Flixodil combo

Patient Information Leaflet

Flixodil Combo; (25 micrograms + 50 micrograms)/metered dose;
inhalation aerosol, suspension
Flixodil Combo; (25 micrograms + 125 micrograms)/metered dose;
inhalation aerosol, suspension
Flixodil Combo; (25 micrograms + 250 micrograms)/metered dose;
inhalation aerosol, suspension
Salmeterol + Fluticasone propionate
Please read carefully the entire leaflet before using this 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 others, even if their symptoms are identical.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Flixodil Combo is and what it is 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 pack and other information

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

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

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

Your doctor has prescribed this medicine to prevent breathing problems associated with asthma.
To ensure proper asthma control, Flixodil Combo must be used every day as directed by your doctor.
Flixodil Combo helps prevent episodes of breathlessness and wheezing. However, it should not
be used to relieve sudden asthma attacks or acute wheezing. If such an attack occurs, a fast-acting
bronchodilator such as salbutamol must be used immediately. The patient should always have
this medicine readily available.

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 Flixodil Combo, discuss this with your doctor or pharmacist,
especially if the patient has:

• 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,
• active or previously treated tuberculosis, or other lung infections.

If the patient experiences blurred vision or other disturbances in vision, they should contact
their doctor.
Flixodil Combo and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken,
as well as any medicines they plan to take, including asthma medications and medicines
available without a prescription.
Flixodil Combo must not be used with certain medicines.
Before starting Flixodil Combo, inform your doctor if the patient is taking:

• beta-blockers (e.g. atenolol, propranolol, and sotalol). Beta-blockers are commonly used to treat high blood pressure or other heart conditions;
• medicines used to treat infections (e.g. ketoconazole, itraconazole, and erythromycin), including certain medicines used to treat HIV (e.g. ritonavir, drugs containing cobicistat); Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of adverse effects, including irregular heartbeat, or may worsen existing side effects. Your doctor may wish to closely monitor the patient's condition while taking such medicines.
• corticosteroids (taken orally or by injection). If the patient has recently taken such medicines, this may increase the risk of adrenal dysfunction.
• diuretics used to treat high blood pressure;
• other bronchodilators (such as salbutamol);
• xanthine derivatives, 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 become
pregnant, she should consult her doctor before using this medicine.
The doctor will assess whether the patient can take Flixodil Combo during this period.
Driving and operating machinery
It is unlikely that Flixodil Combo will affect the ability to drive or operate machinery.

3. How to use Flixodil Combo

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

• Flixodil Combo should be used daily until your doctor advises otherwise. Do not take a higher dose than recommended. If in doubt, consult 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 aged 12 years and older:

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

Children aged 4 to 12 years:

• Flixodil Combo (25 micrograms + 50 micrograms)/metered dose: two inhalations twice daily.
• 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 daily, your doctor may recommend reducing the frequency of Flixodil Combo to once daily. The dose may be administered:

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

It is very important that your doctor instructs you on how many inhalations to take and how often they should be used.
If you are using Flixodil Combo for asthma treatment, your doctor will regularly monitor your symptoms.
If asthma symptoms worsen or asthma control deteriorates, contact your doctor immediately.
You may experience increased wheezing, more frequent chest tightness, or may need to use a higher dose of a fast-acting inhaled medicine to help breathing. In such a case, continue using Flixodil Combo, but do not increase the number of inhalations. Symptoms may worsen and your condition may deteriorate. Contact your doctor, as you may require additional treatment.

Instructions for using the inhaler

• Your doctor, nurse, or pharmacist should instruct you on how to properly use the inhaler. They should periodically check that you are using the inhaler correctly. Using Flixodil Combo incorrectly or not as prescribed may result in the medicine not providing the expected improvement in asthma control.
• The medicine is contained in a pressurized canister within a plastic housing with a mouthpiece.

Checking the inhaler

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

2. To ensure the inhaler is working, shake it vigorously, point the mouthpiece away from you, and release two doses into the air. If the inhaler has not been used for one week or longer, remove the mouthpiece cap, shake the inhaler vigorously, and release two doses into the air.

Using the inhaler
It is important to begin breathing slowly and as steadily as possible even before using the inhaler.

1. Use the inhaler while standing or sitting.
2. Remove the mouthpiece cap from the inhaler (as shown in Figure 1). Check the mouthpiece inside and outside to ensure it is clean and free of foreign objects.
3. Shake the inhaler 4 or 5 times to ensure any foreign particles are removed and the contents are evenly mixed.
4. Hold the inhaler upright with your fingers, placing your thumb on the base of the inhaler, below the mouthpiece. Breathe out deeply, as fully as possible.

5. Place the mouthpiece in your mouth and seal your lips tightly around it. Do not bite the mouthpiece.
6. Begin a slow and deep inhalation. Immediately after starting to inhale through your mouth, press down on the inhaler to release a dose of Flixodil Combo, then continue a steady, deep inhalation.
7. Hold your breath, remove the inhaler from your mouth, and lift your finger off the canister. Hold your breath for several seconds, or as long as is comfortable, then breathe out slowly.
8. If your doctor has prescribed two inhalations, wait approximately 30 seconds before repeating steps 3–7.
9. Rinsing your mouth with water and spitting it out and/or brushing your teeth after inhalation helps prevent hoarseness and oral thrush.
10. After inhalation, always replace the mouthpiece cap to prevent dust from entering. Push the cap firmly into place. If you do not hear a click when attaching the cap, remove it, turn it over, and try again. Do not use excessive force.

Do not rush through steps 4, 5, 6, and 7. It is important to breathe as slowly as possible immediately before inhalation. To ensure the inhalation is performed correctly, initially practice the technique in front of a mirror. If a "mist" escapes from the inhaler, mouth, or nose during inhalation, this indicates incorrect inhalation technique. Repeat the steps starting from step 3.

As with other inhalers, caregivers should ensure that children prescribed Flixodil Combo use the inhaler correctly according to the description above. If you or your child has difficulty using the inhaler, your doctor or another healthcare professional may recommend using the inhaler with an AeroChamber Plus spacer device. Your doctor, nurse, pharmacist, or another healthcare professional should demonstrate how to use and care for the spacer device and answer any questions you may have.

If you use the inhaler with a spacer device, it is important not to stop using it without consulting your doctor or nurse. It is also important not to change the type of spacer device used without consulting your doctor. If you stop using the spacer or change to a different type, your doctor may decide to adjust the dose of medicine required to control asthma symptoms. Always consult your doctor before making any changes to your asthma treatment.

Older children or individuals with weak hands may find it easier to hold the inhaler with both hands. Grip the inhaler with both index fingers on top and both thumbs underneath the mouthpiece.

Cleaning the inhaler
To prevent blockage, clean the inhaler at least once a week.

To clean the inhaler:

• Remove the mouthpiece cap.
• Do not remove the metal canister from the plastic housing during cleaning or at any other time.
• Wipe the mouthpiece inside and outside and the outside of the plastic housing with a dry cloth or tissue.
• Replace the mouthpiece cap. When properly attached, you should hear a click. If you do not hear a click, remove the cap, turn it over, and try again. Do not use excessive force.

Do not immerse the metal canister in water.

Accidentally using more Flixodil Combo than recommended
It is important to use the inhaler as directed. If you accidentally use more than the recommended dose, inform your doctor or pharmacist.

Symptoms may include: faster than normal heartbeat, tremors, dizziness, headache, muscle weakness, and joint pain.

If higher doses have been used for a prolonged period, contact your doctor or pharmacist for advice, as high doses of Flixodil Combo may reduce steroid hormone production 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 Flixodil Combo treatment
It is very important to take Flixodil Combo every day as prescribed. Continue taking the medicine until your doctor advises you to stop. Do not suddenly stop taking Flixodil Combo or reduce the dose, as your symptoms may worsen.

Additionally, abruptly stopping or reducing the dose of Flixodil Combo may (very rarely) cause adrenal gland dysfunction (adrenal insufficiency), which may lead to the following adverse effects:

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

When the body is under stress due to fever, injury (such as a car accident), infection, or surgery, adrenal insufficiency may worsen and any of the adverse effects listed above may occur.

If you experience any of these adverse effects, inform your doctor or pharmacist. To prevent these effects, your doctor may prescribe additional corticosteroids in tablet form (e.g., prednisolone).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
To reduce the risk of side effects, your doctor will recommend the lowest dose of
Flixodil Combo that controls your asthma.
Allergic reactions: The patient may experience sudden breathing difficulties immediately after
using Flixodil Combo. Worsening of wheezing, cough, or shortness of breath may occur, as well as itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or
throat). There may also be a sensation of very rapid heartbeat, weakness, or dizziness (which may
lead to falling or loss of consciousness). If any of these symptoms occur suddenly after using Flixodil Combo, you must stop using Flixodil Combo and contact your doctor immediately. Allergic reactions to Flixodil Combo
occur uncommonly (may occur in fewer than 1 in 100 patients taking the medicine).
Other side effects:
Very common (occur in more than 1 in 10 patients):

• Headache – this side effect usually decreases during continued treatment.
• Increased frequency of colds has been reported in patients with COPD.

Common (occur in fewer than 1 in 10 patients):

• Oral and pharyngeal candidiasis (painful creamy-yellow lesions), tongue pain, hoarseness, loss of voice, and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing teeth immediately after each inhalation may be helpful. Your doctor may prescribe an antifungal medicine to treat candidiasis.
• Joint pain, joint swelling, 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 inform your doctor if any of the following symptoms occur while taking Flixodil Combo – these may be signs of lung infection: fever or chills, increased mucus production, change in mucus colour, worsening cough, or increased difficulty breathing.
• Easy bruising and traumatic fractures.
• Sinusitis (feeling of pressure and fullness in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
• Decreased blood potassium levels (the patient may experience irregular heartbeat, muscle weakness, cramps).

Uncommon (occur in fewer than 1 in 100 patients):

• Increased blood sugar (glucose) levels (hyperglycaemia). In patients with diabetes, more frequent monitoring of blood glucose levels and adjustment of previously used antidiabetic medication doses 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 dangerous and tend to decrease during continued treatment.
• Atrial fibrillation.
• Ischaemic heart disease, characterised by chest pain or pressure, and shortness of breath.
• Sleep disturbances.
• Anxiety (nervousness).
• Allergic skin rash.

Rare (occur in fewer than 1 in 1,000 patients):

• Wheezing or breathing difficulties worsening immediately after taking Flixodil Combo. If such symptoms occur, you must stop using Flixodil Combo, use a fast-acting inhaled medicine to relieve breathing, and contact your doctor immediately.
• Flixodil Combo may interfere with the body's normal production of steroid hormones, especially when high doses are used for a long time. These effects include:
  • slowed growth in children and adolescents,
  • decreased bone mass,
  • glaucoma,
  • increased body weight,
  • rounded (moon-shaped) face (Cushing's syndrome).

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

• Behavioural changes such as excessive excitability and irritability (these side effects occur mainly in children).
• Irregular heartbeat or extra beats (arrhythmias). You should inform your doctor, but do not stop using Flixodil Combo unless instructed by your doctor.
• Fungal infection of the oesophagus, which may cause difficulty swallowing.

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

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

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, you should inform 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 responsible entity.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Flixodil Combo

Keep the medicine out of sight and reach of children.
Store 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 inhaled medicines in pressurized containers, the therapeutic effect of this medicine may be reduced 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 stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and the abbreviation Lot indicates the batch number.
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 package and other information

What Flixodil Combo contains

• The active substances are salmeterol and fluticasone propionate. Each metered dose 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 pressurised white or almost white suspension for inhalation.
Aluminium container with a metering valve, mouthpiece made of PP and closure made of PP, all packed in a cardboard box.
1 inhaler with 120 doses in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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)
Italy
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Poland