Atroaldo 20 micrograms/puff solution for inhalation in pressurized container
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
ATROALDO 20 micrograms/dose inhalation solution in pressurised container
Ipratropium bromide
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 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
- What ATROALDO is and what it is used for
- What you need to know before using ATROALDO
- How to use ATROALDO
- Possible side effects
- How to store ATROALDO
- Contents of the pack and other information
1. What ATROALDO is and what it is used for
ATROALDO contains ipratropium bromide as the active substance and belongs to a group of medicines called inhaled bronchodilators.
It is used for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary diseases (COPD), including chronic bronchitis and emphysema.
2. What you need to know before using ATROALDO
Do not use ATROALDO if:
- You are allergic to atropine, its derivatives (for example, tiotropium), or to any of the other components of this medicine (listed in section 6).
- You are experiencing acute attacks of cough, wheezing, and breathing difficulty (bronchospasm) requiring rapid relief.
Warnings and precautions
Consult your doctor or pharmacist before starting to use this medicine:
- If you have cystic fibrosis, as you may be more prone to gastrointestinal motility disorders.
- If you experience acute breathing difficulty that worsens rapidly. You must consult your doctor immediately.
- Immediate allergic reactions may occur, such as hives, angioedema, skin rash, cough, wheezing, breathing difficulty (bronchospasm), swelling of the mouth and throat (oropharyngeal edema), or generalized allergic reaction (anaphylaxis).
- If you have prostatic hyperplasia or bladder neck obstruction.
- If you are predisposed to increased eye pressure (narrow-angle glaucoma).
- If the solution is accidentally sprayed into the eyes, ocular complications such as pupil dilation, increased intraocular pressure, narrow-angle glaucoma, or eye pain may occur. Therefore, it is essential to strictly follow your doctor's instructions for administration.
- If you experience a combination of eye symptoms such as eye pain or discomfort, blurred vision, halos around lights, or colored images, together with eye redness, these may be signs of narrow-angle glaucoma, and you should consult a doctor immediately.
Other medicines and ATROALDO
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Beta-adrenergic agents and xanthine derivatives may enhance the bronchodilating effect. ATROALDO may intensify the anticholinergic effects of other drugs.
This medicine may be used concomitantly with other drugs commonly used in the treatment of chronic obstructive pulmonary disease, including sympathomimetic bronchodilators, methylxanthines, steroids, and disodium cromoglycate, without occurrence of harmful interactions.
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.
The safety of this medicine during pregnancy has not been established. The benefit of using this medicine should be carefully weighed against the potential risk to the fetus, and usual precautions for drug use during pregnancy should be observed.
It is unknown whether this medicine is excreted in breast milk. However, it is unlikely that significant amounts of the medicine would be ingested by the infant, particularly because the preparation is administered by inhalation. Nevertheless, since many drugs are excreted in breast milk, caution should be exercised when administering this medicine to breastfeeding women.
Driving and using machines:
No harmful effects on driving have been reported.
ATROALDO contains ethanol
This medicine contains approximately 8.4 mg of alcohol (ethanol) per inhalation. The amount of alcohol per inhalation is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol contained in this medicine does not produce any noticeable effect.
3. How to use ATROALDO
Instructions for proper use:
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The dosage must be individually adjusted.
For adults and children over 6 years of age, the following dosage is recommended:
2 inhalations (equivalent to 40 micrograms of anhydrous ipratropium bromide), 4 times daily.
Since the need for increasingly higher doses may suggest that additional treatment with another drug is necessary, the total daily dose should generally not exceed 12 inhalations (240 micrograms of anhydrous ipratropium bromide).
You should consult your doctor whenever you do not achieve significant improvement or if your condition worsens, so that a new treatment plan can be determined. You should also contact your doctor immediately if you experience significant breathing difficulty or if breathing difficulty worsens rapidly.
In children, this medicine should only be administered on a doctor's advice and always under adult supervision.
Your doctor will advise you on how long you should continue treatment with this medicine. Do not stop treatment prematurely, as only your doctor is qualified to give you precise instructions.
Instructions for correct administration of the preparation:
This medicine is administered by inhalation. Proper handling of the inhalation solution is crucial for successful treatment.
Before each use, follow these steps:
- Remove the protective cap (fig. 1). If this is a new inhaler or has not been used for several days, shake the container (fig. 2) and release one spray to ensure proper functioning of the inhaler. If the inhaler is used regularly, proceed to the following instructions:
B Shake the inhaler.
C Empty your lungs of as much air as possible.
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Position the inhaler in your mouth as shown in the illustration (fig. 3).
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Take as deep a breath as possible.
While inhaling, press down on the canister as indicated by the arrows in the illustration (fig. 4).
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Remove the inhaler from your mouth and try to hold your breath for a few seconds, then exhale slowly.
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The plastic mouthpiece should be cleaned regularly. To do this, remove the canister from the inhaler and rinse it thoroughly with water.
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Store with the protective cap in place to protect it from dust and dirt.
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It is advisable to rinse your mouth with water after each inhalation.
If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
If you use more ATROALDO than you should
Symptoms such as dry mouth, visual accommodation disorders, and tachycardia may occur.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount ingested.
If you forget to take ATROALDO
Do not take a double dose to make up for missed doses.
If you have any further questions about using this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported:
Frequent (affects 1 in 10 people)
- Headache
- Dizziness
- Cough
- Pharyngitis
- Paradoxical bronchospasm (airway obstruction)
- Dry mouth
- Gastrointestinal motility disorders (e.g. constipation, diarrhoea, and vomiting)
Uncommon (affects less than 1 in 100 people)
- Urticaria (including giant urticaria), rash, and pruritus
- Visual accommodation disorders, narrow-angle glaucoma (increased intraocular pressure)
- Increased heart rate
Rare (affects less than 1 in 1,000 people)
- Anaphylactic reactions, swelling of the tongue, lips, and face (angioneurotic oedema)
- Increased intraocular pressure, eye pain, pupil dilation (mydriasis)
- Palpitations, supraventricular tachycardia, atrial fibrillation
- Laryngeal spasm
- Nausea
- Urinary retention
If you consider any of the 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, talk to 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 Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of ATROALDO.
Keep this medicine out of the sight and reach of children.
Store below 30 °C. Keep in the original packaging to protect from light. Do not freeze.
If the inhaler is very cold, remove the cartridge and warm it in the hand for a few minutes before use. Do not use any other method to warm it.
The container is under pressure. Do not pierce, break, or burn, even if it appears to be empty.
Do not use ATROALDO after the expiry date stated on the packaging after Exp.: The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your 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 container and other information
Composition of ATROALDO:
- The active substance is ipratropium bromide.
- The other components (excipients) are anhydrous citric acid, purified water, ethanol, and Norflurane (HFA-134a).
Each puff contains 21 micrograms of ipratropium bromide monohydrate (equivalent to 20 micrograms of anhydrous ipratropium bromide).
This medicinal product contains fluorinated greenhouse gases.
Each inhaler contains 11.85 g of Norflurane (HFA-134a), corresponding to 0.0169 tonnes of CO2 equivalent (global warming potential GWP = 1,430).
Nature of the product and contents of the container
ATROALDO is a clear, colourless solution supplied in a 10 ml container (200 doses) with a metering valve and an oral adapter.
The clinical pack is a carton containing 20 containers of 10 ml with 200 doses per container.
Marketing Authorization Holder and Manufacturer
Laboratorio Aldo-Unión, S.L.
Baronesa de Maldá, 73
08950 Esplugues de Llobregat (Barcelona)
Spain
Date of the most recent revision of this leaflet: September 2025
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/