Inaladuo 25 micrograms/250 micrograms/ inhalation, suspension for inhalation in pressurised container

Patient Information Leaflet

Introduction

Patient Information Leaflet

Inaladuo 25 micrograms/250 micrograms/inhalation, pressurised inhalation suspension

salmeterol/fluticasone propionate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Inaladuo is and what it is used for

Inaladuo contains two active substances, salmeterol and fluticasone propionate:

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

Your doctor has prescribed this medicine to help prevent breathing problems such as asthma.

You should use Inaladuo every day as directed by your doctor. This will ensure the medication works properly to control your asthma.

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

2. What you need to know before using Inaladuo

Do not use Inaladuo:

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

Warnings and precautions

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

• Heart problems, including rapid or irregular heartbeat.
• Hyperactive thyroid.
• High blood pressure.
• Diabetes mellitus (Inaladuo may increase blood sugar levels).
• Low potassium levels in the blood.
• Current or past tuberculosis (TB) or other lung infections.

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

Other medicines and Inaladuo

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines for asthma or those obtained without a prescription. The reason is that, in some cases, Inaladuo should not be used together with certain other medicines.

Inform your doctor if you are taking any of the following medicines before starting to use Inaladuo:

• β-blockers (such as atenolol, propranolol, and sotalol). β-blockers are mostly used to treat high blood pressure or other heart conditions.
• Medicines to treat infections (such as ketoconazole, itraconazol, and erythromycin), including some medicines for HIV (such as ritonavir, cobicistat). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This may increase your risk of adverse effects with Inaladuo, including irregular heartbeats, or may worsen side effects. Therefore, your doctor may monitor you closely if you are taking these medicines.
• Corticosteroids (oral or injectable). If you have recently taken these medicines, it may increase the risk that this medicine affects your adrenal gland.
• Diuretics, also known as "water pills", used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthines. These are often used to treat asthma.

Pregnancy and breastfeeding

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

Driving and using machines

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

3. How to use Inaladuo

Follow exactly the administration instructions for this medicine given 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 first talking to your doctor.
• Inaladuo must be inhaled through the mouth into the lungs.

Adults and adolescents aged 12 years and older

• Inaladuo 25/50 micrograms: 2 actuations twice daily
• Inaladuo 25/125 micrograms: 2 actuations twice daily
• Inaladuo 25/250 micrograms: 2 actuations twice daily

Children aged 4 to 12 years

• Inaladuo 25/50 micrograms: 2 actuations twice daily

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

Your symptoms may become well controlled with Inaladuo taken twice daily. If so, your doctor may decide to reduce your dose to once daily. The dose may be changed to:

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

It is very important that you follow your doctor’s instructions regarding how many actuations and how often you should take 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 increasing difficulty breathing, see your doctor immediately. You may notice more wheezing or a greater feeling of breathlessness, or find that you need to use your fast-acting rescue medication more frequently. If any of these occur, you should continue using Inaladuo, but do not increase the number of actuations. Your respiratory condition may worsen and you could become 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. They should periodically check that you are using it correctly. Not using the Inaladuo inhaler properly or as prescribed may result in your asthma not improving as it should.
• The medicine is contained in a pressurized cartridge inside a plastic casing with a mouthpiece.
• The inhaler has a counter on the back that shows how many actuations remain. Each time you activate the inhaler, one actuation is released and the counter decreases by one.
• Be careful not to drop the inhaler, as this may cause the counter to decrease by one unit.

Checking the inhaler

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

1. To ensure it works, shake the inhaler well, point the mouthpiece away from you, and press down on the cartridge to release one actuation into the air. Repeat these steps—shaking the inhaler before releasing each actuation—until the dose counter reads 120. If you have not used your inhaler for one week or longer, release two actuations of the medicine into the air.

Using the inhaler

It is important to begin inhaling as slowly as possible just before using your inhaler.

1. It is advisable to stand or sit upright while using the inhaler.
2. Remove the mouthpiece cap (as shown in the figure). Check inside and outside that the mouthpiece is clean and free of foreign particles.
3. Shake the inhaler 4 or 5 times to ensure any foreign particles are removed and that the contents of the inhaler are properly mixed.

1. Hold the inhaler in an upright position with your thumb on the base of the inhaler, below the mouthpiece. Breathe out as much air as possible.

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

1. Breathe in slowly and deeply through your mouth. Immediately after starting to inhale, press firmly on the top of the inhaler to release the medicine. Do this while continuing to inhale deeply and steadily.

1. Hold your breath, remove the inhaler from your mouth, and take your finger off the top of the inhaler. Continue holding your breath for a few seconds, as long as you can.

1. Wait approximately half a minute between each actuation of the medicine, then repeat steps 3 to 7.

2. Afterwards, rinse your mouth with water, spit it out, and/or brush your teeth. This will help prevent mouth ulcers and hoarseness.

3. After use, always immediately replace the mouthpiece cap to protect it from dust. When the mouthpiece cap is correctly placed, it will make a “click” sound. If it does not click, rotate the mouthpiece cap, turn it upside down, and try again. Do not use excessive force.

Take your time with steps 4, 5, 6, and 7. It is important that you breathe out as slowly as possible just before using the inhaler. The first few times you use the inhaler, you should use it in front of a mirror. If you see “mist” escaping from the top of the inhaler or from the sides of your mouth, start again from step 3.

As with all inhalers, caregivers must ensure that children using the Inaladuo Inhaler use the correct inhalation technique described above.

If you or your child finds it difficult to use the inhaler, your doctor, nurse, or other healthcare professional may recommend using the inhaler with a Volumatic spacer device. Your doctor, nurse, pharmacist, or other healthcare professional should show you how to use the spacer device with your inhaler, how to maintain your spacer device, and answer any questions you may have. If you are using the spacer device with your inhaler, it is important that you do not stop using it without first consulting your doctor or nurse. It is also important that you do not change the type of spacer device you are using without discussing it with your doctor. If you stop using the spacer device or change the type of spacer device, your doctor may need to adjust the dose of medicine required to control your asthma. Always consult your doctor before making any changes to your asthma treatment.

Some children or people with weak 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 obtain a replacement inhaler when the counter reads 020. Stop using the inhaler when the counter reads 000, as the remaining actuations in the cartridge may not be sufficient to deliver a full dose. Never attempt to alter the counter numbers or remove the counter from the metal cartridge.

Cleaning the inhaler

To prevent blockage of your inhaler, it is important to clean it at least once a week.

To clean your inhaler:

• Remove the mouthpiece cap.
• Do not remove the metal cartridge from the plastic casing at any time.
• Clean the inside and outside of the mouthpiece and the plastic casing with a dry tissue.
• Replace the mouthpiece cap. It will make a “click” when correctly placed. If it does not click, rotate the mouthpiece cap, turn it upside down, 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 directed. If you have accidentally taken a higher dose than recommended, consult your doctor or pharmacist. You may notice that your heart beats faster than normal and feel tremors. You may also experience headache, dizziness, muscle weakness, and joint pain.

If you have used large doses over long periods of time, you should seek advice from your doctor or pharmacist. This is because high concentrations of Inaladuo may reduce the amount of steroid hormones produced by the adrenal gland.

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

If you forget to use Inaladuo

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

If you stop treatment with Inaladuo

It is very important that you use Inaladuo every day as directed. Continue taking it until your doctor tells you to stop. Do not stop treatment with Inaladuo abruptly. This could cause your breathing to worsen.

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

These adverse effects may include any of the following:

• Stomach pain.
• Tiredness and loss of appetite, feeling unwell.
• Nausea and diarrhea.
• Weight loss.
• Headache or drowsiness.
• Low blood sugar levels.
• Low blood pressure and seizures (fits).

When your body is under stress, such as fever, trauma (e.g., traffic 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 oral corticosteroids during that time (such as prednisolone).

If you have any further questions about the use of this medicine, ask your doctor, nurse, or pharmacist.

4. Possible side effects

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, coughing, or shortness of breath. You may also notice itching, rash (hives), or swelling (usually of the face, lips, tongue, or throat). You may also suddenly feel that your heart is beating very fast, feel dizzy, or feel like you are losing consciousness (which may lead to collapse or loss of consciousness). If you experience any of these effects, or if they occur suddenly after using Inaladuo, stop using Inaladuo and contact your doctor immediately. Allergic reactions to Inaladuo are uncommon (affecting fewer than 1 in 100 people).

Other side effects listed below:

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

• Headache, which usually improves with continued treatment.
• Increased incidence of colds has been reported in patients with COPD.

Common (may affect fewer than 1 in 10 people)

• Oral and throat candidiasis (itching, yellow-cream colored sores). Also, tongue pain, hoarseness, and throat irritation. Rinsing your mouth with water and spitting it out and/or brushing your teeth immediately after each dose of medication may help. For treatment of candidiasis, your doctor may prescribe antifungal medication (to treat fungal infections).
• Joint 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). Inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum color, fever, chills, increased coughing, or increased breathing difficulty.
• Bruising and fractures.
• Sinus inflammation (feeling of pressure or congestion in the nose, cheeks, and behind the eyes, sometimes with throbbing pain).
• Reduction in blood potassium levels (you may feel irregular heartbeats, muscle weakness, or cramps).

Uncommon (may affect fewer than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycemia). If you have diabetes, your blood sugar levels will need to be monitored more frequently, and your usual diabetes treatment may need to be adjusted if necessary.
• Cataracts (clouding of the eye's lens).
• Very fast heart rate (tachycardia).
• Tremors and a fast or irregular heartbeat (palpitations). These side effects are usually harmless and decrease with continued treatment.
• Chest pain.
• Feeling anxious (occurs mainly in children).
• Sleep disorders.
• Skin rash.
• Allergic skin rash.

Rare (may affect fewer than 1 in 1,000 people)

• Breathing difficulties or wheezing that worsen immediately after using Inaladuo. If this occurs, stop using Inaladuo. Use your "rescue" fast-acting inhaler to improve your breathing and contact your doctor immediately.

• Inaladuo may increase the normal production of steroid hormones, particularly if you have been taking high doses for long periods of time. Effects include:

• Delayed growth in children and adolescents.

• Decreased bone mineral density.

• Glaucoma.

• Weight gain.

• Rounded face (moon face) (Cushing's syndrome).

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

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

Frequency not known, but may also occur:

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Inaladuo

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date stated on the label and the carton, following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25 ºC. Do not refrigerate or freeze.

As with most pressurized inhalers, the therapeutic effect of the medicine may be reduced when the cartridge is cold.

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

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Inaladuo

• Each metered dose contains: 25 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate.
• The other component is a propellant: norflurane (HFA 134a).

This medicinal product contains fluorinated greenhouse gases.

Each inhaler contains 12 g of HFC-134a (also known as norflurane or HFA 134a), equivalent to 0.0172 tonnes of CO2 (global warming potential GWP = 1,430).

Nature of the product and contents of the pack

• Inaladuo Inhaler is presented in a pressurized container with a dose counter, which delivers the medicine as a suspension for inhalation through the mouth into the lungs.
• The cartridge contains a white to off-white suspension for inhalation.
• The cartridges are contained within a plastic device incorporating a mouthpiece and a mouthpiece cover.

The devices are supplied in packs of 1 inhaler.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

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.

Date of the most recent revision of this leaflet: 01/2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/