PLUSVENT 25/125 micrograms/inhalation, pressurized inhalation suspension

Introduction

Package Leaflet: Information for the User

Plusvent 25 micrograms/125 micrograms/inhalation, inhalation suspension in a pressurized 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Plusvent and what is it used for
2. What you need to know before you use Plusvent
3. How to use Plusvent
4. Possible side effects
5. Storing Plusvent
6. Contents of the pack and other information

1. What is Plusvent and what is it used for

Plusvent contains two active substances, salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help to 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 Plusvent every day as your doctor has recommended. This will ensure that the medicine works correctly to control your asthma.

Plusventhelps toprevent shortness of breathand wheezing.However, Plusvent should not be used to relieve a sudden attack of shortness of breath or wheezing.In such cases,you should useyour 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 you use Plusvent

Do not use Plusvent

• 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 you start using Plusvent if you have:

• Heart problems, including a fast or irregular heartbeat.
• Overactive thyroid gland.
• High blood pressure.
• Diabetes mellitus (Plusvent may increase blood sugar levels).
• Low levels of potassium in the blood.
• Tuberculosis (TB) now 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 might use any other medicines, including those for asthma or those bought without a prescription. This is because, in some cases, Plusvent should not be used with other medicines.

Tell your doctor if you are taking any of the following medicines before you start using 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 getting side effects with Plusvent, including irregular heartbeats, or may make side effects worse. Your doctor may need to monitor you closely if you are taking these medicines.
• Corticosteroids (oral or injectable). If you have taken these medicines recently, you may have an increased risk of this medicine affecting your adrenal gland.
• Diuretics, also known as water tablets, used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines that contain xanthine. 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 have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

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

3. How to use Plusvent

Follow the instructions for using this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask 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 you are not sure, ask your doctor or pharmacist.
• Do not stop taking Plusvent or reduce your dose without talking to your doctor first.
• Plusvent should be inhaled into your lungs through your mouth.

Adults and adolescents 12 years and older

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

Children 4 to 12 years of age

• Plusvent 25/50 micrograms 2 inhalations 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 this is the case, your doctor may decide to reduce your dose to once a day. The dose may be changed to:

• once at night if you have night-time symptoms,
• once in the morning if you have day-time symptoms.

It is very important that you follow your doctor's instructions about how many inhalations to take and how often to take them.

If you are using Plusvent to treat asthma, your doctor will want to check your symptoms regularly. If your asthma gets worse or you have more difficulty breathing, see your doctor as soon as possible. You may notice more wheezing, or a feeling of shortness of breath more often, or you may need to use your fast-acting "rescue" medication more often. If any of these happen, you should continue to use Plusvent, but do not increase the number of inhalations. Your lung disease may get worse and you may 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 how you use it from time to time. Not using Plusvent inhaler correctly or as prescribed may mean that your asthma does not improve as it should.
• The medicine is in a pressurized canister inside a plastic casing with a mouthpiece.
• The inhaler has a counter on the back that tells you how many inhalations are left. Each time you use the inhaler, one inhalation is released and the counter goes down by one.
• Be careful not to drop the inhaler, as this may cause the counter to count down.

Checking the inhaler

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

1. To make sure it works, shake the inhaler well, point the mouthpiece away from you and press the canister down to release one inhalation into the air. Repeat these steps, shaking the inhaler before releasing each inhalation, until the counter shows 120. If you have not used your inhaler for a week or more, release two inhalations into the air.

Using the inhaler

It is important to start breathing in 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 inside and outside that the mouthpiece is clean and free from any foreign objects.
3. Shake the inhaler 4 or 5 times to ensure that any foreign objects are removed and the contents of the inhaler are mixed properly.

1. Hold the inhaler in an upright position with your thumb on the base of the inhaler, below the mouthpiece. Breathe out as slowly as possible.

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

1. Take a slow, 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 slowly and deeply.

1. Hold your breath, remove the inhaler from your mouth by taking your finger off the top of the inhaler. Continue to hold your breath for a few seconds, as long as you can.

1. Wait for about half a minute between each inhalation of the medicine and then repeat steps 3 to 7.

1. After use, 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, always replace the mouthpiece cover immediately, to keep it free from dust. When the mouthpiece cover is replaced correctly, it will click. If it does not click, turn the mouthpiece cover, put it back on and try again. Do not use too much force.

Take your time with steps 4, 5, 6 and 7. It is important that just before using the inhaler, you breathe out as slowly as possible. 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 inhalation technique described above correctly.

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 spacer device. Your doctor, nurse, pharmacist or other healthcare professional should show you how to use the spacer device with your inhaler, how to keep your spacer device clean and answer any questions you may have. If you are using the spacer device with your inhaler, it is important that you do not stop using it without consulting your doctor or nurse first. It is also important that you do not change the type of spacer device you are using without consulting your doctor. If you stop using the spacer device or change the type of spacer device, 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 weak hands 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 counter shows 020. Stop using the inhaler when the counter shows 000, as the inhalations left in the canister may not be enough to give you a full dose. Never try to change the numbers on the counter or remove the counter from the metal canister.

Cleaning the inhaler

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

To clean your inhaler:

• Remove the mouthpiece cover.
• Do not take the metal canister out of the plastic casing at any time.
• Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth.
• Replace the mouthpiece cover. It will click when it is put back correctly. If it does not click, turn the mouthpiece cover, put it back on and try again. Do not use too much force.

Do not put the metal canister in water.

If you use more Plusvent than you should

It is very important to use the inhaler as directed. If you accidentally take a higher dose than recommended, talk to your doctor or pharmacist. You may notice that your heart beats faster than normal and you may feel shaky. You may also get a headache, feel dizzy, weak or have muscle pain.

If you have used high doses for a long time, you should ask your doctor or pharmacist for advice. This is because high levels of Plusvent 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, telephone: 91 562 04 20, stating the medicine and the amount taken.

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 using Plusvent

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

Also, if you stop taking Plusvent suddenly or reduce your dose, you may (very rarely) get problems with your adrenal gland (adrenal insufficiency), which can sometimes cause side effects.

These side effects may include:

• Stomach pain.
• Tiredness and loss of appetite, feeling unwell.
• Feeling sick and diarrhea.
• Weight loss.
• Headache or drowsiness.
• Low blood sugar levels.
• Low blood pressure and fits (seizures).

When your body is under stress, such as from fever, injury (e.g. car accident), infection or surgery, adrenal insufficiency may get worse and you may get any of the above side effects.

If you get any side effects, talk to your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe a higher dose of steroid tablets during this time (such as prednisolone).

If you have any further questions on 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 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 worsensimmediatelyafter 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 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 with continued treatment.
• 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 medicine 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 potassium levels in the blood (you may feel irregular heartbeats, muscle weakness, cramps).

Uncommon (may affect less than 1 in 100 people).

• Increased blood sugar (glucose) levels (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 quick-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.
• Round 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 do so.
• Fungal infection in the esophagus (throat), which can cause difficulty swallowing.

Frequency not known, but may also occur:

• 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 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 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 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 SIGRE point in the pharmacy. 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

Composition of Plusvent

• 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).

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

• The devices are 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/