before you start taking 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms of disease as 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.

BRONCORAL NEO is an inhalation medication that allows the active ingredient to be deposited directly in your lungs. It is used to treat coughs and breathing difficulties in patients with moderate to severe asthma. Its active ingredient, formoterol fumarate, belongs to a group of medications called bronchodilators, which facilitate breathing by relaxing spasms of the respiratory tract muscles in the lungs. Regular use of BRONCORAL NEO, along with corticosteroids (both inhaled and oral), will help prevent long-term respiratory problems.

BRONCORAL NEO may also be used for the relief of symptoms such as cough, wheezing, and breathing difficulty in patients with chronic obstructive pulmonary disease (COPD) who require regular long-term bronchodilator therapy.

Do not useBroncoral Neo:

• if you are allergic to formoterol or any of the other components of this medication (listed in section 6).
• for treating a sudden asthma attack.It will not help. Use a rescue inhaler for this purpose and always carry it with you.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Broncoral Neo if:

-you have a serious heart disease, especially if you have recently had a heart attack, coronary heart disease, or severe heart muscle weakness (congestive heart failure)

-you have heart rhythm disorders, such as increased heart rate, heart valve abnormalities, or certain electrocardiographic abnormalities, or any other heart disease

-you have narrowed blood vessels, especially arteries, or abnormal enlargement of the blood vessel wall

-you have high blood pressure

-you have high blood sugar levels (diabetes mellitus)

-you have low potassium levels in the blood

-you have hyperthyroidism

-you have adrenal gland tumors that produce or do not produce epinephrine

- you are about to undergo surgery or receive halogenated anesthetics.

Other medications and Broncoral Neo

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Some medications may interfere with the action ofBroncoral Neo, such as:

-for treating heart rhythm disorders (e.g., quinidine, disopyramide, procainamide)

-for treating heart disease (e.g., digitalis),

-for treating nasal congestion (e.g., ephedrine)

-called beta-adrenergic blockers used to treat heart disease or glaucoma (increased intraocular pressure), whether in tablet or eye drop form

-containing erythromycin (used to treat infections)

-for treating depression symptoms: monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazid) or tricyclic antidepressants (e.g., amitriptyline and imipramine)

-for treating severe mental disorders (e.g., chlorpromazine and trifluperazine)

-for treating allergic reactions (such as antihistamines, e.g., terfenadine, astemizole, and mizolastine)

• for treating bronchial asthma (e.g., theophylline, aminophylline, or corticosteroids)

-that stimulate urine production (such as diuretics)

-for treating Parkinson's disease (e.g., Levodopa)

-containing oxytocin, which causes uterine contractions

-for treating hypothyroidism (e.g., Thyroxine).

The addition of anticholinergics (such as tiotropium or ipratropium bromide) to Broncoral Neo treatment may help open the airways further.

You have also been prescribed corticosteroids for your respiratory problems. It is very important that you continue to use them regularly.Do not stopusing them or change the dose when starting to takeBroncoral Neo.

Pregnancy and breastfeeding

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

The use ofBroncoral Neoduring pregnancy is only indicated if absolutely necessary.

Driving and operating machinery

It is unlikely thatBroncoral Neowill have any influence on your ability to drive and operate machinery.

Broncoral Neo contains ethanol

This medication contains small amounts of ethanol (alcohol): 8.9 mg of alcohol (ethanol) per puff, which corresponds to 0.25 mg/kg per dose of two puffs in adults and equivalent to 0.44 mg/kg per dose of two puffs in adolescents. The amount in two puffs of this medication is equivalent to less than 1 ml of wine or beer. The small amount of alcohol in this medication has no perceptible effects.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor.

Asthma

The dose ofBroncoral Neoyou should inhale will depend on the type and severity of asthma you suffer from. Your dose will be determined by your doctor and it is essential that you only take the prescribed dose, regularly.

The usual dose for adults, including the elderly and adolescents from 12 years old, is 1 puff in the morning and 1 puff atnight. Thismeans that you need to take a total daily dose ofBroncoral Neoof 2 puffs (24 micrograms).

If you suffer from more severe asthma, your doctor may prescribe 4 puffs a day (48 micrograms), 2 puffs in the morning and 2 puffs at night.

Themaximum daily doseof Broncoral Neo is 48 micrograms (4 puffs) and it is essential that youdo not takemoretotal daily dose than prescribed by your doctor.

This productis not suitable for asthmatic children under 12 years old.

Chronic Obstructive Pulmonary Disease (COPD)

The usual dose for adults (over 18 years old), including the elderly, is 1 puff in the morning and 1 puff atnight. Thismeans that you need to take a total of 2 puffs (24 micrograms) ofBroncoral Neoper day.

If you suffer from more severe COPD, your doctor may prescribe 4 puffs a day (48 micrograms), 2 puffs in the morning and 2 puffs at night.

Themaximum daily doseof Broncoral Neo is 48 micrograms (4 puffs) and it is essential that youdo not takemoretotal daily dose than prescribed by your doctor.

Do not take more than 2 puffs at the same time.

This product is not suitable for COPD patients under 18 years old.

Do not use Broncoral Neo to treat an acute asthma attack.For this, you should use a "rescue" inhaler prescribed by your doctor, which you should always carry with you.

If you use moreBroncoral Neothan you should

You may notice an increase in heart rate and have tremors. You may also experience headaches, tremors, nausea, and vomiting or feel drowsy. Inform your doctor as soon as possible.

If youforget to use Broncoral Neo

If you forget to take Broncoral Neo, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and continue with your regular dosing schedule.Do not take a double dose to compensate for the missed doses.

Do not stop taking or reducethe dose ofBroncoral Neoor any other medication for your respiratory disease, simply because you are feeling better, without consulting your doctor first. It is very important to use these medications regularly.

Do not increaseyour dose ofBroncoral Neowithout consulting your doctor first.

If you feel you are having difficulty breathing or wheezing while using Broncoral Neo, you should continue using Broncoral Neo but visit your doctor as soon as possible, you may need additional treatment. Once your asthma is well controlled, your doctor may consider it appropriate to gradually reduce the dose of Broncoral Neo.

Instructions for use

It is essential that you know how to use your inhaler correctly. Your doctor, nurse, or pharmacist will teach you how to use your inhaler correctly. You must carefully follow their instructions to learnhow,whenandhow manypuffs to administer. In this prospectus, the correct instructions are detailed. If you are unsure of how to proceed or have difficulty inhaling, consult your doctor, nurse, or pharmacist.

Checking your inhaler.If your inhaler is new, or you have not used it for 3 days or more, you must discharge a puff into the air to ensure it is working properly.

Whenever possible, you should be standing or sitting upright when applying the inhalation.

1.-Remove the protective cap from the mouthpiece of the inhaler and hold it between your thumb and index finger as shown.

2.-Breathe in as deeply as possible.

3.-Hold the container vertically, as shown, with your thumb at the base of the mouthpiece; place the inhaler in your mouth, between your teeth, and press firmly with your lips.

4.-Breathe in deeply through your mouth and, at the same time, press the top of the inhaler to release a puff.

5.-Hold your breath as long as possible without straining and, finally, remove the inhaler from your mouth.

6.If you need another inhalation, keep the inhaler in a vertical position and wait for half a minute, and then repeat steps2 to5.

7.After use, replace the protective cap to prevent it from getting dirty. Place it firmly in position.

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IMPORTANT. Do not perform steps 2, 3, 4, and 5 too quickly.

Before inhalation, it is essential that you breathe as slowly as possible.

If some of the gas escapes from the top of the inhaler or from the corner of your lips, Broncoral Neo will not reach your lungs as it should. Take another puff carefully following the instructions from step 2.

If you have any difficulty, consult your doctor, nurse, or pharmacist.

Cleaning the inhaler

It is essential to clean the inhaler regularly, at least once or twice a week, to ensure proper functioning.

• Remove the aluminum container from the plastic inhaler and remove the protective cap from the mouthpiece.
• Clear the plastic inhaler and the protective cap with warm water.
• Do not wet the aluminum container with water.
• Dry the inhaler and the protective cap thoroughly in a warm place. Avoid high temperatures.
• Replace the aluminum container and the protective cap of the mouthpiece.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. The following are possible side effects listed by frequency. If you are unsure about the side effects mentioned, consult your doctor to have them explained to you.

If you experience worsening difficulty breathing or wheezing after using the inhaler, stop using Broncoral Neo and inform your doctor immediately. This is caused by a narrowing of the airways in your lungs, although it occurs only in rare instances.

Frequent(affects at least 1 in 10 people):

• exceptionally rapid heartbeats and palpitations, cough, tremors (mild), headache.

Occasional(affects at least 1 in 100 people):

• muscle cramps, muscle pain, nausea, agitation, nervousness, sleep disturbances, dizziness, taste abnormalities, throat irritation, increased heart rate, arrhythmias with increased heart rate, decreased potassium levels in the blood, increased blood sugar levels, increased insulin levels in the blood, free fatty acids, glycerol, and ketones, excessive sweating.

Rare(affects at least 1 in 1,000 people):

• absence of heartbeats caused by premature contraction of the ventricles, sensation of chest pressure, increased or decreased blood pressure, bronchospasm of the muscles after the use of inhaled medications, severe decrease in blood pressure, kidney inflammation, hypersensitivity reactions such as itching, skin rash, bronchospasm, urticaria, persistent skin and mucous membrane swelling for several days.

Very rare(affects at least 1 in 10,000 people):

• acute worsening of asthma, breathing difficulty, swelling of the hands and/or feet, irregular heartbeats, reduced platelet count, hyperexcitability, abnormal behavior, hallucinations.

Some side effects, such as tremors, nausea, taste abnormalities, throat irritation, excessive sweating, nervousness, headache, dizziness, and muscle cramps, may spontaneously resolve after one to two weeks of continued treatment.

Reporting of 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 Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keepthis medicationout of the sight and reach of children.

• Do not use this medication after three months of purchase at the pharmacy, or after the expiration date that appears on the box and label. The expiration date is the last day of the month indicated.

• Do not store at a temperature above30°C.

• If the inhaler is very cold, remove the aluminum container from the inhaler and warm it by holding itbetween your handsfor a few minutes before using. Do not useany other heat sourceever.

• Precaution. The aluminum container contains a pressurized liquid. Do not expose to temperatures above50°C. Also, do not pierce the container.

• Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGREpoint at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Broncoral Neo

• The active ingredient of Broncoral Neo is formoterol fumarate dihydrate. Each actuation provides 12 micrograms of formoterol fumarate dihydrate. This corresponds to a released dose of 10.1 micrograms.
• The other components are: hydrochloric acid, ethanol, and norflurano (HFC-134a).

This medicine contains fluorinated greenhouse gases.

Each inhaler of 50 actuations contains 5.842 g of norflurano (HFC-134a) corresponding to 0.008 tonnes of CO2 equivalent (global warming potential GWP = 1430).

Each inhaler of 100 actuations contains 9.087 g of norflurano (HFC-134a) corresponding to 0.013 tonnes of CO2 equivalent (global warming potential GWP = 1430).

Each inhaler of 120 actuations contains 10.384 g of norflurano (HFC-134a) corresponding to 0.015 tonnes of CO2 equivalent (global warming potential GWP = 1430).

Appearance of the product and contents of the package

Broncoral Neo is presented in the form of an inhalation solution in a pressurized aluminum container, provided with a plastic inhaler and protective cap.

Each package contains 1 inhaler that provides 50, 100, or 120 actuations.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Chiesi España, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

Manufacturer and Batch Release Responsible

Chiesi Farmaceutici S.p.A., Via San Leonardo 96, 43122 Parma, Italy

Alternative Manufacturer and Batch Release Responsible

Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, 1010 Wien, Austria

This medicine has been authorized in the following Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following trade names:

Last review date of this leaflet:July 2024.

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