Prospecto: information for the patient

Beclo-Asma 50 micrograms/pulse solution for inhalation in a pressurized container

dipropionato de beclometasona

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1. What is Beclo-Asma 50 micrograms/pulse and for what it is used

2. What you need to know before starting to use Beclo-Asma 50 micrograms/pulse

3. How to use Beclo-Asma 50 micrograms/pulse

4. Possible adverse effects

5. Storage of Beclo-Asma 50 micrograms/pulse

6. Contents of the container and additional informationl

Beclo-Asma 50 micrograms/actuation contains as its active ingredient dipropionate of beclometasone, which belongs to a group of medicines called corticosteroids. Corticosteroids are used for the treatment of asthma as they have among other things, an anti-inflammatory action. They reduce swelling and irritation in the walls of the small airways through which air passes in the lungs and thus facilitate breathing.

Beclo-Asma is used to prevent asthma symptoms in people who need regular treatment.

Corticosteroids also help to prevent asthma attacks.

It is not indicated for the relief of acute bronchospasm.

Do not use Beclo-Asma 50 micrograms/pulsation:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Beclo-Asma 50 micrograms/pulsation:

• 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.
• If you have a history of diabetes mellitus (as this medication may increase blood glucose levels),
• If you have used high doses of this medication for a prolonged period of time and experience the following symptoms:

• Weight gain and rounding of the face (moon face) (Cushing's syndrome),
• Unclear symptoms, such as abdominal pain, nausea, diarrhea, headache, or drowsiness (adrenal suppression, acute adrenal crisis). These symptoms are more likely to occur during an infection, such as viral infections or stomach upset,
• Bone loss,
• Eye problems (cataracts and glaucoma),
• Delayed growth (this mainly occurs in children and adolescents).

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

Patients who have previously been treated with beclometasone should be aware that this medication does not contain chlorofluorocarbon (CFC) propellants. The active ingredient is the same. The only differences that may be noticed are the taste and sensation of the spray in the mouth, as well as the sound of the inhaler during use.

Use it exactly as your doctor instructs. Your doctor may change your dosage regimen.

Use in athletes

Inform athletes that this medication contains beclometasone dipropionate, which may result in a positive analytical test for doping control.

Other medications and Beclo-Asma 50

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication.

Some medications may increase the effects of Beclo-Asma 50 micrograms/pulsation, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

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

Pregnancy and breastfeeding

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

Pregnancy: there is insufficient evidence on the use of the product during pregnancy.

The use of beclometasone dipropionate during pregnancy requires weighing the potential benefits of the medication against the possible risks.

Breastfeeding: it is likely that beclometasone will be excreted in breast milk. However, considering the relatively low doses used via inhalation, it is likely that levels will be low. In breastfeeding mothers, the therapeutic benefits of the medication should be weighed against the potential risks for the mother and baby.

Driving and operating machinery

Beclo-Asma 50 micrograms/pulsation has no known effects on driving and operating machinery.

Beclo-Asma 50 micrograms/pulsation contains ethanol

This medicationcontains 4.7 mg of alcohol(ethanol) in each inhalation. The amount of alcohol in each inhalation of this medication is equivalent to less than 1 ml of beer or 1 ml of wine. Thesmall amountof alcohol contained in this medication does not produce any noticeable effect.

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Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubts, consult your doctor or pharmacist again.

Remember to use your medication.

Beclo-Asma should only be used by inhalation.

Your doctor will indicate the duration of your treatment with Beclo-Asma. Do not suspend the treatment before, even if you feel better, unless your doctor tells you to or notes that your breathing worsens when you take the medication. The usual recommended doses are as follows:

Adults and children over 12 years old

The initial dose for mild or moderate asthma is one inhalation (50 micrograms) twice a day. This dose can be increased to two inhalations (100 micrograms) twice a day.

For more severe asthma, the usual dose is up to four inhalations (200 micrograms) twice a day.

The maximum recommended dose is 800 micrograms per day.

Children from 6 to 11 years old

The dose should be established by your doctor and depending on the individual response of each patient. In general, it is recommended to use half the doses recommended for adults (maximum 400 micrograms per day in two divided doses). Children should receive an appropriate initial dose of Beclo-Asma according to the severity of their disease. The dose can then be adjusted until an adequate control is achieved or reduced to the minimum effective dose according to the individual response.

If you start using Beclo-Asma instead of, or at the same time as, oral steroids, you should carry a warning card indicating that you take steroids until your doctor tells you that you no longer need it.

If you have difficulties or do not understand the instructions, consult your doctor or pharmacist.

You may notice the benefits of the medication several days after starting treatment. It is very important to use it regularly every day. Do not interrupt treatment even if you feel better, unless your doctor tells you to or notes that your breathing worsens when you take the medication.

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.

Instructions for correct administration of the preparation:

Beclo-Asma 50 micrograms/puff is administered by inhalation. The correct handling of this medication is crucial for the success of the treatment.

Before each application, the following guidelines will be observed:

1. Remove the protective cover (fig. 1). If it is a new inhaler or has not been used for a week, shake the container (fig. 2) and perform two puffs to ensure the proper functioning of the inhaler. If the inhaler is used regularly, proceed to the following instructions:
2. Shake the inhaler
3. Exhale as much air as possible from your lungs.

D.Adapt the inhaler to your mouth according to the position indicated in the drawing (fig. 3).

E.Breathe in as deeply as possible. You should press, according to the arrows in the drawing (fig. 4), the device while making this inspiration.

F.Remove the inhaler from your mouth and try to hold your breath for a few seconds and then exhale slowly.

G.The plastic mouthpiece should be cleaned periodically. To do this, remove it from the aerosol and rinse it with plenty of water at least once a week. Before use, it should be dry. Do not wet the metal cartridge.

H.Store with the protective cover in place to protect it from dust and dirt.

I.It is recommended to rinse your mouth with water after each inhalation.

If you estimate that the action of Beclo-Asma 50 micrograms/puff is too strong or too weak, inform your doctor or pharmacist.

If you use more Beclo-Asma 50 micrograms/puff than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forgot to take Beclo-Asma 50 micrograms/puff

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

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects have been reported:

-Frequent (may affect up to 1 in 10 people): oral and/or throat candidiasis (aphthous stomatitis), hoarseness and/or throat irritation, taste alterations.

-Infrequent (may affect up to 1 in 100 people): headache, dizziness, tremors, cough, increased asthma symptoms, nausea, urticaria, itching, pruritus, erythema, purpura.

-Rare (may affect up to 1 in 1,000 people): allergic reactions, angioedema in eyes, throat, lips, and face, paradoxical bronchospasm.

-Very rare (may affect up to 1 in 10,000 people): adrenal suppression, growth delay in children and adolescents, cataracts, glaucoma, decreased bone mineral density.

-Unknown frequency (cannot be estimated from available data): hyperactivity, sleep disorders, anxiety, depression, aggression, behavioral changes (commonly in children), and blurred vision.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication 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 with the hand for a few minutes before using. Do not use any other method to warm it.

The containercontains a pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce the container even when it appears to be empty.

Do not use this medication after the expiration date that appears on the container after Cad.:. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Beclo-Asma 50 micrograms/actuation:

• The active ingredient is dipropionate of beclometasone.
• The other components (excipients) are anhydrous ethanol and Norflurane.

Each inhalation contains 50 micrograms of dipropionate of beclometasone.

Appearance of the product and contents of the packaging:

Beclo-Asma 50 micrograms/actuation is a transparent and colorless solution that is presented in a 10 ml (200 applications) container with a dosing valve and oral adapter.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona – Spain

Date of the last review of this leaflet:10/2017

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