Becotide 50 micrograms/inhalation solution for inhalation in pressurized container
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Becotide 50 micrograms/inhalation, solution for inhalation in pressurised container
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, ask 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.
Leaflet contents
- What Becotide is and what it is used for
- What you need to know before using Becotide
- How to use Becotide
- Possible side effects
- How to store Becotide
- Contents of the pack and other information
1. What Becotide is and what it is used for
Beclometasone dipropionate belongs to a group of medicines called corticosteroids, commonly referred to 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 misused by some athletes and taken as tablets or by injection.
Becotide is used to prevent asthma symptoms in people who require regular treatment.
2. What you need to know before using Becotide
Do not use Becotide
- 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
Talk to 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 injection
- if you are being or have been treated for tuberculosis.
Patients who have previously used Becotide should be aware that the current formulation does not contain chlorofluorocarbon (CFC) propellants. You must use it exactly as directed by your doctor. Your doctor may adjust your dosage regimen.
The active ingredient in CFC-free Becotide is exactly the same as in the previous CFC-containing Becotide. 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 Becotide 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 Becotide
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 Becotide, so your doctor will monitor you closely 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
Becotide is unlikely to affect your ability to drive or operate machinery.
Becotide contains ethanol
This medicine contains 7.68 mg of alcohol (ethanol) per dose unit, equivalent to 13.01% 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 Becotide
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 tell you how long to continue treatment with Becotide. Do not stop treatment early, even if you feel better, unless your doctor advises you to do so or you notice your breathing worsens when taking the medicine.
Becotide must only be used by inhalation.
Adults
Two inhalations (100 micrograms) per dose, three or four times daily. In severe cases, treatment may be started with 12–16 inhalations per day, reducing to the normal dose once improvement begins. The maximum daily dose must not exceed 20 inhalations.
Use in children
One or two inhalations (50–100 micrograms) per dose, two, three, or four times daily. The maximum daily dose must not exceed 10 inhalations in children under 12 years of age.
If you have recently started using Becotide instead of, or in addition to, oral steroids, you must carry a steroid warning 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 this. If you take or use more than one medicine, be careful not to confuse them.
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 a week or more, shake well and release one puff into the air to make sure it works properly.
If you feel that the effect of Becotide is too strong or too weak, inform your doctor or pharmacist.
Instructions for use:
- Remove the mouthpiece cap by gently pressing the sides.
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Check that there are no foreign particles inside or outside the inhaler, including the mouthpiece.
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Shake the inhaler well to ensure any foreign particles are removed and the contents are properly mixed.
- Hold the inhaler vertically between the index finger and thumb, placing the thumb on the base, below the mouthpiece.
- Breathe out as much air as reasonably possible, then place the mouthpiece in your mouth, between the teeth, sealing your lips around it without biting.
- Immediately after starting to inhale through the mouth, press down on the top of the inhaler to release the medication, and continue inhaling deeply and steadily.
- Hold your breath and remove the inhaler from your mouth, taking your finger off the top of the inhaler. Continue holding your breath as long as reasonably possible.
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If a second inhalation is to be taken, keep the inhaler upright and wait approximately half a minute before repeating steps 3 to 7.
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Replace the mouthpiece cap firmly, pushing and fitting 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.
Young children may need help, with their parents operating the inhaler for them. Encourage the child to breathe out, and operate the inhaler just after the child begins to inhale. Practice the technique together. Older children or people with weak hands should hold the inhaler with both hands, placing both index fingers on 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 or Babyhaler (a spacer device for children under 5 years of age).
Cleaning the inhaler
Clean the inhaler at least once a week.
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A mild detergent or a solution of the type used for cleaning 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 Becotide than you should
It is important that you take your dose exactly as prescribed by your doctor. Do not increase or decrease your dose without medical supervision.
If you have used more Becotide than you should, contact your doctor, pharmacist, or the Toxicology Information Service immediately, telephone: 91 562 04 20.
If you forget to use Becotide
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 will experience them.
Adverse effects due to the administration of Becotide may include:
Very common (may affect more than 1 in 10 people)
- Oral and/or throat 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 an appropriate spacer device, such as Volumatic or Babyhaler (a spacer device for children under five years of age), 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 rashes, urticaria, pruritus, and/or erythema.
Rare (may affect up to 1 in 10,000 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 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 difficulty or wheezing worsens, stop treatment immediately and contact your doctor as soon as possible.
Reporting of adverse effects
If you experience any 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 Becotide
Immediately after using the medicine, replace the mouthpiece protector by pushing it firmly 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 administered in pressurized inhalation canisters, the therapeutic effect of this medicine may decrease 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 drains or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Becotide
- The active substance is 50 micrograms of beclometasone dipropionate per dose.
- The other components are norflurane (HFA 134a), glycerol (E422) and ethanol.
This medicinal product contains fluorinated greenhouse gases.
Each inhaler contains 12.1 g of HFC-134a (also known as norflurane or HFA 134a), equivalent to 0.0173 tonnes of CO2 (global warming potential GWP = 1,430).
Nature of the product and pack contents
Becotide 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
Manufacturer:
Glaxo Wellcome Production
Zone Industrielle N. 2
23 rue Lavoiser
27000 Evreux – France
Date of the most recent review of this leaflet: 01/2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/