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

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.
• If you have any doubts, you should 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 side effects 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 packaging 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 to 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 the 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 asthma medicines and medicines that are 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-adrenolytics (e.g., atenolol, propranolol, and sotalol). Beta-adrenolytics 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 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.
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 recommended 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, the patient 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 cause asthma symptoms to be well-controlled. 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 asthma control, 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 properly use the inhaler. They should periodically check that the patient is using the inhaler correctly. Not using Duexon as recommended 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, the patient should check that the inhaler is working. The patient should remove the cap from the mouthpiece by gently pressing the sides of the cap with their thumb and index finger.
• 2. To make sure the inhaler is working, the patient should shake the container vigorously, move the mouthpiece away from them, 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, the patient should release two doses of the medicine into the air.

How to use the inhaler:

It is essential that the patient starts to breathe in as slowly as possible before using the inhaler.

• 1. The patient should use the inhaler standing or sitting.
• 2. The patient should remove the mouthpiece cap (as described in step 1 of the inhaler check instructions). The patient should check the mouthpiece outside and inside to make sure it is clean and free of foreign objects.

• 3. The patient should shake the inhaler 4 or 5 times to make sure that any foreign objects are removed and that the contents of the inhaler are well mixed.
• 4. The patient should hold the inhaler upright, with their thumb on the base of the inhaler below the mouthpiece. The patient should breathe out slowly and gently as much as they can without feeling uncomfortable.
• 5. The patient should put the mouthpiece in their mouth between their teeth. The patient should close their lips around the mouthpiece. The patient should not bite the mouthpiece.
• 6. The patient should breathe in slowly and deeply through their mouth. As soon as they start to breathe in, they should press the inhaler to release the medicine. At the same time, the patient should continue to breathe in slowly and deeply.
• 7. The patient should hold their breath and remove the inhaler from their mouth, and take their finger off the base of the inhaler. The patient should hold their breath for a few seconds or as long as they feel comfortable, then breathe out slowly.
• 8. To take another inhalation, the patient should wait about half a minute before repeating the steps described in points 3-7.
• 9. After inhalation, the patient should rinse their mouth with water and spit it out and/or brush their teeth. This may help prevent fungal infections of the mouth and throat, as well as hoarseness.
• 10. The patient should always put the cap back on the mouthpiece after use, in the correct position, to prevent dust from entering. The cap should click into place. If it does not click, the patient should turn the cap and try again. The patient should not use excessive force.

The patient should not rush through the steps described in points 4, 5, 6, and 7. It is very important that the patient starts to breathe in as slowly as possible before using the inhaler. Initially, the patient should use the inhaler in front of a mirror. If a "mist" is seen coming out of the inhaler or from the corners of the mouth during inhalation, the patient should repeat the steps, starting from point 3.
As with other inhalers, caregivers should ensure that children who have been prescribed Duexon use the inhaler correctly, according to the above description. If the patient or child has difficulty using the inhaler, the doctor or another healthcare professional may recommend using the inhaler with a spacer, such as the AeroChamber Plus. The doctor, nurse, or pharmacist, or another 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 that they do not stop using it without consulting their doctor or nurse. It is also essential that they do not change the type of spacer used without consulting their 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:
The patient should remove the cap from the mouthpiece.
The patient should never remove the metal container from the plastic casing.
The patient should clean the mouthpiece inside and outside, and the plastic casing outside, with a dry cloth or tissue.
The patient should put the cap back on the mouthpiece. The cap should click into place. If it does not click, the patient should turn the cap and try again. The patient should not use excessive force.
The patient should not immerse the metal container in water.

Using a higher dose of Duexon than recommended

It is essential to use the inhaler as instructed. If a higher dose than recommended is used accidentally, the patient should tell their doctor or pharmacist. The patient may experience a faster than normal heartbeat, tremors, dizziness, headache, weakness, and joint pain.
If the patient uses higher doses for a long time, they 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. The patient should take the next dose at the scheduled time.

Stopping the use of Duexon

It is essential to take Duexon every day, as recommended 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 greater difficulty in breathing.
Additionally, sudden stopping or reduction of Duexon 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 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 side effects, including any side effects 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).
If the patient has any further doubts about the use of this medicine, they 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 lowest dose of Duexon that will control the 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 fast heartbeat or fainting and dizziness (which can lead to falling 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 not very common (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.
There have been reports of an increased frequency of colds 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 the 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 mucus, change in the color of mucus, fever, chills, worsening cough, increased difficulty breathing.
Easier bruising and fractures.
Sinusitis (feeling of tension and fullness in the nose, cheeks, and behind the eyes, sometimes with a pulsating headache).
Decreased potassium levels in the blood (the patient may experience irregular heartbeat, muscle weakness, spasms).

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 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.
Atrial fibrillation.
Coronary heart disease, whose symptoms 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.The patient should use a fast-acting inhalation medicine and contact their doctor immediately.
Duexon may interfere with 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 (Cushing's syndrome).
The doctor will regularly check if the patient is experiencing such side effects and ensure that the patient is using the lowest dose of Duexon that will control the asthma.
Changes in behavior, such as excessive excitement and irritability (these symptoms occur mainly in children).
Irregular heartbeat or extra beats (arrhythmia). The patient should inform their doctor, 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 side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. 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,
phone: +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.

The patient should 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.
The medicine should be stored at a temperature below 25°C.
The patient should always put the cap back on the mouthpiece after use, in the correct position. The patient should not use excessive force.
The container contains a pressurized liquid. The patient should not expose the container to temperatures above 50°C, and should protect it from sunlight. The patient should 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 packaging 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 is equivalent 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 container is a pressurized aluminum container containing a white or almost white suspension 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: