SERETIDE 25 micrograms/50 micrograms INHALATION, PRESSURED INHALER SUSPENSION

Introduction

Package Leaflet: Information for the User

Seretide 25 micrograms/50 micrograms/inhalation, inhalation suspension in pressurised container

salmeterol/fluticasone propionate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What is Seretide and what is it used for

Seretide contains two active ingredients, salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help to keep the airways in the lungs open, making it easier to breathe. 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 medicine to help prevent breathing problems such as asthma.

You should use Seretide every day, as your doctor has recommended. This will help to keep your asthma under control.

Seretide helps to prevent shortness of breath and wheezing. However, Seretide should not be used to relieve a sudden attack of shortness of breath or wheezing. In this case, you should use your fast-acting "rescue" medicine, such as salbutamol. You should always carry your fast-acting "rescue" medicine with you.

2. What you need to know before you use Seretide

Do not use Seretide

• if you are allergic to salmeterol, fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor before you start using Seretide if you have:

• heart problems, including an irregular heartbeat or a very fast heart rate.
• an overactive thyroid gland.
• high blood pressure.
• diabetes mellitus (Seretide may increase your blood sugar levels).
• low levels of potassium in your blood.
• tuberculosis (TB) now or in the past, or other lung infections.

Let your doctor know if you have any vision problems or changes in your vision.

Other medicines and Seretide

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those for asthma or those bought without a prescription. This is because Seretide should not be used with some other medicines.

Tell your doctor if you are taking any of the following medicines before you start using Seretide:

• 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, itraconazole 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 getting side effects with Seretide, including irregular heartbeats or may make side effects worse. Your doctor may wish to monitor you closely if you are taking these medicines.
• corticosteroids (oral or injectable). If you have taken these medicines recently, you may be at risk of your adrenal gland not working properly.
• diuretics (also known as "water tablets" used to treat high blood pressure).
• other bronchodilators (such as salbutamol).
• medicines containing xanthines. These are often used to treat asthma.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Seretide is unlikely to affect your ability to drive or use machines.

3. How to use Seretide

Follow your doctor's instructions carefully. If you are not sure how to use your inhaler, ask your doctor, nurse or pharmacist.

• Use Seretide every day, until your doctor advises 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 Seretide or reduce your dose without talking to your doctor first.
• Seretide should be inhaled into your lungs through your mouth.

Adults and adolescents 12 years and older

• Seretide 25/50 micrograms 2 inhalations twice a day
• Seretide 25/125 micrograms 2 inhalations twice a day
• Seretide 25/250 micrograms 2 inhalations twice a day

Children 4 to 12 years of age

• Seretide 25/50 micrograms 2 inhalations twice a day

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

Your symptoms may be well controlled using Seretide twice a day. If this is the case, your doctor may decide to reduce your dose to once a day. The dose may be reduced to:

• once at night if you have night-timesymptoms,
• once in the morning if you have day-timesymptoms.

It is very important that you follow your doctor's instructions on how many inhalations to take and how often to take them.

If you are using Seretide to treat asthma, your doctor will want to check your symptoms regularly. If your asthma gets worse or you get more shortness of breath, wheezing or coughing, or if you use more of your fast-acting "rescue" medicine than usual, you should see your doctor as soon as possible. You may need a change in your treatment or a different medicine.

Instructions on how to use the inhaler

• Your doctor, nurse or pharmacist should show you how to use your inhaler. They should check how you use it from time to time. Not using the inhaler properly or as prescribed may mean that the medicine is not working as it should to control your asthma.
• The medicine is contained in a pressurised canister within a plastic casing with a mouthpiece.
• The inhaler has a counter on the back which shows how many doses are left. Each time you press the inhaler, a dose is released and the counter will count down by one.
• Take care not to drop the inhaler as this may cause the counter to count down.

Checking the inhaler

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

1. To make sure that it is working, shake the inhaler well, point the mouthpiece away from you and press the canister to release a dose into the air. Repeat these steps, shaking the inhaler before releasing each dose, until the dose counter reads 120. If you have not used your inhaler for a week or more, release two doses into the air.

Using the inhaler

It is very important that you start to breathe in as slowly as possible just before using your inhaler.

1. It is recommended that you stand or sit upright when using your inhaler.
2. Remove the mouthpiece cover (as shown in the picture). Check that the mouthpiece is clean and free from any blockages.
3. Shake the inhaler 4 or 5 times to ensure that any loose objects are removed and that the contents of the inhaler are well mixed.

1. Hold the inhaler upright with your thumb on the base, below the mouthpiece. Breathe out as slowly as possible.

1. Put 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. As you start to breathe in, press the top of the inhaler to release a dose. Do this while you are still breathing in.

1. Hold your breath for as long as is comfortable. Take the inhaler from your mouth and breathe out slowly.

1. Wait about half a minute between doses. Then repeat the steps.

1. After use, rinse your mouth with water and spit out. You can also brush your teeth.

1. After use, always replace the mouthpiece cover. It will click into place. If it does not click, turn the cover and try again. Do not use force.

Take your time when using your inhaler. It is very important that you breathe in as slowly as possible just before using your inhaler. The first few times you use your inhaler, you should use it in front of a mirror. If you see "mist" coming from the top of the inhaler or from the sides of your mouth, you should start again from step 3.

As with all inhalers, caregivers should ensure that children using Seretide use the correct inhalation technique, as described above.

If you or your child find it difficult to use the inhaler, your doctor, nurse or pharmacist may recommend the use of a Volumatic spacer. Your doctor, nurse, pharmacist or other healthcare professional should show you how to use the spacer with your inhaler, how to clean it and answer any questions you may have. If you are using a spacer, do not stop using it without talking to your doctor first. It is also important that you do not change the type of spacer you use without talking to your doctor. If you stop using your spacer or change the type of spacer you use, your doctor may need to change the dose of your medicine.

Some children or people with weak hands may find it easier to hold the inhaler with both hands. Put your thumbs on the bottom of the inhaler and your fingers on the top of the inhaler.

You should get a replacement inhaler when the counter shows 020. Stop using the inhaler when the counter shows 000. You will not get the right dose of medicine if you continue to use the inhaler after this point. Never try to alter the numbers on the counter or detach the counter from the metal canister.

Cleaning your inhaler

To prevent your inhaler from getting blocked, it is important to clean it at least once a week.

To clean your inhaler:

• Remove the mouthpiece cover.
• Do not pull the metal canister out of the plastic casing.
• Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.
• Replace the mouthpiece cover. It will click into place. If it does not click, turn the cover and try again. Do not use force.

Do not put the metal canister in water.

If you use more Seretide than you should

It is very important to use the inhaler as instructed. If you accidentally take more than the recommended dose, talk to your doctor or pharmacist. You may notice that your heart is beating faster than usual, and you may feel shaky. You may also have a headache, feel tired, have muscle weakness and pain in your joints.

If you have used too much Seretide for a long time, you should talk to your doctor or pharmacist. This is because using too much Seretide can reduce the amount of steroid hormones produced by your adrenal gland.

In case of overdose, contact your doctor or pharmacist or call the national Poison Centre, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to use Seretide

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

If you stop using Seretide

It is very important that you use Seretide every day as prescribed by your doctor. Do not stop using Seretide or reduce your dose without talking to your doctor first.This could make your breathing worse.

Also, if you stop taking Seretide suddenly or reduce your dose, you may (very rarely) get problems with your adrenal gland (adrenal insufficiency), which can cause side effects. These side effects may include:

• stomach pain.
• tiredness and loss of appetite, feeling unwell.
• being sick (vomiting) and diarrhoea.
• weight loss.
• headache or feeling drowsy.
• low blood sugar levels.
• low blood pressure and fits (seizures).

When your body is under stress, such as from fever, trauma (such as car accident), infection or surgery, adrenal insufficiency can get worse and you may have any of the side effects listed above.

If you get any side effects, talk to your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe extra corticosteroid tablets during this time (such as prednisolone).

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. To reduce the appearance of adverse effects, your doctor will prescribe the lowest dose of Seretide that controls your asthma.

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

The following are other adverse effects:

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

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

Common (may affect up to 1 in 10 people)

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

The following adverse 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 production of sputum, change in the color of sputum, fever, chills, increased coughing, increased difficulty breathing.
• Bruises and fractures.
• Sinusitis (feeling of tension or congestion in the nose, cheeks, and behind the eyes, sometimes with a pulsating pain).
• Decreased levels of potassium in the blood (you may feel irregular heartbeats, muscle weakness, cramps).

Uncommon (may affect up to 1 in 100 people)

• Increased levels of sugar (glucose) in the blood (hyperglycemia). If you have diabetes, you will need to check your blood sugar levels more frequently and adjust your usual diabetic treatment if necessary.
• Cataracts (opacity of the eye lens).
• Very fast heart rate (tachycardia).
• Feeling tremors and a fast or irregular heartbeat (palpitations). These adverse effects are usually harmless and decrease as treatment continues.
• Chest pain.
• Feeling of anxiety (occurs mainly in children).
• Sleep disorders.
• Skin rash.
• Allergic rash on the skin.

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

• Breathing difficulties or wheezing that worsen immediately after using Seretide. If this happens, stop using Seretide. Use your rapid-acting "rescue" inhaler to improve your breathing and inform your doctor immediately.
• Seretide may increase the normal production of steroid hormones, particularly if you have been taking high doses for long periods. The 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 any of these adverse effects and ensure that you are taking the lowest dose of Seretide 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 Seretide unless your doctor tells you to do so.
• Fungal infection in the esophagus (throat), which can cause difficulty swallowing.

Not known: frequency cannot be estimated from available data

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's pharmacovigilance system: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Seretide

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the label and on the packaging 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 medicine 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 puncture, break, or burn the cartridge even if it appears to be empty.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Seretide Composition

• Each pressurized dose contains: 25 micrograms of salmeterol (as salmeterol xinafoate) and 50 micrograms of fluticasone propionate.
• The other component is a propellant: norflurane (HFA 134a).

This medicine contains fluorinated greenhouse gases.

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

Product Appearance and Packaging Contents

• Seretide Inhaler is presented in a pressurized packaging with a counter, which releases the medicine in the form of a suspension for inhalation through the mouth into 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 it.

The devices are available in packaging of 1, 2, or 3 inhalers.

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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.

This medicine is authorized in the member states of the European Economic Area under the following names:

Austria Seretide Dosieraerosol

Belgium Seretide

Denmark Seretide

Finland Seretide Evohaler

France Seretide

Germany Atmadisc

Greece Seretide Inhaler

Iceland Seretide

Ireland Seretide Evohaler

Italy Seretide

Luxembourg Seretide

Netherlands Seretide

Portugal Seretaide Inalador

Spain Seretide

Sweden Seretide Evohaler

Date of the last revision of this prospectus:01/2025

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