Prospecto: information for the user

Betamican 25 micrograms/inhalation, suspension for inhalation in a pressurized container

salmeterol (xinafoate)

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Betamican and for what it is used

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

3.How to use Betamican

4.Possible adverse effects

5.Storage of Betamican

6.Contents of the container and additional information

Betamican belongs to a group of medications known as bronchodilators.

Betamican is indicated for the regular long-term treatment of reversible airway obstruction caused by asthma and chronic bronchitis (COPD). For asthma, it will be administered in combination with a long-term anti-inflammatory therapy with inhaled or oral glucocorticoids.

No use Betamican

• 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:

• If you 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 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 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 more frequent feelings of choking.

- You have to use your rescue medication more frequently.

If any of the above situations occur, do not increase the number of Betamican 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.

Patients who have previously been treated with Betamican should be aware that it no longer contains chlorofluorocarbon (CFC) propellants for aerosols. It should be used exactly as instructed by your doctor. Your doctor may change your dosage regimen.

The active ingredient in CFC-free Betamican is exactly the same as that in the original Betamican containing CFCs. The only differences you may notice are the taste and the sensation of the spray in your mouth, as well as the sound of the inhaler during use. This is due to the change of propellant to eliminate the CFCs. This modification does not affect the mechanism of action of the medication. CFC-free Betamican can be used in the same way as the original.

Other medications and Betamican

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, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Important information about some of the components of Betamican

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

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 at night.

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

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

If you have been prescribed Betamican for your asthma, you should continue using 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.

It is very important that you follow your doctor's instructions on the number of times and how often you should use Betamican. 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

• Two inhalations (50 micrograms) twice a day. If your doctor advises you, you can increase this dose to four inhalations (100 micrograms) twice a day.

Use in children and adolescents

• Children over 4 years old: two inhalations (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:

Before using for the first time the inhaler or if it has not been used for a week or more, remove the mouthpiece protector by pressing it gently on both sides, shake the inhaler well, and release two applications to the air to ensure, in this way, the functioning of the inhaler.

Using the inhaler:

1. Remove the mouthpiece protector, pressing it gently on both sides.

1. Check that there are no foreign particles inside and outside the inhaler, including the mouthpiece.

1. Shake the inhaler well to ensure the elimination of any foreign particles and that the content of the inhaler is mixed properly.

1. Hold the inhaler in a vertical position between the index and middle fingers, placing the thumb on the base, below the mouthpiece.

1. Breathe in as much air as possible and then introduce the mouthpiece into the mouth, between the teeth, closing the lips over the device, but not biting it.

1. Immediately after starting to breathe in through the mouth, press the top of the inhaler to release the medication and continue breathing in deeply and constantly.

1. Hold your breath and remove the inhaler from the mouth, taking your finger off the top of the inhaler. Continue holding your breath as long as possible.

1. If you are going to administer another inhalation, hold the inhaler in a vertical position and wait for approximately half a minute before repeating steps 3 to 7.

1. Replace the mouthpiece protector by pushing it firmly and adjusting it until you hear a click.

IMPORTANT

Do not perform steps 5, 6, and 7 quickly. It is essential to start breathing as slowly as possible, just before pressing the inhaler.

Practice in front of a mirror during the first times. If you see a "kind of fog" coming out of the top of the inhaler or from the sides of the mouth, start again from step 2.

Patients who find difficulty in coordinating the handling of the inhaler with the inhalation may use an appropriate inhalation chamber (BABYHALER, inhalation chamber for children up to 5 years old).

Small children may need help, with their parents handling the inhaler for them. Encourage the child to breathe in and handle the inhaler just after the child starts breathing in. Practice together the technique. Older children or people with fragile hands should hold the inhaler with both hands; for this, they will place the two index fingers on the top of the inhaler and the two thumbs on the base, below the mouthpiece.

If your doctor has given you different instructions for using the inhaler, follow them carefully. Inform your doctor if you have any difficulty.

Cleaning:

Clean the inhaler at least once a week.

1. Remove the mouthpiece protector.
2. Do not remove the cartridge from the plastic casing.
3. Clean the mouthpiece and the plastic casing inside and outside with a dry cloth, a paper tissue, or a little cotton.
4. Replace the mouthpiece protector.

DO NOT SUBMERGE THE METAL CONTAINER IN WATER.

Consult your doctor or pharmacist if you have any doubts.

If you use more Betamican than you should

If you have used Betamican 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 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 your doctor immediately or to the nearest hospital emergency room. Bring this leaflet or the medication with you.

If you forgot to use Betamican

If you forget to take a dose, do not worry. 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 questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine may 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, STOP taking this medicine and inform your doctor immediately:

• Sudden onset of wheezing or chest tightness.
• Swelling of eyelids, face, or lips.
• Rash or urticaria 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 sensation persists, inform your doctor, but do not stop treatment unless they tell you to.

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

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

• 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 people)

• 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 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 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).
• Irritation of the throat or pharynx, paradoxical bronchospasm (narrowing of the bronchi walls with reduced air entry 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.

Push the mouthpiece cover firmly and close it with a snap to ensure it is in place.

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

Do not store at a temperature above30ºC. Do not freeze.

Store in the original packaging to protect it from direct sunlight.

If the inhaler is very cold, remove the cartridge andwarm it with your handfor a few minutes before use.Do not use any other method to warm it.

The cartridge contains a pressurized liquid. Do not expose to temperatures above 50ºC. Do not pierce, break, or burn the cartridge, even if it is empty.

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

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

Composition of Betamican

• The active ingredient is 25 micrograms of salmeterol (as xinafoate) per application.
• The other component is norflurano (HFA 134a).

This medication contains fluorinated greenhouse gases.

Each inhaler contains 12 g of HFC-134a (also known as norflurano or HFA 134a) corresponding to 0.0172 tons of CO2 equivalent (global warming potential PCG = 1,430).

Appearance of the product and contents of the packaging

Betamican is a pressurized inhalation suspension. Each inhaler provides 120 applications.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Phone: +34 900 202 700

[email protected]

Responsible 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 (Burgos) –Spain.

Last review date of this leaflet:01/2025

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