Label: information for the user

Formodual 200micrograms/6micrograms/pulse solution for inhalation in a pressurized container.

dipropionato de beclometasona/fumarato de formoterol dihidrato

For use in adults

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section4.

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

The two active principles are:

Dipropionate of beclometasone, which belongs to a group of medications known as corticosteroids that have an anti-inflammatory action that reduces inflammation and irritation in the lungs.

Fumarate of formoterol dihydrate, which belongs to a group of medications known as long-acting bronchodilators that relax the muscles of the respiratory tract, making it easier to breathe.

The combination of these two active principles facilitates breathing. They also help prevent asthma symptoms, such as difficulty breathing, wheezing, and coughing.

Formodual is used to treat asthma in adults.

If you have been prescribed Formodual, it is likely that:

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

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

No use Formodual:

• If you are allergic to dipropionate beclometasona or to fumarato dihidrato formoterol or to any of the other components of this medication (including in section 6).

Advertencias and precautions

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

• heart problems, such as angina (chest pain, chest pain), heart failure, narrowing of the arteries, heart valve disease or any other known heart anomaly

• high blood pressure or if you know you have an aneurysm (an abnormal bulge of the blood vessel wall)

• 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

• hyperactive thyroid gland

• low potassium levels in the blood

• any liver or kidney disease
  
• diabetes (inhalation of high doses of formoterol may cause an increase in blood glucose levels. When starting to use this medication and occasionally during treatment, you will need to undergo additional blood tests to control blood sugar levels)

• adrenal gland tumor (called pheochromocytoma)
  
• if you are to receive anesthesia. Depending on the type of anesthetic, you may need to stop using Formodual for 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 must avoid taking alcohol for any reason.

Consult your doctor before starting to use Formodual if you are in any of the circumstances mentioned.

If you have or have had medical problems or allergies or if you are unsure if you can use Formodual, consult your doctor, nurse specializing in asthma or pharmacist before starting to use this medication.

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

If high doses of inhaled corticosteroids are administered for prolonged periods, you may need more corticosteroids in situations of stress. Such situations include hospital admission after an accident, the existence of a serious injury or before a surgical procedure. In this case, your treating doctor will decide if you need to increase the dose of corticosteroids and may prescribe tablets or injections of steroids.

In case you need to go to the hospital,remember to bring with you all your medications and inhalers, including Formodual and other medications or tablets 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 and adolescents under 18 years old.

Other medications and Formodual

Inform your doctor, pharmacist or nurse if you are using or have recently used other medications, even those purchased without a prescription. This is because Formodual may affect the way some medications work. In addition, some medications may affect the way Formodual works.

Particularly, inform your doctor or pharmacist if you are using any of the following medications:

• Some medications may increase the effects of Formodual, so your doctor will make close controls if you are taking these medications (including some for HIV: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medications used to treat various conditions, such as heart problems, high blood pressure or glaucoma (increased intraocular pressure). If you need to use beta-blockers (including eye drops), the effect of formoterol may be reduced or even canceled.
• Beta-adrenergic medications (medications with the same action as formoterol) may increase the effects of formoterol.
• Medications to treat heart rhythm disorders (quinidine, disopyramide, procainamide).
• Medications to treat allergic reactions (antihistamines such as terfenadine).
• Medications to treat depression or psychiatric disorders such as monoamine oxidase inhibitors (for example phenelzine, isocarboxazid) or tricyclic antidepressants (for example amitriptyline and imipramine), or phenothiazines.
• Medications to treat Parkinson's disease (levodopa).
• Medications to treat hypothyroidism (levotiroxine).
• Medications containing oxytocin (which causes uterine contraction).
• Medications used to treat psychiatric disorders such as monoamine oxidase inhibitors (MAO), including similar drugs, such as furazolidone and procarbazine.
• Medications to treat heart disease (digoxin).
• Other medications used to treat asthma (theophylline, aminophylline or steroids).
• Diuretics.

Also inform your doctor if you are to receive general anesthesia for a surgical or dental procedure.

Pregnancy, breastfeeding and fertility

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

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

Driving and operating machinery

It is unlikely that Formodual will have an effect on your ability to drive and operate machinery.

Formodual contains alcohol

Formodual contains 9 mg of alcohol (ethanol) in each discharge, equivalent to 0.25 mg/kg per dose of two puffs. The amount in two puffs of this medication is equivalent to less than 1 ml of wine or beer. The small amount of alcohol contained in this medication has no perceptible effect.

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

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

Dose:

Adults and elderly patients:
The recommended dose is two puffs twice a day.

The maximum daily dose is 4 puffs.

Remember: you should always carry the rapid-acting rescue inhaler with you in case your asthma symptoms worsen or if you experience a sudden asthma attack.

Patients at risk

No dose adjustment is necessary for 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 should not receive this medication.

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

If symptoms worsen or are difficult to control (for example, if you increase the use of the rapid-acting rescue inhaler), or if the rescue inhaler does not improve symptoms, see your doctor immediately. Your asthma may be worsening, and your doctor may need to modify the dose of Formodual or prescribe an alternative treatment.

Administration form:

Formodual is for inhalation use.

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 that indicates how many doses are left. Each time you press the container, a dose of medication is released, and the counter is decremented. Avoid dropping the inhaler, as this could cause the counter to decrement a 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 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

Whenever possible, stand or sit upright to perform the inhalation.

Before starting the inhalation, check the dose counter: any number between "1" and "120" indicates that doses are available. If the dose counter shows "0", there are no doses available - 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 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. Inhale slowly and deeply through your 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, it may be easier to hold the inhaler with both hands: place 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 exhale slowly. Do not expel air through the inhaler.

If you need another dose, hold the inhaler in a vertical position for approximately half a minute and 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.

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

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

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 inhale, you can use the spacer device AeroChamber Plus. Consult your doctor, pharmacist, or nurse about this device.

It is essential that you read the leaflet provided with the AeroChamber Plus device and follow the instructions for use and cleaning meticulously.

Cleaning

You must clean the inhaler once a week.

When cleaning, 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.

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, cardiac rhythm disturbances, certain electrocardiographic changes (heart tracing), headache, tremors, drowsiness, high blood glucose levels, low potassium levels in the blood, and high blood glucose levels. Your doctor may request blood tests to check your potassium and glucose levels in the blood.
• Taking too much beclometasone dipropionate may cause short-term alterations in the functioning of the adrenal glands. This situation will improve in a few days; however, your doctor may need to 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. However, if it is almost time for your next dose, skip the missed dose and only take the next dose at your scheduled time.Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Formodual

Although you may feel better, do not stop taking Formodual or reduce the dose. If you want 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 other questions about the use of this medication, ask your doctor or pharmacist.

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

As with other treatments using inhalers, there is a risk of worsening breathing difficulty and immediate coughing immediately after using Formodual, known asparadoxical bronchospasm. If this happens,IMMEDIATELY STOP using Formodualand use your rescue inhaler with quick action to treat breathing difficulty and coughing symptoms. Contact your doctor immediately.

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

Other possible side effects are listed below according to their frequency.

Frequent(may affect 1 in 10 patients):

• oral and throat fungal infections
• headache
• hoarseness
• sore throat

Occasional(may affect 1 in 100 patients):

• palpitations, exceptionally rapid heart rate, and cardiac rhythm disorders
• certain electrocardiogram (ECG) alterations
• increased blood pressure
• flu-like symptoms
• sinusitis
• rinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• vaginal fungal infections
• nausea
• alteration or decrease in taste
• lip burning
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhea
• muscle pain and cramps
• face and throat redness
• increased blood flow to certain tissues in the body
• excessive sweating
• tremors
• restlessness
• dizziness
• eruption or rash
• alterations in certain blood components:
• • decrease in white blood cell count
  • increase in platelet count
  • decrease in blood potassium concentration
  • increase in blood sugar
  • increase in blood insulin, free fatty acids, and ketone bodies

The following side effects have also been reported as “occasional” in patients with chronic obstructive pulmonary disease:

• pneumonia; inform your doctor if you experience any of the following symptoms: increased sputum production, changes in sputum color, fever, increased coughing, worsening respiratory problems
• decrease in blood cortisol concentration; caused by the effect of corticosteroids on the adrenal gland
• irregular heartbeats

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

• chest tightness
• sensation of lost heartbeats (due to premature contraction of the heart ventricles)
• decreased blood pressure
• kidney inflammation
• skin and mucous membrane swelling persisting for several days

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

• breathing difficulty
• worsening asthma
• decrease in platelet count
• swelling of hands and feet

The inhalation of corticosteroids in high doses for a prolonged period may cause systemic effects in very rare cases, including:that include:

• problems with adrenal gland function (suppression of adrenal function)
• decrease in bone mineral density (bone weakening)
• growth delay in children and adolescents
• increased intraocular pressure (glaucoma)
• cataracts

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

• sleep problems
• depression or anxiety
• nervousness
• excitement or irritability

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

• blurred vision

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this prospectus.

You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products 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.

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 medication after 3months from the date you acquired the inhaler at the pharmacy 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.

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 or pierce it.

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

Composition of Formodual

The active principles are: beclometasone dipropionate and formoterol fumarate dihydrate.

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

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

This medicine contains fluorinated greenhouse gases.

Each inhaler contains 10.356 g of norflurano (HFC-134a) corresponding to 0.015tonnes of CO2equivalent (global warming potential PCG = 1430).

Appearance of the product and contents of the package

Formodual is a solution for inhalation in a pressurized container contained in an aluminum-coated container with a dosing valve, equipped with a plastic push-buttonthat incorporates a dose counter (container with 120 doses) or a dose indicator (container with 180 doses),with a plastic protective cap.

Each package contains:

1 pressurized container (which provides 120puffs)

2 pressurized containers (which provide 120puffs each)

1 pressurized container (which provides 180puffs)

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

CHIESI ESPAÑA, S.A.U.

Plaza de Europa, 41-43, 10th floor

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

Responsible manufacturer for the release of batches:

Chiesi Farmaceutici S.p.A.

ViaSan 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 and Paolo Chiesi

41260 La Chaussée Saint-Victor

France

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

France, Spain, United Kingdom: Formodual

Germany: Kantos Master 200 Mikrogramm/6 Mikrogramm per Inhalation Druckgasinhalation, Lösung

Belgium, Luxembourg, Greece: Inuvair

Bulgaria, Lithuania, Latvia, Estonia, Cyprus, Romania: Foster

Italy: Inuver

Denmark, Finland: Innovair

Norway: Inuxair

Last review date of this leaflet:November 2023.

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