Prospecto: information for the user

Budesonide Aldo-Union 64 micrograms nasal spray EFG

Budesonide

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 questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isBudesonide Aldo-Union 64 microgramsand for what it is used

2. What you need to know before starting to useBudesonide Aldo-Union 64 micrograms

3. How to useBudesonide Aldo-Union 64 micrograms

4. Possible adverse effects

5. Storage ofBudesonide Aldo-Union 64 micrograms

6. Contents of the package and additional information

Budesonida Aldo-Unión64 microgramos contains the active ingredient budesonida, which belongs to a group of medicines called glucocorticoids and is used to reduce inflammation of the nasal mucosa (the inner lining of the nose).

Budesonida Aldo-Unión 64 microgramos is used to treat the symptoms of seasonal allergic rhinitis (“hay fever”) as well as perennial (year-round) allergic and non-allergic rhinitis in adults and children 6 years of age or older.

Budesonida Aldo-Unión 64 microgramos may also be used in adults to treat the symptoms of nasal polyps and/or to prevent the formation of new nasal polyps after surgical removal.

No useBudesonida Aldo-Unión64 microgramos suspension for nasal inhalation EFG:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Budesonida Aldo-Unión64 microgramosif:

- You suffer fromsevere or frequent nasal bleeding.

- If you have recently suffered fromnasal ulcers, have undergone nasal surgery or have suffered anasal woundthat has not healed properly.

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

- You have ever suffered fromglaucoma(increased eye pressure) orcataracts.

- You have aneye infection.

- You havediabetes.

- You haveliver problems.

Consult your doctor or pharmacist if you suffer from any of the following conditions while using Budesonida Aldo-Unión64 microgramos:

-Blurred visionor othervisual disturbances

- Any sign ofinfection, such as persistent fever

If symptoms persist or worsen, or if new symptoms appear, stop using Budesonida Aldo-Unión64 microgramosand consult your doctor.

Children and adolescents

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

Use of Budesonida Aldo-Unión64 microgramoswith other medications:

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication. This includes medications purchased without a prescription and herbal remedies. Some medications may increase the effects of Budesonida Aldo-Unión64 microgramos. In particular, inform your doctor or pharmacist if you are taking the following medications:

?To treatfungus infections(such as itraconazole or ketoconazole).

?You are taking antibiotics (such as clarithromycin)

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

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

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

?You are taking anothermedication with corticosteroids(such as creams for eczema, inhalers for asthma, tablets, injections, nasal sprays, eye or nasal drops).

?You have recently stopped usingtablets with corticosteroidssuch asprednisolone 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 medication. You must contact your doctor as soon as possible if you become pregnant while taking Budesonida Aldo-Unión64 microgramos.

Driving and operating machinery

No indication is found that Budesonida Aldo-Unión64 microgramosmay affect your ability to drive or operate machinery.

Warning to athletes: It is reported to athletes that this medication 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 withBudesonida Aldo-Unión 64 micrograms64 micrograms; do not exceed the recommended treatment duration.

Do not share the inhaler 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 withBudesonida Aldo-Unión64 micrograms64 micrograms before the allergy period begins.Budesonida Aldo-Unión64 micrograms does not provide immediate relief from symptoms. It may take several days of treatment withBudesonida Aldo-Unión64 micrograms64 micrograms for you to notice relief from symptoms (sometimes up to 2 weeks).

Budesonida Aldo-Unión64 micrograms does not alleviate ocular allergy symptoms. If you notice eye discomfort, your doctor may prescribe another medication to alleviate these symptoms.

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 old.

If you use moreBudesonida Aldo-Unión64 micrograms than you should:

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 occur, 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 useBudesonida Aldo-Unión64 micrograms:

Do not take a double dose to compensate for the missed dose. 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 usingBudesonida Aldo-Unión64 micrograms64 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 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 inhaler, to keep the nasal applicator clean, it should be carefully cleaned with a clean tissue or cloth.

If the inhaler does not work, it is possible that the nasal applicator is blocked. Never try to unblock it or enlarge the orifice of the trigger with a pin or sharp object. This could make the inhaler 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 reaction 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 of fainting.

Other side effects include:

Frequent (may affect 1 in 10 patients):

Nasal, throat, or sinus infections.

Nasal bleeding (epistaxis) or nasal irritation.

Pain in the mouth and/or throat.

Ear 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.

Change in voice.

Haematomas.

Blurred vision.

Other side effects of unknown frequency include:

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

Glaucoma (increase in intraocular 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 occasions (especially in children) of mental or behavioral disorders, such as hyperactivity, sleep disorders, nervousness, depression, or aggression.

Reporting of 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 of Pharmacovigilance of Medicines 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 Budesonida Aldo-Union 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. Deposit the packaging and unused medications at your local SIGRE collection 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 Budesonida Aldo-Unión 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:

Budesonida Aldo-Unión 64 micrograms is a white aqueous suspension that is 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 Maldà, 73

08950 Esplugues de Llobregat

BARCELONA – SPAIN

Last review date of this leaflet:December 2024.

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/