Leaflet: information for the user

Salmeterol/fluticasone propionate 25 micrograms/125 micrograms/inhalation, pressurized inhalation suspension

salmeterol/propionato de fluticasona

Read this leaflet carefully before you start 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Inaladuo contains two active ingredients, salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways in the lungs open, making it easier for air to enter and leave. The effects last for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces inflammation and irritation in the lungs.

Your doctor has prescribed this medication to help prevent respiratory problems such as asthma.

You must use Inaladuo every day as recommended by your doctor. This will ensure the medication works correctly in controlling your asthma.

Inaladuo helps prevent shortness of breath and wheezing. However, Inaladuo should not be used to relieve a sudden attack of shortness of breath or wheezing. In such a case, you must use your quick-relief rescue medication, such as salbutamol. You should always carry your quick-relief rescue medication with you.

Do not use Inaladuo:

• if you are allergic to salmeterol, fluticasone propionate, or any other component, norflurane (HFA 134a).

Warnings and precautions

Consult your doctor before starting to use Inaladuo if you have:

• Cardiac alterations, including rapid or irregular heartbeat.
• Hyperthyroidism.
• High blood pressure.
• Diabetes mellitus (Inaladuo may increase blood sugar levels).
• Low levels of potassium in the blood.
• Tuberculosis (TB) today or in the past, or other lung infections.

Contact your doctor if you experience blurred vision or other visual disturbances.

Other medications and Inaladuo

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those for asthma or those obtained without a prescription. This is because, in some cases, Inaladuo should not be administered with other medications.

Inform your doctor if you take any of the following medications before starting to use Inaladuo:

• β-blockers (such as atenolol, propranolol, and sotalol). β-blockers are used mainly to treat hypertension or other cardiac conditions.
• Medications to treat infections (such as ketoconazole, itraconazole, and erythromycin), including some HIV medications (such as ritonavir, cobicistat). Some of these medications may increase the amount of fluticasone propionate or salmeterol in your body. This may increase your risk of experiencing adverse effects with Inaladuo, including irregular heartbeat, or may worsen the adverse effects. Your doctor may perform close monitoring if you are taking these medications.
• Corticosteroids (oral or injectable). If you have taken these medications recently, you may increase the risk of this medication affecting your adrenal gland.
• Diuretics, also known as medications to urinate, used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medications containing xanthine. They are often used to treat asthma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Inaladuo is unlikely to affect your ability to drive or operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Use Inaladuo every day until your doctor tells you to stop. Do not take more than the recommended dose. If in doubt, consult your doctor or pharmacist.
• Do not stop taking Inaladuo or reduce your dose without talking to your doctor first.
• Inaladuo must be inhaled through the mouth into the lungs.

Adults and adolescents 12 years and older

• Inaladuo 25/50 micrograms2 applications twice a day
• Inaladuo 25/125 micrograms2 applications twice a day
• Inaladuo 25/250 micrograms2 applications twice a day

Children 4 to 12 years of age

• Inaladuo 25/50 micrograms2 applications twice a day

Inaladuo is not recommended for use in children under 4 years of age.

Your symptoms may be well controlled using Inaladuo twice a day. If so, your doctor may decide to reduce your dose to once a day. The dose may change to:

• once at night if you have nocturnal symptomssymptoms,
• once in the morning if you have diurnal symptomssymptoms.

It is very important to follow your doctor's instructions on how many applications and how often to administer them.

If you are using Inaladuo to treat asthma, your doctor will want to monitor your symptoms regularly.If your asthma worsens or you have greater difficulty breathing, see your doctor immediately.You may notice more wheezing, or a feeling of choking more often, or that you have to use your rescue medication more frequently. If any of these things happen, you should continue using Inaladuo, but do not increase the number of applications. Your respiratory disease may worsen and seriously ill. See your doctor, as you may need additional treatment.

Instructions for use

• Your doctor, nurse, or pharmacist should teach you how to use your inhaler. Periodically, they should check how you use it. Not using Inaladuo inhaler properly or as prescribed may result in your asthma not improving as it should.
• The medication is located in a pressure cartridge within a plastic casing with a mouthpiece.
• The inhaler has a counter on the back that informs you of how many applications are left. Each time you activate the inhaler, one application will be released and the counter will decrease by one unit.
• Be careful not to drop the inhaler, as this may cause the counter to decrease some units.

Checking the inhaler

1. If you are using the inhaler for the first time, check that it works properly. Remove the mouthpiece protector by pressing it gently on the sides with your thumb and index finger and pulling it off.

1. To ensure it works, shake the inhaler well, direct the mouthpiece away from you, and press the cartridge down to release one application into the air. Repeat these steps, shaking the inhaler before releasing each application, until the counter marks 120. If you have not used your inhaler for a week or more, release two applications of the medication into the air.

Using the inhaler

It is essential to start inhaling as slowly as possible just before using your inhaler.

1.It is recommended that you stand or sit upright while using the inhaler.

2.Remove the mouthpiece protector (as shown in the figure). Check inside and outside that the mouthpiece is clean and free of any foreign particles.

3.Shake the inhaler 4 or 5 times to ensure the removal of any foreign particles and that the contents of the inhaler are mixed properly.

4.Hold the inhaler in a vertical position with your thumb on the base of the inhaler, below the mouthpiece. Exhale as much air as possible.

5.Place the mouthpiece in your mouth, between your teeth. Close your lips around the mouthpiece. Do not bite it.

6.Take a deep breath in through your mouth slowly and deeply. Immediately after starting to breathe in, press firmly on the top of the inhaler to release the medication. Do this while continuing to breathe in deeply and constantly.

7.Hold your breath, remove the inhaler from your mouth by releasing your thumb from the top of the inhaler. Continue holding your breath for a few seconds, as long as possible.

1. Wait approximately half a minute between each medication application and then repeat steps 3 to 7.

1. After that, rinse your mouth with water and spit it out and/or brush your teeth. This will help prevent mouth ulcers and sore throat.

1. After using it,always put the mouthpiece protector back on immediately to preserve it from dust. When the mouthpiece protector is put back on correctly, it will make a "click" sound. If it does not make a "click" sound, turn the mouthpiece protector around, put it back on, and try again. Do not use excessive force.

Take your time in steps 4, 5, 6, and 7. It is essential to breathe out as slowly as possible just before using the inhaler. The first time you use the inhaler, you should use it in front of a mirror. If you see "fog" coming out of the top of the inhaler or from the sides of your mouth, you should start again from step 3.

Just like all inhalers, caregivers should ensure that children using Inaladuo Inhaler use the inhalation technique described above correctly.

If you or your child find it difficult to use the inhaler, your doctor, nurse, or other healthcare professional may recommend using the inhaler with the Volumatic inhalation chamber. Your doctor, nurse, pharmacist, or other healthcare professional should show you how to use the inhalation chamber with your inhaler, how to store your inhalation chamber, and answer any questions you may have. If you are using the inhalation chamber with your inhaler, it is essential that you do not stop using it without consulting your doctor or nurse first. Also, it is essential that you do not change the type of inhalation chamber you are using without consulting your doctor. If you stop using the inhalation chamber or change the type of inhalation chamber, your doctor may need to change the dose of medication needed to control your asthma. Always consult your doctor before making any changes to your asthma treatment.

Some children or people with little hand strength may find it easier to hold the inhaler with both hands. Place both index fingers on the top of the inhaler and both thumbs on the base, below the mouthpiece.

You should get a replacement inhaler when the marker indicates 020. Stop using the inhaler when the marker indicates 000, as the remaining applications in the cartridge may not be enough to complete a dose. Never try to modify the marker number or remove the marker from the metal cartridge.

Cleaning the inhaler

To prevent your inhaler from blocking, it is essential to clean it at least once a week.

To clean your inhaler:

• Remove the mouthpiece protector.
• Do not remove the metal cartridge from the plastic casing at any time.
• Clean the inside and outside of the mouthpiece and plastic casing with a dry cloth.
• Put the mouthpiece protector back on. It will make a "click" sound when it is put back on correctly. If it does not make a "click" sound, turn the mouthpiece protector around, put it back on, and try again. Do not use excessive force.

Do not immerse the metal cartridge in water.

If you use more Inaladuo than you should

It is very important to use the inhaler as instructed. If you accidentally take a higher dose than recommended, consult your doctor or pharmacist. You may notice that your heart beats faster than normal and you feel tremors. You may also have headaches, dizziness, muscle weakness, and joint pain.

If you have used high doses for a long time, you should ask your doctor or pharmacist for advice. This is because high concentrations of Inaladuo can reduce the amount of steroid hormones produced by the adrenal gland.

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount administered.

If you forget to use Inaladuo

Do not take a double dose to compensate for the missed doses. Take the next dose at the usual time.

If you interrupt treatment with Inaladuo

It is very important to use Inaladuo every day as instructed.Continue taking it until your doctor tells you to stop. Do not stop using Inaladuo abruptly. This could make your breathing worse.

Additionally, if you stop taking Inaladuo suddenly or reduce your dose, you may (very rarely) cause problems with your adrenal gland (adrenal insufficiency), which sometimes causes adverse effects.

These adverse effects may include any of the following:

• Stomach pain.
• Fatigue and loss of appetite, feeling unwell.
• Discomfort and diarrhea.
• Weight loss.
• Headache or drowsiness.
• Low blood sugar levels.
• Hypotension and convulsions (seizures).

When your body is under stress, such as fever, trauma (e.g., car accident), infection, or surgery, adrenal insufficiency may worsen and you may experience any of the adverse effects listed above.

If you experience any adverse effects, consult your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe an additional dose of corticosteroids in tablets during that time (such as prednisolone).

If you have any other questions about using this medication, ask your doctor, nurse, or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. To reduce the occurrence of side effects, your doctor will prescribe the lowest dose of Inaladuo that controls your asthma.

Allergic reactions: you may notice that your breathing suddenly worsens immediately after using Inaladuo.You may experience wheezing and coughing or shortness of breath. You may also notice itching, hives (urticaria), and swelling (usually on the face, lips, tongue, or throat). You may also feel, suddenly, that your heart is beating very fast, feel like you are losing consciousness, and dizziness (which can lead to collapse or loss of consciousness).If you experience any of these effects or if they appear suddenly after using Inaladuo, stop taking Inaladuo and inform your doctor immediately.Allergic reactions to Inaladuo are rare (affect less than 1 in 100 people).

The following are other side effects:

Very common(can affect more than 1 in 10 people)

• Headache, usually improves with continued treatment.
• An increase in the number of colds in patients with COPD has been reported.

Common(can affect less than 1 in 10 people)

• Candidiasis (itching, appearance of yellowish-creamy ulcers) in the mouth and throat. Also, tongue pain, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing your teeth immediately after each dose of medication may help you. For the treatment of candidiasis, your doctor may prescribe antifungal medication (for the treatment of fungal infections).
• Joint pain, inflammation, and muscle pain.
• Muscle cramps.

The following side effects have been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):

• Pneumonia and bronchitis (pulmonary infection). Inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum color, fever, chills, increased cough, increased difficulty breathing.
• Cardiac arrhythmias and fractures.
• Swelling of the sinuses (sensation of tension or congestion in the nose, cheeks, and behind the eyes, sometimes with a pulsating pain).
• Reduction of potassium levels in the blood (you may feel irregular heartbeats, muscle weakness, cramps).

Rare (can affect less than 1 in 100 people)

• Increased blood sugar levels (hyperglycemia). If you have diabetes, you will need to monitor your blood sugar levels more frequently and adjust your usual diabetes treatment as needed.
• Cataracts (opacity of the lens of the eye).
• Very fast heart rate (tachycardia).
• Feeling tremors and a fast or irregular heart rate (palpitations). These side effects are usually harmless and decrease when treatment continues.
• Chest pain.
• Sensation of concern (occurs mainly in children).
• Sleep disturbances.
• Skin rash.
• Allergic skin eruption.

Rare (can affect less than 1 in 1,000 people)

• Worsening respiratory difficulties or wheezing that worsen immediately after using Inaladuo.If this happens, stop using Inaladuo.Use your quick-acting rescue inhaler to improve your breathing andinform your doctor immediately.
• Inaladuo may increase normal hormone steroid production, particularly if you have been taking high doses for long periods of time. The effects include:

-Delayed growth in children and adolescents.

-Decreased bone mineral density.

-Glaucoma.

-Weight gain.

-Round face (moon-shaped) (Cushing's syndrome).

Your doctor will regularly monitor any of these side effects and ensure that you are taking the lowest dose of Inaladuo to control your asthma.

• Changes in behavior, such as hyperactivity and irritability (these effects occur mainly in children).
• Irregular heartbeats or extra heartbeats (arrhythmias). Consult your doctor, but do not stop taking Inaladuo unless your doctor tells you to.
• Fungal infection of the esophagus (throat), which can cause difficulty swallowing.

Unknown frequency, but may also occur:

• Depression or aggression. It is more likely that these effects will appear in children.
• Blurred vision.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the case after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.Do not refrigerate or freeze.

As with most pressurized inhalers, the therapeutic effect of the medication may decrease when the cartridge is cold.

The cartridge contains a pressurized liquid. Do not expose to temperatures above 50°C, protect from direct sunlight. Do not pierce, break, or burn the cartridge even if it appears empty.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Inaladuo

• Each pressurized dose contains: 25 micrograms of salmeterol (as xinafoate of salmeterol) and 125micrograms of fluticasone propionate.
• The other component is a propellant: norflurano (HFA 134a).

This medicine contains fluorinated greenhouse gases.

Each inhaler contains 12 g of HFC-134a (also known as norflurano or HFA 134a) corresponding to 0.0172 tons of CO2equivalent (global warming potential PCG = 1 430).

Appearance of the product and contents of the packaging

• Inaladuo Inhaler is presented in a pressurized container with a counter, which releases the medicine in the form of a suspension for inhalation through the mouth to the lungs.
• The cartridge contains a white to off-white inhalation suspension.
• The cartridges are located inside a plastic device that incorporates a mouthpiece and a protector for the same.

The devices are located in packaging of 1 inhaler.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible for manufacturing:

Glaxo Wellcome, S.A.

Avenida de Extremadura, 3 – 09400 Aranda de Duero (Burgos), Spain.

or

Glaxo Wellcome Production

Zone Industrielle No.2, 23 Rue Lavoisier, La Madeleine, 27000 Evreux, France.

Tel: +33 2 3223 5500;

Fax: +33 2 3223 5558

or

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36,D-23843 Bad Oldesloe, Germany.

Last review date of this leaflet:01/2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/