SALFLUMIX 50 mcg/250 mcg Powder

Contents of the leaflet

1. What is Salflumix Easyhaler and what is it used for
2. Important information before using Salflumix Easyhaler
   1. When not to use Salflumix Easyhaler:
   2. Warnings and precautions
   3. Salflumix Easyhaler and other medications
   4. Pregnancy and breastfeeding
   5. Driving and operating machinery
   6. Salflumix Easyhaler contains lactose monohydrate
3. How to use Salflumix Easyhaler
   1. Asthma
   2. Adults and adolescents over 12 years of age
   3. Children under 12 years of age
   4. Adults with chronic obstructive pulmonary disease (COPD)
   5. If the symptoms of asthma or breathing difficulties worsen, the patient should immediately inform their doctor.
   6. Using a higher dose of Salflumix Easyhaler than recommended
   7. Missing a dose of Salflumix Easyhaler
   8. Stopping the use of Salflumix Easyhaler
   9. Instructions for using the inhaler are at the end of the leaflet.
4. Possible side effects
   1. Allergic reactions: the patient may experience sudden breathing difficulties immediately after using Salflumix Easyhaler.
   2. Pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD) (Common side effects)
   3. Reporting side effects
5. How to store Salflumix Easyhaler
   1. The medication should be stored out of sight and reach of children.
6. Contents of the packaging and other information
   1. What Salflumix Easyhaler contains
   2. What Salflumix Easyhaler looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer:
   5. Date of last revision of the leaflet: 07.2025
   6. How to use the Easyhaler inhaler
   7. Information about the Easyhaler inhaler
   8. Using the Easyhaler inhaler for the first time
   9. CORRECT USE OF THE INHALER
   10. After using the inhaler:
   11. Cleaning the Easyhaler inhaler
   12. To remember
   13. In case of any further questions about using this medication, the patient should consult their doctor or pharmacist.

1. What is Salflumix Easyhaler and what is it used for

Salflumix Easyhaler is a combination medication containing two active substances: salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help maintain the patency of the airways. This facilitates the flow of inhaled and exhaled air. The effect of the medication lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation of the lungs.

The doctor may prescribe this medication to prevent breathing disorders that occur in:

• asthma
• chronic obstructive pulmonary disease (COPD). Salflumix Easyhaler in a dose of 50 micrograms + 500 micrograms reduces the number of exacerbations of the disease.

Salflumix Easyhaler should be used daily as recommended by the doctor. This will ensure the proper functioning of the medication to control the symptoms of asthma or COPD.
Salflumix Easyhaler prevents the occurrence of shortness of breath and wheezing.
However, Salflumix Easyhaler should not be used to control sudden attacks of shortness of breath or wheezing. In such a situation, a fast-acting inhalation medication should be used to relieve symptoms, such as salbutamol. A fast-acting inhalation medication should always be carried with you.

2. Important information before using Salflumix Easyhaler

When not to use Salflumix Easyhaler:

Warnings and precautions

Before starting to use Salflumix Easyhaler, the patient should discuss with their doctor if they have:

• heart disease, including irregular or rapid heartbeat
• hyperthyroidism
• high blood pressure
• diabetes (Salflumix Easyhaler may increase blood sugar levels)
• low potassium levels in the blood
• tuberculosis, currently or in the past, or other lung infections.

The patient should inform their doctor if they experience blurred vision or other vision disturbances.

Salflumix Easyhaler and other medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, including other medications used to treat asthma and over-the-counter medications. Salflumix Easyhaler may not be suitable for use with certain other medications.
Before starting to use Salflumix Easyhaler, the patient should inform their doctor if they are taking:

• beta-blockers (such as atenolol, propranolol, and sotalol). Beta-blockers are most commonly used to treat high blood pressure or other heart diseases.
• medications used to treat infections (such as ketoconazole, itraconazole, and erythromycin, as well as some medications used to treat HIV infection: ritonavir, cobicistat). Some of these medications may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the effect of Salflumix Easyhaler and increase the risk of side effects, including irregular heartbeat. The doctor may want to closely monitor the patient's condition while taking such medications.
• corticosteroids (taken orally or by injection). If the patient has recently taken such medications, it may increase the risk of Salflumix Easyhaler affecting the adrenal glands.
• diuretics used to treat high blood pressure
• other bronchodilators (such as salbutamol)
• medications containing xanthine derivatives. These are 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 medication.

Driving and operating machinery

It is unlikely that Salflumix Easyhaler will affect the ability to drive and operate machinery.

Salflumix Easyhaler contains lactose monohydrate

Salflumix Easyhaler contains approximately 17.1 mg of lactose monohydrate as an excipient.
In people with lactose intolerance, this amount of lactose is not usually a problem.
The excipient - lactose contains small amounts of milk protein, which can cause allergic reactions. If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the medication.

3. How to use Salflumix Easyhaler

This medication should always be used as recommended by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

• Salflumix Easyhaler should be used daily until the doctor recommends stopping the treatment. The patient should not take a higher dose than recommended.
• The patient should not stop using Salflumix Easyhaler or reduce the dose without consulting their doctor first.
• Salflumix Easyhaler should be inhaled through the mouth into the lungs.

Asthma

Adults and adolescents over 12 years of age

• Salflumix Easyhaler, 50 micrograms + 250 micrograms - one inhalation twice a day.
• Salflumix Easyhaler, 50 micrograms + 500 micrograms - one inhalation twice a day.

Children under 12 years of age

• Salflumix Easyhaler is not recommended for use in children under 12 years of age.

Adults with chronic obstructive pulmonary disease (COPD)

• Salflumix Easyhaler, 50 micrograms + 500 micrograms - one inhalation twice a day.

If the symptoms of asthma are well-controlled while using Salflumix Easyhaler twice a day, the doctor may recommend reducing the frequency of use to once a day. The dose can 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 for the patient to follow the doctor's instructions on how many inhalations to use and how often to take the medication.

If the patient is using Salflumix Easyhaler for asthma, the doctor will regularly check the patient's symptoms.

If the symptoms of asthma or breathing difficulties worsen, the patient should immediately inform their doctor.

There may be an increase in wheezing, more frequent occurrence of chest tightness, or the need to use a higher dose of a fast-acting inhalation medication to relieve symptoms. In such a situation, the patient should continue to use the medication, 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.

Using a higher dose of Salflumix Easyhaler than recommended

It is essential to use the inhaler as instructed. If a higher dose than recommended is used by mistake, the patient should inform their doctor or pharmacist. The patient may experience a faster than usual heartbeat and trembling. They may also experience dizziness, headache, muscle weakness, and joint pain.
If the patient has been taking too high doses of Salflumix Easyhaler for an extended period, they should consult their doctor or pharmacist for advice, as taking too high doses of Salflumix Easyhaler may lead to a decrease in the production of steroid hormones by the adrenal glands.

Missing a dose of Salflumix Easyhaler

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

Stopping the use of Salflumix Easyhaler

It is crucial to take Salflumix Easyhaler daily, as recommended by the doctor. The medication should be taken until the doctor recommends stopping the treatment. The patient should not stop using Salflumix Easyhaler or suddenly reduce the dose. This may lead to worsening breathing problems.
Additionally, suddenly stopping or reducing the dose of Salflumix Easyhaler may (very rarely) cause adrenal gland problems (adrenal insufficiency), which can sometimes lead to side effects.
These side effects 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 due to 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, they should inform their doctor or pharmacist. The doctor may prescribe additional corticosteroids in the form of tablets (e.g., prednisolone) to prevent these symptoms.
In case of any further doubts about using this medication, the patient should consult their doctor, pharmacist, or nurse.

Instructions for using the inhaler are at the end of the leaflet.

4. Possible side effects

Like all medications, Salflumix Easyhaler can cause side effects, although not everybody gets them.
To minimize the risk of side effects, the doctor will prescribe the smallest dose of Salflumix Easyhaler that controls asthma or COPD.

Allergic reactions: the patient may experience sudden breathing difficulties immediately after using Salflumix Easyhaler.

The patient may experience a very wheezy breath, cough, or shortness of breath. They may also experience itching, rash (hives), and swelling (usually of the face, lips, tongue, and throat) or a very rapid heartbeat or fainting and dizziness (which can lead to loss of consciousness or fainting). If any of the above side effects occur or appear suddenly after using Salflumix Easyhaler, the patient should stop using Salflumix Easyhaler and immediately inform their doctor.Allergic reactions to Salflumix Easyhaler are uncommon (they may occur less often than in 1 in 100 people).

Pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD) (Common side effects)

The patient should inform their doctorif they experience any of the following symptoms while using Salflumix Easyhaler, as they may be symptoms of a lung infection:

• fever or chills
• increased production of sputum, change in sputum color
• increased cough or difficulty breathing.

Other side effects are listed below:
Very common ( may occur more often than in 1 in 10 people):

• headache - its severity usually decreases with continued treatment
• in patients with chronic obstructive pulmonary disease (COPD), an increased frequency of colds has been reported.

Common ( may occur less often than in 1 in 10 people):

• thrush (painful, creamy-white, raised patches) in the mouth and throat. Also, tongue pain, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out after each dose may be helpful. The doctor may prescribe an antifungal medication to treat thrush.
• pains, joint swelling, and muscle pain
• muscle spasms.

In patients with chronic obstructive pulmonary disease (COPD), the following common side effects have also been reported:

• bruising and fractures
• sinusitis (feeling of tension or fullness in the nose, cheeks, and behind the eyes, sometimes with a throbbing pain)
• decreased potassium levels in the blood (may cause irregular heartbeat, muscle weakness, and spasms).

Uncommon ( may occur less often than in 1 in 100 people):

• increased blood sugar (glucose) levels (hyperglycemia). In diabetic patients, it may be necessary to monitor blood glucose levels more frequently and adjust the current antidiabetic treatment.
• 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 their severity decreases with continued treatment
• chest pain
• feeling of restlessness (this effect occurs mainly in children)
• sleep disturbances
• allergic skin rash.

Rare ( may occur less often than in 1 in 1,000 people):

• breathing difficulties or wheezing that worsen immediately after using Salflumix Easyhaler.In such a situation, the patient should stop using the Salflumix Easyhaler inhaler. They should use a fast-acting inhalation medication to relieve symptoms and immediately contact their doctor.
• Salflumix Easyhaler may disrupt the normal production of steroid hormones in the body, especially when using high doses for a long time. This includes the following effects:
• slowed growth in children and adolescents
• decreased bone mass
• glaucoma
• weight gain
• rounded (moon-shaped) face (Cushing's syndrome) The doctor will regularly check if the patient is experiencing any of these side effects and ensure that the patient is using the smallest dose of Salflumix Easyhaler necessary to control the symptoms of asthma.
• changes in behavior, such as excessive activity and irritability (these effects occur mainly in children).
• irregular or abnormal heartbeat, or extra beats (arrhythmias). The patient should inform their doctor, but not stop using Salflumix Easyhaler unless the doctor recommends stopping the treatment.
• fungal infection of the esophagus, which can cause difficulty swallowing.

Unknown ( frequency cannot be estimated from the available data):

• depression or aggression. The occurrence of these 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 inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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.
Reporting side effects will help to gather more information on the safety of the medication.

5. How to store Salflumix Easyhaler

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

• Do not use this medication after the expiry date stated on the carton, pouch, and inhaler label after "EXP". The expiry date refers to the last day of the month stated.
• The Salflumix Easyhaler inhaler should be replaced after 1 month (in the case of 50 micrograms + 250 micrograms) or 2 months (in the case of 50 micrograms + 500 micrograms) after opening the pouch. To remember this, the patient should write down the date of opening the pouch.
• After opening the pouch, do not store above 25°C. Protect from moisture. The Easyhaler inhaler can be used in its protective packaging.
• If the Salflumix Easyhaler inhaler gets damp, it should be replaced with a new one.
• Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Salflumix Easyhaler contains

• Each dose contains salmeterol xinafoate, equivalent to 50 micrograms of salmeterol and 250 or 500 micrograms of fluticasone propionate.
• The other ingredient is lactose monohydrate (which contains milk proteins).

What Salflumix Easyhaler looks like and contents of the pack

Salflumix Easyhaler is an inhaler filled with medication. The inhalation powder is white. Each inhaler contains 60 doses and has a white body with a purple upper part.
Salflumix Easyhaler is available in a pack containing 1 inhaler of 60 doses, in protective packaging or without protective packaging, in a carton. If the patient needs protective packaging, they should contact the marketing authorization holder (details below).

Marketing authorization holder:

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer:

Orion Corporation, Orion Pharma
Orionintie 1
02200 Espoo
Finland
To obtain more detailed information about this medication, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

Date of last revision of the leaflet: 07.2025

Detailed and up-to-date information about the use of this medication is available by scanning the QR code (located on both the outer packaging and the inhaler label) using a smartphone. The same information is available on the website: www.oeh.fi/sfpl
QR code for the website www.oeh.fi/sfpl

How to use the Easyhaler inhaler

Information about the Easyhaler inhaler

The Salflumix Easyhaler inhaler may differ from the inhalers the patient has used in the past. Therefore, it is essential to use it correctly, as incorrect use may result in the patient not receiving the correct amount of medication. This may lead to worsening of the patient's condition or inadequate treatment of asthma or COPD.
The doctor, nurse, or pharmacist will show the patient how to use the inhaler correctly. The patient should make sure they understand how to use the inhaler correctly. In case of doubts, the patient should consult their doctor, nurse, or pharmacist. As with all inhalers, caregivers should ensure that children prescribed Salflumix Easyhaler use the correct inhalation technique, as described below. The patient can also watch a video tutorial at: www.oeh.fi/sfpl

Using the Easyhaler inhaler for the first time

The Easyhaler inhaler is supplied in a laminated pouch. The pouch should not be opened until the patient is ready to start using the medication, as it helps to keep the powder in the inhaler dry. If the patient is ready to start treatment, they should open the pouch and write down the opening date, for example, in a calendar. The Salflumix Easyhaler inhaler can be used for 1 month (in the case of 50 micrograms + 250 micrograms) or 2 months (in the case of 50 micrograms + 500 micrograms) after removal from the pouch. To remember this, the patient should write down the date of opening the pouch.

CORRECT USE OF THE INHALER

Step 2: CLICKING Holding the inhaler upright, hold it with the index finger and thumb. Press the inhaler until a click is heard, and then release the pressure on the inhaler until a click is heard again. This will release a dose of the medication. The inhaler can only be clicked once.

CLICK 1 TIME

Important information to remember The inhaler will not click if the mouthpiece cover is not removed. The inhaler can only be clicked once. If the inhaler is clicked more than once, the powder should be removed from the mouthpiece, as described below. To release a dose of the medication, press the inhaler before inhaling, but not at the same time. While pressing and inhaling the dose, hold the inhaler upright, which will prevent the powder from falling out of the inhalation channel before inhaling.

Step 3: INHALATION Holding the inhaler upright. Breathe normally. Place the mouthpiece in the mouth between the teeth and close the lips tightly around the mouthpiece. Take a strong and deep breath. Remove the inhaler from the mouth, hold the breath for at least 5 seconds, and then breathe normally.

INHALATION

Important information to remember It is essential to ensure that the entire mouthpiece is in the mouth, which allows the correct delivery of the medication to the lungs. It is essential to ensure that the lips are tightly closed around the mouthpiece.

Do not exhale into the inhaler. This is important: it may block the inhaler. If the patient exhales into the inhaler, they should remove the powder from the mouthpiece, as described below.

After using the inhaler:

• Replace the mouthpiece cover to prevent accidental activation of the inhaler.
• After taking a dose, rinse the mouth with water and spit it out. This will help prevent thrush and hoarseness.

How to remove powder from the mouthpiece In case of accidental clicking of the inhaler or multiple clicking of the inhaler, or exhaling into the inhaler, the powder should be removed from the mouthpiece: Tap the mouthpiece on a table or hand to remove the powder. Then, start again from the "Shaking-Clicking-Inhalation" steps.

Cleaning the Easyhaler inhaler

The inhaler should be kept dry and clean. If necessary, the mouthpiece of the inhaler can be cleaned with a dry cloth or tissue. Do not use water. The powder in the Easyhaler inhaler is sensitive to moisture.

Using the Easyhaler inhaler in protective packaging The Easyhaler inhaler can be used in protective packaging, which may help to increase the product's shelf life. Before placing the inhaler in the protective packaging, ensure that the mouthpiece cover is covering the mouthpiece, which will prevent accidental activation of the inhaler. The inhaler can be used without removing it from the protective packaging. Use as described above, 1. Shaking, 2. Clicking, 3. Inhalation. Remember to: Hold the inhaler upright while clicking and inhaling. Replace the mouthpiece cover after taking a dose to prevent accidental activation of the inhaler.

Switching to a new Easyhaler inhaler The inhaler has a dose counter that shows the number of doses left. The counter turns every five activations. When the dose counter turns red, it means that there are 20 doses left. If the patient does not have a new Easyhaler inhaler, they should contact their doctor to obtain a new prescription. When the dose counter shows 0, the patient should replace the Easyhaler inhaler. If the patient is using protective packaging, they should keep it and place the new inhaler in it.

To remember

• 1. Shaking, 2. Clicking, 3. Inhalation.
• After taking a dose, rinse the mouth with water and spit it out.
• Do not allow the inhaler to get damp, and protect it from moisture .

In case of any further questions about using this medication, the patient should consult their doctor or pharmacist.