Fostex

Leaflet accompanying the packaging: information for the user

Fostex, (200 micrograms + 6 micrograms)/inhalation dose, inhalation aerosol, solution

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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Fostex and what is it used for
• 2. Important information before using Fostex
• 3. How to use Fostex
• 4. Possible side effects
• 5. How to store Fostex
• 6. Package contents and other information

1. What is Fostex and what is it used for

Fostex is a solution in an inhalation aerosol, containing two active substances, which are inhaled directly into the lungs through the mouthpiece of the inhaler.
The medicine contains two active substances:
Beclometasone dipropionate, belonging to a group of medicines called corticosteroids, which have an anti-inflammatory effect by reducing swelling and irritation of the lungs.
Formoterol fumarate dihydrate, belonging to a group of long-acting bronchodilators, which relax the muscles in the airways and make breathing easier.
Together, these two active substances make breathing easier. They also help prevent asthma symptoms, such as: shortness of breath, wheezing, and coughing.

Fostex is intended for the treatment of asthma in adults.

Fostex is used in patients who:

• asthma symptoms are not sufficiently controlled with inhaled corticosteroids and a short-acting bronchodilator used as needed, or
• adequate control of asthma symptoms has been achieved with both inhaled corticosteroids and long-acting bronchodilators.

1/10

2. Important information before using Fostex

When not to use Fostex:

• if the patient is allergic to beclometasone dipropionate or formoterol fumarate dihydrate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Fostex, you should discuss it with your doctor, pharmacist, or nurse:

• if the patient has heart disease, such as: angina pectoris (chest pain), heart failure, coronary artery disease, heart valve defects, or any other heart disease
• if the patient has high blood pressure or an aneurysm (abnormal dilation of a blood vessel wall)
• if the patient has arrhythmias, such as: rapid or irregular heartbeat, rapid pulse, or palpitations, or if there is any information about abnormal heart rhythm
• if the patient has hyperthyroidism
• if the patient has low potassium levels in the blood
• if the patient has liver or kidney disease
• if the patient has diabetes (inhalation of large doses of formoterol may cause an increase in blood glucose levels, so before starting to use this medicine, as well as from time to time during treatment, additional blood tests may be necessary to determine blood sugar levels)
• if the patient has a pheochromocytoma (a tumor of the adrenal gland)
• if the patient is scheduled for general anesthesia. Depending on the type of anesthesia, it may be necessary to discontinue Fostex at least 12 hours before anesthesia
• if the patient is being treated or has been treated for tuberculosis or if the patient has a viral or fungal infection in the chest
• if the patient needs to avoid consuming alcohol for any reason.

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

Before using this medicine, you should consult a 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.
Your doctor may from time to time order a blood test to check the level of potassium in your blood, especially

in patients with severe asthma.

If the patient is taking high doses of inhaled corticosteroids for a long time, they may be more likely to require administration of corticosteroids during periods of stress. Stressful situations may include: hospitalization after an accident, serious injury, or waiting for surgery. In such situations, the doctor will decide on the possible increase in the dose of corticosteroids or may prescribe other steroids in the form of tablets or injections.
If hospitalization is necessary, the patient should remember to take all their medicines and inhalers, including Fostex, as well as over-the-counter medicines, if possible, in their original packaging.

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Children and adolescents

Fostex should not be used in children and adolescents under the age of 18.

Fostex and other medicines

You should tell your doctor, pharmacist, or nurse about all the medicines you are taking, including those obtained without a prescription.
This is necessary because Fostex may affect the action of some other medicines.
Similarly, some medicines may affect the action of Fostex.
In particular, you should tell your doctor, pharmacist, or nurse if you are using the following medicines:

• certain medicines may enhance the effect of Fostex and the doctor may want to closely monitor the condition of the patient taking such medicines (including certain HIV medicines: ritonavir, cobicistat);
• beta-blockers. Beta-blockers are medicines used to treat many diseases, including heart disease, high blood pressure, and glaucoma (increased pressure in the eye). If the administration of beta-blockers is necessary (including eye drops), the effect of formoterol may be reduced or formoterol may not work at all;
• medicines that stimulate beta-adrenergic receptors (medicines that work in the same way as formoterol) - may enhance the effect of formoterol;
• medicines used to treat irregular heartbeat (quinidine, disopyramide, procainamide);
• medicines used to treat allergies (antihistamines);
• medicines used to treat symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazid), tricyclic antidepressants (e.g., amitriptyline and imipramine), phenothiazines;
• medicines used to treat Parkinson's disease (L-dopa);
• medicines used to treat hypothyroidism (L-thyroxine);
• medicines containing oxytocin (which cause uterine contractions);
• medicines used to treat mental disorders, such as monoamine oxidase inhibitors (MAOIs) or medicines with similar properties, such as furazolidone and procarbazine;
• medicines used to treat heart disease (digoxin);
• other medicines used to treat asthma (theophylline, aminophylline, or steroids);
• diuretics.

You should also inform your doctor if you are scheduled to undergo general anesthesia for surgery or a dental procedure.

Pregnancy, breastfeeding, and fertility

There are no clinical data on the use of Fostex during pregnancy.
Fostex should not be used if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, or if the patient is breastfeeding, unless the doctor decides otherwise.
3/10

Driving and using machines

It is unlikely that Fostex will affect the ability to drive and use machines.

Fostex contains alcohol

Fostex contains 9 mg of alcohol (ethanol) per inhalation, which is equivalent to 0.25 mg/kg body weight per dose, when two inhalations are used. The amount of alcohol in two inhalations 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

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Your doctor will regularly check that you are taking the optimal dose of Fostex.
The doctor will determine the smallest dose that provides the best control of asthma symptoms.

Dosage: Adults and the elderly

The recommended dose is two inhalations twice a day.
The maximum daily dose is 4 inhalations.

Remember: You should always carry a fast-acting inhalation medicine to relieve asthma symptoms or an acute asthma attack.

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.

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.

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

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

Do not increase the dose.

If you feel that the effect of the medicine is insufficient, you should always consult your doctor before increasing the dose of the medicine.

If asthma symptoms worsen:

If asthma symptoms worsen or are difficult to control (e.g., when the patient needs to use another inhalation medicine to relieve symptoms more frequently) or the inhalation medicine does not relieve symptoms, you should immediately inform your doctor. This may indicate a worsening of asthma, and the doctor may decide to change the dose of Fostex or use another treatment.

Method of administration:

Fostex is intended for inhalation use.

This medicine is in a pressurized container, in a plastic casing with a mouthpiece. At the back of the inhaler, there is a dose counter that shows how many doses of the medicine are left. After each press of the inhaler, the dose counter rotates slightly. The number of remaining doses is shown at intervals of 20 doses. You should be careful not to drop the inhaler, as this may cause the next dose to be counted.
4/10

Testing the inhaler:

Before the first use of the inhaler, or if the inhaler has not been used for 14 days or longer, you should perform a test of the inhaler to ensure that it is working properly.

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

How to use the inhaler:

If possible, you should stand or sit upright while inhaling.
Before inhaling, you should check the dose counter: any value between "1" and "180" indicates that there are still doses of the medicine left in the container. If the dose counter shows "0", it means that there are no more doses of the medicine left and you should discard the old inhaler and purchase a new one.

• 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust or other contaminants.
• 2. Exhale slowly and deeply.
• 3. Hold the container in an upright position, with the stem pointing upwards, and then place the mouthpiece between your lips. Do not bite on it.
• 4. Take a slow and deep breath in through your mouth. Immediately after starting to inhale, firmly pressthe top of the inhaler to release one inhalation of the medicine. People with a weak grip will find it easier to hold the inhaler with both hands: they should then place both index fingers on the top of the inhaler and both thumbs on the bottom.
• 5. Hold your breath for as long as possible, then remove the inhaler from your mouth and exhale slowly. Do not exhale into the inhaler.

To take another dose of the medicine, you should continue to hold the inhaler in an upright position for about half a minute, then repeat the steps 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 replace the protective cap and check the dose counter.
5/10
In order to reduce the risk of fungal infection of the mouth and throat, you should rinse your mouth or throat with water or brush your teeth after each inhalation.

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

You should stop using the inhaler if the counter shows the number 0, as the medicine left in the container may not provide a full dose.

If a "mist" appears over the top opening of the mouthpiece or from the side of the mouth, it means that Fostex is not reaching the lungs as it should. You should take another dose, following the instructions, starting again from point 2.
If you feel that the effect of Fostex 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 (AeroChamber Plus). You should ask your doctor or pharmacist about this device.
It is essential to carefully read the leaflet that comes with the AeroChamber Plus spacer and follow the instructions for use and cleaning.

Cleaning the inhaler:

The inhaler should be cleaned once a week.

When cleaning, do not remove the container 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 off the inhaler.
• 2. Wipe the mouthpiece and the dose counter with a dry cloth or tissue from the inside and outside.
• 3. Replace the protective cap.

Using a higher dose of Fostex than recommended

• using a higher dose of formoterol than recommended may cause the following symptoms: nausea, vomiting, rapid heartbeat, palpitations, arrhythmias, changes in the electrocardiogram (ECG), headache, tremors, drowsiness, excessive acid production in the blood, decreased potassium levels in the blood, increased glucose levels in the blood. The doctor may recommend a blood test to check potassium and glucose levels in the blood.
• using a higher dose of beclometasone dipropionate than recommended 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.

If any of these symptoms occur, 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, you should not take the missed dose, but take the next dose at the usual planned time. Do not take a double doseto make up for the missed dose.

Stopping the use of Fostex

Even if you feel better, you should not stop using Fostex or reduce the dose without consulting your doctor. It is very important to regularly take the medicine, even when asthma symptoms have disappeared.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.
6/10

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 taking Fostex, known as paradoxical bronchospasm. You should immediately STOP taking Fostexand use a fast-acting inhaled bronchodilator to relieve shortness of breath and wheezing. You should immediately contact your doctor.
You should immediately inform your doctorif you experience any allergic reactions, such as: skin allergies, itching, skin rash, skin redness, swelling of the skin or mucous membranes, especially of the eyes, face, lips, and throat.
Other possible side effects are listed below, depending on their frequency.

• Frequent(occurring in less than 1 in 10 people):
• fungal infections (of the mouth and throat),
• headache,
• hoarseness,
• sore throat.

Uncommon(occurring in less than 1 in 100 people):

• palpitations, abnormal rapid heartbeat, and arrhythmias,
• changes in the electrocardiogram (ECG),
• increased blood pressure,
• flu-like symptoms,
• sinusitis,
• nasal congestion,
• otitis media,
• throat irritation,
• cough and cough with expectoration,
• asthma attack,
• vaginal fungal infections,
• nausea,
• taste disturbances,
• lip burning,
• dryness of the mouth mucosa,
• difficulty swallowing,
• indigestion,
• stomach upset,
• diarrhea,
• muscle pain and muscle cramps,
• facial redness,
• increased blood flow to some tissues,
• increased sweating,
• tremors,
• restlessness, especially motor restlessness,
• dizziness,
• hives.
• changes in some blood test results: decreased white blood cell count, increased platelet count, decreased potassium levels in the blood,

7/10
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:

• pneumonia: you should inform your doctor if you experience any of the following symptoms: increased production of sputum, change in the color of sputum, fever, increased cough, increased breathing difficulties,
• 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 people):

• feeling of pressure in the chest,
• arrhythmias (caused by premature contraction of the heart chambers),
• decreased blood pressure,
• kidney inflammation,
• swelling of the skin and mucous membranes, lasting for several days.

Very rare(occurring in less than 1 in 10,000 people):

• shortness of breath,
• worsening of asthma,
• decreased platelet count,
• swelling of the hands and feet.

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 (suppression of adrenal function),
• decreased bone density (osteoporosis),
• growth retardation in children and adolescents,
• increased intraocular pressure (glaucoma),
• cataract.

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

• sleep disturbances,
• depression or feeling of depression,
• nervousness,
• excessive stimulation or irritability. These side effects are more likely to occur in children, but the frequency of these side effects is unknown.
• blurred vision.

Reporting side effects

If you experience any side effects, including any side effects not listed in this 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 provide more information on the safety of this medicine.
8/10

5. How to store Fostex

The medicine should be stored out of sight and reach of children.
Information for the pharmacist:
Store in a refrigerator at a temperature between 2°C and 8°C. Store for a maximum of 18 months.
Information for the patient:
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 after the abbreviation "Exp". The expiry date refers to the last day of the specified month.
Do not store above 25°C.
If the inhaler has been exposed to very low temperatures, you should warm it in your hands for a few minutes before using the medicine. You should 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 needed. This will help protect the environment.

6. Package contents and other information

What Fostex contains:

• The active substances of the medicine are: beclometasone dipropionate and formoterol fumarate dihydrate. One metered dose from the inhaler contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose through the mouthpiece, containing 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.
• Other ingredients are: norflurane (HFC 134a), anhydrous ethanol, hydrochloric acid. This medicine contains fluorinated greenhouse gases. Each inhaler contains 14.239 g of norflurane (HFC 134a), which corresponds to 0.020 tons of CO2 equivalent (GWP =
• 1430).

What Fostex looks like and what the package contains

Fostex is available as an inhalation solution, in a pressurized aluminum container with a metering valve, in a plastic casing with a mouthpiece, in a cardboard box. The casing is equipped with a plastic mouthpiece cover and has a dose counter (container with 120 doses) or a dose indicator (container with 180 doses). Each package contains:

• one pressurized container (which delivers 120 inhalations),
• two pressurized containers (each delivering 120 inhalations),
• one pressurized container (which delivers 180 inhalations). Not all pack sizes may be marketed.

Marketing authorization holder:

Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122 Parma, Italy
9/10

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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria, Greece, Spain, Netherlands, Portugal, Slovakia, Slovenia, Hungary, Italy: Foster
France: Innovair
Germany: Kantos 200 micrograms/6 micrograms per inhalation, pressurized inhalation, solution
Poland: Fostex
Czech Republic: Combair
United Kingdom: Fostair

Date of last revision of the leaflet: 12/2024

{Marketing authorization holder's logo}
10/10