Prospect: information for the patient

Atrovent Monodosis 250 micrograms/2 ml solution for inhalation by nebulizer

bromide of ipratropium

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Atrovent Monodosis belongs to a group of medicines called anticholinergic bronchodilators, which work by relaxing the muscles of the bronchi, thereby facilitating airflow and breathing.

Atrovent Monodosis 250 micrograms/2 ml inhalation solution for nebulizer is a medicine used in the treatment of reversible airway obstruction in children aged 6 to 12 years.

Atrovent Monodosis may be administered in combination with beta-adrenergics (other bronchodilator medicines, such as salbutamol) in the treatment of acute bronchospasm causing reversible airway obstruction, in cases where treatment with a beta-adrenergic medicine does not provide sufficient bronchial muscle dilation.

No use Atrovent Monodosis:

• If you are allergic (hypersensitive) to ipratropium bromide, to substances similar to ipratropium such as atropine or its derivatives, or to any of the other components included in section 6.
• In acute episodes of bronchospasm (difficulty breathing) where a rapid response is required.

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Atrovent Monodosis.

• If you are predisposed to narrow-angle glaucoma (increased eye pressure), have prostate hypertrophy (enlargement of the prostate) or urinary flow obstruction (difficulty urinating).

• Isolated cases of eye complications, such as mydriasis (pupil dilation), narrow-angle glaucoma (increased eye pressure), and eye pain have occurred when ipratropium bromide, alone or in combination with a beta-2 adrenergic agonist (medications that dilate the bronchial muscles, such as salbutamol), has penetrated the eyes due to improper application.

• Eye pain or discomfort, blurred vision, halos, or colored images in association with eye redness due to conjunctival congestion and corneal edema may be signs of increased eye pressure (narrow-angle glaucoma). If any combination of these symptoms appears, consult your doctor immediately to initiate treatment with a miotic eye drop (which causes pupil constriction and reduces eye pressure).

• Avoid allowing the product to come into contact with the eyes during nebulization, especially in patients who are predisposed to increased intraocular pressure, so a mouthpiece or nasal mask is recommended.

• Patients with cystic fibrosis (a disease that alters the secretions of mucous and sweat glands, affecting various organs) may be more prone to gastrointestinal motility disorders.

• In exceptional cases, immediate hypersensitivity reactions (rapid-onset allergic reactions) may occur after administration of Atrovent Monodosis, such as urticaria, angioedema (sudden skin or mucous membrane swelling), skin rash, bronchospasm (bronchial muscle contraction that hinders breathing), and oropharyngeal edema (swelling of the mouth and throat).

• As with other inhaled medications, Atrovent Monodosis may cause paradoxical bronchospasm, which can be life-threatening. If it occurs, treatment should be immediately discontinued and your doctor notified to substitute with an alternative treatment.

Other medications and Atrovent Monodosis

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The simultaneous administration of Atrovent Monodosis with other anticholinergic medications for a long period is not recommended.

Beta-adrenergics (e.g. salbutamol) and xanthine derivatives (e.g. theophylline) are other bronchodilators and may potentiate the bronchodilatory effect. Atrovent Monodosis may increase the anticholinergic effects of other medications.

Atrovent Monodosis can be administered with other medications commonly used in the treatment of reversible airway obstruction, including beta-adrenergics (e.g. salbutamol), methylxanthines (e.g. theophylline), steroids, and cromoglic acid, without the appearance of interactions that require dose adjustment.

The simultaneous administration of nebulized ipratropium bromide and beta-mimetics may increase the risk of acute glaucoma in patients with a history of narrow-angle glaucoma (increased intraocular pressure).

Solutions for inhalation of Atrovent Monodosis and cromoglic acid containing benzalkonium chloride as a preservative should not be administered simultaneously in the same nebulizer, due to the risk of precipitation.

Pregnancy, lactation, and fertility

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

Although the preparation is specifically indicated in pediatrics, the following precautions are specified for pregnancy and lactation.

Despite the fact that no risk has been demonstrated in preclinical studies, its safety during pregnancy has not been established. Therefore, the usual precautions for the use of medications during this period should be observed, especially during the first three months.

The passage of ipratropium bromide into breast milk is unknown. However, it is unlikely that it can be ingested by the infant in significant amounts, especially since the preparation is administered by inhalation. Nevertheless, it should be administered with caution to breastfeeding women.

Driving and operating machinery

No studies are available on the effects on the ability to drive and operate machinery. However, it is warned that adverse effects such as dizziness, eye focusing difficulties, pupil dilation, and blurred vision may occur during treatment with Atrovent. Therefore, caution is recommended when driving and operating machinery.

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.

Remember to use your medication.

Your doctor will determine the duration of treatment.

If you consider that the action of Atrovent Monodosis is too strong or too weak, inform your doctor or pharmacist.

Atrovent Monodosis solution can be inhaled (aspirated) using devices called ultrasonic, electric, or manual nebulizers (e.g. Bird, De Vilbiss, Pari), or with assisted breathing positive pressure intermittently. If oxygen supply is available at the wall, the solution should be administered with a flow of 6-8 liters per minute.

It is recommended that the particle size of the nebulized solution be between 1 and 10 microns, although approximately 50% of the total mass of the aerosol should be contained in particles less than 5 microns.

In case of need, the solution can be diluted in physiological serum.

Guidelines for the use of single-dose containers:

Single-dose containers should be used only for inhalation with suitable nebulizer devices and should not be administered orally.

Since single-dose containers do not contain preservatives, it is essential to use their contents immediately after opening the container, to avoid contamination. Partially used, opened, or damaged single-dose containers should be discarded.

The administration of Atrovent Monodosis solution should be adapted to the individual needs of each patient; patients should be under medical supervision during treatment.It is recommended not to exceed the recommended daily dose for both acute and maintenance treatment.The recommended doses are:

Children aged 6 to 12 years:

Maintenance treatment

1 single-dose container, 3-4 times a day.

Acute attacks

In cases where only a beta-adrenergic medication is used, it may not provide sufficient bronchial muscle dilation. In these cases, Atrovent Monodosis can be administered in association with an inhaled beta-adrenergic (e.g. salbutamol), whose dose will be established by the doctor. The dose of Atrovent Monodosis in this case is 1 single-dose container; repeated doses can be administered until the patient stabilizes.

Generally, the daily dose should not be exceeded during treatment. Daily doses of more than 1 mg (more than 4 single-dose containers) should be administered exclusively under medical supervision.

If treatment does not result in significant improvement or if the patient's condition worsens, it is necessary to consult the doctor to determine a new treatment. In case of acute dyspnea or rapidly worsening dyspnea (respiratory difficulties), the doctor should be consulted immediately.

If you use more Atrovent Monodosis than you should:

No specific manifestations of overdose have been described. Due to the wide therapeutic margin of Atrovent Monodosis and the inhalation administration of the preparation, it is not expected that serious anticholinergic symptoms will appear.

In case of mild anticholinergic symptoms such as dry mouth, visual accommodation disorders (eye focusing problems), and tachycardia (increased heart rate), the treatment to follow should be to alleviate the symptoms.

If you have used more Atrovent Monodosis than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Atrovent Monodosis

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The frequent adverse effects ( at least 1 in every 100 patients ) are headache (cephalgia), dizziness, cough, throat irritation, nausea, dry mouth, gastrointestinal motility disorders (e.g., change in bowel habit, gastroesophageal reflux, dyspepsia (indigestion)).

The infrequent adverse effects ( at least 1 in every 1,000 patients ) are hypersensitivity, anaphylactic reaction (severe allergic reaction), blurred vision, mydriasis (pupil dilation), increased intraocular pressure, halos or colored images associated with eye redness (glaucoma), eye pain, halos or blurred vision, eye redness, corneal edema (corneal swelling), palpitations, supraventricular tachycardia, constipation, diarrhea, vomiting, stomatitis (mouth inflammation), oral edema (swelling of the mouth), rash, pruritus (itching), angioedema (swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing) and urinary retention.

The rare adverse effects ( at least 1 in every 10,000 patients ) are bronchospasm (chest tightness, wheezing, or shortness of breath), paradoxical bronchospasm (narrowing of the bronchial walls due to the inhalation itself), laryngeal spasm, pharyngeal edema (throat swelling), dry throat, visual accommodation disorder (difficulty focusing the eye), urticaria, increased heart rate, and atrial fibrillation.

The very rare adverse effects (less than 1 in every 10,000 patients) are tremors, metallic or unpleasant taste, nasal congestion, insomnia, fatigue or weakness not typical, and hypotension.

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 of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Atrovent Monodosis

• The active ingredient is bromide of ipratropium. Each monodose vial of 2 ml contains 261 micrograms of bromide of ipratropium monohydrate (equivalent to 250 micrograms of anhydrous bromide of ipratropium).
• The other components are: sodium chloride, hydrochloric acid, and purified water.

Appearance of the product and contents of the packaging

Atrovent Monodosis 250 micrograms/2 ml is a solution for inhalation via nebulizer that is presented in boxes of 20 monodose vials with 2 ml of solution for inhalation via nebulizer and in a clinical vial with 100 monodose vials of 2 ml of nebulizer solution.

Holder of the marketing authorization

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

Responsible for manufacturing

Laboratoire Unither

Zone Industrialle de Longpré

10 rue Andre Durouchez

80084 AMIENS Cedex 2

France

This leaflet was approved in April 2019

The 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/.