BUDENA 64 micrograms NASAL SPRAY SUSPENSION

1. What is BUDENA 64 micrograms and what is it used for

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

Budena 64 micrograms is used to treat the symptoms of seasonal allergic rhinitis ("hay fever") and perennial allergic and non-allergic rhinitis, in both adults and children aged 6 years and older.

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

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

Do not use Budena 64 micrograms:

• If you are allergic (hypersensitive) to budesonide or 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

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

• You have severe or frequent nosebleeds
• You have recently had nasal ulcers, have had nasal surgery, or have had a nasal injury that has not healed well.
• You have tuberculosis, a chest infection, chickenpox, or measles, or have been in contact with someone who has tuberculosis, chickenpox, or measles.
• You have had glaucoma (increased eye pressure) or cataracts in the past.
• You have an eye infection.
• You have diabetes.
• You have liver problems.

Talk to your doctor or pharmacist if you experience any of the following while using Budena 64 micrograms:

• Blurred vision or other visual disturbances
• Any sign of infection, such as persistent fever

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

Children and adolescents

The long-term effects of Budena 64 micrograms in children are not known, but it may cause growth retardation. If growth retardation is observed, you should consult your doctor to assess the treatment.

Using Budena 64 micrograms 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 Budena 64 micrograms. In particular, tell your doctor or pharmacist if you are taking the following medicines:

? For treating fungal infections(such as itraconazole or ketoconazole).

? You are taking antibiotics (such as clarithromycin)

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

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

? You are taking estrogens as hormone replacement therapy or birth control pills.

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

? You have recently stopped using tablet corticosteroidssuch as prednisolone or corticosteroid injections.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. You should contact your doctor as soon as possible if you become pregnant during treatment with Budena 64 micrograms.

Driving and using machines

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

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

3. How to use Budena 64 micrograms.

Follow the instructions for administration of this medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor's instructions may differ from the information contained in this package leaflet. The dose should 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 spray with other people due to the risk of contagion.

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

Adults and children from 6 years: the usual starting dose is two sprays in each nostril in the morning. It can also be administered as one spray in each nostril, morning and evening. Once an improvement in symptoms is achieved, your doctor may reduce the dose.

If you have seasonal allergic rhinitis ("hay fever"), you should start treatment with Budena 64 micrograms before the allergy season begins. Budena 64 micrograms does not provide immediate relief of symptoms. Several days of treatment with Budena 64 micrograms may be necessary before you notice relief of symptoms (sometimes up to 2 weeks).

Budena 64 micrograms does not relieve eye symptoms of allergy. If you experience eye discomfort, your doctor may prescribe another medicine to relieve these symptoms.

Treatment of nasal polyps/prevention after polypectomy:

The usual dose is two sprays in each nostril in the morning. It can also be administered as one spray in each nostril, morning and evening. Once an improvement in symptoms is achieved, your doctor may reduce the dose.

Use in children

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

If you use more Budena 64 micrograms than you should:

Accidental administration of more than the recommended dose on a single occasion is unlikely to cause problems. If this happens over a long period (months), it is possible that side 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 medicine and the amount ingested.

If you forget to use Budena 64 micrograms:

Do not take a double dose to make up for forgotten doses. Simply apply the next dose as needed.

Instructions for correct administration of the preparation:

Read the following 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 you do not use it daily, it is necessary to recharge the pump. In this case, a single press in the air will be sufficient.

1. Clean both nostrils 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 a nostril and press the number of times indicated by your doctor (1 or 2). Repeat the operation in the other nostril.
4. Replace the cap. Do not use the product more times than prescribed.

Cleaning:

After using the spray, to keep the nozzle clean, carefully clean the nasal applicator with a tissue or a clean cloth.

If the spray does not work, the nozzle may be blocked. Never try to unblock it or make the hole in the sprayer larger with a pin or sharp object. This could cause the sprayer to stop working.

The nasal applicator is removed by gently pulling it upwards.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

? Sudden signs of allergic reaction such as rash, itching, hives, or redness of the skin, swelling of the face, lips, mouth, tongue, or other parts of the body, difficulty breathing, wheezing, or difficulty swallowing or breathing or feeling of fainting.

Other side effects include:

Frequent (may affect 1 in 10 patients):

? Nasal, throat, or sinus infections.

? Nosebleeds (epistaxis) or nasal irritation.

? Mouth or throat pain.

? Ear infections

? Headache

? Abdominal discomfort

? Fever

Uncommon (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 next to the kidneys).
• Nasal ulcers or perforation of the membrane that separates the nostrils (nasal septum).
• Voice changes
• Bruising
• Blurred vision.

Other side effects of which the frequency is not known include:

• Cataracts (loss of transparency of the lens in the eye).
• Glaucoma (increased eye pressure).
• Angioedema.
• Dermatitis.
• Erythema.
• Rash.
• Urticaria.

Other side effects in children

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

Mental or behavioral disorders, such as hyperactivity, sleep disorders, nervousness, depression, or aggression, have been reported rarely (especially in children).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

.

5. Storage of Budena 64 micrograms.

This medicine does not require special storage conditions.

Do not freeze.

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

Replace the protective cap after using Budena 64 micrograms.

Do not use this medicine after the expiry date which is stated on the container after "CAD". The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and further information.

Composition of Budena 64 micrograms:

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

Appearance of the product and package contents:

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Laboratorio ALDO-UNIÓN, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

BARCELONA – SPAIN

Date of last revision of this package leaflet:December 2024.

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/