PULMICORT 0.50 mg/ml SUSPENSION FOR NEBULIZER INHALATION

2. What you need to know before you use Pulmicort 0.50 mg/ml suspension for inhalation by nebulizer

Do not use Pulmicort 0.50 mg/ml suspension for inhalation by nebulizer:

• if you are allergic to budesonide or any of the other ingredients of Pulmicort 0.50 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 0.50 mg/ml and you are 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 this 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 you 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 since this medicine may cause growth retardation.

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

Not all nebulizers are suitable for use with Pulmicort. DO NOTuse ultrasonic nebulizers with Pulmicort 0.50 mg/ml suspension for inhalation by nebulizer.

Use of Pulmicort 0.50 mg/ml suspension for inhalation by nebulizer with other medicines

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

• Medicines for treating fungal infections (such as itraconazole and ketoconazole).
• Medicines for HIV (such as ritonavir or cobicistat).
• Cimetidine (a medicine for stomach acidity).

Use in athletes

Athletes are informed that this medicine 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 medicine.

There is no evidence that Pulmicort 0.50 mg/ml suspension for inhalation by nebulizer can harm the mother or the child during pregnancy or breastfeeding. However, you should contact your doctor as soon as possible if you become pregnant during treatment with Pulmicort 0.50 mg/ml suspension for inhalation by nebulizer.

Pulmicort passes into breast milk, but in minimal amounts that do not affect the baby.

Use in children

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

Driving and using machines

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

3. How to use Pulmicort 0.50 mg/ml suspension for inhalation by nebulizer

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

Method of use and route of administration

Pulmicort 0.50 mg/ml suspension for inhalation by nebulizer should only be used for inhalation by a nebulizer. Do not use ultrasonic nebulizers, as they are not suitable for the administration of this medicine. 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 0.50 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, tell 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 2 ampoules) may be administered. Subsequently, your doctor may consider it necessary to adjust the dose. Daily doses of up to 1 mg (1 ampoule) can be administered as a single dose. In cases where the lowest dose (0.25 mg/day) is needed, 1 ml of Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer should be used.

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

It is possible that Pulmicort may 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 you 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 2 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 0.50 mg/ml suspension for inhalation by nebulizer

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

2. Hold the plastic unit in a vertical position and open by twisting 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 liquid surface 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 nebulizer chamber and 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 0.50 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, it is unlikely to cause harmful effects. If you use too much Pulmicort over a long period (months), it is possible that side 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the package and the package leaflet of the medicine 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 0.50 mg/ml suspension for inhalation by nebulizer

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Usually, no side effects occur during the use of Pulmicort. However, tell your doctor about the following side effects that bother you or do not go away:

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

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

Uncommon side 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 side 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.

Side 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 treated with corticosteroid tablets, switching to inhaled corticosteroids may cause some symptoms such as fatigue, abdominal pain, weakness, or vomiting to reappear. If any of these symptoms occur, 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.

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 think any of the side effects you are experiencing is serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. 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, https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pulmicort 0.50 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 full ampoule in one dose, protect it from light.

Store in a vertical position.

Do not freeze.

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

Do not use this medicine after the expiry date that appears on the pouch and on the packaging after EXP. The expiry date is the last day of the month indicated.

• Remember the date you first opened the pouch. 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.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pulmicort 0.50 mg/ml suspension for inhalation by nebulizer

The active ingredient of Pulmicort 0.50 mg/ml suspension for inhalation by nebulizer is budesonide. Each sterile ampoule of 2 ml contains 1 mg of budesonide. The other ingredients (excipients) are: disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate, and water for injection.

Appearance of the product and packaging contents

Pulmicort 0.50 mg/ml is a sterile suspension for inhalation by 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

Marketing authorization 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 last revision of this leaflet:November 2019

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