Leaflet: information for the user

ATROALDO 20 micrograms/actuation solution for inhalation in a pressurized container

bromide of ipratropium

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is ATROALDO and what it is used for

2. What you need to know before starting to use ATROALDO

3. How to use ATROALDO

4. Possible side effects

5. Storage of ATROALDO

6. Contents of the container and additional information

ATROALDOcontains bromide of ipratropium as its active ingredient and belongs to the group of medications known as inhalation bronchodilators.

It is used for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary diseases (COPD), including chronic bronchitis and emphysema.

No useATROALDOif:

• If you are allergic to atropine, its derivatives (for example tiotropium), or any of the other components of this medication (listed in section 6).
• If you experience acute asthma attacks, wheezing, and difficulty breathing (bronchospasm) that require immediate response.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication:

• If you have cystic fibrosis, as you may be more prone to gastrointestinal motility disorders.
• When experiencing acute difficulty breathing that worsens rapidly. You should consult your doctor immediately.
• May appear immediate allergic reactions, such as urticaria, angioedema, skin rash, cough, wheezing, and difficulty breathing (bronchospasm), swelling of the mouth and throat (oropharyngeal edema), and generalized allergic reaction (anaphylaxis).
• When suffering from benign prostatic hyperplasia or bladder neck obstruction.
• If you are predisposed to increased eye pressure (narrow-angle glaucoma).
• When you spray the solution in your eyes, complications such as pupil dilation, increased intraocular pressure, narrow-angle glaucoma, eye pain, so you must strictly follow your doctor's instructions for administration.
• When you experience a combination of eye symptoms such as eye pain or discomfort, blurred vision, halos, or colored images, along with eye redness, which may be signs of narrow-angle glaucoma, you should consult a doctor.

Other medications and ATROALDO

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Beta-adrenergics and xanthine derivatives may potentiate the bronchodilator effect of ATROALDO.ATROALDOmay enhance the anticholinergic effects of other medications.

This medicationcan be administered concurrently with other commonly used medications for the treatment of chronic obstructive pulmonary disease, including sympathomimetic bronchodilators, methylxanthines, steroids, and cromoglicic acid, without the appearance of harmful interactions.

Pregnancy and lactation:

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of this medication during pregnancy has not been established. The potential risk to the fetus should be carefully weighed against the benefits of using this medication, so the usual precautions for using medications during this period should be observed.

The excretion of this medication in breast milk is unknown. However, it is unlikely that this medication will be ingested by the infant in significant quantities, especially since the preparation is administered via inhalation. Nevertheless, due to the fact that many medications are excreted in breast milk, it should be administered with caution to women in the lactation period.

Driving and operating machinery:

No adverse effects on driving have been described.

ATROALDO contains ethanol

This medication contains approximately 8.4 mg of alcohol (ethanol) per inhalation.The amount of alcohol in this medication per inhalation is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol contained in this medication does not produce any perceptible effect.

Instructions for proper use:

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The dosage must be adjusted individually.

For adults and children over 6 years old, the following dosage is recommended:

2 inhalations (equivalent to 40 micrograms of anhydrous ipratropium bromide), 4 times a day.

Since the need for increasing doses suggests that additional treatment with another medication may be necessary, a total daily dose of 12 inhalations (240 micrograms of anhydrous ipratropium bromide) should not be exceeded.

You must consult your doctor whenever you do not experience significant improvement or when your condition worsens, in order to determine a new therapeutic program. You should also consult your doctor promptly in case of significant difficulty breathing or when breathing difficulty rapidly worsens.

This medication should only be administered to children under the indication of a doctor and always under the supervision of an adult.

Your doctor will indicate the duration of your treatment with this medication. Do not discontinue treatment prematurely, as your doctor is the only one who can provide you with precise instructions.

Instructions for correct administration of the preparation:

This medication is administered via inhalation. Proper handling of the inhalation solution is crucial for the success of the treatment.

Before each application, the following guidelines will be observed:

A.Remove the protective cover (fig. 1). If it is a new inhaler or has not been used for several days, shake the container (fig. 2) and perform a pulse to ensure proper functioning of the inhaler. If the inhaler is used regularly, proceed to the following instructions:

BShake the inhaler.

CExhale as much air as possible from your lungs.

D.Attach the inhaler to your mouth as indicated in the drawing (fig. 3).

E.Take a deep breath.

You must press, as indicated by the arrows in the drawing (fig. 4), the device while taking this breath.

F.Remove the inhaler from your mouth and try to retain the air in your lungs for a few seconds and then exhale slowly.

G.It is recommended to periodically clean the plastic mouthpiece. To do this, remove the actuator from the inhaler and rinse it with plenty of water.

H.Store with the protective cover in place to protect it from dust and dirt.

I.It is recommended to rinse your mouth with water after each inhalation.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you use more ATROALDO than you should:

You may experience symptoms such as dry mouth, visual accommodation disorders, and tachycardia.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forgot to take ATROALDO:

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medicationmay produce adverse effects, although not all people will experience them.

The following adverse effects have been reported:

Frequent(affect 1 in 10 people)

• Headache
• Dizziness
• Cough
• Pharyngitis
• Paradoxical bronchospasm (obstruction of the airways)
• Dry mouth
• Gastrointestinal motility disorders (e.g. constipation, diarrhea, and vomiting).

Infrequent(affect less than 1 in 100 people)

• Urticaria (including giant urticaria), rash, and pruritus
• Visual accommodation disturbances, narrow-angle glaucoma (increased intraocular pressure)
• Increased heart rate

Rare(affect less than 1 in 1000 people)

• Anaphylactic reactions, swelling of the tongue, lips, and face (angioneuritic edema)
• Increased intraocular pressure, eye pain, and pupillary dilation (mydriasis)
• Palpitations, supraventricular tachycardia, atrial fibrillation
• Laryngeal spasm
• Nausea
• Urinary retention

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reportingadverse effects, you can contribute to providing more information about the safety ofthis medication

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

Store below 30 °C. Store in the original packaging to protect it from light. Do not freeze.

If the inhaler is very cold, remove the cartridge and warm with the hand for a few minutes before using. Do not use any other method to warm it.

The container is under pressure. Do not pierce, break, or burn it even when it appears to be empty.

Do not use ATROALDOafter the expiration date that appears on the container after Cad.: The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGREpoint of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

Composition ofATROALDO:

• The active principle is bromide of ipratropium.
• The other components (excipients) are anhydrous citric acid, purified water, ethanol, and Norflurane.

Each inhalation contains 21 micrograms of bromide of ipratropium monohydrate (equivalent to 20 micrograms of anhydrous bromide of ipratropium).

Appearance of the product and contents of the packaging

ATROALDOis a transparent and colorless solution that is presented in a 10 ml (200 doses) container with a dosing valve and oral adapter.

The clinical packaging is a case containing 20 containers of 10 ml with 200 doses per container.

Holder of the marketing authorization and responsible for manufacturing

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat (Barcelona)

Spain

Last review date of this leaflet:July 2010.

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