Leaflet: information for the user

Budesonide Aldo-Union 50 micrograms/actuation

Pressurized inhalation suspension

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, pharmacist or nurse.
• 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, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What isBudesonide Aldo-Union 50 microgramsand what it is used for

2. What you need to know before you start usingBudesonide Aldo-Union 50 micrograms

3. How to useBudesonide Aldo-Union 50 micrograms

4. Possible side effects

5. Storage ofBudesonide Aldo-Union 50 micrograms

6. Contents of the pack and additional information

Budesonide is an effective non-halogenated corticosteroid for asthma treatment due to its anti-inflammatory properties.

It is indicated for:

- Treatment of bronchial asthma in patients who have not previously responded to bronchodilator and/or antiallergic therapy.

Do not useBudesonida Aldo-Unión 50 micrograms:

- If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Budesonida Aldo-Unión 50 micrograms.

Be especially careful withthis medication:

• if you have fungal or viral respiratory tract infections or pulmonary tuberculosis.
• if you have previously been treated with oral corticosteroids: the transition from oral corticosteroid treatment to budesonide inhalation treatment should be done with special caution, mainly due to the slow normalization of the hypothalamic-pituitary-adrenal function, previously altered by oral corticosteroid therapy. This normalization may take several months to occur. During this change of medication,Youmay recover the original symptoms (rhinitis, eczema) or experience fatigue, headaches, muscle or joint pain, and occasionally nausea and vomiting. In these cases, you should proceed with additional symptomatic treatment.

This medication is only used as maintenance treatment, it should not be used for the treatment of acute asthma attacks (sudden onset of shortness of breath and wheezing).

Do not stop the budesonide treatment suddenly.

You should be aware of the possibility of the appearance of paradoxical bronchospasm with an increase in wheezing "pits" after administration. If the pits appear suddenly after using this medication, stop using it and consult your doctorimmediately,as you may need to change treatment.

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

Important information about one of the components ofBudesonida Aldo-Unión 50 micrograms:

It is informed to athletes that this medication contains a component that may establish a positive analytical result for doping control.

Other medications andBudesonida Aldo-Unión 50 micrograms

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

Some medications may increase the effects of budesonide, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

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

This medication will only be administered during pregnancy or breastfeeding when, in the doctor's opinion, the expected benefit for the mother outweighs any possible risk to the fetus.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been described.

Budesonida Aldo-Unión 50 micrograms contains ethanol:

This medication contains 0.5 mg of alcohol (ethanol) in each inhalation. The amount of alcohol in this medication is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medication does not produce any noticeable effect.

Remember to take your medication.

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

This medicationis administered via inhalation.

The dosage must be individualized.

Unless your doctor has given you different instructions, follow the following dosage:

Use in adults

Adults:200-1600 micrograms per day, divided into 2-4 administrations.

Use in children and adolescents

Children aged 2-7 years:200-400 micrograms per day, divided into 2-4 administrations.

Children aged 7 years and older:200-800 micrograms per day, divided into 2-4 administrations.

Once the desired clinical effects are achieved, your doctor may reduce the dose gradually to the minimum amount necessary to control symptoms.

If you estimate that the action of this medication is too strong or too weak, inform your doctor. Do not modify your dose without first speaking with your doctor.

After using the inhaler, rinse your mouth with water. Do not swallow. This will make it less likely for adverse effects to occur in the mouth or throat.

Instructions for correct administration of the preparation:

Before using the medication, check the expiration date.

1. Remove the cap (fig. 1). In case of a new inhaler or if it has not been used for several days, shake the aerosol (fig. 2) and perform a pulse to ensure the good functioning of the inhaler. In case of regular use, proceed to the following instructions:
2. Shake the inhaler (fig. 2).
3. Exhale as much air as possible from your lungs.
4. Attach the aerosol to your mouth according to the position indicated in the drawing (fig. 3).
5. Take a deep breath.

You must press, according to the arrows in the drawing (fig. 4), the device while taking this breath.

F. Remove the aerosol from your mouth and try to hold your breath for a few seconds.

G. You should periodically clean the oral adapter-pulsator of the aerosol. To do this, remove the pulsator from the aerosol and clean it with a cloth or a paper towel.

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

Your doctor should check that you know how to use the inhaler and synchronize the breath with the pulse.Optional cameras can be used to achieve better dose utilization and facilitate the arrival of the medication to the lungs.

The inhaler has a dose indicator that can be seen through a small opening or window of the pulsator and indicates how many applications are left. In a new inhaler, you can read through the window of the pulsator a "200". This number corresponds to the dose left in the inhaler. As the inhaler is used, the dose indicator decreases by 5-7 pulses until it reaches 0.

When there are approximately 40 doses left, the indicator changes from green to red (see figure 5) to remind the patient to consult their doctor if they need to continue treatment or if they need a new prescription. Discard the inhaler once the indicator reaches "0".

(figure 5)

If you use moreBudesonida Aldo-Unión 50 microgramsthan 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.

Although no toxic symptoms are expected from overdose or accidental ingestion, if you have inhaled moreBudesonida Aldo-Unión 50 microgramsthan you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicological Information Service. Phone 91 562 04 20.

If you notice any symptoms of edema, facial swelling, or full moon face, etc., inform your doctor so that appropriate measures can be taken.

If you forgot to useBudesonida Aldo-Unión 50 micrograms

Do not use a double dose to compensate for the missed doses.

Like all medications,this medicationcanproduce adverse effects, although not all people will experience them.

Occasionally, cases of mild throat irritation, cough, and hoarseness have been described. Similarly, cases of over-infection by Candida in the oral, pharyngeal, and laryngeal cavities have been reported. In most cases, it responds to topical antifungal therapy, without the need to interrupt budesonide treatment. In exceptional cases, skin allergic reactions (urticaria, dermatitis) associated with the use of topical corticosteroids have been described.

It should be taken into account the possibility of the appearance of paradoxical bronchospasm with an increase in "pitting" sibilance after administration. If the pitting sounds appear suddenly after using this medication, stop using it and consult with the doctorimmediately,as you may need to change treatment.

Unknown frequency (cannot be estimated from available data):

Sleep disturbances, depression or feeling of concern, restlessness, nervousness, excitability, or irritability (these effects are more likely to occur in children), and blurred vision (see also section 2:Warnings and Precautions).

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus.

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 Medicines for Human Use: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.

Store below30°C,protect from direct sunlight and do not freeze or refrigerate.

The container contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not puncture the container even if it appears empty.

Do not use this medication after the expiration date that appears on the packaging after CAD:. 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 containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition ofBudesonide Aldo-Union 50 micrograms.

- The active ingredient is budesonide.

- The other components (excipients) are oleic acid, ethanol, and Norflurano.

Appearance of the product and contents of the packaging

Budesonide Aldo-Union 50 micrograms is presented in the form of an inhalation suspension in a pressure container with a dose indicator in a 10 ml format that allows for 200 applications.

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:March 2023

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