Budesonide Aldo-Union 64 micrograms nasal spray suspension EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Budesonide Aldo-Unión 64 micrograms nasal spray suspension EFG

Budesonide

Read the entire leaflet carefully before you start using this medicine, because 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 should not give it to other people, even if they have the same symptoms as you, because it could 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

1. What Budesonide Aldo-Unión 64 micrograms is and what it is used for
2. What you need to know before using Budesonide Aldo-Unión 64 micrograms
3. How to use Budesonide Aldo-Unión 64 micrograms
4. Possible side effects
5. How to store Budesonide Aldo-Unión 64 micrograms
6. Contents of the pack and other information

1. What Budesonida Aldo-Unión 64 micrograms is and what it is used for

Budesonida Aldo-Unión 64 micrograms contains as its active substance budesonide, which belongs to a group of medicines called glucocorticoids and is used to reduce inflammation of the nasal mucosa (the inside lining of the nose).

Budesonida Aldo-Unión 64 micrograms is used to treat symptoms of seasonal allergic rhinitis ("hay fever"), as well as perennial (year-round) allergic and non-allergic rhinitis, in both adults and children aged 6 years and older.

Budesonida Aldo-Unión 64 micrograms may also be used in adult patients to treat symptoms of nasal polyps and/or to prevent the recurrence of nasal polyps after their surgical removal.

2. What you need to know before using Budesonida Aldo-Unión 64 micrograms.

Do not use Budesonida Aldo-Unión 64 micrograms nasal spray suspension EFG:

• If you are allergic (hypersensitive) to budesonide or to any of the other components 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 Budesonida Aldo-Unión 64 micrograms if:

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

Talk to your doctor or pharmacist if you develop any of the following conditions while using Budesonida Aldo-Unión 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, you should stop using Budesonida Aldo-Unión 64 micrograms and consult your doctor.

Children and adolescents

The long-term effects in children are not known, but it may cause growth retardation. If slowed growth is observed, consult your doctor to reassess treatment.

Use of Budesonida Aldo-Unión 64 micrograms with other medicines:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines purchased without a prescription and herbal remedies. Some medicines may increase the effects of Budesonida Aldo-Unión 64 micrograms. In particular, inform your doctor or pharmacist if you are taking the following medicines:

• Medicines for fungal infections (such as itraconazole or ketoconazole).

• Antibiotics (such as clarithromycin).

• Medicines for HIV (such as saquinavir, atazanavir, indinavir, nelfinavir, ritonavir, or medicines containing cobicistat).

• Cimetidine (a medicine for stomach acidity).

• Estrogens as hormone replacement therapy or contraceptive pills.

• Another medicine containing corticosteroids (such as creams for eczema, asthma inhalers, tablets, injections, nasal sprays, eye or nose drops).

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You should contact your doctor as soon as possible if you become pregnant during treatment with Budesonida Aldo-Unión 64 micrograms.

Driving and use of machines

There are no indications that Budesonida Aldo-Unión 64 micrograms may affect your ability to drive or operate machinery.

Warning for athletes: Athletes are advised that this medicine contains a component that may result in a positive finding in doping control tests.

3. How to use Budesonida Aldo-Unión 64 micrograms

Follow exactly the instructions for use of this medicine provided in this leaflet or those given 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 leaflet. The dose should be individualized.

Your doctor will indicate the duration of treatment with Budesonida Aldo-Unión 64 micrograms; do not exceed the recommended treatment duration.

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

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

Adults and children aged 6 years and older: 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 Aldo-Unión 64 micrograms before the allergy season begins. Budesonida Aldo-Unión 64 micrograms does not provide immediate relief of symptoms. It may take several days of treatment with Budesonida Aldo-Unión 64 micrograms before you notice symptom relief (sometimes up to 2 weeks).

Budesonida Aldo-Unión 64 micrograms does not relieve ocular allergy symptoms. If you experience eye discomfort, your doctor may prescribe another medication to relieve these symptoms.

Treatment of nasal polyposis/prevention after polypectomy:

The usual 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.

Use in children

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

If you use more Budesonida Aldo-Unión 64 micrograms than you should:

A single administration of more than the recommended dose usually does not cause harmful effects. However, if this occurs over a long period of time (months), adverse effects may occur, and 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 at +34915620420, indicating the medicine and the amount ingested.

If you forget to use Budesonida Aldo-Unión 64 micrograms:

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

Instructions for correct administration of the preparation:

Read the following instructions carefully and follow them precisely.

Before using Budesonida Aldo-Unión 64 micrograms for the first time, shake the container and press the pump several times (5–10 times) until a uniform spray appears (see Figure 1).

If the spray is not used daily, the pump must be re-primed. In this case, a single spray into the air is sufficient.

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

Cleaning:

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

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

The nasal applicator is removed by gently pulling it upwards.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

? sudden signs of an 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 faint.

Other adverse effects include:

Common (may affect up to 1 in 10 patients):

? Infections of the nose, throat or sinuses.

? Nosebleeds (epistaxis) or nasal irritation.

? Pain in the mouth and/or throat.

? Ear infection.

? 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 above the kidneys).
• Nasal ulcers or perforation of the membrane separating the nasal passages (nasal septum).
• Voice changes.
• Bruising.
• Blurred vision.

Adverse effects for which frequency is unknown:

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

Other side effects in children

Reduced growth has been reported in children treated with nasal corticosteroids. In children, the following adverse 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 behavioural disorders such as hyperactivity, sleep disorders, nervousness, depression or aggression have been reported rarely (especially in children).

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 Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Budesonida Aldo-Unión 64 micrograms

This medicine does not require any special storage conditions.

Do not freeze.

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

Replace the protective cap after using Budesonida Aldo-Unión 64 micrograms.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your usual pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information.

Composition of Budesonida Aldo-Unión 64 micrograms:

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

Appearance of the product and contents of the pack:

Budesonida Aldo-Unión 64 micrograms is a white aqueous suspension supplied in a brown glass container containing 120 doses or 200 doses, equipped with a metering pump and a nasal adapter.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Laboratorio ALDO-UNIÓN, S.L.

Baronesa de Maldà, 73

08950 Esplugues de Llobregat

BARCELONA – SPAIN

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

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