Becloforte 250 micrograms/inhalation solution for inhalation in pressurized container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Becloforte 250 micrograms/inhalation, pressurised inhalation solution

beclometasone dipropionate

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

Contents of the leaflet

1. What Becloforte is and what it is used for

2. What you need to know before using Becloforte

3. How to use Becloforte

4. Possible adverse effects

5. How to store Becloforte

6. Contents of the pack and other information

1. What Becloforte is and what it is used for

Beclometasone dipropionate belongs to a group of medicines called corticosteroids, commonly known simply as steroids. Corticosteroids are used in the treatment of asthma because they have, among other effects, an anti-inflammatory action. They reduce swelling and irritation in the walls of the small airways through which air passes in the lungs, thereby making breathing easier.

Corticosteroids also help prevent asthma attacks.

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

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

2. What you need to know before using Becloforte

Do not use Becloforte

• if you are allergic to beclometasone dipropionate or to any of the other ingredients of this medicine (listed in section 6)
• to treat 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 oral or injectable steroid tablets
• if you are being or have been treated for tuberculosis.

Patients previously treated with Becloforte should be aware that the current formulation does not contain chlorofluorocarbon propellants (CFCs). The medicine must be used exactly as directed by your doctor. Your doctor may adjust your dosage regimen.

The active ingredient in CFC-free Becloforte is exactly the same as in the CFC-containing Becloforte. The only differences you may notice are the taste and the sensation of the spray in the mouth, as well as the sound of the inhaler during use. These changes are due to the replacement of the propellant to eliminate CFCs. This modification does not affect the drug's mechanism of action. CFC-free Becloforte can be used in the same way as the previous formulation.

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

Other medicines and Becloforte

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Tell 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 closely monitor you if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 operate machinery.

Becloforte contains ethanol

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

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

3. How to use Becloforte

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

Remember to use your medicine regularly.

Your doctor will determine the duration of your treatment with Becloforte. Do not stop treatment early, even if you feel better, unless your doctor advises you to do so or you notice that your breathing worsens when taking the medicine.

Becloforte is for inhalation use only.

Adults

The following doses are recommended, to be selected by your doctor:

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

If necessary, depending on the patient's response and always under medical supervision, the dose may be increased to 2 inhalations (500 micrograms) per dose, three or four times daily.

Use in children

Becloforte is not indicated for use in children.

If you have just started using Becloforte instead of, or in addition to, oral steroids, you should carry a steroid alert card until your doctor tells you that it is no longer needed.

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

Do not use this medicine to treat a sudden attack of breathing difficulty, as it will not help. You will need a different type of medicine for that. 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 the inhaler is used, or if it has not been used for one week or more, shake it well and release one puff into the air to ensure that it is working properly.

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

Instructions for use:

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

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

2. Shake the inhaler well to remove any foreign particles and to ensure that the contents are properly mixed.

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

1. Breathe out as much air as reasonably possible, then place the mouthpiece in your mouth between your teeth, sealing your lips around the device without biting it.

1. Immediately after starting to inhale slowly through your mouth, press down on the top of the inhaler to release the medication, and continue inhaling deeply and steadily.

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

1. If a second inhalation is required, keep the inhaler in an upright position and wait approximately half a minute before repeating steps 3 to 7.

2. Replace the mouthpiece cap by firmly pushing and adjusting it until you hear a click.

IMPORTANT

Do not carry out steps 5, 6, and 7 too quickly. It is important to begin inhaling as slowly as possible, just before pressing the inhaler. Practice in front of a mirror the first few times. If you see a "mist" escaping from the top of the inhaler or from the sides of your mouth, start again from step 2.

People with weak hands should hold the inhaler with both hands: place both index fingers on the top of the inhaler and both thumbs on the base, below the mouthpiece.

Patients who have difficulty coordinating the use of the inhaler with inhalation may alternatively use a suitable spacer device, 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 may be added to the water. Rinse thoroughly with clean water before drying. DO NOT IMMERSE THE METAL CARTRIDGE IN WATER.

If you use more Becloforte than you should

It is important that you take your dose exactly as instructed by your physician. You must not increase or decrease your dose without medical supervision.

If you have used more Becloforte than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20.

If you forget to use Becloforte

Do not take a double dose to make up for missed doses; simply wait until your next scheduled dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects due to the administration of Becloforte may include:

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 such cases, gargle with water and spit it out immediately after each dose. Using a suitable inhalation spacer device, Volumatic, may help. Consult your doctor, but do not stop treatment unless your doctor tells you to.

Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1,000 people)

• Allergic reactions, manifesting as swelling of the eyelids, face, lips, and/or throat (angioedema).
• Respiratory disturbances such as dyspnea (shortness of breath or difficulty breathing) and/or bronchospasm (narrowing of the bronchial walls resulting in reduced airflow).
• Anaphylactic or anaphylactoid reactions (severe allergic reactions that may impair breathing or alter your level of consciousness).
• Growth retardation in children and adolescents.
• Rounded 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 contact your doctor as soon as possible.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Becloforte

Immediately after using the medicine, replace the mouthpiece protector by firmly pushing it back into place until you hear a click. Do not use excessive force.

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 from direct sunlight.

As with many medications delivered in pressurized inhalation canisters, the therapeutic effect of this medicine may be reduced when the canister is cold.

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

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

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

6. Contents of the pack and other information

Composition of Becloforte

• The active substance is 250 micrograms of beclometasone dipropionate per dose.
• 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), equivalent to 0.0169 tonnes of CO2 (global warming potential GWP = 1,430).

Appearance of the product and contents of the pack

Becloforte is a solution for inhalation in a pressurised container. Each inhaler provides 200 doses.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 Lavoisier

27000 Evreux – France

Date of the most recent revision of this leaflet: 01/2025

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/