Duobexon

PACKAGE LEAFLET

Package leaflet: Information for the user

DUOBEXON 100 micrograms/6 micrograms per dose, pressurized solution for

inhalation
beclometasone dipropionate/formoterol fumarate dihydrate
equivalent medicine
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Keep this patient information leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their
symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What DUOBEXON is and what it is used for

DUOBEXON is a pressurized inhalation solution containing two active substances which are inhaled through the mouth and released directly into the lungs.
The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids which have an anti-inflammatory effect, reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators which relax the muscles of the airways and help you breathe more easily.
Together, these two active substances make breathing easier, providing relief from symptoms such as shortness of breath, wheezing and cough in patients with asthma or COPD, and also help prevent asthma symptoms.

Asthma
DUOBEXON is indicated for the regular treatment of asthma in adult patients in whom:

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

COPD
DUOBEXON may also be used to treat symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a long-term lung airway disease mainly caused by cigarette smoking.
DUOBEXON is for use in adults.

2. What you need to know before using DUOBEXON

Do not use DUOBEXON:
if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate or to any
of the excipients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before using DUOBEXON:

• If you have heart problems, such as angina (chest pain, heart pain), if you have recently had a myocardial infarction, heart failure, narrowing of the arteries around the heart (coronary heart disease), valvular heart disease, or any other known heart abnormality, or if you have a condition known as obstructive hypertrophic cardiomyopathy (also known as HOCM, a condition in which the heart muscle is abnormal).
• If you have narrowing of the arteries (also known as arteriosclerosis), if you have high blood pressure, or if you know you have an aneurysm (an abnormal dilation of the blood vessel wall).
• If you have heart rhythm disorders such as rapid or irregular heartbeat, rapid pulse, or palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal.
• If you have an overactive thyroid gland.
• If you have low levels of potassium in your blood.
• If you have any liver or kidney disorders.
• If you have diabetes (if you inhale high doses of formoterol, your blood sugar may rise, and you may therefore need additional blood tests to monitor your blood glucose levels when you start using this inhaler and occasionally during treatment).
• If you have a tumour of the adrenal gland (known as phaeochromocytoma).
• If you are due to undergo anaesthesia. Depending on the type of anaesthesia, you may need to stop taking DUOBEXON at least 12 hours before anaesthesia.
• If you are currently being treated, or have ever been treated, for tuberculosis (TB), or if you have a known viral or fungal infection of the chest.
• If you need to avoid alcohol for any reason.

If any of the conditions listed above apply to you, always inform your doctor before
using DUOBEXON.
If you have or have had any medical problems or allergies, or if you are unsure whether you can use
DUOBEXON, consult your doctor or pharmacist before using this medicine.
Treatment with a beta-agonist such as formoterol contained in DUOBEXON may cause a sudden drop in serum potassium levels (hypokalaemia).
If you have severe asthma, you must take particular care. This is due to low oxygen levels in the blood, and certain other treatments you may be taking alongside DUOBEXON, such as medicines for heart conditions or hypertension known as diuretics, or other medicines used to treat asthma, may worsen the reduction in potassium levels. For this reason, your doctor may wish to monitor your blood potassium levels periodically.
If you are taking higher doses of inhaled corticosteroids for long periods, you may require additional corticosteroids during times of stress. Stressful situations may include hospitalisation after an accident, severe injury, or surgery. In such cases, your treating doctor will decide whether you may need an increased dose of corticosteroids and may prescribe steroid tablets or injectable steroids.
If you need to go to hospital, remember to bring all your medicines and inhalers with you, including DUOBEXON and any over-the-counter medicines or tablets, preferably in their original packaging.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
DUOBEXON must not be used in children and adolescents under 18 years of age until further data are available.
Other medicines and DUOBEXON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. This is because DUOBEXON may affect how some other medicines work. In addition, some medicines may affect how DUOBEXON works.
In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following
medicines:
Some medicines may increase the effects of DUOBEXON, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV medicines: ritonavir, cobicistat).
Beta-blockers. Beta-blockers are medicines used to treat many conditions, including heart problems, hypertension, and glaucoma (increased pressure in the eyes). If you need to use beta-blockers, including eye drops, 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 increase the effects of formoterol.
Medicines used to treat heart rhythm disorders (quinidine, disopyramide, procainamide).
Medicines used to treat allergic reactions (antihistamines).
Medicines for treating symptoms of depression or mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarbazide), tricyclic antidepressants (e.g. amitriptyline and imipramine), phenothiazines.
Medicines for treating Parkinson's disease (L-dopa).
Medicines for treating hypothyroidism (L-thyroxine).
Medicines containing oxytocin (which causes uterine contractions).
Medicines for treating mental disorders such as monoamine oxidase inhibitors (MAOIs), including medicines with similar properties such as furazolidone and procarbazine.
Medicines for treating heart conditions (digoxin).
Other medicines used to treat asthma (theophylline, aminophylline, or steroids).
Diuretics.
You should also inform your doctor if you are about to undergo general anaesthesia for surgery or a dental procedure.
Pregnancy, breastfeeding and fertility
There are no clinical data on the use of DUOBEXON during pregnancy.
Do not take DUOBEXON if you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, unless your doctor has advised you to do so.
Driving and using machines
It is unlikely that DUOBEXON will affect your ability to drive or use machinery.
DUOBEXON contains alcohol
This medicine contains 7 mg of alcohol (ethanol) per dose, equivalent to 0.20 mg/kg for a two-dose administration. The amount in two doses of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
For those engaged in sports
Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use DUOBEXON

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Asthma
Your doctor will regularly monitor you to ensure you are taking the optimal dose of
DUOBEXON. Your doctor will adjust your treatment to the lowest dose that best controls your
symptoms.
DUOBEXON may be prescribed by your doctor in two different ways:
a) Daily use of DUOBEXON for the treatment of asthma, together with a
“reliever” inhaler for treating sudden worsening of asthma symptoms,
such as shortness of breath, wheezing and coughing
Adults and elderly:
The recommended dose of this medicine is one or two inhalations twice daily. The maximum
daily dose is 4 inhalations.
Remember: You must always carry your “reliever” inhaler with you for rapid action to treat worsening asthma symptoms or a sudden asthma attack.
b) Daily use of DUOBEXON for asthma treatment and additional use of
DUOBEXON to treat sudden worsening of asthma symptoms, such as
shortness of breath, wheezing and coughing
Adults and elderly:
The recommended dose is one inhalation in the morning and one inhalation in the evening.
You should also use DUOBEXON as a “reliever” inhaler to treat sudden asthma symptoms.
If you experience asthma symptoms, take one inhalation and wait a few minutes.
If you do not feel better, take another inhalation.
Do not take more than 6 “reliever” inhalations per day.
The maximum daily dose of DUOBEXON as the sole inhaler for asthma is 8 inhalations.
If you feel you need more inhalations per day to control your asthma symptoms, consult your doctor. Your treatment may need to be changed.
Use in children and adolescents under 18 years of age:
Children and adolescents under 18 years of age MUST NOT take this medicine.
Chronic obstructive pulmonary disease (COPD)
Adults and elderly
The recommended dose is two inhalations in the morning and two inhalations in the evening.
At-risk patients
Dose adjustment is not required in elderly patients. There is no information available on the use of
DUOBEXON in patients with hepatic or renal impairment.
DUOBEXON is effective in the treatment of asthma with a beclometasone
dipropionate dosage that may be lower than that of other inhalers containing
beclometasone dipropionate. If you were previously using a different beclometasone
dipropionate inhaler, your doctor will advise you on the exact dose of DUOBEXON to
take for asthma treatment.
Do not increase the dose
If you feel the medicine is not very effective, always consult your doctor before increasing the
dose.
If your breathing worsens

• If you experience worsening shortness of breath or wheezing (audible whistling breathing) immediately after inhaling the medicine, stop using DUOBEXON immediately and use your rapid-acting “reliever” inhaler right away. You must contact your doctor immediately. Your doctor will assess your symptoms and, if necessary, may start a different treatment. See also section 4. Possible side effects.

If your asthma worsens
If your symptoms worsen or are difficult to control (for example, if you are using your
“reliever” inhaler or DUOBEXON as a reliever more frequently), or if your
“reliever” inhaler or DUOBEXON does not improve your symptoms, contact your doctor immediately.
Your asthma may be worsening and your doctor may need to increase your DUOBEXON dose or
prescribe an alternative treatment.
Method of administration
DUOBEXON is for inhalation use only.
This medicine is contained in a pressurized canister inserted into a plastic casing with a mouthpiece. On the back of the inhaler there is a dose counter for 120 doses and a dose indicator for
180 actuations, which shows the number of doses remaining.
For the 120-actuation pack, each time the canister is pressed, one dose of medicine is released and the counter decreases by one number. Be careful not to drop the inhaler, as this may cause the dose counter to decrease by one dose.
For the 180-actuation pack, the dose indicator shows the approximate number of
actuations (sprays) remaining in the canister. The dose indicator window displays the number of sprays left in the inhaler in units of twenty (e.g., 180, 120, 100, 80, etc.). When 20 actuations remain, the display shows the number 20, indicating that the canister is nearing the end of its life.
When 180 actuations have been delivered, the display shows the number 0.
The indicator will stop moving at "0".
Checking the inhaler function
Before using the inhaler for the first time, or if the inhaler has not been used for 14 days or more,
you must check that the inhaler is working properly.

• Remove the protective cap from the mouthpiece.
• Hold the inhaler upright with the mouthpiece pointing downwards.
• Point the mouthpiece away from you and press firmly on the canister to release one dose.
• If you have not used the inhaler for 14 days or more, press firmly on the canister once to release one actuation.
• For the 120-dose pack, check the dose counter. If you are using the inhaler for the first time, the counter should read 120.
• For the 180-dose pack, check the dose indicator. If you are using the inhaler for the first time, the indicator should read 180.

How to use the inhaler
Whenever possible, remain standing or sit upright while inhaling.
Before starting to inhale, check the dose counter or dose indicator to see how many doses are
left. If the dose counter or dose indicator shows "0", no doses remain: dispose of
the inhaler and obtain a new one.

1 2 3 4 5

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust, dirt or any foreign object (Figure 1).
2. Breathe out as slowly and deeply as possible (Figure 2).
3. Hold the canister vertically with the body of the inhaler upright, and place your lips around the mouthpiece. Do not bite the mouthpiece (Figure 3).
4. Breathe in slowly and deeply through your mouth and, immediately after starting to inhale, press firmly on the top of the inhaler to release one dose. If you have weak hands, it may be easier to hold the inhaler with both hands: place your index fingers on the top of the inhaler and both thumbs on the bottom of the inhaler (Image 4).
5. Hold your breath as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not breathe out into the inhaler (Figure 5).

If another actuation is needed, keep 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 counter for the 120-dose pack or the dose indicator for the 180-actuation pack.
To reduce the risk of a fungal infection in the mouth and throat, rinse your mouth, gargle with water, or brush your teeth every time you use the inhaler.
When to replace the inhaler
You should obtain a new inhaler when the dose counter shows the number 20. Stop using
the inhaler when the dose counter shows 0, as the remaining doses in the device may not be sufficient to deliver a full dose, and start using a new inhaler.
If after inhalation you see a “mist” escaping from the inhaler or from the sides of your mouth, this
means that DUOBEXON is not reaching your lungs as it should. Perform another
actuation by following the instructions and repeating steps 2 to 5.
If you think the effect of DUOBEXON is too strong or not strong enough, inform your doctor or
pharmacist.
If you have difficulty using the inhaler when starting to inhale, you may use the AeroChamber Plus spacer device. Ask your doctor, pharmacist or nurse for information about this device.
It is important to read the Patient Information Leaflet provided with the AeroChamber Plus spacer device and carefully follow the instructions on how to use and clean it.
Cleaning
The inhaler should be cleaned once a week.
During cleaning, do not remove the canister from the actuator and do not use water or other liquids
to clean the inhaler.
To clean the inhaler

1. Remove the protective cap from the mouthpiece by pulling it away from the inhaler.
2. Wipe the inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.
3. Replace the protective cap on the mouthpiece.

If you take more DUOBEXON than you should

• Taking more formoterol than you should may cause the following effects: feeling unwell, malaise, rapid heartbeat, palpitations, heart rhythm disturbances, certain changes in the electrocardiogram (ECG), headache, tremor, drowsiness, excess acid in the blood, low potassium levels in the blood, high blood glucose levels. Your doctor may wish to perform blood tests to monitor your potassium and glucose levels.
• Excessive intake of beclometasone dipropionate may cause temporary disturbances of the adrenal glands. These will improve within a few days, but your doctor may wish to monitor your serum cortisol levels. Inform your doctor if you experience any of these symptoms.

If you forget to take DUOBEXON:
Take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose, but
take the next dose at the correct time.
Do not take a double dose to make up for a forgotten dose.
If you stop treatment with DUOBEXON:
Even if you feel better, do not stop taking DUOBEXON or reduce the dose. If you wish to do so,
talk to your doctor. It is very important that you use DUOBEXON regularly, even in the absence of
symptoms.
If you have any questions about using this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
As with other inhaled treatments, there is a risk of worsening breathlessness and wheezing immediately after using DUOBEXON, a condition known as paradoxical bronchospasm. If this occurs, you must STOP using DUOBEXON IMMEDIATELY and use your "rescue" fast-acting inhaler right away to treat symptoms of breathlessness and wheezing. You must contact your doctor immediately.
Inform your doctor immediately if you experience hypersensitivity reactions such as skin allergy, itching, rash, skin redness, or swelling of the skin or mucous membranes, particularly affecting the eyes, face, lips, and throat.

Other possible side effects are listed below by frequency.

Common (may affect up to 1 in 10 people):

• Fungal infections (of the mouth and throat)
• Headache
• Hoarseness
• Sore throat

Pneumonia in patients with COPD: Inform your doctor if you experience any of the following symptoms while taking DUOBEXON, as they may indicate a lung infection:

• Fever or chills
• Increased mucus production or change in mucus colour
• Worsening cough or increased breathing difficulties

Uncommon (may affect up to 1 in 100 people):
Palpitations, abnormally rapid heartbeat, and heart rhythm disorders
Some changes in the electrocardiogram (ECG)
Influenza-like symptoms
Sinusitis
Rhinitis
Ear inflammation
Throat irritation
Cough and productive cough
Asthma attack
Vaginal fungal infections
Nausea
Abnormal or altered taste sensation
Lip burning
Dry mouth
Difficulty swallowing
Indigestion
Stomach discomfort
Diarrhoea
Muscle pain and cramps
Redness of the face and throat
Increased blood flow to certain body tissues
Excessive sweating
Tremor
Restlessness
Dizziness
Skin rash or urticaria
Changes in certain blood components:
Decrease in white blood cell count
Increase in platelet count in the blood
Decrease in blood potassium levels
Increase in blood sugar levels
Increase in blood levels of insulin, free fatty acids, and ketones

The following adverse effects have been reported as "uncommon" in patients with chronic obstructive pulmonary disease (COPD):
Reduction in blood cortisol levels; this is caused by the effect of corticosteroids on the adrenal gland
Irregular heartbeat

Rare (may affect up to 1 in 1,000 people):
Chest tightness
Missed heartbeat (caused by premature contraction of the heart's ventricles)
Decrease in blood pressure
Increase in blood pressure
Kidney inflammation
Swelling of the skin and mucous membranes persisting for several days

Very rare (may affect up to 1 in 10,000 people):
Shortness of breath
Worsening of asthma
Decrease in platelet count in the blood
Swelling of the hands and feet

Prolonged use of high-dose inhaled corticosteroids may very rarely lead to systemic effects. These include:
Adrenal gland function disorders (adrenal suppression)
Reduction in bone mineral density (bone thinning)
Growth retardation in children and adolescents
Increased pressure in the eyes (glaucoma)
Cataract

Not known (frequency cannot be estimated from the available data):
Sleep disturbances
Depression or anxiety
Nervousness
Hyperexcitability or irritability
These events are more likely in children, but their frequency is unknown.
Blurred vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse.
You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DUOBEXON

Keep this medicine out of sight and reach of children.
Single pack containing one 120-dose or 180-dose inhaler
For the pharmacist
Store in a refrigerator (2-8 °C) for up to 18 months.
Enter the date of dispensing to the patient on the adhesive label on the packaging and affix the label
onto the inhaler. Ensure there is a period of at least 3 months between the date of dispensing and the
expiry date printed on the packaging.
For patients
Do not store the inhaler at temperatures above 25 °C.
Do not use DUOBEXON more than 3 months after the date you received the inhaler from the pharmacist, and never use it beyond the expiry date printed on the box and on the label after "Exp.". The expiry date refers to the last day of that month.
Double or triple packs containing two or three 120-dose inhalers
Before use: store the inhalers in a refrigerator (2-8 °C).
After first use: store the inhalers for a maximum of three months and at a temperature not exceeding 25 °C.
Each time you start using an inhaler, enter the date of first use on the adhesive label on the packaging and apply the label to the inhaler. The inhalers must not be used more than 3 months after first use and must never be used beyond the expiry date printed on the box and on the label after "Exp.".
The expiry date refers to the last day of that month.
Do not freeze.
If the inhaler has been exposed to intense cold, warm it with your hands for several minutes before use. Never warm it using artificial means.
Caution: The container contains pressurized liquid. Do not expose the container to temperatures above 50 °C. Do not pierce the container.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What DUOBEXON contains
The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate.
Each metered valve actuation contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate.
This corresponds to an inhaled dose delivered from the mouthpiece of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
The other components are: anhydrous ethanol, concentrated hydrochloric acid and norflurane (HFA-134a).
This medicinal product contains fluorinated greenhouse gases.
Each 120-dose inhaler contains 8.15 g of HFA-134a, equivalent to 0.012 tonnes of CO₂ (global warming potential GWP = 1,430).
Each 180-dose inhaler contains 11.2 g of HFA-134a, equivalent to 0.016 tonnes of CO₂ (global warming potential GWP = 1,430).

Description of the appearance of DUOBEXON and contents of the pack
DUOBEXON is a pressurised solution for inhalation contained in an aluminium container with a metering valve, fitted into a white plastic inhaler incorporating a dose counter (pack of 120 actuations) or a dose indicator (pack of 180 actuations), with a pink plastic protective cap.
Each pack contains:
1 pressurised container (delivering 120 actuations) or
2 pressurised containers (each delivering 120 actuations) or
3 pressurised containers (each delivering 120 actuations) or
1 pressurised container (delivering 180 actuations).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Genetic S.p.A.
Via G. Della Monica 26
84083 Castel San Giorgio (SA)
Italy

Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano
Italy

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria Duobexon
Italy Duobexon

Package leaflet: information for the user

DUOBEXON 200 micrograms/6 micrograms per actuation, pressurized solution for

inhalation
beclometasone dipropionate/formoterol fumarate dihydrate
equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Keep this patient information leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet

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

1. What DUOBEXON is and what it is used for

DUOBEXON is a pressurized inhalation solution containing two active substances which are inhaled through the mouth and delivered directly into the lungs.
The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which have an anti-inflammatory effect, reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators, which relax the muscles of the airways and help you breathe more easily.
Together, these two active substances make breathing easier, providing relief from symptoms such as shortness of breath, wheezing and cough in patients with asthma, and also help prevent asthma symptoms.
DUOBEXON is indicated for the treatment of asthma in adult patients.
If DUOBEXON has been prescribed for you, it is likely because:

• your asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators "as needed", or
• your asthma responds well to treatment with both corticosteroids and long-acting bronchodilators.

2. What you need to know before using DUOBEXON

Do not use DUOBEXON:
if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate, or to any of
the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using DUOBEXON:

• If you have heart problems, such as angina (chest pain, heart pain), heart failure, narrowed arteries, heart valve disease, or any other known heart condition.
• If you have high blood pressure or if you know you have an aneurysm (an abnormal bulging of blood vessel walls).
• If you have heart rhythm disorders such as rapid or irregular heartbeat, fast pulse, or palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal.
• If you have an overactive thyroid gland.
• If you have low levels of potassium in your blood.
• If you have any liver or kidney problems.
• If you have diabetes (if you inhale high doses of formoterol, your blood sugar may increase. When you start using this medicine and occasionally during treatment, you may need additional blood tests to monitor your blood sugar levels).
• If you have a tumour of the adrenal gland (known as phaeochromocytoma).
• If you are due to undergo anaesthesia. Depending on the type of anaesthesia, you may need to stop taking DUOBEXON at least 12 hours before the anaesthesia.
• If you are currently being treated, or have previously been treated, for tuberculosis (TB), or if you have a known viral or fungal infection in the chest.
• If you need to avoid alcohol for any reason.

If any of the conditions listed above apply to you, always inform your doctor before
using DUOBEXON.
If you have or have had any medical problems or allergies, or if you are unsure whether you can use
DUOBEXON, contact your doctor, a nurse experienced in asthma management, or a pharmacist before
using the inhaler.
Your doctor may want to check your blood potassium levels from time to time, especially if
your asthma is severe. Like many bronchodilators, DUOBEXON may cause a sudden drop in serum
potassium levels (hypokalaemia). This is because lack of oxygen in the blood, combined with
some other treatments you may be taking together with DUOBEXON, can worsen the reduction in
potassium levels.
If you take high doses of inhaled corticosteroids for long periods, you may require additional
corticosteroids during times of stress. Stressful situations may include hospitalisation after an
accident, a serious injury, or surgery. In such cases, your treating doctor will decide whether you
might need an increased dose of corticosteroids and may prescribe steroid tablets or injectable
steroids.
If you need to go to hospital, remember to bring with you all your medicines and inhalers, including
DUOBEXON, and any over-the-counter medicines or tablets you are taking, preferably in their
original packaging.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
DUOBEXON must not be used in children and adolescents under 18 years of age.

Other medicines and DUOBEXON
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other
medicines, including those without a prescription.
This is because DUOBEXON may affect how some other medicines work. In addition, some
medicines may affect how DUOBEXON works.
In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following
medicines:
Some medicines can increase the effects of DUOBEXON, and your doctor may wish to monitor
you closely if you are taking these medicines (including some HIV medicines: ritonavir, cobicistat).
Beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems,
hypertension, and glaucoma (increased pressure in the eyes). If you need to use beta-blockers, including
eye drops, 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 increase the
effects of formoterol.
Medicines used to treat heart rhythm disorders (quinidine, disopyramide, procainamide).
Medicines used to treat allergic reactions (antihistamines).
Medicines used to treat symptoms of depression or mental disorders such as monoamine oxidase
inhibitors (e.g. phenelzine and isocarbazide), 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 causes uterine contractions).
Medicines used to treat mental disorders such as monoamine oxidase inhibitors (MAOIs), including
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 about to undergo general anaesthesia for surgery or
a dental procedure.

Pregnancy, breastfeeding and fertility
There are no clinical data on the use of DUOBEXON during pregnancy.
Do not take DUOBEXON if you are pregnant, think you may be pregnant, are planning a pregnancy, or
are breastfeeding, unless advised by your doctor.

Driving and using machines
It is unlikely that DUOBEXON will affect your ability to drive or use machinery.

DUOBEXON contains alcohol
This medicine contains 9 mg of alcohol (ethanol) per dose, equivalent to 0.25 mg/kg for a two-dose
inhalation. The amount in two doses of this medicine is equivalent to less than 1 ml of beer or 1 ml of
wine. The small amount of alcohol in this medicine will not produce significant effects.

For those engaged in sports
Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use DUOBEXON

Always use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will regularly monitor you to ensure you are taking the optimal dose of
DUOBEXON. Your doctor will adjust your treatment to the lowest dose that best controls your symptoms.
Dosage
Adults and elderly
The recommended dose is two inhalations twice daily.
The maximum daily dose is 4 inhalations.
Remember: You must always carry your fast-acting “rescue” inhaler with you to treat
worsening asthma symptoms or sudden asthma attacks.
Patients at risk
No dose adjustment is necessary for elderly patients. There is no available information on the use of DUOBEXON in patients with liver or kidney problems.
Use in children and adolescents under 18 years of age:
Children and adolescents under 18 years of age MUST NOT take this medicine.
DUOBEXON is effective in the treatment of asthma with a beclometasone
dipropionate dosage that may be lower than that of other inhalers containing this
active ingredient. If you previously used a different beclometasone
dipropionate inhaler, your doctor will advise you on the exact dose of DUOBEXON
to take for asthma treatment.
Do not increase the dose
If you feel the medicine is not very effective, always consult your doctor before increasing the
dosage.
If your asthma worsens
If your symptoms worsen or become difficult to control (for example, if you use your
rescue inhaler more frequently), or if your rescue inhaler does not improve your
symptoms, contact your doctor immediately. Your asthma may be worsening, and your doctor may
need to adjust your DUOBEXON dose or prescribe an alternative treatment.
Method of administration
DUOBEXON is for inhalation use.
This medicine is contained in a pressurized canister inserted into a plastic casing with a mouthpiece. At the back of the inhaler, there is a dose counter for 120 doses and a dose indicator for
180 actuations, which shows the number of doses remaining.
For the 120-dose pack, each time you press the canister, one dose of medicine is released and the counter decreases by one. Be careful not to drop the inhaler, as this may cause the dose counter to decrement unintentionally.
For the 180-dose pack, the dose indicator shows the approximate number of
actuations (sprays) remaining in the canister. The dose indicator window displays the number of
sprays left in multiples of twenty (e.g., 180, 120, 100, 80, etc.). When 20 actuations remain, the display shows the number 20, indicating that the canister is nearing the end of its life.
When 180 actuations have been delivered, the display shows the number 0.
The indicator will stop moving at "0".
Checking the inhaler function
Before using the inhaler for the first time or if it has not been used for 14 days or more,
you must check the inhaler's function to ensure it works properly.

• Remove the protective cap from the mouthpiece.
• Hold the inhaler upright with the mouthpiece pointing downward.
• Move the mouthpiece away and press firmly on the canister to release one dose.
• If you have not used the inhaler for 14 days or more, press firmly on the canister once to release one puff.
• For the 120-dose pack, check the dose counter. If using the inhaler for the first time, the counter should read 120.
• For the 180-dose pack, check the dose indicator. If using the inhaler for the first time, the counter should read 180.

How to use the inhaler
Whenever possible, remain standing or sit upright while inhaling.
Before starting to inhale, check the dose counter or dose indicator to see how many doses remain. If the dose counter or dose indicator shows "0", no doses remain: dispose of
the inhaler and obtain a new one.

1 2 3 4 5

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust, dirt, or any foreign objects (Figure 1).
2. Breathe out as slowly and deeply as possible (Figure 2).
3. Hold the canister vertically, with the body of the inhaler upright, and place your lips around the mouthpiece. Do not bite the mouthpiece (Figure 3).
4. Breathe in slowly and deeply through your mouth and, immediately after starting to inhale, press firmly on the top of the inhaler to release one dose. If you have a weak grip, it may be easier to hold the inhaler with both hands: place your index fingers on top of the inhaler and both thumbs on the bottom of the inhaler (Image 4).
5. Hold your breath as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not breathe out into the inhaler (Figure 5).

If a second inhalation is needed, hold 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 counter for the 120-dose pack or the dose indicator for the 180-dose pack.
To reduce the risk of fungal infection in the mouth and throat, rinse your mouth, gargle with water, or brush your teeth each time you use the inhaler.
When to replace the inhaler
You should obtain a new inhaler when the dose counter indicates the number 20. Stop using
the inhaler when the dose counter shows 0, as the remaining doses in the device
may not be sufficient to deliver a full dose; begin using the new inhaler.
If you see a "mist" escaping from the inhaler or from the sides of your mouth after inhalation,
this means DUOBEXON is not reaching your lungs as intended. Perform another
actuation by following the instructions and repeating steps 2 to 5.
If you think the effect of DUOBEXON is too strong or not strong enough, inform your doctor or
pharmacist.
If you have difficulty using the inhaler when starting to inhale, you may use the
AeroChamber Plus spacer device. Ask your doctor, pharmacist, or nurse for information about
this device.
It is important to read the Patient Information Leaflet provided with the AeroChamber Plus spacer device and carefully follow the instructions on how to use and clean it.
Cleaning
The inhaler should be cleaned once a week.
During cleaning, do not remove the canister from the inhaler and do not use water or other liquids
to clean the inhaler.
To clean the inhaler

1. Remove the protective cap from the mouthpiece by pulling it away from the inhaler.
2. Clean the inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.
3. Replace the protective cap onto the mouthpiece.

If you take more DUOBEXON than you should

• Taking more formoterol than you should may cause the following effects: feeling unwell, malaise, rapid heartbeat, palpitations, heart rhythm disturbances, certain electrocardiogram (ECG) changes, headache, tremor, drowsiness, excess acid in the blood, low potassium levels in the blood, and high blood glucose levels. Your doctor may wish to perform blood tests to monitor your blood potassium and glucose levels.
• Excessive intake of beclometasone dipropionate may cause temporary disturbances in the adrenal glands. These will resolve within a few days, but your doctor may wish to monitor your serum cortisol levels. Inform your doctor if you experience any of these symptoms.

If you forget to take DUOBEXON
Take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose, but
take the next dose at the correct time.
Do not take a double dose to make up for a forgotten dose.
If you stop using DUOBEXON
Even if you feel better, do not stop taking DUOBEXON or reduce your dose. If you wish to do so,
speak with your doctor. It is very important that you use DUOBEXON regularly, even if you have no
symptoms.
If you have any questions about using this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other inhaled treatments, there is a risk of worsening breathlessness and wheezing immediately after using DUOBEXON, a condition known as paradoxical bronchospasm. If this occurs, you must STOP using DUOBEXON IMMEDIATELY and use your "reliever" inhaler with rapid action to treat breathlessness and wheezing symptoms right away. You must contact your doctor immediately.
Inform your doctor immediately if you experience hypersensitivity reactions such as skin allergy, itching, skin rash, skin redness, or swelling of the skin or mucous membranes, particularly affecting the eyes, face, lips, and throat.

Other possible side effects are listed below by frequency.

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):
palpitations, unusually fast heartbeat, and heart rhythm disorders
some changes in the electrocardiogram (ECG)
increased blood pressure
influenza-like symptoms
sinusitis
rhinitis
ear inflammation
throat irritation
cough and productive cough
asthma attack
fungal infections of the vagina
nausea
abnormal or altered sense of taste
burning of the lips
dry mouth
difficulty swallowing
indigestion
stomach disorders
diarrhea
muscle pain and cramps
redness of face and throat
increased blood flow to certain body tissues
excessive sweating
tremor
restlessness
dizziness
skin rash or hives
changes in certain blood components:
reduction in the number of white blood cells
increase in the number of platelets in the blood
reduction in blood potassium levels
increase in blood sugar levels
increase in blood levels of insulin, free fatty acids, and ketones

The following side effects have been reported as "uncommon" in patients with chronic obstructive pulmonary disease (COPD):
pneumonia; inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum colour, fever, increased cough, worsening breathing problems
reduction in cortisol levels in the blood; this is caused by the effect of corticosteroids on the adrenal gland
irregular heartbeat

Rare (may affect up to 1 in 1,000 people):
chest tightness
missed heartbeat (caused by premature contraction of the heart's ventricles)
decrease in blood pressure
kidney inflammation
swelling of the skin and mucous membranes persisting for several days

Very rare (may affect up to 1 in 10,000 people):
breathlessness
worsening of asthma
decrease in the number of platelets in the blood
swelling of hands and feet

Prolonged use of inhaled corticosteroids at high doses may very rarely cause systemic effects.
These include:
adrenal gland function disorders (adrenal suppression)
reduction in bone mineral density (thinning of the bones)
growth retardation in children and adolescents
increased pressure in the eyes (glaucoma)
cataract

Not known (frequency cannot be estimated from the available data):
sleep disorders
depression or anxiety
nervousness
hyperexcitability or irritability
These events are more likely in children, but the frequency is unknown.
Blurred vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DUOBEXON

Keep this medicine out of the sight and reach of children.
Single pack containing one 120-dose or 180-dose inhaler
For the pharmacist
Store in a refrigerator (2-8 °C) for up to 18 months.
Enter the date of dispensing to the patient on the adhesive label on the packaging and affix the label
onto the inhaler. Ensure there is a period of at least 3 months between the date of dispensing and the
expiry date printed on the packaging.
For patients
Do not store the inhaler at temperatures above 25 °C.
Do not use DUOBEXON more than 3 months after the date you received the inhaler from the pharmacist, and never use it beyond the expiry date shown on the box and on the label after "Exp.". The expiry date refers to the last day of that month.
Double or triple packs containing two or three 120-dose inhalers
Before use: store the inhalers in a refrigerator (at 2-8°C).
After first use: store the inhalers for a maximum of three months at a temperature not exceeding 25 °C.
Each time you start using an inhaler, enter the date of first use on the adhesive label on the packaging and apply the label to the inhaler. The inhalers must not be used more than 3 months after first use and must never be used beyond the expiry date shown on the box and on the label after "Exp.".
The expiry date refers to the last day of that month.
Do not freeze.
If the inhaler has been exposed to intense cold, warm it with your hands for several minutes before use. Never warm it with artificial means.
Caution: The container contains pressurized liquid. Do not expose the container to temperatures above 50 °C. Do not pierce the container.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help protect the environment.

6. Package contents and other information

What DUOBEXON contains:
The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate.
Each actuation from the metering valve contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate.
This corresponds to an inhaled dose delivered from the mouthpiece of 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.
The other components are: norflurane (HFA-134a), anhydrous ethanol, concentrated hydrochloric acid.
This medicinal product contains fluorinated greenhouse gases.
Each 120-dose inhaler contains 10.35 g of HFA-134a, equivalent to 0.015 tonnes of CO₂ (global warming potential GWP = 1,430).
Each 180-dose inhaler contains 14.24 g of HFA-134a, equivalent to 0.020 tonnes of CO₂ (global warming potential GWP = 1,430).

Description of the appearance of DUOBEXON and contents of the pack:
DUOBEXON is a pressurized solution for inhalation contained in an aluminium container with a metering valve, inserted into a white plastic actuator incorporating either a dose counter (120-dose pack) or a dose indicator (180-dose pack), with a green plastic protective cap.
Each pack contains:
1 pressurized container (providing 120 doses) or
2 pressurized containers (each providing 120 doses) or
3 pressurized containers (each providing 120 doses) or
1 pressurized container (providing 180 doses).
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Genetic S.p.A.
Via G. Della Monica 26
84083 Castel San Giorgio (SA)
Italy

Manufacturer:
Genetic S.p.A.
Contrada Canfora
84084 Fisciano
Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Duobexon
Italy Duobexon