Fostex

Patient Information Leaflet:

Patient Information

Fostex, (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 symptoms 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 Fostex is and what it is used for
• 2. Important information before using Fostex
• 3. How to use Fostex
• 4. Possible side effects
• 5. How to store Fostex
• 6. Contents of the pack and other information

1. What Fostex is and what it is used for

Fostex is an inhalation aerosol solution containing two active substances which are delivered directly to the lungs when you inhale through the inhaler mouthpiece.
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
Fostex is indicated for regular treatment of asthma in adult patients, where:

• asthma symptoms are not adequately controlled with inhaled corticosteroids and/or as-needed use of short-acting bronchodilators, or
• asthma symptoms are adequately controlled with inhaled corticosteroids and long-acting bronchodilators.

COPD
Fostex may also be used to treat symptoms of severe COPD in adult patients. COPD is a chronic lung disease that is mainly caused by smoking.

2. Important information before using Fostex

When not to use Fostex:

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

Warnings and precautions

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

• if you have heart problems, 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 problems, or a condition known as hypertrophic obstructive cardiomyopathy (a condition where the heart muscle is abnormal);
• if you have narrowing of the arteries (also known as atherosclerosis); if you have high blood pressure or an aneurysm (abnormal widening of a blood vessel);
• if you have irregular heartbeats, such as rapid or irregular heartbeats, rapid pulse, or palpitations, or if you have any information about abnormal heart rhythms;
• if you have an overactive thyroid gland;
• if you have low levels of potassium 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 check blood 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 Fostex 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 drinking alcohol for any reason.

Before using Fostex, 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 Fostex can be used.
Treatment with beta-agonists, such as formoterol contained in Fostex, may cause sudden decreases in blood potassium levels (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 Fostex, such as those used to treat heart or high blood pressure, known as diuretics, or other asthma medicines, may increase the risk of low blood potassium levels. For this reason, your doctor may recommend checking your blood potassium levels from time to time.
If you are taking high doses of inhaled corticosteroids for a long time, you may be more likely to need corticosteroids during stressful periods. Stressful situations may include hospitalization after an accident, serious injury, or pending surgery. In such situations, your doctor will decide whether to increase the dose of corticosteroids or prescribe other steroids in tablet or injection form.
If hospitalization is necessary, you should remember to bring all your medicines and inhalers, including Fostex, as well as any over-the-counter medicines, if possible, in their original packaging.

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

Children and adolescents

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

Fostex 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 Fostex, 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 Fostex. If beta-blockers (including eye drops) are necessary, 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 Fostex with:

• medicines used to treat irregular heart rhythms (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) and may increase the risk of irregular heart rhythms (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 conditions (digoxin) may cause a decrease in blood potassium levels, which can increase the risk of irregular heart rhythms.
• other medicines used to treat asthma (theophylline, aminophylline, or steroids) and diuretics may cause a decrease in blood potassium levels.
• certain anesthetics may increase the risk of irregular heart rhythms.

Pregnancy, breastfeeding, and fertility

There are no clinical data on the use of Fostex during pregnancy.
Fostex 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 Fostex will affect your ability to drive or use machines.

Fostex contains ethanol

Fostex 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 will not have noticeable effects.

3. How to use Fostex

Fostex is for inhalation use only.

This medicine should always be used as directed by 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 Fostex.
Your doctor will determine the smallest dose that will control your asthma symptoms.

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

shortness of breath, wheezing, and coughing,
b) Fostex should be used daily to treat asthma, as well as to provide quick relief in case of sudden asthma symptoms, such as
shortness of breath, wheezing, and coughing.
a) Using Fostex with another inhaled medicine that provides quick relief.
Adults and the elderly:
Typically, 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 sudden asthma symptoms or attacks. b) Using Fostex as the only inhaled medicine for asthma.

Adults and the elderly:
Typically, the recommended dose is one actuation in the morning and one actuation in the evening.
You should also use Fostex as a quick-acting inhaled medicine in case of sudden 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 Fostex 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:
There is no need to adjust the dose in elderly patients. There is no information on the use of Fostex in patients with liver or kidney impairment.

The dose of beclometasone dipropionate in Fostex that 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 that contains beclometasone dipropionate, your doctor will recommend the appropriate dose of Fostex.

Do not increase the dose.

If you feel that the effect of Fostex is too weak or too strong, you should consult your doctor.

Using a higher dose than recommended:

• Using a higher dose than recommended of formoterol may cause the following symptoms: nausea, vomiting, rapid heartbeat, palpitations, irregular heart rhythms, changes in the electrocardiogram (ECG), headache, tremors, drowsiness, excessive acid in the blood, low blood potassium levels, high blood glucose levels. Your doctor may recommend a blood test to check your potassium and glucose levels.
• 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 your cortisol levels.

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

Missing a dose:

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 Fostex:

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

If your breathing difficulties worsen:

If your breathing difficulties worsen or your wheezing worsens immediately after inhaling Fostex, you should stop using Fostex immediately and use a quick-acting inhaled medicine to relieve your symptoms. You should consult your doctor as soon as possible, who will assess your symptoms and, if necessary, prescribe a different 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 Fostex as a quick-acting medicine more frequently), or if a quick-acting inhaled medicine or Fostex 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 the dose of Fostex or prescribe a different treatment.
If you have any further questions on the use of this medicine, you should ask your doctor or pharmacist.

Method of administration:

This medicine is contained in a pressurized inhaler, with a plastic casing and a mouthpiece.
The back of the inhaler has a dose counter, which shows how many doses are left. Each time you press the inhaler, a dose of medicine is released, and the counter will show one dose less. Be careful not to drop the inhaler, as this may cause the counter to count down.

Testing the inhaler:
Before using the inhaler for the first time, or if the inhaler has not been used for 14 days or more, you should perform a test to ensure it is working properly.

• 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 press the canister firmly 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, 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 debris.
• 2. Exhale slowly and deeply.
• 3. Hold the canister upright and 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, press the canister firmly to release one actuation of medicine. 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 base.
• 5. Hold your breath for as long as possible, then remove the inhaler from your mouth and exhale slowly. Do not breathe out through the inhaler.

If you need to take another actuation, keep the inhaler upright for about half a minute before repeating the steps from 2 to 5.
Important:Do not perform steps 2 to 5 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 remaining medicine may not be delivered in full.

If a "mist" appears over the top of the mouthpiece or to the side of the mouth, this means that Fostex is not being delivered to the lungs properly. You should take another actuation, following the instructions from step 2.
To reduce the risk of fungal infections of the mouth and throat, you should rinse your mouth or gargle with water after each inhalation, or brush your teeth.
If you feel that the effect of Fostex is too weak or too strong, 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 essential to read the leaflet provided 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. 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, Fostex 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 Fostex, known as paradoxical bronchospasm. You should stop using Fostex immediatelyand use a quick-acting inhaled medicine to relieve your symptoms. You should consult your doctor as soon as possible.
You should inform 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.

Common(occurring in less than 1 in 10 patients):
Fungal infections (of the mouth and throat), headache, hoarseness, sore throat.
Pneumonia (infection of the lungs) in patients with COPD:
You should tell your doctor if you experience any of the following symptoms while using Fostex; these may be symptoms of pneumonia:

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

Uncommon(occurring in less than 1 in 100 patients):
Palpitations, irregular heartbeats, changes in the electrocardiogram (ECG).
Flu-like symptoms, fungal infections of the vagina, sinusitis, cold, ear infection, throat irritation, cough, cough with expectoration.
Nausea, changes in taste, burning sensation on the lips, dryness of the mouth, difficulty swallowing, indigestion, stomach upset, diarrhea.
Muscle pain and cramps, flushing, increased blood flow to certain tissues, increased sweating, tremors, nervousness, restlessness, dizziness, lightheadedness.
Changes in blood test results: low white blood cell count, high platelet count, low blood potassium levels, high blood glucose levels, high insulin levels, free fatty acids, and ketone bodies in the blood.
The following side effects have also been reported as "uncommon" in patients with COPD:

• low 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 1,000 patients):
Chest tightness, irregular heart rhythms (caused by premature contraction of the heart), increased or decreased blood pressure, kidney inflammation, skin and mucous membrane swelling, persistent for several days.
Very rare(occurring in less than 1 in 10,000 patients):
Shortness of breath, worsening asthma, low platelet count, swelling of the hands and feet.
Unknown frequency(cannot be estimated from available data):
Blurred vision.

Long-term use of inhaled corticosteroids in high doses may

cause systemic effects in very rare cases, including 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 restlessness: 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 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 Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 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 Fostex

Keep this medicine out of the sight and reach of children.
Single pack: 1 canister of 120 doses:
Do not use Fostex 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.
Do not store the inhaler above 25°C.
Double pack: 2 canisters of 120 doses each:
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 becomes cold, warm it in your hands for a few minutes before use. Never use other methods to heat 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 Fostex contains:

• The active substances of Fostex are beclometasone dipropionate and formoterol fumarate dihydrate. One actuation from 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 (GWP = 1430).

What Fostex looks like and contents of the pack:

Fostex is an inhalation aerosol solution contained in a pressurized aluminum canister with a dose counter, a polypropylene plastic actuator with a mouthpiece, and a protective plastic cap, 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
For further information, you should contact your local representative of the marketing authorization holder:
Chiesi Poland Sp. z o.o., Jerozolimskie Avenue 134, 02-305 Warsaw
phone: (22) 620 14 21, fax: (22) 652 37 79, e-mail: info-pl@chiesi.com

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 Fostex

Fostex is intended for inhalation use.

This drug 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 attending physician will regularly check if the patient is taking the optimal dose of Fostex.
The doctor will determine the smallest dose that provides the best control of asthma symptoms.

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

shortness of breath, wheezing and coughing,
b) Fostex 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 Fostex with another inhalation drug that provides relief.
Adults and the elderly:
Typically, the recommended dose is one or two inhalations twice a day.
The maximum daily dose is 4 inhalations.

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

Adults and the elderly:
Usually, the recommended dose is 1 inhalation in the morning and 1 inhalation in the evening.
You should also use Fostex as an inhalation drug that provides relief in case of sudden
asthma symptoms.
If symptoms occur, 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 Fostex 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 drug 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 Fostex in patients with liver or kidney function disorders.

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

beclometasone dipropionate, the doctor will recommend the appropriate dose of Fostex.

Do not increase the dose.

If you feel that the drug's effect is insufficient, you should always consult a doctor
before increasing the dose of the drug.

Using a higher dose of Fostex than recommended:

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

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

Missing a dose of Fostex:

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 Fostex:

You should not reduce the dose or stop using the drug.
Even if you feel better, you should not stop using Fostex or reduce the dose without consulting your doctor. It is very important to take the drug 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 drug, you should stop using Fostex immediately and use a quick-acting inhalation drug that provides relief. You should contact your doctor
as soon as possible, who will assess the symptoms of the disease and, if necessary, recommend other treatment.
See also section 4. "Possible side effects".

In case of worsening asthma symptoms:

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

Method of administration:

This drug is in a pressurized container, in a plastic housing, with a mouthpiece. At the back of the inhaler, there is a dose indicator, which shows how many doses of the drug are left. After each press of the inhaler, the dose indicator rotates slightly. The number of remaining doses is displayed in intervals of 20 doses. 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 a vertical position with the mouthpiece facing down.
• 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 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 a vertical position, with the stem facing up, and then place the mouthpiece between your lips. Do not bite it.

• 4. Take a deep and slow breath in through your mouth. Immediately after starting to inhale, firmly pressthe top part of the inhaler to release one inhalation of the drug. 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 drug, you should continue to hold the inhaler in a vertical position
for about half a minute, and then repeat the steps described in points 2 to 5.
Important:The steps described in points 2 to 5 should not be performed too quickly.
After use, replace the protective cap and check the dose indicator.

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

You should stop using the inhaler if the indicator shows 0, because the remaining drug 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 Fostex 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
rinse your mouth or throat with water, or brush your teeth.
If you feel that the effect of Fostex 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 the AeroChamber Plus inhalation chamber (spacer). 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 cleaning recommendations.

Cleaning the inhaler:

The inhaler should be cleaned once a week. During cleaning, do not remove the container
from the plastic housing, 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 doser from the inside and outside with a dry cloth or tissue.
• 3. Replace the protective cap.

4. Possible side effects

Like all drugs, this drug may cause side effects, although not everyone will experience them.
Similarly to other inhalation drugs, there is a risk of worsening shortness of breath and wheezing immediately after
taking Fostex, known as paradoxical bronchospasm. You should then immediately STOP taking Fostexand use a quick-acting inhalation drug that provides relief to alleviate 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 or mucous membrane swelling, especially of the eyes, face, lips and throat.
Other possible side effects are listed below, depending on their frequency of occurrence.
Frequent(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 Fostex; these may be symptoms of a lung infection:

• fever or chills
• increased mucus production, change in mucus color
• 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, vaginal fungal infections, sinusitis, cold, otitis, throat irritation, cough and coughing up mucus, asthma attack.
Nausea, taste disorders, burning lips, dry mouth, swallowing difficulties, nausea, stomach upset, diarrhea.
Muscle pain and cramps, facial redness, increased blood flow to some 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):
Chest tightness, heart rhythm disorders (caused by premature ventricular contractions), 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 hands and feet.
Unknown(frequency cannot be determined from available data):
Blurred vision.

The use of inhaled corticosteroids in high doses for a long time may

cause systemic side effects in very rare cases.These include: adrenal function disorders (adrenal suppression), decreased bone mineral density (osteoporosis), growth retardation in children and adolescents, increased intraocular pressure (glaucoma), cataract.
Sleep disorders, depression or feelings of depression, 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.
By reporting side effects, you can help gather more information on the safety of the drug.

5. How to store Fostex

The drug should be stored out of sight and reach of children.
The drug 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 drug, warm it in your hands for a few minutes.
Never use other heating methods for the container.
Important: The container contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce the container.
Drugs should not be disposed of in wastewater or household waste. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Contents of the pack and other information

What Fostex contains:

• The active substances of the drug 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 drug 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 Fostex looks like and what the pack contains:

Fostex is available as an inhalation solution, in a pressurized aluminum container, 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: info-pl@chiesi.com

This drug is authorized for marketing in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 12/2024