Duexon

Leaflet accompanying the packaging: patient information

Duexon, (25 micrograms + 50 micrograms)/metered dose, inhalation aerosol, suspension,

suspension

Duexon, (25 micrograms + 125 micrograms)/metered dose, inhalation aerosol, suspension

Duexon, (25 micrograms + 250 micrograms)/metered dose, inhalation aerosol, suspension

Salmeterol + Fluticasone propionate

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Duexon and what is it used for

Duexon contains two active substances, salmeterol (as salmeterol xinafoate) and fluticasone propionate:
Salmeterol is a long-acting bronchodilator. Bronchodilators help maintain the patency of the airways. This facilitates the flow of air to and from the lungs. The effect lasts for at least 12 hours.
Fluticasone propionate is a corticosteroid that reduces swelling and irritation of the lungs.
The doctor has prescribed this medicine to the patient to prevent breathing disorders that occur in asthma.
To ensure proper control of asthma, Duexon must be used every day, as recommended by the doctor.

Duexon prevents the occurrence of shortness of breath and wheezing in the airways. However, Duexon 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

have such a medicine with them.

2. Important information before using Duexon

When not to use Duexon:

• if the patient is allergic (hypersensitive) to salmeterol, fluticasone propionate or norflurane (HFA 134a), an excipient of the medicine.

Warnings and precautions

Before starting to use Duexon, the patient should discuss it with their doctor. The doctor will closely monitor the treatment in case of such conditions as:
heart disease, including irregular or rapid heartbeat,
hyperthyroidism,
high blood pressure,
diabetes (Duexon may increase blood glucose levels),
low potassium levels in the blood,
tuberculosis currently being treated or having been treated, or other lung infections.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Duexon and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those used for asthma and those available without a prescription. This is important because Duexon should not be used with some other medicines.
Before starting to use Duexon, the patient should inform their doctor about taking the following medicines:
Beta-blockers (e.g. atenolol, propranolol and sotalol). Beta-blockers are most often used to treat high blood pressure or other heart diseases.
Medicines used to treat infections (e.g. ketoconazole, itraconazole and erythromycin), including some medicines used to treat HIV (e.g. ritonavir, cobicistat-containing medicines).
Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of side effects, including irregular heartbeat or worsening of 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.
Diuretics used to treat high blood pressure.
Other bronchodilators (such as salbutamol).
Medicines containing xanthine derivatives, 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 or pharmacist before using this medicine. The doctor will assess whether the patient can take Duexon during this period.

Driving and using machines

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

3. How to use Duexon

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Duexon must be used every day, until the doctor recommends otherwise. The patient should not take a higher dose than recommended. In case of doubts, they should consult their doctor or pharmacist.
The patient should not stop using Duexon or reduce the dose without consulting their doctor.
Duexon should be inhaled into the lungs through the mouth.

Adults and adolescents aged 12 and over

Duexon (25 micrograms + 50 micrograms)/metered dose - 2 inhalations twice a day
Duexon (25 micrograms + 125 micrograms)/metered dose - 2 inhalations twice a day
Duexon (25 micrograms + 250 micrograms)/metered dose - 2 inhalations twice a day

Children aged 4 to 12

Duexon (25 micrograms + 50 micrograms)/metered dose - 2 inhalations twice a day
Duexon is not recommended for use in children under 4 years of age.
Using Duexon twice a day may help control asthma symptoms. Then, the doctor may recommend reducing the frequency of using Duexon to once a day. The dose may be changed and may 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 them.
If the patient uses Duexon for asthma, the doctor will regularly check the symptoms of the disease.

In case of worsening asthma symptoms or loss of control over asthma, the patient should

contact their doctor immediately.There may be an increase in wheezing, more frequent chest tightness, or a need for a higher dose of a fast-acting inhalation medicine. In such a situation, the patient should continue using Duexon, but 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 using the inhaler:

The doctor, nurse or pharmacist should instruct the patient on how to use the inhaler properly. They should periodically check if the patient is using the inhaler correctly. Not using Duexon as directed by the doctor or not using the inhaler correctly may cause the medicine to not produce the expected improvement in asthma.
The medicine is in a pressurized aluminum container in a plastic casing with a mouthpiece.

Checking the inhaler:

• 1. Before first use, check if the inhaler is working. Remove the cap from the mouthpiece by gently pressing the sides of the cap with your thumb and index finger.
• 2. To make sure the inhaler is working, shake the container vigorously, move the mouthpiece away from you and press the container to release two doses of the medicine into the air. If the inhaler has not been used for a week or longer, release two doses of the medicine into the air.

How to use the inhaler:

It is essential that patients start breathing as slowly as possible before using the inhaler.

• 1. The inhaler should be used standing or sitting.
• 2. Remove the mouthpiece cap (as described in step 1 of the inhaler check instructions). Check the mouthpiece outside and inside to ensure it is clean and free of foreign objects.

• 3. Shake the inhaler 4 or 5 times to ensure that any foreign objects are removed and the contents of the inhaler are well mixed.
• 4. Hold the inhaler upright with your thumb on the base of the inhaler below the mouthpiece. Take a deep breath out, as much as possible without discomfort.
• 5. Put the mouthpiece in your mouth between your teeth. Close your lips around the mouthpiece. Do not bite the mouthpiece.
• 6. Take a slow and deep breath in through your mouth. Immediately after starting to breathe in, press the inhaler to release the medicine. Continue to breathe in slowly and deeply.
• 7. Hold your breath and remove the inhaler from your mouth, and remove your finger from the base of the inhaler. Hold your breath for a few seconds or as long as is comfortable, then breathe out slowly.
• 8. To take another inhalation, wait about half a minute before repeating the steps described in points 3-7.
• 9. After inhalation, rinse your mouth with water and spit it out and/or brush your teeth. This may help prevent fungal infections of the mouth and throat, as well as hoarseness.
• 10. Always immediately after inhalation, replace the cap on the mouthpiece in the correct position to prevent dust from entering. The cap should click into place. If it does not click, turn the cap and try to replace it again. Do not use excessive force.

Do not rush through the steps described in points 4, 5, 6 and 7. It is very important that patients start breathing as slowly as possible before using the inhaler. Initially, inhalations should be performed standing in front of a mirror. If a "mist" is observed coming out of the inhaler or from the corners of the mouth during inhalation, repeat the steps, starting from step 3.
As with other inhalers, caregivers should ensure that children prescribed Duexon use the inhaler correctly, as described above. If the patient or child has difficulty using the inhaler, the doctor or other healthcare professional may recommend using the inhaler with a spacer, such as the AeroChamber Plus. The doctor, nurse or pharmacist or other healthcare professional should demonstrate how to use the spacer and how to care for it, and answer any questions the patient may have. If the patient uses the inhaler with a spacer, it is essential not to stop using it without consulting the doctor or nurse. It is also essential not to change the type of spacer used without consulting the doctor. If the patient stops using the spacer or changes its type, the doctor may decide to change the dose of the medicine needed to control the symptoms of asthma. Before making any changes to the treatment of asthma, the patient should consult their doctor.

Cleaning the inhaler

To prevent the inhaler from becoming blocked, it is essential to clean it at least once a week.
To clean the inhaler:
Remove the cap from the mouthpiece.
Never remove the metal container from the plastic casing.
Wipe the mouthpiece inside and outside and the plastic casing outside with a dry cloth or tissue.
Replace the cap on the mouthpiece. The cap should click into place. If it does not click, turn the cap and try to replace it again. Do not use excessive force.
Do not immerse the metal container in water.

Using a higher dose of Duexon than recommended

It is essential to use the inhaler as directed. If a higher dose than recommended is used accidentally, the patient should tell their doctor or pharmacist. There may be an increased heart rate, tremors, dizziness, headache, weakness, and joint pain.
If higher doses are used for a long time, the patient should consult their doctor or pharmacist. High doses of Duexon may cause a decrease in the production of steroid hormones by the adrenal glands.

Missing a dose of Duexon

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

Stopping the use of Duexon

It is essential to take Duexon every day, as directed by the doctor. The patient should take the medicine until the doctor recommends stopping it.The patient should not suddenly stop taking Duexon or reduce the dose. This may cause more difficulty breathing.
Additionally, sudden stopping of Duexon or reducing the dose 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 or drowsiness,
low blood sugar,
low blood pressure and seizures.
If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist. To prevent these side effects, the doctor may prescribe additional corticosteroids in tablet form (e.g. prednisolone).
In case of any further doubts about the use of this medicine, the patient should consult their doctor, nurse or pharmacist.

4. Possible side effects

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

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

using Duexon.There may be an increase in wheezing, coughing or shortness of breath. There may also be itching, rash (hives) and swelling (usually of the face, lips, tongue or throat), as well as a feeling of a very rapid heartbeat or fainting and dizziness (which can lead to falls or loss of consciousness). If the patient experiences any of these symptoms soon after using Duexon, they should stop using Duexon and contact their doctor immediately.Allergic reactions to Duexon are uncommon (they may occur less often than in 1 in 100 people).
Other side effects:

Very common side effects (occurring in more than 1 in 10 people):

Headache - this side effect usually decreases over time while continuing treatment.
Increased frequency of colds has been reported in patients with chronic obstructive pulmonary disease (COPD).

Common side effects (occurring in less than 1 in 10 people):

Thrush (painful, creamy-white patches) in the mouth and throat. Also, tongue pain, hoarseness and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing teeth after each inhalation may be helpful. The doctor may prescribe an antifungal medicine to treat thrush.
Pains, joint swelling and muscle pains.
Muscle spasms.
The following side effects have been reported in patients with chronic obstructive pulmonary disease (COPD):
Pneumonia and bronchitis (lung infection). The patient should tell their doctor if they experience any of the following symptoms: increased production of sputum, change in sputum color, fever, chills, worsening cough, increased difficulty breathing.
Easier bruising and fractures.
Sinusitis (feeling of tension and fullness in the nose, cheeks and eyes, sometimes with a throbbing headache).
Decreased potassium levels in the blood (the patient may experience irregular heartbeat, muscle weakness, cramps).

Uncommon side effects (occurring in less than 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 rapid heartbeat (tachycardia).
Feeling of trembling and rapid or irregular heartbeat (palpitations) - these symptoms usually are not serious and decrease over time while continuing treatment.
Atrial fibrillation.
Coronary heart disease, the symptoms of which are: chest pain and feeling of pressure in the chest, shortness of breath.
Anxiety.
Sleep disturbances.
Allergic skin rash.

Rare side effects (occurring in less than 1 in 1000 people):

Wheezing or breathing difficulties worsening immediately after taking Duexon. If such symptoms occur, the patient should

stop using Duexon.They should use a fast-acting inhalation medicine and contact their doctor immediately.
Duexon may disrupt the normal production of steroid hormones by the body, especially when taking high doses for a long time. These symptoms include:
slowed growth in children and adolescents,
decreased bone density,
glaucoma,
weight gain,
rounding (moon-shaped face) of the face (Cushing's syndrome).
The doctor will regularly check if the patient is experiencing such side effects and ensure that the patient is taking the smallest dose of Duexon that will control asthma.
Changes in behavior, such as excessive excitement and irritability (these symptoms occur mainly in children).
Irregular heartbeat or extra beats (arrhythmias). The patient should inform their doctor about this, but should not stop using Duexon unless the 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. The occurrence of these side effects is more likely in children.
Blurred vision.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Duexon

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container and on the carton after: EXP. The expiry date refers to the last day of the month stated.
Store below 25°C.
Always replace the cap on the mouthpiece after use in the correct position. Do not use excessive force.
The container contains a pressurized liquid. Do not expose the container to temperatures above 50°C, protect from sunlight. Do not pierce or burn the container, even if it is empty.
As with most inhalers in pressurized containers, the effectiveness of the medicine may be reduced if the inhaler is cold.
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 pack and other information

What Duexon contains

• The active substances of Duexon are salmeterol (as salmeterol xinafoate) and fluticasone propionate.
• Each metered dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 50, 125 or 250 micrograms of fluticasone propionate.
• The other ingredient of the medicine is the propellant: norflurane (HFA-134a).
• This medicine contains fluorinated greenhouse gases. Each inhaler contains 11.2 g HFA-134a (norflurane) which corresponds to 0.0160 tons of CO2 equivalent (GWP = 1430).

What Duexon looks like and contents of the pack

Duexon is an inhalation aerosol, delivering the medicine in the form of a suspension under pressure to the lungs during inhalation through the mouth.
The pressurized container contains a white or almost white suspension intended for inhalation.
Packaging: Aluminum container with a metering valve, mouthpiece with PP and closure with PP, all in a cardboard box.
Pack size: 1 inhaler containing 120 doses.

Marketing authorization holder:

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

Manufacturer:

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
GENETIC S.p.A.
Contrada Canfora
84084 Fisciano (SA)
Italy

Date of last revision of the leaflet: