DUEXON 50 mcg/100 mcg Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Duexon Pro, (50 micrograms + 100 micrograms)/dose, powder for inhalation, divided
3. Duexon Pro, (50 micrograms + 250 micrograms)/dose, powder for inhalation, divided
4. Duexon Pro, (50 micrograms + 500 micrograms)/dose, powder for inhalation, divided
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Duexon Pro and what is it used for
   1. Duexon Pro is used in the treatment of adults and adolescents from 12 years of age.
   2. Duexon Pro prevents shortness of breath and wheezing in the airways. However, it should not be used to control sudden attacks of shortness of breath or wheezing in the airways.
   3. If such an attack occurs, it is necessary to use a fast-acting bronchodilator, such as salbutamol, immediately. The patient should always carry such a medicine with them.
6. Important information before using Duexon Pro
   1. When not to use Duexon Pro
   2. Warnings and precautions
   3. Children
   4. Duexon Pro and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Duexon Pro contains lactose
7. How to use Duexon Pro
   1. Asthma
   2. Adults and adolescents 12 years and older
   3. Adults with chronic obstructive pulmonary disease (COPD)
   4. In case of worsening of asthma symptoms or breathing difficulties, the patient should immediately
   5. Instructions for use
   6. Using the inhalation device
   7. Cleaning the inhaler
   8. Using a higher dose of Duexon Pro than recommended
   9. Missing a dose of Duexon Pro
   10. Stopping the use of Duexon Pro
8. Possible side effects
   1. Allergic reactions: The patient may experience sudden breathing difficulties immediately after
   2. Pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD) (common side effect)
   3. Very common side effects (may occur more often than in 1 in 10 people)
   4. Common side effects (may occur less often than in 1 in 10 people)
   5. Uncommon side effects (may occur less often than in 1 in 100 people)
   6. Rare side effects (may occur less often than in 1 in 1000 people)
   7. Side effects with unknown frequency (frequency cannot be estimated from the available data)
   8. Reporting side effects
9. How to store Duexon Pro
10. Contents of the packaging and other information
    1. What Duexon Pro contains
    2. What Duexon Pro looks like and contents of the pack
    3. Marketing authorization holder
    4. Importer
    5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    6. Date of last revision of the leaflet: 11/2024

Leaflet accompanying the packaging: patient information

Duexon Pro, (50 micrograms + 100 micrograms)/dose, powder for inhalation, divided

Duexon Pro, (50 micrograms + 250 micrograms)/dose, powder for inhalation, divided

Duexon Pro, (50 micrograms + 500 micrograms)/dose, powder for inhalation, divided

Salmeterol + Fluticasone propionate

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

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

Table of contents of the leaflet

• 1. What is Duexon Pro and what is it used for
• 2. Important information before using Duexon Pro
• 3. How to use Duexon Pro
• 4. Possible side effects
• 5. How to store Duexon Pro
• 6. Contents of the packaging and other information

1. What is Duexon Pro and what is it used for

Duexon Pro contains two active substances: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help maintain the patency of the airways. This makes it easier for air to flow in and out of the lungs. The effect lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation of the lungs.

Duexon Pro is used in the treatment of adults and adolescents from 12 years of age.

The doctor has prescribed this medicine to the patient to prevent breathing disorders that occur in:

• asthma, or
• chronic obstructive pulmonary disease (COPD). Duexon Pro, at a dose of 50 micrograms + 500 micrograms, reduces the number of exacerbations of COPD symptoms.

In order to ensure proper control of asthma or COPD, Duexon Pro must be used every day as recommended by the doctor.

Duexon Pro prevents shortness of breath and wheezing in the airways. However, it should not be used to control sudden attacks of shortness of breath or wheezing in the airways.

If such an attack occurs, it is necessary to use a fast-acting bronchodilator, such as salbutamol, immediately. The patient should always carry such a medicine with them.

2. Important information before using Duexon Pro

When not to use Duexon Pro

• if the patient is allergic to salmeterol, fluticasone propionate, or lactose monohydrate, an excipient of the medicine.

Warnings and precautions

Before starting to use Duexon Pro, the patient should discuss it with their doctor, pharmacist, or nurse if they have:

• heart disease, including irregular or rapid heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes (Duexon Pro may increase blood glucose levels),
• low potassium levels in the blood,
• tuberculosis currently being treated or a history of tuberculosis or other lung infections.

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

Children

This medicine should not be used in children under 12 years of age.

Duexon Pro and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Duexon Pro should not be used with certain medicines.
Before starting to use Duexon Pro, the patient should inform their doctor about taking the following medicines:

• Beta-adrenergic blockers (e.g., atenolol, propranolol, and sotalol). Beta-adrenergic blockers are most often used to treat high blood pressure or other heart diseases, such as angina pectoris.
• Medicines used to treat infections (e.g., ketoconazole, itraconazole, and erythromycin), including some medicines used to treat HIV (e.g., ritonavir, cobicistat-containing products). Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of side effects of Duexon Pro, including irregular heartbeat, or may worsen existing side effects. The doctor may want to closely monitor the patient's condition when taking such medicines.
• Corticosteroids (orally or by injection). If the patient has recently taken such medicines, it may increase the risk of adrenal gland disorders caused by Duexon Pro.
• Diuretics used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine derivatives, such as aminophylline and theophylline, often used to treat asthma.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

Driving and using machines

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

Duexon Pro contains lactose

Each delivered dose of Duexon Pro contains 13 mg of lactose monohydrate. This amount does not cause problems in people with lactose intolerance. The excipient lactose contains small amounts of milk proteins, which may cause allergic reactions.

3. How to use Duexon Pro

This medicine should always be used as recommended by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

• Duexon Pro should be used every day, unless the doctor recommends otherwise. The patient should not take a higher dose than recommended. In case of doubts, the patient should consult their doctor or pharmacist.
• The patient should not stop using Duexon Pro or reduce the dose without consulting their doctor.
• Duexon Pro should be inhaled into the lungs through the mouth.

The recommended dose is:

Asthma

Adults and adolescents 12 years and older

• Duexon Pro (50 micrograms + 100 micrograms)/dose: one inhalation twice a day.
• Duexon Pro (50 micrograms + 250 micrograms)/dose: one inhalation twice a day.
• Duexon Pro (50 micrograms + 500 micrograms)/dose: one inhalation twice a day.

Adults with chronic obstructive pulmonary disease (COPD)

• Duexon Pro (50 micrograms + 500 micrograms)/dose: one inhalation twice a day.

If the symptoms of asthma are well-controlled while using Duexon Pro twice a day, the doctor may recommend reducing the frequency of use of Duexon Pro to once a day.
The dose can be given:

• once a day, in the evening, if the patient's symptoms occur at night,
• once a day, in the morning, if the patient's symptoms occur during the day. It is very important that the doctor instructs the patient on how many inhalations and how often to use.

If the patient is using Duexon Pro for asthma, the doctor will regularly check the symptoms.

In case of worsening of asthma symptoms or breathing difficulties, the patient should immediately

contact their doctor.There may be an increase in wheezing, more frequent chest tightness, or a need to use a higher dose of a fast-acting inhalation medicine to facilitate breathing. In any of these situations, the patient should continue to use Duexon Pro, but should not increase the number of inhalations. The symptoms of the disease may worsen, and the patient's condition may deteriorate. The patient should contact their doctor, as they may need additional treatment.

Instructions for use

• Duexon Pro may differ from inhalers used by the patient in the past, so it is very important to use it correctly. The doctor, nurse, or pharmacist should train the patient in the use of the inhaler. This training is important to ensure that the patient receives the required dose. If the patient has not received this training, they should ask their doctor, nurse, or pharmacist to show them how to use the inhaler correctly, especially before the first use.They should also periodically check that the patient is using the inhalation device correctly. Using Duexon Pro not in accordance with the doctor's recommendation may cause the medicine not to produce the expected improvement in asthma or COPD.
• The inhalation device contains blisters with salmeterol and fluticasone propionate in powder form.
• The inhalation device is equipped with a dose counter, which indicates how many doses of the medicine are left in the inhalation device. The counter indicates the dose number down to 0. The numbers from 5 to 0 appear in red to warn that there are only a few doses of the medicine left in the inhalation device. If the counter shows 0, it means that the inhalation device is empty.

The patient should not open the mouthpiece cover unless they intend to use the inhaler.

Using the inhalation device

• 1. To open the inhalation device, the patient should hold the device with one hand in a horizontal position. They should press the red button with their thumb (see Fig. 1) and slide the light pink (Duexon Pro (50 micrograms + 100 micrograms)/dose), pink (Duexon Pro (50 micrograms + 250 micrograms)/dose), or light purple (Duexon Pro (50 micrograms + 500 micrograms)/dose) mouthpiece cover away from them – until it clicks (see Fig. 2). After performing this action, a small hole appears in the mouthpiece, and the dose of the medicine is placed in the mouthpiece.

Fig. 1
Fig. 2
Note: Each time the mouthpiece cover is opened after the "click", the blister inside opens, and the next dose of powder is ready for inhalation. Therefore, the patient should not open the mouthpiece cover unless they intend to use the inhaler, as the next blister will open, and the medicine will be wasted.

• 2. The patient should hold the inhalation device away from their mouth and perform a slow, deep exhalation. They should not exhale into the inhalation device.
• 3. The patient should put the mouthpiece in their mouth (see Fig. 3). They should perform a deep inhalation from the inhalation device through their mouth, not through their nose. They should remove the inhalation device from their mouth. They should hold their breath for about 10 seconds or as long as it is comfortable. They should perform a slow exhalation.

Fig. 3
The inhaler delivers a dose of the medicine in the form of a very fine powder. The patient may, but does not have to, feel the powder. The patient should not use an additional dose from the inhaler if they do not feel the taste of the medicine.

• 4. The patient should close the inhaler to keep it clean by sliding the light pink (Duexon Pro (50 micrograms + 100 micrograms)/dose), pink (Duexon Pro (50 micrograms + 250 micrograms)/dose), or light purple (Duexon Pro (50 micrograms + 500 micrograms)/dose) mouthpiece cover back – until it clicks (see Fig. 4). The patient will hear a "click". The mouthpiece cover has now returned to its original position. The inhaler is now ready for use at the next scheduled dose.
• 5. After inhaling the medicine, the patient should rinse their mouth with water and spit it out and (or) brush their teeth. This may help prevent hoarseness and thrush.

Fig. 4

Cleaning the inhaler

The patient should keep the inhaler dry and clean.
In case of need, the patient can wipe the mouthpiece of the inhalation device with a dry cloth or tissue.

Using a higher dose of Duexon Pro than recommended

It is important to use the inhalation device as recommended. In case of accidental use of a higher dose than recommended, the patient should tell their doctor or pharmacist. The following may occur: faster than usual heartbeat, tremors, dizziness, headache, weakness, and joint pain.
In case of using higher doses for a long period, the patient should contact their doctor or pharmacist for advice, as high doses of Duexon Pro may cause a decrease in the production of steroid hormones by the adrenal glands.

Missing a dose of Duexon Pro

The patient should not take a double dose of the medicine to make up for a missed dose. They should take the next dose at the scheduled time.

Stopping the use of Duexon Pro

It is very important to take Duexon Pro every day as recommended by the doctor. The patient should take the medicine until their doctor recommends stopping it. The patient should not suddenly stop taking Duexon Pro or reduce the dose, as the symptoms of the disease may worsen.
Additionally, sudden stopping of the use or reduction of the dose of Duexon Pro may (very rarely) cause adrenal gland disorders (adrenal insufficiency), which can sometimes cause side effects. These side effects may include:

• abdominal pain,
• fatigue and loss of appetite, nausea,
• vomiting and diarrhea,
• weight loss,
• headache and drowsiness,
• low blood sugar,
• low blood pressure and seizures.

When the body is under stress, such as from fever, injury (such as a car accident), infection, or surgery, adrenal insufficiency may worsen, and any of the above side effects may occur.
If the patient experiences any of these side effects, they should tell their doctor or pharmacist. To prevent these symptoms, the doctor may prescribe additional corticosteroids in the form of tablets (e.g., prednisolone).
In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To minimize the risk of side effects, the doctor will recommend the smallest dose of this medicine that will control asthma or COPD.

Allergic reactions: The patient may experience sudden breathing difficulties immediately after

using Duexon Pro. There may be an increase in wheezing, coughing, or shortness of breath, as well as itching, rash (hives), and swelling (usually of the face, lips, tongue, or throat). The patient may also experience a very fast heartbeat, weakness, dizziness (which can lead to a fall or loss of consciousness). In case of any of these symptoms, including if they occur suddenly after using Duexon Pro, the patient should stop using Duexon Pro and contact their doctor immediately.Allergic reactions to Duexon Pro are uncommon (they may occur less often than in 1 in 100 people).

Pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD) (common side effect)

The patient should tell their doctorif they experience any of the following symptoms while using Duexon Pro – they may be symptoms of a lung infection:

• Fever or chills.
• Increased production of mucus, change in the color of mucus.
• Worsening of cough or increased breathing difficulties.

Other side effects:

Very common side effects (may occur more often than in 1 in 10 people)

• Headache - this side effect usually decreases over time while continuing treatment.
• There have been reports of an increased frequency of colds in patients with chronic obstructive pulmonary disease (COPD).

Common side effects (may occur less often than in 1 in 10 people)

• Thrush (painful, creamy-white patches) in the mouth and throat, as well as pain in the tongue, hoarseness, and irritation of the throat. Rinsing the mouth with water and spitting it out and (or) brushing the teeth may be helpful. The doctor may recommend an antifungal medicine to treat thrush.
• Pain, swelling of the joints, and muscle pain.
• Muscle cramps.

The following side effects have been reported in patients with chronic obstructive pulmonary disease (COPD):

• Bruising and fractures more easily.
• Sinusitis (feeling of tension and fullness in the nose, cheeks, and behind the eyes, sometimes with a throbbing headache).
• Low potassium levels in the blood (the patient may experience irregular heartbeat, muscle weakness, cramps).

Uncommon side effects (may occur less often than in 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycemia). In patients with diabetes, it may be necessary to monitor blood sugar levels more frequently and adjust the dose of antidiabetic medicines.
• Cataract (clouding of the lens of the eye).
• Very fast heartbeat (tachycardia).
• Feeling of trembling and fast or irregular heartbeat (palpitations) - these symptoms usually are not serious and decrease over time while continuing treatment.
• Chest pain.
• Restlessness (this symptom occurs mainly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare side effects (may occur less often than in 1 in 1000 people)

• Breathing difficulties or wheezing worsening immediately after taking Duexon Pro. In case of such symptoms, the patient should stop using Duexon Pro, use a fast-acting inhalation medicine to facilitate breathing, and contact their doctor immediately.
• Duexon Pro may disrupt the normal production of steroid hormones by the body, especially when taking high doses of the medicine for a long period. These symptoms may include:
• slow growth in children and adolescents,
• decreased bone density,
• glaucoma,
• weight gain,
• rounding of the face (Cushing's syndrome). The doctor will regularly check for these side effects and ensure that the patient is using the smallest dose of this medicine that will control asthma.
• Changes in behavior, such as excessive restlessness and irritability (these symptoms occur mainly in children).
• Irregular or extra heartbeats (arrhythmias). The patient should inform their doctor about this, but should not stop using Duexon Pro unless their doctor recommends it.
• Fungal infection of the esophagus, which can cause difficulty swallowing.

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Depression or aggression (these symptoms are more likely to occur in children).
• Blurred vision.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it will be possible to gather more information on the safety of the use of the medicine.

5. How to store Duexon Pro

• •The medicine should be stored in a place that is out of sight and reach of children.
• The patient should not use this medicine after the expiry date stated on the carton and label of the inhaler after: EXP. The expiry date (EXP) means the last day of the month stated.
• The patient should not store the medicine at a temperature above 30°C.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Duexon Pro contains

The active substances of the medicine are salmeterol and fluticasone propionate.
Duexon Pro (50 micrograms + 100 micrograms)/dose
Each single inhalation provides a delivered dose of 47 micrograms of salmeterol (as salmeterol xinafoate) and 92 micrograms of fluticasone propionate. This is equivalent to a metered dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 100 micrograms of fluticasone propionate.
Duexon Pro (50 micrograms + 250 micrograms)/dose
Each single inhalation provides a delivered dose of 45 micrograms of salmeterol (as salmeterol xinafoate) and 229 micrograms of fluticasone propionate. This is equivalent to a metered dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate.
Duexon Pro (50 micrograms + 500 micrograms)/dose
Each single inhalation provides a delivered dose of 43 micrograms of salmeterol (as salmeterol xinafoate) and 432 micrograms of fluticasone propionate. This is equivalent to a metered dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate.
The other ingredient is lactose monohydrate (see section 2 under "Duexon Pro contains lactose") (which contains milk proteins).

What Duexon Pro looks like and contents of the pack

• Duexon Pro contains a strip of foil with blisters filled with white or off-white powder. The foil protects the inhalation powder from the environment.
• Each dose is divided.
• The inhalation devices are white with a white mouthpiece and light pink (Duexon Pro (50 micrograms + 100 micrograms)/dose), pink (Duexon Pro (50 micrograms + 250 micrograms)/dose), or purple (Duexon Pro (50 micrograms + 500 micrograms)/dose) mouthpiece cover and are packed in cartons containing: 1 inhaler containing 60 inhalations.

Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Importer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Oy Medfiles Ltd.
Volttikatu 5
70700 Kuopio
Finland
Oy Medfiles Ltd.
Volttikatu 8
70700 Kuopio
Finland
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
STADA Arzneimittel GmbH
Muthgasse 36/2
Wien, 1190
Austria
Clonmel Healthcare Limited
Waterford Road, Clonmel
Tipperary, E91 D768
Ireland
STADA Arzneimittel AG
Stadastr. 2 - 18
61118 Bad Vilbel
Germany

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

Austria
Salmeterol/Fluticason STADA 50 micrograms/100 micrograms
single-dose powder for inhalation
Salmeterol/Fluticason STADA 50 micrograms/250 micrograms
single-dose powder for inhalation
Salmeterol/Fluticason STADA 50 micrograms/500 micrograms
single-dose powder for inhalation
France
PROPIONATE DE FLUTICASONE/SALMETEROL EG 100
micrograms/50 micrograms/dose, powder for inhalation in a single-dose container
PROPIONATE DE FLUTICASONE/SALMETEROL EG 250
micrograms/50 micrograms/dose, powder for inhalation in a single-dose container
PROPIONATE DE FLUTICASONE/SALMETEROL EG 500
micrograms/50 micrograms/dose, powder for inhalation in a single-dose container
Germany
Salmeterol/Fluticasonpropionat AL 50 micrograms/100 micrograms
single-dose powder for inhalation
Salmeterol/Fluticasonpropionat AL 50 micrograms/250 micrograms
single-dose powder for inhalation
Salmeterol/Fluticasonpropionat AL 50 micrograms/500 micrograms
single-dose powder for inhalation
Ireland
Sametec Airmaster
Italy
SALMETEROLO E FLUTICASONE EG STADA
Poland
Duexon Pro
Portugal
Inhalok Airmaster 50 micrograms/100 micrograms/dose for inhalation, in a single-dose container
Inhalok Airmaster 50 micrograms/250 micrograms/dose for inhalation, in a single-dose container
Inhalok Airmaster 50 micrograms/500 micrograms/dose for inhalation, in a single-dose container
Inhalok Airmaster 50 micrograms/250 micrograms/inhalation, powder for inhalation (single-dose)
Spain
Inhalok Airmaster 50 micrograms/500 micrograms/inhalation, powder for inhalation (single-dose)
Sweden
Sipova Airmaster
United Kingdom
Fixkoh Airmaster

Date of last revision of the leaflet: 11/2024