PULMICORT 0.25 mg/ml SUSPENSION FOR NEBULIZER INHALATION

Introduction

Prospective: Information for the User

PULMICORT 0.25 mg/ml SUSPENSION FOR INHALATION BY NEBULIZER

(Budesonide)

Contents of the Prospectus

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 starting to use 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 adverse effects
5. Storage of Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer
6. Package contents and additional information

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

Pulmicort 0.25 mg/ml is a 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 very severe subglottic laryngitis that requires hospitalization. It should be used regularly as directed by your doctor.

2. What you need to know before starting to use PULMICORT 0.25 mg/ml suspension for inhalation by nebulizer

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 Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer.

Warnings and precautions

• If you have or have had pulmonary tuberculosis or any other recent infection.
• If you have ever had liver problems.
• If your doctor has prescribed Pulmicort 0.25 mg/ml and you are under treatment with corticosteroid tablets, your doctor may gradually reduce the dose of these tablets (over a period of weeks or months) and may finally 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 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 periodically review 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 your doctor's instructions. Never give it to another person.

Not all nebulizers are suitable for use with Pulmicort. DO NOTuse ultrasonic nebulizers with Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer.

Use of Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. This includes medications purchased without a prescription and herbal remedies. Some medications may increase the effects of Pulmicort, so your doctor will monitor you closely if you are taking these medications. In particular, inform your doctor or pharmacist if you are using any of the following medications:

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

Use in athletes

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 child when used during pregnancy or breastfeeding. However, you should contact your doctor as soon as possible if you become pregnant during treatment with Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer.

Pulmicort passes into breast milk, but in minimal amounts, which do not affect the infant.

Use in children

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

Driving and using machines

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

3. How to use PULMICORT 0.25 mg/ml suspension for inhalation by nebulizer

Follow exactly the administration instructions for 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

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

Dosage, frequency of administration, and duration of treatment

The dose of Pulmicort should be individualized. Your doctor will adjust the dose and prescribe the minimum dose that controls your asthma or subglottic laryngitis 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 may worsen your disease severely. Do not take more doses than your doctor has indicated.

If you think the effect 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 corticosteroid tablets, a higher initial dose (up to 2 mg per day, equivalent to 4 ampoules) may be administered. Subsequently, your doctor may consider it necessary to adjust the dose. Daily doses of up to 1 mg (2 ampoules) can be administered as a single dose.

Adults and elderly: 1 - 2 mg per day (2 - 4 ampoules per day). In very severe cases, the dose can be increased up to 4 mg (8 ampoules). Subsequently, your doctor may consider it necessary to adjust 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 the dose to the minimum dose that allows you to be symptom-free.

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

Remember that Pulmicort has been prescribed for the maintenance treatment of asthma. However, IT WILL NOTrelieve an acute asthma attack once it has started.

Subglottic laryngitis

Infants and children: 2 mg per day (equivalent to 4 ampoules). They can be administered in a single dose or in two doses of 1 mg, separated by a 30-minute interval. 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 top wing (see figure).

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

The ampoule has a black line that indicates the volume of 1 ml when held upside down. If only 1 ml is needed, empty the contents until the surface of the remaining liquid reaches the 1 ml indicator line. Keep the opened container protected from light. Once opened, the ampoules should be used within 12 hours. If you only use 1 ml, note that the remaining content is 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, make sure it fits perfectly when inhaling, and remember to wash your face after use.

Cleaning:

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

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

If you use a dose of Pulmicort higher than you should in a single occasion, no harmful effects are expected to occur. If you use too much Pulmicort for a long period (months), adverse effects may appear. In that case, consult your doctor or pharmacist immediately.

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

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

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

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them. Adverse effects are usually not produced during the use of Pulmicort. However, inform your doctor of the following adverse effects that bother you or do not disappear:

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

• Mild throat irritation.
• Cough.
• Hoarseness
• Fungal infection of the mouth and throat.

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

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

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

• Allergic reactions, including skin rash, contact dermatitis, hives, and angioedema (inflammation of the face, lips, and/or tongue with difficulty swallowing and breathing).
• Bruises on the skin.
• Behavioral changes (especially in children).
• Restlessness.
• Nervousness.
• As with other inhaled treatments, bronchospasm (i.e., contraction of the airways, which causes wheezing) may rarely occur.

• Effects on the adrenal glands (small glands located next to the kidneys).
• Growth retardation.

Adverse effects of unknown frequency that may include

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

Corticosteroids inhaled may 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 (decrease in bone mass).

These effects are much less likely with inhaled corticosteroids than with corticosteroid tablets.

If you were previously under treatment with corticosteroid tablets, switching to inhaled corticosteroids 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.

In rare cases, long-term treatment with high doses may cause a reduction in growth rate in children, mainly in patients previously treated with corticosteroid tablets or especially sensitive ones.

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

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for human use medications, https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of the medication.

5. Storage of PULMICORT 0.25 mg/ml suspension for inhalation by nebulizer

Always keep the unopened ampoules in the aluminum pouch protected from light.

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

Store in a vertical 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 pouch and on the packaging after EXP. The expiration date is the last day of the month indicated.

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

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

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: disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate, and water for injection.

Appearance of the product and package contents

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

Each package contains an aluminum pouch 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.

Marketing authorization holder and manufacturer

Holder:

AstraZeneca Farmacéutica Spain, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Manufacturer:

ASTRAZENECA AB Forskargatan, 18- Södertälje 151 36 Sweden

Date of the last revision of this prospectus:November 2019

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/