Ipratropium bromide Aldo-Union 500 micrograms solution for inhalation by nebulizer

Patient Information Leaflet

Introduction

Patient Information Leaflet

IPRATROPIUM BROMIDE ALDO-UNION 500 micrograms solution for inhalation by nebulizer

(Ipratropium bromide)

Read the 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 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 may 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 IPRATROPIUM BROMIDE ALDO-UNION 500 micrograms is and what it is used for
2. What you need to know before using IPRATROPIUM BROMIDE ALDO-UNION 500 micrograms
3. How to use IPRATROPIUM BROMIDE ALDO-UNION 500 micrograms
4. Possible side effects
5. How to store IPRATROPIUM BROMIDE ALDO-UNION 500 micrograms
6. Contents of the pack and other information

1. What BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms is and what it is used for

BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms is a solution for inhalation by nebulizer.

It is a medicine used in the treatment of bronchospasm associated with chronic obstructive diseases in adults and children over 12 years of age.

BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms may be administered together with beta-adrenergic agents in the treatment of acute bronchospasm associated with reversible airway obstruction, in those cases where therapy with beta-adrenergic agents alone does not provide optimal bronchodilation.

2. What you need to know before using BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms

Do not use BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms:

• If you are allergic to ipratropium bromide or to any of the other ingredients of this medicine (listed in section 6).
• If you are experiencing acute episodes of bronchospasm requiring rapid relief.

Warnings and precautions

Consult your doctor or pharmacist before starting to use BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms.

If you are predisposed to narrow-angle glaucoma, have prostatic hypertrophy (enlarged prostate), or urinary flow obstruction (difficulty urinating).

Isolated cases of ocular complications (such as pupillary dilation, increased intraocular pressure, narrow-angle glaucoma, and eye pain) have occurred when ipratropium bromide has entered the eyes due to improper administration.

Eye pain or discomfort and blurred vision associated with eye redness due to conjunctival congestion and corneal edema may be signs of acute closed-angle glaucoma. If any combination of these symptoms occurs, treatment with a miotic eye drop should be initiated and you should consult your doctor immediately.

Nebulization of the product onto the eyes should be avoided; therefore, the use of a mouthpiece or a nasal mask is recommended.

Patients with cystic fibrosis may be more prone to gastrointestinal motility disorders.

Rarely, immediate hypersensitivity reactions (allergy) may occur after administration of BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms, such as urticaria, angioedema (hives or welts), skin rash, bronchospasm (bronchial constriction), and oropharyngeal edema (swelling of the mouth and throat).

Using BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms with other medicines

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

Beta-adrenergic agents and xanthine derivatives may enhance the bronchodilator effect. BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms may intensify the anticholinergic effects of other drugs.

BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms may be administered together with other drugs commonly used in the treatment of reversible airway obstruction, including sympathomimetic bronchodilators, methylxanthines, steroids, and disodium cromoglycate, without interactions requiring dose adjustment.

Inhalation solutions of BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms and disodium cromoglycate containing benzalkonium chloride as a preservative should not be administered simultaneously in the same nebulizer due to the risk of precipitation.

Pregnancy and breastfeeding

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.

Pregnancy

Although preclinical studies have not shown any risk, the safety of this medicine during pregnancy has not been established. Therefore, usual precautions for using medicines during pregnancy should be observed, especially during the first three months.

Breastfeeding

It is unknown whether BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms is excreted in breast milk. However, it is unlikely that the infant would ingest significant amounts of BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms, particularly since the preparation is administered by inhalation. Nevertheless, because many drugs are excreted in breast milk, caution should be exercised when administering this medicine to nursing women.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

3. How to use BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms

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

The BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms solution may be inhaled using appropriate nebulizing devices of ultrasonic, electric, manual (e.g. Bird, De Vilbiss, Pari) type, or with intermittent positive-pressure assisted ventilation. If wall oxygen supply is available, the solution should be administered with an airflow of 6–8 liters per minute.

It is recommended that the particle size of the nebulized solution range between 1 and 10 microns, although approximately 50% of the aerosol mass should consist of particles smaller than 5 microns.

If necessary, the solution may be diluted with physiological saline.

Instructions for correct administration of the preparation

Read this leaflet carefully before starting to use the medicine.

BROMURO DE IPRATROPIO ALDO-UNIÓN 500 micrograms should be used with a nebulizer fitted with a face mask or a mouthpiece. Your doctor will advise you on the appropriate nebulizer and how to use it. In cases where the solution is administered using an intermittent positive-pressure ventilation device, treatment will be initiated by a specialist. If dilution of the ampoule is required to obtain a final volume suitable for the nebulizer, this must only be performed using a sterile 0.9% sodium chloride solution.

Since each BROMURO DE IPRATROPIO ALDO-UNIÓN 500 micrograms ampoule is a single dose, any remaining solution in the ampoule must be discarded after each treatment.

Ipratropium bromide may be combined with beta-agonists in the same nebulization chamber for simultaneous administration when required.

This medicine is for inhalation via a nebulizer or ventilator and must not be injected or swallowed.

1. Prepare your nebulizer according to the instructions provided by your doctor. Ensure it is clean. Remove a plastic strip containing ampoules from the box, open it, and take out one ampoule. Leave the remaining ampoules in the strip and return the strip to the box.
2. Take the ampoule and open it by twisting the top part.
3. Unless otherwise directed by your doctor, add the entire contents of the plastic ampoule to the nebulizer solution container. If your doctor has instructed you to dilute the solution, this must only be done using a sterile 0.9% sodium chloride solution. Use the amount specified by your doctor.
4. Use the nebulizer according to your doctor's instructions. Remember to ensure the mask is securely fitted and that the nebulization is not directed toward your eyes.
5. After using the nebulizer, clean it according to your doctor's instructions. Discard the empty plastic ampoule.

Since the single-dose containers do not contain preservatives, it is important that their contents be used immediately after opening the ampoule to avoid microbial contamination. Partially used, open, or damaged single-dose containers must be discarded.

Administration of BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms solution should be adjusted according to the individual needs of each patient; patients must remain under medical supervision during treatment. The usual dosage is:

Adults and children over 12 years of age

• Maintenance treatment

1 single-dose ampoule, 3–4 times daily.

• Acute attacks

In cases where monotherapy with beta-adrenergic agents does not provide optimal bronchodilation, BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms may be administered in combination with an inhaled beta-adrenergic agent, the dosage of which will be determined by the physician. The dose of BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms in this case is one single-dose container; repeated doses may be administered until the patient is stabilized.

Generally, the recommended daily dose should not be exceeded. Daily doses exceeding 2 mg must be administered exclusively under medical supervision.

If no significant improvement is achieved with treatment, or if the patient's condition worsens, medical advice must be sought to determine a new therapeutic regimen. In cases of acute dyspnea or rapidly worsening dyspnea (difficulty breathing), consult your doctor immediately.

Your doctor will determine the duration of your treatment with BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms. Do not discontinue treatment prematurely, as the desired effect may not be achieved.

If you use more BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms than you should

Specific symptoms of overdose have not been reported. Due to the wide therapeutic margin of BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms and the inhaled route of administration, serious anticholinergic symptoms are not expected.

If minor systemic anticholinergic effects occur, such as dry mouth, visual accommodation disturbances, or tachycardia (increased heart rate), treatment should be symptomatic.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms

Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms may produce adverse effects, although not everyone experiences them.

The adverse effects observed have been classified by organ systems and by frequency using the following convention:

Very common (affects more than 1 in 10 people); common (affects less than 1 in 10 people but more than 1 in 100 people); uncommon (affects less than 1 in 100 people but more than 1 in 1,000 people); rare (affects less than 1 in 1,000 people but more than 1 in 10,000 people); very rare (affects less than 1 in 10,000 people).

• Immune system disorders:

Uncommon: Urticaria (including giant urticaria).

Rare: Anaphylactic (allergic) reaction; angioedema (swelling) of the tongue, lips, and face.

• Nervous system disorders:

Common: Headache and dizziness.

• Eye disorders:

Uncommon: Visual accommodation difficulties, other ocular side effects such as narrow-angle glaucoma.

Rare: Ocular side effects such as increased intraocular pressure, eye pain, and mydriasis (pupil dilation).

• Cardiac disorders:

Uncommon: Increased heart rate.

Rare: Palpitations, supraventricular tachycardia (accelerated heart rate), atrial fibrillation.

• Respiratory, thoracic and mediastinal disorders:

Common: Cough, local irritation, inhalation-induced bronchospasm.

Rare: Laryngeal spasm.

• Gastrointestinal disorders:

Common: Dry mouth, gastrointestinal motility disorders (e.g.: constipation, diarrhea, vomiting).

Rare: Nausea.

• Skin and subcutaneous tissue disorders:

Uncommon: Skin rash and pruritus (itching).

• Renal and urinary disorders:

Rare: Urinary retention.

Additionally, in rare cases, the following have also been observed: tremors, metallic or unpleasant taste, nasal congestion, insomnia, unusual tiredness or weakness, and hypotension (low blood pressure).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned 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 IPRATROPIUM BROMIDE ALDO-UNION 500 micrograms

Keep out of the sight and reach of children.

Store below 30°C. Keep in the original container to protect from light.

Do not use this medicine after the expiry date stated on the packaging. 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 unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of BROMURO DE IPRATROPIO ALDO-UNION 500 micrograms

• The active substance is anhydrous ipratropium bromide 500 micrograms (equivalent to 522 micrograms of ipratropium bromide monohydrate).

• The other components are: sodium chloride, concentrated hydrochloric acid, and water for injections.

Appearance of the product and contents of the pack

Each pack contains two sachets of 10 single-dose ampoules with 2 ml of solution for inhalation by nebulizer.

Hospital Pack: 100 single-dose ampoules with 2 ml of solution for inhalation by nebulizer.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATORIO ALDO UNION, S.L.

Baronesa de Maldá, 73 08950 Esplugues de Llobregat (Barcelona)

Spain

Manufacturer

LABORATOIRE UNITHER

Espace Industriel Nord

151 rue André Durouchez-CS 28028

80084 AMIENS Cedex 2

Date of the most recent revision of this leaflet: March-2026

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