SEREVENT ACCUHALER 50 micrograms/inhalation, powder for inhalation

2. What you need to know before you use Serevent Accuhaler

Do not use Serevent Accuhaler

• if you are allergic to salmeterol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Serevent Accuhaler:

• If you have ever had to stop taking any other medication for your condition due to allergy problems or other reasons.
• If you are being treated for a thyroid disorder.
• If you are being treated for high blood pressure.
• If you are being treated for heart problems.
• If you have diabetes mellitus.
• If you have a tendency to have low potassium levels in your blood.
• If you are being treated with ketoconazole (a medicine used to treat fungal infections).

If you are using Serevent Accuhaler for your asthma, your doctor will want to see you regularly to check your symptoms. Go to your doctor immediately if:

• Your asthma gets worse.
• You have more difficulty breathing.
• You notice more wheezing.
• You have a feeling of shortness of breath more often.
• You need to use your rescue medication more frequently.

If you experience any of the above situations, do not increase the number of applications of Serevent Accuhaler (your respiratory condition may worsen and you may become seriously ill). Go to your doctor as it may be necessary to change your medication for the treatment of your asthma.

Other medicines and Serevent Accuhaler

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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.

Important information about some of the ingredients of Serevent Accuhaler

Use in athletes: this medicine contains salmeterol, which may produce a positive result in doping tests.

This medicine contains lactose. It may cause allergic reactions in patients with cow's milk protein allergy. If your doctor has told you that you have an intolerance to some sugars, consult with him before using this medicine.

3. How to use Serevent Accuhaler

Follow the instructions for administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to use your medicine. IT IS VERY IMPORTANT TO USE IT REGULARLY EVERY DAY. This will help you stay symptom-free throughout the day and night.

Your doctor will indicate the duration of your treatment with Serevent Accuhaler. Do not stop treatment before, even if you feel better, unless your doctor tells you to.

Serevent Accuhaler should only be used by inhalation and should not be used in children under 4 years of age.

If you have been prescribed Serevent Accuhaler for your asthma, you should continue to use any other medication you are taking to control your asthma. These should include an inhaled corticosteroid or tablets. Continue to take the same doses as before, unless your doctor tells you otherwise. Do this even if you feel better. Do not stop taking your inhaled corticosteroid (or tablets) when you start using Serevent Accuhaler.

It is very important that you follow your doctor's instructions about the number of times and how often you should use Serevent Accuhaler. The instructions for use are given below. If you have difficulties or do not understand the instructions, ask your doctor or pharmacist.

The recommended dose is:

Adults

• One inhalation (50 micrograms) twice a day. If your doctor advises, you may increase this dose up to two inhalations (100 micrograms) twice a day.

Use in children and adolescents

• Children over 4 years: one inhalation (50 micrograms) twice a day.

If you think the action of Serevent is too strong or too weak, tell your doctor or pharmacist.

Instructions for use:

The device has two positions: closed and open.

CLOSED

When you first remove the device from the case, it will be closed.

OPEN

The device contains 60 individual doses of the medicine in powder form. The dose indicator shows how many doses are left.

Each dose is precisely measured and hygienically protected. No maintenance or refilling is required.

The dose indicator on the top of the device shows how many doses are left. The numbers from 5 to 0 will appear in RED to warn that there are few doses left.

Handling the device is easy. When a dose is needed, follow the four simple instructions below:

1. Open
2. Slide
3. Inhale
4. Close

Device operation

When the lever on the device is slid, a small hole opens in the mouthpiece and a dose is made available for inhalation. When the device is closed, the lever automatically returns to its original position and is ready for the next dose. The external casing protects the device when not in use.

1. Open

To open the device, hold the external casing with one hand and place the thumb of the other hand in the hole provided for it. Push with your thumb, moving it away from you until it stops.

1. Slide

Hold the device with the mouthpiece towards you. Slide the lever away from you until it stops, you will hear a "click" sound. The device is ready for use. Each time the lever is pulled back, a dose is made available for inhalation. This is shown by the dose counter. Do not manipulate the lever as doses will be made available that will be wasted.

1. Inhale

Before starting to inhale a dose, read this section carefully:

• Hold the device away from your mouth. Exhale (breathe out) as much as you reasonably can (do not do it inside the device).
• Place the mouthpiece in your lips. Inhale (breathe in) slowly and deeply - through the device, not through your nose.
• Remove the device from your mouth.
• Hold your breath for about 10 seconds or as long as you can.
• Exhale slowly.
• You may not be able to taste or feel the powder on your tongue, even if you have used the device correctly.

1. Close

To close the device, put your thumb in the hole provided for it and slide it towards you until it stops.

When closing the device, you will hear a sharp click. The lever automatically returns to its original position and is ready to be used again.

If your doctor has prescribed two inhalations, close the device and repeat the instructions 1 to 4.

REMEMBER

Keep the device dry.

Keep the device closed when not in use.

Do not exhale into the device.

Slide the lever only when you are ready to take a dose.

Do not exceed the indicated dose.

Keep out of the reach of children.

Consult your doctor or pharmacist if you have any doubts.

If you use more Serevent Accuhaler than you should

If you have used Serevent Accuhaler more than you should, you may notice: that your heart beats faster than usual, headache, tremors, increased blood pressure, low potassium levels in the blood, feeling of agitation and/or dizziness. Consult your doctor or pharmacist immediately or the Toxicology Information Service, phone: 91 562 04 20. If the dose taken was very high, go to the doctor immediately or to the Emergency Department of the nearest hospital. Bring this leaflet or the medicine with you.

If you forget to use Serevent Accuhaler

If you forget a dose, do not worry. Inhale a dose when you remember and then continue as before.

Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some people may be allergic to medicines. If you have any of the following symptoms soon after using Serevent Accuhaler, STOP using this medicine and tell your doctor immediately:

• Sudden onset of wheezing or chest tightness.
• Swelling of the eyelids, face, or lips.
• Rash (hives) or urticaria on any part of the body.

Some people, particularly those taking high doses of this type of medicine, may occasionally feel a little agitated, have a headache, or notice that their heart beats a bit faster than normal, but these effects usually go away as treatment continues. If this feeling continues, tell your doctor but do not stop treatment unless he tells you to.

The following are side effects associated with salmeterol. Tell your doctor if you have any of the following symptoms:

Common side effects(may affect up to 1 in 10 people)

• Tremors and headache. These are characteristics of this type of medication and usually go away over time. Tremors occur more frequently if you receive doses higher than 50 micrograms, twice a day.
• Palpitations, which usually go away over time.
• Muscle cramps.

Uncommon side effects(may affect up to 1 in 100 people)

• Hypersensitivity reactions with skin rash.
• Nervousness.
• Tachycardia (occurs more frequently if you receive doses higher than 50 micrograms, twice a day).

Rare side effects(may affect up to 1 in 1,000 people)

• Hypokalemia (low potassium levels in the blood).
• Insomnia.
• Dizziness.

Very rare side effects(may affect up to 1 in 10,000 people)

• Hypersensitivity reactions including edema (swelling) and angioedema (skin reaction with redness, swelling, itching, and difficulty breathing), bronchospasm (contraction of the bronchi causing difficulty breathing), and anaphylactic shock (severe allergic reaction).
• Hyperglycemia (high blood sugar levels). If you have diabetes, you may need to check your blood sugar levels more frequently and may need to adjust your diabetes treatment.
• Cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia, and extrasystoles (heart rhythm disorders).
• Throat or pharynx irritation, paradoxical bronchospasm (narrowing of the bronchi with decreased air intake and difficulty breathing).
• Nausea.
• Arthralgia (joint pain).
• Unspecific chest pain.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are 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 side effects, you can help provide more information on the safety of this medicine.

5. Storing Serevent Accuhaler

Put the mouthpiece protector on by pushing it firmly and closing it with a snap so that the cap is in place.

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Keep protected from heat and direct sunlight.

Keep protected from moisture.

Do not use this medicine after the expiry date that appears on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Serevent Accuhaler

• The active ingredient is 50 micrograms of salmeterol (as xinafoate) per application.
• The other ingredient is lactose monohydrate (contains cow's milk proteins).

Appearance of the product and packaging contents

Serevent Accuhaler is a powder for inhalation. Each inhalation device contains 60 blisters.

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 PRODUCTIONS, S.A.S

23, Rue Lavoisier - Zone Industrielle Nº 2 (Evreux La Madeleine) - F-27000 - France

or

GLAXO WELLCOME, S.A.

Avda. de Extremadura, 3 (Aranda de Duero) - 09400 - Spain

Date of last revision of this leaflet:September 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/