COMBOTEROL 25 mcg + 250 mcg Aerosol

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Comboterol, (25 µg + 125 µg)/inhalation dose, inhalation aerosol, suspension
3. Comboterol, (25 µg + 250 µg)/inhalation dose, inhalation aerosol, suspension
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Comboterol and what is it used for
   1. Comboterol 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.
5. Important information before using Comboterol
   1. When not to use Comboterol
   2. Warnings and precautions
   3. Comboterol and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
6. How to use Comboterol
   1. Adults and adolescents 12 years and older:
   2. If your asthma symptoms worsen or asthma control deteriorates, you should
   3. Instructions for using the inhaler:
   4. Checking the inhaler
   5. Using the inhaler
   6. Cleaning the inhaler
   7. Using a higher dose of Comboterol than recommended
   8. Missing a dose of Comboterol
   9. Stopping use of Comboterol
7. Possible side effects
   1. Allergic reactions: You may experience sudden breathing difficulties immediately after using Comboterol.
   2. Pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD) (common side effect)
   3. Reporting side effects
8. How to store Comboterol
9. Contents of the pack and other information
   1. What Comboterol contains
   2. What Comboterol looks like and contents of the pack
   3. Marketing authorization holder and importer
   4. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Comboterol, (25 µg + 125 µg)/inhalation dose, inhalation aerosol, suspension

Comboterol, (25 µg + 250 µg)/inhalation dose, inhalation aerosol, suspension

Salmeterol + Fluticasone propionate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Comboterol and what is it used for
• 2. Important information before using Comboterol
• 3. How to use Comboterol
• 4. Possible side effects
• 5. How to store Comboterol
• 6. Contents of the pack and other information

1. What is Comboterol and what is it used for

Comboterol contains two active substances: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help 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 swelling and irritation in the lungs.

Your doctor has prescribed this medicine to prevent breathing problems that occur in asthma. To ensure proper control of asthma, Comboterol must be used every day, as recommended by your doctor.

Comboterol 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.

The doctor will determine the smallest dose of Comboterol that will control your asthma symptoms.

2. Important information before using Comboterol

When not to use Comboterol

Warnings and precautions

Before starting treatment with Comboterol, talk to your doctor, pharmacist, or nurse if you have:

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

Comboterol and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, including those used for asthma and those available without a prescription. Comboterol should not be used with certain medicines. Before starting treatment with Comboterol, tell your doctor if you are taking:

• beta-blockers (e.g., atenolol, propranolol, sotalol). Beta-blockers are most commonly used to treat high blood pressure or other heart diseases.
• medicines used to treat infections (e.g., ritonavir, ketoconazole, itraconazole, and erythromycin). 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 side effects.
• corticosteroids (orally or by injection). If you have 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, breastfeeding, and fertility

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 Comboterol during this period.

Driving and using machines

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

3. How to use Comboterol

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor, nurse, or pharmacist.

• Use Comboterol every day, until your doctor tells you to stop. Do not take more than the recommended dose. If you are not sure, ask your doctor or pharmacist.
• Do not stop using Comboterol or reduce the dose without consulting your doctor.
• Use Comboterol by inhalation into the lungs through the mouth.

Adults and adolescents 12 years and older:

• Comboterol (25 micrograms + 125 micrograms)/inhalation dose - two inhalations twice a day.
• Comboterol (25 micrograms + 250 micrograms)/inhalation dose - two inhalations twice a day.

Comboterol is not recommended for use in children under 12 years of age. Your doctor will determine the smallest dose that will control your asthma symptoms. If your asthma symptoms are well-controlled during twice-daily use of Comboterol, your doctor may recommend reducing the frequency of Comboterol 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 much to inhale and how often. If you are using Comboterol for 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 need to use more of your fast-acting inhaler. In this situation, continue using Comboterol, 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 check your technique periodically to ensure you are using the inhaler correctly. Not using Comboterol as directed or not using the inhaler correctly may mean that the medicine does not work as well as expected to control your asthma.
• The medicine is in a pressurized container, in a plastic casing with a mouthpiece.
• On the front of the inhaler, there is a dose counter that shows how many doses of medicine are left in the inhaler. When using the inhaler, the number shown by the counter decreases usually after 5 to 7 released doses. The counter shows an approximate number of doses of medicine.
• Be careful not to drop the inhaler, as this may cause the dose counter to decrease.

Checking the inhaler

• 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 4 doses of medicine into the air. The counter should show 120, which corresponds to the number of doses in the inhaler. If the inhaler has not been used for a week or more, remove the cap from the mouthpiece, shake the inhaler vigorously, and release 2 doses of medicine into the air.

Using the inhaler

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

• 1. Stand or sit upright when inhaling.
• 2. Remove the cap from the mouthpiece. Check the mouthpiece for foreign objects, and ensure it is clean.

• 3. Shake the inhaler 4 or 5 times to ensure any foreign objects are removed and the contents are well mixed (labeled B).

• 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 (labeled C).

• 5. Put the mouthpiece in your mouth and seal your lips around it. Do not bite the mouthpiece (labeled D).

• 6. Start breathing in slowly and deeply. Immediately after starting to breathe in, press the inhaler to release a dose of medicine, and then continue breathing in slowly and deeply (labeled D).
• 7. Hold your breath, take the inhaler out of your mouth, and remove your finger from the inhaler. Hold your breath for a few seconds or as long as is comfortable, then breathe out slowly (labeled E).

• 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 each inhalation helps 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 as slowly as possible before using the inhaler. To ensure the inhalation is done correctly, initially, you should practice 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. If you have difficulty coordinating your breath with the inhaler, you may be advised to use a spacer with the inhaler. Your doctor, nurse, or pharmacist should instruct you on how to use the inhaler with a spacer and how to care for the spacer, and answer any questions you may have. If you use a spacer, it is essential not to stop using it without consulting your doctor or nurse. It is also crucial not to change the type of spacer without consulting your doctor. If you stop using the spacer or change its type, your doctor may decide to change the dose of Comboterol needed to control your asthma symptoms. Always consult your doctor before making any changes to your asthma treatment. People with weak hands may find it easier to hold the inhaler with both hands. You should hold the inhaler with your index fingers on top of the inhaler and your thumbs on the bottom, below the mouthpiece. If the counter shows "40", remember that the inhaler is almost empty. You should replace the inhaler with a new one when the counter shows "0", as the amount of medicine left in the inhaler may not be sufficient to deliver a full dose. Never try to increase the dose counter reading, as it cannot be reset.

Cleaning the inhaler

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

• Remove the cap from the mouthpiece.
• Do not remove the metal container from the plastic casing during cleaning or at any other time.
• Clean the mouthpiece inside and outside and the plastic casing outside with a dry cloth or tissue.
• Replace the cap on the mouthpiece. When replacing the cap correctly, you will hear a click. If you do not hear a click, remove the cap, 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 Comboterol than recommended

It is essential to use the inhaler as directed. If you accidentally use a higher dose than recommended, tell your doctor or pharmacist. You may experience:

• rapid heartbeat,
• tremors,
• dizziness,
• headache,
• muscle weakness, and
• joint pain.

If you use higher doses for an extended period, consult your doctor or pharmacist for advice, as high doses of Comboterol may cause a decrease in the production of steroid hormones by the adrenal glands.

Missing a dose of Comboterol

If you forget to take a dose, take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

Stopping use of Comboterol

It is crucial to take Comboterol every day, as directed by your doctor. Do not stop taking Comboterol or reduce the dosewithout consulting your doctor, as your symptoms may worsen. Additionally, stopping or reducing the dose of Comboterol may (very rarely) cause adrenal gland problems (adrenal insufficiency), which can lead to side effects, including:

• abdominal pain,
• fatigue and loss of appetite, nausea,
• vomiting and diarrhea,
• weight loss,
• headache and drowsiness,
• low blood sugar, and
• low blood pressure and seizures. When the body is under stress, such as from fever, injury (e.g., a car accident), infection, or surgery, adrenal insufficiency may worsen, and any of the above side effects may occur. If you experience any of these side effects, tell your doctor or pharmacist. To prevent these side effects, your doctor may prescribe additional corticosteroids in tablet form (e.g., prednisolone).

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Comboterol can cause side effects, although not everybody gets them. To minimize the risk of side effects, your doctor will prescribe the smallest dose of Comboterol that will control your asthma symptoms.

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

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 may lead to falls or loss of consciousness). If you experience any of these symptoms soon after using Comboterol, stop using the medicine and contact your doctor immediately.Allergic reactions to Comboterol are uncommon (may affect up to 1 in 100 people). Other side effects:

• Very common side effects(may affect more than 1 in 10 people):
• headache - this side effect usually decreases over time as treatment continues.
• increased frequency of colds in patients with COPD.

Common side effects(may affect up to 1 in 10 people):

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

Pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD) (common side effect)

In patients with chronic obstructive pulmonary disease (COPD), the following side effects have been reported:

• pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD) (common side effect) Tell your doctorif you experience any of the following symptoms while using Comboterol - they may be signs of a lung infection:
• fever or chills.
• increased production of mucus or change in mucus color.
• worsening cough or increased breathing difficulties.
• easy bruising and fractures.
• sinusitis (feeling of tension and fullness in the nose, cheeks, and behind the eyes, sometimes with a pulsating headache).
• low potassium levels in the blood (you may experience irregular heartbeat, muscle weakness, or cramps).

Uncommon side effects(may affect up to 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.
• cataract (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 as treatment continues.
• atrial fibrillation.
• ischemic heart disease, which may cause chest pain or tightness and shortness of breath.
• sleep disturbances.
• restlessness.
• allergic skin rash.

Rare side effects(may affect up to 1 in 1,000 people):

• wheezing or breathing difficulties worsening immediately after using Comboterol.If you experience such symptoms, stop using Comboterol, use a fast-acting inhaler, and contact your doctor immediately.
• Comboterol may affect the normal production of steroid hormones in the body, especially when taking high doses for a long time. These side effects 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 you are using the smallest dose of Comboterol that will control your asthma symptoms.
• changes in behavior, such as excessive excitement and irritability (these symptoms occur mainly in children).
• irregular heartbeat or extra heartbeats (arrhythmias). Tell your doctor, but do not stop using Comboterol unless your doctor tells 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. These side effects are more likely to occur in children.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring, 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 Comboterol

• Keep out of the sight and reach of children.
• Do not use Comboterol after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated.
• After inhalation, replace the cap on the mouthpiece, pushing it back into place. Do not use too much force.
• Do not store above 25°C.
• The metal container contains a pressurized suspension. Do not expose the container to temperatures above 50°C. Do not pierce or burn the container, even if it appears empty. Do not store in a cold place, as this may affect the proper functioning of the inhaler.
• As with most inhalers, the therapeutic effect of this medicine may decrease when the container is cold.

Medicines should 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 pack and other information

What Comboterol contains

• Each dose of Comboterol contains 25 micrograms (μg) of salmeterol (as salmeterol xinafoate) and 125 or 250 micrograms (μg) of fluticasone propionate (delivered by the valve). This corresponds to 21 micrograms of salmeterol and 110 or 220 micrograms of fluticasone propionate delivered by the actuator (delivered dose).
• The other ingredient is the propellant norflurane (HFA 134a).

This medicine contains fluorinated greenhouse gases. Each inhaler contains 12.5 g HFA 134a (norflurane), which corresponds to 0.0179 tons of CO2 equivalent (global warming potential GWP = 1430).

What Comboterol looks like and contents of the pack

• Comboterol is supplied in an inhaler containing the medicine as a pressurized suspension for inhalation through the mouth into the lungs.
• The container contains a homogeneous white suspension.
• The packaging is an aluminum container (FCP) closed with a metering valve, fitted with a plastic actuator with a dose counter, in a cardboard box.
• Pack sizes: 1 container containing 120 doses.

Marketing authorization holder and importer

LEK-AM Pharmaceutical Company Ltd.
ul. Ostrzykowizna 14A
05-170 Zakroczym
Poland
Tel.: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106

Date of last revision of the leaflet: