Duexon pro

Package leaflet: Information for the user

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
Salmeterolum + Fluticasoni propionas
Please read this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. See section 4.

Table of contents

1. What Duexon Pro is and what it is 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 pack and other information

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

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

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

Duexon Pro is used to treat adults and adolescents aged 12 years and older.
Your doctor has prescribed this medicine to prevent breathing problems associated with:

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

To ensure proper control of asthma or COPD, Duexon Pro must be used every day as directed by your doctor.
Duexon Pro prevents shortness of breath and wheezing. However, it should not be used to relieve sudden attacks of breathlessness or wheezing.
If such an attack occurs, a fast-acting bronchodilator, such as salbutamol, must be used immediately. The patient should always have such a medicine available.

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 treatment with Duexon Pro, discuss with your doctor, pharmacist, or
nurse if the patient has:

• heart disease, including irregular or rapid heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes (Duexon Pro may increase blood glucose levels),
• low blood potassium levels,
• active or previously treated tuberculosis or other lung infections.

If the patient experiences blurred vision or other visual disturbances, contact a
doctor.
Children
Do not use this medicine in children under 12 years of age.
Duexon Pro and other medicines
Inform your doctor about all medicines currently used or recently taken, as well as any medicines the patient plans to take. Duexon Pro should not be used with certain medicines.
Before starting treatment with Duexon Pro, inform your doctor if the patient is taking the following medicines:

• Medicines from the beta-blocker group (e.g. atenolol, propranolol, and sotalol). Beta-blockers are commonly used to treat high blood pressure or other heart conditions such as angina pectoris.
• Medicines used to treat infections (e.g. ketoconazole, itraconazole, and erythromycin), including certain medicines used to treat HIV (e.g. ritonavir, drugs containing cobicistat). Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of adverse effects of Duexon Pro, including irregular heartbeat, or may worsen existing adverse effects. Your doctor may wish to closely monitor the patient taking such medicines.
• Corticosteroids (taken orally or by injection). If the patient has recently taken such medicines, this may increase the risk of adrenal suppression caused by Duexon Pro.
• Diuretics used to treat high blood pressure.
• Other bronchodilator medicines (such as salbutamol).
• Medicines containing xanthine derivatives, such as aminophylline and theophylline, commonly used in the treatment of asthma.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor before using this medicine.
Driving and operating machinery
It is unlikely that Duexon Pro will affect the ability to drive or operate machinery.
Duexon Pro contains lactose
Each delivered dose of Duexon Pro contains 13 mg of lactose monohydrate. This amount is unlikely to cause problems in individuals 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 exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

• Duexon Pro should be used daily until your doctor advises otherwise. Do not take a higher dose than recommended. If in doubt, consult your doctor or pharmacist.
• Do not stop using Duexon Pro or reduce the dose without consulting your doctor.
• Duexon Pro should be inhaled into the lungs through the mouth.

Recommended dose:
Asthma
Adults and adolescents aged 12 years and older

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

Adults with chronic obstructive pulmonary disease (COPD)

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

If asthma symptoms are well controlled while using Duexon Pro twice daily, your doctor may recommend reducing the frequency of Duexon Pro to once daily. The dose may be taken:

• once daily in the evening, if symptoms occur at night,
• once daily in the morning, if symptoms occur during the day.

It is very important that your doctor instructs you on how many inhalations to take and how often.

If you are using Duexon Pro for asthma, your doctor will regularly monitor your symptoms.
If asthma symptoms worsen or breathing becomes more difficult, contact your doctor immediately.
You may experience increased wheezing, more frequent chest tightness, or may need to use a higher dose of a fast-acting inhaled medicine to relieve breathing. In any of these situations, continue using Duexon Pro, but do not increase the number of inhalations. Symptoms may worsen and your condition may deteriorate. Contact your doctor, as you may require additional treatment.

Instructions for use

• Duexon Pro may differ from inhalers you have used before, so it is very important to use it correctly. Your doctor, nurse, or pharmacist should train you in how to use the inhaler. This training is essential to ensure you receive the required dose. If you have not received this training, ask your doctor, nurse, or pharmacist to show you how to use the inhaler properly, especially before first use. They should also periodically check that you are using the inhaler correctly. Using Duexon Pro incorrectly may result in the medicine not providing the expected improvement in asthma or COPD.
• The inhaler contains blisters with salmeterol and fluticasone propionate in powder form.
• The inhaler is equipped with a dose counter that shows how many doses remain in the inhaler. The counter displays the dose number down to 0. Numbers from 5 to 0 appear in red to warn that only a few doses remain in the inhaler. When the counter shows 0, the inhaler is empty.

Using the inhaler

1. To open the inhaler, hold it in one hand parallel to the floor. Press the red button with your thumb (see Fig. 1) and with the other hand, slide the light pink (Duexon Pro (50 micrograms + 100 micrograms)/dose), pink (Duexon Pro (50 micrograms + 250 micrograms)/dose), or light violet (Duexon Pro (50 micrograms + 500 micrograms)/dose) mouthpiece cover away from you until it stops, until you hear a "click" (see Fig. 2). After this, a small opening in the mouthpiece becomes visible and a dose of medicine is placed in the mouthpiece.

Fig. 1 Fig. 2
Note: Each time the mouthpiece cover is opened with a "click," a blister inside opens and the next dose of powder is ready for inhalation. Therefore, do not open the mouthpiece cover unless you need to take a dose, as the next blister will open and medicine will be lost.

2. Hold the inhaler at a distance from your mouth and breathe out calmly and deeply. Do not breathe out into the inhaler.
3. Place the mouthpiece in your mouth (see Fig. 3). Breathe in deeply from the inhaler through your mouth, not through your nose. Remove the inhaler from your mouth. Hold your breath for about 10 seconds, or as long as comfortable without discomfort. Then breathe out calmly.

Fig. 3
The inhaler delivers the medicine as a very fine powder. You may, but do not have to, feel the powder. Do not take an additional dose from the inhaler if you do not taste the medicine.

4. Close the inhaler to keep it clean by rotating the light pink (Duexon Pro (50 micrograms + 100 micrograms)/dose), pink (Duexon Pro (50 micrograms + 250 micrograms)/dose), or light violet (Duexon Pro (50 micrograms + 500 micrograms)/dose) mouthpiece cover back toward you until it stops. You will hear a "click" (see Fig. 4). The mouthpiece cover is now returned to its original position. The inhaler is now ready for the next scheduled dose.

5. After inhaling the medicine, rinse your mouth with water and spit out the water and (or) brush your teeth. This may help prevent hoarseness and oral thrush.

Fig. 4

Cleaning the inhaler
Keep the inhaler dry and clean.
If necessary, wipe the mouthpiece of the inhaler with a dry cloth or tissue.

Accidentally using more Duexon Pro than recommended
It is important to use the inhaler as instructed. If you accidentally use more than the recommended dose, inform your doctor or pharmacist. Symptoms may include faster than normal heartbeat, tremors, dizziness, headache, muscle weakness, and joint pain.

If higher doses have been used for a prolonged period, contact your doctor or pharmacist for advice, as high doses of Duexon Pro may reduce the production of steroid hormones by the adrenal glands.

Missing a dose of Duexon Pro
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.

Stopping Duexon Pro treatment
It is very important to take Duexon Pro every day as prescribed. Continue taking the medicine until your doctor advises you to stop. Do not suddenly stop taking Duexon Pro or reduce the dose, as your symptoms may worsen.

Additionally, abruptly stopping or reducing the dose of Duexon Pro may (very rarely) cause adrenal gland dysfunction (adrenal insufficiency), which may lead to adverse effects.

These adverse effects may include any of the following:

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

When the body is under stress due to fever, injury (such as a car accident), infection, or surgery, adrenal insufficiency may worsen and any of the adverse effects listed above may occur.

If you experience any of these adverse effects, inform your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe additional corticosteroids in tablet form (e.g. prednisolone).

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
To reduce the risk of adverse symptoms, your doctor will recommend the lowest dose of
this medicine that provides control of asthma or COPD.
Allergic reactions: The patient may experience sudden breathing difficulties immediately after
using Duexon Pro. Worsening of wheezing, coughing or shortness of breath may occur, as well as
itching, rash (urticaria) and swelling (usually of the face, lips, tongue or throat). There may also be a
sensation of very rapid heartbeat, weakness or dizziness (which may lead to falling or loss of consciousness). If any of these symptoms occur, including sudden onset after using Duexon Pro, treatment with Duexon Pro must be stopped and medical advice must be sought immediately. Allergic reactions to Duexon Pro occur uncommonly (may occur in fewer than 1 in 100 people).
Pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD)
(common adverse reaction)
Tell your doctor if any of the following symptoms occur while using Duexon Pro – these may be signs of lung infection:

• Fever or chills.
• Increased mucus production, change in mucus colour.
• Worsening cough or increased difficulty breathing.

Other adverse reactions:
Very common adverse reactions (may occur in more than 1 in 10 people)

• Headache – this adverse reaction usually decreases with continued treatment.
• Increased incidence of colds has been reported in patients with chronic obstructive pulmonary disease (COPD).

Common adverse reactions (may occur in fewer than 1 in 10 people)

• Oral and throat candidiasis (painful, creamy-white lesions), tongue pain, hoarseness and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing teeth immediately after each inhalation may help. Your doctor may prescribe an antifungal medicine to treat candidiasis.
• Joint pain, joint swelling and muscle pain.
• Muscle cramps.

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

• Easy bruising and fractures.
• Sinusitis (feeling of pressure and fullness in the nose, cheeks and behind the eyes, sometimes with pulsating pain).
• Decreased blood potassium levels (the patient may experience irregular heartbeat, muscle weakness, cramps).

Uncommon adverse reactions (may occur in fewer than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). In patients with diabetes, more frequent monitoring of blood glucose levels and adjustment of the dose of currently used antidiabetic medicines may be necessary.
• Cataract (clouding of the eye lens).
• Very rapid heartbeat (tachycardia).
• Sensation of trembling and rapid or irregular heartbeat (palpitations) – these symptoms are usually not serious and decrease with continued treatment.
• Chest pain.
• Restlessness (this reaction occurs mainly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare adverse reactions (may occur in fewer than 1 in 1000 people)

• Breathing difficulties or worsening wheezing occurring immediately after taking Duexon Pro. If such symptoms occur, Duexon Pro must be discontinued, a fast-acting inhaled medicine to ease breathing should be used, and medical advice must be sought immediately.
• Duexon Pro may interfere with the body's normal production of steroid hormones, especially when high doses are used for a long time. These effects include:
  • slowed growth in children and adolescents,
  • reduced bone mass,
  • glaucoma,
  • increased body weight,
  • rounded (moon-shaped) face (Cushing's syndrome). Your doctor will regularly check for these adverse reactions and ensure that you are using the lowest dose of this medicine that controls asthma effectively.
• Behavioural changes such as excessive excitability and irritability (these reactions occur mainly in children).
• Irregular, uneven heartbeat or extra beats (arrhythmias). Inform your doctor, but do not stop using Duexon Pro unless instructed by your doctor.
• Fungal infection of the oesophagus, which may cause difficulty swallowing.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data)

• Depression or aggression (these reactions are more likely in children).
• Blurred vision.

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

5. How to store Duexon Pro

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and inhaler label after: EXP. The expiry date (EXP) refers to the last day of the stated month.
• Do not store above 30°C.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Duexon Pro contains
The active substances in this medicine are salmeterol and fluticasone propionate.

Duexon Pro (50 micrograms + 100 micrograms)/dose
Each single inhalation delivers a dose (dose leaving the mouthpiece) of
47 micrograms of salmeterol (as salmeterol xinafoate) and 92 micrograms of fluticasone
propionate. This corresponds to a divided 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 delivers a dose (dose leaving the mouthpiece) of
45 micrograms of salmeterol (as salmeterol xinafoate) and 229 micrograms of fluticasone
propionate. This corresponds to a divided 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 delivers a dose (dose leaving the mouthpiece) of
43 micrograms of salmeterol (as salmeterol xinafoate) and 432 micrograms of fluticasone
propionate. This corresponds to a divided 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 foil strip with blisters filled with white or off-white powder. The foil protects the inhaled powder from atmospheric conditions.
• Each dose is individually divided.
• The inhalation devices are white with a white mouthpiece and a light pink (Duexon Pro (50 micrograms + 100 micrograms)/dose), pink (Duexon Pro (50 micrograms + 250 micrograms)/dose), or violet (Duexon Pro (50 micrograms + 500 micrograms)/dose) mouthpiece cap, and are packed in cardboard packages containing: 1 inhaler with 60 inhalations.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Importer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland
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 authorised in the European Economic Area under the following names:

Austria: Salmeterol/Fluticason STADA 50 Mikrogramm /100 Mikrogramm einzeldosiertes Pulver zur Inhalation
Salmeterol/Fluticason STADA 50 Mikrogramm /250 Mikrogramm einzeldosiertes Pulver zur Inhalation
Salmeterol/Fluticason STADA 50 Mikrogramm /500 Mikrogramm einzeldosiertes Pulver zur Inhalation

France: PROPIONATE DE FLUTICASONE/SALMETEROL EG 100 microgrammes/50 microgrammes/dose, poudre pour inhalation en récipient unidose
PROPIONATE DE FLUTICASONE/SALMETEROL EG 250 microgrammes/50 microgrammes/dose, poudre pour inhalation en récipient unidose
PROPIONATE DE FLUTICASONE/SALMETEROL EG 500 microgrammes/50 microgrammes/dose, poudre pour inhalation en récipient unidose

Germany: Salmeterol/Fluticasonpropionat AL 50 Mikrogramm/100 Mikrogramm einzeldosiertes Pulver zur Inhalation
Salmeterol/Fluticasonpropionat AL 50 Mikrogramm/250 Mikrogramm einzeldosiertes Pulver zur Inhalation
Salmeterol/Fluticasonpropionat AL 50 Mikrogramm/500 Mikrogramm einzeldosiertes Pulver zur Inhalation

Ireland: Sametec Airmaster

Italy: SALMETEROLO E FLUTICASONE EG STADA

Poland: Duexon Pro

Portugal: Inhalok Airmaster 50 microgramas/100 microgramas/dose pó para inalação, em recipiente unidose
Inhalok Airmaster 50 microgramas/250 microgramas/dose pó para inalação, em recipiente unidose
Inhalok Airmaster 50 microgramas/500 microgramas/dose pó para inalação, em recipiente unidose

Spain: Inhalok Airmaster 50 microgramos/250 microgramos/inhalación, polvo para inhalación (unidosis)
Inhalok Airmaster 50 microgramos/500 microgramos/inhalación, polvo para inhalación (unidosis)

Sweden: Sipova Airmaster

United Kingdom: Fixkoh Airmaster