Leaflet: information for the user

Betamican Accuhaler 50 micrograms/inhalation, powder for inhalation

salmeterol (xinafoate)

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given 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 Betamican Accuhaler and what it is used for

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

3.How to use Betamican Accuhaler

4.Possible side effects

5.Storage of Betamican Accuhaler

6.Contents of the pack and additional information

Betamican Accuhaler belongs to a group of medicines called bronchodilators.

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

Do not use Betamican Accuhaler

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

Warnings and precautions

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

• Ifyou have ever had to stop taking any other medication for your condition due to allergy or other reasons.
• If you are being treated for any 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 presenting low levels of potassium in the blood.
• If you are being treated with ketoconazole (a medication used to treat fungal infections).

If you are using Betamican Accuhaler for the treatment of your asthma, your doctor will want to see you regularly to check your symptoms. Attend your doctor immediately if:

• Your asthma worsens.
• You have greater difficulty breathing.
• You notice more wheezing.
• You experience a feeling of choking more often.
• You have to use your rescue medication more frequently.

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

Other medications and Betamican Accuhaler

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Important information about some of the components of Betamican Accuhaler

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

This medication contains lactose.It may cause allergic reactions in patients with a milk protein allergy. If your doctor has told you that you have an intolerance to certain sugars, consult with them before using this medication.

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

Remember to use your medication. IT IS VERY IMPORTANT THAT IT IS USED REGULARLY EVERY DAY. This will help you stay free of symptoms throughout the day and night.

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

Betamican Accuhaler should only be used by inhalation and should not be used in children under 4 years old.

If you have been prescribed Betamican Accuhaler for your asthma, you must continue to use any other medication you are taking to control your asthma. These should include an inhaled corticosteroid or tablets. 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 corticosteroid (or tablets) when you start using Betamican Accuhaler.

It is very important that you follow your doctor's instructions on how many times and how often you should use Betamican Accuhaler. The usage instructions 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, you can increase this dose to two inhalations (100 micrograms) twice a day.

Use in children and adolescents

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

If you estimate that the action of Betamican is too strong or too weak, inform your doctor or pharmacist.

Usage instructions:

The device has two positions: closed and open.

CLOSED

When removing the device from the box for the first time, it will be closed.

OPEN

The device contains 60 individual doses of the medication 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 5 to 0 will appear in RED to warn that there are few doses left.

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

1.Open

2.Slide

3.Inhale

4.Close

Device operation

When sliding the device's lever, a small opening is created in the mouthpiece or mouthpiece, and a prepared dose is available for inhalation. 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 reserved hole. Push the thumb away from you as far as it will go.

2.Slide

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

3.Inhale

Before inhaling a dose, read this section carefully:

*Keep the device away from your mouth. Breathe out (exhale) as much as you can (do not breathe out into the device).

*Place the mouthpiece in your mouth. Breathe in (inhale) progressively and intensely – through the device, not through your nose.

*Remove the device from your mouth.

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

*Breathe out slowly.

*You may not be able to taste or feel the powder on your tongue, even if you have used the device correctly.

4.Close

To close the device, place the thumb in the reserved hole and slide it towards you as far as it will go.

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

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

RECORDER

Keep the device dry.

Keep the device closed when not in use.

Do not breathe out into the device.

Slide the lever only when ready to take a dose.

Do not exceed the recommended dose.

Keep out of reach of children.

Consult your doctor or pharmacist if you have any doubts.

If you use more Betamican Accuhaler than you should

If you have used Betamican 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 agitated and/or dizzy. Consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 91 562 04 20. If the dose taken was very high, go to your doctor immediately or to the nearest hospital emergency room. Bring this leaflet or the medication with you.

If you forgot to use Betamican Accuhaler

Do not worry if you forget a dose. Inhale a dose when you remember and then continue as before.

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

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

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

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

• Trembling and headache. These are characteristics of this type of medication and usually disappear over time. Trembling occurs more frequently if you receive doses above 50 micrograms, twice a day.
• Palpitations, which usually disappear over time.
• Muscle cramps.

Less frequent side effects (may affect up to 1 in 100 patients)

• Skin rash due to hypersensitivity reactions.
• Nervousness.
• Tachycardia (occurs more frequently if you receive doses above 50 micrograms, twice a day).

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

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

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

• Hypersensitivity reactions, including edema and angioedema (skin reaction with redness, swelling, itching, and difficulty breathing), bronchospasm (constriction of the bronchi causing difficulty breathing), and anaphylactic shock (severe allergic reaction).
• Hyperglycemia (elevated glucose levels in the blood). If you have diabetes, you may need to monitor your blood sugar levels more frequently and possibly adjust your diabetes treatment.
• Cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia, and extrasystoles (heart rhythm disorders).
• Pharyngitis or laryngitis, paradoxical bronchospasm (narrowing of the bronchi walls with reduced airflow and difficulty breathing).
• Nausea.
• Arthralgia (joint pain).
• Non-specific chest pain.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for 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.

Place the mouthpiece cap firmly and close it with a snap so that the cap is securely in place.

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C.

Store protected from heat and direct sunlight.

Store protected from moisture.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit empty packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty packaging and unused medications. By doing so, you will help protect the environment.

Composition of Betamican Accuhaler

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

Appearance of the product and contents of the packaging

Betamican Accuhaler is an inhalation powder. Each inhalation device contains 60 blisters.

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization:

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 N. 2

23 rue Lavoiser

27000 Evreux – France

Last review date of this leaflet:September 2020.

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