Budesonide nasal Aldo-Unión 100 micrograms/dose nasal suspension for spray

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Budesonide Aldo-Unión Nasal 100 micrograms/dose

nasal spray suspension

Read this 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Budesonide Aldo-Unión Nasal is and what it is used for
2. What you need to know before using Budesonide Aldo-Unión Nasal
3. How to use Budesonide Aldo-Unión Nasal
4. Possible side effects
5. How to store Budesonide Aldo-Unión Nasal
6. Contents of the pack and other information

1. What Budesonida Nasal Aldo-Unión is and what it is used for

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

Budesonida Nasal Aldo-Unión is used for the treatment of symptoms of seasonal allergic rhinitis ("hay fever"), as well as perennial rhinitis (all year round) and vasomotor rhinitis.

2. What you need to know before using Budesonida Nasal Aldo-Unión

Do not use Budesonida Nasal Aldo-Unión

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

Warnings and precautions

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

• If you currently have or have previously had tuberculosis.

• If you have untreated generalized or respiratory tract infections.

• If you have symptoms or signs of a localized nasal infection.

• 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 the treatment of your current condition. Do not take this medicine for other conditions unless instructed by your doctor.

Avoid contact of the product with the eyes. If contact occurs, rinse the eyes immediately with plenty of water.

Children and adolescents

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

Children aged 6 years and older should only use Budesonida Nasal Aldo-Unión under adult supervision to ensure correct administration and that the dose corresponds to that prescribed by the doctor. The doctor will periodically monitor the child's growth, as this medicine may cause growth delay.

Using Budesonida Nasal Aldo-Unión with other medicines:

Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Some medicines may increase the effects of Budesonida Nasal Aldo-Unión, so your doctor will perform careful monitoring if you are taking these medicines (including certain HIV medications: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

There are no indications that this medicine may affect your ability to drive.

Use in athletes

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

3. How to use Budesonida Nasal Aldo-Unión

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The dose should be individualized. Your doctor will indicate the duration of treatment with Budesonida Nasal Aldo-Unión; do not exceed the recommended treatment duration.

Do not share the spray with other people due to the risk of infection.

Allergic seasonal and perennial rhinitis, non-allergic perennial rhinitis:

Adults: The usual starting dose is two sprays into each nostril once in the morning. Alternatively, it may be administered as one spray into each nostril in the morning and evening. Once 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 season begins. This medicine does not provide immediate relief of symptoms. It may take several days of treatment with Budesonida Nasal Aldo-Unión before you notice symptom relief (sometimes up to 2 weeks).

This medicine does not relieve ocular allergy symptoms. If you experience eye discomfort, your doctor may prescribe another medicine to relieve these symptoms.

If symptom relief is not achieved after 3 weeks of treatment, administration of the product should be discontinued. It is advisable to use the lowest effective dose.

In patients with perennial allergic rhinitis, once adequate symptom control 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 again to the initial dose, then adjusted down to the dose at which adequate symptom control was previously achieved.

Use in children and adolescents

The use of this medicine is not recommended in children and adolescents.

Instructions for correct administration of the product:

Before first use:

• Remove the protective cap.
• Shake the bottle-spray assembly well.
• Prime the pump by pressing the nozzle several times until a fine spray is produced.

If the spray is not used daily, it is necessary to prime it once into the air before using it again.

Method of use. For each administration:

• Gently blow your nose.
• Remove the protective cap.
• Shake the bottle-spray assembly.
• Insert the nozzle into one nostril, closing the other nostril with your finger.
• Inhale and press firmly on the bottom of the bottle. Breathe through your mouth and repeat the procedure.
• Repeat the same process in the other nostril.

After use, replace the protective cap.

Cleaning:

After using the spray, clean the nozzle carefully with a tissue or clean cloth to keep it free from blockage.

If the spray does not work, the nozzle may be blocked. Never attempt to unblock it or enlarge the nozzle hole with a pin or sharp object. This could damage the spray device and prevent it from working properly.

The nasal applicator can be removed by gently pulling it upwards.

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

It is important that you take your dose as prescribed by your doctor. You should only use the amount recommended by your doctor; using more or less than prescribed may worsen your symptoms.

Consult your doctor or pharmacist, or call the Toxicology Information Service at telephone: 91 5620420, indicating the medicine and the amount used.

If you forget to use Budesonida Nasal Aldo-Unión:

Do not use a double dose to make up for missed doses. Simply use your next dose as prescribed.

If you have any further 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 everybody gets them.

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

Respiratory, thoracic and mediastinal disorders:

• Common (≥1/100 to <1/10):

• Sneezing

• Nasal itching

• Nasal dryness

• Dysphonia including hoarseness

• Rare (≥1/10,000 to <1/1,000):

• Nasal bleeding

• Throat irritation

• Very rare (<1/10,000):

• Nasal septum perforation

Skin and subcutaneous tissue disorders:

• Uncommon (≥1/1,000 to <1/100):

• Skin allergic reactions

Eye disorders:

• Frequency not known (frequency cannot be estimated from the available data):

• Blurred vision

If you consider any of these 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 through 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 Budesonide Nasal Aldo-Unión

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

Do not store above 30°C.

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

Do not freeze.

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

Do not use this medicine after the expiry date stated on the packaging after "Exp." The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Budesonida Nasal Aldo-Unión

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

Appearance of the product and contents of the pack:

Budesonida Nasal Aldo-Unión is a white aqueous suspension supplied in a brown glass bottle containing 10 ml (200 doses), equipped with a metering pump and a nasal adapter.

Marketing Authorization Holder and Manufacturer:

Laboratorio ALDO-UNIÓN, S.L.

Baronesa de Maldà, 73

08950 Esplugues de Llobregat

BARCELONA – SPAIN

Date of the most recent review of this leaflet: December 2024

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/