Beclo-Asma 100 micrograms/dose solution for inhalation in pressurized container
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Beclo-Asma 100 micrograms/dose is and what it is used for
- 2. What you need to know before using Beclo-Asma 100 micrograms/dose
- 3. How to use Beclo-Asma 100 micrograms/dose
- 4. Possible adverse effects
- 5. Storage of Beclo-Asma 100 micrograms/dose
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Beclo-Asma 100 micrograms/dose inhalation solution in pressurised container
Beclometasone dipropionate
Read all of 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, 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, since it may 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 Beclo-Asma 100 micrograms/dose is and what it is used for
- What you need to know before using Beclo-Asma 100 micrograms/dose
- How to use Beclo-Asma 100 micrograms/dose
- Possible side effects
- How to store Beclo-Asma 100 micrograms/dose
- Contents of the pack and other information
1. What Beclo-Asma 100 micrograms/dose is and what it is used for
Beclo-Asma 100 micrograms/dose contains as its active substance beclometasone dipropionate, which belongs to a group of medicines called corticosteroids. 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 in the lungs, thereby making breathing easier.
Beclo-Asma is used to prevent asthma symptoms in people who require regular treatment.
Corticosteroids also help prevent asthma attacks.
It is not indicated for the relief of acute bronchospasm.
2. What you need to know before using Beclo-Asma 100 micrograms/dose
Do not use Beclo-Asma 100 micrograms/dose:
- 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 using Beclo-Asma 100 micrograms/dose:
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If you have had mouth ulcers
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If you are taking or have recently taken any oral or injectable steroid tablets
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If you are being or have been treated for tuberculosis
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If you have a history of diabetes mellitus (as this medicine may increase blood glucose levels)
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If you have used high doses of this medicine for a prolonged period and experience any of the following symptoms:
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Weight gain and facial rounding (moon face) (Cushing's syndrome)
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Vague symptoms such as abdominal pain, nausea, diarrhoea, headache or drowsiness (adrenal suppression, acute adrenal crisis). These symptoms are more likely during an infection, such as viral infections or stomach upset
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Loss of bone mass
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Eye problems (cataracts and glaucoma)
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Growth retardation (this mainly occurs in children and adolescents)
Contact your doctor if you experience blurred vision or other visual disturbances.
Patients previously treated with beclometasone should be aware that this medicine does not contain chlorofluorocarbon propellants (CFCs). The active ingredient is the same. The only differences you may notice are the taste and sensation of the spray in the mouth, as well as the sound of the inhaler during use.
This medicine must be used exactly as prescribed by your doctor. Your doctor may adjust your dosage regimen.
Use in athletes
Athletes should be informed that this medicine contains beclometasone dipropionate, which may result in a positive doping test.
Other medicines and Beclo-Asma 100
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Some medicines may increase the effects of Beclo-Asma 100 micrograms/dose, so your doctor will monitor you closely if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).
Inform your doctor if you are taking disulfiram or metronidazole, as there is a potential risk of interaction in particularly sensitive individuals.
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.
Pregnancy: There is insufficient evidence regarding the use of this product during pregnancy.
The use of beclometasone dipropionate during pregnancy requires careful assessment of the potential benefits of the drug against possible risks.
Breastfeeding: Beclometasone is likely excreted in breast milk. However, considering the relatively low doses used by inhalation, levels are likely to be low. In breastfeeding mothers, the therapeutic benefits of the drug should be weighed against the potential risks to both mother and infant.
Driving and using machines
Beclo-Asma 100 micrograms/dose has no known effects on driving or operating machinery.
Beclo-Asma 100 micrograms/dose contains ethanol
This medicine contains approximately 4.7 mg of alcohol (ethanol) per inhalation. The amount per inhalation 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 perceptible effect.
3. How to use Beclo-Asma 100 micrograms/dose
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Remember to use your medicine.
Beclo-Asma must only be used by inhalation.
Your doctor will indicate how long your treatment with Beclo-Asma should last. Do not stop treatment earlier, even if you feel better, unless your doctor advises you to do so or you notice that your breathing worsens when taking the medicine. The usual recommended doses are as follows:
Adults and children over 12 years of age
The initial dose for mild or moderate asthma is one inhalation (100 micrograms) twice daily. This dose may be increased to two inhalations (200 micrograms) twice daily.
For more severe asthma, your doctor may recommend up to four inhalations (400 micrograms) twice daily.
The maximum recommended dose is 800 micrograms per day.
Children aged 6 to 11 years
The dose must be determined by the doctor and depends on the individual patient's response. In general, half the doses recommended for adults are advised (maximum 400 micrograms per day in two divided doses). Children should receive an initial dose of Beclo-Asma appropriate to the severity of their condition. The dose may then be adjusted until adequate control is achieved, or reduced to the lowest effective dose according to individual response.
If you start using Beclo-Asma instead of, or at the same time as, oral steroids, you must carry a steroid warning card until your doctor tells you that it is no longer needed.
If you have difficulties or do not understand the instructions, consult your doctor or pharmacist.
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 interrupt treatment even if you feel better, unless your doctor tells you to do so, or if you notice that your breathing worsens when taking the medicine.
Do not use this medicine to treat a sudden attack of breathing difficulty; it will not help you. You will need a different type of medicine for that.
Instructions for correct administration of the preparation:
Beclo-Asma 100 micrograms/dose is administered by inhalation. Correct use of this medicine is crucial for successful treatment.
Before each administration, follow these steps:
- Remove the protective cap (fig. 1). If this is a new inhaler or has not been used for one week, shake the container (fig. 2) and release two sprays to ensure proper functioning of the inhaler. If the inhaler is used regularly, proceed to the following instructions:
Shake the inhaler.- Empty your lungs of air as much as possible.
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Place the inhaler in your mouth as shown in the illustration (fig. 3).
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Take as deep a breath as possible. While inhaling, press down on the canister as indicated by the arrows in the illustration (fig. 4).
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Remove the inhaler from your mouth and try to hold your breath for a few seconds, then exhale slowly.
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The plastic mouthpiece should be cleaned regularly. To do this, remove it from the aerosol and rinse it thoroughly with water at least once a week. It must be dry before use. Do not wet the metal cartridge.
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Store with the protective cap in place to protect it from dust and dirt.
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It is advisable to rinse your mouth with water after each inhalation.
If you think the effect of Beclo-Asma 100 micrograms/dose is too strong or too weak, inform your doctor or pharmacist.
If you use more Beclo-Asma 100 micrograms/dose than you should:
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915620420, stating the medicine and the amount ingested.
If you forget to take Beclo-Asma 100 micrograms/dose
Do not take a double dose to make up for missed doses; simply wait until the next scheduled dose.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have been reported:
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Common (may affect up to 1 in 10 people): oral and/or throat candidiasis (thrush), hoarseness and/or throat irritation, taste disturbances.
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Uncommon (may affect up to 1 in 100 people): headache, dizziness, tremor, cough, increased asthma symptoms, nausea, urticaria, itching, pruritus, erythema, purpura.
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Rare (may affect up to 1 in 1,000 people): allergic reactions, angioedema of eyes, throat, lips and face, paradoxical bronchospasm.
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Very rare (may affect up to 1 in 10,000 people): adrenal suppression, growth retardation in children, cataracts, glaucoma, decreased bone mineral density.
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Frequency not known (cannot be estimated from available data): Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, changes in behaviour (commonly in children), and blurred vision.
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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Beclo-Asma 100 micrograms/dose
Keep this medicine out of the sight and reach of children.
Protect from direct sunlight. Do not freeze.
If the inhaler is very cold, remove the cartridge and warm it in your hand for a few minutes before use. Do not use any other method to warm it.
The container contains a pressurized liquid. Do not expose to temperatures above 50 ºC. Do not pierce the container, even if it appears to be empty.
Do not use this medicine after the expiry date stated on the packaging after EXP:. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Beclo-Asma 100 micrograms/dose:
- The active substance is beclometasone dipropionate.
- The other components (excipients) are anhydrous ethanol and norflurane (HFA-134a).
Each puff contains 100 micrograms of beclometasone dipropionate.
This medicine contains fluorinated greenhouse gases.
Each inhaler contains 12.44 g of norflurane (HFA-134a), equivalent to 0.0178 tonnes of CO2 (global warming potential GWP = 1,430).
Appearance of the product and contents of the pack:
Beclo-Asma 100 micrograms/dose is a clear, colourless solution contained in a 10 ml pressurised canister (200 actuations) with a metering valve and oral adapter.
Marketing Authorisation Holder and Manufacturer:
Laboratorio Aldo-Unión, S.L.
Baronesa de Maldá, 73
08950 Esplugues de Llobregat (Barcelona)
Spain
Date of the most recent revision of this leaflet: September 2025
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/