Fluticomb

Leaflet accompanying the packaging: patient information

Fluticomb, (25 micrograms + 50 micrograms)/metered dose, inhalation aerosol,

suspension

Fluticomb, (25 micrograms + 125 micrograms)/metered dose, inhalation aerosol, suspension

Fluticomb, (25 micrograms + 250 micrograms)/metered dose, inhalation aerosol, suspension

Salmeterol + Fluticasone propionate

It is essential to carefully read the contents of the leaflet before using the medication, as it contains important information for the patient.

• The leaflet should be kept to be able to read it again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medication has been prescribed to a specific person. It should not be given to others. The medication 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Fluticomb and what is it used for
• 2. Important information before using Fluticomb
• 3. How to use Fluticomb
• 4. Possible side effects
• 5. How to store Fluticomb
• 6. Package contents and other information

1. What is Fluticomb and what is it used for

Fluticomb contains two active substances: salmeterol (as salmeterol xinafoate) and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help maintain airway patency. This facilitates airflow to and from 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 medication to the patient to prevent breathing disorders that occur in asthma. To ensure proper control of asthma, Fluticomb must be used every day, as recommended by the doctor.

Fluticomb prevents the occurrence of shortness of breath and wheezing in the airways. However, it should not be used to control 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 have such a medication with them.

It is very important to follow the doctor's instructions and use the medication as directed.

2. Important information before using Fluticomb

When not to use Fluticomb:

Warnings and precautions

Before starting to use Fluticomb, 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 (Fluticomb 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.

Fluticomb and other medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, including those used for asthma and those available without a prescription. Fluticomb should not be used with certain medications. Before starting to use Fluticomb, the patient should inform their doctor about taking the following medications:

• Beta-blockers (e.g., atenolol, propranolol, and sotalol). Beta-blockers are most commonly used to treat high blood pressure or other heart conditions.
• Medications used to treat infections (e.g., ketoconazole, itraconazole, and erythromycin), including some medications used to treat HIV (e.g., ritonavir, cobicistat-containing products). Some of these medications 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 medications.
• Corticosteroids (orally or by injection). If the patient has recently taken such medications, it may increase the risk of adrenal gland disorders.
• Diuretics used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medications 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 medication.

Driving and operating machinery

It is unlikely that Fluticomb will affect the ability to drive or operate machinery.

Athletes

Using the medication without a therapeutic need is considered doping and may still result in a positive doping test.

3. How to use Fluticomb

This medication should always be used as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.

• Fluticomb should be used daily until the doctor recommends otherwise. The recommended dose should not be exceeded. In case of doubts, the doctor or pharmacist should be consulted.
• The use of Fluticomb should not be stopped or the dose reduced without consulting the doctor.
• Fluticomb should be inhaled into the lungs through the mouth.
• The number of doses should always be controlled. The inhaler is designed to deliver 120 doses. However, it is not possible to determine when the inhaler is empty and when 120 doses have been released. A small amount of suspension may remain in the container. Therefore, the inhaler should be replaced after 120 doses to ensure that the correct amount of medication is received with each release.

Adults and adolescents over 12 years old:

• Fluticomb, (25 micrograms + 50 micrograms): two inhalations twice a day.
• Fluticomb, (25 micrograms + 125 micrograms): two inhalations twice a day.
• Fluticomb, (25 micrograms + 250 micrograms): two inhalations twice a day.

Children from 4 to 12 years old:

• Fluticomb (25 micrograms + 50 micrograms): two inhalations twice a day.
• Fluticomb is not recommended for use in children under 4 years old.

If the symptoms are well-controlled while using Fluticomb 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 to follow the doctor's instructions regarding the number of inhalations to use and how often to use them. If the patient is using Fluticomb to treat asthma, the doctor will regularly monitor the symptoms.

In case of worsening asthma symptoms or loss of asthma control, the patient should

immediately contact their doctor.There may be an increase in wheezing, more frequent chest tightness, or a need for a higher dose of a fast-acting inhalation medication to facilitate breathing. In such a situation, the patient should continue to use Fluticomb but not increase the number of inhalations. The symptoms of the disease may worsen, and the patient's 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 properly use the inhaler. They should periodically check that the patient is using the inhaler correctly. Using Fluticomb contrary to the doctor's instructions or improper use of the inhaler may result in the medication not providing the expected improvement in asthma.
• The medication is contained in a pressurized container, in a plastic casing with a mouthpiece.
• A new, full inhaler contains enough medication for at least 120 doses. After 120 releases, the inhaler may no longer contain enough medication to deliver a full dose.

Checking the inhaler

• 1. Before first use, the patient should check that the inhaler is working. The cap should be removed from the mouthpiece by gently pressing the sides of the cap with the thumb and index finger.
• 2. To ensure that the inhaler is working, the patient should shake it vigorously, point the mouthpiece away from themselves, and press the container firmly to release a dose of medication into the air. This process should be repeated, shaking the inhaler and releasing a second dose of medication into the air. Before using the inhaler, two doses of medication should be released into the air.
• 3. After these two attempts, the patient can start using the inhaler.
• 4. If the inhaler has not been used for a week or longer, it should be tested. To do this, the patient should shake it vigorously and then point the mouthpiece away from themselves and press the container firmly to release two doses of medication into the air.

IMPORTANT

The metal containers of the inhaler should never be detached at any time. If the inhaler is very cold (below 0°C), the metal container should be removed from the plastic casing and warmed in the hands for a few minutes before use. The inhaler should never be heated using anything else. After warming and before using the inhaler, the patient should press the container firmly to release two doses of medication into the air.

Reordering

Before the inhaler is empty and all doses have been released, the patient should order a new inhaler. This should be done to avoid running out of medication.

Using the inhaler

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

• 1. Inhalation should be performed standing or sitting upright.
• 2. The cap should be removed from the mouthpiece of the inhaler (as shown in figure A).
• 3. The mouthpiece should be checked outside and inside to ensure it is clean and free of foreign objects.
• 4. The inhaler should be shaken 4 or 5 times to ensure the contents are well mixed (figure B).
• 5. The inhaler should be held with the fingers, with the thumb on the base of the inhaler, below the mouthpiece. The patient should take a deep breath out, as deep as possible (figure C).
• 6. The mouthpiece should be placed in the mouth, between the upper and lower teeth, and sealed with the lips. The mouthpiece should not be bitten.
• 7. The patient should start a slow and deep inhalation through the mouth. Immediately after starting inhalation, the patient should press the inhaler to release a dose of medication, and then continue with a calm, deep inhalation (figure D).
• 8. The breath should be held for a few seconds or as long as it is comfortable, and then the patient should exhale slowly.
• 9. The patient should wait about half a minute before repeating the steps described in points 4 to 8.
• 10. Rinsing the mouth with water and spitting it out and/or brushing the teeth after inhalation can help prevent hoarseness and thrush.
• 11. After inhalation, the cap should always be placed on the mouthpiece to prevent dust from entering it (figure E). The cap should be placed by pressing it into the correct position. A click should be heard when the cap is properly closed. Excessive force should not be used.

The steps described in points 5, 6, 7, and 8 should not be rushed. It is essential to breathe as slowly as possible before inhalation. To ensure that the inhalation is performed correctly, the patient should initially control the inhalation technique in front of a mirror. The "mist" coming out of the inhaler, mouth, or nose during inhalation indicates an incorrect inhalation technique. The patient should repeat the steps, starting from point 4. As with all inhalers, caregivers should ensure that children prescribed Fluticomb use the inhaler correctly, as described above. If the patient has difficulty coordinating their breath and inhalation from the inhaler, the doctor may recommend using the inhaler in combination with an AeroChamber Plus inhalation chamber. The doctor, nurse, or pharmacist should instruct the patient on how to properly use the inhaler with the inhalation chamber and how to care for the inhalation chamber, and answer any questions the patient may have. If the patient uses an inhalation chamber, it is essential not to stop using it without consulting the doctor or nurse. Other inhalation chambers should not be used to inhale Fluticomb, and the type of inhalation chamber used should not be changed. It is also essential that the patient does not change the type of inhalation chamber or stop using it without consulting the doctor. The doctor may decide to change the treatment. The patient should always consult their doctor before making any changes to their asthma treatment. Older children or people with weak hands may find it easier to hold the inhaler with both hands. The patient should hold the inhaler with two index 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:

• The cap should be removed from the mouthpiece.
• The metal container should not be removed from the plastic casing during cleaning or at any other time.
• The mouthpiece should be cleaned inside and outside, and the plastic casing should be cleaned outside with a dry cloth or tissue.
• The cap should be placed on the mouthpiece. A click should be heard when the cap is properly closed. Excessive force should not be used.
• The inhaler should not be washed or submerged in water.

Using a higher dose of Fluticomb than recommended

It is essential to use the inhaler as directed. If a higher dose than recommended is used accidentally, the doctor or pharmacist should be informed. The following symptoms may occur: faster than normal heartbeat, tremors, dizziness, headache, muscle weakness, and joint pain. If higher doses are used for an extended period, the patient should contact their doctor or pharmacist for advice, as high doses of Fluticomb may cause a decrease in the production of steroid hormones by the adrenal glands.

Missing a dose of Fluticomb

A double dose should not be used to make up for a missed dose. The next dose should be taken at the scheduled time.

Stopping the use of Fluticomb

It is very important to take Fluticomb every day as directed by the doctor. The patient should take the medication until the doctor recommends stopping it. The use of Fluticomb should not be stopped suddenly or the dose reduced, as the symptoms of the disease may worsen. Additionally, sudden stopping or reduction of Fluticomb may (very rarely) cause adrenal gland disorders (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 body is under stress due to fever, injury (such as a 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 inform their doctor or pharmacist. To prevent these symptoms, the doctor may prescribe additional corticosteroids in the form of tablets (e.g., prednisolone). If the patient has any further doubts about using this medication, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Fluticomb can cause side effects, although not everyone will experience them. To minimize the risk of side effects, the doctor will recommend the smallest dose of Fluticomb that controls asthma.

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

The patient may experience an increase in 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 rapid heartbeat, weakness, or dizziness (which can lead to falls or loss of consciousness). If any of these symptoms occur suddenly after using Fluticomb, the patient should stop using Fluticomb and contact their doctor immediately.Allergic reactions to Fluticomb are not very common (they may occur less often than in 1 in 100 people). Other side effects:

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

• Headache - this side effect usually decreases over time while continuing treatment.
• There have been reports of an increased incidence of colds in patients with chronic obstructive pulmonary disease (COPD).

Common (may occur less often than in 1 in 10 people):

• Thrush (painful, creamy-white patches) 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 after each inhalation may be helpful. The doctor may recommend an antifungal medication to treat thrush.
• 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). The patient should inform their doctor if they experience any of the following symptoms: increased mucus production, change in mucus color, fever, chills, worsening cough, or increased breathing difficulties.
• Easier 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, or cramps).

Uncommon (may occur less often than in 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 medications being taken.
• Cataract (clouding of the lens of 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.
• Chest pain.
• Anxiety (mainly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare (may occur less often than in 1 in 1000 people):

• Wheezing or breathing difficulties worsening immediately after taking Fluticomb.If such symptoms occur, the patient should stop using Fluticomb, use a fast-acting inhalation medication to facilitate breathing, and contact their doctor immediately.
• Fluticomb may disrupt the normal production of steroid hormones by the body, especially when taking high doses for an extended period. Symptoms may include:
• growth retardation in children and adolescents,
• decreased bone density,
• glaucoma,
• weight gain,
• moon face (Cushing's syndrome). The doctor will regularly check for these side effects and ensure that the patient is using the smallest dose of Fluticomb 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, but not stop using Fluticomb unless the doctor recommends it.
• Fungal infection of the esophagus, which can cause difficulty swallowing.

Side effects with unknown frequency (frequency cannot be determined from 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 this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products 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 marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medication.

5. How to store Fluticomb

The medication should be stored out of sight and reach of children. It should not be stored at a temperature above 25°C. After using the inhaler, the cap should be placed on the mouthpiece by pressing it into the correct position. Excessive force should not be used. The metal container contains a pressurized suspension. It should not be exposed to temperatures above 50°C, and it should be protected from direct sunlight. The container should not be pierced, broken, or burned, even if it seems empty. As with most inhalation medications in pressurized containers, the therapeutic effect of this medication may decrease when the container is cold. The medication should not be used after the expiration date stated on the packaging after EXP. The expiration date indicates the last day of the specified month. The inscription on the packaging after the abbreviation EXP indicates the expiration date, and after the abbreviation Lot, it indicates the batch number. Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Fluticomb contains

• The active substances of Fluticomb are salmeterol and fluticasone propionate. Each metered dose of the medication 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). This medication contains fluorinated greenhouse gases. Each 120-dose inhaler contains 11.2 g of HFA - 134a, which is equivalent to 0.016 tons of CO2 equivalent (GWP = 1430).

What Fluticomb looks like and what the package contains

Fluticomb is supplied in a metered-dose inhaler containing the medication in the form of a pressurized suspension for inhalation through the mouth into the lungs. The container is a pressurized inhalation suspension. The packaging includes an aluminum container with a valve, fitted with a plastic mouthpiece and a purple cap, all in a cardboard box. Each package contains 1 inhaler. Each inhaler contains 120 doses.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer

Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA), Italy, Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, Poland, Date of last revision of the leaflet:March 2025