SERETIDE 25 micrograms/250 micrograms INHALATION, PRESSURED INHALER SUSPENSION

Introduction

Leaflet: Information for the user

Seretide 25 micrograms/250 micrograms/inhalation, suspension for inhalation in a pressurized container

salmeterol/fluticasone propionate

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 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 experience 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

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

1. What Seretide is and what it is used for

Seretide contains two active substances, 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 in and out. 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 ensure that the medicine works correctly to control your asthma.

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 such cases, 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 start using Seretide

Do not use Seretide

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

Warnings and precautions

Talk to your doctor before you start using Seretide if you have:

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

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

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, in some cases, Seretide should not be used with 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 mainly 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 side effects with Seretide, including irregular heartbeats, or may worsen side effects. Your doctor may need 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 a higher risk of this medicine affecting your adrenal gland.
• diuretics, also known as water pills, used to treat high blood pressure.
• other bronchodilators (such as salbutamol).
• medicines that contain xanthines. These are often used to treat asthma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, 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 the instructions for using this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

• Use Seretide 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 taking Seretide or reduce your dose without talking to your doctor first.
• Seretide should be inhaled through the mouth into the lungs.

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 changed 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 about how many inhalations to take and how often to take them.

If you are using Seretide to treat asthma, your doctor will want to monitor your symptoms regularly. If your asthma gets worse or you have more difficulty breathing, see your doctor immediately. You may notice more wheezing, or a feeling of shortness of breath more often, or you may need to use your fast-acting "rescue" medicine more often. If any of these happen, you should continue to use Seretide, but do not increase the number of inhalations. Your lung disease may get worse, and you may become seriously ill. See your doctor, as you may need additional treatment.

Instructions for use

• 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 Seretide inhaler correctly or as prescribed may mean that your asthma does not improve as it should.
• The medicine is in a pressurized canister inside a plastic casing with a mouthpiece.
• The inhaler has a counter on the back that tells you how many inhalations are left. Each time you use the inhaler, one inhalation is released, and the counter goes down by one.
• Be careful 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 works properly. Remove the mouthpiece cover by squeezing gently with your thumb and index finger and pulling.

1. To make sure it works, shake the inhaler well, point the mouthpiece away from you, and press the canister down to release one inhalation into the air. Repeat these steps, shaking the inhaler before releasing each inhalation, until the counter shows 120. If you have not used your inhaler for a week or more, release two inhalations into the air.

Using the inhaler

It is important to start breathing in 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 cover (as shown in the figure). Check inside and outside the mouthpiece and the plastic casing to make sure they are clean and free from any foreign objects.
3. Shake the inhaler 4 or 5 times to ensure that any foreign objects are removed and the contents of the inhaler are mixed properly.

1. Hold the inhaler upright with your thumb on the base of the inhaler, below the mouthpiece. Breathe out as much as you can.

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. Immediately after starting to breathe in, press the top of the inhaler firmly to release the medicine. Do this while continuing to breathe in slowly and deeply.

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

1. Wait for about half a minute between each inhalation of the medicine, and then repeat steps 3 to 7.

1. After use, rinse your mouth with water and spit it out and/or brush your teeth. This will help prevent the appearance of ulcers in the mouth and hoarseness.

1. After using the inhaler, always put the mouthpiece cover back on immediately to protect it from dust. When the mouthpiece cover is put back on correctly, it will click. If it does not click, turn the mouthpiece cover, put it back on, and try again. Do not use excessive force.

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

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

If you or your child find it difficult to use the inhaler, your doctor, nurse, or pharmacist may recommend using the inhaler with the 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 consulting your doctor or nurse first. It is also important that you do not change the type of spacer device you are using without consulting your doctor. If you stop using the spacer device or change the type of spacer device, your doctor may need to change 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 hands may find it easier to hold the inhaler with both hands. Place your two index fingers on the top of the inhaler and your thumbs on the base, below the mouthpiece.

You should get a replacement inhaler when the counter shows 020. Stop using the inhaler when the counter shows 000, as the inhalations left in the canister may not be enough to complete a dose. Never try to change the numbers on the counter or remove the counter from the metal canister.

Cleaning the inhaler

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

To clean your inhaler:

• Remove the mouthpiece cover.
• Do not take the metal canister out of the plastic casing at any time.
• Clean the inside and outside of the mouthpiece and the plastic casing with a dry cloth.
• Put the mouthpiece cover back on. It will click when it is put back on correctly. If it does not click, turn the mouthpiece cover, put it back on, and try again. Do not use excessive 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 exactly as you have been told. If you accidentally take a higher dose than recommended, 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 get a headache, feel dizzy, weak, or have muscle pain.

If you have used high doses for a long time, you should ask your doctor or pharmacist for advice. This is because high levels of Seretide 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, phone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to use Seretide

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

If you stop using Seretide

It is very important that you use Seretide every day, exactly as your doctor has told you. Keep taking it until your doctor tells you to stop. Do not stop using Seretide suddenly.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 sometimes cause side effects.

These side effects may include:

• stomach pain.
• feeling tired and losing your appetite, feeling unwell.
• feeling sick and diarrhea.
• weight loss.
• headache or drowsiness.
• low blood sugar levels.
• low blood pressure and fits (seizures).

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

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

If you have any further questions about 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, which 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 yellow-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 when 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 quick-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 of time. 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 leaflet. You can also report them directly through the Spanish Medicines and Health 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. Storage of Seretide

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

Do not use this medicine after the expiration date stated on the label and carton after EXP. The expiration date is the last day of the month indicated.

Do not store 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 disposed of via 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 250 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 Package Contents

• Seretide 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 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 packs of 1, 2, or 3 inhalers.

Only some pack 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 last revision of this leaflet:01/2025

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