Leaflet: information for the user

Budena 0.5 mg/ml suspension for inhalation by nebulizer

Budesonide

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isBudenaand what it is used for

2. What you need to know before starting to useBudena

3. How to useBudena

4. Possible side effects

5. Storage ofBudena

6. Contents of the pack and additional information

Budena 0.5 mg/ml is a sterile suspension for inhalation through a nebulizer (inhalation device). When you breathe through the mouthpiece or mask, the medication will reach the lungs through the inhaled air.

Budena contains budesonide. Budesonide belongsto 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.

Budena 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.

No use Budena:

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

Warnings and precautions

Consult your doctor or pharmacist before starting budesonide if any of the following situations affect you:

- If you have or have had pulmonary tuberculosis or any recent infection.

- If you have ever had liver problems.

- If your doctor has prescribed budesonide 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 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.

- Budesonide 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. Do not give it to anyone else.

Not all nebulizers are suitable for use with budesonide.DO NOTuse ultrasonic nebulizers with Budena 0.5 mg/ml suspension for inhalation by nebulizer.

Use of Budena with 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 ofbudesonide, 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:

• Antifungal medications (such as itraconazole and ketoconazole).
• Medications for HIV (such as ritonavir or cobicistat).
• Cimetidine (medication for stomach acid).
• Estrogens and steroid contraceptives.

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 if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

There is no evidence that budesonide can harm the mother or child when used during pregnancy or breastfeeding. However, contact your doctor as soon as possible if you become pregnant during treatment with budesonide.

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

Use in children

Budesonide must be administered under the supervision of an adult to ensure the correct administration of the medication.

Driving and operating machinery

The influence of inhaled budesonide on the ability to drive and operate machinery is negligible or insignificant.

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

Form of use and administration route

Budesonide should 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 should know how to use the nebulizer. It is essential that you read the information included 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 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 budesonide treatment. Do not discontinue treatment prematurely, as this will severely worsen your condition. Do not administer more doses than your doctor has indicated.

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

Asthma

Recommended initial dose:

Children from 6 months old: 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. Your doctor may then consider adjusting 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 budesonide 0.25 mg/ml suspension for inhalation through a nebulizer should be used.

Adults and the elderly: 1- 2 mg per day (1 - 2 ampoules per day). In very severe cases, the dose may be increased to 4 mg (4 ampoules). Your doctor may then consider adjusting 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 your dose to the minimum that allows you to be symptom-free.

Budesonide 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 budesonide even when you feel better.

Remember that budesonide has been prescribed for the maintenance treatment of 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 2 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 Budena 0.5 mg/ml suspension for inhalation through a nebulizer

6. Gently shake the chamber again and start the nebulization. During nebulization, breathe in the mist of the nebulized suspension deeply and slowly.

7. When no more mist comes out of the mouthpiece or mask, the treatment will be finished.

8. After finishing, rinse your mouth with water (do not swallow the water) and brush your teeth. If you used a mask, wash your face thoroughly. It is essential to do this to reduce the risk of some side effects associated with this medication.

1. After each use, wash the nebulizer thoroughly. Wash the nebulizer chamber and mouthpiece or mask with warm water using a mild detergent, following the manufacturer's instructions. The nebulizer must be thoroughly cleaned and dried by connecting the chamber to the compressor or air outlet.

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

If you use more Budena than you should

If you use a dose of budesonide higher than the recommended dose in a single occasion, no adverse effects should occur. If you use too much budesonide over 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 budesonide 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 Budena

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

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

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

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

- Mild throat irritation.

- Cough.

- Hoarseness.

- Oral and throat fungal infections.

Infrequent 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).

- Hematomas on the skin.

- 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") may occur.

- Effects on the adrenal glands (small glands located near the kidneys).

- Growth retardation.

Side effects of unknown frequency that may include

- Sleep disorders, hyperactivity, or aggression.

- Glaucoma (increased intraocular pressure).

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

• Bone mineral density changes (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 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, wash your face with water after using the mask.

If you consider any of the side effects you experience to be severe or if you notice any side effect not mentioned in this prospectus, 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date indicated on the box or the package after CAD.The expiration date is the last day of the month indicated.

Store the vials in the original packaging and in the overwrap, protected from light.

Once a vial is opened, it must be used within a maximum of 24 hours. Any unused quantity should be discarded after this time.

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

Medications should not be thrown away through the drains or in the trash. Dispose of the containers and medications you no longer need at your local pharmacy's Punto Sigreor any other medication waste collection system. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Budena

The active principle of Budena 0.5 mg/ml inhalation suspension for nebulizer is budesonide. Each sterile ampoule of 2 ml contains 1 mg of budesonide. The other components (excipients) are: edetate disodium, sodium chloride, polisorbate 80, anhydrous citric acid, sodium citrate, and water for injection.

Appearance of the productand contents of the packaging

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

The ampoules are packaged in strips of 5 ampoules in an aluminum foil pouch that is further packaged in cardboard containers. Packaging is available with 20 ampoules.

Marketing Authorization Holder:

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat, Barcelona

Spain

Responsible for Manufacturing:

Genetic S.p.A.

Nucleo Industriale, Contrada Canfora, 84084 Fisciano (SA)

Italy

Last review date of this leaflet:June 2020

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/