BECLOFORTE 250 micrograms/inhalation PRESSURIZED INHALATION SOLUTION

Introduction

Package Leaflet: Information for the User

Becloforte 250 micrograms/inhalation, inhalation solution in a pressurized container

beclometasone dipropionate

Read this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Becloforte and what is it used for
2. What you need to know before you use Becloforte
3. How to use Becloforte
4. Possible side effects
5. Storage of Becloforte

1. Contents of the pack and further information

1. What is Becloforte and what is it used for

Beclometasone dipropionate belongs to a group of medicines called corticosteroids, simply known as steroids. Corticosteroids are used to treat asthma as they have, among other effects, an anti-inflammatory action. They reduce swelling and irritation in the walls of the small airways in the lungs and make breathing easier.

Corticosteroids also help prevent asthma attacks.

Beclometasone dipropionate should not be confused with other steroids, such as anabolic steroids, which are misused by some athletes and taken as tablets or by injection.

Becloforte is used to prevent asthma symptoms in people who need regular treatment.

2. What you need to know before you use Becloforte

Do not use Becloforte

• if you are allergic to beclometasone dipropionate or any of the other ingredients of this medicine (listed in section 6)
• to treat a sudden attack of breathing difficulties.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Becloforte:

• if you have had thrush in your mouth
• if you are taking or have recently taken any other steroid tablets or injections
• if you are being or have been treated for tuberculosis.

Patients who have previously been treated with Becloforte should be aware that it no longer contains chlorofluorocarbons (CFCs). It should be used exactly as your doctor indicates. Your doctor may change your dosage regimen.

The active ingredient of Becloforte without CFCs is exactly the same as that of Becloforte that contained CFCs. The only differences that may be noticed are the taste and the sensation of feeling the spray in the mouth, as well as the sound of the inhaler during use. This is due to the change of propellant to eliminate CFCs. This modification does not affect the mechanism of action of the drug. Becloforte without CFCs can be used in the same way as the previous one.

Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and Becloforte

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Inform your doctor if you are taking disulfiram or metronidazole, as there is a potential risk of interaction in particularly sensitive individuals.

Some medicines may increase the effects of Becloforte, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

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.

Driving and using machines

Becloforte is unlikely to affect your ability to drive or use machines.

Becloforte contains ethanol

This medicine contains 8.93 mg of alcohol (ethanol) in each unit dose, which is equivalent to 15.12% w/w. The amount in a dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.

The small amount of alcohol in this medicine does not produce any noticeable effect.

3. How to use Becloforte

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist exactly. Do not exceed the recommended dose. If in doubt, consult your doctor or pharmacist again.

Remember to use your medicine.

Your doctor will indicate the duration of your treatment with Becloforte. Do not stop treatment before, even if you feel better, unless your doctor tells you to or you notice that your breathing worsens when taking the medicine.

Becloforte should only be used by inhalation.

Adults

The following doses are recommended, to be chosen by the doctor:

• 1 inhalation (250 micrograms) twice a day.
• 1 inhalation (250 micrograms) four times a day.
• 2 inhalations (500 micrograms) per dose, twice a day.

If necessary, according to the patient's response and always under medical indication, the dose can be increased to 2 inhalations (500 micrograms) per dose, three or four times a day.

Use in children

Becloforte is not indicated in children.

If you have just started using Becloforte, instead of, or at the same time as oral steroids, you should carry a warning card that you are taking steroids until your doctor tells you that you no longer need it.

It may take several days before you notice the benefits produced by the medicine. It is very important that you use it regularly every day.

Do not use this medicine to treat a sudden attack of breathing difficulties, it will not help. You will need a different type of medicine. If you take or use more than one medicine, be careful not to confuse them.

The instructions for use are given below. If you have difficulties or do not understand these instructions, consult your doctor or pharmacist.

Checking the inhaler:

The first time you use the inhaler, or if you have not used it for a week or more, shake it well and perform an application to the air to ensure it works.

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

Instructions for use:

1. Remove the mouthpiece cover by gently squeezing the sides.

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

1. Shake the inhaler well to ensure that any foreign particles are eliminated and that the contents of the inhaler are mixed properly.

1. Hold the inhaler vertically between your index and thumb fingers, placing your thumb on the base, below the mouthpiece.

1. Exhale as much air as you reasonably can and then insert the mouthpiece into your mouth, between your teeth, closing your lips around the device, but without biting it.

1. Immediately after starting to take air through your mouth, press the top of the inhaler to release the medicine and continue taking air deeply and steadily.

1. Hold your breath and remove the inhaler from your mouth, removing your finger from the top of the inhaler. Continue holding your breath for as long as you reasonably can.

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

1. Replace the mouthpiece cover, pushing 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 the first few times. If you see a "kind of mist" coming out of the top of the inhaler or the sides of your mouth, start again from step 2.

People with fragile hands should hold the inhaler with both hands, placing the two index fingers on the top of the inhaler and the two thumbs on the base, below the mouthpiece.

Patients who find it difficult to coordinate the handling of the inhaler with inhalation may alternatively use a suitable inhalation chamber, Volumatic.

Cleaning the inhaler

Clean the inhaler at least once a week.

A mild detergent or a solution of the type used to clean baby bottles can be added to the water. Rinse thoroughly with clean water before drying. DO NOT SUBMERGE THE METAL CARTRIDGE IN WATER.

If you use more Becloforte than you should

It is essential that you take your dose as your doctor has indicated. Do not increase or decrease your dose without medical supervision.

If you have used more Becloforte than you should, consult your doctor or pharmacist immediately or the Toxicology Information Service, phone: 91 562 04 20.

If you forget to use Becloforte

Do not take a double dose to make up for forgotten doses, simply wait for the next dose.

4. Possible side effects

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

The side effects due to the administration of Becloforte may be:

Very common (may affect more than 1 in 10 people)

• Oral and/or pharyngeal candidiasis (thrush).

Common (may affect up to 1 in 10 people)

• Hoarseness and/or throat irritation. In this case, you should gargle with water and spit immediately after each dose. The use of a suitable inhalation chamber, Volumatic, may help. Consult your doctor but do not interrupt treatment unless the doctor tells you to.

Uncommon (may affect up to 1 in 100 people)

• Skin rashes, urticaria, pruritus, and/or erythema.

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

• Allergies, which manifest with swelling of the eyelids, face, lips, and/or throat (angioedema).
• Respiratory disorders such as dyspnea (feeling of lack of air or difficulty breathing) and/or bronchospasm (narrowing of the bronchial walls with decreased air intake).
• Anaphylactic or anaphylactoid reactions (severe allergic reactions that can make breathing difficult or alter your level of consciousness).
• Delayed growth in children and adolescents.
• Round face (moon face) (Cushing's syndrome).
• Loss of bone density.
• Eye problems (cataracts and glaucoma).
• Anxiety, sleep disorders, and mood changes, including hyperactivity and irritability (mainly in children).
• Paradoxical bronchospasm.

Frequency not known:

• Depression or aggression. These effects are more likely to occur in children.
• Blurred vision.

If, despite using your medicine, your breathing difficulties or wheezing worsen, stop treatment immediately and inform your doctor as soon as possible.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect 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. Storage of Becloforte

Immediately after using the medicine, replace the mouthpiece cover by pushing firmly until you hear a click. No excessive force is necessary.

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

Do not store above 30°C.

Do not freeze. Store in the outer packaging to protect it from direct sunlight.

As with many medications administered in inhaler cartridges, the therapeutic effect of this medication may decrease when the cartridge is cold.

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

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If in doubt, 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 further information

Composition of Becloforte

• The active ingredient is 250 micrograms of beclometasone dipropionate per application.
• The other ingredients are norflurane (HFA 134a), glycerol (E422), and ethanol.

This medicine contains fluorinated greenhouse gases.

Each inhaler contains 11.8 g of HFC-134a (also known as norflurane or HFA 134a), which corresponds to 0.0169 tons of CO2 equivalent (global warming potential GWP = 1,430).

Appearance of the product and contents of the pack

Becloforte is an inhalation solution in a pressurized container. Each inhaler provides 200 applications.

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 Production

Zone Industrielle N. 2

23 rue Lavoiser

27000 Evreux – France

Date of the last revision of this leaflet:01/2025

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/