Leaflet: information for the user

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

salmeterol/fluticasone propionate

Read this 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Seretide contains two active ingredients, salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways in the lungs open, making it easier for air to enter and leave. 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 medication to help prevent respiratory problems such as asthma.

You must use Seretide every day as recommended by your doctor. This will ensure the medication works correctly in controlling your asthma.

Seretide helps 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 a case, you must use your quick-relief medication, such as salbutamol. You should carry your quick-relief medication with you at all times.

Do not use Seretide

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

Warnings and precautions

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

• Cardiac abnormalities, including rapid or irregular heartbeat.
• Hyperthyroidism.
• High blood pressure.
• Diabetes mellitus (Seretide may increase blood sugar levels).
• Low levels of potassium in the blood.
• Tuberculosis (TB) today 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 using, have used recently or may need to use any other medicine, including those for asthma or those obtained without a prescription. This is because, in some cases, Seretide should not be administered with other medicines.

Inform your doctor if you take any of the following medicines before starting to use Seretide:

• β-blockers (such as atenolol, propranolol and sotalol). β-blockers are used mainly to treat hypertension or other cardiac conditions.
• Medicines to treat infections (such as ketoconazole, itraconazole and erythromycin), including some HIV medicines (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 the adverse effects. Your doctor may perform close monitoring if you are taking these medicines.
• Corticosteroids (oral or injectable). If you have taken these medicines recently, you may increase the risk of this medicine affecting your adrenal gland.
• Diuretics, also known as urine medicines, used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine. They are often used to treat asthma.

Pregnancy and breastfeeding

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

Driving and operating machinery

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of 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. In case of doubt, consult your doctor or pharmacist.
• Do not stop taking Seretide or reduce your dose without talking to your doctor first.
• Seretide must be inhaled through the mouth into the lungs.

Adults and adolescents 12 years and older

• Seretide 25/50 micrograms2 applications twice a day
• Seretide 25/125 micrograms2 applications twice a day
• Seretide 25/250 micrograms2 applications twice a day

Children 4 to 12 years old

• Seretide 25/50 micrograms2 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 nocturnal symptomssymptoms,
• once in the morning if you have diurnal symptomssymptoms.

It is very important that you follow your doctor's instructions on how many applications and how often you should 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 greater difficulty breathing, see your doctor immediately. You may notice more wheezing, or a feeling of choking more often, or that you have to use your 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 seriously harm you. 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 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 tells you how many applications are left. Each time you activate the inhaler, one application will be released and the counter will decrease by one unit.
• Be careful not to drop the inhaler, as this may cause the counter to decrease some units.

Checking the inhaler

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

1. To make sure it works, shake the inhaler well,point the mouthpiece away from youand pressthe cartridge down to release a puff of medication into the air.Repeat these steps, shaking the inhaler before releasing each puff, until the counter reaches 120. If you have not used your inhaler for a week or more, release two puffs of 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 protector (as shown in the figure). Check inside and out that the mouthpiece is clean and free of any foreign particles.

3.Shake the inhaler 4 or 5 times to ensure any foreign particles are removed and the contents of the inhaler are well mixed.

4.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.

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

6.Take a slow and deep breath in through your mouth. Immediately after starting to breathe in, press firmly on the top of the inhaler to release the medication. Do this while continuing to breathe in deeply and steadily.

7.Hold your breath, remove the inhaler from your mouth by releasing your thumb from the top of the inhaler. Continue holding your breath for a few seconds, as long as possible.

8.Wait about half a minute between each puff of medication and then repeat steps 3 to 7.

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

1. After using it,always put the mouthpiece protector back on immediately to preserve it from dust. When the mouthpiece protector is put back on correctly, it will make a "click" sound. If it does not click, turn the mouthpiece protector around, 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 breathe out as slowly as possible just before using the inhaler. The first time 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 from the sides of your mouth, start again from step 3.

Just like 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 other healthcare professional 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 store 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. Also, it is essential 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 needed to control your asthma. Always consult your doctor before making any changes to your asthma treatment.

Some children or people with limited 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 get a replacement inhaler when the indicator shows 020. Stop using the inhaler when the indicator shows 000, as the remaining applications in the cartridge may not be enough to complete a dose. Never try to modify the indicator number or remove the indicator from the metal cartridge.

Cleaning the inhaler

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

To clean your inhaler:

• Remove the mouthpiece protector.
• Do not remove the metal cartridge from the plastic casing at any time.
• Clean the inside and outside of the mouthpiece and plastic casing with a dry cloth.
• Put the mouthpiece protector back on. It will make a "click" sound when it is put back on correctly. If it does not click, turn the mouthpiece protector around, put it back on, and try again. Do not use excessive force.

Do not submerge the metal cartridge in water.

If you use more Seretide than you should

It is very important to use the inhaler exactly as instructed. 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 feel tremors. You may also have headaches, dizziness, muscle weakness, and joint pain.

If you have used high doses for a long time, you should ask your doctor or pharmacist for advice. This is because high concentrations of Seretide can 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 the missed doses. Take the next dose at the usual time.

If you interrupt treatment with Seretide

It is very important to use Seretide every day as instructed.Continue taking it until your doctor tells you to stop. Do not stop taking Seretide abruptly.This may worsen your breathing.

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

These adverse effects may include any of the following:

• Stomach pain.
• Fatigue and loss of appetite, feeling unwell.
• Discomfort and diarrhea.
• Weight loss.
• Headaches or drowsiness.
• Low blood sugar levels.
• Hypotension and convulsions (seizures).

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 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 corticosteroids in tablets during that time (such as prednisolone).

If you have any other questions about using this medication, ask your doctor, nurse, or pharmacist.

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 Seretide that controls your asthma.

Allergic reactions: you may notice that your breathing suddenly worsens immediately after using Seretide.You may experience wheezing and coughing or shortness of breath. You may also notice itching, hives (urticaria), and swelling (usually of the face, lips, tongue, or throat). You may also feel, suddenly, that your heart is beating very fast, feel like you are losing consciousness, and dizziness (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 (possible in up to 1 in 100 people).

The following are other side effects:

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

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

Common (can affect up to 1 in 10 people)

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

The following side effects have been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):

• Pneumonia and bronchitis (pulmonary infection). Inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum color, fever, chills, increased cough, increased respiratory difficulty.
• Cardiac arrhythmias and fractures.
• Inflammation of the sinuses (sensation of tension or congestion in the nose, cheeks, and behind the eyes, sometimes with a pulsating pain).
• Reduction of potassium levels in the blood (may feel irregular heartbeats, muscle weakness, cramps).

Uncommon (can affect up to 1 in 100 people)

• Increased blood sugar levels (hyperglycemia). If you have diabetes, you will need to monitor your blood sugar levels more frequently and adjust your usual diabetes treatment as needed.
• Cataracts (opacity of the lens of the eye).
• Very fast heart rate (tachycardia).
• Feel tremors and a very fast or irregular heart rate (palpitations). These side effects are usually harmless and decrease when treatment continues.
• Chest pain.
• Feeling of concern (occurs mainly in children).
• Sleep disturbances.
• Skin rash.
• Allergic rash on the skin.

Rare (can affect up to 1 in 10,000 people)

• Worsening of breathing difficulties or wheezing that worsens immediately after using Seretide. If this happens, stop using Seretide. Use your rescue inhaler for quick action to improve your breathing andinform 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-shaped) (Cushing's syndrome).

Your doctor will regularly monitor any of these side 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.
• Fungal infection of the esophagus (throat), which can cause difficulty swallowing.

Unknown: the frequency cannot be estimated from available data

• Depression or aggression. It is more likely that these effects will appear in children.
• Blurred vision.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label and on the case 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 occurs with most pressurized inhalers, the therapeutic effect of the medication 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 pierce, break, or burn the cartridge even if it appears empty.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Seretide

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

This medicine contains fluorinated greenhouse gases.

Each inhaler contains 12 g of HFC-134a (also known as norflurano or HFA 134a) corresponding to 0.0172 tons of CO2equivalent (global warming potential PCG = 1 430).

Appearance of the product and contents of the package

• 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 to the lungs.
• The cartridge contains an inhalation suspension of white to off-white color.
• The cartridges are located inside a plastic device that incorporates a mouthpiece and a protector for the same.

The devices are found 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 with the following names:

AustriaSeretide Dosieraerosol

BelgiumSeretide

DenmarkSeretide

FinlandSeretide Evohaler

FranceSeretide

GermanyAtmadisc

GreeceSeretide Inhaler

IcelandSeretide

IrelandSeretide Evohaler

ItalySeretide

LuxembourgSeretide

NetherlandsSeretide

PortugalSeretaide Inalador

SpainSeretide

SwedenSeretide Evohaler

Last review date of this leaflet:01/2025

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