Budesonide Pulmictan Infantil 50 micrograms/inhalation suspension for inhalation in pressurized container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

BUDESONIDE PULMICTAN PEDIATRIC 50 micrograms/inhalation

pressurised inhalation suspension

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, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Budesonide Pulmictan Pediatric 50 micrograms/inhalation is and what it is used for.
2. What you need to know before using Budesonide Pulmictan Pediatric 50 micrograms/inhalation.
3. How to use Budesonide Pulmictan Pediatric 50 micrograms/inhalation.
4. Possible side effects.
5. How to store Budesonide Pulmictan Pediatric 50 micrograms/inhalation.
6. Contents of the pack and other information.

1. What Budesonida Pulmictan Infantil 50 micrograms/inhalation is and what it is used for

Budesonida Pulmictan Infantil 50 micrograms/inhalation contains the active substance budesonide. Budesonide belongs to a group of medicines called glucocorticoids, which are used to reduce inflammation.

Asthma is caused by inflammation of the airways. Budesonide reduces and prevents this inflammation.

Budesonida Pulmictan Infantil 50 micrograms/inhalation is used for the treatment of asthma. It should be used regularly as directed by your doctor.

By inhaling through the inhaler at the same time as you release a dose, the medicine reaches the lungs through the inhaled air.

2. What you need to know before using Budesonida Pulmictan Infantil 50 micrograms/inhalation

Do not use Budesonida Pulmictan Infantil 50 micrograms/inhalation

• If you are allergic to budesonide or any of the components of Budesonida Pulmictan Infantil 50 micrograms/inhalation.

Inform your doctor so that your medication can be changed to another.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Budesonida Pulmictan Infantil 50 micrograms/inhalation.

Inform your doctor if:

• you are taking or have recently taken any other medicines, including those obtained without a prescription.

• you have ever had an unusual reaction to Budesonida Pulmictan Infantil 50 micrograms/inhalation (budesonide) or any of its components, or to other medicines.

• you have or have had pulmonary tuberculosis.

• you have ever had liver problems.

• you have an untreated bacterial, viral, or fungal infection in your mouth, airways, or lungs.

• your doctor has prescribed Budesonida Pulmictan Infantil 50 micrograms/inhalation and you are still undergoing treatment with corticosteroid tablets, they may gradually reduce the dose of these tablets (over a period of weeks or months) and may eventually discontinue the previous treatment.

In this case, some symptoms may temporarily reappear, such as runny nose, hives, or muscle and joint pain. If any of these symptoms concern you, or if you experience any others such as headache, fatigue, nausea, or vomiting, contact your doctor.

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

Rinse your mouth with water after each inhalation to prevent fungal infection in the mouth.

Budesonida Pulmictan Infantil 50 micrograms/inhalation has been prescribed for the maintenance treatment of asthma. However, it will not relieve an acute asthma attack once it has started.

Other medicines and Budesonida Pulmictan Infantil 50 micrograms/inhalation

Inform your doctor or pharmacist if you are using or have recently used any other medicine, including those obtained without a prescription.

Some medicines may increase the effects of Budesonida Pulmictan Infantil 50 micrograms/inhalation, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Inform your doctor if you are using:

• nasal medications containing corticosteroids
• corticosteroid tablets
• antifungal medications containing ketoconazole and itraconazole
• cimetidine (a medicine for stomach acidity)

Pregnancy, breastfeeding, 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 will only be administered during pregnancy or breastfeeding when, in the doctor's judgment, the expected benefit to the mother outweighs any potential risk to the fetus.

Driving and use of machines

Budesonida Pulmictan Infantil 50 micrograms/inhalation does not affect your ability to drive or operate tools or machinery.

Warning for athletes

Athletes are advised that this medicine contains a component that may result in a positive doping test.

Budesonida Pulmictan Infantil 50 micrograms/inhalation contains ethanol

This medicine contains 0.33% ethanol (alcohol), a small amount corresponding to 0.20 mg/dose.

3. How to use Budesonide Pulmictan Junior 50 micrograms/inhalation

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

Your doctor has indicated the duration of your treatment with Budesonide Pulmictan Junior 50 micrograms/inhalation. Do not stop treatment before your doctor tells you to do so. Do not take more doses than your doctor has prescribed. Consult your doctor if you have any questions about your treatment.

Method of administration and route

Before starting treatment, you must understand how the inhaler works. It is important that you read the information included in the section "Instructions for correct administration of the medicine" regarding preparation, use, and cleaning of the inhaler, and that you follow the instructions carefully.

Remember to always rinse your mouth with water after each inhalation.

The dose of Budesonide Pulmictan Junior 50 micrograms/inhalation should be individualized. Your doctor will adjust the dose and prescribe the lowest dose that controls your asthma symptoms. Follow your doctor's instructions carefully.

Use in children and adolescents

Recommended usual dose in children aged 2–7 years: 4 inhalations (200 micrograms) to 8 inhalations (400 micrograms) per day, divided into 2–4 doses.

Recommended usual dose in children from 7 years of age: 4 inhalations (200 micrograms) to 16 inhalations (800 micrograms) per day, divided into 2–4 doses.

Administration of Budesonide Pulmictan Junior 50 micrograms/inhalation must be supervised by an adult to ensure that the dose is administered correctly and according to the doctor's instructions.

You may notice an improvement in symptoms even during the first day of treatment with Budesonide Pulmictan, although it may take 1 to 2 weeks to achieve full effect. Therefore, it is important that you continue using Budesonide Pulmictan even when you feel well.

In addition to the preventive Budesonide Pulmictan Junior 50 micrograms/inhalation, you may also need a reliever bronchodilator:

Budesonide will NOT stop an asthma attack once it has started. Therefore, it is essential that you always have a fast-acting reliever bronchodilator (a beta2 agonist) available in case of acute asthma symptoms.

If you use a reliever inhaler (a beta2 agonist), you should inhale it before Budesonide Pulmictan Junior 50 micrograms/inhalation (preventive).

Worsening of asthma symptoms during treatment:

Consult your doctor as soon as possible if:

• Your wheezing or chest tightness worsens during treatment
• You need to use your reliever inhaler more often than before
• Your reliever inhaler does not relieve your symptoms as effectively as before

Your asthma may be worsening and you may require additional treatment.

Instructions for correct administration of the medicine

Preparation of the inhaler for use:

Remove the white cap. If this is a new inhaler or has not been used for several days, shake the aerosol and release one puff to ensure proper functioning of the inhaler. If the inhaler is used regularly, proceed to the usage instructions.

Using the inhaler

Inhalation with aerosol only

1. Check that the aerosol is properly assembled to the plastic mouthpiece (1). Shake the device and remove the white cap (2).
2. Hold the canister inverted between your thumb and index finger. Place the mouthpiece in your mouth and seal your lips tightly around it.
3. Breathe out deeply (through your nose), then inhale deeply through your mouth while simultaneously pressing down on the canister to release a single dose.
4. Remove the device from your mouth and hold your breath for a few seconds. Breathe out slowly and replace the white cap (2).

Inhalation with spacer chamber

1. Check that the aerosol is properly assembled to the plastic applicator. Shake the device and remove the white cap.
2. If necessary, attach the adapter to the mouthpiece of the applicator.
3. Attach the adapter, or the applicator directly, to the end of the spacer chamber.
4. Hold the spacer chamber with the mouthpiece directed towards your mouth. Press the canister between your thumb and index finger to release the dose into the chamber.
5. Breathe out deeply, then place the spacer mouthpiece into your mouth and seal your lips tightly around it.
6. Inhale deeply through your mouth. Hold your breath for about ten seconds before breathing out through the spacer mouthpiece.
7. Inhale deeply again to ensure complete inhalation of the administered dose. Hold your breath for a few seconds, then breathe out.
8. Disconnect the aerosol from the spacer and adapter, and replace the white cap on the canister.

Cleaning

The actuator-mouthpiece should be cleaned regularly (at least once a week).

• Remove the actuator from the aerosol and rinse thoroughly with water.
• Store with the cap in place to protect it from dust and dirt.

If you use more Budesonide Pulmictan Junior 50 micrograms/inhalation than you should

If you take a single dose of Budesonide Pulmictan Junior 50 micrograms/inhalation higher than prescribed, harmful effects are unlikely. However, if you have used too much Budesonide Pulmictan Junior 50 micrograms/inhalation over a long period (months), adverse effects may occur. In this case, consult your doctor or pharmacist immediately.

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

If you forget to use Budesonide Pulmictan Junior 50 micrograms/inhalation

If you forget to take a dose of Budesonide Pulmictan Junior 50 micrograms/inhalation, do not take a double dose to make up for the missed dose. Continue your treatment as prescribed by your doctor.

If you stop using Budesonide Pulmictan Junior 50 micrograms/inhalation

Do not stop treatment with Budesonide Pulmictan Junior 50 micrograms/inhalation without consulting your doctor. If you stop using the medicine abruptly, your asthma may worsen.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

Common adverse effects: may affect up to 1 in 10 people

• Mild throat irritation
• Difficulty swallowing
• Cough
• Fungal infection of the mouth and throat (thrush)

To prevent the above-mentioned adverse effects, rinse your mouth and throat with water or brush your teeth after each dose. Do not swallow the rinse water; spit it out.

Uncommon adverse effects: may affect up to 1 in 100 people

• Anxiety
• Depression
• Cataracts
• Blurred vision
• Muscle spasms and tremors

Rare adverse effects: may affect up to 1 in 1,000 people

• Too little or too much cortisol in the blood
• Hypoactive adrenal gland (gland near the kidneys)
• Skin rashes, itching, bruising
• Dysphonia
• Anxiety, nervousness
• Growth retardation and behavioral changes in children

Rare acute allergic reaction:

If, shortly after taking a dose, you experience itching, rash, skin redness, swelling of the eyelids, lips, face or throat, wheezing, low blood pressure or collapse, take the following action:

• Stop taking Budesonida Pulmictan Infantil 50 micrograms/inhalation
• Seek immediate medical advice

Immediate shortness of breath after the dose:

Rarely, inhaled medicines may cause an increase in wheezing and shortness of breath (bronchospasm) immediately after the dose. If this occurs:

• Stop taking Budesonida Pulmictan Infantil 50 micrograms/inhalation
• Take a fast-acting bronchodilator immediately
• Seek immediate medical advice

Very rare adverse effects: may affect up to 1 in 10,000 people

• Glaucoma
• Decreased bone density (weakening of the bones)

Adverse effects with unknown frequency (cannot be estimated from the available data):

• Sleep disturbances
• Aggressive reactions
• Increased motor activity (difficulty staying still)
• Irritability

These effects are more likely to occur in children.

If you were previously on corticosteroid tablets, switching to inhaled corticosteroid treatment may lead to the appearance of certain symptoms such as fatigue, abdominal pain, weakness, or vomiting. If any of these symptoms occur, consult your doctor immediately.

If you think you may be experiencing any of these adverse effects, or if you are concerned about the possibility of experiencing them, consult your doctor or pharmacist.

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 Budesonide Pulmictan Paediatric 50 micrograms/inhalation

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

The container holding your medicine is pressurized. The valve must not be damaged, and the container must not be exposed to high temperatures or direct sunlight. Also, do not pierce, crush, or burn the container, even when it is empty.

Do not refrigerate or freeze. Store below 30 °C. The container must never be exposed to temperatures above 50 °C.

Keep with the valve pointing downwards.

Always replace the protective cap over the mouthpiece after using the inhaler.

Do not use Budesonide Pulmictan after the expiry date stated on the container. 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 at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the container and additional information

Composition of Budesonida Pulmictan Infantil 50 micrograms/inhalation:

The active substance in Budesonida Pulmictan Infantil 50 micrograms/inhalation is budesonide. Each dose (1 inhalation) contains 50 micrograms of budesonide.

The other components (excipients) are: oleic acid, ethanol and 1,1,1,2-tetrafluoroethane (HFA 134a).

This medicinal product contains fluorinated greenhouse gases.

Each inhaler contains 14.03 g of HFA-134a, equivalent to 0.02006 tonnes of CO2 (global warming potential GWP = 1430).

Appearance of the product and contents of the container:

Budesonida Pulmictan Infantil 50 micrograms/inhalation is a suspension for inhalation delivered via a pressurised container.

Each 10 ml container contains approximately 200 doses.

There are two concentrations of Budesonida Pulmictan in pressurised containers: Budesonida Pulmictan 200 micrograms/inhalation and Budesonida Pulmictan Infantil 50 micrograms/inhalation.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

LABORATORIO REIG JOFRÉ, S.A.

Avda. Gran Capità, 10

08970 – Sant Joan Despí

Barcelona, Spain

Manufacturer:

LABORATORIO REIG JOFRÉ, S.A.

Avda. Gran Capità, 10

08970 – Sant Joan Despí

Barcelona, Spain

or

GENETIC S.P.A.

Contrada Canfora, Fisciano, Salerno

Italy

Date of the most recent revision of this leaflet: November 2025