Leaflet: information for the user

BUDESONIDE PULMICTAN INFANTIL 50 micrograms/inhalation

Pressurized suspension for inhalation

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 should not be given to others even if they have the same symptoms, 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.

Budesonida Pulmictan Infantil 50 microgramos/inhalación contains the drug budesonida. Budesonida belongs to a group of medicines called glucocorticoids that are used to reduce inflammation.

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

Budesonida Pulmictan Infantil 50 microgramos/inhalación is used for the treatment of asthma. It should be used regularly as instructed by your doctor.

When you inhale through the inhaler at the same time as you release a dose, the medicine will reach the lungs through the inhaled air.

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 for another one.

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 other medications, including those purchased without a prescription.

• You have ever presented any unusual reaction to Budesonida Pulmictan Infantil 50 micrograms/inhalation (budesonide) or any of its components, or to other medications.
• 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, respiratory tract, or lungs.
• Your doctor has prescribed Budesonida Pulmictan Infantil 50 micrograms/inhalation and you are still under treatment with oral corticosteroids, you may reduce the dose of these tablets gradually (over a period of weeks or months) and may eventually discontinue the previous treatment.

In that case, some symptoms may temporarily reappear, such as nasal discharge, urticaria, or muscle and joint pain. If any of these symptoms concern you, or if you present any other 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 alleviate an acute asthma attack once it has started.

Other medications and Budesonida Pulmictan Infantil 50 micrograms/inhalation

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

Some medications may increase the effects of Budesonida Pulmictan Infantil 50 micrograms/inhalation, 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 using:

• Nasal sprays containing corticosteroids
• Oral corticosteroids
• Antifungal medications containing ketoconazole and itraconazole
• Cimetidine (stomach acid medication)

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan 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

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

Warning to athletes

It is notified to athletes that this medication contains a component that may produce a positive result in doping control tests.

Budesonida Pulmictan Infantil 50 micrograms/inhalation contains ethanol

This medication contains 0.33% ethanol (alcohol), which corresponds to 0.20 mg/dose.

Follow exactly these administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor has indicated the duration of your treatment with Budesonida Pulmictan Infantil 50 micrograms/inhalation. Do not stop treatment before your doctor tells you to. Do not administer more doses than your doctor has indicated. Consult with them about any doubts you may have about the treatment.

Form of use and administration route

Before starting treatment, you should know how the inhaler works. It is essential that you read the information included in the "Instructions for correct administration of the medication" section on the preparation, use, and cleaning of the inhaler and follow the instructions carefully.

Remember to rinse your mouth with water after each inhalation.

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

Use in children and adolescents

Recommended dose in children aged 2-7 years: 4 inhalations (200 micrograms) - 8 inhalations (400 micrograms) per day, divided into 2-4 administrations.

Recommended dose in children aged 7 years and over: 4 inhalations (200 micrograms) - 16 inhalations (800 micrograms) per day, divided into 2-4 administrations.

The administration of Budesonida Pulmictan Infantil 50 micrograms/inhalation will be supervised by an adult to ensure that the dose is administered correctly and in accordance with the doctor's instructions.

You may notice an improvement in symptoms even on the first day of treatment with Budesonida Pulmictan, although it may take 1 to 2 weeks to achieve a complete effect. Therefore, it is essential not to stop using Budesonida Pulmictan even when you feel well.

In addition to the preventive Budesonida Pulmictan Infantil 50 micrograms/inhalation, you may also need a bronchodilator calmant:

Budesonida will not stop an asthma attack once it has started. Therefore, it is essential to always have a quick-acting bronchodilator calmant (beta2 agonist) on hand if you experience acute asthma symptoms.

If you use a bronchodilator calmant (beta2 agonist), you should inhale it before Budesonida Pulmictan Infantil 50 micrograms/inhalation (preventive).

Worsening of asthma symptoms during treatment:

Consult your doctor as soon as possible if:

• Your wheezing (jadeo) or chest pain worsens during treatment
• You need to use the bronchodilator calmant more often than before
• Your bronchodilator calmant does not relieve you as well as before

Your asthma may worsen, and you may need additional treatment.

Instructions for correct administration of the medication

Preparation of the inhaler for use:

Remove the white cap. If it is a new inhaler or has not been used for several days, shake the aerosol and perform a pulse to ensure the good functioning of the inhaler. If the inhaler is used regularly, proceed to the usage instructions.

Use of the inhaler

Inhalation with the aerosol only

1. Check that the aerosol is well assembled to the plastic mouthpiece (1). Shake the set and remove the white cap (2).
2. Hold the container upside down between your thumb and index finger. Insert the mouthpiece into your mouth, pressing your lips around it.
3. Perform a deep exhalation (expel the air through your nose) and then take a deep breath through your mouth, pressing the container at the same time and causing a single discharge.
4. Remove the device from your mouth and hold your breath for a few seconds. Breathe out slowly and store the container by placing the cap (2) again.

Inhalation with expansion chamber

1. Check that the aerosol is well assembled to the plastic mouthpiece. Shake the set and remove the white cap.
2. If necessary, attach the adapter to the mouthpiece of the inhaler.
3. Adjust the adapter, or the inhaler directly, to the end of the expansion chamber.
4. Hold the expansion chamber with the mouthpiece oriented towards your mouth. Press the container between your thumb and index finger, causing the release of the dose inside the chamber.
5. Breathe out deeply and then insert the mouthpiece of the expansion chamber into your mouth, pressing your lips around it.
6. Breathe in deeply through your mouth. Hold your breath for 10 seconds before exhaling through the mouthpiece of the chamber.
7. Breathe in deeply again to ensure the complete inhalation of the administered dose. Hold your breath for a few seconds and breathe out.
8. Disconnect the aerosol from the chamber and the adapter and store the container by placing the white cap again.

Cleaning

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

• Remove the pulsator from the aerosol and rinse with plenty of water.
• Store with the cap in place to protect it from dust and dirt.

If you use more Budesonida Pulmictan Infantil 50 micrograms/inhalation than you should

If you use a dose of Budesonida Pulmictan Infantil 50 micrograms/inhalation greater than the one you should in a single occasion, it is unlikely that you will experience any adverse effects. If you have used too much Budesonida Pulmictan Infantil 50 micrograms/inhalation for a long period (months), you may experience adverse effects. In this case, consult your doctor or pharmacist immediately.

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

If you forget to use Budesonida Pulmictan Infantil 50 micrograms/inhalation

If you forget to use one of the doses of Budesonida Pulmictan Infantil 50 micrograms/inhalation, do not use a double dose to compensate for the missed doses. Continue with the usual treatment as prescribed by your doctor.

If you interrupt treatment with Budesonida Pulmictan Infantil 50 micrograms/inhalation

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

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Frequent side effects:may affect up to 1 in 10 people

To prevent the previously mentioned side effects, you can rinse your mouth and throat with water or brush your teeth after each dose. Do not swallow the rinse water, spit it out

Infrequent side effects:may affect up to 1 in 100 people

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

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

• Low or high cortisol levels in the blood
• Underactive adrenal gland (located near the kidneys)
• Skin eruptions, itching, bruising
• Hoarseness
• Anxiety, nervousness
• Delayed growth and behavioral changes in children

Acute allergic reaction rare:

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, follow these steps:

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

Immediate shortness of breath after the dose:

Rarely, inhaled medications can 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 rapid-acting bronchodilator
• Seek immediate medical advice

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

• Glaucoma
• Bone density decrease (bone weakening)

Side effects of unknown frequency(cannot be estimated from 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 treated with oral corticosteroids, switching to inhaled corticosteroids may cause symptoms such as fatigue, abdominal pain, weakness, or vomiting. If these symptoms occur, consult your doctor immediately.

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

Reporting side effects

Ifyou experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side 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 side effects, you can contribute to providing more information about the safety of this medicine.

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

The container that holds your medication is pressurized. The valve should not be damaged, and the container should not be exposed to high temperatures or direct sunlight. Also, do not pierce, break, or burn the container even if it is empty.

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

Keep with the valve down.

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

Do not use Pulmicort after the expiration date that appears on the container. The expiration date is the last day of the month indicated.

Medications should not be thrown away through the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Budesonida Pulmictan Infantil 50 micrograms/inhalation:

• The active ingredient of Budesonida Pulmictan Infantil 50 micrograms/inhalation is budesonida. Each dose (1 inhalation) contains 50 micrograms of budesonida.
• The other components (excipients) are: oleic acid, ethanol, and 1,1,1,2-tetrafluoroethane (HFA 134a).

Appearance of the product and contents of the packaging:

Budesonida Pulmictan Infantil 50 micrograms/inhalation is a suspension for inhalation through a pressurized container.

Each 10 ml container contains approximately 200 doses.

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

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

LABORATORIO REIG JOFRÉ, S.A.

Avda. Gran Capità, 10

08970 – Sant Joan Despí

Barcelona, Spain

Responsible for manufacturing:

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

Last review date of this leaflet: February 2024