Comboterol

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

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, you should 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, you should 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 packaging 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 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 swelling and inflammation in the lungs.

Your doctor has prescribed this medicine to prevent breathing problems that occur in asthma. To ensure that your asthma is properly controlled, Comboterol must be used every day, as directed 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.

You should always carry a fast-acting bronchodilator, such as salbutamol, with you.

2. Important information before using Comboterol

When not to use Comboterol

• if you are allergic to salmeterol, fluticasone propionate, or the excipient norflurane (HFA 134a).

Warnings and precautions

Before starting to use Comboterol, you should 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

You should 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 to use Comboterol, you should inform 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, you should ask your doctor for advice before using this medicine. Your doctor will assess whether you can use 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

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

• Comboterol should be used every day, until your doctor advises you to stop. Do not take a higher dose than recommended. If you are unsure, you should ask your doctor or pharmacist.
• Do not stop using Comboterol or reduce the dose without consulting your doctor.
• Comboterol should be inhaled into the lungs through the mouth.

Adults and adolescents from 12 years of age:

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

• once a day, in the evening, if you experience symptoms at night,
• once a day, in the morning, if you experience symptoms 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 your 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 to use 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 periodically that you are using the inhaler correctly. Using Comboterol contrary to your doctor's recommendation or using the inhaler incorrectly may result in the medicine not working 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 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 that the inhaler is working, shake it vigorously, point the mouthpiece away from you, and release 4 doses of medicine into the air. The counter should show 120, corresponding to the number of doses in the inhaler. If the inhaler has not been used for a week or longer, remove the cap from the mouthpiece, shake it vigorously, and release two 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. Inhale while standing or sitting.
• 2. Remove the cap from the mouthpiece of the inhaler. Check the mouthpiece outside and inside to ensure it is clean and free of foreign objects (Figure A).

• 3. Shake the inhaler 4 or 5 times to ensure that any foreign objects are removed and the contents of the inhaler are evenly mixed (Figure 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 (Figure C).

• 5. Put the mouthpiece in your mouth and seal your lips around it. Do not bite the mouthpiece (Figure 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 to breathe in slowly and deeply (Figure D).
• 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 (Figure E).

• 8. If your doctor has prescribed two inhalations of the medicine, 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 into place. 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 rush the actions described in points 4, 5, 6, and 7. It is essential to breathe in as slowly as possible before using the inhaler. To ensure that the inhalation is performed correctly, you should initially check how you are taking the medicine 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 actions 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 are using 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 the medicine needed to control your asthma symptoms. You should 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 two fingers on top of the inhaler and both thumbs on the bottom below the mouthpiece. If the counter shows "40", you should remember that the medicine is about to run out. You should replace the inhaler with the medicine 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 counter reading, as it cannot be reset.

Cleaning the inhaler

To prevent the inhaler from clogging, you should 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 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 Comboterol 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,
• muscle weakness and joint pain.

If you use higher doses for an extended period, you should contact 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, you should take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping the use of Comboterol

It is crucial to take Comboterol every day, as directed by your doctor. You should take the medicine until your doctor tells you to stop.Do not stop taking Comboterol or reduce the dose without consulting your doctor.Your symptoms may worsen. Additionally, stopping or reducing the dose of Comboterol may (very rarely) cause adrenal gland problems (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. 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, 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 have any further questions about using this medicine, you should 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.

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

After using Comboterol, you may experience 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 immediately after using Comboterol, you should stop using the medicine and contact your doctor immediately.Allergic reactions to Comboterol are uncommon (they may affect up to 1 in 100 people taking the medicine). Other side effects:

• Very common side effects(may 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 side effects(may affect up to 1 in 10 people):

• thrush (painful, creamy-white patches) in the mouth and throat, as well as pain in the tongue, hoarseness, loss of voice, and irritation of the throat. 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.

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) You should tell your doctor if any of the following symptoms occur while using Comboterol - they may be symptoms of a lung infection:
• fever or chills.
• increased production of sputum or change in sputum color.
• worsening of cough or increased difficulty breathing.
• easy 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, 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 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.
• atrial fibrillation.
• ischemic heart disease, which can cause chest pain and shortness of breath.
• sleep disturbances.
• anxiety.
• allergic skin rash.

Rare side effects(may affect up to 1 in 1000 people):

• wheezing or breathing difficulties worsening immediately after using Comboterol.If you experience such symptoms, you should stop using Comboterol, use a fast-acting inhaler, and contact your doctor immediately.
• Comboterol may disrupt the normal production of steroid hormones by the body, especially when taking high doses of the medicine for an extended period. These symptoms include:
• slowed growth in children and adolescents,
• decreased bone density,
• glaucoma,
• weight gain,
• rounding of the face (Cushing's syndrome). Your doctor will regularly check for these side effects and ensure that you are using the smallest dose of Comboterol that will control 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, but do not stop using Comboterol 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 the available data):

• depression or aggression. The occurrence of these side effects is more likely in children.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported 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. Side effects can also be reported 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 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 to be empty. Do not store in a cold place, as this may affect the proper functioning of the inhaler.
• As with most inhalers in pressurized containers, the therapeutic effect of this medicine may decrease if the container is cold.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 inhaler (delivered dose).
• The other ingredient is the propellant norflurane (HFA 134a).

This medicine contains fluorinated greenhouse gases. Each inhaler contains 12.5 g of 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 consists of 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: