FLIXODIL 25 mcg+ 50 mcg Aerosol

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Flixodil Combo; (25 micrograms + 50 micrograms)/dose metered;
   1. Flixodil Combo; (25 micrograms + 125 micrograms)/dose metered; inhalation aerosol, suspension
   2. Flixodil Combo; (25 micrograms + 250 micrograms)/dose metered; inhalation aerosol, suspension
   3. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   4. Table of contents of the leaflet
3. What is Flixodil Combo and what is it used for
   1. Flixodil Combo prevents shortness of breath and wheezing in the airways. However, it should not be used to relieve sudden attacks of shortness of breath or wheezing in the airways. If such an attack occurs, it is necessary to use a fast-acting bronchodilator, such as salbutamol, immediately. The patient should always carry such a medicine with them.
4. Important information before using Flixodil Combo
   1. When not to use Flixodil Combo
   2. Warnings and precautions
   3. Flixodil Combo and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
5. How to use Flixodil Combo
   1. Adults and adolescents over 12 years of age:
   2. Children from 4 to 12 years of age:
   3. If the patient's asthma symptoms worsen or asthma control deteriorates, they should
   4. Instructions for using the inhaler
   5. Using the inhaler
   6. Cleaning the inhaler
   7. Using a higher dose of Flixodil Combo than recommended
   8. Missing a dose of Flixodil Combo
   9. Stopping use of Flixodil Combo
6. Possible side effects
   1. Allergic reactions: The patient may experience sudden breathing difficulties immediately after
   2. Other side effects:
   3. Reporting side effects
7. How to store Flixodil Combo
8. Contents of the packaging and other information
   1. What Flixodil Combo contains
   2. What Flixodil Combo looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet:

Leaflet accompanying the packaging: information for the user

Flixodil Combo; (25 micrograms + 50 micrograms)/dose metered;

inhalation aerosol, suspension

Flixodil Combo; (25 micrograms + 125 micrograms)/dose metered; inhalation aerosol, suspension

Flixodil Combo; (25 micrograms + 250 micrograms)/dose metered; inhalation aerosol, suspension

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 you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 Flixodil Combo and what is it used for
• 2. Important information before using Flixodil Combo
• 3. How to use Flixodil Combo
• 4. Possible side effects
• 5. How to store Flixodil Combo
• 6. Contents of the packaging and other information

1. What is Flixodil Combo and what is it used for

Flixodil Combo contains two active substances: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help to keep the airways open. This makes it easier for air to get in and out of the lungs. The effect lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and inflammation in the lungs.

The doctor has prescribed this medicine to the patient to prevent breathing problems that occur in asthma. To ensure proper control of asthma, Flixodil Combo must be used every day, as recommended by the doctor.

Flixodil Combo prevents shortness of breath and wheezing in the airways. However, it should not be used to relieve sudden attacks of shortness of breath or wheezing in the airways. If such an attack occurs, it is necessary to use a fast-acting bronchodilator, such as salbutamol, immediately. The patient should always carry such a medicine with them.

It is very important to use a fast-acting bronchodilator, such as salbutamol. The patient should always
carry such a medicine with them.

2. Important information before using Flixodil Combo

When not to use Flixodil Combo

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

Warnings and precautions

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

• heart disease, including irregular or rapid heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes (Flixodil Combo may increase blood glucose levels),
• low potassium levels in the blood,
• tuberculosis currently being treated or a history of tuberculosis, or other lung infections.

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

Flixodil Combo and other medicines

The patient should tell their doctor about all medicines they are currently taking, or have recently taken, and about any medicines they plan to take, including asthma medicines and medicines that are available without a prescription. Flixodil Combo should not be used with certain medicines. Before starting to use Flixodil Combo, the patient should inform their doctor about the use of:

• beta-blockers (e.g. atenolol, propranolol and 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 medicines); Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of side effects, including irregular heartbeat or worsening of existing side effects. The doctor may want to closely monitor the patient's condition while taking such medicines.
• corticosteroids (orally or by injection). If the patient has recently taken such medicines, it may increase the risk of adrenal gland problems.
• diuretics 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 before using this medicine. The doctor will assess whether the patient can take Flixodil Combo during this period.

Driving and using machines

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

3. How to use Flixodil Combo

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

• Flixodil Combo should be used every day, until the doctor recommends otherwise. The patient should not take a higher dose than recommended. In case of doubts, the patient should consult their doctor or pharmacist.
• The patient should not stop using Flixodil Combo or reduce the dose without consulting their doctor.
• Flixodil Combo should be inhaled into the lungs through the mouth.

Adults and adolescents over 12 years of age:

• Flixodil Combo (25 micrograms + 50 micrograms)/dose metered: two inhalations twice a day.
• Flixodil Combo (25 micrograms + 125 micrograms)/dose metered: two inhalations twice a day.
• Flixodil Combo (25 micrograms + 250 micrograms)/dose metered: two inhalations twice a day.

Children from 4 to 12 years of age:

• Flixodil Combo (25 micrograms + 50 micrograms)/dose metered: two inhalations twice a day.
• Flixodil Combo is not recommended for use in children under 4 years of age.

If the patient's asthma symptoms are well controlled while using Flixodil Combo 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 that the doctor instructs the patient on how many inhalations to use and how often to use them. The patient should use Flixodil Combo as directed by their doctor.

If the patient's asthma symptoms worsen or asthma control deteriorates, they should

contact their doctor immediately.The patient may experience increased wheezing, more frequent chest tightness, or may need to use more of their fast-acting inhalation medicine. In this situation, the patient should continue to use Flixodil Combo, but should 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 inhaler

• The doctor, nurse or pharmacist should instruct the patient on how to use the inhaler properly. They should periodically check that the patient is using the inhaler correctly. Not using Flixodil Combo as directed by the doctor or not using the inhaler correctly may mean that the medicine does not work as well as expected to control asthma.
• The medicine is in a pressurized container, in a plastic casing with a mouthpiece.

• 2. To ensure that the inhaler is working, the patient should shake it vigorously, point the mouthpiece away from them, and release two doses into the air. If the inhaler has not been used for a week or more, the patient should remove the cap from the mouthpiece, shake the inhaler vigorously, and release two doses into the air.

Using the inhaler

It is essential to start breathing in slowly, as slowly as possible, before using the inhaler.

• 1. The patient should inhale while standing or sitting.
• 2. The patient should remove the cap from the mouthpiece (as shown in Figure 1). The patient should check the mouthpiece for any blockages.
• 3. The patient should shake the inhaler 4 or 5 times to ensure that any blockages are removed and the contents are well mixed.
• 4. The patient should hold the inhaler upright with their fingers, with their thumb on the base of the inhaler, below the mouthpiece. The patient should breathe out slowly and deeply.

• 5. The patient should put the mouthpiece in their mouth and seal their lips around it. The patient should not bite the mouthpiece.
• 6. The patient should start breathing in slowly and deeply. As soon as they start breathing in, they should press the inhaler to release the dose of Flixodil Combo, and then continue to breathe in slowly and deeply.
• 7. The patient should hold their breath, remove the inhaler from their mouth, and take their finger off the inhaler. The patient should hold their breath for a few seconds, or as long as is comfortable, and then breathe out slowly.
• 8. If the doctor has recommended two inhalations, the patient should wait about half a minute before repeating the steps described in points 3-7.

• 9. Rinsing the mouth with water and spitting it out and/or brushing the teeth after inhalation can help prevent hoarseness and thrush.
• 10. After inhalation, the patient should always replace the cap on the mouthpiece to prevent dust from entering it. The patient should replace the cap by pushing it back into place. If the cap does not click into place, the patient should remove it, turn it around, and try again. The patient should not use too much force.

The patient should not rush through the steps described in points 4, 5, 6, and 7. It is essential to breathe in slowly before using the inhaler. To ensure that the inhalation is done correctly, the patient should practice in front of a mirror. The "mist" that comes out of the inhaler, mouth, or nose during inhalation indicates that the inhalation technique is incorrect. The patient should start again from step 3.

Cleaning the inhaler

To prevent the inhaler from becoming blocked, it should be cleaned at least once a week.

• The patient should remove the cap from the mouthpiece.
• The patient should not remove the metal container from the plastic casing during cleaning or at any other time.
• The patient should clean the mouthpiece inside and outside, and the plastic casing outside, with a dry cloth or tissue.
• The patient should replace the cap on the mouthpiece. When the cap is replaced correctly, it will click into place. If the cap does not click into place, the patient should remove it, turn it around, and try again. The patient should not use too much force.

The patient should not immerse the metal container in water.

Using a higher dose of Flixodil Combo than recommended

It is essential to use the inhaler as directed. If the patient accidentally uses a higher dose than recommended, they should tell their doctor or pharmacist.

The patient may experience: a faster than normal heartbeat, tremors, dizziness, headache, weakness, and joint pain.

If the patient uses higher doses for a long time, they should consult their doctor or pharmacist for advice, as high doses of Flixodil Combo may cause a decrease in the production of steroid hormones by the adrenal glands.

Missing a dose of Flixodil Combo

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

Stopping use of Flixodil Combo

It is very important to take Flixodil Combo every day as directed by the doctor. The patient should
take the medicine until the doctor recommends stopping it. The patient should not suddenly stop taking
Flixodil Combo or reduce the dose, as the symptoms of the disease may worsen.

Additionally, sudden stopping or reduction of Flixodil Combo may (very rarely) cause adrenal gland problems (adrenal insufficiency), which can sometimes cause side effects. These side effects may include:

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

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

4. Possible side effects

Like all medicines, Flixodil Combo can cause side effects, although not everybody gets them. To minimize the risk of side effects, the doctor will prescribe the lowest dose of Flixodil Combo that controls asthma.

Allergic reactions: The patient may experience sudden breathing difficulties immediately after

using Flixodil Combo.The patient may experience increased wheezing, coughing, or shortness of breath, as well as itching, rash (hives), and swelling (usually of the face, lips, tongue, or throat). The patient may also experience a very fast heartbeat, weakness, or dizziness (which can lead to fainting). If the patient experiences any of these symptoms soon after using Flixodil Combo, they should stop using Flixodil Combo and contact their doctor immediately.Allergic reactions to Flixodil Combo are uncommon (they may occur in less than 1 in 100 patients using the medicine).

Other side effects:

Very common(occurring in more than 1 in 10 patients):

• Headache - this side effect usually decreases over time as treatment continues.
• Increased frequency of colds in patients with COPD.

Common(occurring in less than 1 in 10 patients):

• Thrush (painful, creamy-white patches) in the mouth and throat, as well as pain in the tongue, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing the teeth after inhalation can help. The doctor may prescribe an antifungal medicine to treat thrush.
• Pains, swelling of the joints, and muscle pains.
• Muscle cramps.

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

• Pneumonia and bronchitis (lung infection). The patient should tell their doctor if they experience any of the following symptoms while using Flixodil Combo - they may be symptoms of a lung infection: fever or chills, increased production of sputum, change in sputum color, worsening cough, or increased difficulty breathing.
• Easier bruising and fractures.
• Sinusitis (feeling of tension and fullness in the nose, cheeks, and eyes, sometimes with a throbbing headache).
• Decreased potassium levels in the blood (the patient may experience irregular heartbeat, muscle weakness, or cramps).

Uncommon(occurring in less than 1 in 100 patients):

• Increased blood glucose (hyperglycemia) levels. In patients with diabetes, it may be necessary to monitor blood glucose levels more frequently and adjust the dose of their diabetes medicines.
• Cataract (clouding of the lens in the eye).
• Very fast heartbeat (tachycardia).
• Feeling of trembling and fast or irregular heartbeat (palpitations) - these symptoms usually are not serious and decrease over time as treatment continues.
• Atrial fibrillation.
• Ischaemic heart disease, which can cause chest pain and shortness of breath.
• Sleep disturbances.
• Anxiety (nervousness).
• Allergic skin rash.

Rare(occurring in less than 1 in 1,000 patients):

• Wheezing or difficulty breathing worsening immediately after taking Flixodil Combo. If the patient experiences such symptoms, they should stop using Flixodil Combo, use a fast-acting inhalation medicine to help them breathe, and contact their doctor immediately.
• Flixodil Combo may affect the production of steroid hormones in the body, especially when taken in high doses for a long time. Symptoms may include:
• growth retardation in children and adolescents,
• decreased bone density,
• glaucoma,
• weight gain,
• rounding of the face (Cushing's syndrome).

The doctor will regularly check for these side effects and ensure that the patient is using the lowest dose of Flixodil Combo that controls their asthma.

• Changes in behavior, such as excessive excitement and irritability (these symptoms occur mainly in children).
• Irregular heartbeat or extra heartbeats (arrhythmias). The patient should inform their doctor, but should not stop using Flixodil Combo unless their doctor recommends it.
• Fungal infection of the esophagus, which can cause difficulty swallowing.

Side effects with unknown frequency(frequency cannot be estimated from available data):

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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, 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 authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Flixodil Combo

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

Store in a temperature below 25°C.

The metal container contains a pressurized suspension. Do not expose to temperatures above 50°C, protect from direct sunlight. Do not pierce or burn the container, even if it appears to be empty.

As with most inhalation medicines in pressurized containers, the therapeutic effect of this medicine may decrease when the container is cold.

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

The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.

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 Flixodil Combo contains

• The active substances of Flixodil Combo are salmeterol and fluticasone propionate. Each dose metered contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 50, 125, or 250 micrograms of fluticasone propionate.
• The other ingredient is the propellant gas: norflurane (HFA-134a).

What Flixodil Combo looks like and contents of the pack

Flixodil Combo is supplied in an inhaler containing a white or almost white suspension for inhalation under pressure.

An aluminum container with a metering valve, mouthpiece, and cap, all in a cardboard box.

1 inhaler containing 120 doses in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 691 39 00

Manufacturer

Genetic S.p.A., Contrada Canfora, Fisciano (SA), 84084, Italy

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, Poland

Date of last revision of the leaflet: