Atrovent 20 micrograms inhalation solution in pressurized container

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Atrovent 20 micrograms inhalation solution in pressurized 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. Do 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 Atrovent is and what it is used for

2. What you need to know before using Atrovent

3. How to use Atrovent

4. Possible side effects

5. How to store Atrovent

6. Contents of the pack and other information

1. What Atrovent is and what it is used for

Atrovent 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 belongs to the group of medicines known as inhaled bronchodilators.

Atrovent is used for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). COPD is a lung disease characterized by obstruction of airflow through the bronchi, causing difficulty in breathing.

2. What you need to know before using Atrovent

Do not use Atrovent

• 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 ingredients of this medicine (listed in section 6).
• If you experience acute attacks of coughing, wheezing, and breathing difficulty (bronchospasm) that require rapid relief.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Atrovent:

• If you have cystic fibrosis (a disease affecting secretions of mucous and sweat glands, impacting several organs), 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 (swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing), skin rash, cough, wheezing, breathing difficulty (bronchospasm), swelling of the mouth and throat (oropharyngeal edema), or generalized allergic reaction (anaphylaxis).
• If you have benign prostatic hyperplasia (enlarged prostate) or bladder neck obstruction (when the urinary passage from the bladder is blocked).
• If you are predisposed to increased intraocular pressure (narrow-angle glaucoma).
• If the solution is accidentally sprayed into the eyes, eye complications may occur, such as pupil dilation, increased intraocular pressure (narrow-angle glaucoma), or eye pain. Therefore, you must strictly follow your doctor's instructions for administration. The risk of spray entering the eyes is limited, as inhalation is performed using a mouthpiece and is manually controlled.
• If you experience a combination of eye symptoms such as eye pain or discomfort, blurred vision, visual halos (diffuse lights), or colored images along with eye redness, these may be signs of narrow-angle glaucoma, and you should consult a doctor immediately.
• As with other inhaled medications, Atrovent may cause paradoxical bronchospasm, which can be life-threatening. If this occurs, treatment must be stopped immediately, and your doctor should be informed to switch to an alternative therapy.

Other medicines and Atrovent

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

Long-term simultaneous administration of Atrovent 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 bronchodilation. Atrovent may intensify the anticholinergic effects of other medicines.

Atrovent may be used together with other medicines commonly used in the treatment of chronic obstructive pulmonary disease (COPD), including beta-adrenergic agents, methylxanthines (e.g., theophylline), corticosteroids, and disodium cromoglycate, without harmful interactions.

Pregnancy, breastfeeding, and fertility

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 the medicine should be carefully weighed against the potential risk to the fetus, and standard precautions for medicine use during pregnancy should be observed.

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

Driving and using machines

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

Atrovent contains ethanol

This medicine contains approximately 8 mg of alcohol (ethanol) per spray.

The amount in each spray of this medicine 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 Atrovent

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

Remember to use your medicine.

Correct use of the inhalation solution is crucial for the success of treatment.

Before first use of each container, actuate the metering device 1 or 2 times after shaking it.

Before each application, follow these instructions:

(fig. 1)

1. Remove the protective cap.

   1. Perform a deep exhalation (expel air through the mouth).

2. Hold the inhaler with your hand as shown in figure 1 and firmly close your lips around the mouthpiece. The arrow and base of the container should point upwards.

3. Inhale (breathe in) as forcefully as possible and, at the same time, press firmly on the base of the container to release a spray of the inhalation solution. Hold your breath for a few seconds, then remove the mouthpiece and exhale slowly. If you are unable to inhale deeply due to breathing difficulty, you may facilitate breathing by spraying a dose of the solution into your mouth before inhaling the medication.

4. After use, replace the protective cap.

5. If the inhaler has not been used for a period of 3 days, actuate the valve once more.

Since the container is not transparent, it is impossible to see when it is empty.

The container provides 200 doses. When the number of doses indicated on the label has been used (usually after 3 weeks if used as recommended), the container may still appear to contain a small amount of liquid. Nevertheless, the inhaler should be replaced to ensure you receive the correct amount of medication with each inhalation.

Clean the mouthpiece at least once a week. It is important to keep the mouthpiece clean at all times to prevent medication buildup and blockage of the spray. To clean it, remove the protective cap and the container from the mouthpiece. Rinse by passing warm water through the mouthpiece until all visible traces of medication or dirt are removed (figure 2).

(fig. 2)

After cleaning, shake off excess water from the mouthpiece and allow it to air-dry without using any heating device. Once the mouthpiece is dry, reattach the container and the protective cap (figure 3).

(fig. 3)

WARNING: The plastic mouthpiece has been specially designed for use with Atrovent to ensure that the correct amount of medication is delivered each time. The mouthpiece must never be used with another pressurized inhalation solution, and Atrovent must not be used with any other mouthpiece than the one provided with the product.

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

Atrovent 20 micrograms inhalation solution in pressurized container is administered by inhalation.

Dosage (number of inhalations per day) should be adjusted according to individual patient needs. 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 indicate that additional treatment with another drug is required, the total daily dose should generally not exceed 12 inhalations (240 micrograms of anhydrous ipratropium bromide).

Consult your doctor if you do not achieve significant improvement or if your condition worsens, to determine whether a new treatment is needed. Also, consult your doctor immediately if you experience significant breathing difficulty or if breathing difficulty worsens rapidly.

In children, Atrovent should only be administered on a doctor's advice and always under adult supervision.

Your doctor will advise you on the duration of your treatment with Atrovent. Do not stop treatment prematurely, as only your doctor is qualified to give you precise instructions.

If you use more Atrovent than you should

Symptoms such as dry mouth, accommodation disorders (difficulty of the eye to focus), and tachycardia (increased heart rate) may occur.

If you have used more Atrovent than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount taken.

If you forget to use Atrovent

Do not use a double dose to make up for forgotten doses.

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 experiences them.

Frequent adverse effects (occurring in at least 1 in every 100 patients) with Atrovent administration are headache, dizziness, cough, throat irritation, nausea, dry mouth, and gastrointestinal motility disorders (e.g.: changes in bowel habits, gastroesophageal reflux, dyspepsia (indigestion)).

Uncommon adverse effects (occurring in at least 1 in 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 (corneal swelling), palpitations, supraventricular tachycardia, constipation, diarrhea, vomiting, stomatitis (inflammation of the mouth), oral edema (mouth swelling), 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 (occurring in 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 of the eye to focus), urticaria, increased heart rate, and atrial fibrillation.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect 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 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 Atrovent

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

The pressurized container must not be punctured or exposed to temperatures above 50 °C.

Do not use this medicine after the expiry date stated on the container and on the inhaler label following EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Atrovent

• The active substance is ipratropium bromide. Each spray contains 21 micrograms of ipratropium bromide monohydrate (equivalent to 20 micrograms of anhydrous ipratropium bromide).

• The other components are anhydrous citric acid, purified water, ethanol (15% w/w) and HFA 134a (1,1,1,2-tetrafluoroethane).

This medicinal product contains fluorinated greenhouse gases.

Each inhaler contains 12.33 g of HFA 134a, equivalent to 0.01763 tonnes of CO2 (global warming potential GWP = 1430).

Nature of the product and contents of the pack

Atrovent is a pressurized solution for inhalation, available in 10 ml solution containers (200 sprays) for oral inhalation.

Chlorofluorocarbon propellants may damage the ozone layer of the atmosphere. Atrovent does not contain such propellants and contains only the non-chlorofluorocarbon propellant HFA 134a, which does not contribute to ozone layer depletion.

Marketing Authorization Holder

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse, 173

55216 Ingelheim am Rhein

Germany

Date of the most recent review of this leaflet: January 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/.