Formodual

Package Leaflet:

Patient Information

Formodual, (100 micrograms + 6 micrograms)/dose, inhalation aerosol, solution

Beclometasone dipropionate + Formoterol fumarate dihydrate
This medicine is intended for use in adults.

Read all of this leaflet carefully before using this medicine because it contains important information for you.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

• 1. What is Formodual and what is it used for
• 2. Important information 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 is Formodual and what is it used for

Formodual is a solution in an inhalation aerosol, containing two active substances, which are delivered directly to the lungs when you inhale through the mouthpiece of the inhaler.
The medicine contains two active substances: beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which have an anti-inflammatory action by reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators, which relax the muscles in the airways and make it easier to breathe.
Together, these two active substances make it easier to breathe by relieving symptoms such as:
shortness of breath, wheezing, and coughing in patients with asthma or chronic obstructive pulmonary disease (COPD), and also help prevent asthma symptoms.
Asthma
Formodual is indicated for regular treatment of asthma in adult patients, in whom:

• asthma symptoms are not adequately controlled with inhaled corticosteroids and as-needed use of a short-acting bronchodilator, or
• asthma symptoms are adequately controlled with inhaled 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 disease that is mainly caused by smoking.

2. Important information before using Formodual

When not to use Formodual:

• if you are allergic or think you may be allergic to one of the active substances of Formodual, or if you are allergic to other medicines or inhalation products used to treat asthma, or to any of the other ingredients of Formodual (listed in section 6 "Contents of the pack and other information"), you should consult your doctor.

Warnings and precautions

Before starting treatment with Formodual, you should discuss with your doctor, pharmacist, or nurse:

• if you have heart disease, such as angina (chest pain), recent heart attack (myocardial infarction), heart failure, narrowing of the heart arteries (coronary artery disease), heart valve problems, or any other heart disease, or a disease called hypertrophic cardiomyopathy with outflow obstruction (characterized by abnormal heart muscle structure);
• if you have narrowing of the arteries (also known as atherosclerosis); if you have high blood pressure or an aneurysm (abnormal dilation of a blood vessel wall);
• if you have irregular heart rhythms, such as rapid or irregular heartbeat, rapid pulse, or palpitations, or if you have any information about abnormal heart rhythm;
• if you have an overactive thyroid gland;
• if you have low potassium levels in your blood;
• if you have liver or kidney disease;
• if you have diabetes (inhalation of high doses of formoterol may increase blood glucose levels, so before starting treatment with this medicine and at regular intervals during treatment, it may be necessary to perform additional blood tests to determine glucose levels);
• if you have a tumor of the adrenal gland (pheochromocytoma);
• if you are scheduled for general anesthesia. Depending on the type of anesthesia, it may be necessary to stop taking Formodual at least 12 hours before anesthesia;
• if you are being treated or have been treated for tuberculosis or if you have a viral or fungal infection in the chest;
• if you need to avoid consuming alcohol for any reason.

Before using Formodual, you should always inform your doctor if any of the above warnings apply to you.

Before using an inhalation medicine, you should consult your doctor, pharmacist, or nurse if you have any current or past health problems or allergies, or if you are unsure whether Formodual can be used.
Treatment with beta-agonists, such as formoterol contained in Formodual, may cause sudden lowering of potassium levels in the blood (hypokalemia).
Particular care is needed in patients with severe asthma,as low oxygen levels in the blood, as well as the use of other medicines with Formodual, such as those used to treat heart disease or high blood pressure, called diuretics, or other asthma medicines, may increase the risk of lowering potassium levels in the blood. For this reason, your doctor may recommend checking potassium levels in your blood from time to time.
If you are taking high doses of inhaled corticosteroids for a long time, you may need to take corticosteroids during stressful situations. Such situations may include hospitalization after an accident, severe injury, or scheduled surgery. In these situations, your doctor will decide whether to increase the dose of corticosteroids or prescribe other steroids in tablet or injectable form.
If hospitalization is necessary, you should remember to bring all your medicines and inhalers, including Formodual, as well as any medicines you have purchased without a prescription, if possible, in their original packaging.

If you experience blurred vision or other vision disturbances, you should contact your doctor.

Children and adolescents

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

Formodual and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, including those obtained without a prescription.
Certain medicines may increase the effects of Formodual, and your doctor may want to monitor your condition closely if you are taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
You should not use beta-blockers with Formodual.If beta-blockers (including eye drops) need to be used, the effect of formoterol may be reduced or formoterol may not work. On the other hand, concomitant use of other beta-adrenergic medicines (medicines that work in the same way as formoterol) may increase the effect of formoterol.

Concomitant use of Formodual with:

• medicines used to treat irregular heartbeat (quinidine, disopyramide, procainamide), medicines used to treat allergies (antihistamines), medicines used to treat depression or mental disorders, such as monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazid), tricyclic antidepressants (e.g., amitriptyline and imipramine), phenothiazines, may cause changes in the electrocardiogram (ECG, a record of heart activity). They may also increase the risk of irregular heartbeat (ventricular arrhythmias).
• medicines used to treat Parkinson's disease (L-dopa), hypothyroidism (L-thyroxine), medicines containing oxytocin (which can cause uterine contractions), and alcohol may reduce the heart's tolerance to beta-agonists, such as formoterol.
• monoamine oxidase inhibitors (MAOIs) or medicines with similar properties, such as furazolidone and procarbazine, used to treat mental disorders, may cause an increase in blood pressure;
• medicines used to treat heart disease (digoxin) may cause a decrease in potassium levels in the blood, which can increase the risk of irregular heartbeat.
• other medicines used to treat asthma (theophylline, aminophylline, or steroids) and diuretics may cause a decrease in potassium levels in the blood.
• certain anesthetics may increase the risk of irregular heartbeat.

Pregnancy, breastfeeding, and fertility

There are no clinical data on the use of Formodual during pregnancy.
Formodual should not be used if you are pregnant, think you may be pregnant, or plan to have a baby, or if you are breastfeeding, unless your doctor decides otherwise.

Driving and using machines

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

Formodual contains ethanol

Formodual contains 7 mg of ethanol (alcohol) per actuation, which is equivalent to 0.20 mg/kg body weight per dose, when two actuations are used. The amount of alcohol in two actuations of this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine is unlikely to have any noticeable effects.

3. How to use Formodual

Formodual is for inhalation use only.

This medicine should always be used in accordance with the recommendations of your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Asthma

Your doctor will regularly check that you are taking the optimal dose of Formodual. Your doctor will determine the smallest dose that provides the best control of your asthma symptoms.

Your doctor may prescribe Formodual in one of two ways: a) Formodual should be used daily to treat asthma, along with another inhaled medicine that provides quick relief in case of sudden worsening of asthma symptoms,

such as shortness of breath, wheezing, and coughing,
b) Formodual should be used daily to treat asthma, and also in case of sudden worsening of asthma symptoms, such as shortness of breath, wheezing, and coughing.
a) Using Formodual with another inhaled medicine that provides quick relief.
Adults and the elderly:
The recommended dose is one or two actuations twice daily.
The maximum daily dose is 4 actuations.

Remember: You should always carry a quick-acting inhaled medicine with you to treat worsening of asthma symptoms or sudden asthma attacks. b) Using Formodual as the only inhaled medicine for asthma.

Adults and the elderly:
The recommended dose is one actuation in the morning and one actuation in the evening.
You should also use Formodual as a quick-acting inhaled medicine in case of sudden worsening of asthma symptoms.
If symptoms occur, use one actuation and wait a few minutes.
If there is no improvement, use another actuation.

Do not use more than 6 quick-acting actuations in 24 hours.

The maximum daily dose of Formodual is 8 actuations.

If you need to take more actuations to control your asthma symptoms, you should consult your doctor. A change in treatment may be necessary.

Use in children and adolescents under 18 years of age:

This medicine should not be used in children and adolescents under 18 years of age.

Chronic obstructive pulmonary disease (COPD) Adults and the elderly:

The recommended dose is two actuations in the morning and two actuations in the evening.
Special patient groups:
No dose adjustment is needed in elderly patients. There is no information on the use of Formodual in patients with liver or kidney impairment.

The dose of beclometasone dipropionate in Formodual, which is effective in treating asthma, may be lower than the dose contained in other inhaled medicines that contain beclometasone dipropionate. If you have previously used another inhaled medicine

containing beclometasone dipropionate, your doctor will recommend the appropriate dose of Formodual.

Do not increase the dose.

If you feel that the effect of Formodual is too weak, you should always consult your doctor before increasing the dose.

Using a higher dose of Formodual than recommended:

• Using a higher dose of formoterol than recommended may cause the following symptoms: nausea, vomiting, rapid heartbeat, palpitations, irregular heartbeat, changes in the electrocardiogram (ECG, a record of heart activity), headache, tremors, drowsiness, excessive acid production in the blood, decreased potassium levels in the blood, increased glucose levels in the blood. Your doctor may recommend a blood test to check potassium and glucose levels in your blood.
• Using too high a dose of beclometasone dipropionate may cause temporary adrenal gland problems, which will resolve on their own within a few days. Your doctor may recommend a blood test to check cortisol levels in your blood.

If you experience any of these symptoms, you should inform your doctor.

Missing a dose of Formodual:

You should take the missed dose as soon as possible. If it is almost time for your next dose, do not take the missed dose, just take the next dose at the usual time. Do not take a double dose.

Stopping treatment with Formodual:

You should not reduce the dose or stop treatment with Formodual.
Even if you feel better, you should not stop taking Formodual or reduce the dose without consulting your doctor. It is very important to take your medicine regularly, even if your symptoms have improved.

If you experience worsening breathing difficulties:

If you experience worsening breathing difficulties or worsening wheezing immediately after inhaling Formodual, you should stop using Formodual immediately and use a quick-acting inhaled medicine to relieve symptoms. You should consult your doctor as soon as possible, who will assess your symptoms and, if necessary, recommend alternative treatment.
See also section 4 "Possible side effects".

If your asthma symptoms worsen:

If your symptoms worsen or you have difficulty controlling them (e.g., if you need to use another inhaled medicine or Formodual as a quick-acting medicine more frequently), or if a quick-acting inhaled medicine or Formodual does not relieve your symptoms, you should inform your doctor immediately. This may indicate that your asthma is worsening, and your doctor may decide to change your dose of Formodual or prescribe alternative treatment.
If you have any further questions about using this medicine, you should consult your doctor or pharmacist.

Method of administration:

This medicine is contained in a pressurized inhaler, in a plastic casing with a mouthpiece. At the back of the inhaler, there is a dose counter that shows how many doses of medicine are left. After each actuation of the inhaler, a dose of medicine is released, and the counter will show one dose less. You should be careful not to drop the inhaler, as this may cause the counter to count down another dose.
Testing the inhaler:

• 1. Remove the protective cap from the mouthpiece.
• 2. Hold the canister upright with the mouthpiece pointing downwards.
• 3. Point the mouthpiece away from you and firmly press the top of the canister to release one actuation.
• 4. Check the dose counter. If the inhaler is being tested for the first time, the dose counter should show 120.

How to use the inhaler:
If possible, you should stand or sit upright while inhaling.

• 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust or other contaminants.
• 2. Exhale slowly and deeply.
• 3. Hold the canister upright with the mouthpiece pointing upwards and then place the mouthpiece between your lips. Do not bite the mouthpiece.

• 4. Take a slow, deep breath in through your mouth. As you start to breathe in, firmly pressthe top of the canister to release one actuation of medicine. If you have weak hands, it may be easier to hold the inhaler with both hands: place your index fingers on the top of the canister and your thumbs on the base.
• 5. Hold your breath for as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not breathe out into the inhaler.

If you need to take another dose, hold the inhaler upright for about half a minute, then repeat steps 2 to 5.
Important:Steps 2 to 5 should not be performed too quickly.
After use, replace the protective cap and check the dose counter.

If the dose counter shows 20, you should have a new inhaler ready.

You should stop using the inhaler when the counter shows 0, as any medicine left in the canister may not provide a full dose.

If a "mist" appears over the top of the mouthpiece or to the side of the mouth, this means that Formodual is not being delivered to the lungs properly. You should take another dose, following the instructions, starting again from step 2.
To reduce the risk of fungal infections of the mouth and throat, you should rinse your mouth or throat with water after each inhalation, or brush your teeth.
If you feel that the effect of Formodual is too strong or too weak, you should consult your doctor or pharmacist.
If you have difficulty using the inhaler during inhalation, you can use a spacer device (AeroChamber Plus). You should ask your doctor, pharmacist, or nurse about this device.
It is important to carefully read the leaflet that comes with the AeroChamber Plus spacer device and follow the instructions for use and cleaning.

Cleaning the inhaler:

The inhaler should be cleaned once a week. During cleaning, do not remove the canister from the plastic casing, and do not use water or other liquids to clean the inhaler.
Cleaning the inhaler:

• 1. Remove the protective cap from the mouthpiece by pulling it straight off.
• 2. Wipe the mouthpiece and dose counter with a dry cloth or tissue, inside and out.
• 3. Replace the protective cap.

4. Possible side effects

Like all medicines, Formodual can cause side effects, although not everybody gets them.
As with other inhaled medicines, there is a risk of worsening shortness of breath and wheezing immediately after using Formodual, known as paradoxical bronchospasm. You should stop using Formodual immediatelyand use a quick-acting inhaled medicine to relieve symptoms. You should consult your doctor as soon as possible.
You should tell your doctor immediately if you experience any allergic reactions, such as skin allergies, itching, rash, redness, swelling of the skin or mucous membranes, especially of the eyes, face, lips, and throat.
Other possible side effects are listed below by frequency of occurrence.

• Fungal infections (of the mouth and throat), headache, hoarseness, sore throat.
• Pneumonia (lung infection) in patients with COPD:

You should tell your doctor if you experience any of the following symptoms while using Formodual; they may be symptoms of pneumonia:

• fever or chills
• increased production of mucus or change in mucus color
• worsening cough or increased breathing difficulties.

Uncommon(affecting less than 1 in 100 people):
Palpitations, irregular heartbeat, changes in the electrocardiogram (ECG).
Flu-like symptoms, fungal infections of the vagina, sinusitis, common cold, ear infection, throat irritation, cough, coughing up mucus.
Nausea, changes in taste, burning sensation on the lips, dry mouth, difficulty swallowing, indigestion, stomach upset, diarrhea.
Muscle pain and cramps, flushing, increased blood flow to certain tissues, increased sweating, tremors, nervousness, restlessness, dizziness.

• changes in blood test results: decreased white blood cell count, increased platelet count, decreased potassium levels in the blood, increased glucose levels in the blood, increased insulin levels, free fatty acids, and ketone bodies in the blood.

The following side effects have also been reported as "uncommon" in patients with chronic obstructive pulmonary disease:

• decreased cortisol levels in the blood, which is caused by the effect of corticosteroids on the adrenal glands.
• irregular heartbeat.

Rare(affecting less than 1 in 1,000 people):
Chest tightness, irregular heartbeat (caused by premature contraction of the heart), increased or decreased blood pressure, kidney inflammation, skin and mucous membrane swelling, which can last for several days.
Very rare(affecting less than 1 in 10,000 people):
Shortness of breath, worsening asthma, decreased platelet count, swelling of the hands and feet.
Frequency not known(cannot be estimated from available data):
Blurred vision.

Using inhaled corticosteroids in high doses for a long time may

cause systemic effects in very rare cases.These include: adrenal gland problems (suppression of adrenal gland function), decreased bone density (thinning of the bones), growth retardation in children and adolescents, increased eye pressure (glaucoma), cataracts.
Sleep disturbances, depression or feeling depressed, anxiety, nervousness, excessive excitement or irritability: these side effects are more likely to occur in children, but the frequency is unknown.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49 21 301, fax: 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Formodual

Medicines should be kept out of the sight and reach of children.
Single pack: 1 canister containing 120 doses:
Do not use Formodual after 3 months from the date of dispensing from the pharmacy and do not use the medicine after the expiry date stated on the carton and label.
The inhaler should not be stored at temperatures above 25°C.
Double pack: 2 canisters, each containing 120 doses:

Before first use: store in the refrigerator (2°C – 8°C).
After first use: do not store above 25°C. Store for a maximum of 3 months, after which the inhaler should not be used. Do not use this medicine after the expiry date stated on the carton or label. Do not freeze.
If the inhaler is cold, warm it in your hands for a few minutes before use. Never use any other method to warm the canister.
Important:The canister contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce the canister.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Formodual contains:

• The active substances are beclometasone dipropionate and formoterol fumarate dihydrate. One actuation of the inhaler contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
• The other ingredients are ethanol anhydrous, hydrochloric acid, propellant: norflurane (HFC 134a). This medicine contains fluorinated greenhouse gases. Each inhaler contains 8.147 g of norflurane (HFC 134a), which corresponds to 0.012 tons of CO2 equivalent (global warming potential GWP =
• 1430).

What Formodual looks like and contents of the pack:

Formodual is a solution for inhalation, contained in a pressurized canister, coated with aluminum, with a dose counter, fitted with a polypropylene metering valve and a plastic mouthpiece, in a cardboard carton.
Each pack contains one canister, which delivers 120 doses.
Not all pack sizes may be marketed.

Marketing authorization holder:

Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122 Parma, Italy

Manufacturer:

Chiesi Farmaceutici S.p.A., Via San Leonardo 96, 43122 Parma, Italy
Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria
Chiesi SAS, 2 rue des Docteurs Alberto et Paolo Chiesi, 41260 La Chaussée Saint-Victor, France
To obtain further information, you should contact your local representative of the marketing authorization holder:
Chiesi Poland Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw
phone: (22) 620 14 21, fax: (22) 652 37 79, e-mail: [email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 12/2024

3. How to use Formodual

Formodual is intended for inhalation use.

This medicine should always be used in accordance with the doctor's or pharmacist's recommendations. In case of doubts,
you should consult a doctor or pharmacist.

Asthma

The treating doctor will regularly check if the patient is taking the optimal dose of Formodual. The doctor will determine the smallest dose that provides the best control of asthma symptoms.

The doctor may prescribe the use of Formodual in two different ways: a) Formodual should be used daily to treat asthma, along with another inhalation medicine that provides relief in case of sudden worsening of asthma symptoms,

such as shortness of breath, wheezing and coughing,
b) Formodual should be used daily to treat asthma, and also in case of
sudden worsening of asthma symptoms, such as shortness of breath, wheezing and
coughing.
a) Using Formodual with another inhalation medicine that provides relief.
Adults and the elderly:
The recommended dose is usually one or two inhalations twice a day.
The maximum daily dose is 4 inhalations.

Remember: You should always have a quick-acting inhalation medicine with you to treat worsening asthma symptoms or sudden asthma attacks. b) Using Formodual as the only inhalation medicine for asthma.

Adults and the elderly:
The recommended dose is usually 1 inhalation in the morning and 1 inhalation in the evening.
You should also use Formodual as an inhalation medicine that provides relief in case of sudden worsening of asthma symptoms.
In case of worsening asthma symptoms, use 1 inhalation and wait a few minutes.
If there is no improvement, use another inhalation.

Do not use more than 6 relief inhalations in 24 hours.

The maximum daily dose of Formodual is 8 inhalations.

If the patient needs to take a larger number of inhalations to control asthma symptoms,
they should consult a doctor. A change in treatment may be necessary.

Use in children and adolescents under 18 years of age:

This medicine should NOT be used in children and adolescents under 18 years of age.

Chronic obstructive pulmonary disease (COPD) Adults and the elderly:

The recommended dose is two inhalations in the morning and two inhalations in the evening.
Special patient groups:
There is no need to adjust the dosage in elderly patients. There is no information on the use of Formodual in patients with liver or kidney function disorders.

The dose of beclometasone dipropionate in Formodual, which is effective in treating asthma, may be lower than the dose contained in other inhalation medicines containing beclometasone dipropionate. If the patient has previously used another inhalation medicine

containing beclometasone dipropionate, the doctor will recommend the appropriate dose of Formodual.

Do not increase the dose.

In case of feeling that the medicine's effect is insufficient, you should always consult a doctor
before increasing the dose of the medicine.

Using a higher than recommended dose of Formodual:

• Using a higher than recommended dose of formoterol may cause the following symptoms: nausea, vomiting, faster heart rate, palpitations, heart rhythm disorders, changes in the electrocardiogram (heart rate record), headache, tremors, drowsiness, excessive acidic metabolic products in the blood, decreased blood potassium levels, increased blood glucose levels. The doctor may recommend a blood test to check the levels of potassium and glucose in the blood.
• Using too high a dose of beclometasone dipropionate may cause temporary adrenal gland disorders, which resolve on their own within a few days. The doctor may recommend a blood test to check the level of cortisol in the blood serum.

In case of any of these symptoms, you should inform your doctor.

Missing a dose of Formodual:

You should take the missed dose as soon as possible. If it is almost time for the next dose,
do not take the missed dose, only the next scheduled dose. Do not
take a double dose.

Stopping the use of Formodual:

You should not reduce the dose or stop using the medicine.
Even if you feel better, you should not stop using Formodual or reduce the dose without consulting your doctor. It is very important to take the medicine regularly,
even if the symptoms of the disease have disappeared.

In case of worsening breathing difficulties:

In case of worsening breathing difficulties or worsening wheezing immediately after
inhalation of the medicine, you should stop using Formodual immediately and use a quick-acting inhalation medicine that provides relief. You should contact your doctor
as soon as possible, who will assess the symptoms of the disease and, if necessary, recommend the use of another treatment.
See also section 4. "Possible side effects".

In case of worsening asthma symptoms:

In case of worsening symptoms of the disease or difficulty in controlling them (e.g. when the patient needs to use another inhalation medicine or Formodual as a relief medicine more frequently) or when the inhalation medicine that provides relief or Formodual does not alleviate the symptoms, you should immediately inform your doctor.
This may indicate a worsening of asthma, and the doctor may decide to change the dosage of Formodual or use another treatment.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

Method of administration:

This medicine is in a pressurized container, in a plastic case, with a mouthpiece. At the back of the inhaler, there is a dose indicator, which shows how many doses of the medicine are left. After each press of the inhaler, the dose indicator rotates slightly. The number of remaining doses is shown in intervals of 20 doses. You should be careful not to drop the inhaler, as this may cause the next dose to be counted.

• 1. Remove the protective cap from the mouthpiece.
• 2. Hold the container in an upright position with the mouthpiece facing downwards.
• 3. Point the mouthpiece "away from you" and firmly press the top part of the container to release one inhalation.
• 4. Check the dose indicator. If the inhaler is being tested for the first time, the dose indicator should show the number 180.

How to use the inhaler:
If possible, during inhalation, you should stand or sit in an upright position.

• 1. Remove the protective cap from the mouthpiece and check if the mouthpiece is clean and free of dust or other contaminants.
• 2. Perform a slow and deep exhalation.
• 3. Hold the container in an upright position, with the stem facing upwards, and then place the mouthpiece between your lips. Do not bite on it.
• 4. Perform a slow and deep inhalation through your mouth. Immediately after starting the inhalation, firmly pressthe top part of the inhaler to release one inhalation of the medicine. For people

with a weak grip, it will be easier to hold the inhaler with both hands: you should then place both index fingers on the top part of the inhaler and both thumbs on its bottom.

• 5. Hold your breath for as long as possible, then remove the inhaler from your mouth and perform a slow exhalation. Do not exhale into the inhaler.

If you plan to take another dose of the medicine, you should continue to hold the inhaler in an upright position
for about half a minute, and then repeat the actions described in points 2 to 5.
Important:The actions described in points 2 to 5 should not be performed too quickly.
After use, you should put the protective cap back on and check the dose indicator.

If the dose indicator shows the number 20, you should have a new inhaler ready.

You should stop using the inhaler if the indicator shows the number 0, because the medicine left in the container may not ensure the release of a full dose.

In case of a "mist" appearing over the top opening of the mouthpiece or from the side of the mouth, it means
that Formodual will not reach the lungs as it should. You should take another dose, according to the instructions, starting again from point 2.
In order to reduce the risk of fungal infection of the mouth and throat, after each inhalation, you should
rinsing your mouth or throat with water, or brush your teeth.
In case of feeling that the effect of Formodual is too strong or too weak, you should consult a doctor or pharmacist.
In case of difficulties in handling the inhaler during inhalation, you can use an inhalation chamber (spacer) AeroChamber Plus. You should ask your doctor, pharmacist or nurse about this device.
It is important to carefully read the leaflet that comes with the AeroChamber Plus inhalation chamber and follow the instructions for use and recommendations for cleaning.

Cleaning the inhaler:

The inhaler should be cleaned once a week. During cleaning, do not remove the container from the plastic case, do not use water or other liquids to clean the inhaler.
Cleaning the inhaler:

• 1. Remove the protective cap from the mouthpiece by pulling it off the inhaler.
• 2. Wipe the mouthpiece and the doser from the inside and outside with a dry cloth or tissue.
• 3. Put the protective cap back on.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Similarly to other inhalation medicines, there is a risk of worsening shortness of breath and wheezing immediately after taking Formodual, known as paradoxical bronchospasm. You should then immediately STOP using Formodualand
use a quick-acting inhalation medicine that provides relief to alleviate the symptoms of shortness of breath and wheezing. You should contact your doctor
immediately. You should immediately inform your doctor if you experience any hypersensitivity reactions, such as:
skin allergies, itching, skin rash, skin redness, skin swelling or mucous membrane swelling, especially of the eyes, face, lips and throat.
Other possible side effects are listed below, depending on the frequency of occurrence.
Common(occurring in less than 1 in 10 patients):
Fungal infections (of the mouth and throat), headache, hoarseness, sore throat.
Pneumonia (lung infection) in patients with COPD:
You should tell your doctor if any of the following symptoms occur while using Formodual; these may be symptoms of a lung infection:

• fever or chills
• increased production of mucus, change in the color of mucus
• worsening cough or increased breathing difficulties

Uncommon(occurring in less than 1 in 100 patients):
Palpitations, abnormal rapid heart rate and heart rhythm disorders, changes in the electrocardiogram (ECG).
Flu-like symptoms, fungal infections of the vagina, sinusitis, cold, ear infection, throat irritation, cough and cough with expectoration, asthma attack.
Nausea, taste disorders, burning of the lips, dryness of the mouth mucosa, swallowing difficulties, indigestion, stomach upset, diarrhea.
Muscle pain and muscle cramps, facial redness, increased blood flow to certain tissues, increased sweating, tremors, anxiety, especially motor, dizziness, hives.
Changes in the values of some blood parameters: decreased white blood cell count, increased platelet count, decreased blood potassium levels, increased blood glucose levels, increased insulin levels, free fatty acids and ketone bodies in the blood.
The following side effects have also been reported as "uncommon" in patients with chronic obstructive pulmonary disease:

• decreased cortisol levels in the blood, which is caused by the effect of corticosteroids on the adrenal glands.
• irregular heartbeat.

Rare(occurring in less than 1 in 1000 patients):
Feeling of pressure in the chest, heart rhythm disorders (caused by too early contraction of the heart chambers), increased or decreased blood pressure, kidney inflammation, skin and mucous membrane swelling, lasting for several days.
Very rare(occurring in less than 1 in 10,000 patients):
Shortness of breath, worsening asthma, decreased platelet count, swelling of the hands and feet.
Unknown(frequency cannot be determined from available data):
Blurred vision.

Using inhaled corticosteroids in high doses for a long time can

cause systemic effects in very rare cases.These include: adrenal gland disorders (adrenal gland suppression), decreased bone mineral density (osteoporosis), growth retardation in children and adolescents, increased intraocular pressure (glaucoma), cataract.
Sleep disorders, depression or feeling depressed, anxiety, nervousness, excessive stimulation or irritability: these side effects are more likely to occur in children, but the frequency of these side effects is unknown.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: 22 49 21 301, fax: 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Formodual

The medicine should be stored out of sight and reach of children.
The medicine should not be used after 3 months from the date of issue from the pharmacy and should not be used after the expiry date stated on the carton and label.
The inhaler should not be stored at a temperature above 25°C.
In case of cooling the inhaler, before using the medicine, warm it in your hands for a few minutes.
Never use other methods to heat the container.
Important: The container contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce the container.
Medicines should not be disposed of in wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Formodual contains:

• The active substances of the medicine are: beclometasone dipropionate and formoterol fumarate dihydrate. One metered dose from the inhaler contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose through the mouthpiece, containing 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
• Other ingredients are: anhydrous ethanol, hydrochloric acid, propellant gas: norflurane (HFC 134a). This medicine contains fluorinated greenhouse gases. Each inhaler contains 11.202 g of norflurane (HFC 134a), which corresponds to 0.016 tons of CO2 equivalent (global warming potential GWP = 1430).

What Formodual looks like and what the pack contains:

Formodual is available as an inhalation solution, in a pressurized container, coated with aluminum, with a metering valve, equipped with a polypropylene doser with a mouthpiece and a protective plastic cap in a cardboard box.
Each pack contains one container, which delivers 180 doses.

Marketing authorization holder:

Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122 Parma, Italy

Manufacturer:

Chiesi Farmaceutici S.p.A., Via San Leonardo 96, 43122 Parma, Italy
Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria
Chiesi SAS, 2 rue des Docteurs Alberto et Paolo Chiesi 41260 La Chaussée Saint-Victor, France
To obtain detailed information, you should contact the local representative of the marketing authorization holder:
Chiesi Poland Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw
phone: (22) 620 14 21, fax: (22) 652 37 79, e-mail: [email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 12/2024