Duexon
Poland
Table of Contents
Package leaflet: Information for the patient
Duexon, (25 micrograms + 50 micrograms)/metered dose, inhalation aerosol,
suspension
Duexon, (25 micrograms + 125 micrograms)/metered dose, inhalation aerosol,
suspension
Duexon, (25 micrograms + 250 micrograms)/metered dose, inhalation aerosol,
suspension
Salmeterolum + Fluticasoni propionas
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Leaflet contents
- What Duexon is and what it is used for
- What you need to know before using Duexon
- How to use Duexon
- Possible side effects
- How to store Duexon
- Contents of the pack and other information
1. What Duexon is and what it is used for
Duexon contains two active substances, salmeterol (as salmeterol xinafoate) and fluticasone propionate:
Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways open, making it easier to breathe by improving airflow into and out of the lungs. Its effect lasts for at least 12 hours.
Fluticasone propionate is a corticosteroid that reduces swelling and irritation in the lungs.
Your doctor has prescribed this medicine to help prevent breathing problems associated with asthma.
To properly control asthma, Duexon must be used every day as directed by your doctor.
Duexon helps prevent episodes of breathlessness and wheezing. However, Duexon must not be used
to relieve sudden attacks of breathlessness or wheezing. If such an attack occurs, a fast-acting
bronchodilator, such as salbutamol, should be used immediately. You should always have this
medicine readily available.
2. Important information before using Duexon
When not to use Duexon:
- if the patient is allergic (hypersensitive) to salmeterol, fluticasone propionate, or to norflurane (HFA 134a), an excipient of the medicine.
Warnings and precautions
Before starting treatment with Duexon, discuss this with a doctor. The doctor will closely monitor treatment in case of conditions such as:
heart disease, including irregular or rapid heartbeat,
hyperthyroidism,
high blood pressure,
diabetes (Duexon 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.
Duexon and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to take, including asthma medications and over-the-counter drugs. This is important because Duexon should not be used with certain other medicines.
Before starting Duexon, inform the doctor if the patient is taking any of the following medicines:
Beta-blockers (e.g. atenolol, propranolol, sotalol). Beta-blockers are commonly used to treat high blood pressure or other heart conditions.
Medicines used to treat infections (e.g. ketoconazole, itraconazole, erythromycin), including some medicines used in HIV treatment (e.g. ritonavir, medicines containing cobicistat).
Some of these medicines may increase the concentration of fluticasone propionate or salmeterol in the body. This may increase the risk of adverse effects, including irregular heartbeat, or may worsen existing side effects. The doctor may wish to closely monitor the patient taking such medicines.
Corticosteroids (oral or injectable). If the patient has recently taken such medicines, this may increase the risk of adrenal dysfunction.
Diuretics used to treat high blood pressure.
Other bronchodilators (e.g. salbutamol).
Medicines containing xanthine derivatives, commonly used in asthma treatment.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The doctor will assess whether the patient can take Duexon during this period.
Driving and operating machinery
It is unlikely that Duexon will affect the ability to drive or operate machinery.
3. How to use Duexon
This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts,
ask your doctor or pharmacist.
Duexon must be used every day 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 or reduce the dose without first consulting your doctor.
Duexon should be inhaled into the lungs through the mouth.
Adults and adolescents aged 12 years and older
Duexon (25 micrograms + 50 micrograms)/metered dose – 2 inhalations twice daily
Duexon (25 micrograms + 125 micrograms)/metered dose – 2 inhalations twice daily
Duexon (25 micrograms + 250 micrograms)/metered dose – 2 inhalations twice daily
Children aged 4 to 12 years
Duexon (25 micrograms + 50 micrograms)/metered dose – 2 inhalations twice daily
Duexon is not recommended for use in children under 4 years of age.
Using Duexon twice daily may result in good asthma control. In such cases, your doctor may recommend reducing the frequency of Duexon to once daily. The dose may then be changed and administered:
once daily in the evening, if the patient's symptoms occur at night,
once daily in the morning, if the patient's 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 for asthma, your doctor will regularly monitor your symptoms.
If asthma symptoms worsen or asthma control deteriorates, 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 help breathing. In such a case, continue using Duexon, but do not increase the number of inhalations. Your symptoms may worsen and your condition may deteriorate. Contact your doctor, as you may require additional treatment.
Instructions for using the inhaler:
Your doctor, nurse, or pharmacist should instruct you on how to use the inhaler correctly. They should periodically check that you are using the inhaler properly. Incorrect use of Duexon or improper use of the inhaler may result in the medicine not providing the expected improvement in asthma.
The medicine is contained in a pressurized aluminum canister within a plastic housing with a mouthpiece.
Checking the inhaler:
- Before first use, check that the inhaler is working. Remove the mouthpiece cap by gently pressing the sides of the cap with your thumb and index finger.
- To ensure the inhaler is working, shake the canister vigorously, point the mouthpiece away from you, and press the canister to release two doses into the air. If the inhaler has not been used for one week or longer, release two doses into the air before use.
How to use the inhaler:
It is important that patients begin breathing as slowly as possible before using the inhaler.
- Use the inhaler while standing or sitting.
- Remove the mouthpiece cap (as described in point 1 of the inhaler check instructions). Check the mouthpiece inside and outside to ensure it is clean and free of foreign objects.
- Shake the inhaler 4 or 5 times to ensure any foreign particles are removed and the contents are evenly mixed.
- Hold the inhaler upright, with your thumb on the base of the inhaler below the mouthpiece. Breathe out deeply as far as is comfortable.
- Place the mouthpiece in your mouth between your teeth. Seal your lips around the mouthpiece. Do not bite the mouthpiece.
- Begin a slow and deep inhalation through your mouth. As soon as you start inhaling, press down on the inhaler to release the medicine. Continue inhaling slowly and deeply.
- Hold your breath and, during this time, 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 without causing discomfort, then breathe out slowly.
- To perform a second inhalation, wait about half a minute and repeat steps 3–7.
- After inhalation, rinse your mouth with water, spit out the water, and (or) brush your teeth. This may help prevent oral and throat fungal infections (thrush) and hoarseness.
- Always replace the mouthpiece cap immediately after inhalation to prevent dust from entering. The cap should snap into place with a click. If you do not hear a click, rotate the cap and try again. Do not use excessive force.
Do not rush steps 4, 5, 6, and 7. It is very important that patients begin breathing as slowly as possible just before using the inhaler. Initially, practice inhalations while standing in front of a mirror. If you see a "mist" escaping from the inhaler or from the corners of your 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 according to the above instructions. If a patient or child has difficulty using the inhaler, the doctor or healthcare professional may recommend using the inhaler with a spacer device, such as AeroChamber Plus. Your doctor, nurse, pharmacist, or other healthcare professional should demonstrate how to use and care for the spacer device and answer any questions. If you use the inhaler with a spacer device, it is important not to stop using it without consulting your doctor or nurse. It is also important not to change the type of spacer device used without consulting your doctor. If you stop using a spacer device or change to a different type, your doctor may decide to adjust your dose to maintain asthma control. Always consult your doctor before making any changes to your asthma treatment.
Cleaning the inhaler
To prevent blockage, it is important to clean the inhaler at least once a week.
To clean the inhaler:
Remove the mouthpiece cap.
Never remove the metal canister from the plastic housing.
Wipe the mouthpiece and the outside of the plastic housing with a dry cloth or tissue.
Replace the mouthpiece cap. The cap should snap into place with a click. If you do not hear a click, rotate the cap and try again. Do not use excessive force.
Do not immerse the metal canister in water.
Accidental overdose of Duexon
It is important to use the inhaler exactly 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, consult your doctor or pharmacist. High doses of Duexon may reduce the production of steroid hormones by the adrenal glands.
Missed dose of Duexon
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.
Stopping Duexon treatment
It is important to take Duexon every day as directed by your doctor. Continue taking the medicine until your doctor advises you to stop. Do not suddenly stop taking Duexon or reduce the dose, as this may cause increased difficulty in breathing.
Additionally, abruptly stopping or reducing the dose of Duexon may (very rarely) lead to adrenal gland dysfunction (adrenal insufficiency), which may cause the following adverse effects:
abdominal pain,
fatigue and loss of appetite, nausea,
vomiting and diarrhea,
weight loss,
headache or 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 adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe additional corticosteroid tablets (e.g., prednisolone).
If you have any further questions about the use of this medicine, consult your doctor, nurse, or pharmacist.
4. Possible adverse reactions
Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
To reduce the risk of adverse effects, your doctor will recommend the lowest dose of
Duexon that provides asthma control.
Allergic reactions: The patient may experience sudden breathing difficulties immediately after
using Duexon. Wheezing, cough, or shortness of breath may worsen.
Itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or
throat) may also occur, as well as a sensation of very rapid heartbeat or fainting and dizziness (which may
lead to falls or loss of consciousness). If any of these symptoms occur suddenly after using Duexon,
stop using Duexon immediately
and contact your doctor immediately. Allergic reactions to Duexon are uncommon (may occur in fewer than 1 in 100 people).
Other adverse reactions:
Very common adverse reactions (occur in more than 1 in 10 people):
Headache – this adverse reaction usually decreases over time with continued treatment.
Increased frequency of colds has been reported in patients with chronic obstructive pulmonary disease (COPD).
Common adverse reactions (occur in fewer than 1 in 10 people):
Oral thrush (painful, creamy-white lesions) in the mouth and throat. Also, tongue pain, hoarseness, loss of voice, 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 oral thrush.
Joint pain, swelling, and muscle pain.
Muscle cramps.
The following adverse reactions have been reported in patients with chronic obstructive pulmonary disease (COPD):
Pneumonia and bronchitis (lung infection). Inform your doctor if any of the following symptoms occur: increased mucus production, change in mucus color, fever, chills, worsening cough, or increased difficulty breathing.
Easy bruising and traumatic fractures.
Sinusitis (feeling of pressure and fullness in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
Decreased potassium levels in the blood (the patient may experience irregular heartbeat, muscle weakness, cramps).
Uncommon adverse reactions (occur in fewer than 1 in 100 people):
Increased blood sugar (glucose) levels (hyperglycaemia). In diabetic patients, more frequent monitoring of blood glucose levels and adjustment of previously used antidiabetic medications may be necessary.
Cataract (clouding of the eye lens).
Very rapid heartbeat (tachycardia).
Tremor and rapid or irregular heartbeat (palpitations) – these symptoms are usually not serious and decrease over time with continued treatment.
Atrial fibrillation.
Ischaemic heart disease, with symptoms such as chest pain and tightness, shortness of breath.
Anxiety.
Sleep disturbances.
Allergic skin rash.
Rare adverse reactions (occur in fewer than 1 in 1000 people):
Wheezing or breathing difficulties worsening immediately after taking Duexon.
If such symptoms occur, stop using Duexon immediately. Use a fast-acting inhaled medicine to relieve breathing
and contact your doctor immediately.
Duexon may interfere with the body's normal production of steroid hormones, especially when high doses are used for a prolonged period. These effects include:
slowed growth in children and adolescents,
decreased bone mass,
glaucoma,
increased body weight,
facial rounding (moon-shaped face) (Cushing's syndrome).
Your doctor will regularly check for these adverse effects and ensure that you are using the lowest dose of Duexon that controls asthma.
Behavioural changes such as excessive excitability and irritability (these effects occur mainly in children).
Irregular heartbeat or extra beats (arrhythmias). Inform your doctor, but do not stop using Duexon 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 effects are more likely in children.
Blurred vision.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.
5. How to store the medicine Duexon
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container and on the
carton: EXP. The expiry date refers to the last day of the stated month.
Store below 25°C.
After each inhalation, always immediately replace the mouthpiece cap in the correct position. Do not use excessive force.
The container holds pressurised 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 inhaled medicines in pressurised containers, the effectiveness of the medicine may be reduced if the inhaler is cold.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What Duexon contains
- The active substances in this medicine are salmeterol (in the form of 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 this medicine is the propellant gas: norflurane (HFA-134a).
- This medicine contains fluorinated greenhouse gases. Each inhaler contains 11.2 g of HFA-134a (norflurane), equivalent to 0.0160 tonnes of CO2 (global warming potential GWP = 1430).
What Duexon looks like and contents of the pack
Duexon is an inhalation aerosol delivering the medicine as a suspension under pressure to the lungs during oral inhalation.
The pressurised container holds a white or almost white suspension for inhalation.
Packaging: An aluminium container with a metering valve, mouthpiece made of polypropylene (PP) and PP closure cap, all contained in a cardboard box.
Pack size: 1 inhaler with 120 doses.
Marketing Authorisation 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