Plusvent Accuhaler 50 micrograms/100 micrograms/inhalation, powder for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Plusvent Accuhaler 50 micrograms/100 micrograms/inhalation, powder for inhalation

salmeterol/fluticasone propionate

Read the entire 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 should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Plusvent is 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. How to store Plusvent
6. Contents of the pack and other information

1. What Plusvent is and what it is used for

Plusvent 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.
• Chronic Obstructive Pulmonary Disease (COPD). Plusvent Accuhaler, at a dose of 50/500 micrograms, reduces the number of exacerbations of COPD symptoms.

You should use Plusvent every day as directed by your doctor. This will ensure the medicine works properly to control your asthma or COPD.

Plusvent helps prevent breathlessness and wheezing. However, Plusvent must 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 you start using Plusvent

Do not use Plusvent

• if you are allergic to salmeterol, fluticasone propionate, or any of the other ingredients, including lactose monohydrate.

Warnings and precautions

Talk to your doctor before starting treatment if you have:

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

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

Using Plusvent with other medicines

Tell 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. This is because, in some cases, Plusvent should not be taken together with certain other medicines.

Inform 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 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 could increase your risk of side effects from Plusvent, including irregular heartbeats, or make side effects worse. Your doctor will monitor you closely if you are taking these medicines.
• Corticosteroids (oral or injectable). If you have recently taken these medicines, there may be an increased risk that this medicine could affect 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, 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

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

Plusvent Accuhaler contains lactose

Plusvent Accuhaler contains up to 12.5 milligrams of lactose monohydrate per dose. The amount of lactose in this medicine is generally not expected to cause problems in people with lactose intolerance. However, it may cause allergic reactions in patients who are allergic to cow's milk protein. If your doctor has told you that you have an intolerance to certain sugars, consult him before using this medicine.

3. How to use Plusvent

Follow exactly the administration instructions for this medicine given 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 first speaking to your doctor.
• Plusvent must be inhaled through the mouth into the lungs.
• You may not taste or feel the powder on your tongue, even if you have used the Accuhaler correctly.

For asthma

Adults and adolescents aged 12 years and older

Plusvent 50/100 Accuhaler: One inhalation twice daily

Plusvent 50/250 Accuhaler: One inhalation twice daily

Plusvent 50/500 Accuhaler: One inhalation twice daily

Children aged 4 to 12 years

Plusvent 50/100 Accuhaler: One inhalation twice daily

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

For adults with Chronic Obstructive Pulmonary Disease (COPD)

Plusvent 50/500 Accuhaler: One inhalation twice daily

Your symptoms may become well controlled by using Plusvent 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 on how many doses and how often you should take your medication.

If you are using Plusvent 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 or breathlessness more often, or find that you need to use your fast-acting rescue medication more frequently. If any of these occur, you should continue using Plusvent, but do not increase the number of inhalations. Your respiratory condition may worsen 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 periodically check your technique. Not using the Plusvent Accuhaler properly or as prescribed may result in your asthma or COPD not improving as expected.
• This Accuhaler contains blisters containing Plusvent powder.
• There is a dose counter on the top of the Accuhaler indicating how many doses remain. It counts down to 0. Numbers from 5 to 0 appear in red to warn you that only a few doses remain. Once the counter reaches 0, your inhaler is empty.

Using your inhaler

1. To open the Accuhaler, hold the outer casing with one hand and place the thumb of the other hand in the designated thumb grip. Push the thumb away from you as far as it will go. You will hear a "click". This opens a small hole in the mouthpiece.

1. Hold the device with the mouthpiece facing you. You may hold it with either your right or left hand. Slide the lever away from you. You will hear a "click". This delivers the dose of medication into the mouthpiece.

Each time the lever is slid back, a blister is opened and the powder is prepared for inhalation. Do not play with the lever, as this opens the blisters and wastes medication.

1. Keep the Accuhaler away from your mouth. Breathe out as fully as reasonably possible. Do not breathe into the Accuhaler.
2. Place the mouthpiece in your mouth; inhale steadily and deeply through the Accuhaler, not through your nose.

Remove the Accuhaler from your mouth.

Hold your breath for about 10 seconds, or as long as possible.

Breathe out slowly.

1. After use, rinse your mouth with water, spit it out, and/or brush your teeth. This may help prevent mouth ulcers and hoarseness.

2. To close the Accuhaler, slide the lever back toward you with your thumb as far as it will go. You will hear a "click".

The lever will automatically return to its original position.

The Accuhaler is now ready for reuse.

As with all inhalers, caregivers must ensure that children using the Plusvent Accuhaler use the correct inhalation technique described above.

Cleaning your inhaler

To clean, wipe the mouthpiece of the Accuhaler with a dry tissue.

If you use more Plusvent than you should

It is very important to use the inhaler as directed. If you have accidentally taken a higher dose than recommended, consult your doctor or pharmacist. You may notice your heart beating faster than normal and feel tremors. You may also experience dizziness, headache, muscle weakness, and joint pain.

If you have used large doses over long periods of time, you should seek advice from your doctor or pharmacist. This is because high concentrations 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 at telephone number: 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 missed doses. Take the next dose at your usual time.

If you stop using Plusvent

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

Additionally, if you stop taking Plusvent suddenly or reduce your dose, you could (very rarely) develop problems with your adrenal gland (adrenal insufficiency), which sometimes causes 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.
• Hypotension 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 oral corticosteroids during that time (such as prednisolone).

If you have any further 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 everyone will experience them. To reduce the occurrence of adverse effects, your doctor will prescribe the lowest dose of Plusvent that controls your asthma or Chronic Obstructive Pulmonary Disease (COPD).

Allergic reactions: you may notice that your breathing suddenly worsens immediately after using Plusvent. 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 faint, dizzy (which may lead to collapse or loss of consciousness). If you experience any of these effects or if they occur suddenly after using Plusvent, stop taking Plusvent and inform your doctor immediately. Allergic reactions to Plusvent are uncommon (affecting fewer than 1 in 100 people).

Pneumonia (lung infection) in patients with COPD (a common adverse effect)

Inform your doctor if you experience any of the following symptoms while inhaling Plusvent, as they may be signs of a lung infection:

• Fever or chills
• Increased mucus production, change in mucus color
• Increased coughing or worsening breathing difficulties

The following are other adverse effects listed below:

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 Chronic Obstructive Pulmonary Disease (COPD).

Common (may affect fewer than 1 in 10 people)

• Oral and throat candidiasis (itching, yellowish creamy ulcers). 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 (for treatment of 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):

• Bruising and fractures.
• Sinus inflammation (feeling of pressure or congestion in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
• Decreased potassium levels in the blood (you may experience irregular heartbeat, muscle weakness, cramps).

Uncommon (may affect fewer 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 needed.
• Cataracts (clouding of the eye's lens).
• Very rapid 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 rash.

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

• Worsening breathing difficulty (or wheezing) immediately after using Plusvent. If this happens, stop using Plusvent. Use your fast-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 of time. Effects include:

• Delayed growth in children and adolescents.

• Decreased bone mineral density.

• Glaucoma.

• Weight gain.

• Rounded face (moon-shaped face) (Cushing's syndrome).

Your doctor will regularly monitor for any of these adverse effects and ensure you are taking the lowest effective dose of Plusvent to control your asthma.

• Changes in behavior, 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 Plusvent unless your doctor tells you to.
• Fungal infection in the esophagus (throat), which may cause difficulty swallowing.

Frequency not known, but which 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 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 can help provide 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 Plusvent after the expiry date which is stated on the label and the carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If you have any doubts, 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 Plusvent

• Each pre-dispensed dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 100 micrograms of fluticasone propionate.
• The other component is lactose monohydrate (contains milk proteins).

Appearance of the product and contents of the pack

Plusvent Accuhaler contains a strip of blisters. The blisters protect the inhaled powder from atmospheric effects.

Each dose is pre-dispensed.

The devices are available in packs of:

• 1 Accuhaler x 28 inhalations or
• 1 or 3 Accuhaler x 60 inhalations each.

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 Production Zone Industrielle nº 2 23 Rue Lavoisier, La Madeleine 27000 – Evreux (France)

or

Aspen Bad Oldesloe Gmbh, Industriestrasse 32-36, 23843 - Bad Oldesloe (Germany)

This patient information leaflet was last reviewed in July 2020.

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