SERETIDE 25 micrograms/125 micrograms INHALATION, PRESSURED INHALER SUSPENSION

2. What you need to know before taking Seretide

Do not use Seretide

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

Warnings and precautions

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

• Heart problems, including rapid or irregular heartbeat.
• Hyperthyroidism.
• High blood pressure.
• Diabetes mellitus (Seretide may increase blood sugar levels).
• Low potassium levels in the blood.
• Tuberculosis (TB) currently or in the past, or other lung infections.

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

Other medications and Seretide

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those for asthma or those purchased without a prescription. The reason is that, in some cases, Seretide should not be administered with other medications.

Tell your doctor if you are taking any of the following medications before starting to use Seretide:

• β-blockers (such as atenolol, propranolol, and sotalol). β-blockers are mainly used to treat high blood pressure or other heart conditions.
• Medications to treat infections (such as ketoconazole, itraconazole, and erythromycin), including some medications for HIV (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 side effects with Seretide, including irregular heartbeats, or may worsen side effects. Therefore, your doctor may need to monitor you closely if you are taking these medications.
• Corticosteroids (oral or injectable). If you have taken these medications recently, you may be at increased risk of this medication affecting your adrenal gland.
• Diuretics, also known as water pills, used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medications containing xanthine. 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, consult your doctor or pharmacist before using this medication.

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 administering this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult 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 in doubt, consult your doctor or pharmacist.
• Do not stop taking Seretide or reduce the 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 applications twice a day
• Seretide 25/125 micrograms 2 applications twice a day
• Seretide 25/250 micrograms 2 applications twice a day

Children 4 to 12 years old

• Seretide 25/50 micrograms 2 applications 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 so, your doctor may decide to reduce your dose to once a day. The dose may change to:

• once at night if you have nocturnalsymptoms,
• once in the morning if you have diurnalsymptoms.

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

If you are using Seretide to treat asthma, your doctor will want to monitor your symptoms regularly. If your asthma worsens 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 that you need to use your rapid-acting rescue medication more frequently. If any of these things happen, you should continue using Seretide, but do not increase the number of applications. Your respiratory disease may worsen and 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. Periodically, they should check how you use it. Not using the Seretide inhaler properly or as prescribed may result in your asthma not improving as it should.
• The medication is in a pressurized cartridge inside a plastic casing with a mouthpiece.
• The inhaler has a counter on the back that indicates how many applications are left. Each time you actuate the inhaler, one application is released, and the counter decreases by one unit.
• 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 works properly. Remove the mouthpiece cover by gently squeezing the sides with your thumb and index finger and pulling.

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 application counter reads 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 cover (as shown in the figure). Check the inside and outside of the mouthpiece and the plastic casing to ensure they are clean and free of any foreign particles.
3. Shake the inhaler 4 or 5 times to ensure any foreign particles are eliminated and the inhaler contents are mixed properly.

1. 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.

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

1. Take a slow and deep breath in through your mouth. Immediately after starting to breathe in, press the top of the inhaler firmly to release the medication. 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 approximately half a minute between each application of the medication, and then repeat steps 3 to 7.

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

1. After using it, always put the mouthpiece cover back on immediately to protect it from dust. When the mouthpiece cover is put back on correctly, it will make a "click" sound. If it does not click, turn the mouthpiece cover, 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 inhale as slowly as possible just before using your inhaler. 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 correct inhalation technique described above.

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 inhalation chamber. Your doctor, nurse, pharmacist, or other healthcare professional should show you how to use the inhalation chamber with your inhaler, how to maintain 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. It is also crucial 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 required 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 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 indicator shows 020. Stop using the inhaler when the indicator shows 000, as the applications left in the cartridge may not be sufficient to complete a dose. Never try to modify the numbering on the indicator or detach the indicator from the metal cartridge.

Cleaning the inhaler

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

To clean your inhaler:

• Remove the mouthpiece cover.
• Never remove the metal cartridge from the plastic casing.
• Clean the inside and outside of the mouthpiece and the plastic casing with a dry cloth.
• Put the mouthpiece cover back on. It will make a "click" sound 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 cartridge in water.

If you use more Seretide than you should

It is very important to use the inhaler exactly as indicated. 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 may feel tremors. You may also experience headache, dizziness, weakness, and joint pain.

If you have used large doses for extended periods, you should ask your doctor or pharmacist for advice. This is because high concentrations of Seretide may 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 Seretide

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

If you stop treatment with Seretide

It is very important that you use Seretide every day as indicated. Continue taking it until your doctor tells you to stop. Do not stop taking Seretide suddenly.This could make your breathing worse.

Additionally, if you stop taking Seretide suddenly or reduce the dose, you may (very rarely) experience problems with your adrenal gland (adrenal insufficiency), which can sometimes cause side effects.

These side effects may include:

• Stomach pain.
• Fatigue and loss of appetite, feeling unwell.
• Discomfort 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., car accident), infection, or surgery, adrenal insufficiency may worsen, and you may experience any of the above side effects.

If you experience any side 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 further questions about the use of this medication, 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 suddenly feel that your heart is beating very fast, feel like you are losing 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 medication 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 skin rash.

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. 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 website: 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 sight and reach of children.

Do not use this medicine after the expiration date that appears on the label and on the carton 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 125 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 packages of 1, 2, or 3 inhalers.

Only some package 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 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/