Duexon pro
Poland
Table of Contents
Package leaflet: Information for the patient
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
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any questions, please consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
- If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet
- What Duexon Pro is and what it is used for
- Important information before using Duexon Pro
- How to use Duexon Pro
- Possible side effects
- How to store Duexon Pro
- 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 in the treatment of adults and adolescents aged 12 years and older.
Your doctor has prescribed this medicine to prevent breathing problems occurring in:
- 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 treat 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 this 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, consult a 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, they should contact a doctor.
Children
Do not use this medicine in children under 12 years of age.
Duexon Pro and other medicines
Inform the doctor about all medicines currently used or recently used, 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 the doctor if the patient is taking any of the following medicines:
- Beta-blockers (e.g. atenolol, propranolol, and sotalol). Beta-blockers are commonly used to treat high blood pressure or other heart conditions such as angina.
- 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 from Duexon Pro, including irregular heartbeat, or may worsen existing side effects. The 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 bronchodilators (e.g. 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 does not usually 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 the 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:
Bronchial 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 during treatment with Duexon Pro twice daily,
your doctor may recommend reducing the frequency of Duexon Pro to once daily.
The dose may be administered:
- once daily in the evening, if the patient experiences symptoms at night,
- once daily in the morning, if the patient experiences symptoms during the day.
It is very important that the doctor instructs the patient 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 deteriorates, contact your doctor immediately.
There may be an increase in wheezing, more frequent episodes of chest tightness, or you may need a higher dose of a fast-acting inhaled medicine to ease breathing. In any of these situations, continue using Duexon Pro, but do not increase the number of inhalations. Symptoms of the disease 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 previously used by the patient, so it is very important to use it correctly. Your doctor, nurse, or pharmacist should train you in the proper use of the inhaler. This training is essential to ensure that you receive the required dose. If you have not received this training, ask your doctor, nurse, or pharmacist to demonstrate how to use the inhaler correctly, 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 indicating how many doses of medicine remain in the inhaler. The counter displays the number of doses down to 0. Numbers from 5 to 0 appear in red to warn that only a few doses of medicine remain in the inhaler. When the counter shows 0, the inhaler is empty.
Using the inhaler
- To open the inhaler, hold it in one hand parallel to the floor. Press the red button with your thumb and, using 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 and you hear a "click" (see Fig. 1 and Fig. 2). After performing this action, 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 intend to take the medicine, as the next blister will open and medicine will be lost.
- Hold the inhaler at a distance from your mouth and breathe out calmly and deeply. Do not breathe out into the inhaler.
- 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 is comfortable without causing 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.
-
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 restored to its original position. The inhaler is now ready for use at the next scheduled dose.
-
After inhaling the medicine, rinse your mouth with water, 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 are 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.
If you miss 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 sometimes lead to adverse effects.
These adverse effects may include any of the following:
- abdominal pain,
- fatigue and loss of appetite, nausea,
- vomiting and diarrhea,
- weight loss,
- headache and drowsiness,
- low blood sugar levels,
- 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 effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
To reduce the risk of adverse effects, your doctor will prescribe 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, stop using
Duexon Pro immediately and contact your doctor without delay. Allergic reactions to Duexon Pro
occur uncommonly (may occur in fewer than 1 in 100 people).
Lung infection (pneumonia) in patients with chronic obstructive pulmonary disease (COPD)
(common adverse effect)
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 effects:
Very common adverse effects (may occur in more than 1 in 10 people)
- Headache – this adverse effect usually decreases during continued treatment.
- Increased incidence of colds has been reported in patients with chronic obstructive pulmonary disease (COPD).
Common adverse effects (may occur in fewer than 1 in 10 people)
- Oral or pharyngeal 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 be helpful. Your doctor may prescribe an antifungal medicine to treat candidiasis.
- Joint pain, joint swelling, and muscle pain.
- Muscle cramps.
The following adverse effects have been reported in patients with chronic obstructive
pulmonary disease (COPD):
- Increased tendency to 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 effects (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 fast heartbeat (tachycardia).
- Tremor and fast or irregular heartbeat (palpitations) – these symptoms are usually not serious and tend to decrease during continued treatment.
- Chest pain.
- Restlessness (this effect occurs mainly in children).
- Sleep disturbances.
- Allergic skin rash.
Rare adverse effects (may occur in fewer than 1 in 1000 people)
- Breathing difficulties or worsening wheezing occurring immediately after taking Duexon Pro. If such symptoms occur, stop using Duexon Pro, use a fast-acting inhaled medicine to relieve breathing, and contact your doctor 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 may include:
- slowed growth in children and adolescents,
- decreased bone mass,
- glaucoma,
- increased body weight,
- rounded (moon-shaped) face (Cushing's syndrome). Your doctor will regularly check for such adverse effects and ensure that you are using the lowest effective dose of this medicine to control asthma.
- Behavioural changes such as excessive excitability and irritability (these effects 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 effects with unknown frequency (frequency cannot be estimated from available data)
- Depression or aggression (these effects are more likely in children).
- Blurred vision.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the 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 following: EXP. The expiry date (EXP) refers to the last day of the specified 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 in use. This helps 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 (metered dose leaving the mouthpiece) of
47 micrograms of salmeterol (as salmeterol xinafoate) and 92 micrograms of fluticasone
propionate. This corresponds to a divided dose equivalent to 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 (metered dose leaving the mouthpiece) of
45 micrograms of salmeterol (as salmeterol xinafoate) and 229 micrograms of fluticasone
propionate. This corresponds to a divided dose equivalent to 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 (metered dose leaving the mouthpiece) of
43 micrograms of salmeterol (as salmeterol xinafoate) and 432 micrograms of fluticasone
propionate. This corresponds to a divided dose equivalent to 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 inhalation powder from atmospheric conditions.
- Each dose is individually divided.
- The inhalers are white in colour 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 cover, and are packed in cardboard packaging 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 for sale 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