Leaflet: information for the user

Becotide 50 micrograms/inhalation, pressure-packed inhalation solution

dipropionate of beclometasone

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 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 pack and additional information

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

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 tablet or injectable form.

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

No use Becotide

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Becotide:

• 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 Becotide 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 regimen.

The active ingredient of Becotide without CFCs is exactly the same as that of Becotide 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 drug. Becotide 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 Becotide

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 Becotide, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy and Breastfeeding

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

Driving and Operating Machines

Becotide is unlikely to affect your ability to drive or operate machines.

Becotide contains ethanol

This medication contains 7.68 mg of alcohol (ethanol) in each dose unit, equivalent to 13.01% 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 perceptible 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 Becotide. Do not suspend treatment before, even if you feel better, unless your doctor tells you to or notes that your breathing worsens when taking the medication.

Becotide should only be used by inhalation.

Adults

Two inhalations (100 micrograms) per dose, three or four times a day. In severe cases, you can start with 12-16 inhalations per day and reduce to the normal dose as improvement begins. The maximum daily dose should not exceed 20 inhalations.

Use in children

One or two inhalations (50-100 micrograms) per dose, two, three or four times a day. The maximum daily dose should not exceed 10 inhalations in children under 12 years old.

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

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

Do not use this medication to treat a sudden attack of breathing difficulty, it will not help. You will need another 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 an application to the air to ensure it works.

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

Usage instructions:

1. Remove the protector from the mouthpiece, pressing gently on the sides.

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

3. Shake the inhaler well, to ensure the elimination of any foreign particles and that the contents of the inhaler are mixed properly.

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

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

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

7. Hold your breath and remove the inhaler from the mouth, removing the finger from the top of the inhaler. Continue holding your breath as long as reasonably possible.

8. 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.

9. Put the protector back 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 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.

Small children may need help, with their parents handling the inhaler for them. Encourage the child to exhale and handle the inhaler just after the child begins to breathe in. Practice together the technique. Older children or 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 difficulty in coordinating the handling of the inhaler with inhalation may use an alternative inhalation chamber, such as Volumatic or Babyhaler (inhalation chamber for children under 5 years old).

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 Becotide 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 Becotide than you should, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 91 562 04 20.

If you forgot to use Becotide

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

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

The side effects due to the administration of Becotide 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 this case, you should gargle with water and spit immediately after each dose. Using an appropriate inhalation chamber, such as Volumatic or Babyhaler (inhalation chamber for children under five years old), 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 eruptions, urticaria, pruritus, and/or erythema.

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

• Allergies, which manifest with swelling of eyelids, 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 walls of the bronchi with decreased air entry).
• Anaphylactic or anaphylactoid reactions (severe allergic reactions that may hinder breathing or alter your level of 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.

Frequency not known:

• 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 worsen, discontinue treatment immediately and inform your doctor as soon as possible.

Communication of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also communicate them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.The communication of side effects 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 into place until you hear a click. Excessive force is not required.

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C.

Do not freeze. Storein the outer packaging to protect itfrom 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 pointat 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 Becotide

• The active ingredient is 50 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 12.1 g of HFC-134a (also known as norflurane or HFA 134a) corresponding to 0.0173 tons of CO2 equivalent (global warming potential PCG = 1,430).

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible manufacturer

Holderof 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 manufacturer:

Glaxo Wellcome Production

Zone Industrielle N. 2

23 rue Lavoiser

27000 Evreux – France

Last review date of this leaflet:01/2025

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/