PLUSVENT ACCUHALER 50 micrograms/500 micrograms INHALATION, POWDER FOR INHALATION

2. What you need to know before you use Plusvent

Do not use Plusvent

• if you are allergic to salmeterol, fluticasone propionate or to the other component, lactose monohydrate.

Warnings and precautions

Talk to your doctor before starting treatment 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.

Using Plusvent with other medicines

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. The reason is that, in some cases, Plusvent should not be taken with other medicines.

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

• Beta-blockers (such as atenolol, propranolol, and sotalol). Beta-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 side effects with Plusvent, including irregular heartbeats, or may worsen side effects, so your doctor will 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 that contain xanthines. They are often used to treat asthma.

Pregnancy and breastfeeding

If you are pregnant, 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.

Plusvent Accuhaler contains lactose

Plusvent Accuhaler contains up to 12.5 milligrams of lactose monohydrate per dose. The amount of lactose in this medicine normally does not cause problems in people who are lactose intolerant. However, it may cause allergic reactions in patients with a milk protein allergy. If your doctor has told you that you have an intolerance to some sugars, consult them before using this medicine.

3. How to use Plusvent

Follow the instructions for administration of this medicine exactly as your doctor or pharmacist has told you. If you are unsure, 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 unsure, ask your doctor or pharmacist.
• Do not stop taking Plusvent or reduce your dose without talking to your doctor first.
• Plusvent should 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 Accuhaler One inhalation twice a day
• Plusvent 50/250 Accuhaler One inhalation twice a day
• Plusvent 50/500 Accuhaler One inhalation twice a day

Children from 4 to 12 years of age

• Plusvent 50/100 Accuhaler One 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 Accuhaler One inhalation twice a day

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 change 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 applications and how often you should take your medicine.

If you are using Plusvent to treat asthma, your doctor will want to regularly check your symptoms.

If your asthma gets worse or you have greater difficulty breathing, see your doctor immediately. You may notice more wheezing or shortness of breath more often, or you may need to use your "rescue" medication more frequently. If any of these things happen, you should continue to use Plusvent, but do not increase the number of applications. Your respiratory 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 teach you how to use your inhaler. They should check how you use it from time to time. Not using Plusvent Accuhaler correctly or as prescribed may result in your asthma or COPD not improving as it should.
• This Accuhaler contains blisters that contain Plusvent powder.
• There is a dose counter on the top of the Accuhaler that shows how many doses are left. It counts down to 0. The numbers from 5 to 0 will appear in red to warn you that there are few doses left. Once the counter reads 0, your inhaler is empty.

Using your inhaler

1. To open the Accuhaler, hold the outer case with one hand and put the thumb of the other hand in the thumb grip. Push the thumb away from you as far as it will go. 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 either your right or left hand. Slide the lever away from you as far as it will go. You will hear a "click". This will place the dose of medicine in the mouthpiece.

Each time the lever is pulled back, a blister is opened and the powder is prepared for inhalation. Do not play with the lever, as this will open the blisters and waste medicine.

1. Hold the Accuhaler away from your mouth. Breathe out as much as you can. Do not breathe into the Accuhaler.

1. Put the mouthpiece in your mouth; breathe in slowly and deeply through the Accuhaler, not through your nose.

Take the Accuhaler out of your mouth.

Hold your breath for about 10 seconds or as long as you can

Breathe out slowly.

1. Afterwards, rinse your mouth with water and spit it out and/or brush your teeth. This may help prevent thrush in your mouth and hoarseness.

1. To close the Accuhaler, slide the thumb grip back towards you 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 to use again.

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

Cleaning your inhaler

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

If you use more Plusvent than you should

It is very important to use the inhaler exactly as you have been told. 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 have dizziness, headache, weakness, and joint pain.

If you have used high doses for long periods, 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 your doctor has told you. Keep taking it until your doctor tells you to stop. Do not stop using 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 any of the following:

• Stomach pain
• Tiredness and loss of appetite, feeling unwell.
• Being 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 you an additional dose of corticosteroids in tablets during this time (such as prednisolone).

If you have any further questions about 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 or Chronic Obstructive Pulmonary Disease (COPD).

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 andinform your doctor immediately. Allergic reactions to Plusvent are rare (affect less than 1 in 100 people).

Pneumonia (lung infection) in patients with COPD (frequent adverse effect)

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

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

The following adverse effects are listed:

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

• Headache, which usually improves with continued treatment.
• An increase in the number of colds has been reported in patients with Chronic Obstructive Pulmonary Disease (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):

• 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 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, you will need 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)

• Difficulty breathing (or wheezing) that worsens 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 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 the sight and reach of children.

Do not use Plusvent 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 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Plusvent

• Each pre-dispensed dose contains: 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate.
• The other component is lactose monohydrate (contains milk proteins).

Appearance of the Product and Package Contents

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

Each dose is pre-dispensed.

The devices are available in:

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

Not all pack sizes may be 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 last revised in July 2020.

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/