Prospecto: information for the patient

Budesonide Nasal Aldo-Union 100 micrograms/dose

nasal spray suspension

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor, pharmacist or nurse.
• This medication has been prescribed only to you, and you must 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, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

1. What isBudesonide Nasal Aldo-Unionand what is it used for

2. What you need to know before starting to useBudesonide Nasal Aldo-Unión

3. How to useBudesonide Nasal Aldo-Unión

4. Possible adverse effects

5. Storage ofBudesonide Nasal Aldo-Unión

6. Contents of the package and additional information

This medication contains budesonida as its active ingredient, which belongs to a group of medications called glucocorticoids and is used to reduce nasal mucosa inflammation (the inner part of the nose).

Budesonida Nasal Aldo-Uniónis used to treat symptoms of seasonal allergic rhinitis (“hay fever”), as well as perennial and vasomotor rhinitis.

No use Budesonida Nasal Aldo-Unión

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

Warnings and precautions

Consult your doctor or pharmacist before starting to useBudesonida Nasal Aldo-Unión:

• If you have or have had tuberculosis.
• If you have untreated general infections or respiratory tract infections.
• If you have symptoms or signs of a localized infection in the nasal passages.

- If you have previously been treated with systemic steroids.

Contact your doctor if you experience blurred vision or other visual disturbances.

Budesonida Nasal Aldo-Unión has been prescribed for your current condition. Do not take this medication for other conditions without your doctor's instruction.

Avoid contact of the product with the eyes. In case of contact with the eyes, rinse them immediately with abundant water.

Children and adolescents

The administration of Budesonida Nasal Aldo-Unión is not recommended in children under 6 years old.

Children 6 years old or older should use Budesonida Nasal Aldo-Unión only under the supervision of an adult to ensure correct administration and that the dose corresponds to the one prescribed by the doctor. The doctor will periodically review the growth of children as this medication may cause a delay in their growth.

Use of Budesonida Nasal Aldo-Unión withother medications:

Inform your doctor if you are taking or have recently taken other medications, including those purchased without a prescription.

Some medications may increase the effects of Budesonida Nasal Aldo-Unión, so your doctor will perform thorough controls if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

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 clear evidence that this medication harms the mother or child when administered during pregnancy or breastfeeding.

Driving and operating machines

There is no indication that this medication may affect your ability to drive.

Use in athletes

If you are an athlete, be aware that this medication contains budesonide, which may result in a positive test in doping control tests.

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

The dose must be individualized. Your doctor will inform you of the duration of treatment with Budesonida Nasal Aldo-Unión; 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, non-allergic perennial rhinitis:

Adults: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 the symptoms have improved, your doctor may reduce your dose.

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

This medication does not alleviate ocular symptoms of allergy. If you notice eye discomfort, your doctor may prescribe another medication for relief of these symptoms.

If symptom relief is not achieved after 3 weeks of treatment, administration of the preparation should be discontinued. It is advisable to administer the minimum effective dose.

In patients with perennial allergic rhinitis, once adequate control of symptoms has been achieved, the dose should be gradually reduced every 2-4 weeks until the expected clinical effect is maintained. If symptoms return, the dose may be increased to the starting dose and then to the dose at which adequate control of symptoms was achieved.

Use in children and adolescents

This medication is not recommended for use in children and adolescents.

Instructions for correct administration of the preparation:

Before the first application:

• Remove the protective cap.
• Shake the bottle-sprayer combination.
• Operate the trigger as needed to fill the pump mechanism and produce a correct spray.

If not used daily, a trigger pull in the air is necessary before reuse.

Mode of use. In each application:

• Gently blow your nose
• Remove the protective cap
• Shake the bottle-sprayer combination.
• Insert the sprayer into one nasal fossa, covering the other with your finger.
• Inhale and press firmly on the bottom of the bottle. Breathe through your mouth and repeat the process.
• Repeat the same process in the other nasal fossa.

After use, place the protective cap.

Cleaning:

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

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

The nasal applicator is removed by gently pulling upwards.

If you use more Budesonida Nasal Aldo-Unión than you should:

It is essential that you take your dose as indicated by your doctor. You should only use what your doctor recommends; using more or less dose may worsen your symptoms.

Consult your doctor or pharmacist, or call the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount used.

If you forgot to use Budesonida Nasal Aldo-Unión:

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse reactions have been reported, classified by organ system and in decreasing order of frequency:

Respiratory, thoracic, and mediastinal disorders:

• Frequent(≥1/100 to <1)

- Sneezing.

- Nasal itching.

- Nasal dryness.

- Dysphonia including hoarseness

• Rare((≥1/10,000 to <1)

- Nasal bleeding.

- Throat irritation.

• Very rare(<1)

- Perforation of the nasal septum.

Skin and subcutaneous tissue disorders:

• Uncommon(≥1/1000 to <1)

Cutaneous allergic reactions.

Eye disorders:

• Unknown frequency (the frequency cannot be estimated from the available data:

• Blurred vision.

If you consider that any of these adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting 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 can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above30°C.

Store the container in the outer packaging to protect it from light.

Do not freeze.

Replace the protective cap after using Budesonida Nasal Aldo-Union.

Do not use this medication after the expiration date that appears on the container afterCad. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at your local SIGREdrop-off point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need.This will help protect the environment.

Composition ofBudesonida Nasal Aldo-Unión

• The active ingredient is budesonide. Each application contains 100 micrograms of budesonide (2 mg/ml).
• The other components (excipients) are: anhydrous glucose, microcrystalline cellulose, and sodium carmellose, polisorbate 80, sodium edetate, potassium sorbate (E-202), hydrochloric acid, and purified water.

Appearance of the product and contents of the packaging:

Budesonida Nasal Aldo-Uniónis a white aqueous suspension that is presented in a brown glass container containing 10 ml (200 doses), provided with a dosing pump and a nasal adapter.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorio ALDO-UNIÓN, S.L.

Baronesa de Maldà, 73

08950 Esplugues de Llobregat

BARCELONA – SPAIN

Last review date of this leaflet: December 2024

Other sources of information

The 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/“