Flixodil combo

Package leaflet: Information for the user

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 all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Flixodil Combo is and what it is used for
2. What you need to know before you use 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 caused by
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 attacks of breathlessness or wheezing. If such an
attack occurs, you must use a fast-acting bronchodilator, such as salbutamol, immediately. You
should always have such a medicine 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 visual disturbances, 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 the patient plans to take, including asthma medications and
over-the-counter medicines.
Flixodil Combo should 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 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);
• medicines containing 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 have
a baby, 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 directed 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 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.
This may include increased wheezing, more frequent chest tightness, or the need to use a higher dose of a fast-acting, inhaled medicine to relieve breathing difficulties. In such a case, continue using Flixodil Combo, but do not increase the number of inhalations. Your condition may worsen. 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 differently than prescribed or incorrect use of the inhaler may result in the medicine not providing the expected asthma relief.
• The medicine is contained under pressure in a plastic casing 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 slow breathing, as slowly 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 remove any foreign particles and to ensure 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 firmly 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 the Flixodil Combo dose, then continue a calm, deep inhalation.
7. Hold your breath, remove the inhaler from your mouth, and lift your finger from the inhaler cap. Hold your breath for a few seconds or as long as comfortable, then breathe out slowly.
8. If your doctor has prescribed two inhalations, wait approximately half a minute 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 around, 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 correct inhalation technique, initially practice in front of a mirror. If a "mist" is seen escaping from the inhaler, mouth, or nose during inhalation, this indicates incorrect 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 above instructions. If you or your child has difficulty using the inhaler, your doctor or healthcare professional may recommend using the inhaler with an AeroChamber Plus spacer device. Your doctor, nurse, pharmacist, or other 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 a spacer or change the type, your doctor may decide to adjust the dose of medicine needed 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. Hold the inhaler with both index fingers on top and both thumbs underneath, below 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 casing during cleaning or at any other time.
• Wipe the mouthpiece inside and outside and the outside of the plastic casing 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 around, and try again. Do not use excessive force.

Do not immerse the metal canister in water.

Accidental overdose of Flixodil Combo
It is important to use the inhaler as instructed. 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 are 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.

Missed 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 directed. 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 adverse effects.
These adverse effects may include any of the following:

• 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
To reduce the risk of adverse reactions, your doctor will prescribe the lowest dose of
Flixodil Combo that controls your asthma effectively.

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, stop using Flixodil Combo immediately and contact your doctor without delay. Allergic reactions to Flixodil Combo occur uncommonly (may affect fewer than 1 in 100 patients taking the medicine).

Other adverse reactions:

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

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

Common (affects fewer than 1 in 10 patients):

• Oral and throat candidiasis (painful creamy-white lesions), as well as 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 adverse reactions have been reported in patients with chronic obstructive pulmonary disease (COPD):

• Pneumonia and bronchitis (lung infection). Inform your doctor if any of the following symptoms occur during treatment with Flixodil Combo – these may be signs of lung infection: fever or chills, increased mucus production, change in mucus color, worsening cough, or increased breathing difficulties.
• Easy bruising and traumatic fractures.
• Sinusitis (feeling of pressure and fullness in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
• Decreased potassium levels in the blood (the patient may experience irregular heartbeat, muscle weakness, cramps).

Uncommon (affects fewer than 1 in 100 patients):

• Increased blood sugar (glucose) levels (hyperglycaemia). In diabetic patients, more frequent monitoring of blood glucose levels and adjustment of previously prescribed antidiabetic medication doses may be necessary.
• Cataract (clouding of the eye lens).
• Very rapid heartbeat (tachycardia).
• Tremor and rapid or irregular heartbeat (palpitations) – these symptoms are usually not serious and tend to decrease with continued treatment.
• Atrial fibrillation.
• Ischaemic heart disease, manifested by: chest pain or pressure, shortness of breath.
• Sleep disturbances.
• Restlessness (anxiety).
• Allergic skin rash.

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

• Wheezing or breathing difficulties worsening immediately after taking Flixodil Combo. If such symptoms occur, stop using Flixodil Combo immediately, use a fast-acting inhaled medicine to relieve breathing difficulties, 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 prolonged periods. These effects include:
  • slowed growth in children and adolescents,
  • reduced bone mass,
  • glaucoma,
  • increased body weight,
  • facial rounding (moon face) (Cushing's syndrome).

Your doctor will regularly monitor for such adverse reactions and ensure that you are using the lowest effective dose of Flixodil Combo necessary to control your asthma.

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

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Flixodil Combo

Keep the medicine out of the sight and reach of children.
Store below 25°C.
The metal container contains a pressurised suspension. Do not expose to temperatures above 50°C, and protect from direct sunlight. Do not pierce or burn the container, even if it appears to be empty.
As with most inhaled medicines in pressurised 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 after the abbreviation EXP indicates the expiry date, and after 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. 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 metered dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 50, 125, or 250 micrograms of fluticasone propionate.
• The other ingredient is 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 pressurized suspension for inhalation.
Aluminium container with a metering valve, mouthpiece made of PP, and PP cap, all contained 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