InAspir Accuhaler 50 micrograms/inhalation, powder for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Inaspir Accuhaler 50 micrograms/inhalation, inhalation powder

salmeterol (xinafoate)

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Inaspir Accuhaler belongs to a group of medicines called bronchodilators.

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

2. What you need to know before you start using Inaspir Accuhaler

Do not use Inaspir Accuhaler

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Inaspir Accuhaler:

• If you have ever had to stop taking any other medication for your condition due to allergic 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 Inaspir 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 short 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 applications of Inaspir 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 medication.

Other medicines and Inaspir Accuhaler

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

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 components of Inaspir Accuhaler

Use in athletes: This medicinal product contains salmeterol, which may result in a positive doping test.

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

3. How to use Inaspir Accuhaler

Follow exactly the administration instructions for this medicine given by your doctor. If in 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 tell you how long your treatment with Inaspir Accuhaler should last. Do not stop treatment early, even if you feel better, unless your doctor tells you to do so.

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

If Inaspir 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 Inaspir Accuhaler.

It is very important that you follow your doctor's instructions on how many times and how often you should use Inaspir 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 Inaspir is too strong or too weak, inform your doctor or pharmacist.

Instructions for use:

The device has two positions: closed and open.

CLOSED

When first removed from the case, the device 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 that few doses remain.

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

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

How the device works

When the lever is slid, a small opening appears in the mouthpiece, 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 pulled back, one dose becomes available for inhalation. This is shown 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 from your lungs) as much as reasonably possible (do not exhale into the device).
• Place the mouthpiece in your lips. Breathe in (inhale into your lungs) 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 is reset. The device is now ready for reuse.

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 Inaspir Accuhaler than you should

If you have used more Inaspir Accuhaler than prescribed, you may notice your heart beating faster than usual, headache, tremors, increased blood pressure, low potassium levels in the blood, feeling restless and/or dizzy. Contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone: 91 562 04 20. If the dose taken was 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 Inaspir Accuhaler

If you miss a dose, do not worry. Inhale one 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 Inaspir 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 agitated, experience headache, or notice their heart beating faster than normal. These effects usually disappear with continued treatment. If these symptoms persist, 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 over time. Tremor occurs more frequently if you receive doses higher than 50 micrograms twice daily.
• Palpitations, which usually resolve over time.
• Muscle cramps.

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

• Hypersensitivity reactions with skin rash (rash).
• Nervousness.
• Tachycardia (more likely if you receive doses higher than 50 micrograms twice daily).

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

• Hypokalaemia (low potassium levels in the blood).
• 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 (elevated 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 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 Inaspir Accuhaler

Place 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Inaspir Accuhaler

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

Nature of the product and contents of the pack

Inaspir 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 - France

Or

Glaxo Wellcome, S.A.

Avda. de Extremadura, 3

Aranda de Duero (Burgos) - Spain

Date of the most recent revision of this leaflet: September 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/