Leaflet: Information for the User

Plusvent Accuhaler 50 micrograms/250 micrograms/inhalation, powder for inhalationsalmeterol/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 starting to use Plusvent

3. How to use Plusvent

4. Possible side effects

5. Storage of Plusvent

6. Contents of the pack and additional information

Plusvent contains two active ingredients, salmeterol and fluticasone propionate:

Your doctor has prescribed this medication to help prevent respiratory problems such as:

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

You must use Plusvent every day as recommended by your doctor. This will ensure the medication acts correctly in controlling your asthma or COPD.

Plusvent helps prevent 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 rescue medication with rapid action, such as salbutamol. You should carry your rescue medication with rapid action with you at all times.

No use Plusvent

• If you are allergic to salmeterol, fluticasone propionate or lactose monohydrate, another component.

Warnings and precautions

Consult your doctor before starting treatment 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.

Use of Plusvent with other medications

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 take any of the 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, so your doctor will 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 that this medication will affect 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 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 medication.

Driving and operating machinery

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

Plusvent Accuhaler contains lactose

Plusvent Accuhaler contains up to 12.5 milligrams of lactose monohydrate in each dose.The amount of lactose in this medication normally does not cause problems in people with lactose intolerance..It may cause allergic reactions in patients with milk protein allergy. If your doctor has indicated that you have intolerance to certain sugars, consult with him before using this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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. In case of 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.
• You may not be able to taste or feel the powder on your tongue, even if you have used the Accuhaler correctly.

For asthma

Adults and adolescents 12 years and older

• Plusvent 50/100 AccuhalerOne inhalation twice a day
• Plusvent 50/250 AccuhalerOne inhalation twice a day
• Plusvent 50/500 AccuhalerOne inhalation twice a day

Children aged 4 to 12 years

• Plusvent 50/100 AccuhalerOne inhalation twice a day
• Plusvent is not recommended for use in children under 4 years of age.

For adults with Chronic Obstructive Pulmonary Disease (COPD)

Plusvent 50/500 AccuhalerOne inhalation twice a day

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 that you follow your doctor's instructions on how many applications 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 greater difficulty breathing, see your doctor immediately. You may notice more wheezing or a sensation 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 you may 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. Periodically, they should check how you use it. Not using Plusvent Accuhaler properly or as prescribed may result in your asthma or COPD not improving as it should.
• This Accuhaler contains alveoli that contain Plusvent powder.
• There is a dose counter on the top of the Accuhaler that indicates how many doses are left. Counts back, to 0. The numbers from 5 to 0 will appear in red to warn you that there are few doses left. Once the counter marks 0, your inhaler is empty.

Using your inhaler

1. To open the Accuhaler, hold the outer casing with one hand and place your thumb in the reserved hole. Push with your thumb, moving it away from you, until it reaches. You will hear a "click". This will open a small hole in the mouthpiece

1. Hold the device with the mouthpiece towards you. You can hold it with your right or left hand. Slide the lever back. You will hear a "click". This will place the medication dose in the mouthpiece.

Each time the lever is pushed back, an alveolus opens and the powder is prepared to be inhaled. Do not play with the lever, as the alveoli will open and the medication will be wasted.

1. Hold theAccuhaleraway from your mouth. Breathe out as much as reasonably possible. Do not breathe into theAccuhaler.

1. Place the mouthpiece in your lips; take a progressive and intense breath through theAccuhaler, not through your nose.

-Remove theAccuhalerfrom your mouth.

-Hold your breath for 10 seconds or as long as possible.

-Exhale slowly.

5.After rinsing your mouth with water and spitting it out and/or brushing your teeth. This may help prevent mouth ulcers and sore throat.

6.To close theAccuhaler, slide the lever towards you as far as possible with your thumb. You will hear a "click".

The lever will automatically return to its original position.

The Accuhaler is now ready to be used again.

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

Cleaning your inhaler

To clean it, pass a dry cloth over the mouthpiece of theAccuhaler.

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 feel tremors. You may also experience dizziness, headache, muscle weakness, and joint pain.

If you have used large doses for a long time, you should consult 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 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 (rarely) experience problems with your adrenal gland (adrenal insufficiency), which may cause side effects.

These side 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 side effects listed above.

If you experience any side effect, 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 the use of 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 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 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 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).

Pneumonia (lung infection) in patients with COPD (common side effect)

Inform your doctorif you have any of the following symptoms while inhaling Plusvent, they may be symptoms of a lung infection:

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

The following are other side effects:

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

• Headache, which usually improves as treatment continues.
• An increase in the number of colds in patients with Chronic Obstructive Pulmonary Disease (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, hoarseness 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 you. 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):

• Osteoporosis and fractures.
• Swelling 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 crystalline lens of the eye).
• Very fast heart rate (tachycardia).
• You may feel tremors and a very fast or irregular heart rate (palpitations). These side effects are usually harmless and decrease as treatment continues.
• Chest pain.
• Feeling anxious (mainly occurs in children).
• Sleep disturbances
• Skin rash
• Allergic skin eruption.

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

• Difficulty breathing (or wheezing) that worsens immediately after using Plusvent. If this happens, stop using Plusventand use your rescue inhaler for 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.

-Bone mineral density reduction.

-Glaucoma.

-Weight gain.

-Round 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 that the heart has extra beats (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.

Frequency unknown, but may also occur:

• Depression or aggression. It is more likely that these effects will occur 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 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 Plusvent after the expiration date that appears on the label and on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Plusvent

• Each pre-dispensed dose contains: 50 micrograms of salmeterol (as xinafoate of salmeterol) and 250micrograms of fluticasone propionate.
• The other component is lactose monohydrate (contains milk proteins).

Appearance of the product and contents of the packaging

Plusvent Accuhaler contains an alveoli strip. The alveoli protect the inhalation powder from atmospheric effects.

Each dose is pre-dispensed.

The devices are found in packaging of:

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

Only some packaging sizes may be commercially 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 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 leaflet was revised in July 2020.

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