FLIXODIL COMBO 25 mcg + 250 mcg Aerosol

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Flixodil Combo; (25 micrograms + 50 micrograms)/measured dose;
   1. Flixodil Combo; (25 micrograms + 125 micrograms)/measured dose; inhalation aerosol, suspension
   2. Flixodil Combo; (25 micrograms + 250 micrograms)/measured dose; 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. 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 your asthma symptoms worsen or asthma control deteriorates, you 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: You may experience sudden breathing difficulties immediately after using Flixodil Combo.
   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)/measured dose;

inhalation aerosol, suspension

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

Flixodil Combo; (25 micrograms + 250 micrograms)/measured dose; 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

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, making it easier to breathe in and out. The effect lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces inflammation and swelling in the lungs.

Your doctor has prescribed this medicine to prevent breathing problems in asthma. To ensure proper control of asthma, Flixodil Combo must be used every day, as recommended by your 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 the inhaler correctly. 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. Using Flixodil Combo incorrectly or using the inhaler incorrectly may mean that the medicine does not work as well as expected and may increase the risk of side effects.

2. Important information before using Flixodil Combo

When not to use Flixodil Combo

Warnings and precautions

Before starting to use Flixodil Combo, you should discuss this with your doctor or pharmacist, especially if you 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 you experience blurred vision or other vision problems, you should contact your doctor.

Flixodil Combo and other medicines

You should tell your doctor about all medicines you are currently taking, or have recently taken, and about any medicines you plan to take, including those used to treat asthma and those available without a prescription. Flixodil Combo should not be used with certain medicines. Before starting to use Flixodil Combo, you should inform your doctor about taking:

• 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 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, including irregular heartbeat or worsening of existing side effects. Your doctor may want to closely monitor your condition while taking such medicines.
• corticosteroids (orally or by injection). If you have recently taken such medicines, this 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will assess whether you can take Flixodil Combo during this period.

Driving and using machines

It is unlikely that Flixodil Combo will affect your ability to drive or use machines.

3. How to use Flixodil Combo

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist.

• Flixodil Combo should be used every day, as long as your doctor does not advise otherwise. Do not take more than the recommended dose. If you are unsure, ask your doctor or pharmacist.
• Do not stop using Flixodil Combo or reduce the dose without consulting your 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)/measured dose: two inhalations twice a day.
• Flixodil Combo (25 micrograms + 125 micrograms)/measured dose: two inhalations twice a day.
• Flixodil Combo (25 micrograms + 250 micrograms)/measured dose: two inhalations twice a day.

Children from 4 to 12 years of age:

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

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

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

It is very important that your doctor instructs you on how many inhalations to use and how often to use them. If you are using Flixodil Combo to treat asthma, your doctor will regularly check your symptoms.

If your asthma symptoms worsen or asthma control deteriorates, you should

contact your doctor immediately.You may experience increased wheezing, more frequent chest tightness, or increased need for a fast-acting inhaler. In this situation, continue using Flixodil Combo, 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.

Instructions for using the inhaler

• Your doctor, nurse, or pharmacist should instruct you on how to use the inhaler properly. They should periodically check that you are using the inhaler correctly. Using Flixodil Combo incorrectly or using the inhaler incorrectly may mean that the medicine does not work as well as expected and may increase the risk of side effects.
• The medicine is in a pressurized container, in a plastic case with a mouthpiece.

• 1. Before first use, check that the inhaler is working. Remove the cap from the mouthpiece by gently squeezing the sides of the cap between your thumb and index finger.

• 2. To ensure the inhaler is working, shake the inhaler vigorously, point the mouthpiece away from you, and release two doses into the air. If the inhaler has not been used for a week or more, 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. Inhale while standing or sitting.
• 2. Remove the cap from the mouthpiece (as shown in Figure 1). Check the mouthpiece for any foreign objects.
• 3. Shake the inhaler 4 or 5 times to ensure that any foreign objects are removed and the contents are well mixed.
• 4. Hold the inhaler upright with your fingers, with your thumb on the base of the inhaler, below the mouthpiece. Take a deep breath out, as deep as possible.

• 5. Put the mouthpiece in your mouth and seal it with your lips. Do not bite the mouthpiece.
• 6. Start breathing in slowly and deeply. As soon as you start breathing in, press the inhaler to release a dose of Flixodil Combo, and then continue breathing in slowly and deeply.
• 7. Hold your breath, remove the inhaler from your mouth, and take your finger off the inhaler. Hold your breath for a few seconds or as long as is comfortable, then breathe out slowly.
• 8. If your doctor has prescribed two inhalations, wait about half a minute before repeating the steps described in points 3-7.

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

Do not rush 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 performed correctly, initially, you should check your technique in front of a mirror. The "mist" coming out of the inhaler, mouth, or nose during inhalation indicates incorrect inhalation technique. You should repeat the steps starting from point 3. As with other inhalers, caregivers should ensure that children using Flixodil Combo use the inhaler correctly, following the above description. If the patient or child has difficulty using the inhaler, the doctor or another healthcare professional may recommend using the inhaler with a spacer device, AeroChamber Plus. The doctor, nurse, or pharmacist, or another healthcare professional, should demonstrate how to use the spacer device and how to care for it and answer any questions the patient may have. If the patient uses the inhaler with a spacer device, it is essential not to stop using it without consulting a doctor or nurse. It is also essential not to change the type of spacer device used without consulting a doctor. If the patient stops using the spacer device or changes its type, the doctor may decide to change the dose of Flixodil Combo needed to control asthma symptoms. Before making any changes to asthma treatment, you should consult your doctor. Older children or people with weak hands may find it easier to hold the inhaler with both hands. You should hold the inhaler with two fingers on top of the inhaler and both thumbs on the bottom, below the mouthpiece.

Cleaning the inhaler

To prevent the inhaler from clogging, it should be cleaned at least once a week. To clean the inhaler:

• Remove the cap from the mouthpiece.
• Do not remove the metal container from the plastic case during cleaning or at any other time.
• Wipe the mouthpiece inside and outside and the plastic case outside with a dry cloth or tissue.
• Replace the cap on the mouthpiece. When the cap is correctly replaced, you will hear a click. If you do not hear a click when replacing the cap, remove it, turn it around, and try again. Do not use too much force.

Do 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 you accidentally use a higher dose than recommended, you should tell your doctor or pharmacist. You may experience: rapid heartbeat, tremors, dizziness, headache, weakness, and joint pain. If you use higher doses for a long time, you should contact your 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

Do not take a double dose to make up for a missed dose. 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 your doctor. You should take the medicine until your doctor tells you to stop.Do not stop taking Flixodil Combo or reduce the dose without consulting your doctor.Your symptoms may worsen, and your condition may deteriorate. Additionally, stopping or reducing the dose of Flixodil Combo may (very rarely) cause adrenal gland problems (adrenal insufficiency), which can 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 you experience any of these side effects, you should tell your doctor or pharmacist. To prevent these side effects, your doctor may prescribe additional corticosteroids in tablet form (e.g., prednisolone). If you experience any of these side effects, you should tell your doctor or pharmacist.

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, your doctor will prescribe the lowest dose of Flixodil Combo that controls your asthma.

Allergic reactions: You may experience sudden breathing difficulties immediately after using Flixodil Combo.

This may include increased wheezing, coughing, or shortness of breath, as well as itching, rash (hives), and swelling (usually of the face, lips, tongue, or throat).You may also experience a very rapid heartbeat, weakness, dizziness (which can lead to falls or loss of consciousness). If you experience any of these symptoms soon after using Flixodil Combo, you should stop using Flixodil Combo and contact your doctor immediately.Allergic reactions to Flixodil Combo are uncommon (may affect less than 1 in 100 people).

Other side effects:

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

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

Common(affect less than 1 in 10 people):

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

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

• Pneumonia and bronchitis (lung infection). You should tell your doctor if you experience any of the following symptoms while using Flixodil Combo - these may be symptoms of a lung infection: fever or chills, increased production of mucus, change in mucus color, increased coughing, or increased difficulty breathing.
• Easier bruising and fractures.
• Sinusitis (feeling of tension and fullness in the nose, cheeks, and behind the eyes, sometimes with a throbbing headache).
• Low potassium levels in the blood (you may experience irregular heartbeat, muscle weakness, or cramps).

Uncommon(affect less than 1 in 100 people):

• Increased blood sugar (glucose) levels (hyperglycemia). In patients with diabetes, it may be necessary to monitor blood sugar levels more frequently and adjust the dose of antidiabetic medicines.
• Cataracts (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 decrease over time while continuing treatment.
• Atrial fibrillation.
• Ischaemic heart disease, which may cause chest pain and shortness of breath.
• Sleep disturbances.
• Anxiety (nervousness).
• Allergic skin rash.

Rare(affect less than 1 in 1,000 people):

• Wheezing or breathing difficulties worsening immediately after using Flixodil Combo. If you experience such symptoms, you should stop using Flixodil Combo, use a fast-acting inhaler and contact your doctor immediately.
• Flixodil Combo may affect the normal production of steroid hormones in the body, especially when taking high doses for a long time. These symptoms include:
• growth retardation in children and adolescents,
• decreased bone density,
• glaucoma,
• weight gain,
• moon face (Cushing's syndrome).

Your doctor will regularly check for these side effects and ensure that you are using the lowest dose of Flixodil Combo that controls your asthma.

• Changes in behavior, such as excessive excitement and irritability (these symptoms occur mainly in children).
• Irregular heartbeat or extra heartbeats (arrhythmias). You should inform your doctor about this, but do not stop using Flixodil Combo unless your doctor advises you to.
• 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. 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. You can also report side effects 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. You can also report side effects 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 Flixodil Combo

Keep this medicine 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 pressurized inhalers, 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. 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Flixodil Combo contains

• The active substances are salmeterol and fluticasone propionate. Each measured dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 50, 125, or 250 micrograms of fluticasone propionate.
• The other ingredient is the propellant: 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. Aluminum container with a metering valve, mouthpiece with PP, and cap with PP, 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