Budena 0.5 mg/ml suspension for inhalation by nebulizer
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Budena 0.5 mg/ml suspension for inhalation for nebulizer
Budesonide
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Budena is and what it is used for
- What you need to know before using Budena
- How to use Budena
- Possible side effects
- How to store Budena
- Contents of the pack and other information
1. What Budena is and what it is used for
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 your lungs via the inhaled air.
Budena 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.
Budena is used for the 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 Budena
Do not use Budena:
If you are allergic to budesonide or to 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 and you are currently being treated with cortisone-type tablets, your doctor may gradually reduce (over a period of weeks or months) and possibly discontinue the previous treatment. In such cases, certain 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 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 not relieve an acute asthma attack once it has started.
- Contact your doctor if you experience blurred vision or other visual disturbances.
Children
- If this medicine is administered to children, your doctor will periodically monitor their growth, as this medicine may cause growth delay.
Talk to your doctor if you have any other health problems. Do not use this medicine for other conditions unless specifically instructed by your doctor. Never give this medicine to someone else.
Not all nebulizers are suitable for use with budesonide. ULTRASONIC NEBULIZERS MUST NOT BE USED with Budena 0.5 mg/ml inhalation suspension.
Use of Budena with other medicines:
Tell 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 medicines. Some medicines may increase the effects of budesonide, 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).
- Estrogens and steroid contraceptives.
Use in athletes
Athletes are advised that this medicine contains a component that may lead to a positive result in doping control tests.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
There is no evidence that budesonide 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 budesonide.
Budesonide passes into breast milk, but in minimal amounts that have no effect on the nursing infant.
Use in children
Budesonide should always be administered under the supervision of an adult to ensure correct administration of the medicine.
Driving and using machines
The effect of inhaled budesonide on the ability to drive and use machines is negligible or none.
3. How to use Budena
Follow exactly the instructions for administering the medicine as given 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 nebulizer. Do not use ultrasonic nebulizers, as they are not suitable for administering 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 Budena” and carefully follow the instructions.
Dosage, frequency of administration, and duration of treatment
The dose of budesonide should be individualized. Your doctor will adjust the dose and prescribe the lowest amount needed to control your asthma or subglottic laryngitis symptoms. Carefully follow your doctor's instructions.
Your doctor will indicate how long your treatment with budesonide should last. Do not stop treatment prematurely, as this could seriously worsen your condition. Do not take more doses than your doctor has prescribed.
If you feel that the effect of budesonide is too strong or too weak, inform your doctor or pharmacist.
Asthma
Recommended initial 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 2 ampoules). Subsequently, your doctor may consider it necessary to adjust the dose. Daily doses of up to 1 mg (1 ampoule) may be administered as a single dose. In cases where a lower dose is required (0.25 mg/day), 1 ml of budesonide 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 may 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) may be administered as a single dose.
Maintenance dose: Once your symptoms have improved, your doctor may decide to reduce your dose to the lowest level that keeps you symptom-free.
Budesonide may relieve your symptoms within a few days of starting treatment, although it may take 2 to 4 weeks to achieve the full effect. Therefore, it is important that you continue using budesonide even when you start feeling well.
Always remember that budesonide has been prescribed for the maintenance treatment of asthma. However, it does not relieve an acute asthma attack once it has started.
Subglottic laryngitis
Infants and children: 2 mg per day (equivalent to 2 ampoules). This may be administered as a single dose or as two 1 mg doses given 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 Budena 0.5 mg/ml suspension for inhalation by nebulizer
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- Gently shake the reservoir once more and begin nebulization. During nebulization, breathe in the mist from the nebulized suspension deeply and slowly.
- The treatment is complete when no more mist comes out of the mouthpiece or mask.
- 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 important to do this to reduce the risk of certain side effects associated with this medicine.
- After each use, clean the nebulizer thoroughly. Wash the nebulizer reservoir and the mouthpiece or mask with warm water, using a mild detergent, following the manufacturer's instructions. The nebulizer should be thoroughly rinsed and dried by connecting the reservoir to the compressor or air outlet.
Always follow the instructions provided by the nebulizer manufacturer. 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 single dose of budesonide that is higher than recommended, harmful effects are unlikely to occur. However, if you use too much budesonide over a long period (months), adverse effects may appear. In such a case, contact your doctor or pharmacist immediately.
If you have used more budesonide than you should, consult your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount used. It is advisable to bring the medicine’s packaging and leaflet to the healthcare professional.
It is important to use the dose indicated on the outer 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 take a dose of budesonida, do not use a double dose to make up for the missed dose. Continue with your regular treatment as prescribed by your doctor.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. Adverse effects are usually not experienced during the use of budesonide. 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 near the kidneys).
- Growth retardation.
Adverse effects of 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 result in reduced growth velocity in children, particularly in patients previously treated with cortisone-type tablets or those who are especially sensitive.
Facial skin irritation has been observed in some cases when a nebulizer with a facial mask has been used. To prevent facial irritation, wash your 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: www.notificaRAM.es. By reporting adverse 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 box or sachet after EXP. The expiry date refers to the last day of the month indicated.
Store the ampoules in their original packaging and inside the sachet, protected from light.
Once an ampoule has been opened, it must be used within a maximum of 24 hours. Any unused portion must be discarded after this time.
Once the sachet has been opened, the ampoules must be used within 3 months (it is advisable to write the opening date on the sachet to help you remember it).
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the Sigre Point at your usual pharmacy, or any other medicine waste collection system. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Package contents and additional information
Composition of Budena
The active substance in Budena 0.5 mg/ml inhalation suspension for nebulization is budesonide. Each sterile 2 ml ampoule contains 1 mg of budesonide. The other components (excipients) are: disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate, and water for injections.
Presentation of the product and contents of the pack
Budena is supplied as sterile low-density polyethylene ampoules containing 2 ml of a white or almost white suspension for nebulization (to be converted into a fine mist for inhalation).
The ampoules are packed in strips of 5 ampoules per aluminum foil sachet, which are then packaged into cardboard cartons. Packs containing 20 ampoules are available.
Marketing Authorization 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 the most recent revision of this summary: June 2020
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/