Atrovent Monodosis 500 mcg/2 ml solution for inhalation by nebulizer

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Atrovent Monodose 500 micrograms/2 ml solution for inhalation by nebulizer

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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Atrovent Monodose is and what it is used for
2. What you need to know before using Atrovent Monodose
3. How to use Atrovent Monodose
4. Possible adverse effects
5. How to store Atrovent Monodose
6. Contents of the pack and other information

1. What Atrovent Monodosis is and what it is used for

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

Atrovent Monodosis 500 micrograms/2 ml solution for inhalation by nebulizer is a medicine used in the treatment of bronchospasm associated with chronic obstructive diseases in adults and children over 12 years of age.

Atrovent Monodosis may be administered together 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 alone does not provide sufficient bronchial muscle relaxation.

2. What you need to know before using Atrovent Monodosis

Do not 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 of Atrovent Monodosis.
• In acute episodes of bronchospasm (difficulty breathing) requiring a rapid response.

Warnings and precautions

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

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

• Isolated cases of eye complications, such as mydriasis (pupil dilation), narrow-angle glaucoma (increased internal eye pressure), and eye pain, have occurred when ipratropium bromide, alone or combined with a \β2-adrenergic agonist (a medicine that dilates bronchial muscles, such as salbutamol), has entered the eyes due to improper administration.

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

• Avoid contact of the product with the eyes during nebulization, especially in patients predisposed to increased intraocular pressure. Therefore, the use of a mouthpiece or a nasal mask is recommended.

• Patients with cystic fibrosis (a disease affecting secretions from mucous and sweat glands, impacting several organs) may be more prone to gastrointestinal motility disorders.

• In rare cases, immediate hypersensitivity reactions (rapid-onset allergic reactions) may occur after administration of Atrovent Monodosis, such as urticaria, angioedema (sudden swelling of the skin or mucous membranes), skin rash, bronchospasm (contraction of bronchial muscles causing breathing difficulty), 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 this occurs, treatment must be stopped immediately and your doctor informed to switch to an alternative therapy.

Other medicines and Atrovent Monodosis

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Concomitant long-term administration of Atrovent Monodosis with other anticholinergic drugs is not recommended.

Beta-adrenergic agents (e.g., salbutamol) and xanthine derivatives (e.g., theophylline) are other bronchodilator medicines and may enhance the bronchodilator effect. Atrovent Monodosis may increase the anticholinergic effects of other medicines.

Atrovent Monodosis may be administered together with other medicines commonly used in the treatment of reversible airway obstruction, including beta-adrenergic agents (e.g., salbutamol), methylxanthines (e.g., theophylline), steroids, and disodium cromoglycate, without interactions requiring dose adjustment.

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).

Inhalation solutions of Atrovent Monodosis and disodium cromoglycate containing benzalkonium chloride as a preservative must not be administered simultaneously in the same nebulizer due to the risk of precipitation.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

It is unknown whether ipratropium bromide passes into breast milk. However, it is unlikely that significant amounts would be ingested by the infant, particularly since the preparation is administered by inhalation. Nevertheless, caution is advised when administering this medicine to women who are breastfeeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines are available. However, it should be noted that adverse effects such as dizziness, difficulty focusing the eyes, pupil dilation, and blurred vision may occur during treatment with Atrovent. Therefore, caution is recommended when driving or operating machinery.

3. How to use Atrovent Monodosis

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Remember to use your medicine.

Your doctor will determine the duration of treatment.

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

The Atrovent Monodosis solution may be inhaled using devices called ultrasonic, electric, or manual nebulizers (e.g., Bird, De Vilbiss, Pari), or with intermittent positive pressure breathing assistance. If wall oxygen supply is available, the solution should be administered with a flow rate 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 total aerosol mass should consist of particles smaller than 5 microns.

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

Instructions for the use of single-dose containers

Single-dose containers must only be used for inhalation with appropriate nebulizing devices and must not be administered orally.

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

The administration of Atrovent Monodosis solution should be adjusted according to the individual needs of each patient; patients must remain under medical supervision during treatment. It is recommended not to exceed the recommended daily dose, either for acute treatment or for maintenance therapy. The recommended doses are:

Adults and children over 12 years of age

Maintenance treatment

1 single-dose container, 3-4 times daily.

Acute attacks

In cases where only a beta-adrenergic drug is used, it may not provide sufficient bronchial muscle dilation. In such cases, Atrovent Monodosis may be administered in combination with an inhaled beta-adrenergic agent (e.g., salbutamol), the dosage of which will be determined by the physician.

The dose of Atrovent Monodosis in this case is one single-dose container; repeated doses may be administered until the patient stabilizes.

Generally, the recommended daily dose should not be exceeded during treatment. Daily doses exceeding 2 mg (more than 4 single-dose containers) should be administered exclusively under medical supervision.

You should consult your doctor whenever you do not achieve significant improvement or if your condition worsens, so that a new treatment may be determined. In case of acute dyspnea or rapidly worsening dyspnea (difficulty breathing), you must consult your doctor immediately.

If you use more Atrovent Monodosis than you should

Specific manifestations of overdose have not been described. Due to the wide therapeutic margin of Atrovent Monodosis and the inhaled route of administration, serious anticholinergic symptoms are not expected to occur.

In the event of minor anticholinergic symptoms such as dry mouth, accommodation disorders (eye focusing problems), or tachycardia (increased heart rate), treatment should be symptomatic to relieve these effects.

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

If you forget to use Atrovent Monodosis

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Frequent adverse effects (occur in at least 1 out of every 100 patients) are headache (cephalalgia), dizziness, cough, throat irritation, nausea, dry mouth, gastrointestinal motility disorders (for example: change in bowel habits, gastroesophageal reflux, dyspepsia (indigestion)).

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

Rare adverse effects (occur in at least 1 out of 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 constriction, pharyngeal edema (throat swelling), dry throat, visual accommodation disorder (difficulty of the eye to focus), urticaria, increased heart rate, and atrial fibrillation.

Very rare adverse effects (occur in less than 1 out of every 10,000 patients) are tremors, metallic or unpleasant taste, nasal congestion, insomnia, unusual fatigue or weakness, and hypotension.

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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 Atrovent Monodose

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atrovent Monodose

• The active substance is ipratropium bromide. Each 2 ml single-dose container contains 522 micrograms of ipratropium bromide monohydrate (equivalent to 500 micrograms of anhydrous ipratropium bromide).
• The other components are: sodium chloride, hydrochloric acid and purified water.

Appearance of the medicinal product and contents of the pack

Atrovent Monodose 500 micrograms/2 ml is a solution for inhalation by nebulizer, supplied in packs of 20 single-dose containers containing 2 ml of solution for inhalation by nebulizer, and clinical pack containing 100 single-dose containers of 2 ml solution for inhalation by nebulizer.

Marketing Authorization Holder

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

Manufacturer

Laboratoire Unither

Zone Industrielle de Longpré

10 rue Andre Durouchez

80084 AMIENS Cedex 2

France

This leaflet was approved in April 2019

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/.