Leaflet: information for the user

Formodual 100100 micrograms/6micrograms/pulse Solution for inhalation in a pressurized container

dipropionato de beclometasona/fumarato de formoterol dihidrato

For use in adults.

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, consult your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Formodual is a pressurized inhalation solution that contains two active principles that are inhaled through the mouth and released directly into the lungs.

The two active principles are dipropionate of beclometasone and dihydrate of formoterol fumarate. Dipropionate of beclometasone belongs to a group of medications called corticosteroids that have an anti-inflammatory action that reduces inflammation and irritation of the lungs.

Dihydrate of formoterol fumarate belongs to a group of medications called long-acting bronchodilators that relax the muscles of the respiratory tract, making it easier to breathe.

These two active principles 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

Formodual is indicated for the habitual treatment of asthma in adult patients in whom:

• Asthma is insufficiently controlled using inhaled corticosteroids and short-acting bronchodilators administered "as needed".

Or:

• Asthma is well responding to a combined treatment of corticosteroids and long-acting bronchodilators.

COPD

Formodual may also be used to treat the symptoms of chronic obstructive pulmonary disease (COPD) in severe adult patients. COPD is a chronic disease of the pulmonary respiratory tract caused mainly by smoking cigarettes.

No use Formodual:

• If you are allergic to beclomethasone dipropionate or formoterol fumarate dihydrate or if you are allergic to other medications or inhalers used to treat asthma or to any of the other components of this medication (listed in section 6: Contents of the package and additional information), ask your doctor.

Warnings and precautions

Consult your doctor or pharmacist or nurse before using Formodual:

• If you have heart problems, such as angina (heart pain, chest pain), a recent heart attack (myocardial infarction), heart failure, coronary artery narrowing (coronary heart disease), heart valve disease, or any other known heart anomaly, or if you have a condition called hypertrophic obstructive cardiomyopathy (also known as CMH, in which the heart muscle is enlarged).

• If you have narrowed arteries (also known as arteriosclerosis), if you have high blood pressure, or if you know you have an aneurysm (an abnormal bulge in the blood vessel wall).

• If you have heart rhythm disorders, such as increased heart rate or irregular heart rate, rapid pulse, or palpitations, or if you have been informed that you have electrocardiographic alterations.

• 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 will need to undergo additional blood tests to control blood sugar levels when you start using the inhaler and occasionally during treatment).

• If you have an adrenal gland tumor (called pheochromocytoma).

• If you are to receive anesthesia. Depending on the anesthetic agent, you may need to discontinue use of Formodual for at least 12 hours before anesthesia.

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

• If you cannot take alcohol for any reason.

If any of the above conditions apply to you, inform your doctor before using Formodual.

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

The treatment with a β2 agonist like formoterol contained in Formodual may cause a sudden drop in serum potassium concentration (hypokalemia).

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

If you take higher doses of inhaled corticosteroids for prolonged periods, you may need corticosteroids in situations of stress. Such situations include hospital admission after an accident, the existence of a serious injury, or before surgery. In this case, the doctor treating you will decide whether you need to increase the dose of corticosteroids and may prescribe tablets or injections of steroids.

In case of hospital admission, remember to bring with you all your medications and inhalers, including Formodual and any other medications or tablets you have purchased without a prescription, if possible, in their original packaging.

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

Children and adolescents

Formodual should not be used in children or adolescents under 18 years of age, until further data is available.

Other medications and Formodual

Inform your doctor if you are using or have recently used other medications, even those purchased without a prescription.

Some medications may increase the effects of Formodual, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Do not use beta blockers with this medication. If you need to use beta blockers (including eye drops), it is likely that the effect of formoterol will be reduced or even nullified. On the other hand, the use of other beta-adrenergic drugs (drugs that work in the same way as formoterol) may potentiate the effects of formoterol.

The combined use of Formodual with:

• Medications for heart rhythm disorders (quinidine, disopyramide, procainamide), medications for allergic reactions (antihistamines), medications for 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 cause electrocardiographic alterations (ECG, electrocardiogram). They may also increase the risk of heart rhythm disorders (ventricular arrhythmias).

• Medications for Parkinson's disease (L-dopa) or for hypothyroidism (L-thyroxine), medications containing oxytocin (which causes uterine contraction) and alcohol, may reduce cardiac tolerance to β2 agonists, such as formoterol.

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

• Medications for heart disease (digoxin), may cause a drop in serum potassium concentration. This may increase the risk of heart rhythm disorders.

• Other medications used to treat asthma (theophylline, aminophylline, or steroids) and diuretics, may produce a drop in serum potassium concentration.

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

Pregnancy, breastfeeding, and fertility

No clinical data is available on the use of Formodual during pregnancy.

Do not use Formodual if you are pregnant or think you may be pregnant, if you are planning to become pregnant, or if you are breastfeeding, unless your doctor tells you otherwise.

Driving and operating machinery

The influence of Formodual on the ability to drive and operate machinery is negligible or insignificant.

Formodual contains alcohol

Formodual contains 7mg of alcohol (ethanol) in each puff, equivalent to 0.20mg/kg per dose of two puffs. The amount of alcohol in two puffs of this medication is equivalent to less than 1ml of wine or beer. The small amount of alcohol contained in this medication has no perceptible effect.

Formodual is for inhalation use.

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

Asthma

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

Formodual may be prescribed by your doctor in two different ways:

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

1. Use of Formodual along with a separate "rescue" inhaler.

Adults and elderly patients:

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

The maximum daily dose is four puffs.

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

1. Use of Formodual as a single inhaler for asthma:

Adults and elderly patients:

The recommended dose of this medication is one puff in the morning and one puff at night.

You should also use Formodual 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 six rescue puffs per day.

The maximum daily dose of Formodual is eight puffs.

If you think you need more puffs per day to control your asthma symptoms, contact your doctor for advice. You may need to change your treatment.

Use in children and adolescents under 18 years:

Children and adolescents under 18 years of age should not take this medication.

Asthma

Adults and elderly patients:

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

High-risk patients:

Elderly patients do not need dose adjustment. There is no information on the use of Formodual in patients with liver or kidney problems.

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

Do not increase the dose.

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

If you use more Formodual than you should

• If you use more formoterol than you should, you may experience the following adverse effects: nausea, vomiting, rapid pulse, palpitations, cardiac arrhythmias, certain electrocardiographic changes (cardiac signal), headache, tremors, drowsiness, excessive 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.
• Taking too much beclomethasone dipropionate can cause short-term alterations in adrenal gland function. This will improve in a few days; however, your doctor may check your cortisol serum concentration.

Consult your doctor if you experience any of these symptoms.

If you forget to use Formodual:

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 with Formodual:

Do not decrease the dose or stop using the medication.

Although you may feel better, do not stop using Formodual or decrease the dose. If you want to do so, consult your doctor. It is very important to use Formodual regularly, even if you do not have symptoms.

If your breathing difficulties worsen:

If just after inhaling the medication your breathing difficulty or wheezing worsens, stop using Formodual immediately and use your rapid-acting rescue inhaler instead. Contact your doctor quickly. Your doctor will evaluate your symptoms and, if necessary, modify your treatment. See section 4 "Possible adverse effects".

If asthma worsens:

If your symptoms worsen or you find it difficult to control them (for example, if you increase the frequency of use of the separate rescue inhaler or Formodual as a rescue inhaler), or if the rescue inhaler or Formodual do not contribute to improving your symptoms, see your doctor immediately. Your asthma may be worsening, and your doctor may need to adjust the dose of Formodual or prescribe an alternative treatment.

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

Administration form:

This medication is contained in a pressurized container within a plastic cover with a mouthpiece.

There is a counter on the back of the inhaler, which indicates how many doses are left. Each time you press the container, a dose of medication is released, and the counter is reduced by one dose. Avoid dropping the inhaler, as this could cause the counter to be reduced by one dose.

Inhaler check

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 and press the container firmly to release a dose.
4. 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.

1. Remove the protective cap from the mouthpiece and check that it is clean, i.e., free of dust, dirt, or other foreign particles.
2. Breathe in as slowly and deeply 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. Breathe in slowly and deeply through your mouth and, just as you start to breathe in,press firmlythe top of the inhaler to release a dose. If you have weakness in your hands, it may be 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 as long as possible and, finally, remove the inhaler from your mouth and breathe out slowly. Do not expel the air through the inhaler.

If you need to inhale another 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 the protective cap and check the dose counter.

You should have another inhaler as a spare when the counter shows 20. Stop using the inhaler when the counter indicates 0, as although there may be remaining doses in the device, they may not be enough to take the full dose.

If some of the gas escapes from the top of the inhaler or from the corner of your lips, it means that Formodual will not 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 Formodual is too strong or insufficient, consult your doctor or pharmacist.

If you find it difficult to press the inhaler while starting to breathe in, you can use the AeroChamber Plus™spacer device. Consult your doctor, pharmacist, or nurse about the use of this device.

It is essential that you read the prospectus that comes with the AeroChamber Plus™device and carefully follow the instructions on how to use the device and how to clean it.

Cleaning

You must 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 protective cap from the mouthpiece, separating it from the inhaler.
2. Pass a clean, dry cloth or paper through the interior and exterior of the mouthpiece and device.
3. Replace the protective cap on the mouthpiece.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Like with other treatments using inhalers, there is a risk of worsening breathing difficulty and immediate sibilance after using Formodual, known asparadoxical bronchospasm. If this happens,STOP using Formodualand use your quick-acting inhaler immediately to treat breathing difficulty and sibilance symptoms. Contact your doctor right away.

Inform your doctor immediately if you experience hypersensitivity reactions, such as skin allergies, itching, rash, skin redness, skin swelling, or mucous membrane swelling, especially in the eyes, face, lips, and throat.

Other side effects are listed below according to their frequency.

Frequent(in at least 1 in 10 patients):

Fungal infections (of the mouth and throat), headache, hoarseness, sore throat.

Pneumonia (lung infection) in COPD patients: inform your doctor if you have any of the following symptoms while inhaling Formodual, which may be symptoms of a lung infection:

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

Infrequent(in at least 1 in 100 patients):

Palpitations, exceptionally rapid heart rate, and cardiac rhythm disorders, certain electrocardiographic (ECG) changes.

Flu-like symptoms, vaginal fungal infections, sinusitis (inflammation of the paranasal sinuses), rhinitis, ear inflammation, throat irritation, cough, and productive cough, asthma attacks.

Nausea, taste alterations or decreased sense of taste, lip burning, dry mouth, difficulty swallowing, indigestion, stomach discomfort, diarrhea.

Muscle pain and cramps, facial redness, increased blood circulation in certain body tissues, excessive sweating, tremors, restlessness, dizziness, rash, or hives.

Alterations in certain blood components: decreased white blood cell count, increased platelet count, decreased potassium concentration in blood, increased glucose concentration in blood, increased insulin concentration, free fatty acids, and ketones in blood.

The following side effects have also been reported as “infrequent” in patients with Chronic Obstructive Pulmonary Disease.

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

Rare(in at least 1 in 1,000 patients)

Feeling of chest oppression, feeling of lost heartbeats (due to premature contraction of the heart ventricles), increased or decreased blood pressure, kidney inflammation, persistent skin and mucous membrane swelling for several days.

Very rare(in at least 1 in 10,000 patients)

Difficulty breathing, worsening asthma, decreased platelet count, swelling in the hands and feet.

Unknown

Blurred vision

The inhalation of high doses of corticosteroids for a prolonged period may cause systemic effects in very rare cases:these include problems with adrenal gland function (suppression of adrenal function), decreased bone mineral density (bone weakening), growth retardation in children and adolescents, increased intraocular pressure (glaucoma), cataracts.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect not listed 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.

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

Unit dose packaging containing 1 inhaler with 120 doses

Do not use Formodual after 3 months from the date it was dispensed by your pharmacist and never use it after the expiration date appearing on the box and label. Do not store the inhaler at a temperature above 25°C.

Dual packaging containing 2 inhalers with 120 doses

Before using:Store the inhaler in the refrigerator (at 2-8°C).

After the first use:Use the inhaler for a maximum of 3 months and do not store at a temperature above 25°C. Do not use the inhaler after this period and never use it after the expiration date appearing on the box and label. Do not freeze.

If the inhaler has been exposed to intense cold, warm it up with your hands for a few minutes before using. Never heat it artificially.

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

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Formodual

• The active principles 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 released dose from the mouthpiece of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate.

• The other components are: anhydrous ethanol, hydrochloric acid, propellant: norflurane (HFC-134a). This medication contains fluorinated greenhouse gases. Each inhaler contains 8.147 g of norflurane (HFC-134a) corresponding to 0.012 tons of CO2equivalent (global warming potential GWP = 1430).

Appearance of the product and contents of the package

Formodual is a pressurized solution contained in an aluminum-coated container with a dosing valve, equipped with a plastic polypropylene pushbutton with a protective cap.

Each package contains a container that provides 120 actuations.

Only some package sizes may be commercially available.

Marketing Authorization Holder:

Chiesi España S.A.U.

Plaza de Europa, 41-43, 10th floor

08908 L'Hospitalet de Llobregat - Barcelona (Spain)

Responsible for manufacturing and batch release:

Chiesi Farmaceutici S.p.A.

Via San Leonardo 96

43122 Parma - Italy

Alternative laboratories responsible for manufacturing and batch release:

Chiesi S.A.S.

2 rue des Docteurs Alberto and Paolo Chiesi

41260 La Chaussée Saint-Victor

France

Chiesi Pharmaceuticals GmbH

Gonzagagasse 16/16

Viena-1010 - Austria

This medication is authorized in the following Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following trademarks:

Austria: Formodual

France: Formodual

Germany: Kantos Master

Greece: Inuvair

Hungary: Formodual

Italy: Inuver

Spain: Formodual

Belgium: Inuvair

Norway: Inuxair

Luxembourg: Inuvair

Sweden: Innovair

Poland: Formodual

Portugal: Formodual

Slovenia: Formodual

Netherlands: Formodual

United Kingdom: Formodual

Bulgaria: Foster

Cyprus: Foster

Denmark: Innovair

Estonia: Foster

Finland: Innovair

Latvia: Foster

Lithuania: Foster

Romania: Foster

Last review date of this leaflet:november 2023.

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