Leaflet: information for the user

Plusvent 25 micrograms/125 micrograms/inhalation, suspension for inhalation in 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 questions, consult 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.

1.What is Plusvent and what it is used for

2.What you need to know before using Plusvent

3.How to use Plusvent

4.Possible side effects

5.Storage of Plusvent

6.Contents of the container and additional information

Plusvent 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 Plusvent every day as recommended by your doctor. This will ensure the medication works correctly in controlling your asthma.

Plusventhelps toprevent shortness of breath and wheezing.However, Plusvent 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 rescue medication, such as salbutamol.You should always carry your quick-relief rescue medication with you.

No use Plusvent

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

Warnings and Precautions

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

• Cardiac alterations, including rapid or irregular heartbeat.
• Hyperthyroidism.
• High blood pressure.
• Diabetes mellitus (Plusvent 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 Medications and Plusvent

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

Inform your doctor if you takeany ofthe following medications, before starting to use Plusvent:

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

Pregnancy and Lactation

If you are pregnant or in lactation period, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Operating Machines

It is unlikely that Plusvent will affect your ability to drive or operate machines.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Use Plusvent 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 Plusvent or reduce your dose without talking to your doctor first.
• Plusvent must be inhaled through the mouth into the lungs.

Adults and adolescents 12 years and older

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

Children from4 to12 years of age

• Plusvent 25/50 micrograms2 applications twice a day

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

Your symptoms may be well controlled using Plusvent 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 to follow your doctor's instructions on how many applications and how often to administer them.

If you are using Plusvent 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 Plusvent, but do not increase the number of applications. Your respiratory disease may worsen and 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 Plusvent inhaler properly or as prescribed may result in your asthma not improving as it should.
• The medication is contained in a pressurized cartridge within a plastic casing with a mouthpiece.
• The inhaler has a counter on the back that informs you of 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 both sides with your thumb and index finger and pulling it off.

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 counter marks 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 breathing as slowly as possible just before using your inhaler.

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

Just like all inhalers, caregivers should ensure that children using Plusvent 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 marker indicates 020. Stop using the inhaler when the marker indicates 000, as the remaining applications in the cartridge may not be enough to complete a dose. Never try to modify the marker number or remove the marker 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 make a "click" sound, turn the mouthpiece protector around, put it back on, and try again. Do not use excessive force.

Do not immerse the metal cartridge in water.

If you use more Plusvent than you should

It is very important to use the inhaler 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 consult your doctor or pharmacist.This is because high concentrations of Plusvent 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 Plusvent

Do not take a double dose to compensate for the missed doses.Take the next dose at the usual time.

If you interrupt treatment with Plusvent

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

Additionally, if you stop taking Plusvent suddenly or reduce your dose, you may (very rarely) cause problems with your adrenal gland (adrenal insufficiency), which sometimes causes 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.

• Headache 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.

Consult your doctor or pharmacist if you have any adverse effects.To prevent these symptoms, your doctor may prescribe an additional dose of corticosteroids in tablets during that time (such as prednisolone).

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

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 Plusvent that controls your asthma.

Allergic reactions: you may notice that your breathing suddenly worsensimmediatelyafter using Plusvent.You may experience wheezing and coughingor 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 ofthese side effects or if they appear suddenly after using Plusvent, stop taking Plusvent and inform your doctor immediately. Allergic reactions to Plusvent are rare (affect less than 1 in 100 people).

The following are other side effects:

Very common (may 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 (may affect less than 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 outand/or brushing your teethimmediately 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.
• Cardenales 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 (you may feel irregular heartbeats, muscle weakness, cramps).

Rare (may affect less than 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.
• Sensation of concern (occurs mainly in children).
• Sleep disturbances.
• Skin rash.
• Allergic skin eruption.

Rare (may affect less than 1 in 1,000 people).

• Worsening respiratory difficulties or wheezing that worsens immediately after using Plusvent. If this happens,stop using Plusvent. Use your rescue inhaler with rapid action to improve your breathing andinform your doctor immediately.
• Plusvent may increase 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 Plusvent 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 Plusvent unless your doctor tells you to.
• Fungal infection of the esophagus (throat), which can cause difficulty swallowing.

Unknown frequency, but may also occur:

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

Reporting 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 the Spanish System of 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 Plusvent

• Each pressurized dose contains: 25 micrograms of salmeterol (as xinafoate of salmeterol) and 125 micrograms 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 CO2 equivalent (global warming potential PCG = 1,430).

Appearance of the product and contents of the packaging

• Plusvent 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 located in packaging of 1 inhaler.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible for manufacturing:

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.

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/