Fostex Nexthaler

Leaflet accompanying the packaging: patient information

Fostex NEXThaler

(100 micrograms + 6 micrograms)/inhalation dose, inhalation powder
Beclometasone dipropionate anhydrous + Formoterol fumarate dihydrate

Medicine intended for use in adults

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Fostex NEXThaler and what is it used for
• 2. Important information before taking Fostex NEXThaler
• 3. How to take Fostex NEXThaler
• 4. Possible side effects
• 5. How to store Fostex NEXThaler
• 6. Contents of the pack and other information

1. What is Fostex NEXThaler and what is it used for

Fostex NEXThaler is a powder that is inhaled through the mouth to reach the lungs.
The medicine contains two active substances: beclometasone dipropionate anhydrous and formoterol fumarate dihydrate.

• Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which have an anti-inflammatory effect by reducing swelling and irritation of the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines known as long-acting bronchodilators. They relax the muscles in the airways, which helps to widen the airways and make it easier to breathe in and out.

Together, these two active substances help to make breathing easier by relieving symptoms such as:
shortness of breath, wheezing, and coughing in patients with asthma or chronic obstructive pulmonary disease (COPD), and also help to prevent asthma symptoms.

Asthma

Fostex NEXThaler is intended for the treatment of asthma in adults.
Fostex NEXThaler is used in patients whose:

• asthma is not adequately controlled with inhaled corticosteroids and as-needed short-acting bronchodilators or
• have achieved an adequate response to asthma treatment with both corticosteroids and long-acting bronchodilators.

COPD

Fostex NEXThaler may also be used to treat symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic respiratory disease in the lungs that is mainly caused by smoking.

2. Important information before taking Fostex NEXThaler

When not to take Fostex NEXThaler:

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

Warnings and precautions

Before starting treatment with Fostex NEXThaler, discuss with your doctor:

• if the patient has heart disease. This includes any known heart disorders and/or heart function;
• if the patient has arrhythmias, such as rapid or irregular heartbeat, rapid pulse, or palpitations, or if there is any information about an irregular heartbeat;
• if the patient has high blood pressure;
• if the patient has narrowing of the arteries (also known as atherosclerosis) or if an aneurysm (abnormal bulging of a blood vessel wall) has been diagnosed;
• 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. Inhaling high doses of formoterol may increase blood glucose levels, so before starting treatment with this medicine, and from time to time during treatment, additional blood tests may be necessary to determine blood glucose 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 stop taking Fostex NEXThaler 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.

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

If you are unsure whether Fostex NEXThaler can be taken, consult your doctor, nurse, or pharmacist before taking the medicine.

Your doctor may recommend regular measurements of potassium levels in your blood, especially

in patients with severe asthma.Like many bronchodilators, Fostex NEXThaler may cause a sudden drop in potassium levels in the blood (hypokalemia).
Low oxygen levels in the blood in combination with some medicines that you may be taking at the same time with Fostex NEXThaler may cause a further drop in potassium levels in the blood.
If you are taking high doses of inhaled corticosteroids for a long time, you may be more likely to need corticosteroids in stressful situations. Stressful situations may include: hospitalization after an accident, serious injury, or waiting for surgery. In this case, your doctor will decide whether to increase the dose of corticosteroids or prescribe other steroids in the form of tablets or injections.
If hospitalization is necessary, you should remember to bring all your medicines and inhalers, including Fostex NEXThaler, as well as any medicines you have bought without a prescription, if possible, in their original packaging.

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

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age.

Fostex NEXThaler and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take. This is necessary because Fostex NEXThaler may affect the action of some other medicines. Similarly, some medicines may affect the action of Fostex NEXThaler.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• certain medicines may enhance the effect of Fostex NEXThaler, and your doctor may want to monitor your condition closely while taking such medicines (including certain HIV medicines: ritonavir, cobicistat);
• beta-blockers. Beta-blockers are medicines used to treat many diseases, including heart disorders, high blood pressure, or glaucoma (increased pressure in the eye). If beta-blockers (including eye drops) are necessary, the effect of formoterol may be reduced or formoterol may not work at all;
• beta-adrenergic medicines (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 such as terfenadine);
• medicines used to treat symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazid) or tricyclic antidepressants (e.g., amitriptyline and imipramine) or 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.

Also, inform your doctor if you are scheduled for general anesthesia for surgery or a dental procedure.

Pregnancy and breastfeeding

There are no clinical data on the use of Fostex NEXThaler during pregnancy.
If you are pregnant or think you may be pregnant, consult your doctor.
Fostex NEXThaler should not be used during pregnancy unless your doctor decides otherwise.
Your doctor will decide whether to stop taking Fostex NEXThaler during breastfeeding or to take Fostex NEXThaler and stop breastfeeding. Always follow your doctor's instructions.

Driving and using machines

It is unlikely that Fostex NEXThaler will affect your ability to drive or use machines. However, if you experience side effects such as dizziness and/or tremors, they may affect your ability to drive or use machines.

Fostex NEXThaler contains lactose.

Lactose contains small amounts of milk proteins, which may cause allergic reactions in patients.
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Fostex NEXThaler

Always take Fostex NEXThaler exactly as your doctor has told you. If you are not sure, ask your doctor, nurse, or pharmacist.
Fostex NEXThaler uses extrafine particle technology, which delivers a larger proportion of each dose to the lungs.
Therefore, your doctor may prescribe a lower dose of this medicine than the doses of inhaled medicines you have taken before.

Asthma

Your doctor will regularly check that you are taking the optimal dose of Fostex NEXThaler. Once adequate control of asthma is achieved, your doctor may consider gradually reducing the dose of Fostex NEXThaler. Do notchange the dosewithout consulting your doctor.

Your doctor may prescribe Fostex NEXThaler in two different ways: a) Fostex NEXThaler should be taken 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) Fostex NEXThaler should be taken daily to treat asthma, and also
in case of sudden worsening of asthma symptoms, such as shortness of breath,
wheezing, and coughing.
a) Taking Fostex NEXThaler with another inhaled medicine that provides quick relief:

Adults and the elderly:

The recommended dose is 1 or 2 inhalations twice a day.
The maximum daily dose is 4 inhalations.

Remember: Always carry a quick-acting inhaled medicine with you to treat sudden worsening of asthma symptoms or sudden asthma attacks. b) Taking Fostex NEXThaler as the only inhaled medicine for asthma:

Adults and the elderly:

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

Do not take more than 6 quick-acting inhalations in 24 hours.

The maximum daily dose of Fostex NEXThaler is 8 inhalations.

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

Do not increase the dose.

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

Chronic obstructive pulmonary disease (COPD)

Adults and the elderly:

The recommended dose is 2 inhalations in the morning and 2 inhalations in the evening.

How to take Fostex NEXThaler:

Fostex NEXThaler is for inhalation use only.

If possible, stand or sit upright while inhaling.

Accidental intake of a higher dose of Fostex NEXThaler:

• contact your doctor or go to the emergency department of the nearest hospital for advice. Bring the medicine with you so that healthcare professionals can see what you have taken;
• side effects may occur. Inform your doctor about any unusual symptoms, as they may recommend additional tests or take necessary measures.

Missed dose of Fostex NEXThaler:

Take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the usual time. Do nottake a double dose.

Stopping treatment with Fostex NEXThaler:

Even if you feel better, do not stop taking Fostex NEXThaler or reduce the dose without consulting your doctor. It is very important to take Fostex NEXThaler regularly, as prescribed by your doctor, even when your symptoms have disappeared.
If breathing difficulties do not improve:
If your symptoms do not improve after inhaling Fostex NEXThaler, the reason may be incorrect use of the inhaler. Therefore, check the instructions for correct use of the inhaler, which are below, and/or consult your doctor or nurse, who will instruct you again on how to use the inhaler correctly.
In case of worsening asthma symptoms:
If your symptoms worsen or you have difficulty controlling them (e.g., more frequent use of another inhaled medicine or Fostex NEXThaler as a quick-acting medicine) or if your symptoms do not improve with a quick-acting inhaled medicine or Fostex NEXThaler, continue taking Fostex NEXThaler and consult your doctor immediately. Your doctor may decide to change the dose of Fostex NEXThaler or use additional or alternative treatment.
If you have any further questions about taking this medicine, consult your doctor or pharmacist.

INSTRUCTIONS FOR USE OF NEXTHALER INHALER

A. Contents of the packaging

To check what the packaging should contain, see section 6.

If the contents of the packaging do not match the description in section 6, return the inhaler to the person from whom it was purchased and exchange it for a new one.

B. General warnings and precautions

• Do notremove the inhaler from the protective sachet unless it is to be used immediately.
• Use the inhaler as directed.
• Do not open the cap unless it is necessary to take a dose using the inhaler.
• While using the inhaler, store it in a clean and dry place.
• Under no circumstances attempt to disassemblethe inhaler into parts.

C. Main features of the inhaler

Window
Air inlet
counter opening
Cap
Mouthpiece
To take a dose using the inhaler, perform three simple steps: open, inhale, close.

D. Before using a new inhaler

1. Open the sachet and remove the inhaler.

o Do notuse the inhaler if the sachet is not sealed or is damaged

• return the inhaler to the person from whom it was purchased and exchange it for a new one. o On the label attached to the box, write the date of opening the sachet.

2. Check the inhaler.

o If the inhaler appears to be damaged or broken, return it to the person from whom it was purchased and exchange it for a new one.

3. Check the dose counter window. If the inhaler is new, the dose counter will

show "120".
o Do notuse a new inhaler if the dose counter shows a number less than "120". Return it to the person from whom it was purchased and exchange it for a new one.

E. How to use the inhaler

• If you are unsure whether you have taken the correct dose, consult your doctor or pharmacist.
• If you are unsure whether the dose counter has decreased by one after inhalation, wait until the next scheduled inhalation and take the medicine as usual. Do not take an additional dose.

E.1. Opening

1. Hold the inhaler firmly in an upright position.

2. Check the number of doses remaining: any number between "1" and "120" indicates that

there are still doses of medicine left in the inhaler.
o If the dose counter shows "0", it means that there are no more doses left – dispose of the inhaler and purchase a new one.

3. Open the inhaler cap completely.

4. Before inhaling, exhale as deeply as possible.

o Do notexhale through the inhaler.

E.2 Inhaling

If possible, stand or sit upright while inhaling.

1. Lift the inhaler and place it in your mouth, and hold the mouthpiece with your lips.

o Hold the inhaler without blockingthe air inlet.
o Do notinhale through the air inlet.

2. Take a strong and deep breath in through your mouth.

o You may feel a characteristic taste while taking the dose.
o You may hear and feel a click while taking the dose.
o Do notinhale through your nose.
o Do notremove the inhaler from your mouth while inhaling.

3. Remove the inhaler from your mouth.

• 4. Hold your breath for 5 to 10 seconds, or as long as possible.

5. Exhale slowly.

o Do notexhale through the inhaler.

E.3 Closing

• 1. Hold the inhaler in an upright position and close the cap completely.

2. Check that the dose counter has decreased by one.

3. If you need to take another dose, repeat steps E.1 to E.3.

F. Cleaning

• Normally, cleaning the inhaler is not necessary.
• If necessary, the inhaler can be wiped with a dry cloth or tissue. o Do notclean the inhaler with water or other liquids. Store in a dry place.

G. Storage and disposal

For information on storing and disposing of the inhaler, see section 5.

4. Possible side effects

Like all medicines, Fostex NEXThaler can cause side effects, although not everybody gets them.
As with other inhaled medicines, there is a risk of worsening breathing difficulties, coughing, and wheezing immediately after taking Fostex NEXThaler, known as paradoxical bronchospasm. In this case, stop taking Fostex NEXThaler immediatelyand use a quick-acting inhaled bronchodilatorto relieve symptoms. Consult your doctor immediately.
Tell your doctor immediately if you experience any allergic reactions, such as:

skin allergies, itching, rash, redness of the skin, or 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 people):

• tremors;
• pneumonia (lung infection) in patients with COPD

Tell your doctor if you experience any of the following symptoms while taking Fostex NEXThaler; they may be signs of a lung infection:

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

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

• flu-like symptoms, sore throat;
• fungal infections (of the mouth and throat). Rinsing the mouth and throat with water and brushing your teeth immediately after inhalation may help prevent these side effects;
• worsening asthma symptoms, breathing difficulties;
• hoarseness;
• cough;
• rapid or slow heartbeat;
• chest pain;
• headache;
• nausea;
• feeling tired or nervous;
• changes in electrocardiogram (ECG);
• low cortisol levels in urine or blood;
• high potassium levels in the blood;
• high blood glucose levels;
• high levels of fats in the blood.

Rare(frequency cannot be estimated from available data):

• vision disturbances.

Side effects that have been observed with similar inhaled medicines containing beclometasone dipropionate and/or formoterol:

include:

• palpitations;
• irregular heartbeat;
• taste disturbances;
• muscle cramps and pains;
• nervousness, dizziness;
• restlessness;
• sleep disturbances;
• low potassium levels in the blood;
• increased or decreased blood pressure.

Long-term use of high doses of inhaled corticosteroids may

cause systemic effects.These include:

• adrenal gland problems;
• bone thinning;
• delayed growth in children and adolescents;
• increased pressure in the eye (glaucoma), cataracts;
• rapid weight gain, especially in the face and chest;
• sleep disturbances, depression or anxiety, nervousness, tension, overexcitement or irritability. These side effects are more likely to occur in children;
• changes in behavior.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 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 NEXThaler

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton, and sachet after: EXP. The expiry date refers to the last day of the month stated.
Store in the original packaging to protect from moisture. Remove the inhaler from the sachet immediately before its first use.
Before opening the sachet:

No special precautions for storage are necessary.

After opening the sachet:

Do not store above 25°C.
After opening the protective sachet, the medicine should be used within 6 months.
Write the date of opening the sachet on the label attached to the carton.
Medicines should not be disposed of via wastewater or household waste. 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 NEXThaler contains:

The active substances of the medicine are: beclometasone dipropionate anhydrous and formoterol fumarate dihydrate.
Each dose contains 100 micrograms of beclometasone dipropionate anhydrous and 6 micrograms of formoterol fumarate dihydrate.
This corresponds to a delivered dose through the mouthpiece, containing 81.9 micrograms of beclometasone dipropionate anhydrous and 5 micrograms of formoterol fumarate dihydrate.
The other ingredients of the medicine are: lactose monohydrate (containing small amounts of milk proteins) and magnesium stearate.

What Fostex NEXThaler looks like and contents of the pack:

The medicinal product is a white or almost white powder for inhalation in a plastic inhaler.
One pack contains 1, 2, or 3 inhalers, each containing 120 doses of the medicine.
Each inhaler is placed in a tightly closed protective sachet (packaging made of PET/Aluminum/PE or PA/Aluminum/PE), in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder:

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

Manufacturer responsible for batch release:

Chiesi Farmaceutici S.p.A., Via San Leonardo 96, 43122 Parma, Italy
Chiesi SAS, 2 rue des Docteurs Alberto et Paolo Chiesi, 41260 La Chaussée Saint Victor, France
Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria
For more information, contact the representative of the marketing authorization holder in Poland:
Chiesi Poland Sp. z o.o.,
Al. Jerozolimskie 134, 02-305 Warsaw,
tel: (22) 620 14 21, fax: (22) 652 37 79, e-mail: info-pl@chiesi.com

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

Austria:

Foster NEXThaler

Netherlands:

Foster NEXThaler

France:

Innovair NEXThaler

Poland:

Fostex NEXThaler

Czech Republic:

Combair Nexthaler

Portugal:

Foster NEXThaler

Germany:

KANTOS NEXThaler

Slovakia:

Foster NEXThaler 100 micrograms/6 micrograms per dose, powder for inhalation

Slovenia:

Foster NEXThaler 100 micrograms/6 micrograms per inhalation, powder for inhalation

Date of last revision of the leaflet:

Logo [Chiesi]
Detailed and up-to-date information about this medicine is available by scanning the QR code on the leaflet and outer packaging with a smartphone.
QR code
This information is also available on the website: https://qrco.de/Nexthaler100-6-120.

3. How to use Fostex NEXThaler

Fostex NEXThaler should always be used according to the doctor's instructions. In case of doubts, you should consult a doctor, nurse, or pharmacist.
Fostex NEXThaler uses extrafine particle technology, which delivers a larger portion of each dose to the lungs.
Therefore, the doctor may prescribe a lower dose of this medicine than the doses of inhaled medication the patient previously used.

Asthma

The attending physician will regularly check if the patient is taking the optimal dose of Fostex NEXThaler.
When adequate control of asthma is achieved, the doctor may consider gradually reducing the dose of Fostex NEXThaler.
Under no circumstancesshould the dose be changed without prior consultation with the attending physician.

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

such as shortness of breath, wheezing, and cough
b) Fostex NEXThaler should be used daily to treat asthma and also
in case of sudden worsening of asthma symptoms, such as shortness of breath,
wheezing, and cough.
a) Using Fostex NEXThaler with another inhaled medication that provides relief:

Adults and the elderly:

The recommended dose is 1 or 2 inhalations twice a day.
The maximum daily dose is 4 inhalations.

Remember: Always have a quick-acting inhaled medication that provides relief with you to treat worsening asthma symptoms or sudden asthma attacks. b) Using Fostex NEXThaler as the only inhaled medication for asthma:

Adults and the elderly:

The usual recommended dose is one inhalation in the morning and one inhalation in the evening.
Fostex NEXThaler should also be used as an inhaled medication that provides relief in case of sudden worsening of asthma symptoms.
In case of worsening asthma symptoms, one inhalation should be used and waited for a few minutes.
If there is no improvement, another inhalation should be used.

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

The maximum daily dose of Fostex NEXThaler is 8 inhalations.

If a 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.
Do not increase the dose.
If the patient feels that the effect of the medicine is insufficient, they should always consult a doctor before increasing the dose.

Chronic Obstructive Pulmonary Disease (COPD)

Adults and the elderly:

The recommended dose is 2 inhalations in the morning and 2 inhalations in the evening.

How to use Fostex NEXThaler:

Fostex NEXThaler is intended for inhalation use.

If possible, during inhalation, the patient should stand or sit in an upright position.

Accidental intake of a higher dose of Fostex NEXThaler:

• you should immediately contact a doctor or go to the emergency room of the nearest hospital for advice. You should take the medicine with you so that healthcare professionals can see exactly what the patient took;
• side effects may occur. The patient should inform the doctor about any unusual symptoms, as they may recommend additional tests or decide on necessary measures.

Missing a dose of Fostex NEXThaler:

The patient should take the missed dose as soon as possible. If the next dose is approaching, the patient should not take the missed dose, only the next scheduled dose. Do nottake a double dose.

Stopping the use of Fostex NEXThaler:

Even if the patient's condition improves, they should not stop using Fostex NEXThaler or reduce the dose without consulting a doctor. It is very important to regularly take Fostex NEXThaler as prescribed by the doctor, even if the symptoms of the disease disappear.
If breathing difficulties do not subside:
If the symptoms do not decrease after inhaling Fostex NEXThaler, the reason may be its incorrect use. Therefore, the patient should check the instructions for proper use of the inhaler, which can be found below, and/or consult a doctor or nurse who will re-instruct the patient on how to use the inhaler properly.
In case of worsening asthma symptoms:
In case of worsening symptoms or difficulty controlling them (e.g., more frequent use of another inhaled medication or Fostex NEXThaler as a relief medication) or if the symptoms do not improve with the use of a quick-acting inhaled medication or Fostex NEXThaler, the patient should continue using Fostex NEXThaler and immediately consult the attending physician. The doctor may decide to change the dosage of Fostex NEXThaler or use additional or alternative treatment.
If the patient has any further doubts about the use of the medicine, they should consult a doctor or pharmacist.

INSTRUCTIONS FOR USING THE NEXTHALER INHALER

A. Package contents

To check what the package should contain, see section 6.

If the package contents do not match the description in section 6, the inhaler should be returned to the person from whom it was purchased and exchanged for a new one.

B. General warnings and precautions

• Do notremove the inhaler from the protective sachet unless it is to be used immediately.
• The inhaler should be used according to the instructions.
• Do not open the cap unless it is necessary to take the next dose using the inhaler.
• During use, the inhaler should be stored in a clean and dry place.
• Under no circumstances attempt todisassemble the inhaler into parts.

C. Main features of the inhaler

Window
Air inlet
Counter
Cap
Mouthpiece
To take a dose using the inhaler, the patient should perform three simple actions: open, inhale, and close.

D. Before using a new inhaler

1. Open the sachet and remove the inhaler.

o Do notuse the inhaler if the sachet is not sealed or is damaged

• the inhaler should be returned to the person from whom it was purchased and exchanged for a new one. o On the label on the box, the patient should write the date of opening the sachet.

2. Check the inhaler.

o If the inhaler appears to be damaged or broken, it should be returned to the person from whom it was purchased and exchanged for a new one.

3. Check the dose counter window. If the inhaler is new, the dose counter will

show "180".
o Do notuse a new inhaler if the dose counter window shows a number less than "180". The inhaler should be returned to the person from whom it was purchased and exchanged for a new one.

E. How to use the inhaler

• If the patient is unsure whether they have taken the correct dose of the medicine, they should consult a doctor or pharmacist.
• If the patient is unsure whether the counter shows one less inhalation after performing the inhalation, they should wait until the next scheduled inhalation and take the medicine as usual. Do not take an additional dose.

E.1. Opening

1. Hold the inhaler firmly in an upright position.

2. Check the number of remaining doses: any number between "1" and

"180" indicates that there are still doses of the medicine left in the inhaler.
o If the dose counter shows "0", it means that there are no more doses left - the inhaler should be discarded and a new one purchased.

3. Open the inhaler cap completely.

4. Before inhaling, perform a deep exhalation as much as possible.

o Do notexhale through the inhaler.

E.2. Inhaling

If possible, during inhalation, the patient should stand or sit in an upright position.

1. Lift the inhaler, place it in the mouth, and enclose the mouthpiece with the lips.

o While holding the inhaler, do not blockthe air inlet.
o Do notinhale through the air inlet.

2. Perform an energetic and deep inhalation through the mouth.

o During inhalation, the patient may feel a characteristic taste.
o During inhalation, the patient may hear and feel a click.
o Do notinhale through the nose.
o Do notremove the inhaler from the mouth during inhalation.

3. Remove the inhaler from the mouth.

• 4. Hold your breath for 5 to 10 seconds, or as long as possible.

5. Perform a slow exhalation.

o Do notexhale through the inhaler.

E.3. Closing

• 1. Hold the inhaler in an upright position and close the cap completely.

2. Check if the dose counter shows one less dose.

3. If an additional dose is required, repeat steps E.1 to E.3.

F. Cleaning

• Usually, cleaning the inhaler is not necessary.
• If necessary, after use, the inhaler can be wiped with a dry cloth or tissue. o Do notclean the inhaler with water or other liquids. Store in a dry place.

G. Storage and disposal

To obtain information on the storage and disposal of the inhaler, see section 5.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other inhaled medications, there is a risk of worsening breathing difficulties, coughing, and wheezing immediately after taking Fostex NEXThaler,
known as paradoxical bronchospasm. In this case, the patient should immediately STOPusing Fostex NEXThalerand use a quick-acting inhaled bronchodilator
to relieve symptoms. The patient should immediately consult the attending physician.
The patient should immediately inform the doctor if they experience allergic reactions, such as:
skin allergies, itching, skin rash, skin redness, skin swelling, or swelling of the mucous membranes, especially the eyes, face, lips, and throat.
Other possible side effects are listed below according to their frequency.

• shakiness;
• pneumonia (lung infection) in patients with COPD

The patient should tell the doctor if any of the following symptoms occur while using Fostex NEXThaler; these may be symptoms of a lung infection:

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

Frequent(occurring in less than 1 in 10 people):

• flu-like symptoms, sore throat;
• fungal infections (mouth and throat). Rinsing the mouth and throat with water and brushing teeth immediately after inhalation may help prevent these side effects;
• worsening asthma symptoms, breathing difficulties;
• hoarseness;
• cough;
• abnormally fast heart rate;
• abnormally slow heart rate;
• chest pain;
• headache;
• nausea;
• feeling tired or nervous;
• changes in the electrocardiogram (ECG);
• low cortisol levels in urine or blood;
• high potassium levels in the blood;
• high glucose levels in the blood;
• high lipid levels in the blood.

Unknown(frequency cannot be determined from available data):

• vision disturbances.

Side effects that have been observed with similar inhaled medications

containing beclometasone dipropionate and/or formoterol:

• palpitations;
• irregular heartbeat;
• taste disturbances;
• muscle pain and cramps;
• nervousness, dizziness;
• restlessness;
• sleep disturbances;
• decreased potassium levels in the blood;
• increased or decreased blood pressure.

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

cause systemic side effects.These include:

• adrenal gland problems;
• bone thinning;
• delayed growth in children and adolescents;
• increased eye pressure (glaucoma), cataracts;
• rapid weight gain, especially in the face and chest area;
• sleep problems, depression or anxiety, nervousness, tension, overexcitement, or irritability. These side effects are more likely to occur in children;
• behavioral changes.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the patient should tell the doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 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, it is possible to gather more information on the safety of the medicine.

5. How to store Fostex NEXThaler

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label, box, and sachet after: EXP. The expiry date refers to the last day of the month stated.
Store in the original package to protect from moisture. The inhaler should be removed from the sachet just before its first use.
Before opening the sachet for the first time:
There are no special instructions for storing the medicine.
After opening the sachet for the first time:
Do not store above 25°C.
After opening the protective sachet, the medicine should be used within 6 months.
On the label on the box, the patient should write the date of opening the sachet.
Medicines should not be disposed of via wastewater or household waste. The patient should ask the 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 NEXThaler contains:

The active substances of the medicine are: beclometasone dipropionate anhydrous and formoterol fumarate dihydrate.
Each dose contains 100 micrograms of beclometasone dipropionate anhydrous and 6 micrograms of formoterol fumarate dihydrate.
This corresponds to a delivered dose through the mouthpiece, containing 81.9 micrograms of beclometasone dipropionate anhydrous and 5 micrograms of formoterol fumarate dihydrate.
The other ingredients of the medicine are: lactose monohydrate (containing small amounts of milk proteins) and magnesium stearate.

What Fostex NEXThaler looks like and what the package contains:

The medicinal product is a white or almost white powder for inhalation in a plastic inhaler.
One package contains 1, 2, or 3 inhalers, each containing 180 doses of the medicine.
Each inhaler is placed in a tightly closed protective sachet (PET/Aluminum/PE or PA/Aluminum/PE packaging), in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder:

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

Manufacturer responsible for batch release:

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

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

Austria:
Foster NEXThaler
Netherlands:
Foster NEXThaler
France:
Innovair NEXThaler
Poland:
Fostex NEXThaler
Czech Republic:
Combair Nexthaler
Portugal:
Foster NEXThaler
Germany:
KANTOS NEXThaler
Slovakia:
Foster NEXThaler
100 micrograms/6
micrograms
per dose powder for inhalation
Slovenia:
Foster NEXThaler 100
micrograms/6
micrograms per inhalation, powder for inhalation

Date of last revision of the leaflet:

Logo [Chiesi]
Detailed and up-to-date information about this medicine is available by scanning the QR code on the leaflet and outer packaging with a smartphone.
QR code
This information is also available on the website: https://qrco.de/Nexthaler100-6-180.