Flusamix Easyhaler 50 micrograms/500 micrograms/inhalation powder for inhalation: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Flusamix Easyhaler 50 micrograms/500 micrograms/inhalation, powder for inhalation

Salmeterol/fluticasone propionate

Read the entire leaflet carefully before you start 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 questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

What Flusamix Easyhaler is and what it is used for
What you need to know before using Flusamix Easyhaler
How to use Flusamix Easyhaler
Possible adverse effects
How to store Flusamix Easyhaler
Contents of the pack and other information

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

Flusamix Easyhaler contains two active substances, salmeterol and fluticasone propionate:

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

Your doctor has prescribed this medicine to help prevent breathing problems such as:

asthma.
chronic obstructive pulmonary disease (COPD). Flusamix Easyhaler, at a dose of 50/500 micrograms, reduces the number of exacerbations of COPD symptoms.

You must use Flusamix Easyhaler every day as prescribed by your doctor. This will ensure that the medication works properly to control your asthma or COPD.

Flusamix Easyhaler helps prevent shortness of breath and wheezing. However, Flusamix Easyhaler should not be used to relieve a sudden attack of breathlessness or wheezing. In such cases, you must use your fast-acting (‘rescue’) medication, such as salbutamol. You should always carry your fast-acting rescue medication with you.

2. What you need to know before using Flusamix Easyhaler

Do not take Flusamix Easyhaler:

If you are allergic to salmeterol, fluticasone propionate, or any of the other ingredients, lactose monohydrate (which contains small amounts of milk proteins).

Warnings and precautions

Talk to your doctor before starting to use Flusamix Easyhaler if you have:

heart problems, including rapid or irregular heartbeat.
overactive thyroid.
high blood pressure.
diabetes mellitus (Flusamix Easyhaler may increase blood sugar levels).
low potassium levels in the blood.
tuberculosis (TB) currently or in the past, or other lung infections.

Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and Flusamix Easyhaler

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines for asthma or any medicines obtained without a prescription. The reason is that in some cases, Flusamix Easyhaler should not be taken together with certain other medicines.

Tell your doctor if you are taking any of the following medicines before starting to use Flusamix Easyhaler:

β-blockers (such as atenolol, propranolol, and sotalol). β-blockers are mostly used to treat high blood pressure or other heart conditions.
medicines to treat infections (such as ketoconazole, itraconazole, and erythromycin, and some medicines for HIV: ritonavir and cobicistat). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This may increase your risk of experiencing adverse effects with Flusamix Easyhaler, including irregular heartbeats, or may worsen side effects. Your doctor may want to monitor you closely if you are taking these medicines.
corticosteroids (oral or injectable). If you have recently taken these medicines, it may increase the risk of this medicine affecting your adrenal gland.
diuretics, also known as water tablets, used to treat high blood pressure.
other bronchodilators (such as salbutamol).
medicines containing xanthines. 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Flusamix Easyhaler is unlikely to affect your ability to drive or use machinery.

Flusamix Easyhaler contains lactose

Flusamix Easyhaler contains up to 17.1 milligrams of lactose per dose. It may cause allergic reactions in patients allergic to cow's milk protein. If your doctor has told you that you have an intolerance to certain sugars, consult with him before using this medicine.

3. How to use Flusamix Easyhaler

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use Flusamix Easyhaler every day until your doctor tells you to stop. Do not take more than the recommended dose.
Do not stop using Flusamix Easyhaler or reduce your dose without first speaking to your doctor.
Flusamix Easyhaler must be inhaled through the mouth into the lungs.

For asthma

Adults and adolescents aged 12 years and older

One inhalation of Flusamix Easyhaler 50/500 twice daily.

Children under 12 years of age

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

For adults with Chronic Obstructive Pulmonary Disease (COPD)

One inhalation of Flusamix Easyhaler 50/500 twice daily.

If you are using Flusamix Easyhaler to treat asthma, your doctor will want to monitor your symptoms regularly.

Your doctor will help manage your asthma and adjust your medication dose to the lowest level that controls your asthma. If your doctor believes you require a lower dose than those available with Flusamix Easyhaler, they will prescribe an inhaler containing the same active substances as Flusamix Easyhaler but with a lower corticosteroid dose.

It is very important that you follow your doctor's instructions on how many inhalations and how often you should take your medication.

If your asthma worsens or you have increasing difficulty breathing, see your doctor immediately.

You may notice more wheezing or breathlessness, or find you need to use your fast-acting rescue medication more frequently. If any of these occur, continue using Flusamix Easyhaler, but do not increase the number of inhalations. Your respiratory condition may worsen and you could become seriously ill. See your doctor, as you may need additional treatment.

If you use more Flusamix Easyhaler than you should

It is very important to use the inhaler exactly as directed. If you have accidentally taken a higher dose than recommended, consult your doctor or pharmacist. You may notice your heart beating faster than normal, feel tremors, dizziness, headache, muscle weakness, or joint pain.

If you have used large doses over long periods of time, seek advice from your doctor or pharmacist. This is because high levels of Flusamix Easyhaler may reduce the amount of steroid hormones produced by the adrenal gland.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount administered.

If you forget to use Flusamix Easyhaler

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

If you stop treatment with Flusamix Easyhaler

It is very important that you use Flusamix Easyhaler every day as directed. Continue taking it until your doctor tells you to stop. Do not interrupt or abruptly reduce your treatment with Flusamix Easyhaler. Doing so could worsen your breathing.

Additionally, if you suddenly stop using Flusamix Easyhaler or reduce your dose, you could (very rarely) develop problems with your adrenal gland (adrenal insufficiency), which may sometimes cause adverse effects.

These adverse effects may include any of the following:

stomach pain
tiredness and loss of appetite, feeling unwell
nausea and diarrhea
weight loss
headache or drowsiness
low blood sugar levels
hypotension and seizures (fits)

When your body is under stress conditions such as fever, trauma (e.g., traffic accident), infection, or surgery, adrenal insufficiency may worsen, and you could experience any of the adverse effects listed above.

If you experience any adverse effects, consult your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe an additional dose of oral corticosteroids during that time (such as prednisolone).

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

How to use Flusamix Easyhaler

Instructions on how to use the inhaler are located at the end of this leaflet. For complete information, read the instructions “How to use your Easyhaler inhaler” included after section 6 of this leaflet.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them. To reduce the occurrence of adverse effects, your doctor will prescribe the lowest dose of Flusamix Easyhaler that controls your asthma or Chronic Obstructive Pulmonary Disease (COPD).

Allergic reactions: you may notice that your breathing suddenly worsens immediately after using Flusamix Easyhaler. You may experience wheezing, coughing, or shortness of breath. You may also notice itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat). You may also suddenly feel your heart beating very fast, feel faint, or dizzy (which may lead to collapse or loss of consciousness). If you experience any of these effects, or if they occur suddenly after using Flusamix Easyhaler, stop using Flusamix Easyhaler and contact your doctor immediately. Allergic reactions to Flusamix Easyhaler are uncommon (affecting fewer than 1 in 100 people).

Pneumonia (lung infection) in patients with COPD is a common adverse effect.

Inform your doctor if you experience any of the following effects while using Flusamix Easyhaler, as they may be symptoms of a lung infection:

Fever or cold-like symptoms
Increased mucus production or change in mucus color
Worsening cough or increased difficulty breathing

The following are other adverse effects listed below:

Very common (may affect more than 1 in 10 people):

Headache – usually improves with continued treatment
An increased number of colds has been reported in patients with Chronic Obstructive Pulmonary Disease (COPD).

Common (may affect fewer than 1 in 10 people):

Oral and throat candidiasis (itching, yellow-cream-colored sores), also tongue pain, hoarseness, and throat irritation. Rinsing your mouth with water and spitting it out immediately after each dose of medication may help. For treatment of candidiasis, your doctor may prescribe antifungal medication.
Joint pain, joint swelling, and muscle pain.
Muscle cramps.

The following adverse effects have been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):

Bruising and fractures.
Sinus inflammation (feeling of pressure or congestion in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
Decreased blood potassium levels (you may feel irregular heartbeat, muscle weakness, cramps).

Uncommon (may affect fewer than 1 in 100 people):

Increased blood sugar (glucose) levels (hyperglycemia). If you have diabetes, your blood sugar levels will need to be monitored more frequently, and your usual diabetes treatment may need to be adjusted if necessary.
Cataracts (clouding of the eye's lens)
Very fast heart rate (tachycardia)
Tremors and a fast or irregular heartbeat (palpitations). These adverse effects are usually harmless and tend to decrease with continued treatment.
Chest pain
Feeling of anxiety (occurs mainly in children)
Sleep disorders
Allergic skin rash

Rare (may affect fewer than 1 in 1,000 people):

Worsening breathing difficulty (or wheezing) immediately after using Flusamix Easyhaler. If this occurs, stop using Flusamix Easyhaler. Use your fast-acting "rescue" inhaler to improve your breathing and contact your doctor immediately.
Flusamix Easyhaler may increase the normal production of steroid hormones, particularly if you have been taking high doses for long periods. Effects include:
Delayed growth in children and adolescents.
Decreased bone mineral density.
Glaucoma.
Weight gain.
Rounded face (moon face) (Cushing's syndrome).

Your doctor will regularly monitor for any of these adverse effects and ensure you are taking the lowest effective dose of Flusamix Easyhaler to control your asthma.

Behavioral changes such as hyperactivity and irritability (these effects occur mainly in children).
Irregular heartbeat or extra heartbeats (arrhythmias). Consult your doctor, but do not stop taking Flusamix Easyhaler unless your doctor tells you to.
Fungal infection in the esophagus (throat), which may cause difficulty swallowing.

Frequency not known (cannot be estimated from available data):

Depression or aggression. These effects are more likely to occur in children.
Blurred vision.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Flusamix Easyhaler

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, aluminium pouch, and label of your inhaler after EXP. The expiry date refers to the last day of the month indicated.
Replace your Flusamix Easyhaler 2 months after opening the aluminium pouch. Write down the date it was opened to help you remember.
After opening the aluminium pouch, do not store at temperatures above 25°C and protect from moisture. You may use a protective cover with your Easyhaler.
If your Flusamix Easyhaler inhaler gets wet, it must be replaced with a new one.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Flusamix Easyhaler

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

Appearance of the product and contents of the pack

Flusamix Easyhaler is an inhaler containing your medicine. The inhalation powder is white in colour. Each inhaler contains 60 doses and consists of a white body and a violet top.

Flusamix Easyhaler is available in packs of 1, 2 or 3 inhaler(s).

Only some pack sizes may be marketed.

Your pack may include a protective cover. If you require a protective cover, please contact the Marketing Authorisation Holder (see details below).

Marketing Authorisation Holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Orion Pharma S.L.
Avda. Alberto Alcocer 46B, 28016 Madrid, Tel.: 91 599 86 01

Date of the most recent review of this leaflet: July 2025.

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

You can access detailed and up-to-date information on how to administer this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/info/83644.

QR Code

How to use the Easyhaler inhaler

About your Easyhaler inhaler

Flusamix Easyhaler may differ from other inhalers you have used before. Therefore, it is very important that you use it correctly; otherwise, you might not receive the proper dose of medicine. This could make you feel unwell or could result in your asthma or COPD not being adequately treated.

Your doctor, nurse or pharmacist will show you how to use your inhaler correctly. Make sure you understand how to use the inhaler properly. If you are unsure, please contact your doctor, nurse or pharmacist again. As with all inhalers, caregivers must ensure that children prescribed Flusamix Easyhaler use the correct inhalation technique, as described below. You may also use the instructional video available at https://cima.aemps.es/info/83644.

First use of the Easyhaler

The Easyhaler inhaler comes in an aluminum pouch. Only remove it from the pouch when you are ready to start using it, as the pouch keeps the powder inside the inhaler dry.

When you are ready to start treatment, open the pouch and record the date of opening, for example, in your diary.

Use the inhaler for 2 months from the date the pouch was opened.

Medical inhaler with white body, purple top, white mouthpiece labeled as Mouthpiece and blue cap labeled as Cap

HOW TO USE CORRECTLY

Step 1: SHAKE

Remove the cap
Shake the inhaler 3 to 5 times while holding it in an upright position

SHAKE x 3 – 5

A hand lifting upwards towards the

Important points to remember

It is important to keep the inhaler in an upright position
If you accidentally activate the inhaler while shaking, empty the powder from the mouthpiece as shown later

Step 2: ACTUATE

Hold the inhaler upright between your index finger and thumb.
Press down until you hear a “click,” then release it to return to its initial position. This releases the dose of medication.
Press only once

ACTUATE x 1

A hand holding a white medical device and gripping the purple top, pressing downward with the index finger as indicated by the arrow

Important points to remember

The inhaler will not actuate if the cap is still in place.
It should be actuated only once.
If you accidentally actuate it more than once, empty the powder from the mouthpiece as shown later.
Actuate to release the dose before inhaling, not at the same time.

Keep the inhaler upright while actuating and while inhaling the dose. If tilted, the powder may fall out and you will not be able to inhale it.

Step 3: INHALING

Keep the inhaler in an upright position
Breathe normally
Place the mouthpiece in your mouth between your teeth and close your lips firmly around the mouthpiece
Breathe in deeply and forcefully
Remove the inhaler from your mouth and hold your breath for at least 5 seconds. Then breathe normally.

INHALING

Illustration of a human profile using a purple pen-shaped medical device near the mouth for

Important points to remember

Make sure the mouthpiece is fully placed inside your mouth so the medication can reach your lungs
Ensure your lips are tightly sealed around the mouthpiece
Do not exhale into the inhaler. This is important as it could block the inhaler. If you do exhale into the inhaler, empty the powder from the mouthpiece (see below)

After using the inhaler

Replace the cap on the mouthpiece. This will prevent the inhaler from being accidentally activated.
After inhaling, rinse your mouth with water and then spit it out. This will help prevent the development of candidiasis and hoarseness.

How to empty the powder from the mouthpiece

If you have accidentally actuated the inhaler, if you have actuated it more than once, or if you have exhaled into the inhaler, empty the mouthpiece.

Gently tap the mouthpiece on a flat surface or on the palm of your hand.
Start again with the Shake-Actuate-Inhale steps

A hand pressing a white and purple medical device against a flat wooden surface with a purple arrow pointing downward

Cleaning the Easyhaler inhaler

Keep your inhaler dry and clean. If necessary, clean the mouthpiece with a dry cloth. Do not use water: the powder inside the Easyhaler inhaler is sensitive to moisture.

Using the Easyhaler with a protective cover

You may use a protective cover with your Easyhaler. This may enhance the product's durability. The first time you place the inhaler into the protective cover, make sure the cap covers the mouthpiece of the inhaler, as this will prevent accidental activation of the inhaler. You can use the inhaler without removing it from the protective cover.

Follow the instructions given above: 1. Shake - 2. Activate - 3. Inhale.

Remember to:

Keep the inhaler in an upright position when activating it
Replace the cap after taking the dose to prevent accidental activation of the inhaler.

A hand holding a white medical device with a transparent cap and a purple section for the

When to start using a new inhaler

The dose counter shows the number of doses remaining. The dose counter moves with every 5 actuations. When the dose counter starts turning red, 20 doses remain.

If you do not yet have a new Easyhaler inhaler, contact your doctor for a new prescription. When the indicator reaches 0 (zero), you will need to replace the inhaler.

If you use a protective cover, keep it and insert the new inhaler.

White medical device with purple top and a circular magnified view showing a dose counter with black numbers on a white and red background

Remember

1. Shake – 2. Actuate – 3. Inhale
After inhaling, rinse your mouth with water and spit it out
Avoid wetting the inhaler and protect it from moisture

If you have any further questions about this medicine, ask your doctor or pharmacist.