Luforbec 100 micrograms/6 micrograms/puff solution for inhalation in pressurised container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Luforbec 100 micrograms/6 microgram/puff, solution for inhalation in pressurised container.

beclometasone dipropionate / formoterol fumarate dihydrate

For use in adults

Read the entire 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, consult your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.

Contents of the leaflet

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

1. What Luforbec is and what it is used for

Luforbec is a pressurised inhalation solution that contains two active substances which are inhaled through the mouth and delivered directly into the lungs.

The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate. Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which have an anti-inflammatory action that reduces inflammation and irritation in the lungs.

Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators, which relax the muscles in the airways, helping you to breathe more easily.

The combination of these two active substances helps to make breathing easier by providing relief from symptoms such as breathlessness, wheezing, and coughing in patients with asthma or chronic obstructive pulmonary disease (COPD). They also help to prevent asthma symptoms.

Asthma

This medicine is indicated for the regular treatment of asthma in adult patients in whom:

• Asthma is not adequately controlled with inhaled corticosteroids and short-acting bronchodilators taken "as needed".

Or:

• Asthma is well controlled with a combination treatment of corticosteroids and long-acting bronchodilators.

COPD

This medicine may also be used to treat symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic lung airway disease caused mainly by cigarette smoking.

2. What you need to know before using Luforbec

Do not use Luforbec:

• If you are allergic or think you may be allergic to either of the active substances in this medicine, or if you are allergic to other medicines or inhalers used to treat asthma, or to any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information). In such cases, consult your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Luforbec:

• If you have heart problems such as angina (chest pain, heart pain), a recent heart attack (myocardial infarction), heart failure, narrowing of the arteries surrounding the heart (coronary heart disease), heart valve disease, or any other known heart abnormality, or if you have a condition called obstructive hypertrophic cardiomyopathy (also known as HCM, where the heart muscle is enlarged).

• If you have narrowing of the arteries (also called arteriosclerosis), if you have high blood pressure, or if you know you have an aneurysm (an abnormal bulging of the blood vessel wall).

• If you have heart rhythm disorders, such as increased heart rate or irregular heartbeat, a rapid pulse, palpitations, or if you have been told you have electrocardiogram (ECG) abnormalities.

• If your thyroid gland is overactive.

• If your blood potassium levels are low.

• If you have any liver or kidney disease.

• If you have diabetes (inhaling high doses of formoterol may increase blood glucose levels, so you may need additional blood tests to monitor your blood sugar when starting treatment and occasionally during treatment).

• If you have a tumour of the adrenal glands (called a phaeochromocytoma).

• If you are due to receive anaesthesia. Depending on the anaesthetic agent used, you may need to stop using this medicine at least 12 hours before anaesthesia.

• If you are being treated or have previously been treated for tuberculosis (TB), or if you have a known viral or fungal lung infection.

• If you cannot take alcohol for any reason.

Use in athletes

This medicine contains formoterol, which may result in a positive doping test.

If any of the above apply to you, always inform your doctor before using beclometasone/formoterol.

If you have or have had medical problems or allergies, or if you are unsure whether you can use this medicine, consult your doctor, nurse, or pharmacist before using the inhaler.

Treatment with a β2 agonist such as formoterol contained in this medicine may cause a sudden drop in serum potassium levels (hypokalaemia).

Take special care if you have severe asthma. This is because low blood oxygen levels and other treatments you may be receiving alongside beclometasone/formoterol—such as medicines for heart conditions or high blood pressure (known as diuretics) or other medicines used to treat asthma—may worsen the drop in potassium levels. Therefore, your doctor may want to check your blood potassium levels from time to time.

If you are taking higher doses of inhaled corticosteroids for prolonged periods, you may require corticosteroids during times of stress. Such situations include hospital admission following an accident, serious injury, or before surgery. In such cases, your treating doctor will decide whether corticosteroid doses need to be increased and may prescribe steroid tablets or injections.

If you go to hospital, remember to bring all your medicines and inhalers with you, including beclometasone/formoterol and any other medicines or over-the-counter products you are using, preferably in their original packaging.

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

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age until more data become available.

Other medicines and Luforbec

Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Some medicines may increase the effects of beclometasone/formoterol, so your doctor will monitor you closely if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Do not use beta-blockers with this medicine. If you need to use beta-blockers (including eye drops), the effect of formoterol may be reduced or even completely blocked. Conversely, the use of other beta-adrenergic drugs (medicines that work in the same way as formoterol) may enhance the effects of formoterol.

The combined use of Luforbec with:

• Medicines used to treat heart rhythm disorders (quinidine, disopyramide, procainamide), medicines used to treat allergic reactions (antihistamines), medicines used to treat symptoms of depression or psychiatric disorders such as monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazide), tricyclic antidepressants (e.g., amitriptyline and imipramine), and phenothiazines, may lead to electrocardiographic abnormalities (ECG). They may also increase the risk of heart rhythm disorders (ventricular arrhythmias).

• Medicines used to treat Parkinson’s disease (L-dopa) or an underactive thyroid gland (L-thyroxine), medicines containing oxytocin (which causes uterine contractions), and alcohol, may reduce cardiac tolerance to β2 agonists such as formoterol.

• Monoamine oxidase inhibitors (MAOIs), including drugs with similar properties such as furazolidone and procarbazine, used to treat psychiatric disorders, may cause an increase in blood pressure.

• Medicines used to treat heart conditions (digoxin), may cause a drop in serum potassium levels. This may increase the likelihood of heart rhythm disorders.

• Other medicines used to treat asthma (theophylline, aminophylline, or steroids) and diuretics, may cause a drop in serum potassium levels.

• Some anaesthetics may increase the risk of heart rhythm disorders.

Pregnancy, breastfeeding, and fertility

There are no clinical data on the use of beclometasone/formoterol during pregnancy.

Do not use beclometasone/formoterol if you are pregnant or think you might be pregnant, if you are planning to become pregnant, or if you are breastfeeding, unless your doctor specifically advises you to do so.

Driving and using machines

It is unlikely that beclometasone/formoterol will affect your ability to drive or use machines.

Luforbec contains alcohol

This medicine contains 7 mg of alcohol (ethanol) per actuation (puff), equivalent to 0.20 mg/kg for a two-puff dose. The amount in two puffs of this medicine is equivalent to less than 1 ml of wine or beer. The small amount of alcohol in this medicine will not produce any noticeable effect.

3. How to use Luforbec

Luforbec is for inhalation use only.

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

Asthma

Your doctor will periodically review your condition to ensure you are receiving the optimal dose of beclometasone/formoterol. Your doctor will always adjust the treatment to the lowest dose that effectively controls your symptoms.

This medicine may be prescribed by your doctor in two different ways:

1. Use beclometasone/formoterol daily to treat your asthma, together with a separate “reliever” inhaler to treat sudden worsening of asthma symptoms such as difficulty breathing, wheezing, and coughing.
2. Use beclometasone/formoterol daily to treat your asthma and also use beclometasone/formoterol as needed to treat sudden worsening of asthma symptoms such as difficulty breathing, wheezing, and coughing.

a. Using beclometasone/formoterol together with a separate “reliever” inhaler.

Adults and elderly patients:

The recommended dose is one to two actuations twice daily.

The maximum daily dose is 4 actuations.

Remember: Always carry your fast-acting “reliever” inhaler with you to treat sudden worsening of asthma symptoms or an acute asthma attack.

b. Using beclometasone/formoterol as the only inhaler for asthma.

Adults and elderly patients:

The recommended dose is one actuation in the morning and one actuation at night.

You should also use beclometasone/formoterol as a “reliever” inhaler to treat sudden asthma symptoms.

If you experience asthma symptoms, inhale one actuation and wait a few minutes.

If you do not feel better, inhale another actuation.

Do not inhale more than 6 reliever actuations of beclometasone/formoterol per day.

The maximum daily dose of beclometasone/formoterol is 8 actuations.

If you feel you need more actuations per day to control your asthma symptoms, contact your doctor for advice. Your doctor may need to change your treatment.

Use in children and adolescents under 18 years of age:

Children and adolescents under 18 years of age must not take this medicine.

Chronic obstructive pulmonary disease (COPD)

Adults and elderly patients:

The recommended dose is two actuations in the morning and two actuations at night.

Patients at risk:

Elderly patients do not require dose adjustment. Information on the use of this medicine in patients with hepatic or renal impairment is not available.

Luforbec is effective in the treatment of asthma at a dose of beclometasone dipropionate that may be lower than that of other inhalers containing the same component. If you have previously used another inhaler containing beclometasone dipropionate, your doctor will advise you on the exact dose of this medicine to take for asthma.

Do not increase the dose.

If you think the medicine is not working well enough, always consult your doctor before increasing the dose.

If you use more Luforbec than you should

• If you use too much formoterol, you may experience the following adverse effects: nausea, vomiting, rapid pulse, palpitations, cardiac arrhythmias, certain electrocardiographic changes (cardiac signal), headache, tremors, drowsiness, excess acid in the blood, low blood potassium levels, and high blood glucose levels. Your doctor may request blood tests to check your potassium and glucose levels.
• Taking too much beclometasone dipropionate may cause short-term disturbances in adrenal gland function. This condition will resolve within a few days; however, your doctor may check your serum cortisol concentration.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Consult your doctor if you experience any of these symptoms.

If you forget to use Luforbec:

Take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose; simply take the next dose at the usual time. Do not double the dose.

If you stop using Luforbec:

Do not reduce the dose or stop using the medicine.

Even if you feel better, do not stop using Luforbec or reduce the dose. If you wish to do so, consult your doctor. It is very important to use Luforbec regularly even if you have no symptoms.

If your breathing difficulties increase:

If your breathing difficulty or wheezing (audible whistling breathing) worsens immediately after inhaling the medicine, stop using this medicine immediately and use your fast-acting inhaler right away. Contact your doctor immediately. Your doctor will evaluate your symptoms and, if necessary, modify your treatment. See also section 4 "Possible side effects".

If your asthma worsens:

If your symptoms worsen or become difficult to control (for example, if you need to use your separate fast-acting inhaler or beclometasone/formoterol as a reliever inhaler more frequently), or if your fast-acting inhaler or beclometasone/formoterol does not help improve your symptoms, contact your doctor immediately. Your asthma may be worsening, and your doctor may need to adjust your beclometasone/formoterol dose or prescribe an alternative treatment.

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

Method of administration:

This medicine is contained in a pressurized canister within a plastic mouthpiece holder. There is a counter on the front of the inhaler indicating how many doses remain. Each time you press the canister, one dose of medicine is released. The actuator incorporates an integrated dose indicator that accurately counts each actuation and displays every 20 actuations. The dose indicator shows the approximate number of actuations (sprays) remaining in the canister. The dose indicator window displays the number of actuations remaining in units of twenty (e.g., 120, 100, 80, etc.). When 20 actuations remain, the display shows the number 20 on a half-red, half-white background, indicating that the canister is nearing the end. When 120 actuations have been delivered, the display shows the number 0 on a red background. The indicator will stop moving at "0".

Checking your inhaler

Before using the inhaler for the first time, or if you have not used it for 14 days or more, you must check your inhaler to ensure it is working properly.

1. Remove the protective cap from the mouthpiece.
2. Hold the inhaler upright with the mouthpiece at the bottom.
3. Point the mouthpiece away from you.

4.a If using the inhaler for the first time, press the canister firmly down three times to release a dose with each actuation.

4.b If you have not used the inhaler for 14 days or more, press the canister firmly once to release a dose.

5. Check the dose counter. If checking the inhaler for the first time, the counter should read 120.

How to use your inhaler

Whenever possible, stand or sit upright when inhaling. Before starting to inhale, check the dose indicator:

any number between "1" and "120" indicates that doses remain. If the dose indicator shows "0", no doses remain: discard your inhaler and obtain a new one.

1 2 3 4 5

1. Remove the protective cap from the mouthpiece and check that it is clean, i.e., free from dust, dirt, or other foreign particles.
2. Breathe out as slowly and deeply as possible.
3. Hold the canister upright with the body upright and place the mouthpiece between your lips. Do not bite the mouthpiece.
4. Breathe in slowly and deeply through your mouth and, just as you begin to inhale, press firmly on the top of the inhaler to release one dose. If you have weak hands, it may be easier to hold the inhaler with both hands, placing both index fingers on the top of the inhaler and both thumbs on the bottom.
5. Hold your breath as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not exhale into the inhaler.

If you need to inhale another dose, keep the inhaler upright for about half a minute, then repeat steps 2 to 5.

Important: Do not perform steps 2 to 5 too quickly.

After administration, replace the protective cap and check the dose counter.

When to replace your inhaler

You should have a replacement inhaler ready when the counter shows the number 20 and the dose indicator color changes from white to red. Stop using the inhaler when the counter reads 0, as any remaining actuations in the device may not deliver a complete dose.

If you see a “mist” escaping from the top of the inhaler or from the corners of your lips, this means the medicine is not reaching your lungs as it should. Take another dose by following the instructions, starting again from step 2.

To reduce the risk of fungal infection in the mouth and throat, rinse your mouth or gargle with water, or brush your teeth each time you use the inhaler.

If you think the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

If you find it difficult to press the inhaler while starting to breathe in, you may use the AeroChamber Plus spacer device. Consult your doctor, pharmacist, or nurse about using this device. It is important to read the leaflet provided with the AeroChamber Plus spacer device and carefully follow the instructions on how to use and clean the AeroChamber Plus spacer device.

Cleaning

You must clean the inhaler once a week. When cleaning, do not remove the pressurized canister from the device and do not use water or other liquids to clean the inhaler.

To clean the inhaler:

1. Remove the mouthpiece cap by separating it from the inhaler.
2. Wipe the inside and outside of the mouthpiece and device with a clean, dry cloth or paper towel.
3. Replace the mouthpiece cap.

4. Possible adverse effects

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

As with other treatments using inhalers, there is a risk of worsening breathing difficulty and wheezing immediately after using beclometasone/formoterol, known as paradoxical bronchospasm. If this occurs, STOP using beclometasone/formoterol and immediately use your fast-acting inhaler to treat symptoms of breathing difficulty and wheezing. Contact your doctor immediately.

Tell your doctor immediately if you experience hypersensitivity reactions such as skin allergies, itching, rash, skin redness, or swelling of the skin or mucous membranes, particularly affecting the eyes, face, lips, and throat.

Other adverse effects are listed below, classified according to their frequency.

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

• Fungal infections (of the mouth and throat),

• Headache,

• Hoarseness,

• Sore throat.

• Pneumonia in patients with COPD: inform your doctor if you experience any of the following symptoms while using this medicine, as they could be signs of a lung infection:

  • Fever or chills
  • Increased mucus production, change in mucus color
  • Increased cough or increased breathing difficulty

Uncommon (may affect up to 1 in 100 people):

palpitations exceptionally rapid heartbeat and cardiac rhythm disorders, certain electrocardiographic (ECG) abnormalities. influenza-like symptoms fungal infections of the vagina sinus inflammation rinitis ear inflammation throat irritation

cough and productive cough asthma attacks nausea disturbances or decreased sense of taste burning of the lips dry mouth difficulty swallowing indigestion gastric discomfort diarrhea muscle pain and cramps, facial flushing, increased blood circulation in certain body tissues, excessive sweating tremors

restlessness dizziness rash or hives Alterations in certain blood components: decreased number of leukocytes, increased number of platelets, decreased potassium concentration in blood, increased glucose concentration in blood, increased concentration of insulin, free fatty acids, and ketones in blood.

The following adverse reactions have also been reported as "uncommon" in patients with Chronic Obstructive Pulmonary Disease.

• Decrease in the amount of cortisol in the blood; this is caused by the effect of corticosteroids on your adrenal gland.
• Irregular heartbeats.

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

Chest tightness, missed heartbeats (due to premature contraction of the heart ventricles), increase or decrease in blood pressure

inflammation of the kidney, swelling of the skin and mucous membranes persisting for several days

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

difficulty breathing worsening of asthma

decrease in platelet count,

swelling of the hands and feet

Unknown

Blurred vision

Very rarely, systemic effects may occur after prolonged inhalation of high doses of corticosteroids:

These include:

adrenal gland problems (adrenal suppression) decreased bone mineral density (weakening of the bones)

growth retardation (slow growth in children and adolescents) increased intraocular pressure (glaucoma) cataracts

• Sleep disorders, depression, or feeling worried, restless, nervous, over-excited, or irritable. These effects may occur especially in children, but their frequency is unknown.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Luforbec

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

Unit pack containing 1 inhaler with 120 doses.

Do not use this medicine after 3 months from the date your pharmacist dispensed it to you, and never use it after the expiry date stated on the carton and label. The expiry date refers to the last day of the month indicated.

Do not store the inhaler at temperatures above 25°C.

Store the inhaler in a refrigerator (between 2 and 8°C), in an upright position, until use.

Once the package has been opened, the inhaler may be stored at room temperature (not exceeding 25°C) during use. Use the inhaler within a maximum of 3 months, and never use it after the expiry date stated on the carton and label.

If the inhaler has been exposed to extreme cold, warm it with your hands for a few minutes before use. Never heat it by artificial means.

Warning: The container contains pressurized liquid. Do not expose the container to temperatures above 50°C. Do not pierce the container.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Luforbec

• The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate. Each actuation of the metering valve contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose from the mouthpiece of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate.

• The other components are: norflurane (HFC 134a), anhydrous ethanol, maleic acid, and water for injections.

• This medicine contains fluorinated greenhouse gases.

Each inhaler contains 8,120 g of HFC-134a (norflurane), equivalent to 0.012 tonnes of CO2 (global warming potential GWP = 1430).

Nature of the product and pack contents

Each pack contains a container delivering 120 actuations (sprays).

Luforbec is a pressurized solution contained in an aluminum container treated with a fluorocarbon polymer (FCP), sealed with a metering valve. The pressurized container is inserted into a white plastic actuator and a pink cap. The actuator incorporates an integrated dose indicator that accurately counts each actuation and displays the remaining doses every 20 sprays.

Marketing Authorization Holder:

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona

Spain

Manufacturer:

Hormosan Pharma GmbH

Hanauer Landstraße 139 - 143

60314 Frankfurt am Main,

Germany

Eurofins Biopharma Product Testing Finland

Volttikatu 5 ja 8,

Kuopio, 70700,

Finland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Beclomethason/Formoterol Lupin 100 Mikrogramm/6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung

Spain: Luforbec 100 micrograms/6 micrograms/actuation solution for inhalation in pressurized container

Denmark: Ambofoz 100 micrograms/6 micrograms per metered dose. Inhalation aerosol, solution

Netherlands: Ambofoz 100/6 micrograms/dose, aerosol, solution

Norway: Ambofoz 100 micrograms/6 micrograms per dose, inhalation aerosol, solution

Sweden: Ambofoz 100 micrograms/6 micrograms per dose, solution for inhalation aerosol

Date of the most recent review of this leaflet: September 2025

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.