SALFLUMIX 50 mcg/500 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 medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Salflumix Easyhaler contains lactose monohydrate
3. How to use Salflumix Easyhaler
   1. Asthma
   2. Adults and adolescents 12 years and older
   3. Children under 12 years
   4. Adults with chronic obstructive pulmonary disease (COPD)
   5. If your asthma symptoms or breathing difficulties worsen, you should immediately inform your doctor.
   6. Using a higher dose of Salflumix Easyhaler than recommended
   7. Missing a dose of Salflumix Easyhaler
   8. Stopping use of Salflumix Easyhaler
   9. Instructions for using the inhaler are at the end of the leaflet.
4. Possible side effects
   1. Allergic reactions: you 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 medicine should be kept out of the 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. If you have any further questions about using this medicine, you should consult your doctor or pharmacist.

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

Salflumix Easyhaler is a combination medicine that contains two active substances: salmeterol and fluticasone propionate:

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

Your doctor may prescribe this medicine to prevent breathing problems in:

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

Salflumix Easyhaler should be used daily as directed by your doctor. This will ensure that the medicine works properly to control your asthma or COPD symptoms. Salflumix Easyhaler prevents shortness of breath and wheezing. However, Salflumix Easyhaler should not be used to relieve sudden attacks of shortness of breath or wheezing. In such cases, you should use a fast-acting inhaler to relieve symptoms, such as salbutamol. You should always carry a fast-acting inhaler with you.

2. Important information before using Salflumix Easyhaler

When not to use Salflumix Easyhaler:

Warnings and precautions

Before starting to use Salflumix Easyhaler, you should discuss with your doctor if you 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.

You should tell your doctor if you experience blurred vision or other vision disturbances.

Salflumix Easyhaler and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking, or have recently taken, and about any medicines you plan to take, including other medicines for asthma and medicines available without a prescription. Salflumix Easyhaler may not be suitable for use with some other medicines. Before starting to use Salflumix Easyhaler, you should tell your doctor if you 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.
• medicines used to treat infections (such as ketoconazole, itraconazole, and erythromycin, as well as some medicines used to treat HIV infection: ritonavir, cobicistat). Some of these medicines 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. Your doctor may want to closely monitor your condition while taking such medicines.
• corticosteroids (given orally or by injection). If you have recently taken such medicines, it may increase the risk of Salflumix Easyhaler affecting your adrenal glands.
• diuretics used to treat high blood pressure
• other bronchodilators (such as salbutamol)
• medicines containing xanthine derivatives. These are often used to treat asthma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

It is unlikely that Salflumix Easyhaler will affect your ability to drive or use machines.

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 unlikely to cause any problems. The excipient - lactose contains small amounts of milk proteins, which may cause allergic reactions. If you have previously been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to use Salflumix Easyhaler

This medicine should always be used as directed by your doctor or pharmacist. If you are in doubt, you should consult your doctor or pharmacist.

• Salflumix Easyhaler should be used daily until your doctor advises you to stop. Do not take a higher dose than recommended.
• Do not stop using or reduce the dose of Salflumix Easyhaler without consulting your doctor first.
• Salflumix Easyhaler should be inhaled through the mouth into the lungs.

Asthma

Adults and adolescents 12 years and older

• 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

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

Adults with chronic obstructive pulmonary disease (COPD)

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

If your asthma symptoms are well-controlled while using Salflumix Easyhaler twice a day, your doctor may recommend reducing the frequency of use to once a day. The dose can be given:

• once a day, in the evening, if you experience symptoms at night,
• once a day, in the morning, if you experience symptoms during the day. It is very important that you follow your doctor's instructions on how many inhalations to use and how often to take the medicine.

If you are using Salflumix Easyhaler for asthma, your doctor will regularly check your symptoms.

If your asthma symptoms or breathing difficulties worsen, you should immediately inform your doctor.

You may experience worsening wheezing, more frequent chest tightness, or the need to use a higher dose of a fast-acting inhaler to relieve symptoms. In such cases, you should continue to use the medicine, but do not increase the number of inhalations. Your symptoms may worsen, and your condition may deteriorate. You should contact your doctor, as you may need additional treatment.

Using a higher dose of Salflumix Easyhaler than recommended

It is important to use the inhaler as directed. If you accidentally use a higher dose than recommended, you should tell your doctor or pharmacist. You may experience a faster than normal heartbeat and trembling. You may also experience dizziness, headache, weakness, and joint pain. If you take too high a dose of Salflumix Easyhaler for a long time, you should consult your doctor or pharmacist for advice, as taking too high a dose of Salflumix Easyhaler may affect the production of steroid hormones by your adrenal glands.

Missing a dose of Salflumix Easyhaler

Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping use of Salflumix Easyhaler

It is very important to take Salflumix Easyhaler daily as directed by your doctor. You should take the medicine until your doctor advises you to stop. Do not stop using or suddenly reduce the dose of Salflumix Easyhaler. 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 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 your body is under stress, such as due to fever, injury (such as a car accident), infection, or surgery, adrenal insufficiency may worsen, and you may experience any of the above side effects. If you experience any side effects, you should tell your doctor or pharmacist. Your doctor may prescribe additional corticosteroids in tablet form (such as prednisolone) to prevent these symptoms. If you have any further doubts about using this medicine, you should consult your doctor, pharmacist, or nurse.

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

4. Possible side effects

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

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

You may experience a very wheezy breath, cough, or shortness of breath.You 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). If you experience any of the above side effects or if they occur suddenly after using Salflumix Easyhaler, you should stop using Salflumix Easyhaler and immediately inform your 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)

You should inform your doctorif you experience any of the following symptoms while taking Salflumix Easyhaler, as they may be signs of a lung infection:

• fever or chills
• increased mucus production, change in mucus 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 your mouth with water and spitting it out after each dose may be helpful. Your doctor may prescribe an antifungal medicine to treat thrush.
• pains, swelling of joints, 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)
• low potassium levels in the blood (which can 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 in 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 cases, you should stop using the Salflumix Easyhaler inhaler. You should use a fast-acting inhaler to relieve symptoms and immediately contact your doctor.
• Salflumix Easyhaler may affect the normal production of steroid hormones in the body, especially when used in high doses for a long time. This includes the following side effects:
• slowed growth in children and adolescents
• decreased bone density
• glaucoma
• weight gain
• moon face (Cushing's syndrome) Your doctor will regularly check if you are experiencing any of these side effects and ensure that you are using the lowest dose of Salflumix Easyhaler necessary to control your asthma.
• changes in behavior, such as excessive activity and irritability (these effects occur mainly in children).
• irregular or abnormal heartbeat, or extra beats (heart rhythm disturbances). You should inform your doctor, but do not stop using Salflumix Easyhaler unless your doctor advises you to do so.
• 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 side effects is more likely in children.
• blurred vision.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Salflumix Easyhaler

The medicine should be kept out of the sight and reach of children.

• Do not use this medicine 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 (for the 50 micrograms + 250 micrograms strength) or 2 months (for the 50 micrograms + 500 micrograms strength) after opening the pouch. To remember this, you should write down the date you opened 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.
• Medicines should not be disposed of via wastewater or household waste. You should ask your 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 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 medicine. The powder for inhalation 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 a protective packaging or without protective packaging, in a carton. If you need protective packaging, you 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. For more detailed information on this medicine, you 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 on the use of this medicine is available by scanning the QR code (located on both the outer packaging and the inhaler label) using a smartphone. The same information is also 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 be different from the inhalers you have used before. Therefore, it is very important to use it correctly, as incorrect use may mean that you do not get the right amount of medicine. This may lead to your condition getting worse or your asthma or COPD not being treated properly. Your doctor, nurse, or pharmacist will show you how to use the inhaler correctly. You should make sure you understand how to use the inhaler correctly. If you are in doubt, you should consult your doctor, nurse, or pharmacist. As with all inhalers, carers should ensure that children who are prescribed Salflumix Easyhaler use the correct inhalation technique, as described below. You 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. Do not open the pouch until you are ready to start using the medicine, as it helps to keep the powder in the inhaler dry. If you are ready to start treatment, open the pouch and write down the opening date, for example in a calendar. The Salflumix Easyhaler inhaler can be used for 1 month (for the 50 micrograms + 250 micrograms strength) or 2 months (for the 50 micrograms + 500 micrograms strength) after removal from the pouch. To remember this, you should write down the opening date.

CORRECT USE OF THE INHALER

Step 2: CLICKING Holding the inhaler upright, hold it with your index finger and thumb. Press the inhaler until you hear a click, then release the pressure on the inhaler until you hear the click again. This will release a dose of medicine. You can only click once.

CLICK 1 TIME

Important information to remember The inhaler will not click if the mouthpiece cover is not removed. You can only click once. If you click more than once, you should remove the powder from the mouthpiece, see below. To release a dose of medicine, press before inhaling, but not at the same time. While pressing and inhaling the dose, keep the inhaler upright, which prevents the powder from falling out of the inhalation channel before inhaling.

you should remove the powder from the mouthpiece, see below.

After using the inhaler:

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

How to remove powder from the mouthpiece If you accidentally click the inhaler or click it multiple times, or breathe out into the inhaler, you should remove the powder 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

You should keep the inhaler 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 a protective packaging The Easyhaler inhaler can be used in a protective packaging, which may help to extend the shelf life of the product. Before placing the inhaler in the protective packaging, make sure the mouthpiece cover is covering the mouthpiece, which prevents accidental activation of the inhaler. You can use the inhaler without removing it from the protective packaging. Use as instructed above, 1. Shaking, 2. Clicking, 3. Inhalation. Remember to: Keep the inhaler upright while clicking and inhaling. Replace the mouthpiece cover after taking a dose to prevent accidental activation of the inhaler.

Changing to a new Easyhaler inhaler The inhaler has a dose counter, which shows the number of doses left. The counter turns every five activations. When the dose counter turns red, it means there are 20 doses left. If you do not have a new Easyhaler inhaler, you should contact your doctor to get a new prescription. When the dose counter shows 0, you should replace the Easyhaler inhaler. If you are using a protective packaging, you should keep it and place the new inhaler in it.

To remember

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

If you have any further questions about using this medicine, you should consult your doctor or pharmacist.