Leaflet: information for the user

Budena 64 micrograms nasal spray

Budesonide

Read this 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, 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 is Budena 64 micrograms and what it is used for

2. What you need to know before using Budena 64 micrograms

3. How to use Budena 64 micrograms

4. Possible side effects

5. Storage of Budena 64 micrograms

6. Contents of the pack and additional information

Budena 64 micrograms contains as active ingredient budesonide, which belongs to a group of medicines called glucocorticoids and is used to reduce nasal mucosa inflammation (inner part of the nose).

Budena 64 micrograms is used for the treatment of symptoms of seasonal allergic rhinitis (“hay fever”), as well as perennial (all year round) allergic and non-allergic rhinitis, in both adults and children 6 years of age or older.

Budena 64 micrograms may also be used in adults to treat symptoms of nasal polyps and/or to prevent the appearance of new nasal polyps after surgical removal.

Do not use Budena 64 micrograms:

• If you are allergic (hypersensitive) to budesonide or to any of the other ingredients of this medicine (listed in section 6).
• If you have symptoms or signs of a localized infection in the nasal passages.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Budena 64 micrograms if:

- You suffer from severe or frequent nasal bleeding.

- If you have recently had nasal ulcers, have undergone nasal surgery, or have had a nasal injury that has not healed well.

- You suffer from tuberculosis, a chest infection, chickenpox, or measles, or have been in contact with someone who suffers from tuberculosis, chickenpox, or measles.

- You have ever had glaucoma (increased eye pressure) or cataracts.

- You have an eye infection.

- You have diabetes.

- You have liver problems.

Consult your doctor or pharmacist if you suffer from any of the following conditions while using Budena 64 micrograms:

- Blurred vision or other visual disturbances.

- Any sign of infection, such as persistent fever.

If symptoms persist or worsen, or if new symptoms appear, stop using Budena 64 micrograms and consult your doctor.

Children and adolescents

No long-term effects in children are known, but it may cause growth retardation. If growth is observed to slow down, consult your doctor to assess treatment.

Use of Budena 64 micrograms with other medicines:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine. This includes medicines bought without a prescription and herbal remedies. Some medicines may increase the effects of Budena 64 micrograms. In particular, inform your doctor or pharmacist if you are taking the following medicines:

?To treat fungal infections (such as itraconazole or ketoconazole).

?You are taking antibiotics (such as clarithromycin).

?You are taking HIV medicines (such as saquinavir, atazanavir, indinavir, nelfinavir, ritonavir, or medicines containing cobicistat).

?You are taking cimetidine (medicine for stomach acid).

?You are taking estrogens such as hormone replacement therapy or contraceptive pills.

?You are taking another corticosteroid medicine (such as creams for eczema, inhalers for asthma, tablets, injections, nasal sprays, eye or nasal drops).

?You have recently stopped taking corticosteroid tablets such as prednisolone or corticosteroid injections.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. You must contact your doctor as soon as possible if you become pregnant during treatment with Budena 64 micrograms.

Driving and operating machinery

There is no indication that Budena 64 micrograms may affect your ability to drive or operate machinery.

Warning to athletes: This medicine contains a component that may produce a positive result in doping control tests.

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

Your doctor's instructions may differ from the information contained in this leaflet. The dose must be individualized.

Your doctor will indicate the duration of treatment with Budena 64 micrograms; do not exceed the recommended treatment duration.

Do not share the sprayer with other people due to the risk of contagion.

Seasonal and perennial allergic rhinitis, perennial non-allergic rhinitis:

Adults and children aged 6 years and above: the usual dose for an attack is two applications in each nasal fossa in the morning. It can also be administered as one application in each nasal fossa, morning and night. Once symptoms have improved, your doctor may reduce your dose.

If you suffer from seasonal allergic rhinitis ("hay fever"), you should start treatment with Budena 64 micrograms before the allergy period begins. Budena 64 micrograms does not provide immediate relief from symptoms. It may take several days of treatment with Budena 64 micrograms for you to notice relief from symptoms (sometimes up to 2 weeks).

Budena 64 micrograms does not alleviate ocular allergy symptoms. If you notice eye discomfort, your doctor may prescribe another medication for symptom relief.

Nasal polyp treatment/prevention after polyp removal:

The usual dose is two applications in each nasal fossa in the morning. It can also be administered as one application in each nasal fossa, morning and night. Once symptoms have improved, your doctor may reduce your dose.

Use in children

This medication should not be used in children under 6 years of age.

If you use moreBudena 64 micrograms than you should:

The administration of a single dose of more than the recommended dose is usually not harmful. If this occurs over a long period (months), it is possible that adverse effects may appear, so you should consult your doctor or pharmacist. In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone +34915620420, indicating the medication and the amount ingested.

If you forgot to useBudena 64 micrograms:

Do not take a double dose to compensate for the missed doses. Simply apply the next dose as needed..

Instructions for correct administration of the preparation:

Read the following use instructions carefully and follow them carefully.

Before using Budena 64 micrograms for the first time, shake the container and press several times (5-10 times) until a uniform spray of the product appears (see Figure 1).

If it is not used daily, it is necessary to recharge the pump. In this case, a single press in the air will be sufficient.

1. Clean both nasal fossae well. Shake the container and remove the cap.
2. Hold the container in a vertical position as shown in Figure 2
3. Insert the applicator into one nasal orifice and press the number of times indicated by your doctor (1 or 2). Repeat the procedure in the other nasal orifice.
4. Replace the cap. Do not use the product more times than prescribed.

Cleaning:

After using the sprayer, to keep the nasal applicator clean, it should be carefully cleaned with a clean tissue or cloth.

If the sprayer does not work, it is possible that the nozzle is blocked. Never try to unblock it or enlarge the nozzle hole with a pin or sharp object. This could make the sprayer stop working.

The nasal applicator is removed by gently pulling it upwards.

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you experience any of the following symptoms, stop using this nasal spray and consult a doctor immediately:

Signs of sudden allergic reactions such as hives, itching, rashes, or skin redness, swelling of the face, lips, mouth, tongue, or other parts of the body, difficulty breathing, wheezing, or difficulty swallowing or breathing, or feeling faint.

Other side effects include:

Frequent (may affect 1 in 10 patients):

Nasal, throat, or sinus infections.

Nasal bleeding (epistaxis) or nasal irritation.

Oral or throat pain.

Ears infections.

Headache.

Abdominal discomfort.

Fever.

Less frequent (may affect up to 1 in 100 patients):

Muscle cramps.

Rare (may affect up to 1 in 1,000 patients):

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

Nasal ulcers or perforation of the nasal septum.

Changes in voice.

Hematomas.

Blurred vision.

Other side effects of unknown frequency include:

Cataracts (loss of transparency of the lens in the eye).

Glaucoma (increased eye pressure).

Angioedema.

Dermatitis.

Erythema.

Eruption.

Urticaria.

Other side effects in children

There has been reported reduced growth in children treated with nasal corticosteroids. In children, the following side effects have been frequently reported: abdominal discomfort, headache, cough, fever, or high temperature, inflammation, and infections of the ears, tonsils, sinuses, or lungs, or skin rash.

There have been reported rare instances (especially in children) of mental or behavioral disorders, such as hyperactivity, sleep disorders, nervousness, depression, or aggression.

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 Medicinal Products for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

.

This medication does not require special storage conditions.

Do not freeze.

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

Replace the protective cap after using Budena 64 micrograms.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at your local SIGRE drop-off point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Budena 64 micrograms:

• The active ingredient is budesonide.
• The other components are: disodium edetate, potassium sorbate (E-202), anhydrous glucose, microcrystalline cellulose (E- 460) and sodium carboxymethyl cellulose (E-466), polisorbate 80 (E- 433), hydrochloric acid and purified water.

Appearance of the product and contents of the packaging:

Budena 64 micrograms nasal suspension for inhalation is a white aqueous suspension presented in a brown glass container containing 120 doses or 200 doses, provided with a dosing pump and a nasal adapter.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorio ALDO-UNIÓN, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

BARCELONA – SPAIN

Last review date of this leaflet:December 2024.

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/