Patient Information

PULMICORT 0.25 mg/mL SUSPENSION FOR INHALATION BY NEBULIZER

(Budesonide)

1.What Pulmicort 0.25 mg/mL suspension for inhalation by nebulizer is and what it is used for

2.What you need to know before using Pulmicort 0.25 mg/mL suspension for inhalation by nebulizer

3.How to use Pulmicort 0.25 mg/mL suspension for inhalation by nebulizer

4.Possible side effects

5.Storage of Pulmicort 0.25 mg/mL suspension for inhalation by nebulizer

6. Contents of the pack and additional information

Pulmicort0.25 mg/ml isa sterile suspension to be inhaled through a nebulizer (inhalation device). When you breathe through the mouthpiece or mask, the medication will reach the lungs through the inhaled air.

Pulmicort contains budesonide. Budesonide belongs to a group of medications called glucocorticoids that are used to reduce inflammation.

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

Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer is used for the maintenance treatment of asthma and the treatment of severe laryngitis subglottica requiring hospitalization. It should be used regularly as directed by your doctor.

Do not use Pulmicort 0.25 mg/mL suspension for inhalation by nebulizer:

• if you are allergic to budesonide or any of the other components of Pulmicort0.25 mg/mLsuspension for inhalation bynebulizer.

Warnings and precautions

• If you have or have had pulmonary tuberculosis or any recent infection.
• If you have ever had liver problems.
• If your doctor has prescribed Pulmicort 0.25 mg/mL and you are being treated with corticosteroid tablets, your doctor may gradually reduce your dose of these tablets (over a period of weeks or months) and may eventually stop the previous treatment. In this case, some symptoms such as nasal discharge, urticaria, or muscle and joint pain may temporarily reappear. If any of these symptoms concern you, or if you experience any other symptoms such as headache, fatigue, nausea, or vomiting, contact your doctor.
• Pulmicort has been prescribed for the maintenance treatment of asthma. However,IT WILL NOTrelieve an acute asthma attack once it has started.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

• If administered to children, your doctor will regularly check their growth as this medication may cause growth retardation.

Consult your doctor if you have any other health problems.Do not use this medication for other conditions without consulting your doctor. Never give it to another person.

Not all nebulizers are suitable for use with Pulmicort.DO NOTuse ultrasonic nebulizers with Pulmicort0.25 mg/mLsuspension forinhalation bynebulizer.

Use ofPulmicort 0.25 mg/mL suspension for inhalation by nebulizerwith other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes over-the-counter medications and herbal remedies. Some medications may increase the effects of Pulmicort, so your doctor will perform close monitoring if you are taking these medications. In particular, inform your doctor or pharmacist if you are using any of the following medications:

• Medications for fungal infections (such as itraconazole and ketoconazole).
• Medications for HIV (such as ritonavir or cobicistat).
• Cimetidine (medication for stomach acid).

Use in athletes

Inform athletes that this medication contains a component that may produce a positive result in doping control tests.

Pregnancy and breastfeeding

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

There is no evidence that Pulmicort 0.25 mg/mL suspension for inhalation by nebulizer can harm the mother or baby when used during pregnancy or breastfeeding. However, contact your doctor as soon as possible if you become pregnant while taking Pulmicort 0.25 mg/mL suspension for inhalation by nebulizer.

Pulmicort passes into breast milk, but in very small amounts, which have no effect on the infant

Use in children

Pulmicort should always be administered under adult supervision to ensure the correct administration of the medication.

Driving and operating machinery

Pulmicort does not affect your ability to drive or use tools or machines.

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

Form of use and route of administration

Pulmicort0.25 mg/mlsuspension for inhalation bynebulizermust only be used for inhalation through a nebulizer.Do not use ultrasonic nebulizers, as they are not suitable for administering this medication..Before starting treatment, you must know how to use the nebulizer. It is essential that you read the information included in the "How to use Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer" section and follow the instructions carefully.

Dosage, frequency of administration, and duration of treatment

The dose of Pulmicort must be individualized. Your doctor will adjust the dose and prescribe the minimum that will control your asthma or laryngitis subglottica symptoms. Follow your doctor's instructions carefully.

Your doctor will indicate the duration of your treatment with Pulmicort. Do not stop treatment before, as it will severely worsen your condition. Do not administer more doses than your doctor has indicated.

If you estimate that the action of Pulmicort is too strong or too weak, inform your doctor or pharmacist.

Asthma

Recommended initial dose:

Children from 6 months: 0.25 – 1 mg per day.In very severe cases, or in children treated with cortisone tablets, a higher initial dose (up to 2 mg per day, equivalent to 4 ampoules) may be administered. Your doctor may then consider adjusting the dose.Daily doses of up to 1 mg(2 ampoules)can be administered as a single dose.

Adults and elderly: 1- 2 mgper day(2 – 4 ampoules per day).In very severe cases, the dose may be increased to 4 mg(8 ampoules).Your doctor may then consider adjusting the dose.Daily doses of up to 1 mg(2 ampoules)can be administered as a single dose.

Maintenance dose:When your symptoms have improved, your doctor may decide to reduce your dose to the minimum that allows you to be symptom-free.

Pulmicort may provide relief from symptoms within a few days of treatment, although it may take 2 to 4 weeks to achieve a complete effect. Therefore, it is essential that you do not stop using Pulmicort even when you feel well.

Remember that Pulmicorthas been prescribed for the maintenance treatmentof asthma.However,IT WILL NOT RELIEVE AN ACUTE ASTHMA ATTACK ONCE IT HAS STARTED.

Laryngitis subglottica

Infants and children: 2 mg per day (equivalent to 4 ampoules). They can be administered as a single dose or in two doses of 1 mg separated by a 30-minute interval. The administration can be repeated every 12 hours for a maximum of 36 hours or until your doctor considers that your symptoms have improved.

How to use Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer

1.-Before using, gently shake to resuspend the contents of the ampoule.

2.-Hold the plastic unit in a vertical position and open by turning the upper flap (see figure).

3.-Slowly pour the contents of the ampoule into the nebulizer reservoir.

The ampoule has a black line indicating the 1 ml volume when held upside down. If only 1 ml is needed, empty the contents until the surface of the remaining liquid reaches the indicator line for 1 ml. Store the open container protected from light. Once opened, the ampoules must be used within a 12-hour period.If you only use 1 ml, note that the remaining contents are no longer sterile.Gently shake before using the remaining suspension.

Note:

Remember to rinse your mouth after each administration. If you use a face mask, ensure it fits perfectly when inhaling, and remember to wash your face after use.

Cleaning:

The nebulizer chamber and the mouthpiece or face mask must be washed after each administration with mild detergent and warm water (or following the manufacturer's instructions). Then, they must be rinsed and completely dried.

If you use more Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer than you should

If you use a higher dose of Pulmicort than you should in a single occasion, no adverse effects should occur.If you use too much Pulmicortover a long period (months), it is possible that adverse effects may appear.In this case, consult your doctor or pharmacist immediately.

If you have used more Pulmicort than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

It is essential that you use the dose indicated on the packaging (reserved space for the pharmacist) or the dose prescribed by your doctor. Do not increase or decrease your dose without consulting your doctor.

If you forgot to use Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer

If you forget to use one of the Pulmicort doses, do not use a double dose to compensate for the missed doses. Continue with theusual treatment as prescribed by your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.Usually, side effects do not occur during the use of Pulmicort. Nevertheless, inform your doctor about the following side effects that bother you or do not disappear:

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

• Mild throat irritation.
• Cough.
• Snoring.
• Oral and throat fungal infection.

Less frequent side effects:May affect up to 1 in 100 people

• Cataracts (loss of transparency of the crystalline lens in the eye).
• Anxiety.
• Depression.
• Tremors.
• Muscle cramps.
• Blurred vision.

Rare side effects:May affect up to 1 in 1000 people

• Allergic reactions, including skin rash, contact dermatitis, urticaria, and angioedema (inflammation of the face, lips, and/or tongue with difficulty swallowing and breathing).
• Skin hematomas.
• Behavioral changes (especially in children).
• Restlessness.
• Nervousness.
• Like with other inhaled treatments, rarely a bronchospasm(i.e., a contraction of the airways, which causes “ wheezing”).

• Effects on the adrenal glands (small glands located near the kidneys).
• Delayed growth.

Side effects of unknown frequency that may include

• Sleep disorders, hyperactivity, or aggression.
• Glaucoma (increased intraocular pressure).

Inhaled corticosteroids can affect the normal production of steroid hormones in the body, especially if high doses are used for a long time. These effects include:

• Changes in bone mineral density (bone loss).

These effects are much less likely with inhaled corticosteroids than with oral corticosteroids.

If you were previously treated with oral corticosteroids, switching to inhaled corticosteroids may cause some symptoms such as fatigue, abdominal pain, weakness, or vomiting. If these symptoms occur, consult your doctor immediately.

In rare cases, prolonged treatment with high doses may cause a reduction in growth rate in children, mainly in patients previously treated with oral corticosteroids or particularly sensitive.

Skin irritation on the face has been observed in some cases where a nebulizer with a facial mask was used. To prevent facial irritation, wash your face with water after using the mask.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use,https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of the medicine.

Always keep the unopened, sterile ampoules in the aluminum foil package protected from light.

If you do not use a complete ampoule in a dose, protect it from light.

Store in an upright position.

Do not freeze.

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

Do not use this medication after the expiration date that appears on the package and on the container after CAD.The expiration date is the last day of the month indicated.

• Remember the date when you first opened the package. Use the sterile ampoules from a package within three months of opening.
• Each sterile ampoule must be used within 12 hours after opening.If you only use 1 ml, note that the remaining content is no longer sterile.

Medicines should not be disposed of through drains or in the trash. Dispose of the containersand medicines that you do not need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need. In this way, you will help protect the environment.

Composition of Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer

The active ingredient of Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer is budesonide. Each sterile ampoule of 2 ml contains 0.50 mg of budesonide. The other components (excipients) are: edetate disodium, sodium chloride, polisorbate 80, anhydrous citric acid, sodium citrate, and injection water.

Appearance of the product and contents of the packaging

Pulmicort 0.25 mg/ml is a sterile suspension to be inhaled through a nebulizer (inhalation device).

Each package contains an aluminum sachet with 5 sterile ampoules of 2 ml.

There are two concentrations of Pulmicort suspension for inhalation by nebulizer: Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer and Pulmicort 0.50 mg/ml suspension for inhalation by nebulizer.

Holder of the marketing authorization and responsible for manufacturing

Holder:

AstraZeneca Farmacéutica Spain, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Responsible for manufacturing:

ASTRAZENECA AB Forskargatan, 18- Södertälje 151 36 Sweden

Date of the last review of this leaflet:November 2019

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/