BUDENA 0.25 mg/ml SUSPENSION FOR NEBULIZER INHALATION

Introduction

Package Leaflet: Information for the User

Budena 0.25 mg/ml Suspension for Nebulisation

Budesonide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Budena and what is it used for
2. What you need to know before you use Budena
3. How to use Budena
4. Possible side effects
5. Storage of Budena
6. Contents of the pack and other information

1. What is Budena and what is it used for

Budena 0.25 mg/ml is a sterile suspension for inhalation via a nebuliser (inhalation device). When you breathe in through the mouthpiece or mask, the medicine reaches the lungs through the inhaled air.

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

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

Budena is used for the maintenance treatment of asthma and the treatment of severe subglottic laryngitis requiring hospitalisation. It should be used regularly as directed by your doctor.

2. What you need to know before you use Budena

Do not use Budena:

If you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take budesonide if any of the following apply to you:

• 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 budesonide for you 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 worry you, or if you experience any other symptoms such as headache, fatigue, nausea, or vomiting, contact your doctor.
• Budesonide has been prescribed for you 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 administered to children, your doctor will regularly review their growth as this medicine may cause growth retardation.

Talk to 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 nebulisers are suitable for use with budesonide. DO NOTuse ultrasonic nebulisers with Budena 0.25 mg/ml suspension for nebulisation.

Using Budena 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 budesonide, 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).
• Oestrogens and steroid contraceptives.

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 budesonide 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 budesonide.

Budesonide passes into breast milk, but in minimal amounts that do not affect the infant.

Use in children

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

Driving and using machines

The influence of inhaled budesonide on the ability to drive and use machines is negligible.

3. How to use Budena

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

Method of use and route of administration

Budesonide should only be used for inhalation via a nebuliser. Do not use ultrasonic nebulisers, as they are not suitable for administration of this medicine. Before starting treatment, you should know how to use the nebuliser. It is essential that you read the information in the "How to use Budena" section and follow the instructions carefully.

Dosage, frequency of administration, and duration of treatment

The dose of budesonide should be individualised. 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 budesonide. Do not stop treatment before this, as your condition may worsen severely. Do not take more doses than your doctor has indicated.

If you think the effect of budesonide is too strong or too weak, tell your doctor or pharmacist.

Asthma

Recommended initial dose:

Children from 6 months onwards: 0.25-1 mg per day. In 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. Your doctor may then consider it necessary to adjust the dose. Daily doses of up to 1 mg (2 ampoules) may be administered as a single dose.

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

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

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

Remember that budesonide 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 4 ampoules). This may be administered in a single dose or in two doses of 1 mg, separated by a 30-minute interval. Administration may be repeated every 12 hours for a maximum of 36 hours or until your doctor considers that your symptoms have improved.

How to use Budena 0.25 mg/ml suspension for nebulisation

1. Gently shake the reservoir again and start nebulisation. During nebulisation, breathe in the mist of the nebulised suspension deeply and slowly.
2. When no more mist comes out of the mouthpiece or mask, the treatment is finished.
3. When you have finished, rinse your mouth with water (do not swallow the water) and brush your teeth. If you have used a mask, wash your face well. It is essential to do this to reduce the risk of some side effects associated with this medicine.
   1. After each use, wash the nebuliser thoroughly. Wash the nebuliser reservoir and mouthpiece or mask with warm water using a mild detergent, following the manufacturer's instructions. The nebuliser should be rinsed thoroughly and dried by connecting the reservoir to the compressor or air outlet.

It is essential that you always follow the manufacturer's instructions that come with the nebuliser. If you are unsure about how to use the nebuliser, consult your doctor or pharmacist.

If you use more Budenathan you should

If you use a dose of budesonide that is higher than you should in a single occasion, it is unlikely to cause harmful effects. If you use too much budesonide over a long period (months), side effects may occur. In this case, consult your doctor or pharmacist immediately.

If you have used more budesonide 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 packaging 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 Budena

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

If you have any doubts about the use of this medicine, 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 budesonide. However, tell your doctor about the following side effects that you find troublesome or that 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 1,000 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.
• Behavioural 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 frequencywhich 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 temporarily. 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 particularly sensitive patients.

Skin irritation on the face has been observed in some cases where a nebuliser with a facial mask has been 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 are 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 Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Budena

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

Do not use this medicine after the expiry date stated on the carton or pouch after EXP. The expiry date is the last day of the month shown.

Store the ampoules in the original packaging and pouch, protected from light.

Once an ampoule is opened, it must be used within 24 hours. After this time, any unused amount must be discarded.

Once a pouch is opened, the ampoules must be used within 3 months (it is recommended to note the opening date on the pouch to help you remember it)

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your usual pharmacy or any other collection system for medicinal waste. If in doubt, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Budena

The active substance of Budena 0.25 mg/ml suspension for nebulisation is budesonide. Each sterile ampoule of 2 ml contains 0.50 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 pack contents

Budena is presented in low-density polyethylene ampoules with 2 ml of white or off-white suspension to be nebulised (converted into a fine mist for inhalation).

The ampoules are packaged in strips of 5 ampoules in an aluminium pouch, which is then packaged in cardboard boxes. Boxes containing 20 ampoules are available.

Marketing Authorisation Holder:

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat, Barcelona

Spain

Manufacturer:

Genetic S.p.A.

Nucleo Industriale, Contrada Canfora, 84084 Fisciano (SA)

Italy

Date of last revision of this leaflet:June 2020

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/