Simflusal

Leaflet accompanying the packaging: patient information

Symflusal, (50 micrograms + 250 micrograms)/dose, inhalation powder, divided

Symflusal, (50 micrograms + 500 micrograms)/dose, inhalation powder, divided

Salmeterol + Fluticasone propionate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Symflusal and what is it used for

Symflusal contains two active substances, salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help to maintain the patency of the airways. It allows for easier airflow to the lungs. The effect of the medicine lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation of the lungs.

The doctor has prescribed this medicine to the patient to prevent breathing disorders that occur in:

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

To ensure proper control of asthma or COPD, Symflusal must be used every day, as recommended by the doctor.

Symflusal helps to prevent the occurrence of shortness of breath and wheezing, but it should not be used to relieve sudden attacks of shortness of breath or wheezing.

In such cases, it is necessary to use a rapidly acting inhalation medicine, such as salbutamol. The patient should always carry a rapidly acting inhalation medicine with them.

2. Important information before using Symflusal

When not to use Symflusal:

If the patient is allergic to salmeterol and/or fluticasone propionate, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use the medicine, the patient should discuss it with their doctor or pharmacist if they have:

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

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Symflusal and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking, or have recently taken, and about any medicines they plan to take, including those used to treat asthma and any medicines that are available without a prescription.

Before starting to use Symflusal, the patient should inform their doctor about taking the following medicines:

• Beta-blockers (e.g. atenolol, propranolol, sotalol). Beta-blockers are most commonly used to treat high blood pressure or other heart diseases.
• Medicines used to treat infections (e.g. ketoconazole, itraconazole, and erythromycin), including some medicines used to treat HIV (e.g. ritonavir, cobicistat-containing products). Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of side effects caused by the use of Symflusal, including irregular heartbeat, or may worsen side effects. The doctor may want to closely monitor the patient's condition while taking such medicines.
• Corticosteroids (taken orally or by injection). If the patient has recently taken these medicines, it may increase the risk of adrenal insufficiency.
• Diuretics, also known as water pills used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine derivatives, 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 medicine.

Driving and using machines

It is unlikely that Symflusal will affect the patient's ability to drive or use machines.

Symflusal contains lactose monohydrate

The amount of lactose in the medicine is usually not a problem for people with lactose intolerance. Lactose contains small amounts of milk proteins, which may cause allergic reactions.

3. How to use Symflusal

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

• Symflusal should be used every day until the doctor advises otherwise. The patient should not take a higher dose than recommended. In case of doubts, they should consult their doctor or pharmacist.

The patient should not stop using Symflusal or reduce the dose without consulting their doctor first.

• Symflusal should be inhaled into the lungs through the mouth.
• After using the medicine, the patient should rinse their mouth with water and then spit it out.

Adults with asthma

• Symflusal 50 micrograms + 250 micrograms/dose: one inhalation twice a day.
• Symflusal 50 micrograms + 500 micrograms/dose: one inhalation twice a day.

Adults with chronic obstructive pulmonary disease (COPD)

Symflusal 50 micrograms + 500 micrograms/dose: one inhalation twice a day.

Use in children and adolescents

Symflusal should not be used in children and adolescents.

If the patient's asthma symptoms are well-controlled while using Symflusal twice a day, the doctor may recommend reducing the frequency of Symflusal use to once a day. The dose may 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 to follow the doctor's recommendations regarding the number of inhalations and the frequency of use.

If the patient is using Symflusal to treat asthma, the doctor will regularly check the patient's symptoms.

In case of worsening asthma symptoms or difficulty breathing, the patient should contact their doctor immediately.

The patient may experience worsening wheezing, more frequent chest tightness, or the need to use a higher dose of a rapidly acting inhalation medicine. In such a situation, the patient should continue to use Symflusal, but not increase the number of inhalations. The patient's symptoms may worsen, and their condition may deteriorate. The patient should contact their doctor, as they may need additional treatment.

Instructions for using the inhalation device

• The doctor, nurse, or pharmacist should instruct the patient on how to properly use the inhalation device (Elpenhaler). They should periodically check that the patient is using the inhalation device correctly. Using Symflusal in a way that is not in line with the doctor's recommendations or using the inhalation device incorrectly may lead to the medicine not having the expected effect on asthma or COPD.

INSTRUCTIONS FOR USING AND HANDLING THE ELPENHALER INHALER

Below is the instruction for the patient on the proper use of a single dose of the inhalation powder in the form of two active substances packaged in two blisters on a strip (strips with two-chamber blisters) stored in the Elpenhaler inhaler.

DESCRIPTION

Elpenhaler is a device for the simultaneous inhalation of both active substances in the form of a powder. Both active substances form one therapeutic dose. Each active substance is packaged separately in one of the two chambers of a specially designed strip with a two-chamber blister. The strip with a two-chamber blister contains one (1) therapeutic dose.

The Elpenhaler inhaler consists of 3 parts:

• Mouthpiece and its cover (1).
• Surface (2)on which the strip with a two-chamber blister is placed (bearing surface).
• Compartment (3)for storing strips.

The above three parts are connected, but can be opened separately.

The bearing surface consists of:

• Mouting point (2A)for placing the strip with blisters.
• Two recesses (2B)for fitting the two chambers of the blister.
• Two guide rails (2C)that cause the strip with a two-chamber blister to be placed in the correct position on the bearing surface.

The strip with a two-chamber blister contains:

• Two aluminum sheets (4).
• Two blister chambers (5), one containing salmeterol, and the other fluticasone propionate.
• An opening (6).

Using the Elpenhaler inhaler

A. Preparing the device

Open the compartment by pressing, as shown in the drawing, remove the strip, and close the compartment again.

Completely remove the protective cover from the mouthpiece by gently pressing on the surface with the strips.

Unlock and push the mouthpiece back to expose the bearing surface.

Hold the strip with a two-chamber blister with the shiny surface up, so that the blue line is visible, as indicated by the arrow in the drawing. The printed surface of the strip should be facing down.

Place the opening of the strip over the mounting point on the bearing surface, applying gentle pressure, and make sure the strip is properly seated on the mounting point.

The strip with a two-chamber blister will fit into the recesses in the bearing surface, and the guide rails will ensure that the strip is in the correct position.

Close the mouthpiece and pull out the protruding end of the strip horizontally. The dose is ready to use.

B. Performing the inhalation

Hold the device away from the mouth.

Perform a full exhalation. Be careful not to exhale onto the mouthpiece of the device.

Put the Elpenhaler inhaler in the mouth and enclose the mouthpiece with the lips.

Slowly perform a deep inhalation through the mouth (not the nose) until the lungs are full.

Hold the breath for about 5 seconds or as long as possible, and then remove the device from the mouth.

Exhale and continue to breathe normally.

Open the mouthpiece. You will notice that all the powder has been used up, and the blister chambers are empty.

Remove the empty strip and proceed to step C.

C. Cleaning the inhaler

After each use, wipe the mouthpiece of the device and the bearing surface with a dry cloth or a dry paper towel. Do not use water to clean the device.

Close the mouthpiece and put the protective cover around it.

Using a higher dose of Symflusal than recommended

It is important to use the inhaler as directed. If a higher dose than recommended is used by mistake, the patient should consult their doctor or pharmacist.

The patient may experience: rapid heartbeat and tremors. They may also experience: dizziness, headache, muscle weakness, and joint pain.

If the patient takes higher doses for a long time, they should contact their doctor or pharmacist for advice, as higher doses of Symflusal may cause a decrease in the production of steroid hormones by the adrenal glands.

Missing a dose of Symflusal

The patient should not take a double dose of the medicine to make up for a missed dose. The next dose should be taken at the usual time.

Stopping the use of Symflusal

It is very important to take Symflusal every day as directed by the doctor.

The patient should continue to take the medicine until the doctor advises them to stop. The patient should not suddenly stop taking Symflusal or reduce the dose on their own, as breathing problems may worsen.

Additionally, suddenly stopping or reducing the dose of Symflusal may (very rarely) cause adrenal insufficiency, which can sometimes cause side effects.

Side effects may 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 (seizure attacks).

If the body is under stress, for example, due to fever, injury (e.g. car accident), infection, or surgery, adrenal insufficiency may worsen, and any of the above side effects may occur.

If the patient experiences any of these side effects, they should tell their doctor or pharmacist. To prevent the occurrence of these symptoms, the doctor may prescribe additional corticosteroids in the form of tablets (e.g. prednisolone).

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Symflusal can cause side effects, although not everybody gets them.

To minimize the risk of side effects, the doctor will prescribe the smallest dose of Symflusal that will control asthma or COPD.

Allergic reactions: the patient may experience sudden breathing difficulties immediately after taking Symflusal.

The patient may experience wheezing and coughing or shortness of breath. Additionally, the patient may experience itching, rash (hives), and swelling (usually of the face, lips, tongue, or throat) or a feeling of a very rapid heartbeat, weakness, and dizziness (which can lead to a fall or loss of consciousness).

If the patient experiences any of the above symptoms or if they occur suddenly after using Symflusal, they should stop using Symflusal and contact their doctor immediately. Allergic reactions to Symflusal are not very common (they may occur in less than 1 in 100 patients).

Pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD) (common side effect)

The patient should tell their doctor if any of the following symptoms occur while using Symflusal - they may be symptoms of a lung infection:

• fever or chills,
• increased production of sputum, change in the color of sputum,
• worsening cough or increased breathing difficulties.

Other side effects are described below:

Very common (may occur in more than 1 in 10 patients):

• headache - it usually decreases over time while continuing treatment;
• increased frequency of colds in patients with COPD.

Common (may occur in less than 1 in 10 patients):

• thrush (painful, creamy-yellow raised spots) in the mouth and throat, as well as tongue pain, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out, and/or brushing the teeth immediately after each inhalation may be helpful. The doctor may prescribe an antifungal medicine to treat thrush;
• pain, swelling of the joints, and muscle pain;
• muscle cramps.

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

• bruising and fractures;
• sinusitis (feeling of tension and fullness in the nose, cheeks, and behind the eyes, sometimes with a pulsating headache);
• decreased potassium levels in the blood (the patient may experience irregular heartbeat, muscle weakness, cramps).

Uncommon (may occur in less than 1 in 100 patients):

• increased blood sugar levels (hyperglycemia). In patients with diabetes, it may be necessary to monitor blood sugar levels more frequently and adjust the dose of antidiabetic medicines being taken;
• cataract (clouding of the lens of the eye);
• very rapid heartbeat (tachycardia);
• feeling of shakiness (tremor) and rapid or irregular heartbeat (palpitations) - these symptoms are usually harmless and disappear during treatment;
• chest pain;
• feeling of restlessness (anxiety) - this effect is more likely to occur in children;
• sleep disturbances;
• allergic skin rash.

Rare (may occur in less than 1 in 1000 patients):

• breathing difficulties or wheezing, worsening immediately after taking Symflusal. In such a case, the patient should stop using Symflusal, use a rapidly acting inhalation medicine, and contact their doctor immediately;
• Symflusal may affect the proper production of steroid hormones by the body, especially when taking high doses of the medicine for a long time, causing:
• growth retardation in children and adolescents;

Symflusal may also cause:

• decreased bone density;
• glaucoma;
• weight gain;
• moon face (Cushing's syndrome). The doctor will regularly check if the patient is experiencing any of the above side effects and ensure that the patient is using the smallest dose of Symflusal that controls asthma;
• changes in behavior, such as excessive excitement and irritability (these symptoms occur mainly in children);
• irregular heartbeat or extra beats (arrhythmia); the patient should inform their doctor about this, but should not stop using Symflusal unless the doctor advises them to do so;
• fungal infection of the esophagus, which can cause difficulty swallowing.

Frequency not known (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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, e-mail: [email protected].

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Symflusal

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the label and on the packaging after: EXP. The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Symflusal contains

The active substances of Symflusal are salmeterol and fluticasone propionate.

Each ready-to-use dose of Symflusal contains:

50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate

or

50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate.

The other ingredient is lactose monohydrate.

What Symflusal looks like and what the packaging contains

The active substances of Symflusal are salmeterol and fluticasone propionate, which are placed separately in two blister chambers. The blister is placed on a foil strip and contains one therapeutic dose. The strips are stored in the Elpenhaler inhaler, which is placed in a cardboard box.

The foil protects the inhalation powder from the effects of atmospheric factors.

Each dose in the form of a strip with a two-chamber blister is ready to use.

Package sizes:

• Each cardboard box contains one Elpenhaler inhaler with 60 strips with two-chamber blisters. Packaging: 60 doses.
• Each cardboard box contains one Elpenhaler inhaler with 30 strips with two-chamber blisters of the Aluminum/Aluminum type, and one compartment with 30 additional strips with two-chamber blisters of the Aluminum/Aluminum type. Packaging: 60 doses.
• Each cardboard box contains one Elpenhaler inhaler with 30 strips with two-chamber blisters of the Aluminum/Aluminum type. Packaging: 30 doses (single packaging).
• Each packaging contains three Elpenhaler inhalers with 60 strips with two-chamber blisters of the Aluminum/Aluminum type. Packaging: 180 doses.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Symphar Sp. z o.o.

ul. Koszykowa 65

00-667 Warsaw

Manufacturer

ELPEN Pharmaceutical Co. Inc.

95, Marathonos Ave.

GR-19009 Pikermi, Attica

Greece

This medicine is authorized for marketing in the Member States of the European Economic Area under the following names:

Finland

Salmeson 50 micrograms/250 micrograms/dose inhalation powder

Salmeson 50 micrograms/500 micrograms/dose inhalation powder

France

Salmeson 50 micrograms/250 micrograms/dose powder for inhalation in a single-dose container.

Salmeson 50 micrograms/500 micrograms/dose powder for inhalation in a single-dose container.

Norway

Salmeson 50 micrograms/250 micrograms/dose inhalation powder, pre-dispensed.

Salmeson 50 micrograms/500 micrograms/dose inhalation powder, pre-dispensed.

Poland

Symflusal

Sweden

Salmeson 50 micrograms/250 micrograms/dose inhalation powder, divided dose

Salmeson 50 micrograms/500 micrograms/dose inhalation powder, divided dose

Date of last revision of the leaflet:March 2019