Budesonide Aldo-Union 200 micrograms/dose inhalation suspension in pressurised container

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Budesonide Aldo-Unión 200 micrograms/dose

pressurised inhalation suspension

Read all of 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, ask your doctor, pharmacist or nurse.
• 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 may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet.

Contents of the leaflet

1. What Budesonide Aldo-Unión 200 micrograms is and what it is used for
2. What you need to know before using Budesonide Aldo-Unión 200 micrograms
3. How to use Budesonide Aldo-Unión 200 micrograms
4. Possible adverse effects
5. How to store Budesonide Aldo-Unión 200 micrograms
6. Contents of the pack and other information

1. What Budesonida Aldo-Unión 200 micrograms is and what it is used for

Budesonide is a non-halogenated corticosteroid effective in the treatment of asthma due to its anti-inflammatory capacity.

It is indicated for:

• Treatment of bronchial asthma in patients who have not previously responded to therapy with bronchodilators and/or antiallergic agents.

2. What you need to know before starting to use Budesonida Aldo-Unión 200 micrograms

Do not use Budesonida Aldo-Unión 200 micrograms:

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Budesonida Aldo-Unión 200 micrograms.

Take special care with this medicine:

• if you have fungal or viral respiratory infections or pulmonary tuberculosis.
• if you have previously been treated with oral corticosteroids: switching from oral corticosteroid therapy to inhaled budesonide must be done with special caution, mainly due to the slow recovery of hypothalamic-pituitary-adrenal function previously impaired by oral corticosteroid treatment. This recovery may take several months. During this transition, you may experience a return of original symptoms (rhinitis, eczema) or feel tired, have headaches, muscle or joint pain, and occasionally nausea and vomiting. In such cases, symptomatic treatment may be required.

This medicine is intended for maintenance treatment and must not be used to treat acute asthma attacks (sudden episodes of breathlessness and wheezing).

Do not stop treatment with this medicine abruptly.

Be aware of the possibility of paradoxical bronchospasm, with increased wheezing ("whistling sounds"), after administration. If wheezing occurs suddenly after using this medicine, stop using it immediately and consult your doctor, as your treatment may need to be changed.

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

Important information about some of the components of Budesonida Aldo-Unión 200 micrograms:

Athletes should be informed that this medicine contains a component that may lead to a positive analytical result in doping control tests.

Children and adolescents

Another formulation, Budesonida 50 micrograms Aldo-Unión, is specifically indicated for children.

Other medicines and Budesonida Aldo-Unión 200 micrograms

Inform 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 budesonide, and your doctor will closely monitor you if you are taking these (including certain HIV medications: ritonavir, cobicistat).

Pregnancy, breast-feeding and fertility

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.

This medicine should only be administered during pregnancy or breastfeeding if, in the physician's judgment, the expected benefit to the mother outweighs any possible risk to the fetus.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

Budesonida Aldo-Unión 200 micrograms contains ethanol:

This medicine contains 0.5 mg of alcohol (ethanol) per inhalation. The amount per inhalation 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 Budesonida Aldo-Unión 200 micrograms

Remember to use your medicine.

Always follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is administered by inhalation.

Dosage must be individualized.

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

Use in adults

Adults: 200–1600 micrograms daily, divided into 2–4 doses.

Use in children and adolescents

Children aged 2–7 years: 200–400 micrograms daily, divided into 2–4 doses.

Children from 7 years of age: 200–800 micrograms daily, divided into 2–4 doses.

Once the desired clinical effects have been achieved, your doctor may gradually reduce your dose to the lowest amount needed to control your symptoms.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor. Do not change your dose without first talking to your doctor.

Rinse your mouth with water after using the inhaler, but do not swallow. This will reduce the likelihood of adverse effects in the mouth or throat.

Instructions for correct administration of the medicine:

Before using the medicine, check the expiry date.

1. Remove the cap (fig. 1). If this is a new inhaler or has not been used for several days, shake the inhaler (fig. 2) and release one puff to ensure proper functioning of the inhaler. If the inhaler is used regularly, proceed to the next instructions:
2. Shake the inhaler (fig. 2).
3. Empty your lungs of air as much as possible.
4. Place the inhaler in your mouth in the position shown in the drawing (fig. 3).
5. Breathe in as deeply as possible.

While inhaling, press down on the canister as indicated by the arrows in the drawing (fig. 4).

1. Remove the inhaler from your mouth and hold your breath for a few seconds.
2. Clean the mouthpiece of the inhaler regularly. To do this, remove the mouthpiece from the canister and wipe it with a cloth or paper tissue.
3. Store with the cap on to protect it from dust and dirt.

Your doctor should check that you know how to use the inhaler correctly and that you coordinate your inhalation with the actuation. A spacer device may optionally be used to improve dose delivery and facilitate the medicine reaching the lungs.

The inhaler has a dose indicator visible through a small opening or window in the mouthpiece, which shows how many doses remain. On a new inhaler, the indicator will show "120" or "200" through the window (depending on the pack size prescribed to you). These numbers correspond to the number of doses remaining in the inhaler. As the inhaler is used, the dose indicator rotates downward every 5–7 actuations until it reaches 0.

When approximately 40 doses remain, the indicator changes from green to red (see figure 5) to remind the patient to consult their doctor about continuing treatment or obtaining a new prescription. Discard the inhaler once the indicator reaches "0".

(figure 5)

If you use more Budesonida Aldo-Unión 200 micrograms 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.

Although no toxic symptoms are expected following overdose or accidental ingestion, if you have inhaled more budesonide than you should, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If, under any special circumstances, symptoms such as edema, facial swelling, or moon face occur, inform your doctor immediately so that appropriate measures can be taken.

If you forget to use Budesonida Aldo-Unión 200 micrograms

Do not use a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Occasionally, cases of mild throat irritation, cough, and hoarseness have been reported. In addition, cases of Candida superinfection in the oral cavity, pharynx, and larynx have occurred. In most cases, this responds to topical antifungal therapy, without the need to discontinue treatment with budesonide. In rare cases, skin allergic reactions (urticaria, dermatitis) associated with the use of topical corticosteroids have been reported.

The possibility of paradoxical bronchospasm, with increased wheezing, should be considered following administration. If wheezing occurs suddenly after using this medicine, stop using it and consult your doctor immediately, as you may need to change your treatment.

Frequency not known (cannot be estimated from available data):

Sleep disturbances, depression or feelings of worry, 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects 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 Budesonide Aldo-Unión 200 micrograms

Keep this medicine out of the sight and reach of children.

Store below 30°C. Protect from direct sunlight and do not freeze or refrigerate.

The container contains a pressurised 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 medicine after the expiry date stated on the carton after EXP:. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at 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 Budesonida Aldo-Unión 200 micrograms.

• The active substance is budesonide.
• The other components (excipients) are oleic acid, ethanol and norflurane (HFA-134a).

This medicinal product contains fluorinated greenhouse gases.

• 120-dose format: Each inhaler contains 9.44 g of norflurane (HFA-134a), equivalent to 0.0135 tonnes of CO2 (global warming potential GWP = 1,430).
• 200-dose format: Each inhaler contains 14.52 g of norflurane (HFA-134a), equivalent to 0.0208 tonnes of CO2 (global warming potential GWP = 1,430).

Appearance of the product and contents of the pack

Budesonida Aldo-Unión 200 micrograms is presented as a pressurized suspension for inhalation with a dose indicator. Pack sizes: 6 ml pressurized container providing 120 doses, and 10 ml pressurized container providing 200 doses.

Marketing Authorization Holder and Manufacturer

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat (Barcelona)

Spain

Date of the latest revision of this leaflet: September 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.