PLUSVENT 25 micrograms/250 micrograms/inhalation, pressurized inhalation suspension

2. What you need to know before taking Plusvent

Do not use Plusvent

• 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 Plusvent if you have:

• Heart problems, including rapid or irregular heartbeat.
• Hyperthyroidism.
• High blood pressure.
• Diabetes mellitus (Plusvent may increase blood sugar levels).
• Low potassium levels 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 Plusvent

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

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

• 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 experiencing side effects with Plusvent, 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 taken these medicines recently, you may be at increased 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 containing xanthines, 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 medicine.

Driving and using machines

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

3. How to take Plusvent

Follow the instructions for taking this medicine exactly 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 the dose without talking to your doctor first.
• Plusvent should be inhaled through the mouth into the lungs.

Adults and adolescents 12 years and older

• Plusvent 25/50 micrograms 2 applications twice a day
• Plusvent 25/125 micrograms 2 applications twice a day
• Plusvent 25/250 micrograms 2 applications twice a day

Children from4 to12 years old

• Plusvent 25/50 micrograms 2 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 nighttimesymptoms,
• once in the morning if you have daytimesymptoms.

It is very important that you follow your doctor's instructions on how many applications and how often to take 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 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 fast-acting "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 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. They should check periodically how you use it. Not using the Plusvent inhaler properly or as prescribed may result in your asthma not improving as it should.
• The medicine 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 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 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 protector by squeezing it gently on 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 medicine 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 outside that the mouthpiece is clean and free of any foreign particles.
3. Shake the inhaler 4 or 5 times to ensure that any foreign particles are eliminated and that 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. Expel 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 medicine. Do this while continuing to breathe in deeply and steadily.

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 application of the medicine, 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 protector back on immediately to keep it free 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 over, 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 that you start inhaling 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 Plusvent 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 medicine 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 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 applications left in the cartridge may not be sufficient to complete a dose. Never try to modify the numbering on the marker or detach the marker 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 protector.
• Never remove the metal cartridge from the plastic casing.
• 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 over, put it back on, and try again. Do not use excessive force.

Do not put the metal cartridge in water.

If you use more Plusvent than you should

It is very important to use the inhaler exactly as indicated. If you have accidentally taken 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, muscle weakness, and joint pain.

If you have used high doses for extended periods, you should ask your doctor or pharmacist for advice. This is because high concentrations of Plusvent 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 medicine and the amount administered.

If you forget to use Plusvent

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 Plusvent

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

Additionally, if you stop taking Plusvent 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 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 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 other questions about using 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 Plusvent that controls your asthma.

Allergic Reactions: you may notice that your breathing suddenly worsensimmediately after using Plusvent.You may suffer from wheezing and 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 like you are losing consciousness, and dizziness (which can lead to collapse or loss of consciousness). If you experience any ofthese 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 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 less than 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 the 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.
• Inflammation of the sinuses (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 (may feel irregular heartbeats, muscle weakness, cramps).

Uncommon (may affect less than 1 in 100 people)

• Increased levels of sugar (glucose) in the blood (hyperglycemia). If you have diabetes, it will be necessary to monitor 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 is continued.
• Chest pain.
• Feeling of anxiety (occurs mainly in children).
• Sleep disorders.
• Skin rash.
• Allergic skin rash.

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

• Breathing difficulties or wheezing that worsen immediately after using Plusvent. If this happens, stop using Plusvent. Use your rapid-acting "rescue" inhaler to improve your breathing and inform your doctor immediately.
• Plusvent 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 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 in the esophagus (throat), which can cause difficulty swallowing.

Frequency not known, but may also appear:

• 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 does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Plusvent

Keep this medicine out of the 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 disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in 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

Composition of Plusvent

• 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 12g of HFC-134a (also known as norflurane or HFA 134a) which corresponds to 0.0172 tons of CO2 equivalent (global warming potential GWP = 1430).

Appearance of the Product and Package Contents

• 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 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 found in packages of 1 inhaler.

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.

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/