Fostex nexthaler

Patient Information Leaflet

Fostex NEXThaler
(200 micrograms + 12 micrograms)/inhalation dose, inhalation powder
Beclometasone dipropionate + Formoterol fumarate dihydrate
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What Fostex NEXThaler is and what it is used for
2. What you need to know before using Fostex NEXThaler
3. How to use Fostex NEXThaler
4. Possible side effects
5. How to store Fostex NEXThaler
6. Contents of the pack and other information

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

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

• Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which work by reducing inflammation, swelling, and irritation in the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines known as long-acting bronchodilators. These relax the muscles in the airways, thereby widening the air passages and making it easier to breathe in and out.

Together, these two active substances help you breathe more easily 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 NEXThaler is intended for the treatment of asthma in adults.
Fostex NEXThaler is used in patients who:

• have asthma that is not adequately controlled with inhaled corticosteroids and as-needed short-acting bronchodilators, or
• have responded well to asthma treatment with both corticosteroids and long-acting bronchodilators.

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COPD
Fostex NEXThaler may also be used in the treatment of symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic lung disease of the airways, primarily caused by cigarette smoking.

2. Important information before using Fostex NEXThaler

When not to use Fostex NEXThaler:
if the patient is allergic to beclometasone dipropionate, formoterol fumarate dihydrate, milk proteins,
or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Do not use this medicine if the patient has acute asthma symptoms such as breathlessness,
wheezing and coughing, during worsening asthma symptoms or in case of an acute asthma attack.
To relieve symptoms, a fast-acting inhaled reliever medicine should be used, which the patient
should always carry with them.

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

• if the patient has heart diseases. This includes any known heart disorders and/or heart function problems;
• if the patient has heart rhythm disorders such as rapid or irregular heartbeat, increased heart rate or palpitations, or if there is any history of abnormal heart rhythm;
• if the patient has high blood pressure;
• if the patient has arterial narrowing (also known as hardening of the arteries) or has been diagnosed with an aneurysm (an abnormal bulge in the wall of a blood vessel);
• if the patient has hyperthyroidism;
• if the patient has low levels of potassium 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, therefore additional blood tests to monitor blood sugar levels may be necessary before starting treatment and periodically during treatment;
• if the patient has a tumour of the adrenal gland (phaeochromocytoma);
• if the patient is scheduled for general anaesthesia. Depending on the type of anaesthesia, it may be necessary to stop taking Fostex NEXThaler at least 12 hours before anaesthesia;
• if the patient is currently being treated or has previously been treated for pulmonary tuberculosis, or if the patient has a viral or fungal infection within the chest.

Always inform your doctor if any of the above warnings apply to the patient.
If the patient is unsure whether Fostex NEXThaler can be used, they should consult a doctor, nurse or pharmacist before using the medicine.
The treating doctor may recommend periodic monitoring of blood potassium levels, especially in patients with severe asthma. Like many bronchodilator medicines, Fostex NEXThaler may cause a sudden drop in serum potassium levels (hypokalaemia).
Low oxygen levels in the blood combined with certain medicines the patient may be taking concurrently with Fostex NEXThaler may further reduce potassium levels in the blood.

If the patient has been taking high doses of inhaled corticosteroids for a long time, they may require additional corticosteroid treatment during periods of stress. Stress situations include hospital admission following an accident, serious injury, or prior to surgery. In such cases, the treating doctor will decide whether corticosteroid dosage should be increased or whether other steroids should be prescribed in tablet form or by injection.

If hospital treatment becomes necessary, the patient should remember to bring all their medicines and inhalers, including Fostex NEXThaler, as well as any over-the-counter medicines, preferably in their original packaging.

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

Children and adolescents
This medicine should not be given to children and adolescents under 18 years of age.

Fostex NEXThaler and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take. This is important because Fostex NEXThaler may affect the action of certain other medicines. Similarly, some medicines may affect the action of Fostex NEXThaler.

In particular, inform your doctor or pharmacist if the patient is taking the following medicines:

• certain medicines may enhance the effect of Fostex NEXThaler, and the doctor may wish to closely monitor the patient taking such medicines (including some HIV medicines: ritonavir, cobicistat);
• beta-blocking agents. Beta-blockers are medicines used in the treatment of various conditions, including heart disorders, high blood pressure or glaucoma (increased pressure within the eye). If beta-blockers (including eye drops) must be used, 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), which may intensify the effect of formoterol;
• medicines used to treat abnormal heart rhythms (quinidine, disopyramide, procainamide);
• medicines used to treat allergies (antihistamines such as terfenadine);
• medicines used to treat symptoms of depression or psychiatric 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 psychiatric 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);
• diuretic medicines.

You should also inform your doctor if the patient is scheduled to receive general anaesthesia for surgery or a dental procedure.

Pregnancy, breastfeeding and fertility
There are no clinical data on the use of Fostex NEXThaler during pregnancy.
Fostex NEXThaler should not be used if the patient is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, unless otherwise directed by a doctor.

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Driving and using machines
It is unlikely that Fostex NEXThaler will affect the ability to drive or operate machinery. However, if the patient experiences side effects such as dizziness and/or tremor, these may impair the ability to drive or operate machinery.

Fostex NEXThaler contains lactose
Lactose contains small amounts of milk proteins, which may cause allergic reactions in the patient.

3. How to use Fostex NEXThaler

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Fostex NEXThaler uses an extrafine aerosol particle technology, which enables a greater proportion of each dose to reach the lungs. Therefore, your doctor may prescribe a lower dose of this medicine than the dose of the inhaled medicine you previously used.

Asthma

Your doctor will regularly check whether you are taking the optimal dose of Fostex NEXThaler. When adequate asthma control has been achieved, your doctor may consider gradually reducing the dose of Fostex NEXThaler. Under no circumstances should you change the dose without first consulting your doctor.

Adults and elderly patients:

Recommended dose: 1 inhalation twice daily.
Maximum daily dose: 2 inhalations.

Do not use Fostex NEXThaler for the relief of sudden asthma symptoms such as breathlessness, wheezing or coughing.

Note: Always carry a fast-acting, reliever inhaled medicine to alleviate symptoms of asthma exacerbation or sudden asthma attack.

Do not increase the dose of Fostex NEXThaler.
If you feel the medicine is not working adequately, always consult your doctor before increasing the dose.

Chronic Obstructive Pulmonary Disease (COPD)

Adults and elderly patients:

Recommended dose: 1 inhalation twice daily.
Maximum daily dose: 2 inhalations.

How to use Fostex NEXThaler:

Fostex NEXThaler is intended for inhalation use only.

If possible, stand or sit upright during inhalation.

If breathing difficulties persist:

If symptoms do not improve after inhaling Fostex NEXThaler, the cause may be incorrect use of the inhaler. Therefore, check the instructions for correct use of the inhaler below and/or contact your doctor or nurse, who will retrain you in the proper use of the inhaler.

In case of worsening asthma symptoms:

If asthma symptoms worsen or become difficult to control (e.g. more frequent use of another inhaled medicine), or if symptoms do not improve with your rescue inhaled medicine, continue using Fostex NEXThaler and seek immediate medical advice from your doctor. Your doctor may decide that a change in the dose of Fostex NEXThaler is necessary or that additional or alternative treatment is required.

INSTRUCTIONS FOR USING THE NEXThaler INHALER

A. Contents of the pack

To check the contents of the pack, refer to section 6.
If the contents differ from the description in section 6, return the inhaler to the person from whom it was obtained and exchange it for a new one.

B. General warnings and precautions

• Do not remove the inhaler from its protective pouch unless it is to be used immediately.
• Use the inhaler only as directed.
• Do not open the cap unless another dose from the inhaler is required.
• When not in use, store the inhaler in a clean, dry place.
• Under no circumstances should you attempt to disassemble the inhaler.

C. Main features of the inhaler

Dose counter window Air inlet
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 pouch and remove the inhaler.

   • Do not use the inhaler if the pouch is not sealed or is damaged.
     Return it to the person from whom it was obtained and exchange it for a new one.
   • On the label affixed to the box, record the date the pouch was opened.

2. Check the inhaler.

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

3. Check the dose counter window. If the inhaler is new, the dose counter will display "60".

   • Do not use a new inhaler if the dose counter window shows a number less than "60". Return it to the person from whom it was obtained and exchange it for a new one.

E. How to use the inhaler

• If you are unsure whether you have taken the correct dose, contact your doctor or pharmacist.
• If you are uncertain whether the dose counter has decreased by one after inhalation, wait until your next scheduled dose and take the medicine as usual. Do not take an extra 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 "60" indicates that doses remain in the inhaler.
   • If the dose counter displays "0", no doses remain – dispose of the inhaler and obtain a new one.
3. Fully open the inhaler cap.

4. Before inhaling, breathe out as deeply as possible.
   • Do not exhale through the inhaler.

E.2 Performing the inhalation
If possible, stand or sit upright during inhalation.

1. Lift the inhaler, place it in your mouth and close your lips around the mouthpiece.
   • Do not block the air inlet while holding the inhaler.
   • Do not inhale through the air inlet.
2. Breathe in quickly and deeply through your mouth.
   • You may notice a characteristic taste during inhalation.
   • You may hear and feel a click during inhalation.
   • Do not inhale through your nose.
   • Do not remove the inhaler from your mouth during inhalation.

3. Remove the inhaler from your mouth.
4. Hold your breath for 5 to 10 seconds, or as long as possible.
5. Breathe out slowly.
   • Do not exhale through the inhaler.

E.3 Closing

1. Hold the inhaler upright again and fully close the cap.
2. Check that the dose counter has decreased by one.

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

F. Cleaning

• Cleaning the inhaler is generally not necessary.
• If needed, wipe the inhaler with a dry cloth or tissue after use.
  • Do not clean the inhaler with water or other liquids. Store in a dry place.

G. Storage and disposal
For information on storage and disposal of the inhaler, see section 5.

Taking more Fostex NEXThaler than prescribed:

• Contact your doctor immediately or go to the nearest hospital emergency department for advice. Take the medicine with you so healthcare professionals can see exactly what you have taken.
• Adverse effects may occur. Inform your doctor of any unusual symptoms, as they may recommend additional tests or necessary corrective measures.

Missing a dose of Fostex NEXThaler:

Take the missed dose as soon as possible. If it is almost time for your next dose, do not take the missed dose; instead, take the next dose at the usual scheduled time. Do not take a double dose.

Stopping treatment with Fostex NEXThaler:

Even if you feel better, do not stop using Fostex NEXThaler or reduce the dose without consulting your doctor. It is very important to use Fostex NEXThaler regularly as prescribed by your doctor, even when symptoms have subsided.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
As with other inhaled medicines, there is a risk of worsening breathing difficulties, cough, and wheezing immediately after inhaling Fostex NEXThaler, known as paradoxical bronchospasm. In such a case, administration of Fostex NEXThaler must be stopped IMMEDIATELY and a fast-acting inhaled bronchodilator should be used to relieve symptoms. Immediate contact with the treating physician is required.
Inform the doctor immediately if the patient develops allergic reactions such as:
skin allergies, skin itching, skin rash, skin redness, swelling of the skin or mucous membranes, especially eyes, face, lips, and throat.

Other possible adverse reactions are listed below according to their frequency of occurrence.
Common (occur in fewer than 1 in 10 people):

• tremor;
• pneumonia (lung infection) in patients with COPD.

Tell your doctor if any of the following symptoms occur during treatment with Fostex NEXThaler; these may be signs of a lung infection:

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

Uncommon (occur in fewer 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 teeth immediately after inhalation may help prevent these adverse reactions;
• worsening of asthma symptoms, breathing difficulties;
• hoarseness;
• cough;
• unusually fast heartbeat;
• unusually slow heartbeat;
• constricting chest pain;
• headache;
• nausea;
• feeling of fatigue or nervousness;
• changes in electrocardiogram (ECG);
• low cortisol levels in urine or blood;
• high potassium levels in blood;
• high glucose levels in blood;
• high levels of fats in blood.

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Unknown frequency (cannot be estimated from available data):

• visual disturbances.

Adverse reactions observed with similar inhaled medicines containing beclometasone dipropionate and (or) formoterol:

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

Long-term use of inhaled corticosteroids at high doses may lead to systemic effects. These include:

• adrenal gland dysfunction;
• bone thinning;
• growth retardation in children and adolescents;
• increased intraocular pressure (so-called glaucoma), cataract;
• rapid weight gain, particularly in the face and chest area;
• sleep problems, depression or worry, nervousness, tension, hyperactivity or irritability. These adverse reactions are more likely to occur in children;
• behavioral changes.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fostex NEXThaler

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, sachet, and label of the inhaler following the abbreviation: Exp. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture. Remove the inhaler from the sachet immediately before first use.
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Before first opening of the sachet:
No special storage temperature requirements.
After first opening of the sachet:
Do not store above 25°C.
After first opening of the protective sachet, the medicine remains suitable for use for 6 months.
The date of first opening of the sachet should be entered on the label affixed to the carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fostex NEXThaler contains
The active substances in this medicine are: beclometasone dipropionate and formoterol fumarate dihydrate.
Each metered dose (20 mg of inhalation powder) contains 200 micrograms of beclometasone
dipropionate and 12 micrograms of formoterol fumarate dihydrate. This corresponds to the delivered
dose from the mouthpiece containing 173.9 micrograms of beclometasone dipropionate
and 10.4 micrograms of formoterol fumarate dihydrate.
The other ingredients are: lactose monohydrate (containing small amounts of milk proteins)
and magnesium stearate.

What Fostex NEXThaler looks like and contents of the pack
The medicine is a white or almost white inhalation powder contained in a plastic inhaler called a Nexthaler.
One pack contains 1, 2 or 3 inhalers, each containing 60 doses of medicine.
Each inhaler made of ABS with a PP closure is contained in a PET/Aluminium/PE or
Polyamide/Aluminium/PE blister pouch. The pack includes a cardboard outer box.
Not all pack sizes may be marketed.

Marketing Authorisation 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 S.A.S, 2 rue des Docteurs Alberto et Paolo Chiesi, 41260 La Chaussée Saint Victor, France
Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, Innere Stadt, 1010 Vienna, Austria

For further information, please contact the local representative of the Marketing Authorisation 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: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:

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