Formodual 200 micrograms/6 micrograms/puff solution for inhalation in pressurized container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Formodual 200 micrograms/6 micrograms/dose solution for inhalation under pressure.

beclometasone dipropionate/formoterol fumarate dihydrate

For use in adults

Read all of 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, ask 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 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 containing two active substances that are inhaled through the mouth and released directly into the lungs.

The two active substances are:

Beclometasone dipropionate, which belongs to a group of medicines called corticosteroids that have an anti-inflammatory action, reducing inflammation and irritation in your lungs.

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

These two combined active substances make breathing easier. They also help prevent asthma symptoms such as difficulty breathing, wheezing, and coughing.

Formodual is used to treat asthma in adults.

If Formodual has been prescribed for you, it is likely that:

• Your asthma is not sufficiently controlled with inhaled corticosteroids and short-acting bronchodilators taken "as needed", or

• Your asthma responds well to a combination treatment of corticosteroids and long-acting bronchodilators.

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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Formodual if you have any of the following conditions:

• Heart problems, such as angina (chest pain), heart failure, narrowed arteries, heart valve disease, or any other known heart abnormality

• High blood pressure or if you know you have an aneurysm (an abnormal bulge in a blood vessel wall)

• Heart rhythm disorders, such as increased heart rate, irregular heartbeat, rapid pulse, or palpitations, or if you have been told you have electrocardiographic abnormalities

• Overactive thyroid gland

• Low potassium levels in the blood

• Any liver or kidney disease

• Diabetes (inhaling high doses of formoterol may increase blood glucose levels. When you start using this medicine and periodically during treatment, you may need additional blood tests to monitor your blood sugar)

• A tumor of the adrenal glands (called phaeochromocytoma)

• If you are due to receive anesthesia. Depending on the type of anesthetic, you may need to stop using Formodual at least 12 hours before anesthesia

• If you are being or have been treated for tuberculosis (TB), or if you have a known viral or fungal infection in the lungs

• If you need to avoid alcohol for any reason

Always consult your doctor before starting to use Formodual if you are in any of the situations mentioned above.

If you have or have had any medical conditions or allergies, or if you are unsure whether you can use Formodual, consult your doctor, asthma specialist nurse, or pharmacist before starting to use this medicine.

Your doctor may want to check your blood potassium levels from time to time, especially if you have severe asthma. Like many other bronchodilators, Formodual may cause a sudden drop in serum potassium levels (hypokalaemia). This is because lack of oxygen in the blood, combined with other treatments you may be taking alongside Formodual, can worsen the decrease in potassium levels.

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

If you need to go to hospital, remember to bring all your medicines and inhalers with you, including Formodual 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

Formodual must not be used in children and adolescents under 18 years of age.

Other medicines and Formodual

Tell your doctor, pharmacist, or nurse if you are using or have recently used any other medicines, including those obtained without a prescription. This is because Formodual may affect how some medicines work. In addition, some medicines may affect how Formodual works.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Some medicines can increase the effects of Formodual, so your doctor will monitor you closely if you are taking these (including some HIV medications: ritonavir, cobicistat).

• Beta-blockers. Beta-blockers are medicines used to treat various conditions such as heart problems, high blood pressure, or glaucoma (increased pressure in the eye). If you need to use beta-blockers (including eye drops), the effect of formoterol may be reduced or even blocked.

• Beta-adrenergic medicines (medicines with the same action as formoterol) may increase the effects of formoterol.

• Medicines used to treat heart rhythm disorders (quinidine, disopyramide, procainamide).

• Medicines used to treat allergic reactions (antihistamines such as terfenadine).

• Medicines used to treat depression or psychiatric disorders such as monoamine oxidase inhibitors (e.g. phenelzine, isocarboxazid) or tricyclic antidepressants (e.g. amitriptyline and imipramine), or phenothiazines.

• Medicines used to treat Parkinson's disease (levodopa).

• Medicines used to treat hypothyroidism (levothyroxine).

• Medicines containing oxytocin (which causes uterine contractions).

• Medicines used to treat psychiatric disorders such as monoamine oxidase inhibitors (MAOIs), including drugs with similar properties, such as furazolidone and procarbazine.

• Medicines used to treat heart disease (digoxin).

• Other medicines used to treat asthma (theophylline, aminophylline, or steroids).

• Diuretics.

Also inform your doctor if you are due to receive general anesthesia for surgery or dental procedures.

Pregnancy, breastfeeding, and fertility

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

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

Driving and using machines

It is unlikely that Formodual will affect your ability to drive or use machines.

Formodual contains alcohol

Formodual contains 9 mg of alcohol (ethanol) per dose, equivalent to 0.25 mg/kg per 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 contained in this medicine has no noticeable effect.

3. How to use Formodual

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

Your doctor will carry out periodic reviews to ensure you are receiving the optimal dose of Formodual. Your doctor will adjust the treatment to the lowest dose that best controls your symptoms.

Dosage:

Adults and elderly patients: The recommended dose is two actuations twice daily.

The maximum daily dose is 4 actuations.

Remember: you should always carry your fast-acting "rescue" inhaler in case your asthma symptoms worsen or you experience a sudden asthma attack.

Patients at risk

Dose adjustment is not necessary in elderly patients. There is no information available on the use of Formodual in patients with liver or kidney problems.

Use in children and adolescents (under 18 years of age)

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

Formodual is effective for 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 asthma worsens

If symptoms worsen or become difficult to control (for example, if you need to use your fast-acting "rescue" inhaler more frequently), or if the "rescue" inhaler does not improve your symptoms, contact your doctor immediately. Your asthma may be worsening, and your doctor may need to adjust the dose of Formodual or prescribe an alternative treatment.

Method of administration:

Formodual is for inhalation use only.

This medicine is contained in a pressurized canister within a plastic casing with a mouthpiece.

There is a dose counter on the back of the inhaler, which indicates how many doses remain. Each time you press the canister, one dose of medicine is released and the counter decreases by one. 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 firmly press the canister to release one dose.
5. Check the dose counter. After checking your inhaler for the first time, the counter should show 120.

How to use your inhaler

Whenever possible, stand or sit upright when inhaling.

Before starting to inhale, check the dose counter: any number between "1" and "120" indicates that doses remain. If the dose counter shows "0", no doses are left – discard the inhaler and obtain a new one.

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 slowly and as fully 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: place both index fingers on the top of the inhaler and both thumbs on the bottom.
5. Hold your breath for as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not exhale into the inhaler.

If you need another dose, keep the inhaler upright for about half a minute and 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.

To reduce the risk of fungal infections of the mouth and throat, rinse your mouth with water, gargle, or brush your teeth after using the inhaler.

You should obtain a replacement inhaler when the counter shows 20. Stop using the inhaler when the counter reads 0, as although there may be extra actuations remaining 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 as intended. Take another dose following the instructions, starting again at step 2.

If you feel 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 this device.

It is important that you read the leaflet provided with the AeroChamber Plus spacer device and follow the instructions for use and cleaning carefully.

Cleaning

You should 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 detaching 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.

If you use more Formodual than you should

• If you use more formoterol than you should, you may experience the following effects: nausea, vomiting, rapid pulse, palpitations, heart rhythm disturbances, certain electrocardiographic changes (heart tracing), headache, tremor, drowsiness, excess acid in the blood, low potassium levels in the blood, and high blood glucose levels. Your doctor may request blood tests to check your potassium and blood 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 need to 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. However, if it is almost time for your next dose, skip the missed dose and take only the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop using Formodual

Even if you feel better, do not stop taking Formodual or reduce the dose. If you wish to do so, consult your doctor. It is very important that you use Formodual regularly, even if you do not have symptoms.

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

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 Formodual, known as paradoxical bronchospasm. If this occurs, STOP using Formodual immediately and use your fast-acting "rescue" inhaler right away to treat symptoms of breathing difficulty and wheezing. Contact your doctor immediately.

Contact 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 possible adverse effects are listed below according to their frequency.

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

• fungal infections (of the mouth and throat)
• headache
• hoarseness
• sore throat

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

• palpitations, abnormally rapid heartbeat, and heart rhythm disorders
• certain electrocardiographic (ECG) abnormalities
• increased blood pressure
• flu-like symptoms
• sinusitis
• rhinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• fungal infections of the vagina
• nausea
• altered or reduced sense of taste
• burning of the lips
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhea
• muscle pain and cramps
• redness of the face and throat
• increased blood circulation in certain body tissues
• excessive sweating
• tremors
• restlessness
• dizziness
• rash or hives
• changes in certain blood components:
  • decreased number of white blood cells
  • increased number of platelets
  • decreased concentration of potassium in blood
  • increased blood sugar
  • increased concentration of insulin, free fatty acids, and ketone bodies in blood

The following adverse effects have also been reported as "uncommon" in patients with chronic obstructive pulmonary disease (COPD):

• pneumonia; inform your doctor if you experience any of the following symptoms: increased sputum production, changes in sputum color, fever, worsening cough, or increased breathing problems
• reduced cortisol levels in blood; caused by the effect of corticosteroids on the adrenal gland
• irregular heartbeat

Rare (may affect up to 1 in 1,000 patients):

• chest tightness
• sensation of missed heartbeats (due to premature contraction of the heart ventricles)
• decreased blood pressure
• kidney inflammation
• persistent swelling of the skin and mucous membranes lasting several days

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

• difficulty breathing
• worsening of asthma
• decreased number of platelets
• swelling of hands and feet

Long-term, high-dose inhaled corticosteroids may very rarely cause systemic effects, including:

• adrenal gland function problems (adrenal suppression)
• decreased bone mineral density (weakening of bones)
• growth retardation in children and adolescents
• increased intraocular pressure (glaucoma)
• cataracts

Frequency not known (cannot be estimated from available data):

• sleep disorders
• depression or anxiety
• nervousness
• overexcitement or irritability

These effects may occur more frequently in children, but their frequency is unknown.

• Blurred vision

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is an adverse effect not listed in this leaflet.

You can 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 the sight and reach of children.

For the pharmacist:

Store in a refrigerator at 2 °C to 8 °C for a maximum period of 18 months.

For the patient:

Do not use this medicine more than 3 months after the date you obtained the inhaler from the pharmacy, and never use it after the expiry date stated on the carton and label. The expiry date is the last day of the month indicated.

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

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 a pressurised liquid. Do not expose the container to temperatures above 50 °C or pierce it.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines 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 and formoterol fumarate dihydrate.

Each dose from the inhaler contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a dose delivered from the mouthpiece of 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.

The other components are: norflurane (HFC-134a), anhydrous ethanol, hydrochloric acid.

This medicine contains fluorinated greenhouse gases.

Each inhaler contains 10.356 g of norflurane (HFC-134a), equivalent to 0.015 tonnes of CO2 (global warming potential GWP = 1430).

Appearance of the product and contents of the pack

Formodual is a pressurized solution for inhalation contained in an aluminium container coated internally with a metering valve, fitted with a plastic actuator incorporating either a dose counter (pack of 120 doses) or a dose indicator (pack of 180 doses), together with a plastic protective cap.

Each pack contains:

1 pressurized container (delivering 120 actuations)
2 pressurized containers (each delivering 120 actuations)
1 pressurized container (delivering 180 actuations)

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturing Responsible Party

CHIESI ESPAÑA, S.A.U.
Plaza de Europa, 41-43, Planta 10
08908 L’Hospitalet de Llobregat
Barcelona (Spain)

Manufacturer responsible for batch release:

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

or

Chiesi Pharmaceuticals GmbH
Gonzagagasse 16/16
1010 Vienna – Austria

or

Chiesi S.A.S.
2 rue des Docteurs Alberto et Paolo Chiesi
41260 La Chaussée Saint-Victor
France

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

France, Spain, United Kingdom: Formodual
Germany: Kantos Master 200 Mikrogramm/6 Mikrogramm pro Inhalation Druckgasinhalation, Lösung
Belgium, Luxembourg, Greece: Inuvair
Bulgaria, Lithuania, Latvia, Estonia, Cyprus, Romania: Foster
Italy: Inuver
Denmark, Finland: Innovair
Norway: Inuxair

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

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) (http://www.aemps.gob.es/).