Fostex

Patient Information Leaflet

Fostex, (200 micrograms + 6 micrograms)/inhalation, inhalation aerosol, solution
Beclometasone dipropionate + Formoterol fumarate dihydrate
Medicinal product intended for use in adults.
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine 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.

Table of Contents

1. What Fostex is and what it is used for
2. What you need to know 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 a solution in an inhalation aerosol that contains two active substances, which are delivered directly to the lungs when inhaled through the inhaler mouthpiece.
Fostex contains two active substances:
Beclometasone dipropionate, belonging to a group of medicines called corticosteroids, which work anti-inflammatory by reducing swelling and irritation in 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 help breathing and also help prevent asthma symptoms such as breathlessness, wheezing, and coughing.
Fostex is intended for the treatment of asthma in adults.
Fostex is used in patients:

• whose asthma symptoms are not sufficiently controlled with inhaled corticosteroids and a short-acting reliever bronchodilator taken as needed, or
• who have achieved adequate control of asthma symptoms with both inhaled corticosteroids and long-acting bronchodilators.

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2. 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 treatment with Fostex, discuss this with your doctor, pharmacist, or
nurse:

• if the patient has heart diseases, such as: angina pectoris (chest pain, pain in the chest), heart failure, coronary artery narrowing (coronary heart disease), heart valve disorders, or any other heart conditions
• if the patient has high blood pressure or a diagnosed aneurysm (abnormal widening of a blood vessel wall)
• if the patient has heart rhythm disorders, such as rapid or irregular heartbeat, increased pulse, or palpitations, or if there is any history of abnormal heart rhythm
• if the patient has overactive thyroid gland (hyperthyroidism)
• if the patient has low blood potassium levels
• if the patient has liver or kidney disease
• if the patient has diabetes (inhaled 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 therapy)
• if the patient has a tumour of the adrenal gland (pheochromocytoma)
• if the patient is scheduled for general anaesthesia. Depending on the type of anaesthesia, it may be necessary to discontinue Fostex at least 12 hours before the procedure
• if the patient is currently being treated or has ever been treated for pulmonary tuberculosis, or if the patient has a viral or fungal infection within the chest
• if the patient must avoid alcohol consumption for any reason.

Always inform your doctor before using Fostex if any of the above warnings apply to you.
Before using this medicine, consult your doctor, pharmacist, or nurse if you currently have or have had any health problems or allergies, or if you have any doubts about whether Fostex can be used.
Your doctor may periodically order blood tests to monitor potassium levels, especially in patients with severe asthma. Like other bronchodilators, Fostex may cause a sudden decrease in serum potassium levels (hypokalaemia). This is associated with low oxygen levels in the blood caused by taking other medicines concurrently with Fostex, which may worsen the reduction in blood potassium levels.
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If the patient has been taking high doses of inhaled corticosteroids for a prolonged period, they may require additional corticosteroid therapy during periods of stress. Stress situations may include: hospital admission following an accident, serious injury, or prior to surgery. In such cases, your doctor will decide whether to increase the corticosteroid dose or recommend other steroids in tablet form or by injection.
If hospitalization is required, the patient should remember to bring all their medicines and inhalers, including Fostex, as well as any over-the-counter medicines, preferably in their original packaging.
If the patient experiences blurred vision or any other visual disturbances, contact your doctor.
Children and adolescents
Fostex must not be used in children and adolescents under 18 years of age.
Fostex and other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
This is necessary because Fostex may affect the action of certain other medicines. Similarly, some medicines may affect the action of Fostex.
In particular, inform your doctor, pharmacist, or nurse if the patient is taking the following medicines:

• certain medicines may enhance the effects of Fostex, and the doctor may wish to closely monitor the patient taking such medicines (including some HIV medicines: ritonavir, cobicistat);
• beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart diseases, high blood pressure, and glaucoma (increased pressure within the eye). If beta-blockers must be used (including eye drops), the effect of formoterol may be reduced or formoterol may not work at all;
• beta-agonists (medicines acting similarly to formoterol) – may enhance the effects of formoterol;
• medicines used to treat abnormal heart rhythms (quinidine, disopyramide, procainamide);
• medicines used to treat allergies (antihistamines);
• medicines used to treat symptoms of depression or psychiatric disorders, such as monoamine oxidase inhibitors (e.g. phenelzine, isocarboxazid), tricyclic antidepressants (e.g. amitriptyline, 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 psychiatric disorders such as monoamine oxidase inhibitors (MAOIs) or medicines with similar properties, such as furazolidone and procarbazine;
• medicines used to treat heart diseases (digoxin);
• other medicines used to treat asthma (theophylline, aminophylline, or steroids);
• diuretics.

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 during pregnancy.
Fostex must not be used if the patient is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, unless otherwise decided by the doctor.
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Driving and operating machinery
It is unlikely that Fostex will affect the ability to drive or operate machinery.
Fostex contains alcohol
Fostex contains 9 mg of alcohol (ethanol) per spray, equivalent to 0.25 mg/kg body weight per dose when two sprays are used. The amount of alcohol in two sprays of this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to use Fostex

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

Dosage:
Adults and elderly patients
The recommended dose is two sprays twice daily.
The maximum daily dose is 4 sprays.

Important: Always carry a fast-acting inhaled medicine for relief to treat worsening asthma symptoms or sudden asthma attacks.

Special patient groups:
There is no need to adjust the dosage in elderly patients. There is insufficient information
regarding the use of Fostex in patients with hepatic or renal impairment.

Use in children and adolescents under 18 years of age:
Fostex must NOT be used in children and adolescents under 18 years of age.

The dose of beclometasone dipropionate contained in Fostex that is effective in treating asthma may be lower than the dose contained in other inhaled medicines containing beclometasone dipropionate. If you have previously used another inhaled medicine containing beclometasone dipropionate, your doctor will advise you on the appropriate dose of Fostex.

Do not increase the dose.
If you feel the medicine is not effective enough, always consult your doctor before increasing the dose.

In case of worsening asthma symptoms:
If your asthma symptoms worsen or become difficult to control (e.g. if you need to use your reliever inhaler more frequently), or if your reliever inhaler does not relieve symptoms, contact your doctor immediately. This may indicate worsening asthma, and your doctor may decide to change the dose of Fostex or initiate alternative treatment.

Method of administration:
Fostex is intended for inhalation use only.
This medicine comes in a pressurized container housed in a plastic casing with a mouthpiece.
At the back of the inhaler is a dose indicator showing how many doses remain. After each
actuation, the dose indicator rotates slightly. The remaining number of doses is displayed in
intervals of 20 doses. Be careful not to drop the inhaler, as this may result in the loss of a dose.
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Inhaler test:
Before first use, or if the inhaler has not been used for 14 days or longer, perform an inhaler test to ensure it is working properly.

• Remove the protective cap from the mouthpiece.
• Hold the container upright with the mouthpiece pointing downwards.
• Point the mouthpiece away from yourself and firmly press the top of the medicine container to release one spray.
• Check the dose indicator. If this is the first time testing the inhaler, the dose indicator should show 180.

How to use the inhaler:
If possible, stand or sit upright during inhalation.
Before inhaling, check the dose indicator: any number between "1" and "180" indicates that
doses remain in the container. If the dose indicator shows "0", this means no doses remain,
and the inhaler should be discarded and replaced with a new one.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust or other debris.
2. Breathe out as deeply and slowly as possible.
3. Hold the container upright with the body pointing upwards, then place the mouthpiece between your lips. Do not bite down on it.
4. Breathe in deeply and slowly through your mouth. Just after starting to inhale, firmly (forcefully) press the top of the inhaler to release one spray. For those with weak grip, it may be easier to hold the inhaler with both hands: place both index fingers on top of the inhaler and both thumbs on the base.
5. Hold your breath as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not exhale into the inhaler.

To take the next dose, keep holding the inhaler upright for about half a minute, then repeat steps 2 to 5.
Important: Do not perform steps 2 to 5 too quickly.
After use, replace the protective cap and check the dose indicator.
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To reduce the risk of developing fungal infection of the mouth or throat, rinse your mouth or throat with water or brush your teeth immediately after each inhalation.

When the dose indicator shows 20, you should have a new inhaler ready.
Stop using the inhaler when the indicator shows 0, as the remaining medicine may not deliver a full dose.

If you see a "mist" above the top of the mouthpiece or at the corners of your mouth, this means Fostex is not reaching your lungs as it should. You should take another dose according to the instructions, restarting from step 2.

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

If you have difficulty using the inhaler during inhalation, you may use a spacer device (valved holding chamber) AeroChamber Plus. Ask your doctor or pharmacist about this device.
It is important to carefully read the leaflet provided with the AeroChamber Plus spacer and follow the instructions for use and cleaning recommendations.

Cleaning the inhaler:
The inhaler should be cleaned once a week.
Do not remove the container from the plastic casing. Do not use water or other liquids to clean the inhaler.

Cleaning the inhaler:

1. Remove the protective cap by pulling it off the inhaler.
2. Wipe the mouthpiece and actuator inside and outside with a dry cloth or tissue.
3. Replace the protective cap.

Use of a higher than recommended dose of Fostex

• Overdosing on formoterol may cause the following symptoms: nausea, vomiting, faster heartbeat, palpitations, heart rhythm disturbances, changes in electrocardiogram (ECG), headache, tremor, drowsiness, increased levels of acidic metabolic products in the blood, decreased blood potassium levels, and increased blood glucose levels. Your doctor may recommend a blood test to check potassium and glucose levels.
• Overdosing on beclometasone dipropionate may cause temporary adrenal suppression, which resolves spontaneously within a few days. Your doctor may recommend a blood test to check serum cortisol levels. If any of these symptoms occur, inform your doctor immediately.

Missed dose of Fostex
Take the missed dose as soon as possible. If it is almost time for your next scheduled dose,
do not take the missed dose—take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Fostex treatment
Even if you feel better, do not stop using Fostex or reduce the dose without consulting your doctor. It is very important to take the medicine regularly, even when symptoms have subsided.

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

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
As with other inhaled medicines, there is a risk of worsening breathlessness and wheezing immediately after inhaling Fostex, known as paradoxical bronchospasm. In such a case, Fostex must be stopped IMMEDIATELY, and a fast-acting inhaled bronchodilator should be used to relieve breathlessness and wheezing. Contact your doctor immediately.
You should inform your doctor immediately if you experience any hypersensitivity reactions, such as: skin allergies, skin itching, skin rash, redness of the skin, swelling of the skin or mucous membranes, especially of the eyes, face, lips, and throat.
Other possible adverse effects are listed below by frequency of occurrence.
Common (occur less frequently than in 1 out of 10 people):

• fungal infections (of the mouth and throat),
• headache,
• hoarseness,
• sore throat.

Uncommon (occur less frequently than in 1 out of 100 people):

• palpitations, abnormally rapid heartbeat, and heart rhythm disturbances,
• changes in electrocardiogram (ECG),
• increased blood pressure,
• influenza-like symptoms,
• sinusitis,
• nasal mucosal inflammation,
• ear infection,
• throat irritation,
• cough and productive cough,
• asthma attack,
• fungal vaginal infections,
• nausea,
• taste disturbances,
• burning lips,
• dryness of the oral mucosa,
• difficulty swallowing,
• indigestion,
• stomach discomfort,
• diarrhoea,
• muscle pain and muscle cramps,
• facial redness,
• increased blood flow to certain tissues,
• increased sweating,
• tremor,
• restlessness, especially motor restlessness,
• dizziness,
• urticaria (hives),
• changes in certain blood parameters:
  o decreased white blood cell count,
  o increased platelet count,
  o decreased blood potassium concentration,
  o increased blood glucose concentration,
  o increased blood insulin concentration, free fatty acids, and ketone bodies.

The following adverse effects have also been reported as "uncommon" in patients with chronic obstructive pulmonary disease (COPD):

• pneumonia: inform your doctor if any of the following symptoms occur: increased sputum production, change in sputum colour, fever, worsening cough, increased breathing difficulties,
• decreased blood cortisol concentration, caused by the effect of corticosteroids on the adrenal glands,
• irregular heartbeat.

Rare (occur less frequently than in 1 out of 1,000 people):

• feeling of chest tightness,
• heart rhythm disturbances (caused by premature ventricular contractions),
• low blood pressure,
• kidney inflammation,
• skin and mucous membrane swelling lasting for several days.

Very rare (occur less frequently than in 1 out of 10,000 people):

• breathlessness,
• worsening of asthma,
• decreased platelet count,
• swelling of hands and feet.

Long-term, high-dose inhaled corticosteroid therapy may, in very rare cases, lead to systemic effects, including:

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

Frequency unknown (cannot be estimated from available data):

• sleep disturbances,
• depression or depressed mood,
• nervousness,
• excessive excitement or irritability. These adverse effects are more likely in children, but their frequency is unknown.
• blurred vision.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: (22) 49 21 301, fax: (22) 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
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5. How to store Fostex

Keep this medicine out of sight and reach of children.
Information for the pharmacist:
Store in a refrigerator at a temperature of 2°C to 8°C. May be stored for up to 18 months.
Information for the patient:
Do not use this medicine more than 3 months after it has been dispensed from the pharmacy, and do not use this medicine after the expiry date stated on the carton and label after the abbreviation "Exp". The expiry date refers to the last day of the stated month.
Do not store at temperatures above 25°C.
If the inhaler has been exposed to very low temperatures, warm it in your hands for several minutes before use. Never use any other method to heat the container.
Important: The container contains liquid under pressure. Do not expose to temperatures above 50°C. Do not pierce the container.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Fostex contains:

• The active substances 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 the delivered dose via the mouthpiece, containing 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.
• The 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), equivalent to 0.020 tonnes of CO₂-equivalent (global warming potential GWP = 1430).

What Fostex looks like and contents of the pack
Fostex is available as a solution for inhalation, contained in an aluminium pressurised canister fitted with a metering valve, enclosed in a plastic housing, with a mouthpiece protector and a dose counter (canister containing 120 doses) or a dose indicator (canister containing 180 doses), all packed in a cardboard box.
Each pack contains:

• one pressurised canister (delivering 120 sprays),
• two pressurised canisters (each delivering 120 sprays),
• one pressurised canister (delivering 180 sprays).
  Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122 Parma, Italy
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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 detailed information, please contact the local representative of the Marketing Authorisation Holder:
Chiesi Poland Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw, Poland
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:
Austria, Greece, Spain, Netherlands, Portugal, Slovak Republic, Slovenia, Hungary, Italy:
Foster
France: Innovair
Germany: Kantos 200 Mikrogramm/6 Mikrogramm pro Inhalation Druckgasinhalation, Lösung
Poland: Fostex
Czech Republic: Combair
United Kingdom: Fostair
{Marketing Authorisation Holder's logo}
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