Leaflet: information for the user

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

dipropionate of beclometasone

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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the container and additional information

Becloforte, which contains beclometasone dipropionate, belongs to a group of medications called corticosteroids, also known as steroids. Corticosteroids are used to treat asthma because they have an anti-inflammatory action, among others. 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 in pill or injectable form.

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

Do not use Becloforte

• If you are allergic to beclometasone dipropionate or any of the other components of this medication (listed in section 6)
• For the treatment of a sudden attack of breathing difficulty.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Becloforte:

• If you have had mouth ulcers
• If you are taking or have recently taken any type of steroid tablet or injectable
• If you are being or have been treated for tuberculosis.

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

The active ingredient of Becloforte without CFCs is exactly the same as that of the 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 the CFCs. This modification does not affect the mechanism of action of the medication. 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 medications and Becloforte

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

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

Some medications may increase the effects of Becloforte, so your doctor will perform close monitoring if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

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

Driving and operating machinery

Becloforte is unlikely to affect your ability to drive or operate machinery.

Becloforte contains ethanol

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

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. Do not exceed the recommended dose. In case of doubt, consult your doctor or pharmacist again.

Remember to use your medication.

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 notes that your breathing worsens when taking the medication.

Becloforte should only be used by inhalation.

Adults

The following doses are recommended, to be chosen by your 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 for 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.

You may notice the benefits of the medication several days after starting. It is very important that you use it regularly every day.

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

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

Checking the inhaler:

The first time the inhaler is used, or if it has not been used for a week or more, shake well and perform a test inhalation to ensure it is working.

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

Usage instructions:

1. Remove the cap from the mouthpiece, pressing gently on 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 the elimination of any foreign particles and that the contents of the inhaler are mixed properly.

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

1. Breathe in as much air as reasonably possible and then insert 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, releasing the thumb from the top of the inhaler. Continue holding your breath as long as reasonably possible.

1. If another inhalation is to be administered, keep the inhaler in a vertical position and wait for approximately half a minute before repeating steps 3 to 7.

1. Replace the cap on the mouthpiece, 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 notice a "kind of fog" coming out of the top of the inhaler or from the sides of the 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 use an alternative inhalation chamber, Volumatic.

Cleaning the inhaler

Clean the inhaler at least once a week.

You can add a mild detergent or a solution of the type used to clean baby bottles 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 indicated by your doctor. 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 Toxicological Information Service, phone: 91 562 04 20.

If you forgot to use Becloforte

Do not take a double dose to compensate for the missed doses, simply wait for the next dose.

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

The side effects caused by the administration of Becloforte may be:

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

• Mouth and/or throat candidiasis (thrush).

Common (may affect up to 1 in 10 people)

• Hoarseness and/or throat irritation. In such cases, you should gargle with water and spit immediately after each dose. Using a spacer device for inhalation, such as Volumatic, may help. Consult your doctor but do not interrupt treatment unless your doctor tells you to.

Rare (may affect up to 1 in 100 people)

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

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

• Allergies, which manifest with eyelid swelling, face, lips, and/or throat (angioedema).
• Respiratory alterations such as dyspnea (sensation of lack of air or difficulty breathing) and/or bronchospasm (narrowing of the bronchial walls with decreased air entry).
• Anaphylactic or anaphylactoid reactions (severe allergic reactions that may impair breathing or alter consciousness).
• Delayed growth in children and adolescents.
• Rounded face (moon-shaped) (Cushing's syndrome).
• Bone density loss.
• Eye problems (cataracts and glaucoma).
• Anxiety, sleep disorders, and mood changes, including hyperactivity and irritability (mainly in children).
• Paradoxical bronchospasm.

Unknown frequency:

• Depression or aggression. It is more likely that these effects will appear in children.
• Blurred vision.

If, despite using your medicine, your breathing difficulty or wheezing worsens, discontinue treatment immediately and inform your doctor as soon as possible.

Reporting of 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.

Immediately after using the medication, replace the mouthpiece protector by pushing it firmly until you hear a click. Excessive force is not necessary.

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

Do not store at a temperature above 30°C.

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

As with many medications administered in inhalation 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 medication after the expiration date shown on the packaging. 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 Becloforte

• The active ingredient is 250 micrograms of dipropionate of beclometasone per application.
• The other components 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) corresponding to 0.0169 tons of CO2 equivalent (global warming potential PCG = 1,430).

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

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]

Responsible for manufacturing:

Glaxo Wellcome Production

Zone Industrielle N. 2

23 rue Lavoiser

27000 Evreux – France

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

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