Formodual 100 micrograms/6 micrograms/puff solution for inhalation in pressurized container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Formodual 100 micrograms/6 micrograms per actuation Inhalation solution for 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could 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. See section 4.

Contents of the leaflet

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

1. What Formodual is and what it is used for

Formodual 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 your 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.

These two combined active substances help you breathe more easily by providing relief from symptoms such as breathlessness, wheezing and coughing in patients with asthma or chronic obstructive pulmonary disease (COPD), and also help prevent asthma symptoms.

Asthma

Formodual 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 responding well to a combination treatment of corticosteroids and long-acting bronchodilators.

COPD

Formodual 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 Formodual

Do not use Formodual:

• If you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate, 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 further information), consult your doctor.

Warnings and precautions

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

• If you have heart problems, such as angina (chest 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, in which the heart muscle is enlarged).

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

• If you have heart rhythm disorders, such as increased heart rate or irregular heartbeat, a fast pulse, palpitations, or if you have been told you have electrocardiographic abnormalities.

• If your thyroid gland is overactive.

• If your blood potassium level is 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 you start using the inhaler and periodically during treatment).

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

• If you are going to receive anesthesia. Depending on the anesthetic agent used, you may need to stop using Formodual at least 12 hours before anesthesia.

• 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 consume alcohol for any reason.

If any of the above situations apply to you, always 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.

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

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

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

If you go to the hospital, remember to bring all your medicines and inhalers with you, including Formodual and any other medications 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

Formodual must not be used in children and adolescents under 18 years of age until more data are available.

Other medicines and Formodual

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

Some medicines may increase the effects of Formodual, so your doctor will monitor you closely if you are taking these medicines (including certain HIV medications: 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, using other beta-adrenergic drugs (medicines that work similarly to formoterol) may enhance the effects of formoterol.

The combined use of Formodual with:

• Medicines used to treat heart rhythm disorders (quinidine, disopyramide, procainamide), medicines used to treat allergic reactions (antihistamines), medicines used to treat depression or psychiatric disorders such as monoamine oxidase inhibitors (e.g., phenelzine, isocarboxazide), tricyclic antidepressants (e.g., amitriptyline, 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 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 anesthetics may increase the risk of heart rhythm disorders.

Pregnancy, breastfeeding, and fertility

There are no clinical data on the use of Formodual during pregnancy.

Do not use Formodual if you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, unless your doctor specifically advises you to do so.

Driving and using machines

The effect of Formodual on the ability to drive and operate machinery is negligible or none.

Formodual contains alcohol

Formodual contains 7 mg of alcohol (ethanol) per actuation, 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 has no noticeable effect.

3. How to use Formodual

Formodual is for inhalation use only.

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

Asthma

Your doctor will review you periodically to ensure you are taking the optimal dose of Formodual. Your doctor will always adjust treatment to the lowest 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, together with a separate “rescue” inhaler to treat sudden worsening of asthma symptoms such as difficulty breathing, wheezing, and coughing

2. Use Formodual daily to treat your asthma and also use Formodual as needed to treat sudden worsening of asthma symptoms such as difficulty breathing, wheezing, and coughing

3. Use of Formodual together with a separate “rescue” inhaler

Adults and elderly patients:

The recommended dose of this medicine is one to two actuations twice daily.

The maximum daily dose is 4 actuations.

Remember: Always carry a fast-acting “rescue” inhaler with you to treat worsening asthma symptoms or sudden asthma attacks.

2. Use of Formodual as the sole inhaler for asthma

Adults and elderly patients:

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

You should also use Formodual as a “rescue” inhaler to treat sudden asthma symptoms.

If you have 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 rescue actuations per day.

The maximum daily dose of Formodual is 8 actuations.

If you feel you need more actuations 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 of age:

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

COPD

Adults and elderly patients:

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

At-risk patients:

Elderly patients do not require dose adjustment. There is no information available on the use of Formodual in patients with hepatic or renal impairment.

Formodual 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 been using another inhaler containing beclometasone dipropionate, your doctor will advise you on the exact dose of Formodual you should take for asthma.

Do not increase the dose.

If you think the medicine is not very effective, always 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 rhythm disorders, certain electrocardiographic changes (heart 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 improve within a few days; however, your doctor may check your serum cortisol 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 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 Formodual:

Do not reduce the dose or stop using the medicine.

Even if you feel better, do not stop using Formodual or reduce the dose. If you wish to do so, consult your doctor. It is very important to use Formodual 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 Formodual immediately and use your fast-acting inhaler right away. Contact your doctor promptly. Your doctor will assess your symptoms and, if necessary, modify your treatment. See also section 4 "Possible side effects".

If asthma worsens:

If your symptoms worsen or become difficult to control (for example, if you need to use your separate fast-acting inhaler or Formodual as a rescue inhaler more frequently), or if the fast-acting inhaler or Formodual fails to relieve your symptoms, see your doctor immediately. Your asthma may be worsening, and your doctor may need to adjust your Formodual dose or prescribe an alternative treatment.

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

Method of administration:

This medicine is contained in a pressurized canister inside a plastic housing with a mouthpiece.

There is a counter on the back of the inhaler indicating how many doses remain. Each time you press the canister, one dose of medicine is released and the counter reduces by one dose. Avoid dropping the inhaler, as this could cause the counter to reduce by one dose.

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 properly.

1. Before checking the inhaler for the first time, verify that the dose counter shows 121.
2. Remove the protective cap from the mouthpiece.
3. Hold the inhaler upright with the mouthpiece at the bottom.
4. Point the mouthpiece away from you and press firmly on the canister to release one dose.
5. Check the dose counter. After checking your inhaler for the first time, the counter should read 120.

How to use your inhaler

Whenever possible, stand or sit upright when inhaling.

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 facing up and place the mouthpiece between your lips. Do not bite the mouthpiece.
4. Inhale 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, you may find it 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.

You should have a replacement inhaler ready when the counter shows 20. Stop using the inhaler when the counter reads 0, as although there may be remaining actuations in the device, they may not be sufficient for a complete dose.

If some of the gas escapes from the top of the inhaler or from the corners of your lips, Formodual may not reach your lungs properly. Take another dose following the instructions, starting again at 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 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 that you 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 will experience them.

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

Inform your doctor immediately if you experience hypersensitivity reactions such as skin allergies, itching, rash, skin redness, or 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 (at least 1 in 10 patients):

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

Pneumonia (lung infection) in patients with COPD: inform your doctor if you experience any of the following symptoms while inhaling Formodual, as they could indicate a lung infection:

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

Uncommon (at least 1 in 100 patients):

Palpitations, abnormally rapid heartbeat, and heart rhythm disorders; certain electrocardiographic (ECG) abnormalities.

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

Nausea, taste disturbances or reduced sense of taste, burning sensation 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 white blood cell count, increased platelet count, decreased potassium concentration in blood, increased blood glucose concentration, increased insulin, free fatty acids, and ketones in blood.

The following adverse effects have also been reported as "uncommon" in patients with Chronic Obstructive Pulmonary Disease (COPD):

• Reduced blood cortisol levels; this is caused by the effect of corticosteroids on your adrenal gland.
• Irregular heartbeats.

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

Feeling of chest tightness, sensation of missed heartbeats (due to premature ventricular contractions), increased or decreased blood pressure, kidney inflammation, persistent swelling of the skin and mucous membranes lasting several days.

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

Breathing difficulty, worsening of asthma, decreased platelet count, swelling of the hands and feet.

Not known

Blurred vision

Long-term, high-dose inhaled corticosteroids may very rarely cause systemic effects, including adrenal gland dysfunction (adrenal suppression), decreased bone mineral density (bone weakening), growth retardation in children and adolescents, increased intraocular pressure (glaucoma), cataracts.

Sleep disorders, depression, or feelings of anxiety, restlessness, nervousness, over-excitement, or irritability: these effects may occur especially in children, but their frequency is unknown.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Formodual

Keep this medicine out of sight and reach of children.

Single pack containing 1 inhaler of 120 doses

Do not use Formodual after 3 months from the date it was dispensed to you by your pharmacist, and never use it after the expiry date stated on the carton and label. Do not store the inhaler at temperatures above 25 °C.

Double pack containing 2 inhalers of 120 doses

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

After first use: Use the inhaler for a maximum of 3 months and do not store it at temperatures above 25 °C. Do not use the inhaler after this period, and never use it after the expiry date stated on the carton and label. Do not freeze.

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

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Formodual

• 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 dose delivered 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 medicine contains fluorinated greenhouse gases. Each inhaler contains 8.147 g of norflurane (HFC-134a), equivalent to 0.012 tonnes of CO2 (global warming potential GWP = 1430).

Nature of the product and contents of the container

Formodual is a pressurized solution contained in an aluminum container with a metering valve, fitted with a polypropylene plastic actuator with a protective cap.

Each pack contains one container providing 120 actuations.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Chiesi España S.A.U.

Plaza de 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 manufacturers responsible for manufacturing and batch release:

Chiesi S.A.S.

2 rue des Docteurs Alberto et Paolo Chiesi

41260 La Chaussée Saint-Victor

France

Chiesi Pharmaceuticals GmbH

Gonzagagasse 16/16

Vienna-1010 - Austria

This medicine is authorized in the following European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following brand names:

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

Date of the most recent revision of this leaflet: February 2026.

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.