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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Seretide 25 micrograms/250 micrograms/dose, 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 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, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Seretide is and what it is used for
2. What you need to know before using Seretide
3. How to use Seretide
4. Possible side effects
5. How to store Seretide
6. Contents of the pack and other 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 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 directed by your doctor. This will ensure the medicine works properly to control your asthma.

Seretide helps prevent breathlessness and wheezing. However, Seretide should not be used to relieve a sudden attack of breathlessness or wheezing. In such cases, 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 Seretide

Do not use Seretide

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

Warnings and precautions

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

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

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

Other medicines and Seretide

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, Seretide should not be used together with certain other medicines.

Tell your doctor if you are taking any of the following medicines before starting to use 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 experiencing adverse effects with Seretide, 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

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

3. How to use Seretide

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, 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 your dose without first talking to your doctor.
• Seretide must be inhaled through the mouth into the lungs.

Adults and adolescents aged 12 years and older

• Seretide 25/50 micrograms: 2 puffs twice daily
• Seretide 25/125 micrograms: 2 puffs twice daily
• Seretide 25/250 micrograms: 2 puffs twice daily

Children aged 4 to 12 years

• Seretide 25/50 micrograms: 2 puffs twice daily

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

Your symptoms may become well controlled with Seretide 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 puffs and how often you should take 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 increasing difficulty breathing, see your doctor immediately. You may notice more wheezing, 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 must continue using Seretide, but do not increase the number of puffs. 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 show you how to use your inhaler. They should check your technique periodically. Incorrect or improper use of the Seretide inhaler may result in your asthma not being adequately controlled.
• 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 puffs remain. Each time you activate the inhaler, one puff 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 works properly. Remove the mouthpiece cover 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 puff into the air. Repeat these steps—shaking the inhaler before releasing each puff—until the dose counter reads 120. If you have not used your inhaler for one week or longer, release two puffs 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 cover (as shown in the figure). Check inside and outside the mouthpiece to ensure it is clean and free of foreign particles.
3. Shake the inhaler 4 or 5 times to remove any foreign particles and ensure the contents are properly mixed.

1. Hold the inhaler upright, with your thumb placed at 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 down 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 remove your finger from the top of the inhaler. Continue holding your breath for as long as possible.

1. Wait approximately half a minute between each puff, then repeat steps 3 to 7.

2. After use, 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 replace the mouthpiece cover immediately to protect it from dust. When the mouthpiece cover is properly in place, it will make a "click" sound. If it does not click, rotate the mouthpiece cover, turn it over, 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 a "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 Seretide 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 the Volumatic spacer device. Your doctor, nurse, pharmacist, or other healthcare professional should show you how to use the spacer with your inhaler, how to maintain your spacer, and answer any questions you may have. If you are using the spacer with your inhaler, it is important not to stop using it without first consulting your doctor or nurse. It is also important not to change the type of spacer you are using without consulting your doctor. If you stop using the spacer or change the type of spacer, 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 individuals with weak hand strength may find it easier to hold the inhaler with both hands. Place both index fingers on top of the inhaler and both thumbs at the base, below the mouthpiece.

You should get a replacement inhaler when the counter reads 020. Stop using the inhaler when the counter reads 000, as the remaining puffs in the cartridge may not be sufficient to deliver a full dose. Never attempt to alter the counter display or remove the counter from the metal cartridge.

Cleaning the inhaler

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

To clean your inhaler:

• Remove the mouthpiece cover.
• Never remove the metal cartridge from the plastic casing.
• Wipe the inside and outside of the mouthpiece and plastic casing with a dry tissue.
• Replace the mouthpiece cover. It will make a "click" when properly in place. If it does not click, rotate the mouthpiece cover, turn it over, and try again. Do not use excessive force.

Do not immerse the metal cartridge in water.

If you use more Seretide than you should

It is very important to use the inhaler exactly as directed. If you accidentally take more than the recommended dose, 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, you should seek advice from your doctor or pharmacist. This is because high concentrations 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 at 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 missed dose. Take the next dose at your usual time.

If you stop using Seretide

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

Additionally, if you stop taking Seretide suddenly or reduce your dose, you may (very rarely) develop problems with your adrenal gland (adrenal insufficiency), which may sometimes cause 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 corticosteroid tablets 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. To reduce the occurrence 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 experience wheezing, coughing, or shortness of breath. You may also notice itching, rash (urticaria), and 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 about to faint (which could lead to collapse or loss of consciousness). If you experience any of these effects, or if they occur suddenly after using Seretide, stop using Seretide immediately and contact your doctor right away. Allergic reactions to Seretide are uncommon (may 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 with continued treatment.
• An increased number of colds has been reported in patients with COPD.

Common (may affect up to 1 in 10 people)

• Oral and throat candidiasis (itching, yellow-creamy coloured 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, swelling, 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 sputum production, change in sputum colour, fever, chills, increased coughing, or increased difficulty breathing.
• Bruising and fractures.
• Sinusitis (feeling of pressure or congestion in the nose, cheeks, and behind the eyes, sometimes with throbbing pain).
• Decreased potassium levels in the blood (you may feel irregular heartbeat, muscle weakness, or cramps).

Uncommon (may affect up to 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). 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 adverse effects are usually harmless and decrease with continued treatment.
• Chest pain.
• Feeling anxious (occurs mainly in children).
• Sleep disorders.
• Skin rash.
• Allergic skin reaction.

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 fast-acting "rescue" inhaler to improve your breathing and contact 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. Effects include:

• Growth retardation 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 adverse effects and ensure you are taking the lowest dose of Seretide necessary to control your asthma.

• Changes in behaviour, such as hyperactivity and irritability (these effects occur mainly in children).
• Irregular heartbeat or extra heartbeats (arrhythmias). Consult your doctor, but do not stop taking Seretide unless your doctor tells you to.
• Fungal infection of the oesophagus (throat), which may 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you help provide 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 expiry date that appears on the label and the carton after EXP. The expiry date refers to 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 be reduced 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 to be empty.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, 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 Seretide

• 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 medicine 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 pack contents

• Seretide Inhaler is supplied as 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 housed in a plastic device incorporating a mouthpiece and a mouthpiece cap.

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

Only certain pack sizes may be commercially available.

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 European Economic Area member states 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 most recent review of this leaflet: 01/2025

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