Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer

Patient Information Leaflet

Introduction

Patient Information Leaflet

PULMICORT 0.25 mg/ml INHALATION SUSPENSION FOR NEBULISER

(Budesonide)

Package leaflet contents

1. What Pulmicort 0.25 mg/ml inhalation suspension for nebulizer is and what it is used for
2. What you need to know before starting to use Pulmicort 0.25 mg/ml inhalation suspension for nebulizer
3. How to use Pulmicort 0.25 mg/ml inhalation suspension for nebulizer
4. Possible side effects
5. Storage of Pulmicort 0.25 mg/ml inhalation suspension for nebulizer
6. Contents of the pack and other information

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

Pulmicort 0.25 mg/ml is a sterile suspension intended to be inhaled via a nebulizer (inhalation device). When you breathe through the mouthpiece or face mask, the medication will reach your lungs through the inhaled air.

Pulmicort contains budesonide. Budesonide belongs to a group of medicines called glucocorticoids, which are used to reduce inflammation.

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

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

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

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

• if you are allergic to budesonide or to any of the other ingredients of Pulmicort 0.25 mg/ml inhalation suspension for 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 currently being treated with cortisone-type tablets, your doctor may gradually reduce (over a period of weeks or months) the dose of these tablets and may eventually discontinue the previous treatment. In such cases, some symptoms may temporarily reappear, such as runny nose, hives, or muscle and joint pain. If any of these symptoms concern you, or if you experience others such as headache, fatigue, nausea, or vomiting, contact your doctor.
• Pulmicort has been prescribed for the maintenance treatment of asthma. However, it will not relieve an acute asthma attack once it has started.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

• If used in children, your doctor will periodically monitor their growth, as this medicine may cause a delay in growth.

Consult your doctor if you have any other health problems. Do not use this medicine for other conditions unless instructed by your doctor. Never give it to someone else.

Not all nebulizers are suitable for use with Pulmicort. ULTRASONIC NEBULIZERS must NOT be used with Pulmicort 0.25 mg/ml inhalation suspension for nebulizer.

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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 closely monitor you if you are taking these medicines. In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Medicines to treat 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 advised that this medicine contains a component that may result in a positive doping test.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

There is no evidence that Pulmicort 0.25 mg/ml inhalation suspension for nebulizer may 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 while being treated with Pulmicort 0.25 mg/ml inhalation suspension for nebulizer.

Pulmicort passes into breast milk, but in minimal amounts that have no effect on the infant.

Use in children

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

Driving and use of machines

Pulmicort does not affect your ability to drive or operate tools or machinery.

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

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Method of use and route of administration

Pulmicort 0.25 mg/ml inhalation suspension for nebulization must only be used by inhalation through a nebulizer. Do not use ultrasonic nebulizers, as they are not suitable for administration of this medicine. Before starting treatment, you must understand how to operate the nebulizer. It is important that you read the information included in the section “How to use Pulmicort 0.25 mg/ml inhalation suspension for nebulization” and carefully follow the instructions.

Dosage, frequency of administration, and duration of treatment

The dose of Pulmicort should be individualized. Your doctor will adjust the dose and prescribe the lowest 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 prematurely, as this could seriously worsen your condition. Do not administer more doses than your doctor has prescribed.

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

Asthma

Recommended starting dose:

Children from 6 months of age: 0.25 – 1 mg per day. In very severe cases, or in children previously treated with cortisone-type tablets, a higher initial dose may be given (up to 2 mg daily, equivalent to 4 vials). Subsequently, your doctor may consider it necessary to adjust the dose. Daily doses of up to 1 mg (2 vials) may be administered as a single dose.

Adults and elderly: 1 – 2 mg per day (2 – 4 vials per day). In very severe cases, the dose may be increased up to 4 mg (8 vials). Subsequently, your doctor may consider it necessary to adjust the dose. Daily doses of up to 1 mg (2 vials) may be administered as a single dose.

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

Pulmicort may provide symptom relief within a few days of starting treatment, although it may take 2 to 4 weeks to achieve a full effect. Therefore, it is important that you continue using Pulmicort even when you feel well.

Always remember that Pulmicort has been prescribed for the maintenance treatment of asthma. However, it will not relieve an acute asthma attack once it has started.

Subglottic laryngitis

Infants and children: 2 mg per day (equivalent to 4 vials). This may be given as a single dose or in two 1 mg doses administered 30 minutes apart. Administration may be repeated every 12 hours for up to 36 hours or until your doctor considers that your symptoms have improved.

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

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

2.- Hold the plastic unit vertically and open it by twisting the top wing (see figure).

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

The vial 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 1 ml indicator line. Store the opened container protected from light. Once opened, vials must be used within 12 hours. If only 1 ml is used, note that the remaining content is no longer sterile. Gently shake before using the remainder of the suspension.

Note:

Remember to rinse your mouth after each administration. If using a face mask, ensure it fits snugly during inhalation, and remember to wash your face after use.

Cleaning:

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

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

If you use a single dose of Pulmicort higher than recommended, harmful effects are unlikely. However, if you use too much Pulmicort over a long period (months), adverse effects may occur. In such cases, consult your doctor or pharmacist immediately.

If you have used more Pulmicort than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and amount used. It is advisable to bring the packaging and the product leaflet to the healthcare professional.

It is important 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 inhalation suspension for nebulizer

If you forget to take one of your doses of Pulmicort, do not take a double dose to make up for the missed dose. Continue your 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Adverse effects usually do not occur during the use of Pulmicort. However, inform your doctor if you experience any of the following adverse effects that are bothersome or do not go away:

Common 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 eye's lens).
• Anxiety.
• Depression.
• Tremors.
• Muscle cramps.
• Blurred vision.

Rare adverse effects: May affect up to 1 in 1,000 people

• Allergic-type reactions, including skin rash, contact dermatitis, urticaria, and angioedema (swelling of the face, lips and/or tongue with difficulty swallowing and breathing).

• Skin bruising.

• Behavioral changes (especially in children).

• Restlessness.

• Nervousness.

• As with other inhaled treatments, bronchospasm (i.e., contraction of the airways causing "wheezing") may rarely occur.

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

• Growth retardation.

Adverse effects with unknown frequency that may occur

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

Inhaled corticosteroids may affect the normal production of steroid hormones in the body, especially if high doses are used for prolonged periods. These effects include:

• changes in bone mineral density (reduced bone strength).

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

If you were previously treated with cortisone-type tablets, switching to inhaled corticosteroid therapy may cause the appearance of certain symptoms such as fatigue, abdominal pain, weakness, or vomiting. If these symptoms occur, consult your doctor immediately.

Rarely, prolonged treatment with high doses may cause a reduction in growth velocity in children, particularly in patients previously treated with cortisone-type tablets or those especially sensitive.

Facial skin irritation has been observed in some cases when using a nebulizer with a facial mask. To prevent facial irritation, wash the face with water after using the mask.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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

Always keep unopened sterile ampoules in their aluminum foil pouch, protected from light.

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

Store in an upright position.

Do not freeze.

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

Do not use this medicine after the expiry date stated on the pouch and on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Pulmicort 0.25 mg/ml inhalation suspension for nebulizer

The active substance in Pulmicort 0.25 mg/ml inhalation suspension for nebulizer is budesonide. Each sterile 2 ml ampoule 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 contents of the pack

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

Each pack contains an aluminium sachet with 5 sterile 2 ml ampoules.

There are two strengths of Pulmicort inhalation suspension for nebulizer: Pulmicort 0.25 mg/ml inhalation suspension for nebulizer and Pulmicort 0.50 mg/ml inhalation suspension for 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 the most recent review of this leaflet: November 2019

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