BUDESONIDE PULMICTAN 200 micrograms/INHALATION SUSPENSION FOR INHALATION IN A PRESSURIZED CONTAINER

2. What you need to know before you use Budesonida Pulmictan 200 micrograms/inhalation

Do not use Budesonida Pulmictan 200 micrograms/inhalation

• If you are allergic to budesonide or any of the other ingredients of Budesonida Pulmictan 200 micrograms/inhalation.

Tell your doctor so that your medicine can be changed to another one.

Warnings and precautions

Consult your doctor or pharmacist before you start using Budesonida Pulmictan 200 micrograms/inhalation.

Tell your doctor if:

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

• you have ever had an unusual reaction to Budesonida Pulmictan 200 micrograms/inhalation (budesonide) or any of the ingredients, 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 200 micrograms/inhalation and you are still being treated with corticosteroid tablets, your doctor may gradually reduce the dose of these tablets (over a period of weeks or months) and may eventually stop the previous treatment.

In that case, some symptoms such as runny nose, hives or muscle and joint pain may temporarily reappear. If any of these symptoms worry you, or if you have any other symptoms 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 avoid fungal infection in the mouth.

Budesonida Pulmictan 200 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 200 micrograms/inhalation

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

Some medicines may increase the effects of Budesonida Pulmictan 200 micrograms/inhalation, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Tell your doctor if you are using:

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

This medicine will only be used during pregnancy or breastfeeding if, in the doctor's opinion, the benefits to the mother outweigh any possible risks to the baby.

Driving and using machines

Budesonida Pulmictan 200 micrograms/inhalation does not affect your ability to drive or use tools or machines.

Warning for athletes

Athletes are informed that this medicine contains a component that may produce a positive result in doping tests.

Budesonida Pulmictan 200 micrograms/inhalation contains ethanol

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

3. How to use Budesonida Pulmictan 200 micrograms/inhalation

Follow these instructions for using this medicine exactly as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Your doctor has indicated the duration of your treatment with Budesonida Pulmictan 200 micrograms/inhalation. Do not stop treatment before your doctor tells you to. Do not take more doses than your doctor has indicated. Consult your doctor if you have any questions about the treatment.

Method of use and route of administration

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

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

The dose of Budesonida Pulmictan 200 micrograms/inhalation should be individualised. Your doctor will adjust the dose and prescribe the minimum that controls your asthma symptoms. Follow your doctor's instructions carefully.

Use in adults

Recommended dose in adults: 1 inhalation (200 micrograms) - 8 inhalations (1,600 micrograms) per day, divided into 2-4 administrations.

Recommended dose in the elderly: the same dose as adults.

Use in children and adolescents

Recommended dose in children from 7 years: 1 inhalation (200 micrograms) - 4 inhalations (800 micrograms) per day, divided into 2-4 administrations.

Recommended dose in children from 2-7 years: 1 inhalation (200 micrograms) - 2 inhalations (400 micrograms) per day, divided into 2-4 administrations.

The administration of Budesonida Pulmictan 200 micrograms/inhalation in children will 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 Budesonida Pulmictan 200 micrograms/inhalation, although it may take 1 to 2 weeks to achieve a full effect. Therefore, it is essential that you do not stop using Budesonida Pulmictan 200 micrograms/inhalation even when you feel better.

In addition to the preventive Budesonida Pulmictan 200 micrograms/inhalation, you may also need a reliever bronchodilator:

Budesonide will not stop an asthma attack once it has started. Therefore, you should always have a rapid-acting bronchodilator (a beta2 agonist) on hand in case you experience acute asthma symptoms.

If you use a reliever inhaler (a beta2 agonist), you should inhale it before Budesonida Pulmictan 200 micrograms/inhalation (preventive).

Worsening of asthma symptoms during treatment:

Consult your doctor as soon as possible if:

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

Your asthma may worsen and you may need additional treatment.

Instructions for correct administration of the medicine

Preparing 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 puff to ensure the inhaler is working properly. If the inhaler is used regularly, go to the instructions for use.

Using the inhaler

Inhalation with the aerosol alone

1. Check that the aerosol is properly assembled to the plastic mouthpiece (1). Shake the assembly and remove the white cap (2).
2. Hold the canister in an inverted position between your thumb and index finger. Insert the mouthpiece into your mouth, pressing your lips around it.
3. Perform a deep exhalation (expel air through your nose) and then inhale deeply through your mouth, pressing the canister between your fingers and causing a single discharge.
4. Remove the device from your mouth and hold your breath for a few seconds. Exhale slowly and store the canister by putting the cap (2) back on.

Inhalation with a spacer

1. Check that the aerosol is properly assembled to the plastic applicator. Shake the assembly and remove the white cap.
2. If necessary, attach the adapter to the mouthpiece of the applicator.
3. Adjust the adapter, or the applicator itself, to the end of the spacer.
4. Hold the spacer with the mouthpiece facing your mouth. Press the canister between your thumb and index finger, causing the dose to be released inside the spacer.
5. Exhale deeply and then insert the mouthpiece of the spacer into your mouth, pressing your lips around it.
6. Inhale deeply through your mouth. Hold your breath for about ten seconds before exhaling through the mouthpiece of the spacer.
7. Inhale again deeply, to ensure that the entire dose has been inhaled. Hold your breath for a few seconds and then exhale.
8. Disconnect the aerosol from the spacer and adapter and store the canister by putting the white cap back on.

Cleaning

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

• Remove the actuator from the aerosol and rinse with plenty of water.
• Store with the cap on, to protect it from dust and dirt.

If you use more Budesonida Pulmictan 200 micrograms/inhalation than you should

If you use a dose of Budesonida Pulmictan 200 micrograms/inhalation that is higher than you should in a single occasion, it is unlikely that you will experience harmful effects. If you have used too much Budesonida Pulmictan 200 micrograms/inhalation over a long period (months), it is possible that side effects may appear. In that case, consult your doctor or pharmacist immediately.

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

If you forget to use Budesonida Pulmictan 200 micrograms/inhalation

If you forget to use any of the doses of Budesonida Pulmictan, do not use a double dose to make up for the missed doses. Continue with the usual treatment as prescribed by your doctor.

If you stop using Budesonida Pulmictan 200 micrograms/inhalation

Do not stop using Budesonida Pulmictan 200 micrograms/inhalation without consulting your doctor. If you stop using the medicine abruptly, your asthma may worsen.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side 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 side effects, you can rinse your mouth and throat with water or brush your teeth after each dose. Do not swallow the water from the rinses, spit it out.

Uncommon 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 (a gland near the kidneys)
• Skin rashes, itching, bruising
• Hoarseness
• Anxiety, nervousness
• Delayed growth and behaviour changes in children

Acute allergic reaction (rare):

If, shortly after taking a dose, you experience itching, rash, redness, swelling of the eyelids, lips, face or throat, wheezing, low blood pressure or collapse, act as follows:

• Stop taking Budesonida Pulmictan 200 micrograms/inhalation
• Seek medical advice immediately

Shortness of breath immediately after the dose:

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

• Stop taking Budesonida Pulmictan 200 micrograms/inhalation
• Take a rapid-acting bronchodilator quickly
• Seek medical advice immediately

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

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

Side effects of 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 being treated with corticosteroid tablets, switching to inhaled corticosteroid treatment may cause the appearance of some symptoms such as fatigue, abdominal pain, weakness or vomiting. If you experience any of these symptoms, consult your doctor immediately.

If you think you may have any of these side effects, or if you are concerned about the possibility of having them, consult your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Budesonida Pulmictan 200 micrograms/inhalation

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

The container that contains your medicine is pressurised. The valve should not be damaged, and the container should not be exposed to high temperatures or direct sunlight. Similarly, the container should not be punctured, broken or burned, 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 the container with the valve downwards.

Always put the protective cap on the mouthpiece after using the inhaler.

Do not use Budesonida Pulmictan 200 micrograms/inhalation after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Budesonida Pulmictan 200 micrograms/inhalation

• The active ingredient of Budesonida Pulmictan 200 micrograms/inhalation is budesonide. Each dose (1 inhalation) contains 200 micrograms of budesonide.
• The other components (excipients) are: oleic acid, ethanol, and 1,1,1,2-tetrafluoroethane (HFA 134a).

Appearance of the Product and Package Contents

Budesonida Pulmictan 200 micrograms/inhalation is an inhalation suspension in a pressurized container.

Each 5 ml container holds approximately 100 doses.

Each 10 ml container holds approximately 200 doses.

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

Marketing Authorization Holder and Manufacturer:

Marketing Authorization 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 Last Revision of this Leaflet: February 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/