Serevent Accuhaler 50 micrograms/inhalation, powder for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Serevent Accuhaler 50 micrograms/inhalation, inhalation powder

salmeterol (xinafoate)

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Serevent Accuhaler is and what it is used for
2. What you need to know before using Serevent Accuhaler
3. How to use Serevent Accuhaler
4. Possible adverse effects
5. How to store Serevent Accuhaler
6. Contents of the pack and other information

1. What Serevent Accuhaler is and what it is used for

Serevent Accuhaler belongs to a group of medicines called bronchodilators.

Serevent Accuhaler is indicated for the relief of breathing problems in patients with asthma or chronic bronchitis (COPD).

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

Do not use Serevent Accuhaler

• if you are allergic to salmeterol or to any of the other components 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 medicine 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 are prone to low levels of potassium in the blood.
• If you are being treated with ketoconazole (a medicine used to treat fungal infections).

If you are using Serevent Accuhaler for the treatment of your asthma, your doctor will want to see you regularly to monitor your symptoms. Contact your doctor immediately if:

• Your asthma worsens.
• You have increasing difficulty breathing.
• You experience more wheezing.
• You feel more shortness of breath than usual.
• You need to use your rescue medication more frequently.

If any of the above situations occur, do not increase the number of doses of Serevent Accuhaler (your breathing condition may worsen and you may become seriously ill). Contact your doctor, as it may be necessary to change your asthma treatment.

Other medicines and Serevent Accuhaler

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Important information about some of the components of Serevent Accuhaler

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

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

3. How to use Serevent Accuhaler

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

Serevent Accuhaler is for inhalation use only and must not be used in children under 4 years of age.

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

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

Recommended dose:

Adults

• One inhalation (50 micrograms) twice daily. If your doctor advises, this dose may be increased to two inhalations (100 micrograms) twice daily.

Use in children and adolescents

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

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

Instructions for use:

The device has two positions: closed and open.

CLOSED

When you first remove the device from its 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 remain.

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 you that few doses remain.

The device is easy to operate. When a dose is needed, follow the four simple steps below:

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

Operation of the device

When the lever of the device is slid, a small opening in the mouthpiece becomes available, and one dose is ready to inhale. When the device is closed, the lever automatically returns to its original position, ready for the next dose. The outer casing protects the device when not in use.

1. Open

To open the device, hold the outer casing with one hand and place the thumb of the other hand in the designated slot. Push the thumb away from you as far as it will go.

2. Slide

Keep the device with the mouthpiece facing you. Slide the lever away from you as far as it will go. You will hear a "click" sound. The device is now ready for use. Each time the lever is moved backward, one dose becomes available for inhalation. This is indicated by the dose counter. Do not manipulate the lever unnecessarily, as this may waste available doses.

3. Inhale

Before inhaling a dose, read this entire section carefully:

• Keep the device away from your mouth. Breathe out (exhale) as much as reasonably possible (but do not exhale into the device).
• Place the mouthpiece in your lips. Breathe in (inhale) steadily 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 possible.
• Breathe out slowly.
• You may not taste or feel the powder in your mouth, even if you have used the device correctly.

4. Close

To close the device, place your thumb in the designated slot and slide it toward you as far as it will go.

When closing the device, you will hear a distinct click. The lever automatically returns to its original position and resets. The device is now ready for the next use.

If your doctor has prescribed two inhalations, close the device and repeat steps 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 prescribed dose.

Keep out of 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 more Serevent Accuhaler than prescribed, you may experience: faster heartbeat than usual, headache, tremors, increased blood pressure, low blood potassium levels, feeling restless and/or dizzy. Contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20. If the dose taken is very high, go to your doctor or the nearest hospital emergency department immediately. 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 as soon as you remember, then continue as before.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• Sudden onset of wheezing or tightness in the chest.
• Swelling of the eyelids, face, or lips.
• Skin rash (hives) or urticaria anywhere on the body.

Some people, particularly those taking high doses of this type of medicine, may occasionally feel slightly shaky, have a headache, or notice their heart beating faster than normal. These effects usually disappear with continued treatment. If this sensation persists, inform your doctor, but do not stop treatment unless instructed to do so by your doctor.

The following are adverse effects associated with salmeterol. Inform your doctor if you experience any of the following symptoms:

Frequent adverse effects (may affect up to 1 in 10 patients)

• Tremor and headache. These are characteristic of this type of medication and usually disappear with time. Tremor occurs more frequently if you receive doses exceeding 50 micrograms twice daily.
• Palpitations, which normally disappear with time.
• Muscle cramps.

Uncommon adverse effects (may affect up to 1 in 100 patients)

• Hypersensitivity reactions with skin rash (rash).
• Nervousness.
• Tachycardia (occurs more frequently if you receive doses exceeding 50 micrograms twice daily).

Rare adverse effects (may affect up to 1 in 1,000 patients)

• Hypokalaemia (low blood potassium levels).
• Insomnia.
• Dizziness.

Very rare adverse effects (may affect up to 1 in 10,000 patients)

• Hypersensitivity reactions including oedema (swelling) and angioedema (skin reaction with redness, swelling, itching, and difficulty breathing), bronchospasm (contraction of the bronchi causing breathing difficulty), and anaphylactic shock (severe allergic reaction).
• Hyperglycaemia (high blood glucose levels). If you have diabetes, you may need to monitor your blood sugar levels more frequently and may require adjustment of your diabetes treatment.
• Cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia, and extrasystoles (heart rhythm disturbances).
• Irritation of the throat or pharynx, paradoxical bronchospasm (narrowing of the bronchial walls leading to reduced airflow and breathing difficulty).
• Nausea.
• Arthralgia (joint pain).
• Non-specific chest pain.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Serevent Accuhaler

Replace the mouthpiece cover by pressing firmly and closing with a click to ensure the lid is properly in place.

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

Do not store above 30°C.

Store protected from heat and direct sunlight.

Store protected from moisture.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Serevent Accuhaler

• The active substance is 50 micrograms of salmeterol (as xinafoate) per dose.
• The other ingredient is lactose monohydrate (contains milk proteins).

Appearance of the medicinal product and contents of the pack

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 the most recent review of this leaflet: September 2020.

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