BECLOMETHASONE/FORMOTEROL LUPIN 100 micrograms/6 micrograms/actuation pressurized inhalation solution

Introduction

Package Leaflet: Information for the User

Beclometasone/Formoterol Lupin 100 micrograms/6 micrograms/puff, inhalation solution in a pressurised container.

beclometasone dipropionate/formoterol fumarate dihydrate

For use in adults

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, do not pass it on to others, it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, this includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet

1. What is Beclometasone/Formoterol Lupin and what is it used for
2. What you need to know before you start using Beclometasone/Formoterol Lupin
3. How to use Beclometasone/Formoterol Lupin
4. Possible side effects
5. Storage of Beclometasone/Formoterol Lupin
6. Contents of the pack and other information

1. What is Beclometasone/Formoterol Lupin and what is it used for

Beclometasone/Formoterol Lupin is an inhalation solution in a pressurised container that contains two active substances that are inhaled through the mouth and released 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 that have an anti-inflammatory action that reduces inflammation and irritation of your lungs.

Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators that relax the muscles of the airways, making it easier for you to breathe.

These two active substances combined facilitate breathing, as they provide relief from symptoms such as difficulty breathing, wheezing and coughing in asthmatic patients or those with COPD, and also help 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 administered "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 disease of the lung airways caused mainly by smoking cigarettes.

2. What you need to know before you start using Beclometasone/Formoterol Lupin

Do not use Beclometasone/Formoterol Lupin:

• If you are allergic or think you are allergic to one or both of the active substances of this medicine or if you are allergic to other medicines or inhalers used to treat asthma or to any of the other components of this medicine (listed in section 6: Contents of the pack and other information), ask your doctor for advice.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before you start using Beclometasone/Formoterol Lupin:

• If you have heart problems, such as angina (heart pain, chest pain), a recent heart attack (myocardial infarction), heart failure, narrowing of the arteries surrounding the heart (coronary heart disease), a heart valve disease or any other known heart abnormality, or if you have a disease called hypertrophic obstructive cardiomyopathy (also called HOCM, 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 bulge in the vascular wall).

• If you have heart rhythm disorders, such as increased heart rate or irregular heartbeat, have a rapid pulse or suffer from palpitations, or have been informed that you have electrocardiographic changes.

• If your thyroid gland is overactive.

• If your blood potassium level is low.

• If you have any liver or kidney disease.

• If you are diabetic (inhalation of high doses of formoterol may cause an increase in blood glucose levels and, therefore, you may need to have additional blood tests to control blood sugar when you start using the inhaler and from time to time during treatment).

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

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

• If you are going to be treated or have been treated for tuberculosis (TB) or if you have a known viral or fungal lung infection.

• If you cannot drink alcohol for any reason.

Use in athletes

This medicine contains formoterol, which may produce a positive result in doping tests

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

If you have or have had medical problems or allergies or if you are not sure if you can use this medicine, talk to your doctor, nurse or pharmacist before using the inhaler.

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

Be particularly careful if you have severe asthma.The reason is that a lack of oxygen in the blood and other treatments you may be receiving with beclometasone/formoterol, such as medicines to treat heart disease or high blood pressure (known as diuretics) or other medicines used to treat asthma, may worsen the drop in potassium levels. Therefore, your doctor will want to check your potassium level in the blood from time to time.

If you take higher doses of inhaled corticosteroids for prolonged periods, you may need corticosteroids in stressful situations. These situations include hospitalisation after an accident, having a serious injury or before surgery. In such cases, the doctor treating you will decide if it is necessary to increase the dose of corticosteroids and may prescribe steroid tablets or injections.

In case of hospitalisation, remember to take all your medicines and inhalers, including beclometasone/formoterol and any other medicines or tablets purchased without a prescription, preferably in their original packaging.

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

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age, until more data is available.

Other medicines and Beclometasone/Formoterol Lupin

Tell your doctor if you are using or have recently used other medicines, including those purchased 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 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 nullified. On the other hand, the use of other adrenergic beta drugs (drugs that work in the same way as formoterol) may enhance the effects of formoterol.

The combined use of Beclometasone/Formoterol Lupin with:

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

• Medicines to treat Parkinson's disease (L-dopa) or to treat an underactive thyroid gland (L-thyroxine), medicines that contain 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 mental disorders, may cause an increase in blood pressure.

• Medicines to treat heart disease (digoxin), may cause a drop in serum potassium levels. This may increase the risk 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 may be pregnant, if you intend to become pregnant or if you are breastfeeding, unless your doctor advises you to do so.

Driving and using machines

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

Beclometasone/Formoterol Lupin contains alcohol

This medicine contains 7 mg of alcohol (ethanol) per puff, which is equivalent to 0.20 mg/kg per dose of two puffs. 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 does not produce any noticeable effect.

3. How to use Beclometasona/Formoterol Lupin

Beclometasona/Formoterol Lupin is for inhalation use only.

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Asthma

Your doctor will perform regular check-ups to ensure you are taking the optimal dose of beclometasona/formoterol. Your doctor will always adjust the treatment to the minimum dose that best controls your symptoms.

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

1. Use beclometasona/formoteroldaily to treat your asthma along with a separate "rescue" inhaler for sudden worsening of asthma symptoms, such as difficulty breathing, wheezing, and coughing
2. Use beclometasona/formoteroldaily to treat your asthma and also use beclometasona/formoterolto treat sudden worsening of asthma symptoms, such as difficulty breathing, wheezing, and coughing

a. Using beclometasona/formoterolwith a separate "rescue" inhaler.

Adults and elderly patients:

The recommended dose is one to two puffs twice a day.

The maximum daily dose is 4 puffs.

Remember: You should always carry a rapid-acting "rescue" inhaler with you to treat worsening asthma symptoms or a sudden asthma attack.

b. Usingbeclometasona/formoterolas the only inhaler for asthma.

Adults and elderly patients:

The recommended dose is one puff in the morning and one puff in the evening.

You should also use beclometasona/formoterol as a "rescue" inhaler to treat sudden asthma symptoms.

If you have asthma symptoms, inhale one puff and wait a few minutes.

If you do not feel better, inhale another puff.

Do not inhale more than 6 rescue puffs of beclometasona/formoterol per day.

The maximum daily dose of beclometasona/formoterol is 8 puffs.

If you think you need more puffs 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:

Children and adolescents under 18 years of age MUST NOT take this medication.

Chronic Obstructive Pulmonary Disease (COPD)

Adults and elderly patients:

The recommended dose is two puffs in the morning and two puffs in the evening.

Patients at risk:

Elderly patients do not need to have their dose adjusted. There is no information available on the use of this medication in patients with liver or kidney problems.

Beclometasona/Formoterol Lupin is effective for the treatment of asthma at a dose of beclometasona dipropionate that may be lower than that of other inhalers containing the same component. If you have previously been using another inhaler that contained beclometasona dipropionate, your doctor will advise you on the exact dose of this medication you should take for asthma.

Do not increase the dose.

If you think the medication is not very effective, always consult your doctor before increasing the dose.

If you use moreBeclometasona/Formoterol Lupinthan you should

• If you use more formoterol than you should, you may experience the following adverse effects: nausea, vomiting, rapid heartbeat, palpitations, cardiac arrhythmias, certain electrocardiographic changes (heart signal), headache, tremors, drowsiness, excess acid in the blood, low potassium levels in the blood, and high glucose levels in the blood. Your doctor may request blood tests to check your potassium and glucose levels in the blood.
• Taking too much beclometasona dipropionate may cause short-term changes in the functioning of the adrenal glands. This situation will improve in a few days; however, your doctor may check your cortisol levels in the serum.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Consult your doctor if you experience any of these symptoms.

If you forgot to useBeclometasona/Formoterol Lupin:

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

If you interrupt treatment withBeclometasona/Formoterol Lupin:

Do not decrease the dose or stop using the medication.

Even if you feel better, do not stop using Beclometasona/Formoterol Lupin or decrease the dose. If you want to do so, consult your doctor. It is very important to use Beclometasona/Formoterol Lupin regularly even if you do not have symptoms.

If your breathing difficulties increase:

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

If your asthma worsens:

If your symptoms worsen or become difficult to control (for example, if you increase the frequency of use of the separate rapid-acting inhaler or beclometasona/formoterol as a rescue inhaler), or if the rapid-acting inhaler or beclometasona/formoterol does not contribute to improving the symptoms, go to the doctor immediately. Your asthma may be worsening, and your doctor may need to modify the dose of beclometasona/formoterol or prescribe an alternative treatment.

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

Method of administration:

This medication is in a pressurized container inside a plastic casing with a mouthpiece. There is a dose counter on the front of the inhaler that indicates how many doses are left. Each time you press the container, a puff of medication is released. The actuator has an integrated dose indicator that accurately counts each puff and shows every 20 puffs. The dose indicator will show the approximate number of acts (sprays) left in the container. The dose indicator window shows the number of puffs left in the inhaler in units of twenty (e.g., 120, 100, 80, etc.). When there are 20 acts left, the screen shows the number 20 on a half-red and half-white background, indicating that the container is near its end. When 120 acts have been discharged, the screen shows the number 0 on a red background. The indicator will stop moving at "0".

Checking the 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 correctly.

1. Remove the protective cap from the mouthpiece.
2. Hold the inhaler in a vertical position with the mouthpiece at the bottom.
3. Direct the mouthpiece away from you.

4.a If you are using the inhaler for the first time, press the container firmly 3 times to release a dose after each puff.

4.b If you have not used the inhaler in the last 14 days or more, press the container firmly to release a dose.

1. Check the dose counter. If you are checking your inhaler for the first time, the counter should indicate 120.

How to use your inhaler

When possible, stand or sit upright to perform the inhalation. Before starting to inhale, check the dose indicator:

any number between "1" and "120" shows that there are doses left. If the dose indicator shows "0", there are no doses left: discard your inhaler and get a new one.

1 2 3 4 5

1. Remove the protective cap from the mouthpiece and check that it is clean, i.e., that there are no dust, dirt, or other foreign particles.
2. Exhale slowly and deeply as much as possible.
3. Hold the container in a vertical position with the body upwards and place the mouthpiece between your lips. Do not bite the mouthpiece.
4. Inhale slowly and deeply through the mouth and, just as you start to inhale, press the top of the inhaler firmly to release a dose. If you have weakness in your hands, you may find it easier to hold the inhaler with both hands, placing your two index fingers on the top of the inhaler and your two thumbs on the bottom of the inhaler.
5. Hold your breath for as long as you can and finally remove the inhaler from your mouth and exhale slowly. Do not blow into the inhaler.

If you need to inhale a new dose, hold the inhaler in a vertical position for about half a minute and then repeat steps 2 to 5.

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

After administration, close with the protective cap and check the dose counter.

When to replace your inhaler

You should have a replacement inhaler when the counter shows the number 20 and the color of the dose indicator changes from white to red. Stop using the inhaler when the counter reads 0, as the remaining puffs in the device may not be sufficient to take the full dose.

If you notice a "mist" escaping from the top of the inhaler or from the corner of your lips, it means that the medication is not going to reach your lungs as it should. Take another dose 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 medication is too strong or insufficient, consult your doctor or pharmacist.

If you find it difficult to press the inhaler while starting to inhale, you can use the AeroChamber Plus spacer device. Consult your doctor, pharmacist, or nurse about using this device. It is essential that you read the leaflet that comes with the AeroChamber Plus spacer device and follow the instructions carefully on how to use the AeroChamber Plus spacer device and how to clean it.

Cleaning

You should clean the inhaler once a week. When you clean it, do not remove the pressurized container from the device, and do not use water or other liquids to clean the inhaler.

To clean the inhaler:

1. Remove the mouthpiece cap from the inhaler.
2. Pass a clean, dry cloth or paper towel through the inside and outside of the mouthpiece and device.
3. Put the mouthpiece cap back on.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

As with other inhaler treatments, there is a risk of worsening breathing difficulties and wheezing immediately after using beclometasona/formoterol, which is known as paradoxical bronchospasm. If this happens, STOP using beclometasona/formoterol and use your rapid-acting inhaler right awayto treat breathing difficulty and wheezing symptoms. Contact your doctor immediately.

Tell your doctor immediatelyif you experience hypersensitivity reactions, such as skin allergies, itching, rash, redness, swelling of the skin or mucous membranes, especially in the eyes, face, lips, and throat.

Other adverse effects are listed below 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 have any of the following symptoms while inhaling this medication, which could be symptoms of a lung infection:

• Fever or chills
• Increased production of mucus, change in the color of mucus
• Increased coughing or increased breathing difficulties

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

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

• Reduction of cortisol levels 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)

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

Unknown

Blurred vision

Inhalation of corticosteroids at high doses for a prolonged period may cause systemic effects in very rare cases:

These include:

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Beclometasona/Formoterol Lupin

Keep this medication out of sight and reach of children.

Unit packaging containing 1 inhaler of 120 doses

Do not use this medication after 3 months from the date it was dispensed by your pharmacist and never use it 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 the inhaler at a temperature above 25°C.

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

Once the packaging has been opened, it can be stored at room temperature (not above 25°C) during use. Use the inhaler for a maximum of 3 months and never use it after the expiration date that appears on the box and label.

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

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Composition of Beclometasona/Formoterol Lupin

• The active ingredients are: beclometasone dipropionate, formoterol fumarate dihydrate. Each actuation of the dosing 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 injectable preparations.

Appearance of the Product and Container Content

Each container contains a canister that provides 120 actuations (sprays).

Beclometasona/Formoterol Lupin is a pressurized solution contained in an aluminum canister treated with a fluorocarbon polymer (FCP), sealed with a dosing valve. The pressurized canister is inserted into a white plastic actuator and a pink cap. The actuator incorporates an integrated dose indicator that accurately counts each actuation and shows every 20 actuations.

Marketing Authorization Holder:

Lupin Europe GmbH,

Hanauer Landstraße 139-143

60314 Frankfurt am Main,

Germany

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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Beclomethason/Formoterol Lupin 100 Micrograms/6 Micrograms per Actuation Pressurized Inhalation Solution

Spain: Beclometasona/Formoterol Lupin 100 micrograms/6 micrograms/actuation solution for inhalation in a pressurized container

Date of the Last Revision of this Leaflet:August 2024

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