Salflumix easyhaler

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Package leaflet: Information for the patient
Salflumix Easyhaler, (50 micrograms + 250 micrograms)/metered dose, powder for inhalation
Salflumix Easyhaler, (50 micrograms + 500 micrograms)/metered dose, powder for inhalation
Salmeterolum + Fluticasoni propionas
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Salflumix Easyhaler is and what it is used for
2. Important information before using Salflumix Easyhaler
3. How to use Salflumix Easyhaler
4. Possible side effects
5. How to store Salflumix Easyhaler
6. Contents of the pack and other information

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

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

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways open. This makes 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 associated with:

• Asthma
• Chronic obstructive pulmonary disease (COPD). Salflumix Easyhaler at the dose of 50 micrograms + 500 micrograms reduces the number of disease exacerbations.

Salflumix Easyhaler should be used every day as directed by your doctor. This ensures the medicine works properly to control your asthma or COPD symptoms.
Salflumix Easyhaler helps prevent symptoms such as breathlessness and wheezing.
However, Salflumix Easyhaler should not be used to relieve sudden episodes of breathlessness or wheezing. In such cases, a fast-acting inhaled medicine for immediate relief, such as salbutamol, should be used. Always carry a fast-acting inhaled medicine for immediate use.

2. Important information before using Salflumix Easyhaler

When not to use Salflumix Easyhaler:

• if the patient is allergic to salmeterol, fluticasone propionate, or to any of the excipients of the medicine, monohydrate lactose (which contains small amounts of milk protein).

Warnings and precautions
Before starting treatment with Salflumix Easyhaler, consult your doctor if the patient has:

• 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
• active or past tuberculosis, or other lung infections.

Tell your doctor if the patient experiences blurred vision or other visual disturbances.
Salflumix Easyhaler and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use, including other asthma medications and over-the-counter medicines. Salflumix Easyhaler may not be suitable for use with certain other medicines.
Before starting treatment with Salflumix Easyhaler, tell your doctor if the patient is taking the following medicines:

• beta-blockers (such as atenolol, propranolol, and sotalol). Beta-blockers are commonly used to treat high blood pressure or other heart conditions.
• medicines used to treat infections (such as ketoconazole, itraconazole, and erythromycin, and certain 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 enhance the effect of Salflumix Easyhaler and increase the risk of adverse effects, including irregular heartbeat. The doctor may wish to monitor the patient closely when these medicines are used.
• corticosteroids (given orally or by injection). If the patient has recently taken such medicines, this may increase the risk of Salflumix Easyhaler affecting the adrenal glands.
• diuretics used to treat high blood pressure
• other bronchodilators (such as salbutamol)
• medicines containing xanthine derivatives. These are 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 her doctor or pharmacist before using this medicine.
Driving and operating machinery
It is unlikely that Salflumix Easyhaler will affect the ability to drive or operate machinery.
Salflumix Easyhaler contains monohydrate lactose
Salflumix Easyhaler contains approximately 17.1 mg of monohydrate lactose as an excipient.
In individuals with lactose intolerance, this amount of lactose usually does not cause problems.
The excipient lactose contains small amounts of milk protein, which may cause allergic reactions. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to use Salflumix Easyhaler

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure,
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 first consulting your doctor.
• Salflumix Easyhaler should be inhaled through the mouth into the lungs.

Bronchial asthma
Adults and adolescents aged 12 years and older

• Salflumix Easyhaler, 50 micrograms + 250 micrograms – one inhalation twice daily.
• Salflumix Easyhaler, 50 micrograms + 500 micrograms – one inhalation twice daily.

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 daily.

If asthma symptoms are well controlled during treatment with Salflumix Easyhaler twice daily,
your doctor may recommend reducing the frequency to once daily. The dose may be administered:

• once daily in the evening, if symptoms occur at night,
• once daily in the morning, if symptoms occur during the day.

It is very important that the patient follows the doctor’s instructions regarding the number of inhalations and how often the medicine should be taken.

If you are using Salflumix Easyhaler for asthma, your doctor will regularly monitor your symptoms.
If asthma symptoms or breathing difficulties worsen, you must inform your doctor immediately.
This may include increased wheezing, more frequent chest tightness, or the need to use a higher dose of a fast-acting inhaled medicine to help breathing. In such a case, continue using the medicine, but do not increase the number of inhalations. Symptoms may worsen and your condition may deteriorate. You should contact your doctor, as you may require additional treatment.

Taking more than the recommended dose of Salflumix Easyhaler
It is important to use the inhaler exactly as instructed. If you accidentally take more than the recommended dose, inform your doctor or pharmacist. You may experience a faster than normal heartbeat and trembling. Other possible symptoms include dizziness, headache, muscle weakness, and joint pain.
If excessive doses of Salflumix Easyhaler are taken for a prolonged period, you should consult your doctor or pharmacist for advice, as long-term overuse of Salflumix Easyhaler may reduce the production of steroid hormones by the 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 Salflumix Easyhaler
It is very important to take Salflumix Easyhaler daily as directed. You should continue taking the medicine until your doctor advises you to stop. Do not stop or suddenly reduce the dose of Salflumix Easyhaler. This may lead to worsening breathing problems.
Additionally, abruptly stopping Salflumix Easyhaler or reducing the dose may (very rarely) cause adrenal gland dysfunction (adrenal insufficiency), which may lead to adverse effects.
Such adverse effects include:

• abdominal pain
• fatigue and loss of appetite, nausea
• vomiting and diarrhoea
• weight loss
• headache or drowsiness
• low blood sugar levels
• low blood pressure and seizures.

If your body is under stress, for example due to fever, injury (such as a car accident), infection, or surgery, adrenal insufficiency may worsen and any of the above adverse effects may occur.
If you experience any adverse effects, inform your doctor or pharmacist. Your doctor may prescribe additional corticosteroids in tablet form (e.g. prednisolone) to prevent these symptoms.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
Instructions for using the inhaler are provided at the end of this leaflet.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
To reduce the risk of side effects, your doctor will prescribe the lowest dose of Salflumix Easyhaler
that controls your asthma or COPD.
Allergic reactions: patients may experience sudden breathing difficulties immediately after
using Salflumix Easyhaler. A very wheezy cough, coughing or shortness of breath may occur.
Itching, rash (urticaria) and swelling (usually of the face, lips, tongue and throat) or sudden very rapid
heartbeat or faintness and dizziness (which may lead to fainting or loss of consciousness) may also occur.
If any of the above side effects occur, or if they occur suddenly after using Salflumix Easyhaler,
stop using Salflumix Easyhaler immediately and contact your doctor without delay.
Allergic reactions to Salflumix Easyhaler occur uncommonly (may occur in fewer than 1 in 100 people).
Lung infection (pneumonia) in patients with chronic obstructive pulmonary disease (COPD)
(Common side effects)
You should inform your doctor if 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 colour
• worsening cough or increased difficulty breathing.

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

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

Common ( may affect up to 1 in 10 people ):

• oral thrush (painful, creamy-white, raised lesions) in the mouth and throat. Also, tongue pain, hoarseness and throat irritation. Rinsing the mouth with water and spitting it out immediately after each dose may help. Your doctor may prescribe an antifungal medicine to treat oral thrush.
• joint pain, swelling and muscle pain
• muscle cramps.

The following common side effects have also been reported in patients with chronic obstructive
pulmonary disease (COPD):

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

Uncommon ( may affect up to 1 in 100 people ):

• increased blood sugar (glucose) levels (hyperglycaemia). In diabetic patients, more frequent blood glucose monitoring and adjustment of current antidiabetic treatment 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 severity decreases with continued treatment
• chest pain
• feeling of restlessness (this side effect occurs mainly in children)
• sleep disturbances
• allergic skin rash.

Rare ( may affect up to 1 in 1,000 people ):

• breathing difficulties or wheezing that worsen immediately after using Salflumix Easyhaler. In such a case, stop using the Salflumix Easyhaler inhaler. Use an inhaler with a fast-acting medicine to relieve symptoms and ease breathing, and contact your doctor immediately.
• Salflumix Easyhaler may interfere with the body's normal production of steroid hormones, especially when high doses are used for a long time. This includes the following effects:
• slowed growth in children and adolescents
• reduced bone mass
• glaucoma
• weight gain
• rounded (moon-shaped) face (Cushing's syndrome). Your doctor will regularly check whether you are experiencing any of these side effects and ensure that you are using the lowest dose of Salflumix Easyhaler necessary to control asthma symptoms.
• behavioural changes such as excessive activity and irritability (these effects occur mainly in children).
• irregular or uneven heartbeat, or extra beats (arrhythmias). Inform your doctor, but do not stop using Salflumix Easyhaler unless your doctor advises you to do so.
• fungal infection of the oesophagus, which may cause difficulty swallowing.

Not known ( frequency cannot be estimated from available data ):

• depression or aggression. These effects are more likely in children.
• blurred vision.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Salflumix Easyhaler

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard box, bag, and inhaler label after "EXP". The expiry date refers to the last day of the stated month.
• The Salflumix Easyhaler inhaler should be replaced 1 month (for the 50 micrograms + 250 micrograms strength) or 2 months (for the 50 micrograms + 500 micrograms strength) after opening the bag. To help remember, write down the date the bag was opened.
• After opening the bag, do not store at temperatures above 25°C. Protect from moisture. The Easyhaler inhaler may be used in its protective case.
• If the Salflumix Easyhaler inhaler becomes damp, it must be replaced with a new one.
• 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 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 a drug-filled inhaler. The inhalation powder is white. Each
inhaler contains 60 doses and has a white body with a purple top part.
Salflumix Easyhaler is available in a pack containing 1 inhaler with 60 doses,
in a protective pack or without a protective pack, in a cardboard box. If the patient
requires a protective pack, please contact the marketing authorization holder (details given below).
Marketing Authorization Holder:
Orion Corporation
Orionintie 1
02200 Espoo
Finland
Manufacturer:
Orion Corporation, Orion Pharma
Orionintie 1
02200 Espoo
Finland
For further information about this medicinal product, please contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o.o.
[email protected]
Detailed and up-to-date information on the use of this medicinal product is available by scanning the QR code (located both on the outer packaging and on the inhaler label) with 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 inhalers the patient has used previously. Therefore, it is very important to use it correctly, as incorrect use may result in the patient not receiving the proper dose of medicine. This could 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 ensure they understand how to use the inhaler properly. If in doubt, contact the doctor, nurse or pharmacist. As with all inhalers, caregivers should ensure that children prescribed Salflumix Easyhaler use the correct inhalation technique as described below. An instructional video is also available 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 medicine is ready to be used, as it helps keep the dry powder in the inhaler dry. When the patient is ready to start treatment, the pouch should be opened and the date of opening recorded, for example in a calendar. The Salflumix Easyhaler inhaler can be used for 1 month (in the strength of 50 micrograms + 250 micrograms) or for 2 months (in the strength of 50 micrograms + 500 micrograms) after removal from the laminated pouch.

PROPER USE OF THE INHALER

Step 2: CLICKING Hold the inhaler upright, gripping it with your index finger and thumb. Press down on the inhaler until you hear a click, then release the pressure until you hear a second click. This releases a dose of medication. You can only click once.	CLICK ONCE	Important information to remember The inhaler will not click if the mouthpiece cover has not been removed. You can only click once. If you click more than once, remove the powder from the mouthpiece, see below. To release the dose of medication, press before inhaling, but not at the same time. Keep the inhaler upright during pressing and inhaling the medication to prevent the powder from spilling out of the inhalation channel before you inhale.
Step 3: INHALATION Hold the inhaler upright. Breathe normally. Place the mouthpiece in your mouth between your teeth and seal your lips tightly around it. Take a strong, deep breath in. Remove the inhaler from your mouth, hold your breath for at least 5 seconds, then breathe normally.	INHALATION	Important information to remember Ensure the entire mouthpiece is inside your mouth to allow proper delivery of the medication to the lungs. Make sure your lips are tightly sealed around the mouthpiece. Do not exhale into the inhaler. This is important: it may block the inhaler. If you exhale into
		the inhaler, remove the powder from the mouthpiece, see below.

After using the inhaler:

• Replace the cap on the mouthpiece to prevent accidental activation of the inhaler.
• After inhaling the dose, rinse the mouth with water and spit out the water. This will help prevent the occurrence of oral thrush and hoarseness.

How to remove powder from the mouthpiece If the inhaler is accidentally activated, activated multiple times, or if you have exhaled into the inhaler, remove any powder from the mouthpiece: Tap the mouthpiece on a table or your hand to remove the powder. Then repeat the steps "Shake-Click-Inhale" again.

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

Use of the Easyhaler inhaler in the protective case The Easyhaler inhaler can be used within the protective case, which may help extend the product's shelf life. Before placing the inhaler into the protective case, ensure that the mouthpiece cover is closed to prevent accidental activation of the inhaler. The inhaler may be used without removing it from the protective case. Use according to the instructions above: 1. Shaking, 2. Clicking, 3. Inhalation. Remember to: Keep the inhaler upright during clicking and inhalation. Replace the mouthpiece cover after taking a dose to prevent accidental activation of the inhaler.

Switching to a new Easyhaler inhaler The inhaler is equipped with a dose counter indicating the number of doses remaining. The counter rotates every five actuations. When the dose counter turns red, this indicates that 20 doses remain. If the patient does not yet have a new Easyhaler inhaler, they should contact their doctor to obtain a new prescription. When the counter displays 0, the Easyhaler inhaler should be replaced. If the patient uses a protective case, retain it and place the new inhaler inside.

To remember

• 1. Shake, 2. Click, 3. Inhale.
• After administering a dose, rinse the mouth with water and spit the water out.
• Do not allow the inhaler to get wet; protect it from moisture.

If you have any further questions regarding the use of this medicine, please consult your
doctor or pharmacist.